scholarly journals HOW DO THEY ADD UP? THE INTERACTION BETWEEN THE PLACEBO AND TREATMENT EFFECT : A SYSTEMATIC REVIEW.

2021 ◽  
Author(s):  
Rémy Boussageon ◽  
Jeremy Howick ◽  
Raphael Baron ◽  
florian naudet ◽  
bruno falissard ◽  
...  
Keyword(s):  
Systematic Review ◽  
Placebo Effect ◽  
Treatment Effect ◽  
External Validity ◽  
Additive Model ◽  
Specific Effect ◽  
Risk Of Bias ◽  
Pragmatic Trials ◽  
Balanced Placebo Design ◽  
Placebo Design

Aim: The placebo effect and the specific effect are often thought to add up (additive model). Whether this is true or whether there is an interaction between the two, can modify the external validity of a trial. This assumption of additivity was tested by Kleijnen et al. in 1994 but the data produced since then has not been synthetized. In this review, we aimed to systematically review the literature to determine whether additivity held. Methods: We searched Medline and Psychinfo up to 10/01/2019. Studies using the balanced placebo design (BPD), testing two different strengths of placebos, were included. The presence of interaction was evaluated by comparing each group in BPD with analysis of variance or covariance. Results: 30 studies were included and the overall risk of bias was high: four found evidence of additivity and 16 studies found evidence of interaction (seven had evidence of positive additivity). Conclusion: Evidence of additivity between placebo and specific features of treatments was rare in our sample. For ailments that are placebo-responsive, pragmatic trials should be preferred to increase their external validity.

Systematic Review and Meta-Analysis of Randomised, Other-than-Placebo Controlled, Trials of Non-Individualised Homeopathic Treatment

Homeopathy ◽  
2019 ◽  
Vol 108 (02) ◽  
pp. 088-101 ◽  
Author(s):  
Robert Mathie ◽  
Yvonne Fok ◽  
Petter Viksveen ◽  
Aaron To ◽  
Jonathan Davidson
Keyword(s):  
Systematic Review ◽  
Effect Size ◽  
External Validity ◽  
Comparative Effectiveness ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Intervention Design ◽  
Significant Heterogeneity ◽  
Homeopathic Treatment

Introduction This study focuses on randomised controlled trials (RCTs) of non-individualised homeopathic treatment (NIHT) in which the control (comparator) group was other than placebo (OTP). Objectives To determine the comparative effectiveness of NIHT on health-related outcomes in adults and children for any given condition that has been the subject of at least one OTP-controlled trial. For each study, to assess its risk of bias and to determine whether its study attitude was predominantly ‘pragmatic’ or ‘explanatory’. Methods Systematic review. For each eligible trial, published in the peer-reviewed literature up to the end of 2016, we assessed its risk of bias (internal validity) using the seven-domain Cochrane tool, and its relative pragmatic or explanatory attitude (external validity) using the 10-domain PRECIS tool. We grouped RCTs by whether these examined IHT as alternative treatment (study design 1a), adjunctively with another intervention (design 1b), or compared with no intervention (design 2). RCTs were sub-categorised as superiority trials or equivalence/non-inferiority trials. For each RCT, we designated a single ‘main outcome measure’ to use in meta-analysis: ‘effect size’ was reported as odds ratio (OR; values > 1 favouring homeopathy) or standardised mean difference (SMD; values < 0 favouring homeopathy). Results Seventeen RCTs, representing 15 different medical conditions, were eligible for study. Three of the trials were more pragmatic than explanatory, two were more explanatory than pragmatic, and 12 were equally pragmatic and explanatory. Fourteen trials were rated ‘high risk of bias’ overall; the other three trials were rated ‘uncertain risk of bias’ overall. Ten trials had data that were extractable for analysis. Significant heterogeneity undermined the planned meta-analyses or their meaningful interpretation. For the three equivalence or non-inferiority trials with extractable data, the small, non-significant, pooled effect size (SMD = 0.08; p = 0.46) was consistent with a conclusion that NIHT did not differ from treatment by a comparator (Ginkgo biloba or betahistine) for vertigo or (cromolyn sodium) for seasonal allergic rhinitis. Conclusions The current data preclude a decisive conclusion about the comparative effectiveness of NIHT. Generalisability of findings is restricted by the limited external validity identified overall. The highest intrinsic quality was observed in the equivalence and non-inferiority trials of NIHT.

scholarly journals ANTIOXIDANT SUPPLEMENTS IN ALZHEIMER’S DEMENTIA AND MILD COGNITIVE IMPAIRMENT: A SYSTEMATIC REVIEW

2016 ◽  
pp. 1-8
Author(s):  
E.J. Pegg
Keyword(s):  
Oxidative Stress ◽  
Systematic Review ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Treatment Effect ◽  
Risk Of Bias ◽  
Positive Treatment Effect ◽  
Positive Treatment ◽  
Antioxidant Supplements ◽  
Overall Risk

Objective: Current treatments have only a modest effect on impairment in Alzheimer’s Dementia (AD) and there is no treatment currently licensed for Mild Cognitive Impairment (MCI). Oxidative stress is postulated to play a role in the pathogenesis of AD and MCI and this provides a rationale for treatment with antioxidant supplements. The aim of this review is to evaluate the effect of antioxidant supplements in people with AD and MCI. Methods: A systematic review of published randomised controlled trials was carried out. 4 electronic databases were searched. Studies were included if they compared the use of a placebo with the following antioxidant supplements in people with AD or MCI: Vitamin e, vitamin c, selenium, alpha lipoic acid, phenols, zinc, curcumin, beta carotene, coenzyme Q10, melatonin. The primary outcome measure was cognitive impairment. Secondary outcome measures included functional impairment, behavioural disturbance and safety. Results: 10 trials were identified which met the inclusion criteria. Outcome data was not suitable for meta-analysis. 5 studies reported a small positive treatment effect on cognition and 1 reported a negative effect. 2 reported a positive treatment effect on functional ability and 1 on behaviour. There were no consistent adverse effects found overall however two studies raised concern of possible worsening of cognition in certain circumstances. Conclusions: The findings of this systematic review do not support the use of antioxidant supplements to slow cognitive, functional or behavioural deterioration in people with AD or MCI. However the majority of included studies had a high or unknown risk of bias. In the one study which had a low overall risk of bias, there was evidence that antioxidant supplements may have a positive effect on functional decline in AD. The overall risk of harm associated with short term antioxidant supplementation appears to be low however caution is warranted. Further studies evaluating the role of oxidative stress in the pathogenesis of AD are suggested.

scholarly journals Systematic Review and Meta-Analysis of Randomised, Other-than-Placebo Controlled, Trials of Individualised Homeopathic Treatment

Homeopathy ◽  
2018 ◽  
Vol 107 (04) ◽  
pp. 229-243 ◽  
Author(s):  
Susanne Ulbrich-Zürni ◽  
Petter Viksveen ◽  
E. Roberts ◽  
Elizabeth Baitson ◽  
Lynn Legg ◽  
...  
Keyword(s):  
Systematic Review ◽  
High Risk ◽  
External Validity ◽  
Comparative Effectiveness ◽  
Meta Analysis ◽  
Internal Validity ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Homeopathic Treatment ◽  
Pragmatic Study

Background This study focuses on randomised controlled trials (RCTs) of individualised homeopathic treatment (IHT) in which the control (comparator) group was other than placebo (OTP). Aims To determine the comparative effectiveness of IHT on health-related outcomes in adults and children for any clinical condition that has been the subject of at least one OTP-controlled trial. For each study, to assess the risk of bias and to determine whether its study attitude was predominantly ‘pragmatic’ or ‘explanatory’. Methods Systematic review. For each eligible trial, published in the peer-reviewed literature up to the end of 2015, we assessed its risk of bias (internal validity) using the seven-domain Cochrane tool, and its relative pragmatic or explanatory attitude (external validity) using the 10-domain PRECIS tool. We grouped RCTs by whether they examined IHT as an alternative treatment (study design Ia), adjunctively with another intervention (design Ib), or compared with a no-intervention group (design II). For each RCT, we identified a ‘main outcome measure’ to use in meta-analysis: ‘relative effect size’ was reported as odds ratio (OR; values >1 favouring homeopathy) or standardised mean difference (SMD; values < 0 favouring homeopathy). Results Eleven RCTs, representing 11 different medical conditions, were eligible for study. Five of the RCTs (four of which in design Ib) were judged to have pragmatic study attitude, two were explanatory, and four were equally pragmatic and explanatory. Ten trials were rated ‘high risk of bias’ overall: one of these, a pragmatic study with design Ib, had high risk of bias solely regarding participant blinding (a bias that is intrinsic to such trials); the other trial was rated ‘uncertain risk of bias’ overall. Eight trials had data that were extractable for analysis: for four heterogeneous trials with design Ia, the pooled OR was statistically non-significant; collectively for three clinically heterogeneous trials with design Ib, there was a statistically significant SMD favouring adjunctive IHT; in the remaining trial of design 1a, IHT was non-inferior to fluoxetine in the treatment of depression. Conclusions Due to the low quality, the small number and the heterogeneity of studies, the current data preclude a decisive conclusion about the comparative effectiveness of IHT. Generalisability of findings is limited by the variable external validity identified overall; the most pragmatic study attitude was associated with RCTs of adjunctive IHT. Future OTP-controlled trials in homeopathy should aim, as far as possible, to promote both internal validity and external validity.

Exercise interventions in lateral elbow tendinopathy have better outcomes than passive interventions, but the effects are small: a systematic review and meta-analysis of 2123 subjects in 30 trials

2020 ◽  
pp. bjsports-2020-102525
Author(s):  
Stefanos Karanasios ◽  
Vasileios Korakakis ◽  
Rod Whiteley ◽  
Ioannis Vasilogeorgis ◽  
Sarah Woodbridge ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Short Term ◽  
Lateral Elbow ◽  
Long Term Follow Up ◽  
Wait And See ◽  
Lateral Elbow Tendinopathy

ObjectiveTo evaluate the effectiveness of exercise compared with other conservative interventions in the management of lateral elbow tendinopathy (LET) on pain and function.DesignSystematic review and meta-analysis.MethodsWe used the Cochrane risk-of-bias tool 2 for randomised controlled trials (RCTs) to assess risk of bias and the Grading of Recommendations Assessment, Development and Evaluation methodology to grade the certainty of evidence. Self-perceived improvement, pain intensity, pain-free grip strength (PFGS) and elbow disability were used as primary outcome measures.Eligibility criteriaRCTs assessing the effectiveness of exercise alone or as an additive intervention compared with passive interventions, wait-and-see or injections in patients with LET.Results30 RCTs (2123 participants, 5 comparator interventions) were identified. Exercise outperformed (low certainty) corticosteroid injections in all outcomes at all time points except short-term pain reduction. Clinically significant differences were found in PFGS at short-term (mean difference (MD): 12.15, (95% CI) 1.69 to 22.6), mid-term (MD: 22.45, 95% CI 3.63 to 41.3) and long-term follow-up (MD: 18, 95% CI 11.17 to 24.84). Statistically significant differences (very low certainty) for exercise compared with wait-and-see were found only in self-perceived improvement at short-term, pain reduction and elbow disability at short-term and long-term follow-up. Substantial heterogeneity in descriptions of equipment, load, duration and frequency of exercise programmes were evident.ConclusionsLow and very low certainty evidence suggests exercise is effective compared with passive interventions with or without invasive treatment in LET, but the effect is small.PROSPERO registration numberCRD42018082703.

scholarly journals Systematic Review of the Use of Telepathology During Intraoperative Consultation

2019 ◽  
Vol 153 (2) ◽  
pp. 198-209 ◽  
Author(s):  
Robin L Dietz ◽  
Douglas J Hartman ◽  
Liron Pantanowitz
Keyword(s):  
Systematic Review ◽  
Publication Bias ◽  
Frozen Section ◽  
Strong Support ◽  
Risk Of Bias ◽  
Low Risk ◽  
Reference Standard ◽  
Weighted Mean ◽  
Frozen Section Diagnosis ◽  
Conventional Microscopy

Abstract Objective To compare studies that used telepathology systems vs conventional microscopy for intraoperative consultation (frozen-section) diagnosis. Methods A total of 56 telepathology studies with 13,996 cases in aggregate were identified through database searches. Results The concordance of telepathology with the reference standard was generally excellent, with a weighted mean of 96.9%. In comparison, we identified seven studies using conventional intraoperative consultation that showed a weighted mean concordance of 98.3%. Evaluation of the risk of bias showed that most of these studies were low risk. Conclusions Despite limitations such as variation in reporting and publication bias, this systematic review provides strong support for the safety of using telepathology for intraoperative consultations.

scholarly journals Survival and pleurodesis outcome in patients with malignant pleural effusion – a systematic review

2021 ◽  
Vol 6 (1) ◽  
pp. 1-5
Author(s):  
Maged Hassan ◽  
Elinor Harriss ◽  
Rachel M. Mercer ◽  
Najib M. Rahman
Keyword(s):  
Systematic Review ◽  
Pleural Effusion ◽  
Survival Benefit ◽  
Malignant Pleural Effusion ◽  
Risk Of Bias ◽  
Common Condition ◽  
Survival Difference ◽  
Range Difference ◽  
Simple Drainage

Abstract Malignant pleural effusion (MPE) is a common condition that presents with progressive breathlessness. Long term solutions are often required due to recurrence of effusion after simple drainage. Pleurodesis is one of the main options resorted to for long term control of MPE. There is data to suggest there may be a survival benefit for patients with MPE who achieve successful pleurodesis. A systematic review was carried out to explore this correlation and results suggest that there could be a survival difference according to pleurodesis outcome in patients with MPE. Fifteen studies (reported in 13 papers) were included; 13 (86.6%) of the studies showed survival difference in favour of pleurodesis success. The median [interquartile range] difference in survival between the two groups among the different studies was five [3.5–5.8] months. Most of the included studies suffered moderate to severe risk of bias and, thus, large prospective studies of patients undergoing pleurodesis are required to ascertain this effect.

scholarly journals Physical Therapy to Prevent Osteopenia in Preterm Infants: A Systematic Review

Children ◽  
2021 ◽  
Vol 8 (8) ◽  
pp. 664
Author(s):  
Galaad Torró-Ferrero ◽  
Francisco Javier Fernández-Rego ◽  
Antonia Gómez-Conesa
Keyword(s):  
Systematic Review ◽  
Preterm Infants ◽  
Methodological Quality ◽  
Bone Mineralization ◽  
Exercise Program ◽  
Risk Of Bias ◽  
Quantitative Synthesis ◽  
Comprehensive Search ◽  
Design Characteristics ◽  
Almost All

Background: During the last trimester of pregnancy, about 80% of the infant’s calcium is incorporated, and for this reason, preterm infants have less bone mineralization compared to those born at term. The aim of the present systematic review was to identify, evaluate and summarize the studies that deal with the effect of physiotherapy modalities in the prevention and treatment of osteopenia in preterm infants. Methods: A comprehensive search (09/2019–02/2021) using PubMed, Web of Science, SCOPUS, ProQuest, SciELO, Latindex, ScienceDirect, PEDro and ClinicalTrials.gov was carried out. The following data were extracted: The number of participants, characteristics of the participants, design, characteristics of the intervention, outcome measures, time of evaluation and results. A non-quantitative synthesis of the extracted data was performed. The methodological quality and risk of bias were assessed using a PEDro scale and ROB-2 scale, respectively. Results: A total of 16 studies were analyzed, presenting a methodological quality that ranged from 3 to 8 points, and all showed some concerns regarding their risk of bias. Almost all studies (15/16) used passive mobilizations with joint pressure to prevent osteopenia, but they differed in the intensity and frequency of application. Conclusions: A daily exercise program of passive mobilizations with joint pressure, improves bone mineralization in preterm infants admitted to neonatal units.

scholarly journals Effectiveness of Nutritional Education for Obese Older Adults With Frailty: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 401-401
Author(s):  
Yue-Heng Yin ◽  
Liu Yat Justina
Keyword(s):  
Systematic Review ◽  
Physical Function ◽  
Meta Analysis ◽  
Experimental Studies ◽  
Well Being ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Nutritional Education ◽  
Hand Search ◽  
Education Interventions

Abstract Obesity has been shown to intensify the decline of physical function and lead to frailty. Nutrition is an important method in managing obesity and frailty, while seldom reviews have ever explored the effects of nutritional education interventions. We conducted a systematic review (PROSPERO: CRD42019142403) to explore the effectiveness of nutritional education interventions in managing body composition and physio-psychosocial parameters related to frailty. Randomized controlled trials and quasi-experimental studies were searched in CINAHL, Cochrane Library, EMBASE, MEDLINE, PsycINFO, PubMed and Scopus from 2001 to 2019. Hand search for the reference lists of included papers was conducted as well. We assessed the quality of included studies by Cochrane risk of bias tool. Meta-analyses and narrative synthesis were used to analyse the data. Two studies with low risk of bias were screened from 180 articles, which involved 177 older people with an average age of 69.69±4.08 years old. The results showed that nutritional education was significantly effective in reducing body weight and fat mass than exercises, and it was beneficial to enhancing physical function and psychosocial well-being. But the effects of nutritional education in increasing muscle strength were not better than exercises. The combined effects of nutritional education and exercises were superior than either exercises or nutritional education interventions solely in preventing the loss of lean mass and bone marrow density, and in improving physical function. Due to limited numbers of relevant studies, the strong evidence of effectiveness of nutritional education interventions on reversing frailty is still lacking.

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