scholarly journals Effect of Crocus sativus (Saffron) Intake on Top of Standard Treatment, on Disease Outcomes and Comorbidities in Patients with Rheumatic Diseases: Synthesis without Meta-Analysis (SWiM) and Level of Adherence to the CONSORT Statement for Randomized Controlled Trials Delivering Herbal Medicine Interventions

Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4274
Author(s):  
Sotirios G. Tsiogkas ◽  
Maria G. Grammatikopoulou ◽  
Konstantinos Gkiouras ◽  
Efterpi Zafiriou ◽  
Iordanis Papadopoulos ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Consort Statement ◽  
Risk Of Bias ◽  
Crocus Sativus ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Disease Outcomes ◽  
The Consort Statement

Rheumatic diseases (RDs) are often complicated by chronic symptoms and frequent side-effects associated with their treatment. Saffron, a spice derived from the Crocus sativus L. flower, is a popular complementary and alternative medicine among patients with RDs. The present systematic review aimed to summarize the available evidence regarding the efficacy of supplementation with saffron on disease outcomes and comorbidities in patients with RD diagnoses. PubMed, CENTRAL, clinicaltrials.gov and the grey literature were searched until October 2021, and relevant randomized controlled trials (RCTs) were screened for eligibility using Rayyan. Risk of bias was assessed using the Cochrane’s Risk of Bias-2.0 (RoB) tool. A synthesis without meta-analysis (SWiM) was performed by vote counting and an effect direction plot was created. Out of 125 reports, seven fulfilled the eligibility criteria belonging to five RCTs and were included in the SWiM. The RCTs involved patients with rheumatoid arthritis, osteoarthritis and fibromyalgia, and evaluated outcomes related to pain, disease activity, depression, immune response, inflammation, oxidative stress, health, fatigue and functional ability. The majority of trials demonstrated some concerns regarding overall bias. Moreover, the majority of trialists failed to adhere to the formula elaborations suggested by the CONSORT statement for RCTs incorporating herbal medicine interventions. Standardization of herbal medicine confirms its identity, purity and quality; however, the majority of trials failed to adhere to these guidelines. Due to the great heterogeneity and the lack of important information regarding the standardization and content of herbal interventions, it appears that the evidence is not enough to secure a direction of effect for any of the examined outcomes.

scholarly journals Quality Evaluation of Randomized Controlled Trials of Rhodiola Species: A Systematic Review

2021 ◽  
Vol 2021 ◽  
pp. 1-17
Author(s):  
Xiuzhu Li ◽  
Weijie Chen ◽  
Yingqi Xu ◽  
Zuanji Liang ◽  
Hao Hu ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Consort Statement ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Controlled Trials ◽  
China National Knowledge Infrastructure ◽  
Randomized Controlled ◽  
The Consort Statement ◽  
The Cochrane Library

Background. Rhodiola is a worldwide used medicinal plant for its various medicinal functions, and the number of randomized controlled trials (RCTs) of Rhodiola is increasing in recent years. This study aims to evaluate the reporting quality and risk of bias of the current RCT reports of different Rhodiola species. Methods. Six databases including Embase, PubMed, Web of Science, the Cochrane Library, ClinicalTrial.gov, and China National Knowledge Infrastructure were searched to identify RCTs that used Rhodiola as a single intervention and were published in English or Chinese from inception to December 2020. The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement was used as the checklist for assessment, and a scoring system was applied to the evaluation of RCTs. Score 0 represents no reporting or inadequate reporting, and score 1 represents adequate reporting. The risk of bias of the included studies was also assessed using the Cochrane Risk of Bias tool. Results. A total of 39 RCTs were included in this study, including 23 RCTs of Rhodiola rosea (R. rosea), 8 RCTs of Rhodiola crenulata (R. crenulata), and 8 RCTs of Rhodiola wallichiana (R. wallichiana). None of the included studies met all the CONSORT statement criteria, and the reporting quality of RCTs of the three Rhodiola species was all generally poor. Based on the risk of bias assessment, the majority of included studies were judged to have an unclear risk of bias in most domains due to inadequate reporting. Conclusions. There is inadequate reporting among the included RCTs of different Rhodiola species, and RCTs of Rhodiola with higher reporting quality and better methodological quality are needed.

scholarly journals Adherence to the CONSORT statement and risk of bias assessment in Randomized Controlled Trials in rehabilitation journals: a protocol for a meta-research study

2021 ◽  
Author(s):  
Tiziano Innocenti ◽  
Silvia Giagio ◽  
Stefano Salvioli ◽  
Daniel Feller ◽  
Silvia Minnucci ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Random Sample ◽  
Journal Citation Report ◽  
Consort Statement ◽  
Risk Of Bias ◽  
Reporting Guidelines ◽  
Controlled Trials ◽  
Publication Date ◽  
Randomized Controlled ◽  
The Consort Statement

ABSTRACTObjectiveThe aim of this study will be to assess the adherence to the reporting quality standards set forth in the CONSORT Statement checklist of a random sample of randomized controlled trials (RCTs) published in rehabilitation journals, and to assess the association between this adherence and the risk of bias of these RCTs.Methods and AnalysisA cross-sectional analysis is planned on a random sample of 200 RCTs published between 2011and 2020 in the 68 journals indexed under “rehabilitation” category in InCites Journal Citation Report.Randomization will be stratified by publication date and journal ranking (quartile range; Q1-2 and Q3-4) to include an equal number of studies from 2011 to 2015 (Q1-Q2=50 and Q3-Q4=50) and from 2016 to 2020 (Q1-Q2=50 and Q3-Q4=50). RCT with parallel group design will be included. Observational or cohort studies, interim analyses, economic analyses of RCTs, RCT protocols, quasi-experimental design post-trial follow-up studies, subgroup and secondary analyses of previously reported RCTs, RCT with cross-over design, pilot feasibility RCTs, n-of-1 trials, cluster trials, editorials, letters and news reports will be excluded. The primary analysis will address the completeness of the reporting for each study and the relationship between CONSORT adherence and risk of bias. This will be a descriptive analysis through descriptive statistics and graphical representation.Ethics and DisseminationSeveral studies have shown the positive influence of reporting guidelines on the completeness of research reporting but no one investigated the use and the appropriateness of reporting guidelines in physical therapy research. Therefore, this study will add relevant knowledge that may contribute to improve further the reporting of rehabilitation research. The results of this research will be published in a peer-reviewed journal and will be presented at relevant (inter)national scientific events.

scholarly journals Adjuvant Transarterial Chemoembolization Following Curative-Intent Hepatectomy Versus Hepatectomy Alone for Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Cancers ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 2984
Author(s):  
Stepan M. Esagian ◽  
Christos D. Kakos ◽  
Emmanouil Giorgakis ◽  
Lyle Burdine ◽  
J. Camilo Barreto ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Transarterial Chemoembolization ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Curative Intent ◽  
Randomized Controlled

The role of adjuvant transarterial chemoembolization (TACE) for patients with resectable hepatocellular carcinoma (HCC) undergoing hepatectomy is currently unclear. We performed a systematic review of the literature using the MEDLINE, Embase, and Cochrane Library databases. Random-effects meta-analysis was carried out to compare the overall survival (OS) and recurrence-free survival (RFS) of patients with resectable HCC undergoing hepatectomy followed by adjuvant TACE vs. hepatectomy alone in randomized controlled trials (RCTs). The risk of bias was assessed using the Risk of Bias 2.0 tool. Meta-regression analyses were performed to explore the effect of hepatitis B viral status, microvascular invasion, type of resection (anatomic vs. parenchymal-sparing), and tumor size on the outcomes. Ten eligible RCTs, reporting on 1216 patients in total, were identified. The combination of hepatectomy and adjuvant TACE was associated with superior OS (hazard ratio (HR): 0.66, 95% confidence interval (CI): 0.52 to 0.85; p < 0.001) and RFS (HR: 0.70, 95% CI: 0.56 to 0.88; p < 0.001) compared to hepatectomy alone. There were significant concerns regarding the risk of bias in most of the included studies. Overall, adjuvant TACE may be associated with an oncologic benefit in select HCC patients. However, the applicability of these findings may be limited to Eastern Asian populations, due to the geographically restricted sample. High-quality multinational RCTs, as well as predictive tools to optimize patient selection, are necessary before adjuvant TACE can be routinely implemented into standard practice. PROSPERO Registration ID: CRD42021245758.

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 Therapies for Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2017 ◽  
Vol 11 (1) ◽  
pp. 346-354 ◽  
Author(s):  
Kannan Sridharan ◽  
Gowri Sivaramakrishnan
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Meibomian Gland ◽  
Risk Of Bias ◽  
Present Review ◽  
Meibomian Gland Dysfunction ◽  
Controlled Trials ◽  
Schirmer’S Test ◽  
Randomized Controlled

Introduction: Meibomian Gland Dysfunction (MGD) is a common, often overlooked, chronic condition affecting eyes for which various therapies are being evaluated. Considering the absence of a systematic review and meta-analysis, the present review was carried out. Methods: An appropriate search strategy eligibility criteria were framed and electronic databases were scrutinized for appropriate literature. Randomized Controlled Trials (RCTs) enrolling patients diagnosed with MGD were included. Outcome measures were Tear Break Up Time (TBUT), Schirmer’s test, Meibomian Gland (MG) secretion score, MG plugging score, OSDI and SPEED. Cochrane’s tool was used to assess the risk of bias and Forest plot were generated either with fixed or random effects model, with Standardized Mean Difference (SMD). Results: TBUTs, Schirmer’s test and OSDI scores for systemic antimicrobials with placebo were 1.58 [1.33, 1.83], 2.93 [0.78, 5.09] and -3.58 [-4.28, -2.89] respectively. No quantitative synthesis was attempted for either mebiomian plugging or meibomian secretion scores and no significant changes were observed with any other outcome parameter. Conclusion: Only the systemic antimicrobials were found to improve the clinical features of meibomian gland dysfunction. Varying effects of different therapeutic agents (heat therapies, omega-3-fatty acids and castor oil) were identified for MGD but the risk of bias pertaining to randomization and allocation concealment was found to be associated with most of the current RCTs. More high quality evidence is required to confirm the findings of the present review.

A qualitative assessment of randomized controlled trials in otolaryngology

1998 ◽  
Vol 112 (5) ◽  
pp. 460-463 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony
Keyword(s):  
Randomized Controlled Trials ◽  
Consort Statement ◽  
Qualitative Assessment ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Future Assessment ◽  
The Consort Statement ◽  
The Mean ◽  
Better Than

AbstractIn 1996 the CONSORT statement made recommendations on the strict reporting of randomized controlled trials (RCT). This will facilitate the future assessment of such trials and will highlight those trials that have been performed suboptimally and whose results may be biased.We have devised a scoring system, based on CONSORT, to assess RCT quality and by reading each original paper in full we have now assessed the quality of trials published from 1966 to 1995.The mean score for trials identified was 7.3 out of a maximum 12 points. No one journal was significantly better than the others. Trials in rhinology are reported better than head and neck oncology trials (mean scores 7.6 and 6.5 respectively). The past 30 years has not seen an improvement in the quality of the trials.The reporting of RCTs in the ENT literature is poor. CONSORT guidelines now exist and trialists are encouraged to adopt them when conducting future clinical trials.

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