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Hasso Plattner Institute 20

BACKGROUND The benefit of zinc as an adjunct therapy for severe pneumonia is not established. We assessed the benefit of adjunct zinc therapy for severe pneumonia in children and determined whether the study children were zinc deficient. METHODS This was a randomized, parallel group, double-blind, placebo-controlled trial with an allocation ratio of 1:1 conducted in children with severe pneumonia to evaluate the efficacy of daily zinc as an adjunct treatment in preventing 'treatment failure' (presence of any sign of severe pneumonia) on day-5 and day-10 and in reducing the time to resolution of signs of severe pneumonia. Six hundred and four children 2-59 months of age presenting with severe pneumonia at six urban and rural health care facilities in The Gambia were individually randomised to receive placebo (n = 301) or zinc (n = 303) for seven days. To determine if the study children were zinc deficient, supplementation was continued in a randomly selected subgroup of 121 children from each arm for six months post-enrolment, and height-gain, nutritional status, plasma zinc concentrations, and immune competence were compared. RESULTS Percentage of treatment failure were similar in placebo and zinc arms both on day 5 (14.0% vs 14.1%) and day 10 (5.2% vs 5.9%). The time to recovery from lower chest wall indrawing and sternal retraction was longer in the placebo compared to zinc arm (24.4 vs 23.0 hours; P  = 0.011 and 18.7 vs 11.0 hours; P  = 0.006 respectively). The time to resolution for all respiratory symptoms of severity was not significantly different between placebo and zinc arms (42.3 vs 30.9 hours respectively; P  = 0.242). In the six months follow-up sub-group, there was no significant difference in height gain, height-for-age and weight-for-height Z-scores, mid upper arm circumference, plasma zinc concentrations, and anergy at six months post-enrolment. CONCLUSIONS In this population, zinc given as an adjunct treatment for severe pneumonia showed no benefit in treatment failure rates, or clinically important benefit in time to recovery from respiratory symptoms and showed marginal benefit in rapidity of resolution of some signs of severity. This finding does not support routine use of zinc as an adjunct treatment in severe pneumonia in generally zinc replete children. TRIAL REGISTRATION ISRCTN33548493.

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BACKGROUND The data of MARCH (Metformin and AcaRbose in Chinese as the initial Hypoglycaemic treatment) trial demonstrated that acarbose and metformin have similar efficacy as initial therapy for hemoglobin A1c (HbA1c) reduction in Chinese patients with newly diagnosed type 2 diabetes. We investigated whether the therapeutic efficacy was diversified under different body mass index (BMI) status. METHODS All 784 subjects were divided into normal-weight group (BMI<24 kg/m2), overweight group (BMI 24-28 kg/m2) and obese group (BMI≥28 kg/m2). Patients were assigned to 48 weeks of therapy with acarbose or metformin, respectively. The clinical trial registry number was ChiCTR-TRC-08000231. RESULTS The reduction of HbA1c levels and the proportion of patients with HbA1c of 6.5% or less were similar in the three groups after acarbose and metformin treatment. In overweight group, fasting blood glucose (FBG) after metformin treatment showed greater decline compared to acarbose group at 48 weeks [-1.73 (-1.99 to -1.46) vs. -1.37 (-1.61 to -1.12), P<0.05), however the decrease of 2 h post-challenge blood glucose (PBG) after acarbose treatment at 48 weeks was bigger compared to metformin group [-3.34 (-3.83 to-2.84) vs. -2.35 (-2.85 to -1.85), P<0.01]. Both acarbose and metformin treatment resulted in a significant decrease in waist circumference, hip circumference, weight and BMI in the three groups (all P<0.05). CONCLUSION Acarbose and metformin decreased HbA1c levels similarly regardless of BMI status of Chinese type 2 diabetic patients. Acarbose and metformin resulted in a significant and modest improvement of anthropometric parametres in different BMI status. Thus, acarbose treatment may contribute a similar effect on plasma glucose control compared to metformin, even in obesity patients. TRIAL REGISTRATION ChiCTR.org ChiCTR-TRC-08000231.

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BACKGROUND Laryngeal mask airway (LMA) insertion requires an optimal balance of anesthesia. Propofol with different opioids is a preferred combination. Two doses of fentanyl were compared for the efficacy and side effects. MATERIALS AND METHODS 96 patients were randomly distributed into F(1) (fentanyl 1 mcg/kg) and F(2) (fentanyl 2 mcg/kg) groups. The conditions for LMA insertion, hemodynamic profile, bronchoscopic view, and incidence of sore throat were compared. RESULT There was no statistically significant difference in any parameter in the two groups except for a significant fall in systolic and mean arterial pressure in F(2) group. CONCLUSION Both doses of fentanyl (1 and 2 mcg/kg) provide comparable insertion conditions for LMA. Fentanyl in the lower dose provides a more stable hemodynamic profile.

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BACKGROUND Extending contact with participants after the end of an initial intervention is associated with successful maintenance of weight loss and behavior change. However, cost-effective methods of extending intervention contact are needed. OBJECTIVE This study investigated whether extended contact via text message was efficacious in supporting long-term weight loss and physical activity and dietary behavior change in breast cancer survivors. METHODS Following the end of an initial 6-month randomized controlled trial of a telephone-delivered weight loss intervention versus usual care, eligible and consenting intervention participants received a 6-month extended contact intervention via tailored text messages targeting a range of factors proposed to influence the maintenance of behavior change. In this single-group, pre-post designed study, within group changes in weight, moderate-to-vigorous physical activity (Actigraph GT3X+ accelerometers), and total energy intake (2x24 hour dietary recalls) were evaluated from baseline to end of initial intervention (6 months), end of extended contact intervention (12 months), and after a no-contact follow-up (18 months) via linear mixed models. Feasibility of implementation was assessed through systematic tracking of text message delivery process outcomes, and participant satisfaction was assessed through semistructured interviews. RESULTS Participants at baseline (n=29) had a mean age of 54.9 years (SD 8.8), body mass index of 30.0 kg/m(2) (SD 4.2), and were recruited a mean 16.6 months (SD 3.2) post diagnosis. From baseline to 18 months, participants showed statistically significantly lower mean weight (-4.2 kg [95% CI -6.0 to -2.4]; P<.001) and higher physical activity (mean 10.4 mins/day [95% CI 3.6-17.2]; P=.003), but no significant differences in energy intake (P=.200). Participants received a mean of 8 text messages every 2 weeks (range 2-11) and reported a high rate of satisfaction. CONCLUSIONS In comparison to interventions without extended contact, results suggest text message-delivered extended contact may support the attenuation of weight regain and promote the maintenance of physical activity.

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BACKGROUND Total hip arthroplasty (THA) is a common procedure associated with moderate postoperative pain. No nerve block without loss of motor function has been documented for THA. We hypothesised that an ultrasound-guided lateral femoral cutaneous nerve (LFCN) block added to a multimodal postoperative pain regimen would reduce postoperative pain after THA. METHODS One hundred patients who had a THA by the posterior approach were evaluated in this randomised, placebo-controlled, blinded, parallel-group trial comparing an ultrasound-guided LFCN-block with either 8 ml of ropivacaine, 7.5 mg/ml, (Group Ropivacaine) or 8 ml of saline (Group Placebo) given postoperatively. Surgery was performed under spinal anaesthesia. The primary outcome was pain (measured on a Visual Analogue Scale (VAS)) 4 h post-blockade during 30° flexion of the hip. Secondary outcomes were pain at rest, pain during movement, oxycodone consumption (0-24 h), time to mobilisation, ability to mobilise, and length of stay. Patients, assessors and all staff involved with patient care were blinded to the intervention. RESULTS There was no difference in primary outcome between Group Ropivacaine and Group Placebo (VAS 27 mm vs. 31 mm, p = 0.41; difference -5 mm (95% CI: -15 mm - +5 mm). No differences in any of the secondary outcomes were observed. No adverse events, or harms, were observed during the trial. CONCLUSION Pain scores, opioid use, time to mobilisation, and length of stay were low in both Group Ropivacaine and Group Placebo. We found no added analgesic effect of a LFCN-block when combined with paracetamol and ibuprofen after THA by the posterior approach. TRIAL REGISTRATION EudraCT: 2013-004501-12 (December 16th 2013).

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BACKGROUND More than 30% of patients with pleural infection either die or require surgery. Drainage of infected fluid is the key to successful treatment, but intrapleural fibrinolytic therapy did not improve outcomes in an earlier, large, randomized trial therapy (Multicenter Intrapleural Sepsis Trial [MIST1]). METHODS Objective: To evaluate the efficacy and safety of intrapleural DNase alone, alteplase alone, or the combination of both, to improve pleural drainage. Design: Multicenter, double-blind, double-dummy, 2 × 2 factorial randomized trial. Setting: Eleven centers in the United Kingdom (UK). Subjects: Adult patients (mean age 59 years, 72% men), who had clinical evidence of infection, and pleural fluid that had macroscopic purulence, a positive culture or Gram stain for bacteria, or a pH < 7.2. Intervention: Patients were assigned to 1 of the 4 study interventions for 3 days: double placebo, intrapleural tissue plasminogen activator (t-PA) and DNase, t-PA and placebo, or DNase and placebo. Outcomes: The primary outcome was the change in pleural opacity, measured as the percentage of the hemithorax occupied by effusion, on chest radiography on day 7 as compared with day 1. Secondary outcomes included referral for surgery, duration of hospital stay, and adverse events. RESULTS The mean (± SD) change in pleural opacity was greater in the t-PA-DNase group than in the placebo group (-29.5 ± 23.3% vs. -17.2 ± 19.6%; difference, -7.9%; 95% confidence interval [CI], -13.4 to -2.4; P = 0.005). The change observed with t-PA alone and with DNase alone (-17.2 ± 24.3 and -14.7 ± 16.4%, respectively) was not significantly different from that observed with placebo. The frequency of surgical referral at 3 months was lower in the t-PA-DNase group than in the placebo group (2 of 48 patients [4%] vs. 8 of 51 patients [16%]; odds ratio for surgical referral, 0.17; 95% CI, 0.03 to 0.87; P = 0.03) but was greater in the DNase group (18 of 46 patients [39%]) than in the placebo group (odds ratio, 3.56; 95% CI, 1.30 to 9.75; P = 0.01). Combined t-PA-DNase therapy was associated with a reduction in the hospital stay, as compared with placebo (difference, -6.7 days; 95% CI, -12.0 to -1.9; P = 0.006). Hospital stay with either agent alone was not significantly different from that with placebo. The frequency of adverse events did not differ significantly among the groups. CONCLUSIONS Intrapleural t-PA-DNase therapy improved fluid drainage in patients with pleural infection and reduced the frequency of surgical referral and the duration of hospital stay. Treatment with DNase alone or t-PA alone was ineffective.

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BACKGROUND In non-dialysis chronic kidney disease (CKD) patients with dyslipidemia, statin therapy is recommended to prevent cardiovascular complications. Dyslipidemia has been also shown to be an independent risk factor for the progression of CKD. However, it is still unclear whether statin therapy exerts an inhibitory effect on renal deterioration in CKD patients with dyslipidemia. The purpose of the present study was to examine possible therapeutic effects of statin add-on therapy on renal function as well as parameters of lipid and glucose metabolism, arterial stiffness and oxidative stress, in comparison to diet therapy, in CKD patients with dyslipidemia. METHODS This study was a randomized, open-label, and parallel-group trial consisted of a 12-months treatment period in non-dialysis CKD patients with alubuminuria and dyslipidemia. Twenty eight patients were randomly assigned either to receive diet counseling alone (diet therapy group) or diet counseling plus pitavastatin (diet-plus-statin therapy group), to achieve the LDL-cholesterol (LDL-C) target of <100 mg/dl. RESULTS The statin treatment by pitavastatin was well tolerated in all of the patients without any significant adverse events and the average dose of pitavastatin was 1.0 ± 0.0 mg daily after treatment. After the 12-months treatment period, LDL-C was significantly lower in the diet-plus-statin therapy group compared with the diet therapy group (diet vs diet-plus-statin: LDL-C, 126 ± 5 vs 83 ± 4 mg/dL, P < 0.001). On the other hand, the diet-plus-statin therapy did not significantly reduce albuminuria or delay the decline in eGFR compared with the diet therapy, and there was no relationship between the change in LDL-C and the change in eGFR or albuminuria. However, diet therapy as well as diet-plus-statin therapy exerted similar lowering effects on the pentosidine levels (diet therapy group, baseline vs 12 months: 40 ± 4 vs 24 ± 3 ng/mL, P = 0.001; diet-plus-statin therapy, 46 ± 7 vs 34 ± 6 ng/mL, P = 0.008). Furthermore, the results of multivariate regression analysis indicated that the change in pentosidine was a significant contributor to the change in eGFR (β = -0.536, P = 0.011). CONCLUSIONS Although statin add-on therapy did not show additive renal protective effects, the diet therapy as well as the diet-plus-statin therapy could contribute to the reduction in plasma pentosidine in CKD patients with albuminuria and dyslipidemia.

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BACKGROUND No prior studies have examined injection pain associated with Technetium-99m Tilmanocept (TcTM). METHODS This was a randomized, double-blinded study comparing postinjection site pain between filtered Technetium Sulfur Colloid (fTcSC) and TcTM in breast cancer lymphoscintigraphy. Pain was evaluated with a visual analogue scale (VAS) (0-100 mm) and the short-form McGill Pain Questionnaire (SF-MPQ). The primary endpoint was mean difference in VAS scores at 1-min postinjection between fTcSC and TcTM. Secondary endpoints included a comparison of SF-MPQ scores between the groups at 5 min postinjection and construction of a linear mixed effects model to evaluate the changes in pain during the 5-min postinjection period. RESULTS Fifty-two patients underwent injection (27-fTcSC, 25-TcTM). At 1-min postinjection, patients who received fTcSC experienced a mean change in pain of 16.8 mm (standard deviation (SD) 19.5) compared with 0.2 mm (SD 7.3) in TcTM (p = 0.0002). At 5 min postinjection, the mean total score on the SF-MPQ was 2.8 (SD 3.0) for fTcSC versus 2.1 (SD 2.5) for TcTM (p = 0.36). In the mixed effects model, injection agent (p < 0.001), time (p < 0.001) and their interaction (p < 0.001) were associated with change in pain during the 5-min postinjection period. The model found fTcSC resulted in significantly more pain of 15.2 mm (p < 0.001), 11.3 mm (p = 0.001), and 7.5 mm (p = 0.013) at 1, 2, and 3 min postinjection, respectively. CONCLUSIONS Injection with fTcSC causes significantly more pain during the first 3 min postinjection compared with TcTM in women undergoing lymphoscintigraphy for breast cancer.

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BACKGROUND Previously alternate nostril yoga breathing (anuloma-viloma pranayama) was shown to reduce the blood pressure (BP) in people with hypertension. An elevated BP has been associated with poor performance in certain tasks requiring attention and co-ordination. The Purdue pegboard task assesses manual dexterity and eye-hand co-ordination. MATERIAL/METHODS In the present study there were ninety participants with essential hypertension. Their ages ranged from 20 to 59 years (group average age ±S.D., 49.7±9.5 years; sixty males). Participants were randomized as three groups, with thirty participants in each group. One group practiced alternate nostril yoga breathing for 10 minutes, the second group practiced breath awareness for the same duration and the third group was given a control intervention (i.e., reading a magazine with neutral content). Assessments were taken before and after the interventions for participants of the three groups. Assessments included the blood pressure and performance in the Purdue pegboard task. Data were analyzed with a repeated measures ANOVA and post-hoc analyses were Bonferroni adjusted. RESULTS Following alternate nostril breathing (ANYB) there was a significant decrease in systolic and diastolic blood pressure (p<0.001 and p<0.05), and an improvement in Purdue pegboard task scores for both hands (p<0.05), and for the right hand (p<.001). Breath awareness (the control session) also showed a significant decrease in systolic blood pressure (p<0.05). The right hand scores improved in the group reading a magazine (p<0.05). CONCLUSIONS The results suggest that the immediate effect of ANYB is to reduce the BP while improving the performing in a task requiring attention, bimanual dexterity and visuo-motor co-ordination.

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BACKGROUND Internet sites typically contain visual design elements that are unrelated to the quality of the health information presented but that could influence credibility judgments and responses to health advice. To assess the effects of such design elements, or credibility cues, experimentally, we exposed women with different levels of weekly alcohol consumption to a website containing high quality but unpalatable information about a related health risk (breast cancer). The information was presented alongside either positive or negative credibility cues unrelated to information content. OBJECTIVES We explored four research questions: (1) Did the cues influence how the women engaged with the site? (2) Did they influence how the women responded cognitively and emotionally? (3) Did they influence whether the women subsequently acted on the advice? (4) Did the impact of the cues vary with how much alcohol the women reported drinking? METHOD A total of 85 women were randomly assigned to view one of two versions of a website containing the same high-quality content but different cues. One version had positive credibility cues (trustmarks), the other had negative ones (adverts, pharmaceutical sponsorship, and a donation button). Objective measures included visual attention (using eye-tracking equipment), time studying the material, and recall. Subjective measures included cognitive and affective responses and intention to change. Measures of subsequent behavior were taken 1 week later. RESULTS First, the cues did not affect how long the women spent on the site or how long they spent reading the text. However, women in the negative cues condition spent more time looking at a donation button than those in the positive cues condition spent looking at a TRUSTe seal (beta = -.43, P < .001) but less time looking at a logo (beta = .43, P < .001) or at certain other features of the site. Those in the negative cues condition also recalled more site content (beta = -.22, P = .048). Second, there were no effects of the cues on any of the measures of cognition, affect, vulnerability, or intentions. However, third, at follow-up, the positive cues had promoted greater alcohol reduction than the negative cues among those women who had previously reported drinking more heavily (beta = -.22, P = .02). So, fourth, the responses to the cues did vary with how much alcohol the women typically drank. CONCLUSIONS Content-irrelevant images and logos can influence the behavioral response to quality health-risk information. These effects may be subtle, changing with time.

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AIM To compare vonoprazan 10 and 20 mg vs lansoprazole 15 mg as maintenance therapy in healed erosive esophagitis (EE). METHODS A total of 607 patients aged ≥ 20 years, with endoscopically-confirmed healed EE following 8 wk of treatment with vonoprazan 20 mg once daily, were randomized 1:1:1 to receive lansoprazole 15 mg ( n = 201), vonoprazan 10 mg ( n = 202), or vonoprazan 20 mg ( n = 204), once daily. The primary endpoint of the study was the rate of endoscopically-confirmed EE recurrence during a 24-wk maintenance period. The secondary endpoint was the EE recurrence rate at Week 12 during maintenance treatment. Additional efficacy endpoints included the incidence of heartburn and acid reflux, and the EE healing rate 4 wk after the initiation of maintenance treatment. Safety endpoints comprised adverse events (AEs), vital signs, electrocardiogram findings, clinical laboratory results, serum gastrin and pepsinogen I/II levels, and gastric mucosa histopathology results. RESULTS Rates of EE recurrence during the 24-wk maintenance period were 16.8%, 5.1%, and 2.0% with lansoprazole 15 mg, vonoprazan 10 mg, and vonoprazan 20 mg, respectively. Vonoprazan was shown to be non-inferior to lansoprazole 15 mg ( P < 0.0001 for both doses). In a post-hoc analysis, EE recurrence at Week 24 was significantly reduced with vonoprazan at both the 10 mg and the 20 mg dose vs lansoprazole 15 mg (5.1% vs 16.8%, P = 0.0002, and 2.0% vs 16.8%, P < 0.0001, respectively); by contrast, the EE recurrence rate did not differ significantly between the two doses of vonoprazan ( P = 0.1090). The safety profiles of vonoprazan 10 and 20 mg were similar to that of lansoprazole 15 mg in patients with healed EE. Treatment-related AEs were reported in 11.4%, 10.4%, and 10.3% of patients in the lansoprazole 15 mg, vonoprazan 10 mg, and vonoprazan 20 mg arms, respectively. CONCLUSION Our findings confirm the non-inferiority of vonoprazan 10 and 20 mg to lansoprazole 15 mg as maintenance therapy for patients with healed EE.

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BACKGROUND Despite high-level evidence in the literature, the use of single-fraction radiotherapy (rt) for management of painful bone metastases is not widely practiced in the world, as highlighted in several practice-pattern surveys. Fractionation of palliative rt for bone metastases has not been addressed in Iran, where the most common clinical practice is the use of 30 Gy in 10 fractions. Thus, we decided to perform a randomized clinical trial to compare responses in our patients with those reported in the international literature. PATIENTS AND METHODS Adult patients with multiple painful uncomplicated bone metastases were randomized to 8 Gy in a single fraction or 30 Gy in 10 fractions. Pain was graded by the patients on a scale of 1 to 4 just before and again 1 month after the end of rt. Palliative response was defined as "complete" (pain reduction of 2 grades or more), "partial" (pain reduction of 1 grade or more, but less than 2 grades), and "no response" (pain reduction of less than 1 grade). RESULTS We randomized 70 patients in this trial (63% women; mean age: 51.6 years). Sites of treatment included spine (n = 27), sacrum or pelvis (n = 25), extremities (n = 14), ribs (n = 3), and sternum (n = 1). Patients graded their pain before rt in a range from 1.8 to 4.0 (mean: 3.2). All patients finished their scheduled course of rt without incident. Unfortunately, 5 patients died less than 1 month after the end of rt, and 7 did not return for any follow-up and could not be contacted. As a result, only 58 patients (31 who received multiple fractions, and 27 who received a single fraction) were available for evaluation of pain 1 month after treatment. At that time, pain was graded in a range from 1.0 to 4.0 (mean: 2.0). The reduction in pain grade ranged from -0.8 to 2.6 (mean: 1.1). We observed 8 (14%) complete responses, 33 (57%) partial responses, and 17 (29%) no responses, for an overall response rate of 71%. The number of responders was 21 (78%) among those who received a single fraction and 20 (65%) among those who received multiple fractions (p > 0.1). The mean reduction in pain was 1.1 in both groups. The 10-fraction group contained a higher number of complete responders (11 of 31 as compared with 6 of 27 in the 1-fraction group)-a result that was not statistically significant. The mean reduction in pain was 1.4 in patients 50 years of age or younger and 0.9 in patients more than 50 years of age (p = 0.01). Of the 8 complete responses, 7 (87.5%) were seen in the patients 50 years of age or younger, and the mean age of patients with a complete response (38.7 years) was significantly lower than that of patients with a partial response or no response (53.7 years, p = 0.017). By logistic regression, patient sex, primary tumour, rt site, and type of treatment (single-fraction vs. multifraction) did not have any significant effect on pain reduction. The only factor with a significant effect was age (p = 0.002). CONCLUSIONS Our trial showed no significant difference in pain relief after palliative radiotherapy with 1 or 10 fractions in Iranian patients. The overall response rate was 71%, similar to results in the international literature. Younger patients responded better.

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PURPOSE There is a paucity of high-quality evidence concerning mesh choice in open inguinal hernia repair. Using an expertise-based randomized clinical trial design, we aimed to evaluate the postoperative impact of two different mesh types on pain and discomfort, quality of life and sex life. METHODS In two regional hospitals, male patients with primary inguinal hernia were randomized to one of two groups of surgeons that performed the Lichtenstein operation. One group of surgeons used a heavyweight polypropylene mesh (90 g/m 2 , Bard™ Flatmesh, Davol) while the second group employed a lightweight mesh (28 g/m 2 , ULTRAPRO™, Ethicon). Follow-up data were collected by questionnaires and outpatient visits in the range of 1-3 years after surgery. RESULTS Some 412 patients were randomized and 363 patients were analysed. There was no difference in pain between groups after surgery but a statistically significant difference concerning awareness of a groin lump and groin discomfort, favouring the lightweight group 1 year after surgery. No differences in quality of life between groups could be detected but both groups had a substantially better quality of life postoperatively, as compared to before surgery. In the analysis of impact on sex life, no differences between mesh groups were found. CONCLUSION The Lichtenstein operation performed for primary inguinal hernia improves quality of life for most of the male patients, independently of the type of mesh used. The lightweight mesh group experienced less awareness of a groin lump and groin discomfort 1 year postoperatively. ClinicalTrials.gov Identifier: NCT00451893.

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BACKGROUND Despite the fact that numerous medications have been introduced to treat renal colic, none has been proven to relieve the pain rapidly and thoroughly. In this study, we aimed at comparing the effects of intravenous lidocaine versus intravenous morphine in patients suffering from renal colic. METHODS In a prospective randomized double-blind clinical trial performed in the emergency department of Imam Reza educational hospital of Tabriz, Iran, we studied 240 patients, 18-65 years old, who were referred due to renal colic. Patients were divided into two groups. In group I (120 people) single-dose intravenous lidocaine (1.5 mg/kg) was administered and in group II (120 people) single-dose intravenous morphine (0.1 mg/kg) was administered slowly. Visual Analogue Pain Scale (VAS) was recorded while admission, 5, 10, 15 and 30 minutes after injection. Statistical data and results were studied using descriptive statistics as percentage and Mean ± SD. To compare the response to treatment, Mann-Whitney U-test was used in two groups. Consequently, the data were analyzed using the SPSS16 software. RESULTS Pain score measured in two groups five minutes after the injection of lidocaine and morphine were 65 % and 53 % respectively (95% CI 0.60 - 0.69, CI 0.48 - 0.57, p = 0.0002).108 (90 %) patients (95 % CI 0.84 - 0.95) from group I and 84 (70%) patients (95 % CI 0.62 - 0.78) from group II responded appropriately at the end of the complete treatment. The difference was statistically significant (p = 0.0001). CONCLUSIONS Changing the smooth muscle tone and reducing the transmission of afferent sensory pathways, lidocaine causes a significant reduction in pain. TRIAL REGISTRATION Clinical Trials IRCT138901042496N3.

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BACKGROUND & OBJECTIVE Recent meta-analysis reports have called for more randomized trials to evaluate the effectiveness of GIK solution in patients of cardiac surgery. So this study was conducted to evaluate the effectiveness of Glucose-insulin-potassium (GIK) solutions in non-diabetic patients undergoing coronary artery bypass grafting. METHODS A total number of one hundred and sixty (160) patients were randomized into two equal groups; GIK Group and non-GIK group. In GIK group, 5% dextrose containing 70 IU/L regular insulin and 70 meq/L of potassium was administered. The infusion was started at a rate of 30 ml/hour after induction of anesthesia and before the start of cardiopulmonary bypass. The infusion was started again after removal of aortic cross clamp and was continued for six hours after the operation. RESULTS In early post-operative period, peak CKMB levels were high in non-GIK group 48.50±19.79 IU/L versus 33.40±14.69 IU/L in GIK group (p-value <0.001). There was no statistically significant difference in requirements of inotropic support between the groups. The mean duration of inotropic support in GIK group was only 5.50±6.88 hours in GIK group and 8.64±7.74 hours in non-GIK group (p-value 0.008). Mean ventilation time in GIK group was 5.06±2.39 hours versus 6.55±3.58 hours in non-GIK group (p-value 0.002). Similarly, ICU stay period was also shorter in GIK group (p-value 0.01). We did not found any detrimental effect of GIK infusion on non-cardiac complications e.g. renal, pulmonary and neurologic complications. CONCLUSION Glucose-insulin-potassium (GIK) infusion has a beneficial role in myocardial protection and is associated with better post-operative outcomes without increasing the risk of non-cardiac complications.

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INTRODUCTION Adopting the 45° semirecumbent position in mechanically ventilated critically ill patients is recommended, as it has been shown to reduce the incidence of ventilator-associated pneumonia. Although the benefits to the respiratory system are clear, it is not known whether elevating the head of the bed results in hemodynamic instability. We examined the effect of head of bed elevation (HBE) on hemodynamic status and investigated the factors that influence mean arterial pressure (MAP) and central venous oxygen saturation (ScvO2) when patients were positioned at 0°, 30°, and 45°. METHODS Two hundred hemodynamically stable adults on invasive mechanical ventilation admitted to a multidisciplinary surgical intensive care unit were recruited. Patients' characteristics included catecholamine and sedative doses, the original angle of head of bed elevation (HBE), the level of positive end expiratory pressure (PEEP), duration and mode of mechanical ventilation. A sequence of HBE positions (0°, 30°, and 45°) was adopted in random order, and MAP and ScvO2 were measured at each position. Patients acted as their own controls. The influence of degree of HBE and of the covariables on MAP and ScvO2 was analyzed by using liner mixed models. Additionally, uni- and multivariable logistic regression models were used to indentify risk factors for hypotension during HBE, defined as MAP <65 mmHg. RESULTS Changing HBE from supine to 45° caused significant reductions in MAP (from 83.8 mmHg to 71.1 mmHg, P < 0.001) and ScvO2 (76.1% to 74.3%, P < 0.001). Multivariable modeling revealed that mode and duration of mechanical ventilation, the norepinephrine dose, and HBE had statistically significant influences. Pressure-controlled ventilation was the most influential risk factor for hypotension when HBE was 45° (odds ratio (OR) 2.33, 95% confidence interval (CI), 1.23 to 4.76, P = 0.017). CONCLUSIONS HBE to the 45° position is associated with significant decreases in MAP and ScvO2 in mechanically ventilated patients. Pressure-controlled ventilation, higher simplified acute physiology (SAPS II) score, sedation, high catecholamine, and PEEP requirements were identified as independent risk factors for hypotension after backrest elevation. Patients at risk may need positioning at 20° to 30° to overcome the negative effects of HBE, especially in the early phase of intensive care unit admission.

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BACKGROUND This post-hoc sub-analysis investigated whether age (<65 years vs ≥65 years) affects glycemic control or hypoglycemic risk in patients with type 2 diabetes mellitus (T2DM) treated with once-daily insulin detemir. METHODS This was a 26-week, randomized, open-label, phase IV trial involving 2812 patients at 1083 predominantly primary care sites throughout the United States, of which 541 were designated for investigator-led insulin titration. The main efficacy measure was change in HbA1c (A1C) from baseline to Week 26. Patients were stratified by age in the sites designated for the investigator-led titration of insulin detemir. Safety measures included adverse events and change in hypoglycemic event rates from baseline to Week 26. RESULTS At Week 26, mean A1C and fasting plasma glucose decreased in both groups, but mean differences in change from baseline were not significant between groups. Within the group ≥65 years, significant reductions occurred for all daytime hypoglycemia, but there was no significant change from baseline in the other categories. In the group <65 years, reductions from baseline were significant for all hypoglycemic event categories. Changes in hypoglycemia rates from baseline were not significantly different between the age groups and there was no weight increase in either age group. CONCLUSIONS This analysis demonstrates that insulin detemir has similar efficacy and safety profiles for patients with T2DM ≥65 years compared with <65 years when treated via an investigator-led algorithm.

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OBJECTIVE There are controversial findings in the literature on the effects of chest physiotherapy on postextubation lung collapse in pediatric age group. Therefore, we aimed to investigate the efficacy of chest physiotherapy in prevention of postextubation atelectasis in pediatric patients. MATERIALS & METHODS In a case-control study from March 2007 to March 2011, two groups of patients (35 patients in each group) susceptible to lung collapse were enrolled in the study. The studied patients had neuromuscular diseases such as spinal muscular atrophy, Guillain-Barre syndrome, critical illness polyneuropathy/myopathy, and cerebral palsy. The patients were randomly divided into two groups (case and control); The case group underwent daily chest physiotherapy through vibrator and chest percussion and the control group was under supervision. In the latter group, the underlying disease was treated and the lung collapse was managed, if occurred. RESULTS The frequency of atelectasis was lower in the case group who received prophylactic chest physiotherapy compared to the control group (16.6% vs. 40%). CONCLUSION Chest physiotherapy as well as appropriate and regular change of position can considerably reduce the rate of pulmonary collapse in pediatric patients.

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INTRODUCTION Goal-directed therapy (GDT) has been shown to improve outcome when commenced before surgery. This requires pre-operative admission to the intensive care unit (ICU). In cardiac surgery, GDT has proved effective when commenced after surgery. The aim of this study was to evaluate the effect of post-operative GDT on the incidence of complications and duration of hospital stay in patients undergoing general surgery. METHODS This was a randomised controlled trial with concealed allocation. High-risk general surgical patients were allocated to post-operative GDT to attain an oxygen delivery index of 600 ml min(-1) m(-2) or to conventional management. Cardiac output was measured by lithium indicator dilution and pulse power analysis. Patients were followed up for 60 days. RESULTS Sixty-two patients were randomised to GDT and 60 patients to control treatment. The GDT group received more intravenous colloid (1,907 SD +/- 878 ml versus 1,204 SD +/- 898 ml; p < 0.0001) and dopexamine (55 patients (89%) versus 1 patient (2%); p < 0.0001). Fewer GDT patients developed complications (27 patients (44%) versus 41 patients (68%); p = 0.003, relative risk 0.63; 95% confidence intervals 0.46 to 0.87). The number of complications per patient was also reduced (0.7 SD +/- 0.9 per patient versus 1.5 SD +/- 1.5 per patient; p = 0.002). The median duration of hospital stay in the GDT group was significantly reduced (11 days (IQR 7 to 15) versus 14 days (IQR 11 to 27); p = 0.001). There was no significant difference in mortality (seven patients (11.3%) versus nine patients (15%); p = 0.59). CONCLUSION Post-operative GDT is associated with reductions in post-operative complications and duration of hospital stay. The beneficial effects of GDT may be achieved while avoiding the difficulties of pre-operative ICU admission.

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OBJECTIVE To assess the efficacy of radical surgery combined with recombinant adenoviral human p53 (rAd-p53) gene therapy in treatment of resectable non-small cell lung cancer. METHOD A total of 163 patients with resectable NSCLC meeting the inclusion criteria were randomly assigned to two groups: radical surgery alone (S) and radical surgery plus surgical wound surface injection of 2 x 10 12 rAd-p53 units (SP). All patients were followed up for at least 3 years for efficacy and safety. Study endpoints were loco-regional recurrence or distant metastasis (Rec-Met) rate as primary endpoints, and progression free survival (PFS), overall survival (OS) and safety assessments as secondary endpoints. RESULTS Recurrence or metastasis (Rec/Met) after surgery were 24/82 (29.27%) in SP group and 37/81 (45.68%) in S group. The difference in the Rec/Met rate was statistically significant (p = 0.0304) by chi-square test. The hazard ratios after adjusting of age and disease stage (S vs. SP) of PFS and OS are 1.772 (95% CI, 1.102 to 2.848) and 2.047 (95% CI, 1.109 to 3.377), respectively. The 3 years PFS and OS for SP vs. S were 71.9% vs. 46.9%, and 88.4% vs. 67.0%, respectively. Differences in PFS and OS between two treatment groups were significant with the p values of 0.0165 and 0.0191, respectively, using Log-Rank test. CONCLUSIONS The wound surface injection of rAd-p53 showed efficacious effects in preventing recurrence or metastasis and improving PFS and OS after a radical surgery in patients with NSCLC.

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OBJECTIVE Moderate alcohol consumption is associated with reduced incidence of type 2 diabetes and cardiovascular mortality and increases adiponectin concentrations, but effects might differ according to sex and beverage consumed. RESEARCH DESIGN AND METHODS A total of 72 healthy individuals (22-56 years) were enrolled in this randomized controlled crossover trial. After washout, two interventions for 3 weeks followed: ethanol (concentration 12.5%), beer (5.6%), or red wine (12.5%) equivalent to 30 g ethanol/day for men and 20 g/day for women or the same de-alcoholized beverages or water. Adiponectin was measured by sandwich enzyme-linked immunosorbent assay. RESULTS Among women, adiponectin significantly increased after consuming red wine (29.8%, P < 0.05) and increased among men after ethanol solution (17.4%, P < 0.05) and consuming beer (16.1%, P < 0.05). De-alcoholized beverages had no substantial effect on adiponectin concentrations. CONCLUSIONS Moderate amounts of ethanol-containing beverages increased adiponectin concentrations, but sex-specific effects might depend on type of beverage consumed.

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BACKGROUND Dexmedetomidine is an alpha(2) -adrenergic agonist with sedative and analgesic properties. This study aimed to investigate if the use of a continuous dexmedetomidine infusion with i.v. morphine patient-controlled analgesia (PCA) could improve postoperative analgesia while reducing opioid consumption and opioid-related side effects. METHODS In this prospective randomized, double-blinded, controlled study, 39 patients with obstructive sleep apnea syndrome undergoing uvulopalatopharyngoplasty were assigned to two groups. Group D (dexmedetomidine group) received a loading dose of dexmedetomidine 1 μg.kg(-1) i.v., 30 minutes before the anticipated end of surgery, followed by infusion at 0.6 μg.kg(-1) h(-1) for 24 hours. Group P (placebo group) received a bolus and infusion of placebo. In both groups, postoperative pain was initially controlled by i.v. morphine titration and then PCA with morphine. Cumulative PCA morphine consumption, pain intensities, sedation scores, cardiovascular and respiratory variables and opioid-related adverse effects were recorded for 48 hours after operation. RESULTS Compared with placebo group, patients in the dexmedetomidine group required 52.7% less PCA morphine during the first 24 hours postoperatively, with significantly better visual analogue scale scores, less incidence of respiratory obstruction (5 vs. 12 patients, respectively; P = .037) and longer time to first analgesic request (21 (11) vs. 9 (4) minutes; P = .002). Fewer patients in group D experienced nausea and vomiting than those in group P (7 vs. 24 patients, respectively; P < .05). CONCLUSION Continuous dexmedetomidine infusion may be a useful analgesic adjuvant for patients susceptible to opioid-induced respiratory depression.

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BACKGROUND Integrated health care delivery systems devote considerable resources to developing quality improvement (QI) interventions. Clinics serving vulnerable populations rarely have the resources for such development but might benefit greatly from implementing approaches shown to be effective in other settings. Little trial-based research has assessed the feasibility and impact of such cross-setting translation and implementation in community health centers (CHCs). We hypothesized that it would be feasible to implement successful QI interventions from integrated care settings in CHCs and would positively impact the CHCs. METHODS We adapted Kaiser Permanente's successful intervention, which targets guideline-based cardioprotective prescribing for patients with diabetes mellitus (DM), through an iterative, stakeholder-driven process. We then conducted a cluster-randomized pragmatic trial in 11 CHCs in a staggered process with six "early" CHCs implementing the intervention one year before five "'late" CHCs. We measured monthly rates of patients with DM currently prescribed angiotensin converting enzyme (ACE)-inhibitors/statins, if clinically indicated. Through segmented regression analysis, we evaluated the intervention's effects in June 2011-May 2013. Participants included ~6500 adult CHC patients with DM who were indicated for statins/ACE-inhibitors per national guidelines. RESULTS Implementation of the intervention in the CHCs was feasible, with setting-specific adaptations. One year post-implementation, in the early clinics, there were estimated relative increases in guideline-concordant prescribing of 37.6 % (95 % confidence interval (CI); 29.0-46.2 %) among patients indicated for both ACE-inhibitors and statins and 38.7 % (95 % CI; 23.2-54.2 %) among patients indicated for statins. No such increases were seen in the late (control) clinics in that period. CONCLUSIONS To our knowledge, this was the first clinical trial testing the translation and implementation of a successful QI initiative from a private, integrated care setting into CHCs. This proved feasible and had significant impact but required considerable adaptation and implementation support. These results suggest the feasibility of adapting diverse strategies developed in integrated care settings for implementation in under-resourced clinics, with important implications for efficiently improving care quality in such settings. CLINICALTRIALS.gov: NCT02299791 .

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BACKGROUND PEG-based laxatives are considered today the gold standard for the treatment of constipation in children. PEG formulations differ in terms of composition of inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment. We therefore compared the efficacy, tolerability, acceptance and compliance of a new PEG-only formulation compared to a reference PEG-electrolyte (PEG-EL) formulation in resolving faecal impaction and in the treatment of chronic constipation. METHODS Children aged 2-16 years with functional chronic constipation for at least 2 months were randomized to receive PEG-only 0.7 g/kg/day in 2 divided doses or 6.9 g PEG-EL 1-4 sachets according to age for 4 weeks. Children with faecal impaction were randomized to receive PEG-only 1.5/g/kg in 2 divided doses until resolution or for 6 days or PEG-EL with an initial dose of 4 sachets and increasing 2 sachets a day until resolution or for 7 days. RESULTS Ninety-six children were randomized into the study. Five patients withdrew consent before starting treatment. Three children discontinued treatment for refusal due to bad taste of the product (1 PEG-only, 2 PEG-EL); 1 (PEG-EL) for an adverse effect (abdominal pain). Intent-to-treat analysis was carried out in 49 children in the PEG-only group and 42 in the PEG-EL group.No significant differences were observed between the two treatment groups at baseline.Adequate relief of constipation in terms of normalized frequency and painless defecation of soft stools was achieved in all patients in both groups. The number of stools/week was 9.2 ± 3.2 (mean ± SD) in the PEG-only group and 7.8 ± 2.4 in the PEG-EL group (p = 0.025); the number of days with stool was 22.4 ± 5.1 in the PEG-only group and 19.6 ± 7.2 in the PEG-EL group (p = 0.034).In the PEG-only group faecaloma resolution was observed in 5 children on the second day and in 2 children on the third day, while in the PEG-EL group it was observed in 2 children on the second day, in 3 children on the third day and in 1 child on the fifth day.Only 2 patients reported mild treatment-related adverse events: 1 child in the PEG-only group had diarrhoea and vomiting and 1 child in the PEG-EL group had abdominal pain requiring treatment discontinuation. The PEG-only preparation was better tolerated as shown by the lower frequency of nausea than in the PEG-EL group.In the PEG-only group, 96% of patients did not demonstrate any difficulties associated with treatment, as compared with 52% of patients in the PEG-EL group (p < 0.001). Also, the PEG-only formulation taste was better than that of PEG-EL (p < 0.001). The difference between the percentage of subjects who took > 80% of the prescribed dose was in favour of the PEG-only group (98% vs. 88%), though it did not reach a conventional statistical level (p = 0.062). CONCLUSION PEG-only was better tolerated and accepted than PEG-EL in children with chronic constipation. At the higher PEG doses recommended by the manufactures children in the PEG-only group had higher and more regular soft stool frequency than PEG-EL.

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OBJECTIVE The risk of cardiovascular morbidity and mortality is significantly increased in patients with diabetes; thus, it is important to determine whether glucose-lowering therapy affects this risk over time. Changes in cardiovascular risk markers were examined in patients with type 2 diabetes treated with exenatide twice daily (a glucagon-like peptide-1 receptor agonist) or glimepiride (a sulfonylurea) added to metformin in the EURopean EXenAtide (EUREXA) study. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes failing metformin were randomized to add-on exenatide twice daily (n = 515) or glimepiride (n = 514) until treatment failure defined by hemoglobin A1C. Anthropomorphic measures, blood pressure (BP), heart rate, lipids, and high-sensitivity C-reactive protein (hsCRP) over time were evaluated. RESULTS Over 36 months, twice-daily exenatide was associated with improved body weight (-3.9 kg), waist circumference (-3.6 cm), systolic/diastolic BP (-2.5/-2.6 mmHg), high-density lipoprotein (HDL)-cholesterol (0.05 mmol/L), triglycerides (-0.2 mmol/L), and hsCRP (-1.7 mg/L). Heart rate did not increase (-0.3 beats/minute), and low-density lipoprotein-cholesterol (0.2 mmol/L) and total cholesterol (0.1 mmol/L) increased slightly. Between-group differences were significantly in favor of exenatide for body weight (P < 0.0001), waist circumference (P < 0.001), systolic BP (P < 0.001), diastolic BP (P = 0.023), HDL-cholesterol (P = 0.001), and hsCRP (P = 0.004). Fewer patients randomized to exenatide twice daily versus glimepiride required the addition of at least one antihypertensive (20.4 vs 26.4%; P = 0.026) or lipid-lowering medication (8.4 vs 12.8%; P = 0.025). CONCLUSIONS Add-on exenatide twice daily was associated with significant, sustained improvement in several cardiovascular risk markers in patients with type 2 diabetes versus glimepiride. CLINICAL TRIAL REGISTRATION NCT00359762, http://www.ClinicalTrials.gov.

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OBJECTIVE To estimate the incremental cost-effectiveness of infliximab versus conventional combination treatment over 21 months in patients with methotrexate-refractory early rheumatoid arthritis. METHODS In this multicentre, two-arm, parallel, randomised, active-controlled, open-label trial, rheumatoid arthritis patients with <1 year symptom duration were recruited from 15 rheumatology clinics in Sweden between October 2002 and December 2005. After 3-4 months of methotrexate monotherapy, patients not achieving low disease activity were randomised to addition of infliximab or sulfasalazine+hydroxychloroquine (conventional treatment group). Costs of drugs, healthcare use, and productivity losses were retrieved from nationwide registers, while EuroQol 5-Dimensions utility was collected quarterly. RESULTS Of 487 patients initially enrolled, 128 and 130 were randomised to infliximab and conventional treatment, respectively. The infliximab group accumulated higher drug and healthcare costs (€27,487 vs €10,364; adjusted mean difference €16,956 (95% CI 14,647 to 19,162)), while productivity losses did not differ (€33,804 vs €29,220; €3961 (95% CI -3986 to 11,850)), resulting in higher societal cost compared to the conventional group (€61,291 vs €39,584; €20,916 (95% CI 12,800 to 28,660)). Mean accumulated quality-adjusted life-years (QALYs) did not differ (1.10 vs 1.12; adjusted mean difference favouring infliximab treatment 0.01 (95% CI -0.07 to 0.08)). The incremental cost-effectiveness ratios for the infliximab versus conventional treatment strategy were €2,404,197/QALY from the societal perspective and €1,948,919/QALY from the healthcare perspective. CONCLUSIONS In early, methotrexate-refractory rheumatoid arthritis, a treatment strategy commencing with addition of infliximab, as compared to sulfasalazine+hydroxychloroquine, was not cost-effective over 21 months at willingness to pay levels generally considered acceptable. TRIAL REGISTRATION NUMBER NCT00764725.

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BACKGROUND Angiotensin Receptor Blockades (ARB) is becoming a first line drug for essential Hypertension for many types of patient. Losartan is the prototype of ARB due to its vast clinical trials. Home Blood pressure monitoring can provide accurate evaluation of certain drug effect on blood pressure with small number of patient samples. Local production of medicine has made the Medicine readily available and could bring about clinical improvement. Our hypothesis was that Thai population with essential hypertension responded quite well to Losartan and Generic Losartan was not inferior to Original- Losartan. OBJECTIVE To evaluate the effectiveness and safety in BP reduction by Losartan in certain Thai population and to compare these parameters between Generic Losartan and Original-Losartan using both office and HBPM method. METHOD After a two-week run-in period when they would learn to use HBPM device and their blood pressure were still recorded to be higher than 140/90 by office BP or 135/85 by HBPM with or without previous medical regimen, 24 patients were randomized to receive either Generic Losartan or Original-Losartan for 6 weeks. Then they would cross over to receive the alternative and were followed again at 6 weeks. HBPM was performed in the morning and in the evening for 5 days, at baseline, and after 6 & 12 weeks. Office BP measurements were obtained at baseline and after 6 & 12 weeks. RESULT One patient in each group dropped out from the study. 22 patients with average age of 54 and averaged office BP 154/88 completed the 12 weeks study. By office BP, SBP was reduced by 27±14.2 at week 6 and 28±15.1 mmHg at week 12. By HBPM, SBP dropped by 17±10.8 at week 6 and by 18±9. at week12. At the end of 12 weeks 68% (15/22) of patients had Office BP <140/90 and 64% (14/22) of patients had HBPM <135/85. There was no significant difference of BP reduction at week 6 between Original-xLosartan and Generic Losartan group. After crossover the BP reduction was maintained in both groups. The percentage of patient whose Office BP <140/90 or HBPM <135/85 were not different among the two Losartan groups. There was no serious adverse side effect. CONCLUSION Using both office BP and HBPM this group of Thai patient with essential hypertension responded well to Losartan and Generic Losartan.

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PURPOSE This study investigated the effects of Coleus Forskohlii (CF) on body composition, and determined the safety and efficacy of supplementation. METHODS In a double blind and randomized manner, 23 females supplemented their diet with ForsLeantrade mark (250 mg of 10% CF extract, (n = 7) or a placebo [P] (n = 12) two times per day for 12-wks. Body composition (DEXA), body weight, and psychometric instruments were obtained at 0, 4, 8 & 12 weeks of supplementation. Fasting blood samples and dietary records (4-d) were obtained at 0 and 12-wks. Side effects were recorded on a weekly basis. Data were analyzed by repeated measures ANOVA and are presented as mean changes from baseline for the CF and placebo groups, respectively. RESULTS No significant differences were observed in caloric or macronutrient intake. CF tended to mitigate gains in body mass (-0.7 +/- 1.8, 1.0 +/- 2.5 kg, p = 0.10) and scanned mass (-0.2 +/- 1.3, 1.7 +/- 2.9 kg, p = 0.08) with no significant differences in fat mass (-0.2 +/- 0.7, 1.1 +/- 2.3 kg, p = 0.16), fat free mass (-0.1 +/- 1.3, 0.6 +/- 1.2 kg, p = 0.21), or body fat (-0.2 +/- 1.0, 0.4 +/- 1.4%, p = 0.40). Subjects in the CF group tended to report less fatigue (p = 0.07), hunger (p = 0.02), and fullness (p = 0.04). No clinically significant interactions were seen in metabolic markers, blood lipids, muscle and liver enzymes, electrolytes, red cells, white cells, hormones (insulin, TSH, T3, and T4), heart rate, blood pressure, or weekly reports of side effects. CONCLUSION Results suggest that CF does not appear to promote weight loss but may help mitigate weight gain in overweight females with apparently no clinically significant side effects.

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INTRODUCTION The purpose of this pilot study is to assess the feasibility, acceptability, and safety of a new feeding protocol designed to enhance the delivery of enteral nutrition (EN). METHODS In a prospective before and after study, we evaluated a new protocol compared to our standard feeding protocol. Innovative elements of the new protocol included setting daily volume based goals instead of hourly rate targets, initiating motility agents and protein supplements on Day 1, liberalizing the gastric residual volume threshold, and the option to use trophic feeds. Bedside nurses filled out questionnaires to assess the acceptability of the new approach and we assessed patients' nutritional and clinical outcomes. RESULTS We enrolled 20 mechanically ventilated patients who stayed in the Intensive Care Unit for more than three days in the before group and 30 such patients in the after group. On a scale where 1 = totally unacceptable and 10 = totally acceptable, 30 nurses rated the new protocol as 7.1 (range 1 to 10) and no incidents compromising patient safety were observed. In the before group, on average, patients received 58.8% of their energy and 61.2% of their protein requirements by EN compared to 67.9% and 73.6% in the after group (P = 0.33 and 0.13). When the subgroup of patients prescribed to receive full volume feeds in the after group were evaluated (n = 18), they received 83.2% and 89.4% of their energy and protein requirements by EN respectively (P = 0.02 for energy and 0.002 for protein compared to the before group). The rates of vomiting, regurgitation, aspiration, and pneumonia were similar between the two groups. CONCLUSIONS This new feeding protocol seems to be safe and acceptable to critical care nurses. The adoption of this protocol may be associated with enhanced delivery of EN but further trials are warranted to evaluate its effect on nutritional and clinical endpoints. TRIAL REGISTRATION ClinicalTrials.gov NCT01102348.

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OBJECTIVES The aim of this study was to evaluate the effect of dentin remineralization using proanthocyanidin (PA), fluoride varnish and casein phosphopeptide amorphous calcium phosphate (CPP-ACP) paste and their various combinations on microhardness of demineralized root dentin. MATERIALS AND METHODS One-hundred and twenty freshly extracted sound human premolars were selected and randomly divided into eight groups for dentin treatment as follows. C: Deionized water (control); PA: 6.5% PA solution; F: fluoride varnish (5% NaF, 22600 ppm fluoride); CP: CCP-ACP; PAF: 6.5% PA + fluoride varnish; PACP: 6.5% PA + CCP-ACP; FCP: fluoride varnish + CCP-ACP and PAFCP: 6.5% PA + fluoride varnish + CCP-ACP. All specimens were subjected to Vickers microhardness test (500 g, 10 seconds, 3 points). Data were analyzed using one-way ANOVA and Tukey's post hoc test. The significance level was set at 0.05. RESULTS The mean and standard deviation (SD) values of Vickers hardness number (VHN) in groups C, PA, F, CP, PAF, PACP, FCP and PAFCP were 37.39±4.97, 38.68±4.62, 48.28±2.68, 41.91±3.32, 48.59±2.55, 53.34±2.57, 48.413±4.00 and 55.20±1.82, respectively. Pairwise comparisons of the groups revealed that there was no significant difference between groups C and PA, PA and CP, F and PAF, F and FCP, PAF and FCP, and PACP and FPACP (P>0.05); but significant differences were observed between other groups (P<0.05). CONCLUSIONS The results of this study showed that the tested dentin treatments increased the microhardness of demineralized root dentin except for PA application.

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OBJECTIVE Comparing sublingual and vaginal misoprostol in second trimester pregnancy termination. MATERIALS AND METHODS In this study 268 women at 12-24 weeks of gestation candidate for pregnancy termination were enrolled. Women were randomly divided in two groups. The first group received 400 µg sublingual misoprostol and vaginal placebo and the second group received 400 µg vaginal misoprostol and sublingual placebo every 4 hours for a maximum of five doses. The course of misoprostol was repeated if the women did not abort within 24 hours. RESULTS The median induction-to-abortion interval was shorter in sublingual group (12/72 hours in sublingual and 14/67 hours in vaginal). There was no significant difference in the success rate at 24 and 48 hours and in side effects. The preference for the sublingual route of administration was higher. CONCLUSION Both vaginal and sublingual misoprostol are effective for medical abortion in second trimester termination. But it appears from shorter induction interval in sublingual and higher acceptability that sublingual route is a better choice.

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BACKGROUND Efforts to improve access to treatment for common illnesses in children less than five years initially targeted malaria alone under the home management of malaria strategy. However under this strategy, children with other illnesses were often wrongly treated with anti-malarials. Integrated community case management of common childhood illnesses is now recommended but its effect on promptness of appropriate pneumonia treatment is unclear. OBJECTIVES To determine the effect of integrated malaria and pneumonia management on receiving prompt and appropriate antibiotics for pneumonia symptoms and treatment outcomes as well as determine associated factors. METHODS A follow-up study was nested within a cluster-randomized trial that compared under-five mortality in areas where community health workers (CHWs) treated children with malaria and pneumonia (intervention areas) and where they treated children with malaria only (control areas). Children treated by CHWs were enrolled on the day of seeking treatment from CHWs (609 intervention, 667 control) and demographic, illness, and treatment seeking information was collected. Further information on illness and treatment outcomes was collected on day four. The primary outcome was prompt and appropriate antibiotics for pneumonia symptoms and the secondary outcome was treatment outcomes on day four. RESULTS Children in the intervention areas were more likely to receive prompt and appropriate antibiotics for pneumonia symptoms compared to children in the control areas (RR = 3.51, 95%CI = 1.75-7.03). Children in the intervention areas were also less likely to have temperature ≥37.5°C on day four (RR = 0.29, 95%CI = 0.11-0.78). The decrease in fast breathing between day one and four was greater in the intervention (9.2%) compared to the control areas (4.2%, p-value = 0.01). CONCLUSIONS Integrated community management of malaria and pneumonia increases prompt and appropriate treatment for pneumonia symptoms and improves treatment outcomes. TRIAL REGISTRATION ISRCTN ISRCTN52966230.

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STATEMENT OF THE PROBLEM Researchers have long been in search of products to enhance healing and patient comfort postoperatively. PURPOSE This study aimed to assess the efficacy of propolis extract in combination with Coe-Pak TM dressing for pain relief and wound healing after crown lengthening surgery. MATERIALS AND METHOD This randomized clinical trial was performed on 36 patients who were randomly divided into two groups of Coe-Pak TM dressing with (trial group) and without (control group) propolis extract. Pain and burning sensation by use of visual analog scale (VAS) and number of analgesics taken were asked from patients. Gingival color and consistency, bleeding on probing (BOP) and presence of infection were studied 7 days after dressing removal. RESULTS Although a large number of patients in the trial group did not have burning sensation, this difference was not significant between the two groups ( p > 0.05). In both groups, the majority of patients experienced moderate and mild pain and there was no pain in the trial group after three days. No significant difference was noted between the two groups in pain score and number of analgesics taken ( p > 0.05). The two groups were not significantly different in terms of inflammation and healing process (BOP, gingival consistency and color), after 7 days ( p > 0.05). CONCLUSION The study results showed no difference in use of Coe-Pak TM dressing with and without propolis extract in terms of postoperative pain and healing process following the crown lengthening surgery. More studies are required to confirm these results.

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Background The Secondary Prevention in Uppsala Primary Healthcare Project (SUPRIM) was a randomized controlled trial of a group-based cognitive behavioural therapy stress management programme for patients with coronary heart disease. The project was successful in reducing the risk of fatal or non-fatal first recurrent cardiovascular events. The aim of this study was to analyse the effect of cognitive behavioural therapy on self-rated stress, somatic anxiety, vital exhaustion and depression and to study the associations of these factors with the reduction in cardiovascular events. Methods A total of 362 patients were randomly assigned to intervention or usual care groups. The psychological outcomes were assessed five times during 24 months and analysed using linear mixed models. The mediating roles of the outcomes were analysed using joint modelling of the longitudinal and time to event data. Results The intervention had a positive effect on somatic anxiety ( p < 0.05), reflecting a beneficial development over time compared with the controls. Stress, vital exhaustion and depression did not differ between the groups over time. Mediator analysis suggested that somatic anxiety may have mediated the effect of treatment on cardiovascular events. Conclusions The intervention had a small positive effect on somatic anxiety, but did not affect stress, vital exhaustion or depression in patients with coronary heart disease. Somatic anxiety was associated with an increased risk of cardiovascular events and might act as a partial mediator in the treatment effect on cardiovascular events. However, the mechanisms between the intervention and the protective cardiovascular outcome remain to be identified.

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OBJECTIVE To investigate the clinical effect of budesonide nebulization in the treatment of ventilator associated pneumonia of newborns and its safety. METHODS Forty-five newborns who had ventilator associated pneumonia and were admitted into the Binzhou People's Hospital between May 2014 and May 2015 were selected and included as an observation group. Moreover, another forty-five newborns who had ventilator associated pneumonia but did not undergo budesonide treatment in 2014 were randomly selected and included as a control group. Patients in the observation group were given budesonide suspension nebulization in addition to the conventional treatment. The evaluation indicators for therapeutic effect were compared between the two groups. The changes of head circumference, height and weight and death rate were observed by follow up after treatment. RESULTS The mechanical ventilation time, time for recovering from chest X-ray scan and hospitalization time of patients in the observation group were shorter than that of the control group, and the difference had statistical significance (P<0.05). The oxygen index of the patients in the observation group was significantly improved compared to that of the control group, and the difference had statistical significance (P<0.05). Patients in the two groups were followed up for six months after discharge. The head circumference, height and weight of the patients in the observation group in the 3 rd and 6 th month were compared to those of the control group, suggesting no significant differences (P>0.05). The cumulative death rate of the observation group in the 6 th month after treatment was significantly lower than that of the control group, and the difference had statistical significance (P<0.05). CONCLUSION Treating ventilator associated pneumonia of newborns with budesonide nebulization can effectively shorten mechanical ventilation time, time for recovering from chest X-ray scan and hospitalization time, improve pulmonary diffusion function and reduce the death rate, without affecting the growth and development of patients in the future.

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OBJECTIVES This study aimed to compare the microleakage beneath metallic brackets following two different methods of enamel preparation and light curing. MATERIALS AND METHODS A total of 120 bovine deciduous lower incisors were randomly divided into four groups of 30 teeth. The preparations were as follows: Group I: Acid etching + Transbond XT primer + direct illumination, group II: acid etching + Transbond XT primer + transillumination, group III: Transbond XT self-etching primer + direct illumination and Group IV: Transbond XT self-etching primer + transillumination. Dye penetration was used as the method of microleakage evaluation. Sections made at the enamel-adhesive and adhesive-bracket interfaces were evaluated under a stereomicroscope. The Kruskal-Wallis and Mann-Whitney U tests were used for statistical analysis. The level of significance was set at P<0.05. RESULTS All groups showed greater microleakage at the gingival in comparison to the incisal margin and the differences were significant among groups with transillumination (P<0.001). No significant differences were observed in the microleakage scores at the gingival and incisal margins in any of the interfaces (P>0.05). Mesiodistal margins of the self-etching group with direct illumination showed significantly lower scores in comparison with acid etched group (P<0.05). CONCLUSION Use of self-etching primers for bonding of orthodontic brackets yields acceptable results if all bracket margins are cured directly.

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OBJECTIVES ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. METHODS In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. RESULTS A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. CONCLUSIONS Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. TRIAL REGISTRATION NUMBER NCT01970475; Results.

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BACKGROUND The objective of the study was to evaluate the effect of a written invitation letter to the spouses of new antenatal clinic attendees on attendance by couples and on male partner acceptance of HIV testing at subsequent antenatal clinic visits. METHODS The trial was conducted with 1060 new attendees from October 2009 to February 2010 in an antenatal clinic at Mbale Regional Referral Hospital, Mbale District, eastern Uganda. The intervention comprised an invitation letter delivered to the spouses of new antenatal attendees, while the control group received an information letter, a leaflet, concerning antenatal care. The primary outcome measure was the proportion of pregnant women who attended antenatal care with their male partners during a follow-up period of four weeks. Eligible pregnant women were randomly assigned to the intervention or non-intervention groups using a randomization sequence, which was computer generated utilizing a random sequence generator (RANDOM ORG) that employed a simple randomization procedure. Respondents, health workers and research assistants were masked to group assignments. RESULTS The trial was completed with 530 women enrolled in each group. Participants were analyzed as originally assigned (intention to treat). For the primary outcome, the percentage of trial participants who attended the antenatal clinic with their partners were 16.2% (86/530) and 14.2% (75/530) in the intervention and non-intervention groups, respectively (OR = 1.2; 95% CI: 0.8, 1.6). For the secondary outcome, most of the 161 male partners attended the antenatal clinic; 82 of 86 (95%) in the intervention group and 68 of 75 (91%) in the non-intervention group were tested for HIV (OR = 2.1; 95% CI: 0.6 to 7.5). CONCLUSIONS The effect of the intervention and the control on couple antenatal attendance was similar. In addition, the trial demonstrated that a simple intervention, such as a letter to the spouse, could increase couple antenatal clinic attendance by 10%. Significantly, the majority of male partners who attended the antenatal clinic accepted HIV testing. Therefore, to further evaluate this simple and cost-effective intervention method, adequately powered studies are required to assess its effectiveness in increasing partner participation in antenatal clinics and the programme for prevention of mother to child transmission of HIV. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01144234.

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BACKGROUND Perioperative thermal disturbances during orthotopic liver transplantation (OLT) are common. We hypothesized that in patients undergoing OLT the use of a humidified high flow CO 2 warming system maintains higher intraoperative temperatures when compared to standardized multimodal strategies to maintain thermoregulatory homeostasis. METHODS We performed a randomized pilot study in adult patients undergoing primary OLT. Participants were randomized to receive either open wound humidification with a high flow CO 2 warming system in addition to standard care (Humidification group) or to standard care alone (Control group). The primary end point was nasopharyngeal core temperature measured 5 min immediately prior to reperfusion of the donor liver (Stage 3 - 5 min). Secondary endpoints included intraoperative PaCO 2 , minute ventilation and the use of vasoconstrictors. RESULTS Eleven patients were randomized to each group. Both groups were similar for age, body mass index, MELD, SOFA and APACHE II scores, baseline temperature, and duration of surgery. Immediately prior to reperfusion (Stage 3 - 5 min) the mean (SD) core temperature was higher in the Humidification Group compared to the Control Group: 36.0 °C (0.13) vs. 35.4 °C (0.22), p = 0.028. Repeated measured ANOVA showed that core temperatures over time during the stages of the transplant were higher in the Humidification Group compared to the Control Group (p < 0.0001). There were no significant differences in the ETCO 2 , PaCO 2 , minute ventilation, or inotropic support. CONCLUSION The humidified high flow CO 2 warming system was superior to standardized multimodal strategies in maintaining normothermia in patients undergoing OLT. Use of the device was feasible and did not interfere with any aspects of surgery. A larger study is needed to investigate if the improved thermoregulation observed is associated with improved patient outcomes. TRIAL REGISTRATION ACTRN12616001631493 . Retrospectively registered 25 November 2016.

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OBJECTIVE To evaluate the efficacy, safety and dose response of a novel oral Janus kinase inhibitor, peficitinib (ASP015K), as monotherapy in Japanese patients with moderate to severe rheumatoid arthritis (RA). METHODS In a 12-week, double-blind study, 281 adult patients with RA with active disease not on concomitant disease-modifying antirheumatic drug therapy were randomised equally to once-daily placebo or peficitinib 25, 50, 100 and 150 mg. The primary endpoint was American College of Rheumatology (ACR) 20 response in the peficitinib treatment groups versus placebo at week 12. RESULTS Mean age was 53.0 years, 81.1% were female and 25.3% had previously used antitumour necrosis factor therapy. Peficitinib 50, 100 and 150 mg each showed statistically significantly higher ACR20 response rates compared with placebo, and response rates increased up to 150 mg with a statistically significant dose response. The total incidence of treatment-emergent adverse events (TEAEs) was similar between the placebo (64.3%) and peficitinib 25, 50, 100 and 150 mg groups (70.9%, 64.9%, 52.7% and 67.2%, respectively). TEAEs occurring more frequently in the peficitinib group compared with the placebo group included nasopharyngitis, increased blood creatine phosphokinase and diarrhoea. No cases of serious infections were reported. Herpes zoster occurred in four patients (two each in peficitinib 25 and 100 mg). CONCLUSIONS Treatment with peficitinib as monotherapy for 12 weeks in Japanese patients with moderate to severe RA is efficacious and showed acceptable safety profile. These findings support further developments of peficitinib for RA treatment. TRIAL REGISTRATION NUMBER NCT01649999; Results.

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OBJECTIVE Continuous glucose monitoring (CGM) has been demonstrated to improve glycemic control in adults with type 1 diabetes but less so in children. We designed a study to assess CGM benefit in young children aged 4 to 9 years with type 1 diabetes. RESEARCH DESIGN AND METHODS After a run-in phase, 146 children with type 1 diabetes (mean age 7.5 ± 1.7 years, 64% on pumps, median diabetes duration 3.5 years) were randomly assigned to CGM or to usual care. The primary outcome was reduction in HbA(1c) at 26 weeks by ≥0.5% without the occurrence of severe hypoglycemia. RESULTS The primary outcome was achieved by 19% in the CGM group and 28% in the control group (P = 0.17). Mean change in HbA(1c) was -0.1% in each group (P = 0.79). Severe hypoglycemia rates were similarly low in both groups. CGM wear decreased over time, with only 41% averaging at least 6 days/week at 26 weeks. There was no correlation between CGM use and change in HbA(1c) (r(s) = -0.09, P = 0.44). CGM wear was well tolerated, and parental satisfaction with CGM was high. However, parental fear of hypoglycemia was not reduced. CONCLUSIONS CGM in 4- to 9-year-olds did not improve glycemic control despite a high degree of parental satisfaction with CGM. We postulate that this finding may be related in part to limited use of the CGM glucose data in day-to-day management and to an unremitting fear of hypoglycemia. Overcoming the barriers that prevent integration of these critical glucose data into day-to-day management remains a challenge.

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BACKGROUND Competitive examinations, particularly in mathematics, have made emotional stress a major problem for preuniversity students, emotions like aggression toward fellow students and teachers increase. Mindfulness is a quality that reduces both emotional stress and aggression, so increasing mindfulness should be helpful. AIMS To study the effects of Yoga Pranayama (YP) and Vedic Mathematics (VM) on mindfulness, aggression, and emotion regulation. METHODS Participants were 12 th graders attending a preuniversity college in Chikkamagaluru, India, of both genders. Exclusion criteria included major psychological problems. Three classes were arbitrarily assigned to one of three interventions, which consisted of 15 days each of 30 min daily instruction in YP, Group 1, VM, Group 2, or 30 min ordinary class work, Group 3, the control group. Assessments were made using the Mindfulness Attention Awareness Scale, the Nonphysical Aggression Scale from Pittsburgh Youth Study, and the Emotion Regulation Questionnaire. STATISTICAL ANALYSIS USED SPSS 19.0. RESULTS Mindfulness, aggression, and negative emotional regulation changed significantly for the YP group, while mindfulness alone improved significantly for the VM group. No group changed on positive emotion regulation. Controls apparently improved on aggression. An interesting post hoc correlation analysis is also reported, among other things directly linking increased mindfulness to decreased aggression. CONCLUSIONS The study showed positive effects of traditional methods of decreasing emotional pressure on students facing preuniversity mathematics examinations. Increasing mindfulness is considered a way of increasing emotion regulation, so the failure of this study to provide evidence for that is of interest.

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BACKGROUND AND AIMS Propofol (2, 6-di-isopropylphenol) used for the induction of anaesthesia often causes mild to severe pain or discomfort on injection. We designed this double-blind study to compare the efficacy of methylprednisolone and lignocaine in reducing the pain of propofol injection in patients scheduled for cardiac surgery. METHODS A total of 165 adult patients, scheduled for elective cardiac surgery, were divided into three groups: saline (group S, n = 55), lignocaine 20 mg (Group L, n = 55) and methylprednisolone 125 mg diluted into 2 ml of distilled water (Group MP, n = 55). Drugs were administered after tourniquet application and occlusion was released after 1 min and 1/4 th of the total dose of propofol (2 mg/kg) was administered at the rate of 0.5 ml/s. Pain on propofol injection was evaluated by four-point verbal rating scale. Statistical methods used included Student's t -test and Chi-square test/Fisher's exact test. RESULTS The overall incidence of pain was 70.9% in the saline group, 30.9% in the lignocaine group and 36.4% in the methylprednisolone group. The intensity of pain was significantly less in patients receiving methylprednisolone and lignocaine than those receiving saline ( P < 0.012). CONCLUSION Pre-treatment with intravenous methylprednisolone was found to be as effective as lignocaine in reducing propofol injection-induced pain.

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BACKGROUND Posture instability and unsteady gait disorders in Parkinson's Disease (PD) usually contribute to fall-related fractures. Fall-related trauma in PD is the most common reason for injury. Despite providing modern care for PD patients (PP) in the recent years, anti-PD drugs have no effect on falling. There is an urgent need to administer exercise interventions to reduce falls and related injuries in the rehabilitation program of PP. OBJECTIVES To explore the effect of a selective 10-week corrective exercise with an emphasis on gait training activities (GTA) on the number of falls (NOFs), fear of falling, functional balance, timed up and go (TUG) test among PD patients. PATIENTS AND METHODS A purposeful sampling was performed on PP who had fallen or were at risk of falling in 2014. The study intervention consisted of a 10-week (3 sessions each week, each lasting 60 min) corrective exercise program. Participants were randomly allocated to control and two exercise groups; the exercise group with balance pad (EGBP) or exercise group with no balance pad (EGNBP). The analysis of variance (ANOVA) and paired t-test were used for comparison between the groups (P ≤ 0.05). RESULTS Administrating a selective corrective exercise in exercise group with balance pad (EGBP) showed a significant difference in number of falls (NOF), Fall Efficacy Scale-international (FES-I), Berg balance scale (BBS) (and timed up and go) TUG (P = 0.001); while administrating the same exercise in exercise group with no balance pad (EGNBP) showed no significant difference in NOF (P = 0.225) and a significant difference in FES-I (P = 0.031), BBS (P = 0.047) and TUG (P = 0.012). The control group showed no significant difference in each of the dependent variables. CONCLUSIONS Performing a selective corrective exercise on balance pad improves falling and functional balance in idiopathic PD.

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BACKGROUND Improving patients' health-related quality of life (HRQoL) is recognized as a fundamental part of asthma management. The aims of this study were to evaluate the long-term efficacy (including symptom-free days and exacerbations) and impact on HRQoL of a stable-dose regimen of salmeterol/fluticasone propionate (SAL/FP) and an adjustable maintenance dosing (AMD) regimen of formoterol/budesonide (FOR/BUD) where treatment is adjusted based on symptoms [SAM40056]. METHODS A total of 688 outpatients with asthma receiving regular low-dose inhaled corticosteroids (ICS) plus a long-acting beta2-agonist, or medium dose ICS alone participated in this randomized, double-blind, double-dummy, parallel-group, 1-year trial, which was conducted in 91 centers in 15 countries. Patients were randomized to receive 1 inhalation of SAL/FP 50/250 mug BID or 2 inhalations of FOR/BUD 6/200 mug BID during Weeks 1-4. For Weeks 5-52, patients meeting strict continuation criteria for stable asthma at Week 4 received AMD with FOR/BUD or stable-dose SAL/FP. RESULTS The percentage of symptom-free days was significantly greater (58.8% vs 52.1%; p = 0.034) and the annual exacerbation rate was significantly lower (47%; p = 0.008) with stable-dose SAL/FP compared with FOR/BUD AMD. A total of 568 patients completed the Asthma Quality of Life Questionnaire (AQLQ) at least once during the study. The mean change from baseline in AQLQ overall score was numerically greater with SAL/FP than FOR/BUD at week 28 and week 52, but did not reach statistical significance (p = 0.121 at Week 52). However, in a post hoc logistic regression analyses for any AQLQ improvement, significant benefits with SAL/FP were seen at both time points (p = 0.038 and p = 0.009, respectively). The minimally important difference of >/= 0.5-point improvement in AQLQ overall score was achieved by a significantly greater number of patients receiving SAL/FP at Week 28 (68% vs 60%; p = 0.049); a trend for this difference remained at Week 52 (71% vs 65%) (p = 0.205). CONCLUSION In this population of patients with persistent asthma, stable-dose SAL/FP resulted in significantly greater increases in symptom-free days, a reduction in exacerbation rates, and provided greater HRQoL benefits compared with FOR/BUD AMD. TRIAL REGISTRATION Clinical Trials registration number NCT00479739.

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BACKGROUND The use of goal directed fluid protocols in intermediate risk patients undergoing hip or knee replacement was studied in few trials using invasive monitoring. For this reason we have implemented two different fluid management protocols, both based on a novel totally non-invasive arterial pressure monitoring device and compared them to the standard (no-protocol) treatment applied before the transition in our academic institution. METHODS Three treatment groups were compared in this prospective study: the observational (CONTROL, N = 40) group before adoption of fluid protocols and two randomized groups after the transition to protocol fluid management with the use of the continuous non-invasive blood pressure monitoring (CNAP®) device. In the PRESSURE group (N = 40) standard variables were used for restrictive fluid therapy. Goal directed fluid therapy using pulse pressure variation was used in the GDFT arm (N = 40). The influence on the rate of postoperative complications, on the hospital length of stay and other parameters was assessed. RESULTS Both protocols were associated with decreased fluid administration and maintained hemodynamic stability. Reduced rate of postoperative infection and organ complications (22 (55 %) vs. 33 (83 %) patients; p = 0.016; relative risk 0.67 (0.49-0.91)) was observed in the GDFT group compared to CONTROL. Lower number of patients receiving transfusion (4 (10 %) in GDFT vs. 17 (43 %) in CONTROL; p = 0.005) might contribute to this observation. No significant differences were observed in other end-points. CONCLUSION In our study, the use of the fluid protocol based on pulse pressure variation assessed using continuous non-invasive arterial pressure measurement seems to be associated with a reduction in postoperative complications and transfusion needs as compared to standard no-protocol treatment. TRIAL REGISTRATION ACTRN12612001014842.

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STATEMENT OF THE PROBLEM Porcelain laminate veneer is an esthetic restoration used as an alternative to full veneer crowns and requires minimal tooth preparation. In restoration with porcelain laminate veneers, both the longevity of the laminate and conservation of the sound tooth structure are imperative. PURPOSE The present study aimed to investigate the shear bond strength of porcelain laminates to prepared- and unprepared- anterior teeth in order to compare their longevity and success rate. MATERIALS AND METHOD Thirty extracted maxillary central incisors were randomly divided into 3 groups regarding their preparation methods. The preparation methods were full-preparation in group A, full-preparation and finishing with fine diamond bur in group B, and no-preparation, only grinding with diamond bur in group C. After conditioning the teeth, ceramic veneers (IP S e.max) were silanated and then cemented with DuoLink luting cement. The shear bond strength was measured for each group and failure mode was determined by stereomicroscopic examination. RESULTS Group C exhibited the highest shear bond strength. The shear bond strength was significantly different between groups C and B ( p < 0.05). However, the difference between group A and C was insignificant, as was the difference between group A and B ( p > 0.05). Adhesion failure mode was found to be more common than the cohesive mode. CONCLUSION Regarding the shear bond strength of unprepared anterior teeth to porcelain laminate veneers yielded by this study, no-preparation veneers might be used when the enamel is affected by wearing, trauma, or abrasion. It can also be used in patients who refuse the treatments which involve tooth reduction and preparation.

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BACKGROUND Epidural hematoma is a rare but serious complication. According to previous studies, it is not prevented by suction drains. This study evaluated the following alternative hypothesis: the larger the diameter of a suction drain, the less the remaining epidural hematoma after spinal surgery. METHODS This was a randomized prospective study. Patients who underwent posterior lumbar decompression and instrumented fusion were divided into two groups: the large drain (LD, 2.8-mm-diameter tube) and small drain (SD, 1.6-mm-diameter tube) groups according to the diameter of the suction drains. All patients were consecutive and allocated alternately according to the date of operations. Suction drains were removed on day 3 and magnetic resonance imaging was performed on day 7 postoperatively. The size of remaining hematomas was measured by the degree of thecal sac compression in cross section using the following 4-point numeric scale: G1, less than one quarter; G2, between one quarter and half; G3, more than half; and G4, more than subtotal obstruction. RESULTS There were 39 patients with LDs and 38 with SDs. They did not differ significantly in terms of sex, number of fusion segments, revision or not, antiplatelet medication, intraoperative injection of tranexamic acid. However, patient age differed significantly between the two groups (LD, 63.3 years and < SD, 68.6 years; p = 0.007). The two groups did not differ significantly in terms of prothrombin time, activated partial thromboplastin time, platelet number, blood loss, or operation duration. However, platelet function analysis exhibited a significant difference (LD, 164.7 seconds and < SD, 222.3 seconds; p = 0.002). The two blinded readers showed high consistency (Kappa value = 0.740; p = 0.000). The results of reader 1 were as follows: LD and SD had 21 and 21 cases of G1, 9 and 11 cases of G2, 6 and 6 cases of G3, and 3 and 0 cases of G4, respectively. The results of reader 2 were as follows: LD and SD had 22 and 23 cases of G1, 7 and 9 cases of G2, 7 and 6 cases of G3, and 3 and 0 cases of G4, respectively. There was no difference between the two groups (reader 1, p = 0.636; reader 2, p = 0.466). CONCLUSIONS The alternative hypothesis was rejected. Therefore, postoperative spinal epidural hematoma would not be prevented by LD.

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BACKGROUND Mental health policy makers encourage the development of electronic decision aids to increase patient participation in medical decision making. Evidence is needed to determine whether these decision aids are helpful in clinical practice and whether they lead to increased patient involvement and better outcomes. OBJECTIVE This study reports the outcome of a randomized controlled trial and process evaluation of a Web-based intervention to facilitate shared decision making for people with psychotic disorders. METHODS The study was carried out in a Dutch mental health institution. Patients were recruited from 2 outpatient teams for patients with psychosis (N=250). Patients in the intervention condition (n=124) were provided an account to access a Web-based information and decision tool aimed to support patients in acquiring an overview of their needs and appropriate treatment options provided by their mental health care organization. Patients were given the opportunity to use the Web-based tool either on their own (at their home computer or at a computer of the service) or with the support of an assistant. Patients in the control group received care as usual (n=126). Half of the patients in the sample were patients experiencing a first episode of psychosis; the other half were patients with a chronic psychosis. Primary outcome was patient-perceived involvement in medical decision making, measured with the Combined Outcome Measure for Risk Communication and Treatment Decision-making Effectiveness (COMRADE). Process evaluation consisted of questionnaire-based surveys, open interviews, and researcher observation. RESULTS In all, 73 patients completed the follow-up measurement and were included in the final analysis (response rate 29.2%). More than one-third (48/124, 38.7%) of the patients who were provided access to the Web-based decision aid used it, and most used its full functionality. No differences were found between the intervention and control conditions on perceived involvement in medical decision making (COMRADE satisfaction with communication: F1,68=0.422, P=.52; COMRADE confidence in decision: F1,67=0.086, P=.77). In addition, results of the process evaluation suggest that the intervention did not optimally fit in with routine practice of the participating teams. CONCLUSIONS The development of electronic decision aids to facilitate shared medical decision making is encouraged and many people with a psychotic disorder can work with them. This holds for both first-episode patients and long-term care patients, although the latter group might need more assistance. However, results of this paper could not support the assumption that the use of electronic decision aids increases patient involvement in medical decision making. This may be because of weak implementation of the study protocol and a low response rate.

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PURPOSE To evaluate the comparative therapeutic efficacy of radiofrequency ablation (RFA) and hepatic resection for the treatment of colorectal liver metastasis (CRLM). METHODS Between 1996 and 2008, 177 patients underwent RFA, 278 underwent hepatic resection and 27 underwent combination therapy for CRLM. Comparative analysis of clinical outcomes was performed including number of liver metastases, tumor size, and time of CRLM. RESULTS Based on multivariate analysis, overall survival (OS) correlated with the number of liver metastases and the use of combined chemotherapy (P < 0.001, respectively). Disease-free survival (DFS) also correlated with the number of liver metastases (P < 0.001). In the 226 patients with solitary CRLM < 3 cm, OS and DFS rates did not differ between the RFA group and the resection group (P = 0.962 and P = 0.980). In the 70 patients with solitary CRLM ≥ 3 cm, DFS was significantly lower in the RFA group as compared with the resection group (P = 0.015). CONCLUSION The results indicate that RFA may be a safe alternative treatment for solitary CRLM less than 3 cm, with outcomes equivalent to those achieved with hepatic resection. A randomized controlled study comparing RFA and resection for patients with single small metastasis would help to determine the most efficient treatment modalities for CRLM.

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BACKGROUND Persistent hyperlactatemia during septic shock is multifactorial. Hypoperfusion-related anaerobic production and adrenergic-driven aerobic generation together with impaired lactate clearance have been implicated. An excessive adrenergic response could contribute to persistent hyperlactatemia and adrenergic modulation might be beneficial. We assessed the effects of dexmedetomidine and esmolol on hemodynamics, lactate generation, and exogenous lactate clearance during endotoxin-induced septic shock. METHODS Eighteen anesthetized and mechanically ventilated sheep were subjected to a multimodal hemodynamic/perfusion assessment including hepatic and portal vein catheterizations, total hepatic blood flow, and muscle microdialysis. After monitoring, all received a bolus and continuous infusion of endotoxin. After 1 h they were volume resuscitated, and then randomized to endotoxin-control, endotoxin-dexmedetomidine (sequential doses of 0.5 and 1.0 μg/k/h) or endotoxin-esmolol (titrated to decrease basal heart rate by 20 %) groups. Samples were taken at four time points, and exogenous lactate clearance using an intravenous administration of sodium L-lactate (1 mmol/kg) was performed at the end of the experiments. RESULTS Dexmedetomidine and esmolol were hemodynamically well tolerated. The dexmedetomidine group exhibited lower epinephrine levels, but no difference in muscle lactate. Despite progressive hypotension in all groups, both dexmedetomidine and esmolol were associated with lower arterial and portal vein lactate levels. Exogenous lactate clearance was significantly higher in the dexmedetomidine and esmolol groups. CONCLUSIONS Dexmedetomidine and esmolol were associated with lower arterial and portal lactate levels, and less impairment of exogenous lactate clearance in a model of septic shock. The use of dexmedetomidine and esmolol appears to be associated with beneficial effects on gut lactate generation and lactate clearance and exhibits no negative impact on systemic hemodynamics.

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BACKGROUND In two clinical trials, low-grade fever was observed more frequently after coadministration than after separate administration of two recommended routine pediatric vaccines. Since fever is an important issue with vaccine tolerability, we performed this open-label study on the efficacy and safety of prophylactic use of paracetamol (acetaminophen, Benuron®) in children administered routine 7-valent pneumococcal conjugate vaccine (PCV-7) coadministered with hexavalent vaccine (diphtheria-tetanus-acellular pertussis-hepatitis B, poliovirus, Haemophilus influenzae type b vaccine [DTPa-HBV-IPV/Hib]) in Germany. METHODS Healthy infants (N = 301) who received a 3-dose infant series of PCV-7 and DTPa-HBV-IPV/Hib plus a toddler dose were randomly assigned 1:1 to prophylactic paracetamol (125 mg or 250 mg suppositories, based on body weight) at vaccination, and at 6-8 hour intervals thereafter, or a control group that received no paracetamol. Rectal temperature and local and other systemic reactions were measured for 4 days post vaccination; adverse events were collected throughout the study. RESULTS In the intent-to-treat population, paracetamol reduced the incidence of fever ≥38°C, but this reduction was only significant for the infant series, with computed efficacy of 43.0% (95% confidence interval [CI]: 17.4, 61.2), and not significant after the toddler dose (efficacy 15.9%; 95% CI: -19.9, 41.3); results were similar in the per protocol (PP) population. Fever >39°C was rare during the infant series, such that there were too few cases for assessment. After the toddler dose, paracetamol effectively reduced fever >39°C, reaching statistical significance in the PP population only (efficacy 79%; 95% CI: 3.9, 97.7). Paracetamol also reduced reactogenicity, but there were few significant differences between groups after any dose. No vaccine-related serious adverse events were reported. CONCLUSIONS Paracetamol effectively prevented fever and other reactions, mainly during the infant series. However, as events were generally mild and of no concern in either group our data support current recommendations to administer paracetamol to treat symptoms only and not for routine prophylaxis. TRIAL REGISTRATION NCT00294294.

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BACKGROUND Fluticasone furoate (FF) is a novel long-acting inhaled corticosteroid (ICS). This double-blind, placebo-controlled randomized study evaluated the efficacy and safety of FF 200 mcg or 400 mcg once daily, either in the morning or in the evening, and FF 200 mcg twice daily (morning and evening), for 8 weeks in patients with persistent asthma. METHODS Asthma patients maintained on ICS for ≥ 3 months with baseline morning forced expiratory volume in one second (FEV(1)) 50-80% of predicted normal value and FEV(1) reversibility of ≥ 12% and ≥ 200 ml were eligible. The primary endpoint was mean change from baseline FEV(1) at week 8 in pre-dose (morning or evening [depending on regimen], pre-rescue bronchodilator) FEV(1). RESULTS A total of 545 patients received one of five FF treatment groups and 101 patients received placebo (intent-to-treat population). Each of the five FF treatment groups produced a statistically significant improvement in pre-dose FEV(1) compared with placebo (p < 0.05). FF 400 mcg once daily in the evening and FF 200 mcg twice daily produced similar placebo-adjusted improvements in evening pre-dose FEV(1) at week 8 (240 ml vs. 235 ml). FF 400 mcg once daily in the morning, although effective, resulted in a smaller improvement in morning pre-dose FEV(1) than FF 200 mcg twice daily at week 8 (315 ml vs. 202 ml). The incidence of oral candidiasis was low (0-4%) and UC excretion was comparable with placebo for all FF groups. CONCLUSIONS FF at total daily doses of 200 mcg or 400 mcg was significantly more effective than placebo. FF 400 mcg once daily in the evening had similar efficacy to FF 200 mcg twice daily and all FF regimens had a safety tolerability profile generally similar to placebo. This indicates that inhaled FF is an effective and well tolerated once-daily treatment for mild-to-moderate asthma. TRIAL REGISTRATION NCT00398645.

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OBJECTIVES To compare the costs and cost-effectiveness of managing patients with uncontrolled blood pressure (BP) using telemonitoring versus usual care from the perspective of the National Health Service (NHS). DESIGN Within trial post hoc economic evaluation of data from a pragmatic randomised controlled trial using an intention-to-treat approach. SETTING 20 socioeconomically diverse general practices in Lothian, Scotland. PARTICIPANTS 401 primary care patients aged 29-95 with uncontrolled daytime ambulatory blood pressure (ABP) (≥135/85, but <210/135 mm Hg). INTERVENTION Participants were centrally randomised to 6 months of a telemonitoring service comprising of self-monitoring of BP transmitted to a secure website for review by the attending nurse/doctor and patient, with optional automated patient decision-support by text/email (n=200) or usual care (n-201). Randomisation was undertaken with minimisation for age, sex, family practice, use of three or more hypertension drugs and self-monitoring history. MAIN OUTCOME MEASURES Mean difference in total NHS costs between trial arms and blinded assessment of mean cost per 1 mm Hg systolic BP point reduced. RESULTS Home telemonitoring of BP costs significantly more than usual care (mean difference per patient £115.32 (95% CI £83.49 to £146.63; p<0.001)). Increased costs were due to telemonitoring service costs, patient training and additional general practitioner and nurse consultations. The mean cost of systolic BP reduction was £25.56/mm Hg (95% CI £16.06 to £46.89) per patient. CONCLUSIONS Over the 6-month trial period, supported telemonitoring was more effective at reducing BP than usual care but also more expensive. If clinical gains are maintained, these additional costs would be very likely to be compensated for by reductions in the cost of future cardiovascular events. Longer-term modelling of costs and outcomes is required to fully examine the cost-effectiveness implications. TRIAL REGISTRATION International Standard Randomised Controlled Trials, number ISRCTN72614272.

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BACKGROUND Intermittent preventive treatment in pregnancy has not been evaluated outside of Africa. Low birthweight (LBW, <2,500 g) is common in Papua New Guinea (PNG) and contributing factors include malaria and reproductive tract infections. METHODS From November 2009 to February 2013, we conducted a parallel group, randomised controlled trial in pregnant women (≤ 26 gestational weeks) in PNG. Sulphadoxine-pyrimethamine (1,500/75 mg) plus azithromycin (1 g twice daily for 2 days) (SPAZ) monthly from second trimester (intervention) was compared against sulphadoxine-pyrimethamine and chloroquine (450 to 600 mg, daily for three days) (SPCQ) given once, followed by SPCQ placebo (control). Women were assigned to treatment (1:1) using a randomisation sequence with block sizes of 32. Participants were blinded to assignments. The primary outcome was LBW. Analysis was by intention-to-treat. RESULTS Of 2,793 women randomised, 2,021 (72.4%) were included in the primary outcome analysis (SPCQ: 1,008; SPAZ: 1,013). The prevalence of LBW was 15.1% (305/2,021). SPAZ reduced LBW (risk ratio [RR]: 0.74, 95% CI: 0.60-0.91, P = 0.005; absolute risk reduction (ARR): 4.5%, 95% CI: 1.4-7.6; number needed to treat: 22), and preterm delivery (0.62, 95% CI: 0.43-0.89, P = 0.010), and increased mean birthweight (41.9 g, 95% CI: 0.2-83.6, P = 0.049). SPAZ reduced maternal parasitaemia (RR: 0.57, 95% CI: 0.35-0.95, P = 0.029) and active placental malaria (0.68, 95% CI: 0.47-0.98, P = 0.037), and reduced carriage of gonorrhoea (0.66, 95% CI: 0.44-0.99, P = 0.041) at second visit. There were no treatment-related serious adverse events (SAEs), and the number of SAEs (intervention 13.1% [181/1,378], control 12.7% [174/1,374], P = 0.712) and AEs (intervention 10.5% [144/1,378], control 10.8% [149/1,374], P = 0.737) was similar. A major limitation of the study was the high loss to follow-up for birthweight. CONCLUSIONS SPAZ was efficacious and safe in reducing LBW, possibly acting through multiple mechanisms including the effect on malaria and on sexually transmitted infections. The efficacy of SPAZ in the presence of resistant parasites and the contribution of AZ to bacterial antibiotic resistance require further study. The ability of SPAZ to improve pregnancy outcomes warrants further evaluation. TRIAL REGISTRATION ClinicalTrials.gov NCT01136850 (06 April 2010).

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BACKGROUND Arthroscopy is often used to treat patients with chronic patellofemoral pain syndrome (PFPS). As there is a lack of evidence, we conducted a randomized controlled trial to study the efficacy of arthroscopy in patients with chronic PFPS. METHODS A total of 56 patients with chronic PFPS were randomized into two treatment groups: an arthroscopy group (N = 28), treated with knee arthroscopy and an 8-week home exercise program, and a control group (N = 28), treated with the 8-week home exercise program only. The arthroscopy included finding-specific surgical procedures according to current recommendations. The primary outcome was the Kujala score on patellofemoral pain and function at 9 months following randomization. Secondary outcomes were visual analog scales (VASs) to assess activity-related symptoms. We also estimated the direct healthcare costs. RESULTS Both groups showed marked improvement during the follow-up. The mean improvement in the Kujala score was 12.9 (95% confidence interval (CI) 8.2-17.6) in the arthroscopy group and 11.4 (95% CI 6.9-15.8) in the control group. However, there was no difference between the groups in mean improvement in the Kujala score (group difference 1.1 (95% CI -7.4 - 5.2)) or in any of the VAS scores. Total direct healthcare costs in the arthroscopy group were estimated to exceed on average those of the control group by euro901 per patient (p < 0.001). CONCLUSION In this controlled trial involving patients with chronic PFPS, the outcome when arthroscopy was used in addition to a home exercise program was no better than when the home exercise program was used alone. TRIAL REGISTRATION Current Controlled Trials ISRCTN 41800323.

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OBJECTIVE To examine the effects of Diet (D) and Exercise (E) interventions on cardiovascular fitness, waist circumference, blood lipids, glucose metabolism, inflammation markers, insulin-like growth factor 1 (IGF-1) and blood pressure in overweight and obese lactating women. METHODS At 10-14 wk postpartum, 68 Swedish women with a self-reported pre-pregnancy BMI of 25-35 kg/m(2) were randomized to a 12-wk behavior modification treatment with D, E, both or control using a 2×2 factorial design. The goal of D treatment was to reduce body weight by 0.5 kg/wk, accomplished by decreasing energy intake by 500 kcal/d and monitoring weight loss through self-weighing. The goal of E treatment was to perform 4 45-min walks per wk at 60-70% of max heart-rate using a heart-rate monitor. Effects were measured 12 wk and 1 y after randomization. General Linear Modeling was used to study main and interaction effects adjusted for baseline values of dependent variable. RESULTS There was a significant main effect of the D treatment, decreasing waist circumference (P = 0.001), total cholesterol (P = 0.007), LDL-cholesterol (P = 0.003) and fasting insulin (P = 0.042), at the end of the 12-wk treatment. The decreased waist circumference (P<0.001) and insulin (P = 0.024) was sustained and HDL-cholesterol increased (P = 0.005) at the 1-y follow-up. No effects from the E treatment or any interaction effects were observed. CONCLUSIONS Dietary behavior modification that produced sustained weight loss among overweight and obese lactating women also improved risk factors for cardiovascular disease and type 2 diabetes. This intervention may not only reduce weight-related risks with future pregnancies but also long-term risk for metabolic disease. TRIAL REGISTRATION ClinicalTrials.gov NCT01343238.

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BACKGROUND Children use all of their senses when exploring new foods, and sensory-based food education provides new possibilities for promoting healthy dietary habits. OBJECTIVE To evaluate the effect of sensory-based food education activities on children's willingness to eat test samples of selected vegetables and berries. DESIGN Two kindergartens in Hanko, Finland, participated in the study and the subjects were children aged 3-6 years, divided in the intervention (n=44) and control (n=24) kindergarten. In the intervention kindergarten, five sensory-based food education sessions focusing on vegetables and berries were implemented, once per week for 5 weeks. A tasting protocol was performed with the children at baseline and after the intervention. The willingness to eat (5 different vegetables and 3 Finnish berries) was categorised. Parents also filled in a questionnaire on the children's food preferences at home. RESULTS In the intervention kindergarten, the willingness to eat the samples increased significantly (p≤0.001, Wilcoxon and Friedman), while in the control kindergarten, no significant change was observed when all of the test samples were taken into account. The parental report of their children's preferences and children's actual eating of the test samples corresponded relatively weakly. CONCLUSIONS Sensory-based food education activities may promote a willingness to eat vegetables and berries. Child-centred test methods are important for evaluating the effects of dietary interventions among children.

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BACKGROUND AND AIMS This study aimed to determine whether a separate written consent form improved the efficacy of the informed consent process for anesthesia in adult patients undergoing elective surgery at a tertiary care teaching hospital. MATERIAL AND METHODS We randomized patients into two groups prospectively. The first group (Group A) signed the hospital's standard Consent for Operation form only while the second group (Group B) signed a separate Consent for Anesthesia form additionally. Patients were interviewed postoperatively with an eight-item questionnaire with responses in a 5-point Likert scale. A composite adequacy of consent index was generated from the responses and analyzed. RESULTS Two hundred patients (100 in each group) were studied. All patients indicated that the anesthesiologist(s) had their permission to proceed with their anesthesia care. The mean adequacy of consent index score in Group B was higher than that of Group A (30.6 ± 4.6 [standard deviation (SD)] vs. 27.9 ± 5.2 [SD]) (P < 0.001). The separate written consent had a positive impact on the patients' understanding of the nature and purpose of the intended anesthesia procedures (P = 0.04), satisfaction with the adequacy of information provided about common side effects (P < 0.001) and rare but serious complications (P = 0.008). CONCLUSIONS A separate written consent for anesthesia improved the efficacy of the informed consent process with respect to better information about the nature and purpose of anesthesia, common side effects, and rare but serious complications.

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BACKGROUND AND AIMS We designed a study to compare the effectiveness of dexmedetomidine plus ketamine combination with dexmedetomidine alone in search of an ideal sedation regime, which would achieve better intubating conditions, hemodynamic stability, and sedation for awake fiberoptic nasotracheal intubation. MATERIALS AND METHODS A total of 60 adult patients of age group 18-60 years with American Society of Anesthesiologists I and II posted for elective surgery under general anesthesia were randomly divided into two groups of 30 each in this prospective randomized controlled double-blinded study. Groups I and II patients received a bolus dose of dexmedetomidine at 1 mcg/kg over 10 min followed by a continuous infusion of dexmedetomidine at 0.5 mcg/kg/h. Upon completion of the dexmedetomidine bolus, Group I patients received 15 mg of ketamine and an infusion of ketamine at 20 mg/h followed by awake fiberoptic nasotracheal intubation, while Group II patients upon completion of dexmedetomidine bolus received plain normal saline instead of ketamine. Hemodynamic variables like heart rate (HR) and mean arterial pressure (MAP), oxygen saturation, electrocardiogram changes, sedation score (modified Observer assessment of alertness/sedation score), intubation score (vocal cord movement and coughing), grimace score, time taken for intubation, amount of lignocaine used were noted during the course of study. Patient satisfaction score and level of recall were assessed during the postoperative visit the next day. RESULTS Group I patients maintained a stable HR and MAP (<10% fall when compared with the baseline value). Sedation score (3.47 vs. 3.93) and patient satisfaction score were better in Group I patients. There was no significant difference in intubation scores, grimace scores, oxygen saturation and level of recall when compared between the two groups (P > 0.05). CONCLUSION The use of dexmedetomidine plus ketamine combination in awake fiberoptic nasotracheal intubation provided better hemodynamic stability and sedation than dexmedetomidine alone.

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BACKGROUND Mizoribine (MZR) is an immunosuppressive drug used in Japan for treating patients with lupus nephritis and nephrotic syndrome and has been also reportedly effective in patients with immunoglobulin A (IgA) nephropathy. However, to date, few randomized control studies of MZR are performed in patients with IgA nephropathy. Therefore, this prospective, open-label, randomized, controlled trial aimed to investigate the efficacy and safety of adding MZR to standard treatment in these patients, and was conducted between April 1, 2009, and March 31, 2016, as a multicenter study. METHODS Patients were randomly assigned (1:1) to receiving standard treatment plus MZR (MZR group) or standard treatment (control group). MZR was administered orally at a dose of 150 mg once daily for 12 months. RESULTS Primary outcomes were the percentage reduction in urinary protein excretion from baseline and the rate of patients with hematuria disappearance 36 months after study initiation. Secondary outcomes were the rate of patients with proteinuria disappearance, clinical remission rate, absolute changes in estimated glomerular filtration rate from baseline, and the change in daily dose of prednisolone. Forty-two patients were randomly assigned to MZR (n = 21) and control groups (n = 21). Nine patients in MZR group and 15 patients in the control group completed the study. No significant differences were observed between the two groups with respect to primary and secondary outcomes. CONCLUSION The addition of MZR to standard treatment has no beneficial effect on reducing urinary protein excretion and hematuria when treating patients with IgA nephropathy.

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PURPOSE To evaluate the clinical effects of magnesium sulfate in the treatment of diffuse axonal injury (DAI). PATIENTS AND METHODS This study was a randomized, double-blind, placebo-controlled trial conducted in the First Affiliated Hospital of Sun Yat-sen University, Guangzhou and Zhuhai People's Hospital, Zhuhai, two trauma center hospitals. A total of 128 patients suffered from DAI, with initial Glasgow coma scale (GCS) scores of 3-8. They were randomly divided into two groups: magnesium sulfate treatment (MST) group (n=64) and control group (n=64). The MST group received 250 μmol/kg magnesium sulfate intravenously 20 minutes after admission, followed by 750 μmol/kg magnesium sulfate intravenously daily for 5 days. The control group received standard management without MST. GCS scores and serum neuron-specific enolase values were measured and recorded at admission, and on days 3 and 7 after injury. Outcomes were determined by Glasgow outcome scale scores at discharge and at 3 months' follow-up, respectively. RESULTS After the 7-day treatment, patients in the MST group, compared with those in the control group, had a lower serum neuron-specific enolase level (25.40±6.66 vs 29.58±7.32, respectively, P =0.001) and higher GCS score (8.23±2.72 vs 7.05±2.64, respectively, P =0.016). Although the length of stay and mortality did not differ between the groups in the intensive care unit, Glasgow outcome scale score was significantly lower in the MST group at discharge (3.30±1.35 vs 3.90±1.10, P =0.004) and 3 months after discharge (2.95±1.48 vs 3.66±1.44, P =0.009). CONCLUSION Early treatment with magnesium sulfate resulted in a significant improvement in DAI outcome. Further studies are needed to confirm the clinical significance of treatment of DAI patients with magnesium sulfate.

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OBJECTIVES Obesity is associated with hyperactivation of the reward system for high-calorie (HC) versus low-calorie (LC) food cues, which encourages unhealthy food selection and overeating. However, the extent to which this hyperactivation can be reversed is uncertain, and to date there has been no demonstration of changes by behavioral intervention. SUBJECTS AND METHODS We used functional magnetic resonance imaging to measure changes in activation of the striatum for food images at baseline and 6 months in a pilot study of 13 overweight or obese adults randomized to a control group or a novel weight-loss intervention. RESULTS Compared to controls, intervention participants achieved significant weight loss (-6.3±1.0 kg versus +2.1±1.1 kg, P<0.001) and had increased activation for LC food images with a composition consistent with that recommended in the behavioral intervention at 6 months versus baseline in the right ventral putamen (P=0.04), decreased activation for HC images of typically consumed foods in the left dorsal putamen (P=0.01). There was also a large significant shift in relative activation favoring LC versus HC foods in both regions (P<0.04). CONCLUSIONS This study provides the first demonstration of a positive shift in activation of the reward system toward healthy versus unhealthy food cues in a behavioral intervention, suggesting new avenues to enhance behavioral treatments of obesity.

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OBJECTIVE To assess the association between antidepressant medicine use and risk of developing diabetes during the Diabetes Prevention Program (DPP) and Diabetes Prevention Program Outcomes Study (DPPOS). RESEARCH DESIGN AND METHODS DPP/DPPOS participants were assessed for diabetes every 6 months and for antidepressant use every 3 months in DPP and every 6 months in DPPOS for a median 10.0-year follow-up. RESULTS Controlled for factors associated with diabetes risk, continuous antidepressant use compared with no use was associated with diabetes risk in the placebo (adjusted hazard ratio 2.34 [95% CI 1.32-4.15]) and lifestyle (2.48 [1.45-4.22]) arms, but not in the metformin arm (0.55 [0.25-1.19]). CONCLUSIONS Continuous antidepressant use was significantly associated with diabetes risk in the placebo and lifestyle arms. Measured confounders and mediators did not account for this association, which could represent a drug effect or reflect differences not assessed in this study between antidepressant users and nonusers.

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BACKGROUND There are no randomised controlled trials to demonstrate whether lifestyle modifications can improve pregnancy outcomes of gestational diabetes mellitus (GDM) diagnosed by the International Association of Diabetes and Pregnancy Study Group's (IADPSG) criteria. We tested the effectiveness of lifestyle modifications implemented in a 3-tier's shared care (SC) on pregnancy outcomes of GDM. METHODS Between December 2010 and October 2012, we randomly assigned 700 women with IADPSG-defined GDM but without diabetes at 26.3 (interquartile range: 25.4-27.3) gestational weeks in Tianjin, China, to receive SC or usual care (UC). The SC group received individual consultations and group sessions and performed regular self-monitoring of blood glucose compared to one hospital-based education session in the UC group. The outcomes were macrosomia defined as birth weight ≥ 4.0 kg and the pregnancy-induced hypertension (PIH). RESULTS Women in the SC (n = 339) and UC (n = 361) groups delivered their infants at similar gestational weeks. Birth weight of infants in the SC group was lower than that in the UC group (3469 vs. 3371 grams, P = 0.021). The rate of macrosomia was 11.2% (38/339) in the SC group compared to 17.5% (63/361) in the UC group with relative risk (RR) of 0.64 (95% CI: 0.44-0.93). The rate of PIH was 8.0% (27/339) in the SC compared to 4.4% (16/361) in the UC with RR of 1.80 (0.99-3.28). Apgar score at 1 min < 7 was lower but preeclampsia was higher in the SC than in the UC. CONCLUSIONS Lifestyle modifications using a SC system improved pregnancy outcomes in Chinese women with GDM. TRIAL REGISTRATION Clinicaltrials.gov; NCT01565564.

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OBJECTIVES To describe participants' adherence to multiple components (attendance, energy intake, fat gram, exercise goals, and self-monitoring eating and exercise behaviors) of a standard behavioral treatment program (SBT) for weight loss and how adherence to these components may influence weight loss and biomarkers (triglycerides, low density lipoproteins [LDL], high density lipoprotein, and insulin) during the intensive and less-intensive intervention phases. METHODS A secondary analysis of a randomized clinical trial consisting of a SBT with either fat-restricted standard or lacto-ovo vegetarian diet. The 12-month intervention was delivered in 33 group sessions. The first six months reflected the intensive phase; the second six months, the less-intensive intervention phase. We conducted the analysis without regard to treatment assignment. Eligible participants included overweight/obese adults (N = 176; mean body mass index = 34.0 kg/m(2)). The sample was 86.9% female, 70.5% White, and 44.4 +/- 8.6 years old. The outcome measures included weight and biomarkers. RESULTS There was a significant decline in adherence to each treatment component over time (P < 0.0001). In the first six months, adherence to attendance, self-monitoring and the energy goal were significantly associated with greater weight loss (P < 0.05). Adherence to attendance and exercise remained significantly associated with weight loss in the second six months (P < 0.05). Adherence to attendance, self-monitoring and exercise had indirect effects through weight loss on LDL, triglycerides, and insulin (P < 0.05). CONCLUSIONS We observed a decline in adherence to each treatment component as the intervention intensity was reduced. Adherence to multiple treatment components was associated with greater weight loss and improvements in biomarkers. Future research needs to focus on improving and maintaining adherence to all components of the treatment protocol to promote weight loss and maintenance.

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BACKGROUND This randomized, double-blind, multi-center, non-inferiority trial was conducted to assess the efficacy and safety of a cross-linked hyaluronate (XLHA, single injection form) compared with a linear high molecular hyaluronate (HMWHA, thrice injection form) in patients with symptomatic knee osteoarthritis. METHODS Two hundred eighty seven patients with osteoarthritis (Kellgren-Lawrence grade I to III) were randomized to each group. Three weekly injections were given in both groups but two times of saline injections preceded XLHA injection to maintain double-blindness. Primary endpoint was the change of weight-bearing pain (WBP) at 12 weeks after the last injection. Secondary endpoints included Western Ontario and McMaster Universities Osteoarthritis index; patient's and investigator's global assessment; pain at rest, at night, or in motion; OMERACT-OARSI responder rate; proportion of patients achieving at least 20 mm or 40% decrease in WBP; and rate of rescue medicine use and its total consumption. RESULTS Mean changes of WBP at 12 weeks after the last injection were -33.3 mm with XLHA and -29.2 mm with HMWHA, proving non-inferiority of XLHA to HMWHA as the lower bound of 95% CI (-1.9 mm, 10.1 mm) was well above the predefined margin (-10 mm). There were no significant between-group differences in all secondary endpoints. Injection site pain was the most common adverse event and no remarkable safety issue was identified. CONCLUSIONS This study demonstrated that a single injection of XLHA was non-inferior to three weekly injections of HMWHA in terms of WBP reduction, and supports XLHA as an effective and safe treatment for knee osteoarthritis. TRIAL REGISTRATION ClinicalTrials.gov ( NCT01510535 ). This trial was registered on January 6, 2012.

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BACKGROUND Promoting awareness of autism in populations who work with children may result in an earlier diagnosis of the condition. In this study, a computer assisted learning (CAL) package, containing educationally appropriate knowledge about autism was developed; and the effectiveness of this CAL package was evaluated. METHODS The CAL package was developed using computer software, "Xerte" and "Flash Macromedia". The effectiveness of the CAL package was evaluated in 32 childcare students in the UK, who were randomised to watch the CAL package or to read the information leaflet containing the same information (n = 16 in each group). Retention performance, level of enjoyment, and level of confidence to identify a child with autism, after the interventions, were evaluated. The data obtained from two studied groups was analysed using unpaired Student's t-test, 95% confidence interval, and effect size. RESULTS Students who watched the CAL package had superior retention performance percentage scores (p = 0.02, 95% CI = 0.83-12.19, effect size = 0.8) and level of enjoyment (p = 0.04, 95% CI = 0.03-2.75, effect size = 0.7) compared with students who read the information leaflet. However, there was no significant difference in level of confidence to identify a child with autism (p = 0.39, 95% CI = -1.80-0.72, effect size = -0.3). CONCLUSION The CAL package developed was an effective method of educating people who work with children about autism.

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AIM Urinary kallidinogenase (UK) has shown promise in improving cerebral perfusion. This study aimed to examine how UK affects cognitive status and serum levels of amyloid betas (Aβs) 1-40 and 1-42 in patients with cerebral arterial stenosis. METHODS Ninety patients with cerebral arterial stenosis were enrolled, of whom 45 patients received UK + conventional treatment (UK group), and 45 patients received conventional treatment alone as control group. Cognitive status and Aβ1-40 and Aβ1-42 serum levels were determined before treatment and at 4 weeks and 8 weeks after treatment. RESULTS At 4 weeks after treatment, cognitive status in patients treated with UK clearly improved accompanied by Aβ1-40 serum levels decreasing while there was no change of Aβ1-42. Cognitive status in patients receiving UK continued to improve, Aβ1-40 serum levels declined further as well as Aβ1-42 serum levels began to decrease dramatically at 8 weeks after treatment. CONCLUSION UK could improve cognitive status and decrease both Aβ1-40 and Aβ1-42 serum levels to prevent ischemic cerebral injury, which represents a good option for patients with cerebral arterial stenosis.

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BACKGROUND Mycophenolic acid (MPA) is widely used as part of immunosuppressive regimens following allograft transplantation. The large pharmacokinetic (PK) and pharmacodynamic (PD) variability and narrow therapeutic range of MPA provide a potential for therapeutic drug monitoring. The objective of this pilot study was to investigate the MPA PK and PD relation in combination with belatacept (2nd generation CTLA4-Ig) or cyclosporine (CsA). METHODS Seven renal allograft recipients were randomized to either belatacept (n = 4) or cyclosporine (n = 3) based immunosuppression. Samples for MPA PK and PD evaluations were collected predose and at 1, 2 and 13 weeks posttransplant. Plasma concentrations of MPA were determined by HPLC-UV. Activity of inosine monophosphate dehydrogenase (IMPDH) and the expressions of two IMPDH isoforms were measured in CD4+ cells by HPLC-UV and real-time reverse-transcription PCR, respectively. Subsets of T cells were characterized by flow cytometry. RESULTS The MPA exposure tended to be higher among belatacept patients than in CsA patients at week 1 (P = 0.057). Further, MPA concentrations (AUC0-9 h and C0) increased with time in both groups and were higher at week 13 than at week 2 (P = 0.031, n = 6). In contrast to the postdose reductions of IMPDH activity observed early posttransplant, IMPDH activity within both treatment groups was elevated throughout the dosing interval at week 13. Transient postdose increments were also observed for IMPDH1 expression, starting at week 1. Higher MPA exposure was associated with larger elevations of IMPDH1 (r = 0.81, P = 0.023, n = 7 for MPA and IMPDH1 AUC0-9 h at week 1). The maximum IMPDH1 expression was 52 (13-177)% higher at week 13 compared to week 1 (P = 0.031, n = 6). One patient showed lower MPA exposure with time and did neither display elevations of IMPDH activity nor IMPDH1 expression. No difference was observed in T cell subsets between treatment groups. CONCLUSION The significant influence of MPA on IMPDH1 expression, possibly mediated through reduced guanine nucleotide levels, could explain the elevations of IMPDH activity within dosing intervals at week 13. The present regulation of IMPDH in CD4+ cells should be considered when interpreting measurements of IMPDH inhibition.

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BACKGROUND Most individuals at risk for developing cardiovascular disease (CVD) can reduce risk factors through diet and exercise before resorting to drug treatment. The effect of a combination of resistance training with vegetable-based (soy) versus animal-based (whey) protein supplementation on CVD risk reduction has received little study. The study's purpose was to examine the effects of 12 weeks of resistance exercise training with soy versus whey protein supplementation on strength gains, body composition and serum lipid changes in overweight, hyperlipidemic men. METHODS Twenty-eight overweight, male subjects (BMI 25-30) with serum cholesterol >200 mg/dl were randomly divided into 3 groups (placebo (n = 9), and soy (n = 9) or whey (n = 10) supplementation) and participated in supervised resistance training for 12 weeks. Supplements were provided in a double blind fashion. RESULTS All 3 groups had significant gains in strength, averaging 47% in all major muscle groups and significant increases in fat free mass (2.6%), with no difference among groups. Percent body fat and waist-to-hip ratio decreased significantly in all 3 groups an average of 8% and 2%, respectively, with no difference among groups. Total serum cholesterol decreased significantly, again with no difference among groups. CONCLUSION Participation in a 12 week resistance exercise training program significantly increased strength and improved both body composition and serum cholesterol in overweight, hypercholesterolemic men with no added benefit from protein supplementation.

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BACKGROUND Web-based, computer-tailored nutrition education interventions can be effective in modifying self-reported dietary behaviors. Traditional computer-tailored programs primarily targeted individual cognitions (knowledge, awareness, attitude, self-efficacy). Tailoring on additional variables such as self-regulation processes and environmental-level factors (the home food environment arrangement and perception of availability and prices of healthy food products in supermarkets) may improve efficacy and effect sizes (ES) of Web-based computer-tailored nutrition education interventions. OBJECTIVE This study evaluated the short- and medium-term efficacy and educational differences in efficacy of a cognitive and environmental feedback version of a Web-based computer-tailored nutrition education intervention on self-reported fruit, vegetable, high-energy snack, and saturated fat intake compared to generic nutrition information in the total sample and among participants who did not comply with dietary guidelines (the risk groups). METHODS A randomized controlled trial was conducted with a basic (tailored intervention targeting individual cognition and self-regulation processes; n=456), plus (basic intervention additionally targeting environmental-level factors; n=459), and control (generic nutrition information; n=434) group. Participants were recruited from the general population and randomly assigned to a study group. Self-reported fruit, vegetable, high-energy snack, and saturated fat intake were assessed at baseline and at 1- (T1) and 4-months (T2) postintervention using online questionnaires. Linear mixed model analyses examined group differences in change over time. Educational differences were examined with group×time×education interaction terms. RESULTS In the total sample, the basic (T1: ES=-0.30; T2: ES=-0.18) and plus intervention groups (T1: ES=-0.29; T2: ES=-0.27) had larger decreases in high-energy snack intake than the control group. The basic version resulted in a larger decrease in saturated fat intake than the control intervention (T1: ES=-0.19; T2: ES=-0.17). In the risk groups, the basic version caused larger decreases in fat (T1: ES=-0.28; T2: ES=-0.28) and high-energy snack intake (T1: ES=-0.34; T2: ES=-0.20) than the control intervention. The plus version resulted in a larger increase in fruit (T1: ES=0.25; T2: ES=0.37) and a larger decrease in high-energy snack intake (T1: ES=-0.38; T2: ES=-0.32) than the control intervention. For high-energy snack intake, educational differences were found. Stratified analyses showed that the plus version was most effective for high-educated participants. CONCLUSIONS Both intervention versions were more effective in improving some of the self-reported dietary behaviors than generic nutrition information, especially in the risk groups, among both higher- and lower-educated participants. For fruit intake, only the plus version was more effective than providing generic nutrition information. Although feasible, incorporating environmental-level information is time-consuming. Therefore, the basic version may be more feasible for further implementation, although inclusion of feedback on the arrangement of the home food environment and on availability and prices may be considered for fruit and, for high-educated people, for high-energy snack intake. TRIAL REGISTRATION Netherlands Trial Registry NTR3396; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3396 (Archived by WebCite at http://www.webcitation.org/6VNZbdL6w).

1significant effect

BACKGROUND Dexmedetomidine is a highly selective α2 adrenergic agonist that has been shown to decrease the intensity of opioid-induced hyperalgesia (OIH). We aimed to investigate the antihyperalgesic effects of dexmedetomidine on high-dose remifentanil-induced hyperalgesia. METHODS Ninety American Society of Anesthesiologists physical status I-II patients undergoing laparoscopically assisted vaginal hysterectomy (LAVH) were randomly assigned to one of the following three groups, each of which received either dexmedetomidine (an initial dose of 1.0 µg/kg for 10 min, followed by a continuous infusion of 0.7 µg/kg/hr) or placebo saline 15 min before the induction of anesthesia and intraoperative remifentanil infusion: group C received a placebo and 0.05 µg/kg/min remifentanil; group RH received a placebo and 0.3 µg/kg/min remifentanil; and group DRH received dexmedetomidine and 0.3 µg/kg/min remifentanil. RESULTS The mechanical hyperalgesia threshold 24 hr after surgery was significantly lower in group RH than in the other two groups. Postoperative pain intensity using visual analog scale (VAS) and cumulative volume of a patient-controlled analgesia (PCA) containing morphine over 24 hr were significantly greater in group RH than in group DRH. The time to the first postoperative analgesic requirement was significantly shorter in group RH than in the other two groups. The desflurane requirement was significantly greater in group C than in the other groups. The frequency of hypotension and bradycardia was significantly higher, but shivering and postoperative nausea and vomiting were significantly lower in group DRH than in the other two groups. CONCLUSIONS High-doses of remifentanil induced hyperalgesia, which presented a decreased mechanical hyperalgesia threshold, enhanced pain intensity, a shorter time to first postoperative analgesic requirement, and greater morphine consumption, but dexmedetomidine efficiently alleviated those symptoms. Dexmedetomidine may be a novel and effective treatment option for preventing or attenuating OIH.

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BACKGROUND Among the most important and effective factors affecting the efficiency of the human workforce are accuracy, promptness, and ability. In the context of promoting levels and quality of productivity, the aim of this study was to investigate the effects of exposure to noise on the rate of errors, speed of work, and capability in performing manual activities. METHODS This experimental study was conducted on 96 students (52 female and 44 male) of the Isfahan Medical Science University with the average and standard deviations of age, height, and weight of 22.81 (3.04) years, 171.67 (8.51) cm, and 65.05 (13.13) kg, respectively. Sampling was conducted with a randomized block design. Along with controlling for intervening factors, a combination of sound pressure levels [65 dB (A), 85 dB (A), and 95 dB (A)] and exposure times (0, 20, and 40) were used for evaluation of precision and speed of action of the participants, in the ergonomic test of two-hand coordination. Data was analyzed by SPSS18 software using a descriptive and analytical statistical method by analysis of covariance (ANCOVA) repeated measures. RESULTS The results of this study showed that increasing sound pressure level from 65 to 95 dB in network 'A' increased the speed of work (P < 0.05). Increase in the exposure time (0 to 40 min of exposure) and gender showed no significant differences statistically in speed of work (P > 0.05). Male participants got annoyed from the noise more than females. Also, increase in sound pressure level increased the rate of error (P < 0.05). CONCLUSIONS According to the results of this research, increasing the sound pressure level decreased efficiency and increased the errors and in exposure to sounds less than 85 dB in the beginning, the efficiency decreased initially and then increased in a mild slope.

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BACKGROUND Obesity is associated with an atherogenic lipid profile characterized by a predominance of small LDL and HDL particles. Weight loss, by dietary restriction or exercise, increases LDL particle size. Whether these interventions can augment HDL size in conjunction with LDL size remains unknown. OBJECTIVE This study compared the effects of alternate day fasting (ADF), calorie restriction (CR), and endurance exercise on LDL and HDL particle size in overweight and obese subjects. METHODS In a 12-week parallel-arm trial, adult subjects (n = 60) were randomized to 1 of 4 groups: 1) ADF (75% energy restriction for 24-h alternated with ad libitum feeding for 24-h), 2) CR (25% energy restriction every day), 3) exercise (moderate intensity training 3 x/week), or 4) control. RESULTS Body weight was reduced (P < 0.001) by ADF, CR, and exercise (5.2 ± 1.1%, 5.0 ± 1.4%, 5.1 ± 0.9%, respectively). Plasma LDL cholesterol decreased (P < 0.05) with ADF (10 ± 4%) and CR (8 ± 4%), whereas HDL cholesterol increased (P < 0.05) with exercise (16 ± 5%). Integrated LDL particle size was augmented (P = 0.01) by ADF and CR. The proportion of small LDL particles decreased (P = 0.04) with ADF only, and the proportion of large HDL particles increased (P = 0.03) with exercise only. CONCLUSION These results indicate that dietary restriction increases LDL particle size, while endurance training augments HDL particle size, with minimal weight loss. None of these interventions concomitantly increased both LDL and HDL particle size, however.

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INTRODUCTION Most dental procedures require a dry working environment. Although many evaporative drying methods are available, an additional reduction of salivary flow would often be helpful. METHODS This prospective randomized cross-over study compares salivary production in 31 volunteers during direct, indirect, and non-suggestive (control group) intervention. Overall, each volunteer underwent four salivation measurements, i.e. two measurements during two different types of hypnotic suggestion (indirect and direct) arranged in random order and two control sections. All four measurements were conducted successively. RESULTS Both suggestive methods significantly reduced salivary production in comparison to the two control sections (direct suggestion Δ = 1.46 grams per 5 min, p < 0.001, indirect suggestion Δ = 0.94 grams per 5 min, p = 0.039). Direct suggestion showed a significantly higher reduction of salivary production than indirect suggestion (Δ = -0.53 grams per 5 min, p = 0.001). CONCLUSIONS Hypnotic suggestion represents a simple and inexpensive method to reduce salivation and could thus create a better working environment for more comfortable dental treatments for both patients and dentists.

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INTRODUCTION Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. METHOD In this 6-month, phase 3, randomized, placebo-controlled trial, 611 patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR) were randomized 4:4:1:1 to receive: tofacitinib 5 mg BID or tofacitinib 10 mg BID for the duration of the study, or placebo for 3 months followed by tofacitinib 5 mg BID or tofacitinib 10 mg BID. Patient-reported outcomes (PROs) included: Patient Global Assessment of Disease Activity (PtGA); Patient Assessment of Pain (Pain); Health Assessment Questionnaire-Disability Index (HAQ-DI); Medical Outcomes Survey (MOS) Short Form-36 (SF-36); Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); and MOS Sleep Scale. Time-to-event data (PtGA and Pain) were collected using an interactive voice response system daily diary (baseline through day 14). RESULTS At month 3, tofacitinib 5 and 10 mg BID demonstrated statistically significant improvements versus placebo in PtGA (both p < 0.0001), Pain (both p < 0.0001), HAQ-DI (both p < 0.0001), SF-36 Physical (p < 0.0001) and Mental (p < 0.05 [5 mg BID] and p < 0.0001 [10 mg BID]), Component Summary scores and all domain scores (p < 0.05-p < 0.0001) and FACIT-F (both p < 0.0001). Statistically significant changes from baseline in MOS Sleep Scale were reported for 10 mg BID (p < 0.05). Benefits of tofacitinib treatment were rapid in onset and significant improvements were reported at week 2 for PtGA, Pain and HAQ-DI, and differentiation from baseline was seen as early as 3 days after treatment initiation for interactive voice response system (IVRS) PtGA and IVRS Pain. The numbers needed to treat for patients to report changes greater than or equal to the minimum clinically important difference in PtGA, Pain, HAQ-DI, SF-36 Physical Component Summary score and FACIT-F ranged between 4.0-6.1 (5 mg BID) and 3.2-5.0 (10 mg BID). CONCLUSION Tofacitinib monotherapy in DMARD-IR patients resulted in statistically significant and clinically meaningful improvements in multiple PROs versus placebo at month 3, with sustained improvements over 6 months. TRIAL REGISTRATION Clinicaltrials.gov registration NCT00814307 , registered 22 December 2008.

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BACKGROUND Intra-articular injections of platelet-rich plasma (PRP) to treat symptoms of knee osteoarthritis (OA) have been successfully used in young patients and in the early stages of disease. No previous studies have analyzed outcomes of PRP injections during the late stages. HYPOTHESIS PRP reduces pain and leads to a more effective and lasting functional recovery than corticosteroid with local anesthetic. STUDY DESIGN Randomized controlled trial; Level of evidence, 2. METHODS A total of 75 patients with symptomatic knee OA (Kellgren-Lawrence grade 3 to 4) were enrolled in this study between August 2013 and July 2014. Patients were randomized to treatment either with a single leukocyte-reduced PRP or corticosteroid intra-articular injection. The primary variable was visual analog scale assessment at 1 month. Secondary outcomes were the Knee injury and Osteoarthritis Outcome Score (KOOS) and Short Form-36 (SF-36) at 1, 3, and 6 months after treatment. Patient satisfaction at final follow-up was assessed. Both groups were homogeneous and comparable in baseline characteristics. RESULTS All variables improved in both groups. Statistical differences between groups were not found for the majority of the outcome variables, although the magnitude of improvements tended to be greater in the PRP group. Quality-of-life differences between values at 3 and 6 months versus baseline increased significantly more in the study group ( P = .05 and .03, respectively), and so did general health perception differences at 6 months ( P = .018). CONCLUSION A single PRP intra-articular injection is effective for relieving pain and improving activities of daily living and quality of life in late-stage knee OA. For patients with late-stage knee OA who are 67 years or older, 1 intra-articular injection of PRP has similar results to 1 shot of corticosteroid.

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BACKGROUND Approximately one third of all patients who have been successfully treated for cancer suffer from chronic cancer-related fatigue (CCRF). Effective and easily accessible interventions are needed for these patients. OBJECTIVE The current paper reports on the results of a 3-armed randomized controlled trial investigating the clinical effectiveness of two different guided Web-based interventions for reducing CCRF compared to an active control condition. METHODS Severely fatigued cancer survivors were recruited via online and offline channels, and self-registered on an open-access website. After eligibility checks, 167 participants were randomized via an embedded automated randomization function into: (1) physiotherapist-guided Ambulant Activity Feedback (AAF) therapy encompassing the use of an accelerometer (n=62); (2) psychologist-guided Web-based mindfulness-based cognitive therapy (eMBCT; n=55); or (3) an unguided active control condition receiving psycho-educational emails (n=50). All interventions lasted nine weeks. Fatigue severity was self-assessed using the Checklist Individual Strength - Fatigue Severity subscale (primary outcome) six times from baseline (T0b) to six months (T2). Mental health was self-assessed three times using the Hospital Anxiety and Depression Scale and Positive and Negative Affect Schedule (secondary outcome). Treatment dropout was investigated. RESULTS Multiple group latent growth curve analysis, corrected for individual time between assessments, showed that fatigue severity decreased significantly more in the AAF and eMBCT groups compared to the psycho-educational group. The analyses were checked by a researcher who was blind to allocation. Clinically relevant changes in fatigue severity were observed in 66% (41/62) of patients in AAF, 49% (27/55) of patients in eMBCT, and 12% (6/50) of patients in psycho-education. Dropout was 18% (11/62) in AAF, mainly due to technical problems and poor usability of the accelerometer, and 38% (21/55) in eMBCT, mainly due to the perceived high intensity of the program. CONCLUSIONS Both the AAF and eMBCT interventions are effective for managing fatigue severity compared to receiving psycho-educational emails. TRIAL REGISTRATION Trialregister.nl NTR3483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3483 (Archived by WebCite at http://www.webcitation.org/6NWZqon3o).

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BACKGROUND Cardiovascular disease (CVD) is a common problem of middle-aged and older adults. Increased arterial stiffness is a CVD risk factor. Whole-body vibration (WBV) is a simple and convenient exercise for middle-aged and older adults; however, there have been few studies investigating the effect of WBV on arterial stiffness. This study mainly investigated the effect of WBV on arterial stiffness in middle-aged and older adults. METHODS A total of 38 (21 women and 17 men) middle-aged and elderly subjects (average age, 61.9 years) were randomly divided into the WBV group and the control group for a 3-month trial. The WBV group received an intervention of 30 Hz and 3.2 g WBV in a natural full standing posture at a sports center. The brachial-ankle pulse wave velocity (baPWV), a marker of systemic arterial stiffness, and blood pressure and heart rate were measured before and after the intervention. RESULTS After 3 months, there were no significant changes in blood pressure or heart rate in both groups. However, the bilateral baPWV was significantly reduced in the WBV group (decreased by 0.65 m/second [P=0.014]; 0.63 m/second [P=0.041] in either side), but not in the control group. The comparison between the two groups was not statistically significant. CONCLUSION This study found that 3 months of WBV had a positive effect on arterial stiffness in middle-aged and older adults and could therefore be regarded as a supplementary exercise. Larger-scale studies are needed to confirm the effects of WBV in the future.

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BACKGROUND Transrectal ultrasound-guided prostate biopsy (TRUSPB) is considered the procedure of choice for the diagnosis of prostate cancer. Men undergoing this biopsy experience high psychological stress. Different studies recommend techniques as sedation, lidocaine gel intrarectally, periprostatic nerve block alone, or nitrous oxide inhalation as effective methods of analgesia during procedural-related pain or discomfort. We evaluated three techniques for pain relief during TRUSPB and evaluated if there was any increase in the incidence of complications when employing either technique. SETTING Assiut University Hospital, Assiut, Egypt. METHODS Three hundred patients of age 43-92-year-old underwent TRUSPBs. Patients were allocated randomly into three equal groups to receive intravenous (IV) diazepam 5 mg slowly (Group I), bilateral periprostatic nerve block by 10 ml of 1% lidocaine solution injected under ultrasound guidance (Group II), or combined IV diazepam and the periprostatic nerve block (Group III). RESULTS The mean pain score was 4.95 for patients in Group I, 4.15 for patients in Group II, and 2.18 for patients in Group III with statistically significant findings ( F = 120.27, P < 0.001). TRUSPB under combined IV sedation and local anesthesia had no significant increase in the incidence of complications. CONCLUSIONS Patients should have analgesia during TRUSPB to decrease the procedure pain and to improve tolerance permitting proper aiming for biopsy cores without increasing the patient distress. The combined IV sedation and local periprostatic nerve block are efficient in controlling and limiting pain better than employing each technique alone with no significant increase in complications incidence.

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BACKGROUND Research in quality of life traditionally relies on paper-and-pencil questionnaires. Easy access to the Internet has inspired a number of studies that use the Internet to collect questionnaire data. However, Internet-based data collection may differ from traditional methods with respect to response rate and data quality as well as the validity and reliability of the involved scales. OBJECTIVE We used a randomized design to compare a paper-and-pencil questionnaire with an Internet version of the same questionnaire with respect to differences in response rate and completeness of data. METHODS Women referred for mammography at a Danish public hospital from September 2004 to April 2005, aged less than 67 years and without a history of breast cancer, were eligible for the study. The women received the invitation to participate along with the usual letter from the Department of Radiology. A total of 533 women were invited to participate. They were randomized to receive either a paper questionnaire, with a prepaid return envelope, or a guideline on how to fill in the Internet-based version online. The questionnaire consisted of 17 pages with a total of 119 items, including the Short Form-36, Multidimensional Fatigue Inventory-20, Hospital Anxiety and Depression Scale, and questions regarding social status, education level, occupation, and access to the Internet. Nonrespondents received a postal reminder giving them the option of filling out the other version of the questionnaire. RESULTS The response rate before the reminder was 17.9% for the Internet group compared to 73.2% for the paper-and-pencil group (risk difference 55.3%, P < .001). After the reminder, when the participant could chose between versions of the questionnaire, the total response rate for the Internet and paper-and-pencil group was 64.2% and 76.5%, respectively (risk difference 12.2%, P = .002). For the Internet version, 97.8% filled in a complete questionnaire without missing data, while 63.4% filled in a complete questionnaire for the paper-and-pencil version (risk difference 34.5%, P < .001). CONCLUSIONS The Internet version of the questionnaire was superior with respect to completeness of data, but the response rate in this population of unselected patients was low. The general population has yet to become more familiar with the Internet before an online survey can be the first choice of researchers, although it is worthwhile considering within selected populations of patients as it saves resources and provides more complete answers. An Internet version may be combined with the traditional version of a questionnaire, and in follow-up studies of patients it may be more feasible to offer Internet versions.

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BACKGROUND Malignant pleural effusion is a common problem in patients with solid tumours. It has a significant impact on quality of life, and, hence, there is a substantial need to investigate new agents to treat it. PATIENTS AND METHODS This is a prospective randomised controlled study, including patients with symptomatic recurrent malignant pleural effusion of different primaries. Patients were randomised into two groups: the first group received five ampoules of mistletoe preparation with defined lectin content (Viscum Fraxini-2, ATOS Pharma) diluted in 10 cc glucose 5% solution. Re-instillation was repeated every week until complete dryness of the pleural fluid was achieved (the maximum duration of the therapy was eight weeks). The second group received 60 units of bleomycin once intrapleurally. AIMS The primary aim of this paper was to evaluate the efficacy of mistletoe preparation as a palliative treatment for malignant pleural effusions in comparison with bleomycin. The secondary aim was to evaluate the tolerability of the mistletoe preparation. RESULTS A total of 23 patients were included and followed up during the study from December 2007 to January 2012: 13 patients received mistletoe preparation, and ten patients received bleomycin. Overall clinical response was reported in 61.5% of the mistletoe preparation arm versus 30% in bleomycin arm (p = 0.2138), 95% CI = (-0.1203, 0.6325). The toxicity of both arms was mild and manageable; the mistletoe preparation arm included fever, chills, headache, malaise, and, in two cases, allergic reaction, which was controlled by discontinuation of the drug and steroid injection. CONCLUSION Mistletoe preparation is an efficient and well tolerated sclerosant agent which needs further investigation.

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BACKGROUND Recently, the use of ketamine as a systemic and local analgesic drug in reducing post-operative pain is studied more frequently. OBJECTIVES The aim of the present study was to assess the analgesic efficacy of IV ketamine injection inaddition to nephrostomy tract infiltration of ketamine-bupivacaine on postoperative pain relief after tubeless percutaneous nephrolithotomy (PCNL). PATIENTS AND METHODS Patients (n = 100), with renal stone who were candidates for PCNL were randomized to five groups with 20 cases in each: Group C, 10 mL of saline solution was infiltrated into the nephrostomy tract; Group B, 10 mL of 0.25% bupivacaine was infiltrated into the nephrostomy tract; Group BK1, 10 mL of 0.25% bupivacaine plus 0.5 mg/kg ketamine was infiltrated into the nephrostomy tract; Group BK2, 10 mL of 0.25% bupivacaine plus 1.5 mg/kg ketamine was infiltrated into the nephrostomy tract; Group K, 10 mL of saline solution containing 0.5 mg/kg ketamine was intravenously administered. Post-operative pain scores were compared between groups as the primary objective. Comparison of Sedation Scores, rescue analgesic consumption, time to the first rescue analgesics administration, hemodynamic and SpO2 values were regarded as the secondary objective. RESULTS Mean VAS scores in the first 30 min and total analgesic consumption in the first 24 h of post-operative period were significantly lower in groups BK1 and BK2 in comparison with the other groups (P < 0.05). Also, time to first rescue analgesics administration was longer in the same groups (P < 0.05). CONCLUSIONS Infiltration of ketamine plus bupivacaine provides superior analgesic effects in PCNL surgery compared with other methods.

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PURPOSE The objective of this study was to explore the pharmacology of GSK961081, a bi-functional bronchodilator, in healthy volunteers. METHODS Two randomized, double-blind, placebo-controlled studies were conducted. Following optimization of the propranolol dosing regimen (study 1), we conducted a five-period crossover study (study 2) in which subjects received the following treatments: dry powder inhaler (DPI) GSK961081 400 µg + oral placebo, DPI GSK961081 1,200 µg + oral placebo, DPI GSK961081 400 µg + oral propranolol 80 mg, DPI GSK961081 1,200 µg + oral propranolol 80 mg and DPI and oral placebo. GSK961081 (or inhaled placebo) was dosed at 0 h. Propranolol (or oral placebo) was dosed at -8, -2, 4, 10, and 16 h. The primary endpoint for both studies was bronchodilation, measured by specific airway conductance (sGaw), which was assessed at 0, 1, 4, 7, 12, 22, and 24 h in study 2. Tolerability and pharmacokinetics were secondary endpoints. RESULTS Studies 1 and 2 enrolled 18 and 23 subjects, respectively. In study 2, bronchodilation was seen for 24 h following GSK961081 400 and 1,200 μg. In the presence of β2 blockade, GSK961081 1,200 μg demonstrated bronchodilation in the first 4 h after dosing (treatment difference from placebo at 1 h: 1.206; 90% confidence interval [CI] 1.126-1.292; and at 4 h: 1.124; 90% CI 1.078-1.173) but not at 7 h onwards. In the presence of β2 blockade, GSK961081 400 μg demonstrated bronchodilation in the first 1 h after dosing (treatment difference from placebo: 1.193; 90% CI 1.117-1.274), but not at 4 h onwards. Adverse events were reported for 21 (study 1) and 15 subjects (study 2); none were serious, and there were no deaths. CONCLUSION The duration of bronchodilation as a result of receiving the muscarinic antagonist component alone was shorter than that from the muscarinic antagonist β2 agonist combination. Removing the β2 agonist component may underestimate the contribution of the muscarinic antagonist component to the bronchodilation of the combination.

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BACKGROUND Although intravenous (i.v.) lidocaine is used as a perioperative analgesic in abdominal surgery, evidence of efficacy is limited. The infusion dose and duration remain unclear. This study aimed to investigate the effect of a longer low-dose 48-hour infusion regimen on these outcomes. METHODS Fifty-eight adults undergoing elective open colorectal surgery were randomized into the lidocaine group (1.5 mg/kg bolus followed by 1 mg/kg/h infusion for 48 hours) and control group. After surgery, patients were given a fentanyl patient-controlled analgesia machine and time to first bowel movement (primary outcome) and flatus were recorded. Postoperative pain scores and fentanyl consumption were assessed for 72 hours. RESULTS There was no significant difference in time to first bowel movement (80.1 ± 42.2 vs. 82.5 ± 40.4 hours; P = 0.830), time to first flatus (64.7 ± 38.5 vs. 70.0 ± 31.2 hours; P = 0.568), length of hospital stay (9 [8-13] vs. 11 [9-14) days; P = 0.531], nor postoperative pain scores in the lidocaine vs. control groups. Cumulative opioid consumption was significantly lower in the lidocaine vs. the control group from 24 hours onwards. At 72 hours, cumulative opioid consumption (µg fentanyl) in the lidocaine group (1,570 [825-3,587]) was over 40% lower than in the placebo group (2,730 [1,778-5,327]; P = 0.039). CONCLUSIONS A 48-hour low-dose i.v. lidocaine infusion does not significantly speed the return of bowel function in patients undergoing elective open colorectal surgery. It was associated with reduced postoperative opioid consumption, but not with earlier hospital discharge, or lower pain scores.

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BACKGROUND Chronic work-related stress is an independent risk factor for cardiometabolic diseases and associated mortality, particularly when compounded by a sedentary work environment. The purpose of this study was to determine if an office worksite-based hatha yoga program could improve physiological stress, evaluated via heart rate variability (HRV), and associated health-related outcomes in a cohort of office workers. METHODS Thirty-seven adults employed in university-based office positions were randomized upon the completion of baseline testing to an experimental or control group. The experimental group completed a 10-week yoga program prescribed three sessions per week during lunch hour (50 min per session). An experienced instructor led the sessions, which emphasized asanas (postures) and vinyasa (exercises). The primary outcome was the high frequency (HF) power component of HRV. Secondary outcomes included additional HRV parameters, musculoskeletal fitness (i.e. push-up, side-bridge, and sit & reach tests) and psychological indices (i.e. state and trait anxiety, quality of life and job satisfaction). RESULTS All measures of HRV failed to change in the experimental group versus the control group, except that the experimental group significantly increased LF:HF (p = 0.04) and reduced pNN50 (p = 0.04) versus control, contrary to our hypotheses. Flexibility, evaluated via sit & reach test increased in the experimental group versus the control group (p < 0.001). No other adaptations were noted. Post hoc analysis comparing participants who completed ≥70% of yoga sessions (n = 11) to control (n = 19) yielded the same findings, except that the high adherers also reduced state anxiety (p = 0.02) and RMSSD (p = 0.05), and tended to improve the push-up test (p = 0.07) versus control. CONCLUSIONS A 10-week hatha yoga intervention delivered at the office worksite during lunch hour did not improve HF power or other HRV parameters. However, improvements in flexibility, state anxiety and musculoskeletal fitness were noted with high adherence. Future investigations should incorporate strategies to promote adherence, involve more frequent and longer durations of yoga training, and enrol cohorts who suffer from higher levels of work-related stress. TRIAL REGISTRATION ACTRN12611000536965.

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UNLABELLED Patients with COPD using long-term oxygen therapy (LTOT) over 15 h per day have improved outcomes. As inhalation of dry cold gas is detrimental to mucociliary clearance, humidified nasal high flow (NHF) oxygen may reduce frequency of exacerbations, while improving lung function and quality of life in this cohort. In this randomised crossover study, we assessed short-term physiological responses to NHF therapy in 30 males chronically treated with LTOT. LTOT (2-4 L/min) through nasal cannula was compared with NHF at 30 L/min from an AIRVO through an Optiflow nasal interface with entrained supplemental oxygen. Comparing NHF with LTOT: transcutaneous carbon dioxide (TcCO2) (43.3 vs 46.7 mm Hg, p<0.001), transcutaneous oxygen (TcO2) (97.1 vs 101.2 mm Hg, p=0.01), I:E ratio (0.75 vs 0.86, p=0.02) and respiratory rate (RR) (15.4 vs 19.2 bpm, p<0.001) were lower; and tidal volume (Vt) (0.50 vs 0.40, p=0.003) and end-expiratory lung volume (EELV) (174% vs 113%, p<0.001) were higher. EELV is expressed as relative change from baseline (%Δ). Subjective dyspnoea and interface comfort favoured LTOT. NHF decreased TcCO2, I:E ratio and RR, with a concurrent increase in EELV and Vt compared with LTOT. This demonstrates a potential mechanistic rationale behind the improved outcomes observed in long-term treatment with NHF in oxygen-dependent patients. TRIAL REGISTRATION NUMBER ACTRN12613000028707.

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BACKGROUND The aim of this study was to investigate whether needles introduce skin plugs into joints during arthrocentesis. MATERIAL AND METHODS In the first part of this study, the arthrocentesis site was scrubbed with a fluorescein sodium swab, and 90 needles were inserted through the joint tissue and collected for examination under a fluorescence microscope. In the second part of this study, the joints were injected using 720 needles of different gauges. Two different randomly assigned needle insertion techniques were used: needle insertion straight through the joint capsule (subgroup 1) or insertion of the needle into the subcutaneous tissue followed by flushing of the needle with 0.5 mL of 0.9% normal saline prior to advancing the needle through the joint capsule (subgroup 2). RESULTS Of the 90 needle tips examined in the first part of this study, 21 had high-grade fluorescein contamination. In the second part of this study, the incidence of tissue, epidermis, and dermis contamination in subgroup 1 was 57.2%, 43.1%, and 25.0%, respectively. There was no significant difference in the incidence among different gauge needles, except for a difference in epidermis contamination between the 21-gauge and 23-gauge needles. Compared to subgroup 1, subgroup 2 had a significantly lower OR for tissue contamination. CONCLUSIONS It is common to introduce tissue coring with epidermis and dermis into the joint during arthrocentesis, which poses a potential risk for septic arthritis. However, tissue contamination of the joint may be reduced by flushing saline through the needle into the subcutaneous tissues prior to entering the joint capsule.

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BACKGROUND Luteinizing hormone (LH) is essential for normal follicular development and oocyte maturation. In particular, fluctuations of LH during the follicular phase have a significant impact on morphological and functional changes of the oocyte and determine its meiotic status and ability to be fertilized. OBJECTIVE This prospective randomized controlled trial examined effects of endogenous follicular phase LH levels on oocyte maturity and IVF outcomes in fixed vs. flexible in vitro fertilization. MATERIALS AND METHODS Normo-ovulatory women age <39 yr (n=213) were randomized to fixed or flexible gonadotrophin-releasing hormone (GnRH) antagonist protocols. Follicular phase LH, estradiol, and progesterone profiles were measured. Oocytes retrieved, implantation rate, and pregnancy rate were compared between the two groups. RESULTS LH profiles were similar in both protocols. A lower trend of LH values at the end of ovarian stimulation correlated significantly with a higher pregnancy rate, regardless of protocol (p=0.02). Estradiol levels were statistically different with respect to time points within treatment groups (p<0.0001), but not between groups (p=0.43), or pregnancy outcomes (p=0.2595). Progesterone profiles were similar between groups. No differences were found in retrieved oocytes numbers, fertilization rate or embryos obtained. Significantly, younger age and a higher number of antral follicles were correlated with positive results. CONCLUSION Fixed and flexible GnRH antagonist protocols did not produce an oscillation of endogenous LH values correlated to the outcome of ovarian stimulation.

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BACKGROUND The World Health Organization stresses the importance of accessible and (cost)effective caregiver support, given the expected increase in the number of people with dementia and the detrimental impact on the mental health of family caregivers. METHODS This study assessed the effectiveness of the Internet intervention 'Mastery over Dementia'. In a RCT, 251 caregivers, of whom six were lost at baseline, were randomly assigned to two groups. Caregivers in the experimental group (N = 149) were compared to caregivers who received a minimal intervention consisting of e-bulletins (N = 96). Outcomes were symptoms of depression (Center for Epidemiologic Studies Depression Scale: CES-D) and anxiety (Hospital Anxiety and Depression Scale: HADS-A). All data were collected via the Internet, and an intention-to-treat analysis was carried out. RESULTS Almost all caregivers were spouses or children (in-law). They were predominantly female and lived with the care recipient in the same household. Age of the caregivers varied from 26 to 87 years. Level of education varied from primary school to university, with almost half of them holding a bachelor's degree or higher. Regression analyses showed that caregivers in the experimental group showed significantly lower symptoms of depression (p = .034) and anxiety (p = .007) post intervention after adjustment for baseline differences in the primary outcome scores and the functional status of the patients with dementia. Effect sizes were moderate for symptoms of anxiety (.48) and small for depressive symptoms (.26). CONCLUSIONS The Internet course 'Mastery over Dementia' offers an effective treatment for family caregivers of people with dementia reducing symptoms of depression and anxiety. The results of this study justify further development of Internet interventions for family caregivers of people with dementia and suggest that such interventions are promising for keeping support for family caregivers accessible and affordable. The findings are even more promising because future generations of family caregivers will be more familiar with the Internet. TRIAL REGISTRATION Dutch Trial Register NTR-2051 www.trialregister.nl/trialreg/admin/rctview.asp?TC=2051.

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BACKGROUND Burn injuries can have adverse effects on quality of life of patients and can disturb their physiological, psychological, social and spiritual well-being. This study aimed to investigate the effect of multimedia self-care program on quality of life in burn patients. METHODS This Randomized controlled clinical trial was conducted from November 2015 to December 2016. The samples were hospitalized burn patients with 10% to 45% of 1 st , 2 nd and 3 rd degree burns of total body surface area (TBSA). The patients were randomly allocated into experimental (n=50) and control (n=50) groups. Both groups received the routine in-person self-care trainings of the hospital and then the experimental group received self-care compact disks. The quality of life questionnaire in both groups were completed before intervention and after 3-months and statistically analyzed. RESULTS Accordingly, the changes in quality of life and the dimensions between both groups after 3 month of intervention were significant. The changes in quality of life in experiment group was significantly greater than control group for physical, psychological and social variables. CONCLUSION According to the findings, using multimedia self-care programs can improve burn patient's quality of life, so it is recommended for nurses and hospital staffs of burn injury wards to use multimedia self-care programs as a complementary therapy measure.

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BACKGROUND Budesonide/formoterol is an effective treatment for both asthma and chronic obstructive pulmonary disease. This study compared the efficacy and safety of a novel hydrofluoroalkane (HFA) pressurised metered-dose inhaler (pMDI) formulation of budesonide/formoterol with that of budesonide pMDI and budesonide/formoterol dry-powder inhaler (DPI; Turbuhaler). METHODS This was a 12-week, multinational, randomised, double-blind, double-dummy study involving patients aged > or = 12 years with asthma. All patients had a forced expiratory volume in 1 s of 50-90% predicted normal and were inadequately controlled on inhaled corticosteroids (500-1600 microg/day) alone. Following a 2-week run-in, during which they received their usual medication, patients were randomised (two inhalations twice daily) to budesonide pMDI 200 microg, budesonide/formoterol DPI 160/4.5 microg or budesonide/formoterol pMDI 160/4.5 microg. The primary efficacy end-point was change from baseline in morning peak expiratory flow (PEF). RESULTS In total, 680 patients were randomised, of whom 668 were included in the primary analysis. Therapeutically equivalent increases in morning PEF were observed with budesonide/formoterol pMDI (29.3 l/min) and budesonide/formoterol DPI (32.0 l/min) (95% confidence interval: -10.4 to 4.9; p = 0.48). The increase in morning PEF with budesonide/formoterol pMDI was significantly higher than with budesonide pMDI (+28.7 l/min; p < 0.001). Similar improvements with budesonide/formoterol pMDI vs. budesonide pMDI were seen for all secondary efficacy end-points. Both combination treatments were similarly well tolerated. CONCLUSIONS Budesonide/formoterol, administered via the HFA pMDI or DPI, is an effective and well-tolerated treatment for adult and adolescent patients with asthma, with both devices being therapeutically equivalent.

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BACKGROUND Gastrointestinal (GI) disturbances such as diarrhea and flatulence are the most frequent adverse effects associated with miglustat therapy in type 1 Gaucher disease (GD1) and Niemann-Pick disease type C (NP-C), and the most common recorded reason for stopping treatment during clinical trials and in clinical practice settings. Miglustat-related GI disturbances are thought to arise from the inhibition of intestinal disaccharidases, mainly sucrase isomaltase. We report the effects of a co-administered dietary probiotic, S. boulardii, on the GI tolerability of miglustat in healthy adult subjects. METHODS In a double-blind, placebo-controlled, two-period, two-treatment cross-over trial, healthy adult male and female subjects were randomly allocated to treatment sequences, A-B and B-A (treatment A - miglustat 100 mg t.i.d. + placebo; treatment B - miglustat 100 mg t.i.d. + S. boulardii [500 mg, b.i.d.]). GI tolerability data were collected in patient diaries. The primary endpoint was the total number of 'diarrhea days' (≥3 loose stools within a 24-h period meeting Bristol Stool Scores [BSS] 6-7) based on WHO criteria. Secondary endpoints comprised numerous other diarrhea and GI tolerability indices. RESULTS Twenty-one subjects received randomized therapy in each treatment sequence (total N = 42), and overall, 37 (88 %) subjects completed the study. The total number of diarrhea days was <1.5 for both treatment sequences, and approximately 60 % of subjects did not experience diarrhea during either treatment period. The mean (SD) number of diarrhea days was lower with miglustat + S. boulardii (0.8 [2.4] days) than with miglustat + placebo (1.3 [2.4] days), but the paired treatment difference was not statistically significant (-0.5 [2.4] days; p = 0.159). However, a significant treatment difference (-0.7 [1.9]; p < 0.05) was identified after post hoc exclusion of a clear outlier who had a very high number of diarrhea days (n = 13) and inconsistent GI tolerability reporting. The incidence of the GI AEs was higher with miglustat + placebo (82 %) than with miglustat + S. boulardii (73 %). There were no between-treatment differences in miglustat pharmacokinetics. CONCLUSIONS Although the primary endpoint was not met, the results of the post-hoc analysis suggest that co-administration of miglustat with S. boulardii might improve GI tolerability.

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BACKGROUND The amount of sedation and muscle relaxation of the jaw may have an impact on complications caused by laryngeal mask airway (LMA). The aim of this study is to evaluate the effect of low-dose Atracurium on conditions of insertion, complications, and hemodynamic responses to LMA insertion following induction of anesthesia with propofol, in patients undergoing cataract surgery. PATIENTS AND METHODS In this double-blind randomized clinical trial study, 60 patients were randomly divided into two groups. Initially, the patients in the study group received 0.15 mg/kg intravenous injection of atracurium, and the patients in the control group received 2 ml of intravenous injection of normal saline, after which anesthesia in both groups were induced with midazolam, fentanyl, lidocaine, and propofol. The amount of jaw relaxation, ease of insertion, and the time needed for insertion, hemodynamic responses and complications of LMA insertion were evaluated. RESULTS Jaw relaxation and ease of LMA insertion in the study group was significantly better than that of the control group ( P = 0.02). Average time needed for LMA placement in the study group (5/06 ± 0.52 second) was significantly lower than the control group (5/76 ± 0.67 second) ( P = 0.001). Hemodynamic response to LMA insertion was similar in both groups. Sore throat at recovery and 24 h after surgery in the control group was significantly higher than that of the study group (3/30 vs. 10/30) ( P = 0.01). CONCLUSIONS Using low doses of atracurium decreases the time needed for LMA insertion and sore throat after the operation. Atracurium also increases jaw relaxation and facilitates the placement of LMA.

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OBJECTIVE To compare the safety and effectiveness of flexible ureteroscopy (F-URS) with transperitoneal laparoscopic ureterolithotomy (TPLU) in cases of obstructive pyelonephritis secondary to large proximal ureteral stones. METHODS A series of 42 patients presenting with obstructive pyelonephritis due to proximal ureteral stones larger than 1.5 cm were included from April 2006 to February 2015 in this comparative study. After drainage of pyonephrosis and resolution of sepsis, 22 patients treated with TPLU (Group I), and 20 patients were treated with F-URS (Group II). Preoperative patient and stone characteristics, procedure-related parameters and clinical outcomes were assessed for each group. RESULTS It was seen that both methods were effective in the treatment of large proximal ureteral stones. However TPLU provided a higher stone- free rate (100% vs 80%. p=0.043) and lower retreatment rate. There was no difference between the groups for the operative time and complication rate. On the other hand, patients treated with F-URS had less postoperative pain (p=0.008), a shorter hospital stay (p<0.001) and a faster return to daily activities (p<0.001). CONCLUSIONS The results of our study show that both F-URS and TPLU are safe and effective surgical procedures for treatment of large proximal ureteral stones after controlling obstructive pyelonephritis. However, TPLU has a higher stone-free rate with comparable operating time and complication rate as compared to F-URS. On the other hand F-URS has the advantages of less postoperative pain, shorter hospital stay and faster return to daily activities.

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BACKGROUND Inconsistent effects of school-based obesity prevention interventions may be related to how different subgroups receive them. The aim of this study was to evaluate the effect of an intervention program, including fact sheets to parents and classroom components, on intake of sugar-sweetened beverages (SSB) and screen time. Further, to explore whether potential effects and parental involvement varied by adolescents' gender, weight status (WS) and parental educational level. METHODS In total, 1465 11-year-olds participated at the pre-test and the 8 month mid-way assessment of the HEIA study. Parents (n = 349) contributed with process evaluation data. Self-reported intake of SSB was collected from the 11-year-olds assessing frequency and amount, while time used on watching TV/DVD and computer/game-use (weekday and weekend day) were assed by frequency measures. Data on awareness of the intervention and dose received were collected from parents. Covariance analyses (ANCOVA) were conducted testing for effects by gender and for moderation by WS and parental education. RESULTS Time spent on TV/DVD (week p = 0.001, weekend p = 0.03) and computer/game-use (week p = 0.004, weekend p <.001), and the intake of SSB during weekend days (p = 0.04), were significantly lower among girls in the intervention group compared to the control group girls after 8 months. Girls' WS did not moderate these findings. However, no significant effects of the intervention were found for boys, but moderation effects were found for WS (week days: TV/DVD, p = 0.03 and computer/games, p = 0.02). There were no moderating effects of parental education for neither boys nor girls with respect to intake of SSB, time used for watching TV/DVD and computer/game-use. Parental awareness of the intervention was significantly higher among the parents of girls, while the parents of boys were more satisfied with the fact sheets. CONCLUSIONS The preventive initiatives appeared to change behaviour in girls only. This study suggests that exploration of potential beneficial or negative effects of intervention in subgroups is important. In formative evaluation of obesity prevention studies it seems warranted to include issues related to gender, WS and parental involvement in order to enhance the effectiveness of preventive initiatives.

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OBJECTIVE Two approaches are used to treat Graves' disease with radioiodine ((131)I)-the fixed dose approach and the other based on dosimetry. A prospective study was performed to compare the results of these two approaches in a randomized patient population, as such study is lacking in the Indian population till date. MATERIALS AND METHODS Patients with Graves' disease were randomized into two groups: (1) Fixed dose group and the (2) Calculated dose group, each comprising of 20 patients. All the patients underwent detailed clinical and biochemical evaluation. Thyroid mass was determined by high resolution ultrasound machine with linear transducer of 7-11 MHz. Patients were given 185-370 kBq (5-10 uCi) of (131)I and 24 hr radioiodine uptake (RAIU) was calculated using thyroid uptake probe and thyroid phantom. Fixed dose group patients were administered 185MBq of (131)I. Calculated dose group patients were given (131)I as per the following formula: Calculated dose = [3700 kBq/g × estimated thyroid wt. (g)] ÷ 24 hr RAIU (%). Success of first dose of radioiodine was defined as clinically/biochemically euthyroid/hypothyroid status at the end of 3 months without the need for further therapy. RESULTS In the fixed dose group, eight patients were hyperthyroid, four were euthyroid, and eight were hypothyroid after the first dose at 3 months. Success rate of first dose was 60%. In calculated dose group, seven patients were hyperthyroid, eight were euthyroid, and five were hypothyroid. Success rate of first dose was 65%. CONCLUSIONS There is no statistically significant difference between the success rates of the two methods at 3 months. Hence, fixed dose approach may be used for treatment of Graves' disease as it is simple and convenient for the patient. Longer follow-up with higher number of patients should be done to confirm or contradict our findings.

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OBJECTIVE To examine whether SMS text messaging facilitates a reduction of weight and waist circumference (WC) and favourable changes in lipid profile and insulin levels in clinically healthy overweight and obese subjects. DESIGN A randomised controlled trial. SETTING AND INTERVENTION Primary care health centre in Riga, Latvia. Text messaging once in two weeks. SUBJECTS A total of 123 overweight and obese men and women aged 30-45 years with no cardiovascular diseases (CVDs) or diabetes. MAIN OUTCOME MEASURES changes in anthropometric parameters (weight, WC, body mass index (BMI)) and biochemical parameters (lipids, fasting glucose and insulin). RESULTS We found a statistically significant decrease in weight (2.4%), BMI and WC (4.8%) in the intervention group, while the control group showed a statistically non-significant increase in weight and BMI and decrease in WC. Between group results obtained over the course of a year showed statistically significant mean differences between weight (-3.4 kg (95% CI -5.5, -1.3)), BMI kg/m 2 (-1.14 (95% CI -1.9, -0.41)), WC (-4.6 cm (95% CI -6.8, -2.3)), hip circumference (-4.0 cm (95% CI -5.9, -2.0)) and fasting insulin (2.43 μU/ml (95% CI 0.6, 4.3)). Mean differences of changes in glucose and lipid levels were statistically non significant: fasting glucose (-0.01 mmol/l (95% CI -0.19, 0.17)), TC mmol/l (-0.04 mmol/l (95% CI -0.29, 0.21)), HDL-C (0.14 mmol/l (95% CI -0.65, 0.09)), LDL-C (-0.02 mmol/l (95% CI -0.22, 0.18)) and TG (0.23 mmol/l (95% CI -0.06, 0.52)). CONCLUSIONS SMS messaging in clinically healthy overweight and obese subjects facilitates a slight decrease in weight, BMI and WC. It is anticipated that the implications of this strategy might facilitate the design of preventive and promotive strategies among high risk groups in Latvia.

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BACKGROUND Premenstrual syndrome (PMS) is a combination of physical, psychological, or behavioral changes in the late secretary phase of menstrual cycle and interferes with interpersonal relationships or activities. The purpose was to assess the effects of 8 weeks of regular aerobic exercise on PMS in non-athlete girls. MATERIALS AND METHODS This quasi-experimental study was conducted on 40 non-athlete girl students aged 18-25 years at Khorasgan Azad University, with a diagnosis of PMS. The instruments included personal information and a medical questionnaire, a form of premenstrual symptoms DSM-IV, the GHQ 28 questionnaire, and the Beck Depression and Anxiety questionnaire, and also, daily symptoms were recorded for 4 months (two courses before the training period and two during training). Individuals in the experimental group practiced aerobic exercise for 8 weeks, three sessions per week for 60 min. The subjects were evaluated during the first (the pre-test), second (the mid-test), and third menstrual period (the post-test). Statistical analysis used in this study is t-test and repeated measurement analysis of variance (ANOVA). RESULTS Results showed that the mean scores of PMS and symptoms declined after 8 weeks of training in the experimental group. The comparison of the two groups showed that the mean scores of PMS, for symptoms during and after exercise, were significantly different (P ≤ 0.001) and the percentages of scores PMS changes, physical, and psychological symptoms of experimental and control groups had a significant difference (P ≤ 0.001) after 8 weeks of training. CONCLUSIONS Overall, the findings showed that 8 weeks of aerobic exercise is effective in reducing the symptoms of PMS and can be used as a treatment.

1significant effect