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Hasso Plattner Institute 18

BACKGROUND Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The aim was to evaluate the effectiveness at 1-year follow-up of a manualised group-based programme ('FACETS') for managing MS-fatigue. METHODS One-year follow-up of a pragmatic multi-centre randomised controlled trial. People with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcome measures were fatigue severity (Global Fatigue Severity subscale of the Fatigue Assessment Instrument), self-efficacy (MS-Fatigue Self-Efficacy) and disease-specific quality of life (MS Impact Scale). RESULTS Between May 2008 and November 2009, 164 participants were randomised. Primary outcome data were available at 1 year for 131 (80%). The benefits demonstrated at 4-months in the FACETS arm for fatigue severity and self-efficacy largely persisted, with a slight reduction in standardised effect sizes (SES) (-0.29, p = 0.06 and 0.34, p = 0.09, respectively). There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at 4-months (SES -0.24, p = 0.046). No adverse events were reported. CONCLUSIONS Improvements in fatigue severity and self-efficacy at 4-months follow-up following attendance of FACETS were mostly sustained at 1 year with additional improvements in MS impact. The FACETS programme provides modest long-term benefits to people with MS-fatigue. TRIAL REGISTRATION ISRCTN76517470.

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OBJECTIVE To compare the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) and oral norethisterone acetate (NET) for treatment of non-atypical endometrial hyperplasia in perimenopausal women. METHODS One hundred and twenty perimenopausal women with non-atypical endometrial hyperplasia were selected in this randomized controlled trial. Patients received LNG-IUS (n=59) or NET (n=61; 15 mg/day for 3 weeks/cycle) for 3-6 months. Outpatient follow-up with endometrial biopsies were undertaken at 3, 6, and 12 months intervals after treatment. Outcome measures were; the regression rate, the time to regression and hysterectomy rate. RESULTS A significantly higher regression rate was noted in the LNG-IUS group than in NET group at the 3rd, 6th and 12th month follow-up visits using intention-to-treat analysis (67.8% vs. 47.5%, relative risk [RR], 1.42; 79.7% vs. 60.7%, RR, 1.31; and 88.1% vs. 55.7%, RR, 1.58, respectively). However, no significant difference was found regarding the median time to regression (3 months). The hysterectomy rate during the follow-up period was significantly higher in the NET group (57.4% vs.22%, p<0.001). CONCLUSION LNG-IUS treatment of non-atypical endometrial hyperplasia in perimenopausal women is more effective than NET for achieving disease regression for the majority within 1 year. Moreover, it can reduce the number of hysterectomies performed.

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CONTEXT AND BACKGROUND Dose sparing action of one adjuvant for another in regional anesthesia. AIMS AND OBJECTIVES To evaluate and compare the clonidine-ropivacaine combination with fentanyl-ropivacaine in epidural anesthesia and also to find out whether addition of clonidine can reduce the dose of fentanyl in epidural anesthesia. MATERIALS AND METHODS 60 patients of ASA grade I and II between the ages of 21 and 55 years, who underwent lower abdominal surgeries, were included randomly into three clinically controlled study groups comprising 20 patients in each. They were administered epidural anesthesia with ropivacaine-clonidine (RC), ropivacaine-fentanyl (RF) or ropivacaine-fentanyl-clonidine (RCF). Per-op and post-op block characteristics as well as hemodynamic parameters were observed and recorded. Statistical data were compiled and analyzed using non-parametric tests and P<0.05 was considered as significant value. RESULTS The demographic profile of the patients in all the three groups was similar as were the various block characteristics. The reduction of clonidine and fentanyl in the RCF group did not make any significant difference (P>0.05) in the analgesic properties of drug combination and hemodynamic parameters as compared to RC and RF groups. However, there was significant reduction of incidence of side effects in the RCF group (P<0.05) and it resulted in increased patient comfort. CONCLUSIONS The analgesic properties of the clonidine and fentanyl when used as adjuvant to ropivacaine in epidural anesthesia are almost comparable and both can be used in combination at lower dosages without impairing the pharmacodynamic profile of the drugs as well as with a significant reduction in side effects.

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BACKGROUND/AIMS Suppression of gastrointestinal (GI) peristalsis during GI endoscopy commonly requires antispasmodic agents such as hyoscine butylbromide, atropine, glucagon, and cimetropium bromide. This study examined the efficacy of oral phloroglucin for the suppression of peristalsis, its impact on patient compliance, and any associated complications, and compared it with intravenous or intramuscular cimetropium bromide administration. METHODS This was a randomized, investigator-blind, prospective comparative study. A total of 172 patients were randomized into two groups according to the following medications administered prior to upper endoscopy: oral phloroglucin (group A, n=86), and cimetropium bromide (group B, n=86). The numbers and the degrees of peristalsis events at the antrum and second duodenal portion were assessed for 30 seconds. RESULTS A significantly higher number of gastric peristalsis events was observed in group A (0.49 vs. 0.08, p<0.001), but the difference was not clinically significant. No significant difference between both groups was found in the occurrence of duodenal peristalsis events (1.79 vs. 1.63, p=0.569). The incidence of dry mouth was significantly higher with cimetropium bromide than with phloroglucin (50% vs. 15.1%, p<0.001). CONCLUSIONS Oral phloroglucin can be used as an antispasmodic agent during upper endoscopy, and shows antispasmodic efficacy and adverse effects similar to those of cimetropium bromide.

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AIM To assess the effectiveness of laparoscopic stentless pyeloplasty for congenital ureteropelvic junction obstruction. MATERIALS AND METHODS This was a prospective comparative study conducted over a period of 5 years. The study included 35 cases of primary ureteropelvic junction obstruction (UPJO) with mean age of 29.5 years, divided in two groups- Group A (stent-less, 18 patients) and Group B (stented, 17 patients). Follow up ranged from one to 4years (mean 2 years). Transperitoneal laparoscopic Anderson- Hyene's pyeloplasty was standard for both the groups. Perioperative and postoperative complications were prospectively collected and analyzed by Statistical Package for Social Sciences (SPSS) 17 version using Pearson chi square test. RESULTS Both the groups were comparable with respect to preoperative differential renal function (DRF) and time required for maximum activity in minutes (tmax.min). Average post operative DRF was significantly higher than preoperative DRF in both the groups. Average tmax was significantly lower after pyeloplasty than pre operative tmax. Mean operative time, mean duration of urethral catheter, and mean duration of drain removal were comparable in both the groups. However bothersome irritative lower urinary tract symptoms (LUTS) and hematuria were significantly more in group B patients (P < 0.0001 and <0.013 respectively). CONCLUSION In experienced hands, laparoscopic stentless pyeloplasty is as effective method for treating UPJO as its stented counterpart. It is cost effective, avoids stent-related morbidity, and could be performed without compromising the success rate. However, more randomized studies are needed to evaluate the safety of stentless pyeloplasty.

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BACKGROUND/AIM The aim of the study was to compare laparoscopic and open appendectomy (OA) in terms of primary outcome measures. STUDY DESIGN A randomized controlled trial. Place and duration of the study: Khyber Teaching Hospital, Peshawar, Pakistan, February 2008 to December 2009. PATIENTS AND METHODS A total of 160 patients were divided into two groups, A and B. Group A patients were subjected to laparoscopic appendectomy (LA), whereas Group B patients were subjected to OA. Data regarding age, gender, and primary outcome measures, such as hospital stay, operative duration, and postoperative complication, were recorded and analyzed. Percentages were calculated for categorical data, whereas numerical data were represented as mean ± SD. Chi-square test and t test were used to compare categorical and numerical variables, respectively. Probability ≤ 0.05 (P ≤ 0.05) was considered significant. RESULTS After randomization, 72 patients in group A and 75 patients in group B were analyzed. The mean age of patients in groups A and B was 23.09 ± 8.51 and 23.12 ± 10.42 years, respectively, (P = 0.981). The mean hospital stay was 1.52 ± 0.76 days in group A and 1.70 ± 1.06 days in group B (P = 0.294). The mean operative duration in group A and B were 47.54 ± 12.82 min and 31.36 ± 11.43 min, respectively (P < 0.001). Pain (overall level) was significantly less in group A compared with group B (P = 0.004). The two groups were comparable in terms of other postoperative complications, such as hematoma (P = 0.87), paralytic ileus (P = 0.086), urinary retention (P = 0.504), and wound infection (P = 0.134). CONCLUSION LA is an equivalent procedure and not superior to OA in terms of primary outcome measures.

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PURPOSE We report time to erectile function (EF)-recovery data from a multicenter, randomized, double-blind, double-dummy, placebo-controlled trial evaluating tadalafil started after bilateral nerve-sparing radical prostatectomy (nsRP). METHODS Patients ≤68 years were randomized post-nsRP 1:1:1 to 9-month double-blind treatment (DBT) with tadalafil 5 mg once daily (OaD), 20 mg tadalafil on demand ("pro-re-nata"; PRN), or placebo, followed by 6-week drug-free washout (DFW) and 3-month open-label OaD treatment. Secondary outcome measures included Kaplan-Meier estimates of time to EF-recovery (IIEF-EF ≥ 22) during DBT (Cox proportional hazard model adjusting for treatment, age, and country). RESULTS A total of 423 patients were randomized to tadalafil OaD (N = 139), PRN (N = 143), and placebo (N = 141); 114/122/155 completed DBT. The proportion of patients achieving IIEF-EF ≥22 at some point during DBT with OaD, PRN, and placebo was 29.5, 23.9, and 18.4 %, respectively. DBT was too short to achieve EF-recovery (IIEF-EF ≥ 22) in >50 % of patients; median time to EF-recovery was non-estimable. Time for 25 % of patients to achieve EF-recovery (95 % CI) was 5.8 (4.9, 9.2) months for OaD versus 9.0 (5.5, 9.2) and 9.3 (9.0, 9.9) months for PRN and placebo, respectively. Showing a significant overall treatment effect (p = 0.038), the probability for EF-recovery was significantly higher for OaD versus placebo [hazard ratio (HR); 95 % CI 1.9; 1.2, 3.1; p = 0.011], but not for PRN versus placebo (p = 0.140). Of 57 OaD patients (41.0 %) with ED improved (by ≥1 IIEF-EF severity grade) at the end of DBT, 16 (28.1 % of 57) maintained this improvement through DFW and 27 (47.4 %) declined but maintained improvement from baseline after DFW. CONCLUSIONS Data suggest that the use of tadalafil OaD can significantly shorten the time to EF-recovery post-nsRP compared with placebo.

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OBJECTIVES Perhexiline is thought to modulate metabolism by inhibiting mitochondrial carnitine palmitoyltransferase-1, reducing fatty acid uptake and increasing carbohydrate utilization. This study assessed whether preoperative perhexiline improves markers of myocardial protection in patients undergoing coronary artery bypass graft surgery and analysed its effect on the myocardial metabolome. METHODS In a prospective, randomized, double-blind, placebo-controlled trial, patients at two centres were randomized to receive either oral perhexiline or placebo for at least 5 days prior to surgery. The primary outcome was a low cardiac output episode in the first 6 h. All pre-specified analyses were conducted according to the intention-to-treat principle with a statistical power of 90% to detect a relative risk of 0.5 and a conventional one-sided α-value of 0.025. A subset of pre-ischaemic left ventricular biopsies was analysed using mass spectrometry-based metabolomics. RESULTS Over a 3-year period, 286 patients were randomized, received the intervention and were included in the analysis. The incidence rate of a low cardiac output episode in the perhexiline arm was 36.7% (51/139) vs 34.7% (51/147) in the control arm [odds ratio (OR) 0.92, 95% confidence interval (CI) 0.56-1.50, P = 0.74]. Perhexiline was associated with a reduction in the cardiac index at 6 h [difference in means 0.19, 95% CI 0.07-0.31, P = 0.001] and an increase in inotropic support in the first 12 h (OR 0.55, 95% CI 0.34-0.89, P = 0.015). There were no significant differences in myocardial injury with troponin-T or electrocardiogram, reoperation, renal dysfunction or length of stay. No difference in the preischaemic left ventricular metabolism was identified between groups on metabolomics analysis. CONCLUSIONS Preoperative perhexiline does not improve myocardial protection in patients undergoing coronary surgery and in fact reduced perioperative cardiac output, increasing the need for inotropic support. Perhexiline has no significant effect on the mass spectrometry-visible polar myocardial metabolome in vivo in humans, supporting the suggestion that it acts via a pathway that is independent of myocardial carnitine palmitoyltransferase inhibition and may explain the lack of clinical benefit observed following surgery. CLINICALTRIALSGOV ID NCT00845364.

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BACKGROUND AND AIMS The main purpose of treating and caring for patients with chronic viral hepatitis is to promote life satisfaction and a feeling of well-being in patients suffering from this disease. The aim of this study was to evaluate the effect of education on quality of life in patients with chronic hepatitis who were treated with Interferon alpha. METHODS This quasi-experimental study was conducted on 60 patients with viral hepatitis. The intervention included teaching them the method of self injection of Interferon alpha 2 b, giving them educational pamphlets and then following their continuing treatment with interferon. Patients were randomly assigned to two 30-patient groups. The data- gathering tool was a demographic characteristics questionnaire and the Quality of Life Questionnaire for Patients with Chronic Liver Disease (CLDQ). The educational program was done in four 45- minute sessions for the case group and their relatives. The follow-up period was 12 weeks. Quality of life in patients with chronic hepatitis was measured before initiating interferon therapy, and after the educational period. Quality of life in the two groups was compared. RESULTS The total quality of life score in the two groups before therapy did not show any significant difference (P = 0.351); while 12 weeks after education there was a significant difference between the two groups (P < 0.001) in three items including abdominal symptoms (P = 0.01), worry (P < 0.001) and emotional factors (P < 0.001). The other three items did not show a significant difference between the two groups. The total quality of life score in the case group was significantly different before and after education (P < 0.001), and improved after education. The total quality of life score in the control group did not differ significantly after 12 weeks (P = 0.143). CONCLUSIONS Planning short and simple educational programs has a significant effect on the patient's control of his/her disease and its side effects; and can improve quality of life, life satisfaction, and mechanisms of coping with treatment in patients with viral hepatitis.

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BACKGROUND Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. METHODS This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. RESULTS The participants' mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (P<0.05). Also, a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation (P=0.003). After 8 days, however, the difference in the wound healing score was not significant (P=0.283). Overall, 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. CONCLUSION According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel.

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BACKGROUND A variety of surgical treatment methods for carpal tunnel syndrome are introduced recently, including open surgery, endoscopic and the Knifelight. It is hypothesized that Knifelight method could decrease scar tenderness and time before return to daily activities for patients and is accompanied with less disturbance to fine sensory nerves. OBJECTIVES To compare the Knifelight instrument and open carpal tunnel release with respect to scar length, operation duration, recovery time needed before return to work and amount of pain three weeks after surgery in patients with neurophysiologically confirmed carpal tunnel syndrome. PATIENTS AND METHODS FIFTY NINE PATIENTS WITH INDICATION FOR CARPAL TUNNEL RELEASE RANDOMLY ASSIGNED INTO TWO GROUPS: open (n=30) or Knifelight (n=29). The patients compared regarding scar length, operation duration, time to return to daily activities and amount of pain at three weeks after operation based on Visual Analog Scale. RESULTS There was no significant differences regarding age and sex in the two groups. The scar length, operation duration and time before return to daily activities were significantly lower in the Knifelight group. Although the mean visual analogue scale of Knifelight group found to be lower than the other, it was not statistically significant. CONCLUSIONS The Knifelight technique is accompanied with advantages over the open surgery regarding operation time, scar length and time to return to daily activities. The pain relieve based on Visual Analog Scale was not statistically different from conventional open surgery.

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CONTEXT AND OBJECTIVE Titrating the dosage of growth hormone (GH) to serum levels of insulin-like growth factor-I (IGF-I) is a feasible treatment strategy in children with GH deficiency (GHD) and idiopathic short stature (ISS). The objective was to assess the dose-sparing effect and theoretical safety of IGF-I-based GH therapy. DESIGN, SETTING AND PATIENTS This was a post hoc analysis of a previously described 2-year, multicenter, open-label, randomized, outpatient, controlled clinical trial in 172 prepubertal short children [age 7·5 ± 2·4 years; height standard deviation score (HSDS) -2·64 ± 0·61] classified by baseline peak GH levels as GHD (<7 ng/ml) or ISS (≥7 ng/ml). INTERVENTION Conventional weight-based dosing of GH (0·04 mg/kg/day) (n = 34) or GH dosing titrated to an IGF-I target of 0 SDS (IGF0T; n = 70) or an IGF-I target of +2 SDS (IGF2T; n = 68). MAIN OUTCOME MEASURES Change in HSDS per GH mg/kg/day dose (∆HSDS/GH dose ratio) and proportion of IGF-I levels above +2 SDS at the end of 2 years. RESULTS GH dosing titrated to an IGF-I target of 0 SDS was the most dose-sparing treatment regimen for GHD or ISS children (mean±SE ∆HSDS/GH dose ratios 48·1 ± 4·4 and 32·5 ± 2·8, respectively) compared with conventional dosing (30·3 ± 6·6 and 21·3 ± 3·5, respectively; P = 0·02, P = 0·005) and IGF2T (32·7 ± 4·8 and 16·3 ± 2·8, respectively; P = 0·02, P < 0·0001). IGF0T also resulted in the fewest IGF-I excursions above +2 SDS (6·8% vs 30·0% for conventional dosing; P < 0·01). CONCLUSIONS IGF-I-based GH dosing, targeted to age- and gender-adjusted means, may offer a more dose-sparing and potentially safer mode of therapy than traditional weight-based dosing.

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BACKGROUND Any defect in extremities of the body can affect different life aspects. OBJECTIVES The purpose of this study was to investigate the effect of Roy's adaptation model-guided education on promoting the adaptation of veterans with lower extremities amputation. PATIENTS AND METHODS In a randomized clinical trial, 60 veterans with lower extremities amputation referring to Kowsar Orthotics and Prosthetics Center of veterans clinic in Tehran, Iran, were recruited with convenience method and were randomly assigned to intervention and control groups during 2013 - 2014. For data collection, Roy's adaptation model questionnaire was used. After completing the questionnaires in both groups, maladaptive behaviors were determined in the intervention group and an education program based on Roy's adaptation model was implemented. After two months, both groups completed the questionnaires again. Data was analyzed with SPSS software. RESULTS Independent t-test showed statistically significant differences between the two groups in the post-test stage in terms of the total score of adaptation (P = 0.001) as well as physiologic (P = 0.0001) and role function modes (P = 0.004). The total score of adaptation (139.43 ± 5.45 to 127.54 ± 14.55, P = 0.006) as well as the scores of physiologic (60.26 ± 5.45 to 53.73 ± 7.79, P = 0.001) and role function (20.30 ± 2.42 to 18.13 ± 3.18, P = 0.01) modes in the intervention group significantly increased, whereas the scores of self-concept (42.10 ± 4.71 to 39.40 ± 5.67, P = 0.21) and interdependence (16.76 ± 2.22 to 16.30 ± 2.57, P = 0.44) modes in the two stages did not have a significant difference. CONCLUSIONS Findings of this research indicated that the Roy's adaptation model-guided education promoted the adaptation level of physiologic and role function modes in veterans with lower extremities amputation. However, this intervention could not promote adaptation in self-concept and interdependence modes. More intervention is advised based on Roy's adaptation model for improving the adaptation of veterans with lower extremities.

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BACKGROUND/OBJECTIVE Recent literature has identified links between vitamin B12 deficiency and depression.We compared the clinical response of SSRI-monotherapy with that of B12-augmentation in a sample of depressed patients with low normal B12 levels who responded inadequately to the first trial with the SSRIs. METHODS Patients with depression and low normal B12 levels were randomized to a control arm (antidepressant only) or treatment arm (antidepressants and injectable vitamin B12 supplementation). RESULTS A total of 199 depressed patients were screened. Out of 73 patients with low normal B12 levels 34 (47%) were randomized to the treatment group while 39 (53%) were randomized to the control arm. At three months follow up 100% of the treatment group showed at least a 20% reduction in HAM-D score, while only 69% in the control arm showed at least a 20% reduction in HAM-D score (p<0.001). The findings remained significant after adjusting for baseline HAM-D score (p=0.001). CONCLUSION Vitamin B12 supplementation with antidepressants significantly improved depressive symptoms in our cohort.

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BACKGROUND One of the issues in prostatectomy surgery is bleeding. Although tranexamic acid (TRA) is an antifibrinolytic agent for reducing bleeding, controversies surround its use. OBJECTIVES In this study, the effect of local administration of TRA on reducing bleeding during prostatectomy surgery was evaluated. METHODS A total of 186 patients who underwent prostatectomy surgery were assessed in this clinical trial study. Patients were divided randomly into two groups. After prostate removal, TRA (500 mg TRA with 5 mL total volume) to the intervention group and normal saline to the control group were sprayed with the same volume. At the end of surgery, the prescribed blood bags were measured and recorded. Hemoglobin and platelet levels were recorded 6 hours after the test. Moreover, the amounts of blood inside the blood bags in the first 24 hours, the second 24 hours, and the total length of hospital stay were recorded and compared in each group. RESULTS By comparing the measured values before and after surgery, we found that the amounts of hemoglobin, hematocrit, and platelet decreased. The mean blood loss in the intervention group was recorded at 340 mL and that in the control group was 515 mL. The maximum bleeding in the control group was almost twice as much as that in the intervention group. Blood loss in the intervention group with the administration of TRA was significantly lesser than that in the control group (P = 0.01). The decrease in platelet level in the intervention group was significantly lower than that in the control group (P = 0.03). CONCLUSIONS The present study showed that local administration of TRA significantly reduces bleeding after prostatectomy surgery and is effective in preventing postoperative hemoglobin decrease.

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BACKGROUND Antidepressant drugs such as selective serotonin re-uptake inhibitors (SSRIs) remediate negative biases in emotional processing in depressed patients in both behavioural and neural outcome measures. However, it is not clear if these effects occur before, or as a consequence of, changes in clinical state. METHOD In the present study, we investigated the effects of short-term SSRI treatment in depressed patients on the neural response to fearful faces prior to clinical improvement in mood. Altogether, 42 unmedicated depressed patients received SSRI treatment (10 mg escitalopram daily) or placebo in a randomised, parallel-group design. The neural response to fearful and happy faces was measured on day 7 of treatment using functional magnetic resonance imaging. A group of healthy controls was imaged in the same way. RESULTS Amygdala responses to fearful facial expressions were significantly greater in depressed patients compared to healthy controls. However, this response was normalised in patients receiving 7 days treatment with escitalopram. There was no significant difference in clinical depression ratings at 7 days between the escitalopram and placebo-treated patients. CONCLUSIONS Our results suggest that short-term SSRI treatment in depressed patients remediates amygdala hyperactivity in response to negative emotional stimuli prior to clinical improvement in depressed mood. This supports the hypothesis that the clinical effects of antidepressant treatment may be mediated in part through early changes in emotional processing. Further studies will be needed to show if these early effects of antidepressant medication predict eventual clinical outcome.

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AIMS This post hoc assessment evaluated the efficacy and safety of once-daily, prandial glucagon-like peptide-1 receptor agonist lixisenatide in patients with type 2 diabetes (T2D) and normal renal function (estimated glomerular filtration rate ≥90 mL/min), or mild (60-89 mL/min) or moderate (30-59 mL/min) renal impairment. METHODS Patients from 9 lixisenatide trials in the GetGoal clinical trial programme were categorized by baseline creatinine clearance: normal renal function (lixisenatide n = 2094, placebo n = 1150); renal impairment (mild: lixisenatide n = 637, placebo n = 414; moderate: lixisenatide n = 122, placebo n = 68). Meta-analyses of placebo-adjusted mean differences between baseline renal categories were performed for efficacy and safety outcomes. RESULTS HbA1c, 2-hour postprandial plasma glucose and fasting plasma glucose were comparably reduced in lixisenatide-treated patients with normal renal function, and mild and moderate renal impairment. The most common adverse events (AEs) in all renal function categories were gastrointestinal (GI), predominantly nausea and vomiting. A 14% higher incidence of GI AEs and a 10% higher incidence of nausea and vomiting were seen with mild impairment vs normal function (P = .003 for both), but no significant differences were observed between the mild and moderate impairment categories (P = .99 and P = .57, respectively), or between the moderate impairment and normal categories (P = .16 and P = .65, respectively). Additionally, the incidence of hypoglycaemia was similar in all categories. CONCLUSIONS This study demonstrates that baseline renal status does not affect efficacy outcomes in lixisenatide- vs placebo-treated patients, and that no lixisenatide dose adjustment is required for patients with T2D with mild or moderate renal impairment.

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INTRODUCTION For the total knee arthroplasty in valgus deformed knee, superiority of the medial or lateral approach is still controversial. We compared the short-term result of two approach groups. MATERIALS AND METHODS Forty-seven knees in rheumatoid arthritis with valgus deformity from 6° to 24° were randomly divided into two group; medial approach (24 knees) and lateral approach (24 knees). We used Scorpio NRG PS for all knees. Median postoperative periods were 43 months in both groups. We compared the surgical time, and alignment on standing radiograph, range of motion (ROM) pre/postoperatively, and degrees of soft-tissue release procedure, and lateral laxity measured by stress radiograph immediately after operation and at final follow-up. RESULT Pre/postoperative alignment, surgical time, lateral laxity, and preoperative ROM had no significant in two groups; however, postoperative flexion was superior in lateral approach group 123.8°, 109° in medial approach group. All cases required iliotibial band (ITB) release at Gerdy's tubercle, 83 % ITB at joint level, 21 % lateral collateral ligament (LCL), 17 % popliteus tendon (PT) in medial approach group, and 88 % ITB at Gerdy's tubercle, 46 % ITB at joint level, 13 % LCL, 4 % PT in lateral approach group. DISCUSSION In the valgus knee, lateral structures are tight. Lateral approach can directly adjust the tight structure, and also less vascular compromise to the patella than medial approach with lateral patellar release. Less invasiveness to the quadriceps muscle in lateral approach could result into better range of motion after the surgery.

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BACKGROUND Systematic screening for depression in high-risk patients is recommended but remains controversial. The aim of this study was to assess the effectiveness of such screening in everyday clinical practice on depression recognition. METHODS A pragmatic, cluster randomized, controlled study that randomized primary care physicians (PCPs) in Spain either to an intervention or control group. The intervention group (35-PCPs) received training in depression screening and used depression screening routinely for at least 6 months. The control group (34-PCPs) managed depression in their usual manner. Adherence to (1-6; never-very frequently), feasibility (1-4; unfeasible-very feasible), and acceptance (1-5; very poor-very good) of the screening were evaluated. Underrecognition (primary outcome) and undertreatment rates of major depressive disorder (MDD) in the two groups were compared 6 months after randomization in a random sample of 3737 patients assigned to these PCPs using logistic regression adjusting for the clustering effect. RESULTS No significant differences were found for recognition rates (58.0% vs. 48.1% intervention vs. control; OR [95%CI] 1.40 [0.73-2.68], p = 0.309). The undertreatment rate did not differ significantly either (p = 0.390). The mean adherence to depression screening was 4.4 ± 1.0 ('occasionally'), the mean feasibility was 3.1 ± 0.5 ('moderately feasible'), and the mean acceptance was 4.2 ± 0.6 ('good'). CONCLUSIONS This research was not able to show effectiveness of the systematic screening for MDD in high-risk patients on depression recognition in primary care. The poor adherence to screening implementation could partially explain the results. These reflect the difficulties of putting into practice the clinical guidelines usually based on interventional research. TRIAL REGISTRATION Clinicaltrials.gov NCT01662817.

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OBJECTIVE To compare the effect of aquatic and land-based physiotherapy in reducing musculoskeletal hip and lower back pain and increasing overall physical capabilities of sickle cell disease patients. METHODS Informed written consent was obtained from all volunteers who were submitted to evaluations using different functional scales: Lequesne's Algofunctional Questionnaire and Oswestry Disability Index, trunk and hip range of motion, goniometry, trunk and hip muscle strength assessment using load cell, and surface electromyography of the iliocostalis, long dorsal (longissimus), gluteus maximus, gluteus medius and tensor fasciae latae muscles. Ten patients were randomized into two groups: aquatic physiotherapy with a mean age of 42 years (range: 25-67) and conventional physiotherapy with a mean age of 49 years (range: 43-59). Both groups were submitted to a twelve-week program of two sessions weekly. RESULTS After the intervention, significant improvements were observed regarding the Lequesne index (p-value=0.0217), Oswestry Disability Index (p-value=0.0112), range of motion of trunk extension (p-value=0.0320), trunk flexion muscle strength (p-value=0.0459), hip extension and abduction muscle strength (p-value=0.0062 and p-value=0.0257, respectively). Range of motion of trunk and hip flexion, extension, adduction and abduction, trunk extensor muscle strength and all surface electromyography variables showed no significant statistical difference. CONCLUSION Physical therapy is efficient to treat musculoskeletal dysfunctions in sickle cell disease patients, irrespective of the technique; however, aquatic therapy showed a trend toward improvement in muscle strength. Further studies with a larger patient sample and longer periods of therapy are necessary to confirm these results.

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OBJECTIVE To test the hypothesis that replacement of sucrose with isomaltulose in sweet foods and beverages improves metabolic control in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS One hundred ten patients with type 2 diabetes were randomized to receive sweet foods containing either 50 g/day isomaltulose or sucrose for 12 weeks as part of their habitual diet under free-living conditions. HbA(1c) at 12 weeks was the primary outcome parameter. RESULTS In the final analysis comprising 101 patients, isomaltulose did not significantly affect HbA(1c) at 12 weeks (sucrose: 7.39 ± 0.78%; isomaltulose: 7.24 ± 0.76%; regression coefficient [b]: 0.02 [95% CI: -0.21 to 0.25], P = 0.844). Triglycerides at 12 weeks were significantly lower in the isomaltulose versus the sucrose group (b: 34.01 [6.59-61.44], P = 0.016). Other secondary parameters did not significantly differ between groups. CONCLUSIONS Isomaltulose did not influence glycemic control assessed as HbA(1c) in type 2 diabetes under free-living conditions but was associated with lower triglyceride levels.

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INTRODUCTION The incidence of malnutrition in hospitalized patients is reported to be high. In particular, patients with esophageal cancer are prone to malnutrition, due to preoperative digestive system dysfunctions and short-term non-oral feeding postoperatively. Selection of an appropriate method for feeding in the postoperative period is important in these patients. MATERIALS AND METHODS In this randomized clinical trial, 40 patients with esophageal cancer who had undergone esophagectomy between September 2008 and October 2009 were randomly assigned into either enteral feeding or parenteral feeding groups, with the same calorie intake in each group. The level of serum total protein, albumin, prealbumin, transferrin, C3, C4 and hs-C-reactive protein (hs-CRP), as well as the rate of surgical complications, restoration of bowel movements and cost was assessed in each group. RESULTS Our results showed that there was no significant difference between the groups in terms of serum albumin, prealbumin or transferrin. However, C3 and C4 levels were significantly higher in the enteral feeding group compared with the parenteral group, while hs-CRP level was significantly lower in the enteral feeding group. Bowel movements were restored sooner and costs of treatment were lower in the enteral group. Postoperative complications did not differ significantly between the groups. There was one death in the parenteral group 10 days after surgery due to myocardial infarction. CONCLUSION The results of our study showed that enteral feeding can be used effectively in the first days after surgery, with few early complications and similar nutritional outcomes compared with the parenteral method. Enteral feeding was associated with reduced inflammation and was associated with an improvement in immunological responses, quicker return of bowel movements, and reduced costs in comparison with parenteral feeding.

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BACKGROUND Opium is a highly addictive agent and the most common narcotic often misused in Iran. The pharmacokinetic of anesthetic drugs in patients with opium addiction is one of the great challenges for anesthesiologists. Hemodynamic instability and postoperative side effects are of these challenges which should be managed correctly. OBJECTIVES In this study we aimed to assess the effects of clonidine upon post anesthesia shivering and recovery time in patients with and without opium addiction after general anesthesia to decrease the subsequent complications related to the shivering and elongation of recovery time. PATIENTS AND METHODS In a randomized clinical trial, 160 patients candidates for elective leg fracture operations under general anesthesia were studied in four groups of 40 patients: Group 1 (placebo 1) were patients without addiction who got placebo 90 minutes before the operation. Group 2 (placebo 2) were patients with opium addiction which received placebo as group 1. Group 3 (Clonidine 1) patients without addiction who got clonidine 90 minutes before the operation and group 4 (Clonidine 2) who were opium addicted ones which received clonidine as premedication. RESULTS None of the patients with and without addiction in clonidine groups had shivering after the operation but in placebo groups shivering was observed and the difference between clonidine and placebo groups was statistically significant (P < 0.01). Recovery time in clonidine groups of patients with and without addiction was less than placebo ones (both P < 0.01) which the magnitude of difference was higher in opium addicted than non-addicted patients (P = 0.04). CONCLUSIONS Premedication with clonidine in patients with and without opium addiction can be effective to decrease the incidence of shivering and recovery time after operation.

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BACKGROUND Health-related quality of life (HRQoL) has been used to assess subjects' prognosis and recovery following hip fracture. However, evidence is mixed regarding the effectiveness of interventions to improve HRQoL of elders with hip fracture. The purposes of this study were to identify distinct HRQoL trajectories and to evaluate the effects of two care models on these trajectories over 12 months following hip-fracture surgery. METHODS For this secondary analysis, data came from a randomized controlled trial of subjects with hip fracture receiving three treatment care models: interdisciplinary care (n = 97), comprehensive care (n = 91), and usual care (n = 93). Interdisciplinary care consisted of geriatric consultation, discharge planning, and 4 months of in-home rehabilitation. Comprehensive care consisted of interdisciplinary care plus management of malnutrition and depressive symptoms, fall prevention, and 12 months of in-home rehabilitation. Usual care included only in-hospital rehabilitation and occasional discharge planning, without geriatric consultation and in-home rehabilitation. Mental and physical HRQoL were measured at 1, 3, 6, and 12 months after discharge by the physical component summary scale (PCS) and mental component summary scale (MCS), respectively, of the Medical Outcomes Study Short Form 36, Taiwan version. Latent class growth modeling was used to identify PCS and MCS trajectories and to evaluate how they were affected by the interdisciplinary and comprehensive care models. RESULTS We identified three quadratic PCS trajectories: poor PCS (n = 103, 36.6 %), moderate PCS (n = 96, 34.2 %), and good PCS (n = 82, 29.2 %). In contrast, we found three linear MCS trajectories: poor MCS (n = 39, 13.9 %), moderate MCS (n = 84, 29.9 %), and good MCS (n = 158, 56.2 %). Subjects in the comprehensive care and interdisciplinary care groups were more likely to experience a good PCS trajectory (b = 0.99, odds ratio [OR] = 2.69, confidence interval [CI] = 7.24-1.00, p = 0.049, and b = 1.32, OR = 3.75, CI = 10.53-1.33, p = 0.012, respectively) than those who received usual care. However, neither care model improved MCS. CONCLUSIONS The interdisciplinary and comprehensive care models improved recovery from hip fracture by increasing subjects' odds for following a trajectory of good physical functioning after hospitalization. TRIAL REGISTRATION ClinicalTrials.gov ( NCT01350557 ).

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BACKGROUND Brief family intervention may have a positive impact on family caregivers for patients with mental disorders. We assessed the effectiveness of a group psycho-educational program on family caregivers for patients with schizophrenia and mood disorders. METHODS This randomized controlled trial was performed on 100 caregivers for patients with mental disorders attending the Isfahan Behavioral Sciences Research Center (IBSRC), in Isfahan, Iran. One hundred family caregivers of patients with schizophrenia (n = 50) and mood disorders (n = 50) were selected and assigned randomly to either a psycho-educational group intervention or routine care in each diagnosis category. The caregivers were followed for 3 months. Caregiver burden was assessed using the Zarit Burden Interview RESULTS The mean scores of the Zarit caregiver burden decreased significantly for the group that participated in the psycho-educational program, while scores in the control group did not change significantly. CONCLUSIONS This group intervention program was effective to reduce the caregiver burden for both categories of mental disorders in the Iranian population. This group intervention program may improve the quality of life of patients and caregivers by improving the standards of care giving. TRIAL REGISTRATION RCT registration number: IRCT138804272200N.

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BACKGROUND Alirocumab undergoes target-mediated clearance via binding of proprotein convertase subtilisin/kexin type 9 (PCSK9). Statins increase PCSK9 levels; the effects of nonstatin lipid-lowering therapies are unclear. Every-4-weeks dosing of alirocumab may be appropriate for some patients in absence of background statin but is not yet approved. METHODS AND RESULTS Low-density lipoprotein cholesterol (LDL-C), PCSK9, and alirocumab levels were assessed in subjects (LDL-C >130 mg/dL, n=24/group) after a 4-week run-in taking oral ezetimibe, fenofibrate, or ezetimibe placebo, when alirocumab 150 mg every 4 weeks (days 1, 29, and 57) was added. Maximal mean LDL-C reductions from day -1 baseline (prealirocumab) occurred on day 71 in all groups: alirocumab plus placebo, 47.4%; alirocumab plus ezetimibe, 56.6%; and alirocumab plus fenofibrate, 54.3%. LDL-C reductions were sustained through day 85 with alirocumab plus placebo (47.0%); the duration of effect was slightly diminished at day 85 versus day 71 with ezetimibe (49.6%) or fenofibrate combinations (43.2%). Free PCSK9 concentrations were lowest at day 71 in all groups, then increased over time; by day 85, free PCSK9 concentrations were higher, and alirocumab levels lower, with alirocumab plus fenofibrate, and to a lesser extent alirocumab plus ezetimibe, versus alirocumab plus placebo. CONCLUSIONS Alirocumab 150 mg every 4 weeks produced maximal LDL-C reductions of 47% in combination with placebo and 54% to 57% in combination with ezetimibe or fenofibrate. The oral lipid-lowering therapies appear to increase PCSK9 levels, leading to increased alirocumab clearance. Although the duration of effect was modestly diminished with alirocumab plus ezetimibe/fenofibrate versus placebo, the effect was less than observed in trials with background statins, and it would not preclude the use of alirocumab every 4 weeks in patients taking these nonstatin lipid-lowering therapies concomitantly. CLINICAL TRIAL REGISTRATION URL: http://www.Clinicaltrials.gov. Unique identifier: NCT01723735.

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BACKGROUND Some patients with chronic obstructive pulmonary disease (COPD) may benefit from oral steroid therapy. These steroid-responsive patients are diagnosed based on laboratory spirometry. We hypothesize that daily, home-based spirometry is a better tool. METHODS Thirty patients with COPD underwent a single-blinded study, with a crossover design. They received 2 weeks of placebo followed by 2 weeks of prednisone therapy (40 mg/day). Laboratory spirometry was done at the beginning and end of the study and daily home-based spirometry was done twice a day. RESULTS Analysis of variance model was used. The variability of the median day-to-day forced expiratory volume in 1 s (FEV₁) was 72.5 mL (25th percentile of 40 mL and 75th percentile of 130 mL). The daily FEV₁ variation was 70 mL (25th percentile of 50 mL and 75th percentile of 100 mL). The overall laboratory FEV₁ variability was larger after the steroid course (P < 0.001), but not clinically significant. The variability was not significant postplacebo treatment compared with the baseline values. For home-based spirometry, steroid treatment was not significantly different. The majority (97%) completed more than 80% of the measurements. Ninety percent of the performed tests were considered acceptable. Only 53% of the tests were considered accurate. Overall both laboratory and home-based measurements did not show significant association between airway responsiveness and dyspnea or exercise capacity. CONCLUSION Twice-daily home measurements of FEV₁ might be better than the conventional approach to identify steroid responsive COPD patients. However, this finding was only statistically but not clinically significant. Therefore, we would not recommend this approach to identify COPD patients with steroid responsiveness.

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BACKGROUND The World Health Organization announced the acceptable level of cesarean section (CS) as 10-15%. In recent years, the rate of CS has been increasing irregularly. Lack of appropriate knowledge and attitude among couples plays a major role in this regard. This study tried to compare the effects of a childbirth training workshop on knowledge, attitude, and delivery method. MATERIALS AND METHODS The present study is a randomized clinical trial conducted in four stages on 180 subjects referring to Isfahan health care centers in three groups of mothers (alone), couples (mothers and their respective partners), and control. After sampling, a pre-test and intervention in the form of an educational workshop were conducted. Then, post-test was conducted immediately after, 1 month later, and in puerperium in all three groups. Data were analyzed by SPSS version 15. RESULTS The analysis showed that the knowledge mean was statically significant in mothers (P < 0.0001), couples (P < 0.0001), and control group (P < 0.0001) before and after intervention. Also, the attitude mean was statically significant in mothers (P < 0.0001), couples (P < 0.0001), and control groups (P < 0.0001) before and after intervention. Analysis of delivery method showed that in mothers, couples, and control groups, normal vaginal delivery was the most preferred method in that order, w hich was significant (P = 0.017). CONCLUSIONS Workshop education of pregnant women and their spouses was effective on encouraging them to natural delivery. Therefore, designing educational and counseling programs through collaborative methods for mothers and their spouses is suggested to reduce the rate of cesarean deliveries.

1significant effect