Randomized Controlled Trial

Background: Depression is highly prevalent in the working population and is associated with significant loss of workdays; however, access to evidence- based treatment is limited. Objective: This study evaluated the effectiveness of a Web-based intervention in reducing mild to moderate depression and sickness absence. Methods: In an open-label randomized controlled trial, participants were recruited from a large-scale statutory health insurance and were assigned to two groups. The intervention group had access to a 12 week Web-based program consisting of structured interactive sessions and therapist support upon request. The wait-list control group had access to unguided Web- based psycho-education. Depressive symptoms were self-assessed at baseline, post-treatment, and follow-up (12 weeks after treatment) using the Patient Health Questionnaire (PHQ-9) and Beck Depression Inventory (BDI-II) as primary outcome measures. Data on sickness absence was retrieved from health insurance records. Intention-to-treat (ITT) analysis and per-protocol (PP) analysis were performed. Results: Of the 180 participants who were randomized, 88 completed the post-assessment (retention rate: 48.8%, 88/180). ITT analysis showed a significant between-group difference in depressive symptoms during post- treatment in favor of the intervention group, corresponding to a moderate effect size (PHQ-9: d=0.55, 95% CI 0.25-0.85, P<.001, and BDI-II: d=0.41, CI 0.11-0.70, P=.004). PP analysis partially supported this result, but showed a non-significant effect on one primary outcome (PHQ-9: d=0.61, 95% CI 0.15-1.07, P=.04, and BDI-II: d=0.25 95% CI −0.18 to 0.65, P=.37). Analysis of clinical significance using reliable change index revealed that significantly more participants who used the Web-based intervention (63%, 63/100) responded to the treatment versus the control group (33%, 27/80; P<.001). The number needed to treat (NNT) was 4.08. Within both groups, there was a reduction in work absence frequency (IG: −67.23%, P<.001, CG: −82.61%, P<.001), but no statistical difference in sickness absence between groups was found (P=.07). Conclusions: The Web-based intervention was effective in reducing depressive symptoms among adults with sickness absence. As this trial achieved a lower power than calculated, its results should be replicated in a larger sample. Further validation of health insurance records as an outcome measure for eHealth trials is needed. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 02446836; http://www.isrctn.com/ISRCTN02446836 (Archived by WebCite at http://www.webcitation.org/6jx4SObnw

A randomized controlled trial

Objective We report on the effect of hemoadsorption therapy to reduce cytokines in septic patients with respiratory failure. Methods This was a randomized, controlled, open-label, multicenter trial. Mechanically ventilated patients with severe sepsis or septic shock and acute lung injury or acute respiratory distress syndrome were eligible for study inclusion. Patients were randomly assigned to either therapy with CytoSorb hemoperfusion for 6 hours per day for up to 7 consecutive days (treatment), or no hemoperfusion (control). Primary outcome was change in normalized IL-6-serum concentrations during study day 1 and 7. Results 97 of the 100 randomized patients were analyzed. We were not able to detect differences in systemic plasma IL-6 levels between the two groups (n = 75; p = 0.15). Significant IL-6 elimination, averaging between 5 and 18% per blood pass throughout the entire treatment period was recorded. In the unadjusted analysis, 60-day-mortality was significantly higher in the treatment group (44.7%) compared to the control group (26.0%; p = 0.039). The proportion of patients receiving renal replacement therapy at the time of enrollment was higher in the treatment group (31.9%) when compared to the control group (16.3%). After adjustment for patient morbidity and baseline imbalances, no association of hemoperfusion with mortality was found (p = 0.19). Conclusions In this patient population with predominantly septic shock and multiple organ failure, hemoadsorption removed IL-6 but this did not lead to lower plasma IL-6-levels. We did not detect statistically significant differences in the secondary outcomes multiple organ dysfunction score, ventilation time and time course of oxygenation

A randomized controlled trial and economic evaluation of the Parents Under Pressure Program for parents in substance abuse treatment

Background There is growing interest in the provision of parenting support to substance misusing parents. Methods This pragmatic, multi-center randomized controlled trial compared an intensive one-to-one parenting program (Parents under Pressure, PuP) with Treatment as Usual (TAU) in the UK. Parents were engaged in community-based substance misuse services and were primary caregivers of children less than 2.5 years of age. The primary outcome was child abuse potential, and secondary outcomes included measures of parental emotional regulation assessed at baseline, 6 and 12-months. A prospective economic evaluation was also conducted. Results Of 127 eligible parents, 115 met the inclusion criteria, and subsequently parents were randomly assigned to receive PuP (n = 48) or TAU (n = 52). Child abuse potential was significantly improved in those receiving the PuP program while those in TAU showed a deterioration across time in both intent-to-treat (p < 0.03) and per-protocol analyses (p < 0.01). There was also significant reliable change (recovery/improvement) in 30.6% of the PuP group compared with 10.3% of the TAU group (p < 0.02), and deterioration in 3% compared with 18% (p < 0.02). The probability that the program is cost-effective was approximately 51.8% if decision-makers are willing to pay £1000 for a unit improvement in the primary outcome, increasing to 98.0% at a £20,000 cost-effectiveness threshold for this measure. Conclusions Up to one-third of substance dependent parents of children under 3-years of age can be supported to improve their parenting, using a modular, one-to-one parenting program. Further research is needed

a randomized controlled trial

Diurnal carbohydrate and fat distribution modulates glycaemic control in rodents. In humans, the optimal timing of both macronutrients and its effects on glycaemic control after prolonged consumption are not studied in detail. In this cross-over trial, 29 non-obese men were randomized to two four-week diets: (1) carbohydrate-rich meals until 13.30 and fat-rich meals between 16.30 and 22.00 (HC/HF) versus (2) inverse sequence of meals (HF/HC). After each trial period two meal tolerance tests were performed, at 09.00 and 15.40, respectively, according to the previous intervention. On the HF/HC diet, whole-day glucose level was increased by 7.9% (p = 0.026) in subjects with impaired fasting glucose and/or impaired glucose tolerance (IFG/IGT, n = 11), and GLP-1 by 10.2% (p = 0.041) in normal glucose-tolerant subjects (NGT, n = 18). Diet effects on fasting GLP-1 (p = 0.009) and PYY (p = 0.034) levels were observed in IFG/IGT, but not in NGT. Afternoon decline of glucose tolerance was more pronounced in IFG/IGT and associated with a stronger decrease of postprandial GLP-1 and PYY levels, but not with changes of cortisol rhythm. In conclusion, the HF/HC diet shows an unfavourable effect on glycaemic control in IFG/IGT, but not in NGT subjects. Consequently, large, carbohydrate-rich dinners should be avoided, primarily by subjects with impaired glucose metabolism

Noninvasive vagus nerve stimulation as acute therapy for migraine. The randomized PRESTO study

Objective: To evaluate the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS; gammaCore; electroCore, LLC, Basking Ridge, NJ) for the acute treatment of migraine in a multicenter, double-blind, randomized, sham-controlled trial. Methods: A total of 248 participants with episodic migraine with/without aura were randomized to receive nVNS or sham within 20 minutes from pain onset. Participants were to repeat treatment if pain had not improved in 15 minutes. Results: nVNS (n = 120) was superior to sham (n = 123) for pain freedom at 30 minutes (12.7% vs 4.2%; p = 0.012) and 60 minutes (21.0% vs 10.0%; p = 0.023) but not at 120 minutes (30.4% vs 19.7%; p = 0.067; primary endpoint; logistic regression) after the first treated attack. A post hoc repeatedmeasures test provided further insight into the therapeutic benefit of nVNS through 30, 60, and 120 minutes (odds ratio 2.3; 95% confidence interval 1.2, 4.4; p = 0.012). nVNS demonstrated benefits across other endpoints including pain relief at 120minutes and was safe and well-tolerated. Conclusion: This randomized sham-controlled trial supports the abortive efficacy of nVNS as early as 30 minutes and up to 60 minutes after an attack. Findings also suggest effective pain relief, tolerability, and practicality of nVNS for the acute treatment of episodic migraine

Zinc Supplementation during Pregnancy: A Randomized Controlled Trial

Zinc deficiency during pregnancy has been related to adverse pregnancy outcomes. However, the results of zinc-supplementation trials have not been consistent in improvement of pregnancies outcomes. This study was undertaken to investigate whether zinc supplementation was associated with pregnancy complications in Iranian women during the last 2 trimesters. It also assessed the anthropometric measurements of infants at birth. A double-blind placebo-controlled trial was conducted in Ardabil Province located in northwest of Iran. One-hundred ninty-six pregnant women between 16-20 weeks of gestation were recruited from urban healthcare centres. These women had no evidence of hypertension, diabetes, renal disease, history of prematurity, premature rupture of membranes (PROM) or low birth weight (LBW) infants. They were randomly assigned to receive zinc (50 mg daily) or placebo until delivery. Basic information was collected on socioeconomic status, reproductive and disease histories before randomization. The subjects were monthly followed during pregnancy and maternal complications were carefully recorded. The weight, length and head circumference of each infant was measured within 24h of birth. Of the 196 women, 17 were excluded from the study (9 in the zinc group and 8 in the placebo group, NS). The supplementation had no significant effect on prematurity, preeclampcia, PROM and stillbirth as well as gestational age, infant length and head circumference. The incidence of low birth weight was significantly lower in those under Zinc than placebo (p = 0.01). Meanwhile, pregnancy-induced hypertension and intrauterine growth retardation (IUGR) were observed only in the placebo group. The birth weight was also higher in the zinc group than that in the placebo group (p = 0.03). Supplementation with 50mg elemental zinc during pregnancy improved birth weight but did not reduce maternal complications

Improving end-of-life care in acute geriatric hospital wards using the Care Programme for the Last Days of Life : study protocol for a phase 3 cluster randomized controlled trial

Background: The Care Programme for the Last Days of Life has been developed to improve the quality of end-of-life care in acute geriatric hospital wards. The programme is based on existing end-of-life care programmes but modeled to the acute geriatric care setting. There is a lack of evidence of the effectiveness of end-of-life care programmes and the effects that may be achieved in patients dying in an acute geriatric hospital setting are unknown. The aim of this paper is to describe the research protocol of a cluster randomized controlled trial to evaluate the effects of the Care Programme for the Last Days of Life. Methods and design: A cluster randomized controlled trial will be conducted. Ten hospitals with one or more acute geriatric wards will conduct a one-year baseline assessment during which care will be provided as usual. For each patient dying in the ward, a questionnaire will be filled in by a nurse, a physician and a family carer. At the end of the baseline assessment hospitals will be randomized to receive intervention (implementation of the Care Programme) or no intervention. Subsequently, the Care Programme will be implemented in the intervention hospitals over a six-month period. A one-year post-intervention assessment will be performed immediately after the baseline assessment in the control hospitals and after the implementation period in the intervention hospitals. Primary outcomes are symptom frequency and symptom burden of patients in the last 48 hours of life. Discussion: This will be the first cluster randomized controlled trial to evaluate the effect of the Care Programme for the Last Days of Life for the acute geriatric hospital setting. The results will enable us to evaluate whether implementation of the Care Programme has positive effects on end-of-life care during the last days of life in this patient population and which components of the Care Programme contribute to improving the quality of end-of-life care

Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in acute lung injury to reduce pulmonary dysfunction (HARP-2) trial : study protocol for a randomized controlled trial

Acute lung injury (ALI) is a common devastating clinical syndrome characterized by life-threatening respiratory failure requiring mechanical ventilation and multiple organ failure. There are in vitro, animal studies and pre-clinical data suggesting that statins may be beneficial in ALI. The Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial is a multicenter, prospective, randomized, allocation concealed, double-blind, placebo-controlled clinical trial which aims to test the hypothesis that treatment with simvastatin will improve clinical outcomes in patients with ALI

Does physical therapy improve symptoms of fibromyalgia?

Physical therapy is minimally effective in the treatment of fibromyalgia, with immediate post-treatment improvement in pain and tender points, and both short- and longer-term improved self-efficacy (confidence in performing tasks) (strength of recommendation [SOR]: B, 1 small, high-quality randomized controlled trial, 4 additional small randomized controlled trials). Multidisciplinary rehabilitation is probably not effective for this disorder but warrants future research, as trial quality is poor (SOR: B, systematic review of 4 small or low-quality and 3 additional randomized controlled trials on widespread pain conditions)

Acupuncture randomized trials (ART) in patients with chronic low back pain and osteoarthritis of the knee - Design and protocols

Background: We report on the study design and protocols of two randomized controlled trials (Acupuncture Randomized Trials = ART) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee, respectively. Objective: To investigate whether acupuncture is more efficacious than (a) no treatment or (b) minimal acupuncture in the treatment of low back pain and osteoarthritis. Design: Two randomized, controlled, multicenter trials with three treatment arms and a total follow-up time of 52 weeks. Setting: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. Patients: 300 patients will be included in each study. In the low back pain trial, patients will be included according to clinical diagnosis. In the osteoarthritis pain trial, patients will be included according to the American College of Rheumatology criteria. Interventions: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) minimal acupuncture at non-acupuncture points (75 patients), or (3) no treatment for two months followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. Main Outcome Measure: The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters: pain intensity as measured by a visual analogue scale (VAS; 0-100 mm) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score (WOMAC) in the osteoarthritis trial. Outlook: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy