The pregnancy rate of the no-treatment group in randomized clinical trials of endometriosis therapy

1989 ◽  
Vol 52 (6) ◽  
pp. 906-907 ◽  
Author(s):  
Johannes L.H. Evers
Keyword(s):  
Clinical Trials ◽  
Treatment Group ◽  
Pregnancy Rate ◽  
Randomized Clinical Trials

scholarly journals Evaluation of the Value of Attribution in the Interpretation of Adverse Event Data: A North Central Cancer Treatment Group and American College of Surgeons Oncology Group Investigation

2010 ◽  
Vol 28 (18) ◽  
pp. 3002-3007 ◽  
Author(s):  
Shauna L. Hillman ◽  
Sumithra J. Mandrekar ◽  
Brian Bot ◽  
Ronald P. DeMatteo ◽  
Edith A. Perez ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Treatment Group ◽  
Cancer Treatment ◽  
Randomized Clinical Trials ◽  
Study Drug ◽  
Phase Iii ◽  
Oncology Group ◽  
North Central ◽  
American College Of Surgeons ◽  
Group Trial

Purpose In March 1998, Common Toxicity Criteria (CTC) version 2.0 introduced the collection of attribution of adverse events (AEs) to study drug. We investigate whether attribution adds value to the interpretation of AE data. Patients and Methods Patients in the placebo arm of two phase III trials—North Central Cancer Treatment Group Trial 97-24-51 (carboxyamino-triazole v placebo in advanced non–small-cell lung cancer) and American College of Surgeons Oncology Group Trial Z9001 (imatinib mesylate v placebo after resection of primary gastrointestinal stromal tumors)—were studied. Attribution was categorized as unrelated (not related or unlikely) and related (possible, probable, or definite). Results In total, 398 patients (84 from Trial 97-24-51 and 314 from Trial Z9001) and 7,736 AEs were included; 47% and 50% of the placebo-arm AEs, respectively, were reported as related. When the same AE was reported in the same patient on multiple visits, the attribution category changed at least once 36% and 31% of the time. AE type and sex (Trial Z9001) and AE type and performance status (Trial 97-24-51) were associated with a higher likelihood of AEs being deemed related. Conclusion Nearly 50% of AEs were reported as attributed to study drug on the placebo arm of two randomized clinical trials. These data provide strong evidence that AE attribution is difficult to determine, unreliable, and of questionable value in interpreting AE data in randomized clinical trials.

scholarly journals A systematic review of the effect of omega-3 supplements on meibomian gland dysfunction

2020 ◽  
Vol 12 ◽  
pp. 251584142095218
Author(s):  
Mashael Al-Namaeh
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Treatment Group ◽  
Randomized Clinical Trials ◽  
Meibomian Gland ◽  
Meibomian Gland Dysfunction ◽  
Control Group ◽  
Sodium Fluorescein ◽  
Omega 3 ◽  
Break Up

Introduction: Meibomian gland dysfunction (MGD) is the leading cause of dry eye syndrome (DES). Many ocular disorders including DES and blepharitis can be linked to MGD. If we treat MGD, we can treat related diseases easily. Purpose: This systematic review is intended to determine the efficacy of omega-3 supplementation in MGD patients. Methods: This systematic review included an electronic search on PubMed and Clinicaltrials.gov to include all randomized clinical trials (RCTs) using omega-3 as a treatment for MGD. Results: Database search yielded to one RCT and six clinical trials through the MEDLINE of a total of 350 participants for the systematic review and meta-analysis study. The investigated treatment group (omega-3 group) had a positive effect on MGD protection in the invasive sodium fluorescein-tear break up time (NaFl-TBUT) score compared with the placebo group (odd ratio = 8.72, 95% confidence interval: 4.73, 16.09; p < 0.001). These data suggest that the odd ratios of the omega-3 group to control group increased the likelihood of the improved stated outcome tear break up time (TBUT) being achieved in the treatment group. No evidence of publication bias was detected in the funnel plot inspection or the Egger’s statistical test ( p = 0.2944). Conclusions: A moderate daily dose of omega-3 may be a beneficial therapeutic for MGD. Omega-3 has been beneficial in many diseases, such as heart attack prevention and agerelated macular degeneration, and this systematic review emphasizes its protection against MGD. In addition, this review emphasizes the precision of noninvasive TBUT (NITBUT) compared with invasive NaFl-TBUT which may suggest the importance of NITBUT in the clinic.

scholarly journals Often claimed, rarely tested: differences in individual drug response

2018 ◽  
Author(s):  
Stephanie Winkelbeiner ◽  
Stefan Leucht ◽  
John M. Kane ◽  
Philipp Homan
Keyword(s):  
Clinical Trials ◽  
Treatment Group ◽  
Antipsychotic Drugs ◽  
Randomized Clinical Trials ◽  
World Health ◽  
Response To Treatment ◽  
Individual Treatment ◽  
Control Group ◽  
Reasonable Assumption ◽  
Personal Element

An assumption among clinicians and researchers is that patients with schizophrenia vary considerably in their response to antipsychotic drugs in randomized clinical trials (RCTs). To evaluate the overall variation in individual treatment response from random variation by comparing the variability between treatment and control groups. DATA SOURCES Cochrane Schizophrenia, MEDLINE/PubMed, Embase, PsycINFO, Cochrane CENTRAL, BIOSIS Previews, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform from January 1, 1955, to December 31, 2016. Double-blind, placebo-controlled, RCTs of adults with a diagnosis of schizophrenia spectrum disorders and prescription for licensed antipsychoticdrugs. Means and SDs of the Positive and Negative Syndrome Scale pretreatmentand posttreatment outcome difference scores were extracted. Data quality and validity were ensured by following the PRISMA guidelines. The outcome measurewas the overall variability ratio of treatment to control in ameta-analysis across RCTs. Individual variability ratios were weighted by the inverse-variance method and entered into a random-effects model. A personal element of response was hypothesized to be reflected by a substantial overall increase in variability in the treatment group compared with the control group. An RCT was simulated, comprising 30 patients with schizophrenia randomized to either the treatment or the control group. The different components of variation in RCTs were illustrated with simulated data. In addition, we assessed the variability ratio in 52 RCTs involving 15 360 patients with a schizophrenia or schizoaffective diagnosis. The variability was slightly lower in the treatment compared with the control group (variability ratio = 0.97; 95% CI, 0.95-0.99; P = .01). In this study, no evidence was found in RCTs that antipsychotic drugs increased the outcome variance, suggesting no personal element of response to treatment but instead indicating that the variance was slightly lower in the treatment group than in the control group; although the study cannot rule out that subsets of patients respond differently to treatment, it suggests that the averagetreatment effect is a reasonable assumption for the individual patient.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

2001 ◽  
Vol 21 (02) ◽  
pp. 77-81 ◽  
Author(s):  
G. Finazzi
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Collaborative Study ◽  
Clinical Problem ◽  
Vascular Events ◽  
Dose Oral ◽  
Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

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