ObjectiveThis study aimed to assess the registration quality of clinical trials (CTs) with traditional Chinese medicine (TCM) in the WHO International Clinical Trials Registry Platform (ICTRP) and identify the common problems if any.MethodsThe ICTRP database was searched for all TCM CTs that were registered up to 31 December 2017. Registered information of each trial was collected from specific registry involved in ICTRP through hyperlink. The primary analysis was to assess the reporting quality of registered trials with TCM interventions, which is based on the minimum 20 items of WHO Trial Registration Data Set (TRDS, V.1.2.1) plus optional additional three items recommended by ICTRP, and some specific items for TCM information (including TCM intervention, diagnosis, outcome and rationale). Descriptive statistics were additionally used to analyse the baseline characteristics of TCM trial registrations.ResultsA total of 3339 records in 15 registries were examined. The number of TCM registered trials has increased rapidly after the requirement of mandatory trial registration proposed by International Committee of Medical Journal Editors on 1 July 2005, and the top two registries were Chinese Clinical Trial Registry and ClincialTrials.gov. Of 3339 trials, 61% were prospective registration and 12.8% shared resultant publications. There were 2955 interventional trials but none of them had a 100% reporting rate of the minimum 20 items and additional three items. The reporting quality of these 23 items was not optimal due to 11 of them had a lower reporting rate (<65%). For TCM details, 49.2% lacked information on description of TCM intervention(s), 85.9% did not contain TCM diagnosis criteria, 92.6% did not use TCM outcome(s) and 67.1% lacked information on TCM background and rationale.ConclusionThe registration quality of TCM CTs should be improved by prospective registration, full completion of WHO TRDS, full reporting of TCM information and results sharing. Further full set of trial registration items for TCM trials should be developed thus to standardise the content of TCM trial registration.
Introduction: Pattern differentiation is a critical component for traditional Chinese medicine (TCM) diagnosis and treatment. However, the issue of whether pattern differentiation is appropriately applied in TCM interventional trials, including Chinese herbal medicine (CHM) interventions and non-herbal TCM interventions, is unclear. The aim of this study was to i) systematically review the current status of pattern differentiation used in WHO-registered clinical trials for different types of TCM interventions; and ii) provide suggestions for improving the use of pattern differentiation in future clinical trial design. Methods: The World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) database was searched for all TCM interventional trials registered up to 31 December 2017. In this systematic review trials with a TCM pattern differentiation in their design were included. Descriptive statistics were collated to demonstrate the characteristics of pattern differentiation applied for different TCM interventional trials. Results: Among 2,955 TCM interventional trials registered during 1999-2017, 376 (12.7%) trials included pattern differentiation. Of 376 trials, the use of pattern differentiation was identified in-title (30.6%), objective (50.5%), participants inclusion 4 (100%), outcomes (43.6%) and study background (12.5%). Further, 85.4% reported the specific name of the TCM intervention, 10.6% provided the intervention's targeted pattern, 83.8% reported the specific name of the TCM pattern, 7.2% presented diagnostic criteria for the pattern studied, and 19.1% adopted a pattern-related outcome as primary outcome for evaluation. Conclusion: The reporting and application of pattern differentiation in TCM trials were inadequate and confusing, which was mainly due to lack of clarity regarding study design, objectives, diagnostic criteria and outcomes.
BackgroundPhysical identical and pharmacological inert are the basic requirements for placebo design, which are essential in clinical trials to evaluate the efficacy of an intervention. However, it is difficult to makeup a placebo of Chinese herbal medicine (CHM) because of special color, taste and smell, etc. Currently, there is no specific requirements and standards for the creation of a CHM-placebo. The purpose of this study is to review the characteristics of the CHM-placebo design and application in registered clinical trials with CHM interventions and identify the common problems, if any.MethodsThe World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) was systematically searched for CHM interventional trials with placebo-controlled design up to 31 December 2017. Registered information of each included trial was collected from specific registries involved in ICTRP through hyperlinks. Descriptive statistics were used to analyze the characteristics of placebo design in CHM trial registrations.ResultsA total of 889 CHM interventional trials were registered from 1999 to 2017, and 40.8% (363) of them included CHM-placebo control design. The common ways of their design were: placebo as sole control (191, 52.6%); placebo as add-on control with baseline treatment (84, 23.1%); and placebo as double-dummy control (57, 15.7%). Among 363 included trials, 46 (12.7%) reported the compositions of placebos, including CHM ingredients (17 trials), excipients and other agents (29 trials). 2 (0.6%) reported pharmacological inert testing, and 52 (14.3%) descripted their placebos to be physically identical with the CHMs. 14 (3.9%) reported quality control of placebos, and 2 (0.6%) provided blinding assessment of placebos.ConclusionsThe placebos included in most CHM trial registrations is not optimal in terms of placebo design, application, evaluation and reporting. Specific guidelines or standards of CHM-placebo design, including usage requirements, preparation specifications, quality assessments and reporting guidelines should be developed thus to improve their quality.
Background: The standards for reporting interventions in clinical trials of cupping (STRICTOC), in the form of a checklist and explanations for users, were designed to improve reporting of cupping trials, particularly the interventions, and thereby facilitating their interpretation and replication. Methods: A group of clinical experts, methodologists, epidemiologists, and editors has developed this STRICTOC checklist through a comprehensive process, including registration of this guideline, literature review, solicitation of comments, consensus meeting, revision, and finalization. Results: The STRICTOC checklist includes 6 items and 16 sub-items, namely cupping rationale, details of cupping, treatment regimen, other components of treatment, treatment provider background, and control or comparator interventions. Illustrative examples of each item are also provided. Conclusions: It is intended that the STRICTOC, in conjunction with both the main Consolidated Standards of Reporting Trials (CONSORT) Statement and extension for nonpharmacologic treatment, will raise the reporting quality of clinical trials of cupping. Trial registration We have registered this study on the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network: http://www.equat or-netwo rk.org/libra ry/repor ting-guide lines-under-devel opmen t/repor tingguide lines-under-devel opmen t-for-clini cal-trial s/#STRIC TOC.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.