scholarly journals Placebo response in trials of drug treatments for cancer-related fatigue: a systematic review, meta-analysis and meta-regression

2020 ◽  
Vol 10 (4) ◽  
pp. 385-394 ◽  
Author(s):  
Rocio Roji ◽  
Patrick Stone ◽  
Federico Ricciardi ◽  
Bridget Candy
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Placebo Response ◽  
Risk Of Bias ◽  
Small Samples ◽  
Contributing Factors ◽  
Cancer Related Fatigue ◽  
Study Results ◽  
Meta Regression ◽  
Multiple Drugs

BackgroundCancer-related fatigue (CRF) is one of the most distressing symptoms experienced by patients. There is no gold standard treatment, although multiple drugs have been tested with little evidence of efficacy. Randomised controlled trials (RCTs) of these drugs have commented on the existence or size of the placebo response (PR). The objective of this systematic review was to establish the magnitude of the PR in RCTs of drugs to relieve CRF and to identify contributing factors.MethodRCTs were included in which the objective was to treat CRF. A meta-analysis was conducted using the standardised mean change (SMC) between baseline and final measurement in the placebo group. To explore factors that may be associated with the PR (eg, population or drug), a meta-regression was undertaken. Risk of bias was assessed using the revised Cochrane tool.ResultsFrom 3916 citations, 30 relevant RCTs were identified. All had limitations that increased their risk of bias. The pooled SMC in reduction in fatigue status in placebo groups was −0.23 (95% confidence intervals −0.42 to −0.04). None of the variables analysed in the meta-regression were statistically significant related to PR.ConclusionThere is some evidence, based on trials with small samples, that the PR in trials testing drugs for CRF is non-trivial in size and statistically significant. We recommend that researchers planning drug studies in CRF should consider implementing alternative trial designs to better account for PR and decrease impact on the study results.

scholarly journals Effects of open-label placebos in clinical trials: a systematic review and meta-analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Melina von Wernsdorff ◽  
Martin Loef ◽  
Brunna Tuschen-Caffier ◽  
Stefan Schmidt
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Medical Condition ◽  
Data Extraction ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Open Label ◽  
Cancer Related Fatigue ◽  
Promising Treatment ◽  
Irritable Bowel

AbstractOpen-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving a placebo. The objective of our study is to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and thirteen studies were included into the systematic review. Eleven trials were eligible for meta-analysis. These trials assessed effects of OLPs on back pain, cancer-related fatigue, attention deficit hyperactivity disorder, allergic rhinitis, major depression, irritable bowel syndrome and menopausal hot flushes. Risk of bias was moderate among all studies. We found a significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions but the respective research is in its infancy. More research is needed, especially with respect to different medical and mental disorders and instructions accompanying the OLP administration as well as the role of expectations and mindsets.

scholarly journals Effects of Supervised Multimodal Exercise Interventions on Cancer-Related Fatigue: Systematic Review and Meta-Analysis of Randomized Controlled Trials

2015 ◽  
Vol 2015 ◽  
pp. 1-13 ◽  
Author(s):  
José Francisco Meneses-Echávez ◽  
Emilio González-Jiménez ◽  
Robinson Ramírez-Vélez
Keyword(s):  
Systematic Review ◽  
Resistance Training ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Exercise Interventions ◽  
Training Interventions ◽  
Randomized Controlled ◽  
Cancer Related Fatigue

Objective. Cancer-related fatigue (CRF) is the most common and devastating problem in cancer patients even after successful treatment. This study aimed to determine the effects of supervised multimodal exercise interventions on cancer-related fatigue through a systematic review and meta-analysis.Design. A systematic review was conducted to determine the effectiveness of multimodal exercise interventions on CRF. Databases of PubMed, CENTRAL, EMBASE, and OVID were searched between January and March 2014 to retrieve randomized controlled trials. Risk of bias was evaluated using the PEDro scale.Results. Nine studiesn=772were included in both systematic review and meta-analysis. Multimodal interventions including aerobic exercise, resistance training, and stretching improved CRF symptoms (SMD=-0.23; 95% CI: −0.37 to −0.09;P=0.001). These effects were also significant in patients undergoing chemotherapyP<0.0001. Nonsignificant differences were found for resistance training interventionsP=0.30. Slight evidence of publication bias was observedP=0.04. The studies had a low risk of bias (PEDro scale mean score of 6.4 (standard deviation (SD) ± 1.0)).Conclusion. Supervised multimodal exercise interventions including aerobic, resistance, and stretching exercises are effective in controlling CRF. These findings suggest that these exercise protocols should be included as a crucial part of the rehabilitation programs for cancer survivors and patients during anticancer treatments.

scholarly journals Calorie Restriction With Exercise Intervention Improves Inflammatory Response in Overweight and Obese Adults: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Yubo Liu ◽  
Feng Hong ◽  
Veeranjaneya Reddy Lebaka ◽  
Arifullah Mohammed ◽  
Lei Ji ◽  
...  
Keyword(s):  
Systematic Review ◽  
Inflammatory Response ◽  
Sedentary Lifestyle ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Inflammatory Biomarkers ◽  
Obese Adults ◽  
Lifestyle Behavior ◽  
Tnf Α ◽  
Meta Regression

Background/Purpose: In this systematic review and meta-analysis, we assessed the effects of exercise (EX) combined with calorie restriction (CR) intervention on inflammatory biomarkers, and correlations between biomarkers and participants’ characteristics were calculated in overweight and obese adults.Methods: An article search was conducted through PubMed, Web of Science, EMBASE, the Cochrane database, Scopus, and Google Scholar to identify articles published up to April 2021. Studies that examined the effect of EX + CR intervention on inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), and compared them with a CR trial in overweight and obese adults were included. We calculated the pooled effect by meta-analysis, identified the correlations (between inflammatory biomarkers and participants’ characteristics) through meta-regression, and explored the beneficial variable through subgroup analysis. The Cochrane risk of bias tool and Methodological Index for Non-randomized Studies were used to assess the risk of bias for the included trials.Results: A total of 23 trials, including 1196 overweight and obese adults, were included in the meta-analysis. The pooled effect showed that EX + CR intervention significantly decreased CRP levels (P = 0.02), but had no effect on IL-6 (P = 0.62) and TNF-α (P = 0.11). Meta-regression analysis showed that the effect of EX + CR on CRP, IL-6, and TNF-α changes was correlated with lifestyle behavior of adults (Coef. = −0.380, P = 0.018; Coef. = −0.359, P = 0.031; Coef. = −0.424, P = 0.041, respectively), but not with age and BMI. The subgroup analysis results revealed that participants with sedentary lifestyle behavior did not respond to EX + CR intervention, as we found no changes in CRP, IL-6, and TNF-α concentrations (P = 0.84, P = 0.16, P = 0.92, respectively). However, EX + CR intervention significantly decreased CRP (P = 0.0003; SMD = −0.39; 95%CI: −0.60 to −0.18), IL-6 (P = 0.04; SMD = −0.21; 95%CI: −0.40 to −0.01) and TNF-α (P = 0.006; SMD = −0.40, 95%CI: −0.68 to −0.12) in adults without a sedentary lifestyle or with a normal lifestyle. Furthermore, the values between sedentary and normal lifestyle subgroups were statistically significant for CRP, IL-6, and TNF-α.Conclusion: Our findings showed that combination EX + CR intervention effectively decreased CRP, IL-6, and TNF-α in overweight and obese adults with active lifestyles, but not with sedentary lifestyle behavior. We suggest that ‘lifestyle behavior’ is a considerable factor when designing new intervention programs for overweight or obese adults to improve their inflammatory response.

scholarly journals The Efficacy of Triptolide in Preventing Diabetic Kidney Diseases: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Dongning Liang ◽  
Hanwen Mai ◽  
Fangyi Ruan ◽  
Haiyan Fu
Keyword(s):  
Systematic Review ◽  
Serum Creatinine ◽  
Blood Urea Nitrogen ◽  
Meta Analysis ◽  
Renin Angiotensin System ◽  
Risk Of Bias ◽  
Urea Nitrogen ◽  
Angiotensin System ◽  
Meta Regression ◽  
Ras Inhibitors

Ethnopharmacological Relevance: Triptolide (TP), the primary biologically active ingredient of Tripterygium wilfordii Hook F (TWHF), possesses the potential to solve the shortcomings of TWHF in treating diabetic kidney disease (DKD) in the clinic.Aim of the Study: We conducted a meta-analysis to evaluate the efficacy of TP in treating DKD and offer solid evidence for further clinical applications of TP.Materials and Methods: Eight databases (CNKI, VIP, CBM, WanFang, PubMed, Web of Science, EMBASE, and Cochrane library) were electronically searched for eligible studies until October 17, 2020. We selected animal experimental studies using TP versus renin–angiotensin system inhibitors or nonfunctional liquids to treat DKD by following the inclusion and exclusion criteria. Two researchers independently extracted data from the included studies and assessed the risk of bias with the Systematic Review Centre for Laboratory Animal Experimentation Risk of Bias tool. Fixed-effects meta-analyses, subgroup analyses, and meta-regression were conducted using RevMan 5.3 software. Inplasy registration number: INPLASY2020100042.Results: Twenty-six studies were included. Meta-analysis showed that TP significantly reduced albuminuria (14 studies; standardized mean difference SMD: −1.44 [−1.65, −1.23], I2 = 87%), urine albumin/urine creatinine ratio (UACR) (8 studies; SMD: –5.03 [–5.74, −4.33], I2 = 84%), total proteinuria (4 studies; SMD: –3.12 [–3.75, −2.49], I2 = 0%), serum creatinine (18 studies; SMD: –0.30 [–0.49, −0.12], I2 = 76%), and blood urea nitrogen (12 studies; SMD: –0.40 [–0.60, −0.20], I2 value = 55%) in DKD animals, compared to the vehicle control. However, on comparing TP to the renin–angiotensin system (RAS) inhibitors in DKD treatment, there was no marked difference in ameliorating albuminuria (3 studies; SMD: –0.35 [–0.72, 0.02], I2 = 41%), serum creatinine (3 studies; SMD: –0.07 [–0.62, 0.48], I2 = 10%), and blood urea nitrogen (2 studies; SMD: –0.35 [–0.97, 0.28], I2 = 0%). Of note, TP exhibited higher capacities in reducing UACR (2 studies; SMD: –0.66 [–1.31, −0.01], I2 = 0%) and total proteinuria (2 studies; SMD: –1.18 [–1.86, −2049], I2 = 0%). Meta-regression implicated that the efficacy of TP in reducing DKD albuminuria was associated with applied dosages. In addition, publication bias has not been detected on attenuating albuminuria between TP and RAS inhibitors after the diagnosis of DKD.Systematic Review Registration:https://clinicaltrials.gov/, identifier INPLASY2020100042

scholarly journals Pheochromocytomas and paragangliomas in von Hippel-Lindau disease: not a needle in a haystack

2021 ◽  
Author(s):  
João Castro-Teles ◽  
Bernardo Sousa-Pinto ◽  
Sandra Rebelo ◽  
Duarte Pignatelli
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Internal Validity ◽  
Risk Of Bias ◽  
Bias Analysis ◽  
Von Hippel Lindau ◽  
Von Hippel Lindau Disease ◽  
Meta Regression ◽  
Meta Regression Analysis

Objective: Pheochromocytomas are a hallmark feature of von Hippel-Lindau disease (vHL). To our knowledge, this is the first systematic review with meta-analysis evaluating the frequency of pheochromocytomas and/or paragangliomas (PPGL) in patients with vHL, as well as among patients with different vHL subtypes. Design: Systematic review with meta-analysis. Methods: We searched on MEDLINE, Scopus and Web of Science. We included primary studies assessing participants with vHL and reporting on the frequency of PPGL. We performed random-effects meta-analysis to quantitatively assess the frequency of PPGL, followed by meta-regression and subgroup analysis. Risk of bias analysis was performed to assess primary studies’ methodological quality. Results: We included 80 primary studies. In 4263 patients with vHL, the pooled frequency of PPGL was 19.4% (95% confidence interval (CI)=15.9-23.6%, I²=86.1%). The frequency increased to 60.0% in patients with vHL type 2 (95%CI=53.4-66.3%, I²=54.6%) and was determined to be of 58.2% in patients with vHL type 2A (95%CI=49.7-66.3%, I²=36.2%), compared to 49.8% in vHL type 2B (95%CI=39.9-59.7%, I²=42.7%), and 84.1% in vHL type 2C (95%CI=75.1-93.1%, I²=0%). In meta-regression analysis, more recent studies were associated with a higher frequency of PPGL. All studies had at least one internal validity item classified as 'high risk of bias', with 13% studies having low risk of bias in all external validity items. Conclusions: PPGL are a common manifestation of vHL. Despite methodological limitations and differences across primary studies, our results point to the importance of PPGL screening in patients with vHL.

scholarly journals Stigma for Common Mental Disorders in Racial Minorities and Majorities A Systematic Review and Meta-Analysis

2020 ◽  
Author(s):  
ozlem eylem ◽  
Leonore de Wit ◽  
Annemieke van straten ◽  
Lena Steubl ◽  
Zaneta Melissourgaki ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mental Illness ◽  
Mental Disorders ◽  
Common Mental Disorders ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Racial Minorities ◽  
Mental Illness Stigma ◽  
Regression Analyses ◽  
Meta Regression

Abstract Background There is a strong stigma attached to mental disorders preventing those affected from getting psychological help. The consequences of stigma are worse for racial and/or ethnic minorities who often experience other social adversities such as poverty and discrimination within policies and institutions. This is the first systematic review and meta-analysis summarizing the evidence on the impact of differences in mental illness stigma between racial minorities and majorities. Methods This systematic review and meta-analysis included cross-sectional studies comparing mental illness stigma between racial minorities and majorities. Systematic searches were conducted in the bibliographic databases of PubMed, PsycINFO and EMBASE until 20th December 2018. Outcomes were extracted from published reports, meta-analyses and meta-regression analyses were conducted in CMA software. Results After screening 2,787 abstracts, 29 studies with 193,418 participants (N=35,836 in racial minorities) were eligible for analyses. Racial minorities showed more stigma than racial majorities (g=0.20 (95% CI: 0.12~0.27) for common mental disorders. Sensitivity analyses showed robustness of these results. Multivariate meta-regression analyses pointed to the possible moderating role of the number of studies with high risk of bias on the effect size. Racial minorities have more stigma for common mental disorders when compared with majorities. Limitations included moderate to high risk of bias, high heterogeneity, few studies in most comparisons, and the use of non-standardized outcome measures. Conclusions An important clinical implication of these findings would be to tailor anti-stigma strategies according to specific racial and/or ethnic backgrounds with the intention to improve mental health outreach. These limitations suggest a need for more high quality research on stigma. Key words: stigma; mental illness stigma; common mental disorders; racial minorities

scholarly journals Diabetes and Risk of Surgical Site Infection: A Systematic Review and Meta-analysis

2015 ◽  
Vol 37 (1) ◽  
pp. 88-99 ◽  
Author(s):  
Emily T. Martin ◽  
Keith S. Kaye ◽  
Caitlin Knott ◽  
Huong Nguyen ◽  
Maressa Santarossa ◽  
...  
Keyword(s):  
Systematic Review ◽  
Surgical Site Infection ◽  
Meta Analysis ◽  
Diabetic Patients ◽  
Site Infection ◽  
Glucose Levels ◽  
Search Terms ◽  
Study Results ◽  
Control And Prevention ◽  
Meta Regression

OBJECTIVETo determine the independent association between diabetes and surgical site infection (SSI) across multiple surgical procedures.DESIGNSystematic review and meta-analysis.METHODSStudies indexed in PubMed published between December 1985 and through July 2015 were identified through the search terms “risk factors” or “glucose” and “surgical site infection.” A total of 3,631 abstracts were identified through the initial search terms. Full texts were reviewed for 522 articles. Of these, 94 articles met the criteria for inclusion. Standardized data collection forms were used to extract study-specific estimates for diabetes, blood glucose levels, and body mass index (BMI). A random-effects meta-analysis was used to generate pooled estimates, and meta-regression was used to evaluate specific hypothesized sources of heterogeneity.RESULTSThe primary outcome was SSI, as defined by the Centers for Disease Control and Prevention surveillance criteria. The overall effect size for the association between diabetes and SSI was odds ratio (OR)=1.53 (95% predictive interval [PI], 1.11–2.12; I2, 57.2%). SSI class, study design, or patient BMI did not significantly impact study results in a meta-regression model. The association was higher for cardiac surgery 2.03 (95% PI, 1.13–4.05) compared with surgeries of other types (P=.001).CONCLUSIONSThese results support the consideration of diabetes as an independent risk factor for SSIs for multiple surgical procedure types. Continued efforts are needed to improve surgical outcomes for diabetic patients.Infect. Control Hosp. Epidemiol.2015;37(1):88–99

scholarly journals Opioid versus opioid-free analgesia after surgical discharge: protocol for a systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e035443
Author(s):  
Charbel El-Kefraoui ◽  
Ghadeer Olleik ◽  
Marc-Aurele Chay ◽  
Araz Kouyoumdjian ◽  
Philip Nguyen-Powanda ◽  
...  
Keyword(s):  
Systematic Review ◽  
Postoperative Pain ◽  
Pain Intensity ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Major Surgery ◽  
Manuscript Submission ◽  
Health Crisis ◽  
Study Results

IntroductionExcessive prescribing after surgery has contributed to a public health crisis of opioid addiction and overdose in North America. However, the value of prescribing opioids to manage postoperative pain after surgical discharge remains unclear. We propose a systematic review and meta-analysis to assess the extent to which opioid analgesia impact postoperative pain intensity and adverse events in comparison to opioid-free analgesia in patients discharged after surgery.Methods and analysisMajor electronic databases (MEDLINE, Embase, Cochrane Library, Scopus, AMED, BIOSIS, CINAHL and PsycINFO) will be searched for multi-dose randomised-trials examining the comparative effectiveness of opioid versus opioid-free analgesia after surgical discharge. Studies published from January 1990 to July 2019 will be targeted, with no language restrictions. The search will be re-run before manuscript submission to include most recent literature. We will consider studies involving patients undergoing minor and major surgery. Teams of reviewers will, independently and in duplicate, assess eligibility, extract data and evaluate risk of bias. Our main outcomes of interest are pain intensity and postoperative vomiting. Study results will be pooled using random effects models. When trials report outcomes for a common domain (eg, pain intensity) using different scales, we will convert effect sizes to a common standard metric (eg, Visual Analogue Scale). Minimally important clinical differences reported in previous literature will be considered when interpreting results. Subgroup analyses defined a priori will be conducted to explore heterogeneity. Risk of bias will be assessed according to the Cochrane Collaboration's Risk of Bias Tool 2.0. The quality of evidence for all outcomes will be evaluated using the GRADE rating system.Ethics and disseminationEthical approval is not required since this is a systematic review of published studies. Our results will be published in a peer-reviewed journal and presented at relevant conferences. Further knowledge dissemination will be sought via public and patient organisations focussed on pain and opioid-related harms.

Sign in / Sign up

Export Citation Format

Share Document