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.

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 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 EFFICACY OF SPIRULINA FOR ALLERGIC RHINITIS

2021 ◽  
Author(s):  
Iury Gomes Batista ◽  
Osmar Cleyton Person ◽  
Fernando Veiga Angelico Junior ◽  
Priscila Bogar
Keyword(s):  
Clinical Trials ◽  
Allergic Rhinitis ◽  
Randomized Clinical Trials ◽  
Nasal Congestion ◽  
Control Group ◽  
Cochrane Central Register ◽  
Level Of Evidence ◽  
Runny Nose ◽  
Trial Quality ◽  
Central Register

Introduction: Allergic rhinitis is a condition of high prevalence in the population and widely studied, with several treatments being consecrated for its control. Spirulina is a dietary supplement that modulates immune function, and has been shown to modulate the inflammatory response of allergic rhinitis. Purpose: To evaluate spirulina in the treatment and control of allergic rhinitis. Material and Methods: This is a systematic review of randomized clinical trials. Searches were performed for randomized clinical trials relating spirulina to allergic rhinitis in five electronic databases: Cochrane - Central Register of Controlled Trials - CENTRAL (2021), PUBMED (1966-2021), EMBASE (1974-2021), LILACS (1982-2021) AND SCOPUS (2021). Two investigators independently extracted data and assessed trial quality. Results: Two clinical trials involving a total of 215 patients were included. Both studies assessed the efficacy of spirulina in improving allergic rhinitis as the primary outcome. The first study described a significant reduction in runny nose, nasal congestion and itching over time of medication use (p 0.001) and in the second study the prevalence of rhinorrhea (P = 0.021), nasal congestion or obstruction (P = 0.039) and decreased smell (P = 0.030) were significantly less in the experimental group than in the control group. Conclusions: The included studies were in favor of the use of spirrulina. However, the level of evidence is very low and limited. We should have caution due to the small number of clinical trials and participants in these studies. It is recommended to carry out new RCTs following the CONSORT standardization.

scholarly journals Efficacy and safety of tetramethylpyrazine phosphate on pulmonary hypertension: study protocol for a randomized controlled study

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yuqin Chen ◽  
Wenjun He ◽  
Haiping Ouyang ◽  
Chunli Liu ◽  
Cheng Hong ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Treatment Group ◽  
Phase Iii ◽  
World Health ◽  
Controlled Study ◽  
Stable Phase ◽  
Control Group ◽  
Efficacy And Safety ◽  
Traditional Chinese Herbal Medicine ◽  
Health Organization

Abstract Background Tetramethylpyrazine (TMP), an active ingredient in the traditional Chinese herbal medicine Rhizoma Chuanxiong, has been used clinically for the prevention and treatment of cardiovascular disease. The benefits of TMP are largely attributed to its anti-oxidative and vasodilative properties. However, the efficacy of TMP in the treatment of pulmonary hypertension (PH) is unknown. We hypothesized that TMP may have a therapeutic effect in patients with PH. Methods/design A randomized, single-blinded, clinical study with a TMP treatment group and a control group will be conducted to evaluate the efficacy and safety of TMP intervention in patients with PH. The recruitment target is 120 subjects meeting the following criteria: (i) at rest and at sea level, mean pulmonary artery pressure above 20 mmHg and pulmonary capillary wedge pressure below 15 mmHg; (ii) type 1 or 4 PH in the stable phase; (iii) age 15–70 years; (iv) 6-min walk distance between 100 and 450 m; (v) World Health Organization (WHO) functional classification of pulmonary hypertension of II, III, or IV. Subjects will be assigned randomly into two groups at a ratio of 1:2 (control:TMP). Both groups will receive routine treatment, and the treatment group will also receive oral TMP (100 mg) three times a day for 16 weeks. All patients will be followed up for 4, 8, 12, and 16 weeks; symptoms and patient compliance will be recorded. Discussion We aimed to determine the efficacy and safety of TMP for the treatment of PH. Trial registration Chinese Clinical Trial Register, ChiCTR1800018664. Registered on 2 October 2018.

scholarly journals Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists

2020 ◽  
Vol 41 (1) ◽  
pp. 9-20
Author(s):  
Louise B. Russell ◽  
Laurie A. Norton ◽  
David Pagnotti ◽  
Christianne Sevinc ◽  
Sophia Anderson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Financial Incentives ◽  
Behavioral Interventions ◽  
Randomized Clinical Trials ◽  
Financial Incentive ◽  
Trial Data ◽  
Control Group ◽  
Cost Information ◽  
Billing Data ◽  
Pragmatic Clinical Trials

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source of cost information but rarely incorporate costing studies. This article provides a guide for researchers to help them collect and analyze, during the trial and with little additional effort, the information needed to inform potential adopters of the costs of adopting a behavioral intervention. A key challenge in using trial data is the separation of implementation costs, the costs an adopter would incur, from research costs. Based on experience with 3 randomized clinical trials of behavioral interventions, this article explains how to frame the costing problem, including how to think about costs associated with the control group, and describes methods for collecting data on individual costs: specifications for costing a technology platform that supports the specialized functions required, how to set up a time log to collect data on the time staff spend on implementation, and issues in getting data on device, overhead, and financial incentive costs.

scholarly journals Análise da Revisão Cochrane: Terapêutica Farmacológica da Hiperuricemia em Doentes Hipertensos. Cochrane Database Syst Rev. 2017;4:CD008652.

2017 ◽  
Vol 30 (5) ◽  
pp. 356
Author(s):  
Miguel Bigotte Vieira ◽  
Rute Baeta Baptista ◽  
João Costa ◽  
António Vaz-Carneiro
Keyword(s):  
Blood Pressure ◽  
Clinical Trials ◽  
Uric Acid ◽  
Serum Uric Acid ◽  
Randomized Clinical Trials ◽  
Experimental Studies ◽  
Public Health Problem ◽  
Primary Hypertension ◽  
World Health ◽  
Cochrane Central Register

Arterial hypertension is a public health problem that affects approximately 25% of the world’s adult population. The association between hypertension and hyperuricemia has been shown on epidemiological and experimental studies. However, it is unclear whether lowering serum uric acid might lower blood pressure. This Cochrane systematic review - a revised edition of a previously published one - intended as primary objective to evaluate the effect of hypouricemic drugs in patients with primary hypertension or prehypertension. The secondary objectives were to evaluate the efficacy and safety of hypouricemic drugs. A systematic search until February 2016 on controlled, randomized or quasi-randomized trials comparing the effect of hypouricemic drug versus placebo in hypertensive or prehypertensive patients was performed on the following databases: The Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, The World Health Organization International Clinical Trials Registry Platform, e ClinicalTrials.gov. LILACS database up to March 2016 was also searched and the authors of relevant studies were contacted. There were 349 identified papers, 21 were preselected and three randomized clinical trials (211 patients) were included in the qualitative analysis and in the meta-analysis. Two of the trials were conducted exclusively on adolescents. The authors conclude that hypouricemic drugs are not effective in lowering blood pressure in patients with hyperuricemia and primary prehypertension or hypertension. However, this strategy might be more effective in the specific population of adolescents with prehypertension or mild primary hypertension recently diagnosed. Hypouricemic drugs effectively reduce serum uric acid level and withdrawals of therapy due to adverse effects were not superior in the treated group, comparing to placebo; however, one patient withdrew due to a severe cutaneous reaction.

scholarly journals The Application of Beta-Tricalcium Phosphate in Implant Dentistry: A Systematic Evaluation of Clinical Studies

Materials ◽  
2022 ◽  
Vol 15 (2) ◽  
pp. 655
Author(s):  
Elisabet Roca-Millan ◽  
Enric Jané-Salas ◽  
Antonio Marí-Roig ◽  
Álvaro Jiménez-Guerra ◽  
Iván Ortiz-García ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Survival Rate ◽  
Tricalcium Phosphate ◽  
Randomized Clinical Trials ◽  
Systematic Evaluation ◽  
Control Group ◽  
Cochrane Central Register ◽  
Graft Material ◽  
Synthetic Graft ◽  
Implant Dentistry

The demand for synthetic graft materials in implant dentistry is rising. This systematic review aims to evaluate the survival rate of dental implants placed simultaneously with bone regeneration procedures using the material β-tricalcium phosphate, one of the most promising synthetic graft materials. The electronic search was conducted in PubMed, Scielo, and the Cochrane Central Register of Controlled Trials. There were five randomized clinical trials, one of which was a non-randomized controlled clinical trial and four of which were observational studies without a control group included. Implant survival rate and other clinical, radiographic, and histological parameters did not differ from those of implants placed simultaneously with another type of graft material, or placed in blood clots or natural alveolar ridges. Based on the available literature, β-tricalcium phosphate seems to be a promising graft material in implant dentistry. Nevertheless, more randomized clinical trials, with long follow-up periods, preoperative and postoperative CBCT, and histological analysis, are necessary to assess its long-term behavior.

Use of Nonhuman Milks in the Dietary Management of Young Children With Acute Diarrhea: A Meta-Analysis of Clinical Trials

PEDIATRICS ◽  
1994 ◽  
Vol 93 (1) ◽  
pp. 17-27
Author(s):  
Kenneth H. Brown ◽  
Janet M. Peerson ◽  
Olivier Fontaine
Keyword(s):  
Clinical Trials ◽  
Young Children ◽  
Treatment Failure ◽  
Acute Diarrhea ◽  
Randomized Clinical Trials ◽  
World Health ◽  
Milk Formula ◽  
Failure Rates ◽  
Treatment Protocols ◽  
Oral Rehydration

Objective. To assess the effects of continued feeding of nonhuman milks or formulas to young children during acute diarrhea on their treatment failure rates, stool frequency and amount, diarrheal duration, and change in body weight. Methods. A total of 29 randomized clinical trials of 2215 patients were identified by computerized bibliographic search and review of published articles. Data were abstracted and analyzed using standard meta-analytic procedures. Results. Among studies that compared lactose-containing milk or formula diets with lactose-free regimens, those children who received the lactose-containing diets during acute diarrhea were twice as likely to have a treatment failure as those who received a lactose-free diet (22% vs 12%, respectively; P &lt; .001). However, the excess treatment failure rates occurred only in those studies that included patients whose initial degree of dehydration, as reported by authors, was severe, or that were conducted before 1985, when appropriate diarrhea treatment protocols were first widely accepted. Among studies of patients with mild diarrhea, all but one of which were completed after 1985, the overall treatment failure rates in the lactose groups were similar to the rates in the lactose-free groups (13% vs 15%). These results suggest that children with mild or no dehydration and those who are managed according to appropriate treatment protocols, such as that promoted by the World Health Organization, can be treated as successfully with lactose-containing diets as with lactose-free ones. The pooled information from studies that compared undiluted lactose-containing milks with the same milks offered at reduced concentration concluded that (1) children who received undiluted milks were marginally more likely to experience treatment failure than those who received diluted milk (16% vs 12%, P = .05), (2) the differences in stool output were small and of limited clinical importance, and (3) children who received the undiluted milk diets gained 0.25 SD more weight than those who received the diluted ones (P = .004). In addition, as with the previous set of studies, there were no differences in the pooled treatment failure rates between the respective groups in those studies of mildly dehydrated patients conducted after 1985 (14% vs 12%). Conclusions. The vast majority of young children with acute diarrhea can be successfully managed with continued feeding of undiluted nonhuman milks. Routine dilution of milk and routine use of lactose-free milk formula are therefore not necessary, especially when oral rehydration therapy and early feeding (in addition to milk) form the basic approach to the clinical management of diarrhea in infants and children.

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