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The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov.

ABSTRACT: Objective:The aim of this review is to characterize current status of global TCM clinical trials registered in ClinicalTrials.gov. Methods:We examined all the trials registered within ClinicalTrials.gov up to 25 September 2015, focusing on study interventions to identify TCM-related trials, and extracted 1,270 TCM trials from the data set. Results:Overall, 691 (54.4%) trials were acupuncture, and 454 (35.8%) trials were herbal medicines. Differences in TCM trial intervention types were also evident among the specific therapeutic areas. Among all trials, 55.7% that were small studies enrolled <100 subjects, and only 8.7% of completed studies had reported results of trials. As for the location, the United States was second to China in conducting the most TCM trials. Conclusion:This review is the first snapshot of the landscape of TCM clinical trials registered in ClinicalTrials.gov, providing the basis for treatment and prevention of diseases within TCM and offering useful information that will guide future research on TCM.

SUBMITTER: Chen J

PROVIDER: S-EPMC5613643 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov.

Chen Junchao J Huang Jihan J Li Jordan V JV Lv Yinghua Y He Yingchun Y Zheng Qingshan Q

Evidence-based complementary and alternative medicine : eCAM 20170824

<h4>Objective</h4>The aim of this review is to characterize current status of global TCM clinical trials registered in ClinicalTrials.gov.<h4>Methods</h4>We examined all the trials registered within ClinicalTrials.gov up to 25 September 2015, focusing on study interventions to identify TCM-related trials, and extracted 1,270 TCM trials from the data set.<h4>Results</h4>Overall, 691 (54.4%) trials were acupuncture, and 454 (35.8%) trials were herbal medicines. Differences in TCM trial interventio ...[more]

PMID: 29138646

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Project description:BackgroundWell-designed trials are of paramount importance in improving the delivery of care to patients with kidney disease. However, it remains unknown whether contemporary clinical trials within nephrology are of sufficient quality and quantity to meet this need.Study designSystematic review.Setting & populationStudies registered with ClinicalTrials.gov.Selection criteria for studiesInterventional (ie, nonobservational) studies (both randomized and nonrandomized) registered between October 2007 and September 2010 were included for analysis. Studies were reviewed independently by physicians and classified by clinical specialty.PredictorNephrology versus cardiology versus other trials.OutcomesSelect clinical trial characteristics.ResultsOf 40,970 trials overall, 1,054 (2.6%) were classified as nephrology. Most nephrology trials were for treatment (75.4%) or prevention (15.7%), with very few diagnostic, screening, or health services research studies. Most nephrology trials were randomized (72.3%). Study designs included 24.9% with a single study group, 64.0% that included parallel groups, and 9.4% that were crossover trials. Nephrology trials, compared with 2,264 cardiology trials (5.5% overall), were more likely to be smaller (64.5% vs 48.0% enrolling≤100 patients), phases 1-2 (29.0% vs 19.7%), and unblinded (66.2% vs 53.3%; P<0.05 for all). Nephrology trials also were more likely than cardiology trials to include a drug intervention (72.4% vs 41.9%) and less likely to report having a data monitoring committee (40.3% vs 48.5%; P<0.05 for all). Finally, there were few trials funded by the National Institutes of Health (NIH; 3.3%, nephrology; 4.2%, cardiology).LimitationsDoes not include all trials performed worldwide, and frequent categorization of funding source as university may underestimate NIH support.ConclusionsCritical differences remain between clinical trials in nephrology and other specialties. Improving care for patients with kidney disease will require a concerted effort to increase the scope, quality, and quantity of clinical trials within nephrology.

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The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov.

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The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov.

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