Analysis of Outcome Measures in Randomized Controlled Trials of Traditional Chinese Medicine for Aplastic Anemia
Objective:To analyze the current status of the use of outcome measures in randomized controlled trials(RCTs)of TCM for aplastic anemia(AA),providing a reference for the construction of a core outcome set(COS)for TCM treatment of AA.Methods:A comprehensive literature search was conducted in databases including China National Knowledge Infrastructure(CNKI),WanFang Data,PubMed,Cochrane Library,and Embase databases.Additionally,relevant studies were identified through the Chinese Clinical Trial Registry(ChiCTR)and ClinicalTrials.gov.Studies were screened according to inclusion criteria,the risk of bias was assessed,and the usage of various outcome measures was statistically analyzed.Results:A total of 326 RCTs were included,with sample sizes ranging from 5 to 1 222 cases,reporting a total of 198 outcome measures with a cumulative application frequency of 2 020 times.Outcome measures were categorized into seven domains based on functional attributes:TCM syndromes,symptoms and signs,laboratory tests,quality of life,long-term prognosis,economic evaluation,and safety events.Efficacy rate and TCM syndrome scores were identified as high-frequency outcome measures(reported 302 and 52 times,respectively),which are primary choices for core outcome measures in TCM treatment of AA.Secondly,considerations should include TCM syndrome efficacy rate,adverse reactions,quality of life scores,and survival quality.Conclusion:RCTs of TCM treatment for AA exhibit issues such as non-standardized diagnostic criteria for TCM syndromes,inconsistent clinical efficacy evaluation standards,a plethora of outcome measures with significant variations in their frequency and application,and a deficiency of TCM's characteristic outcome measures.Establishing a COS for TCM treatment of AA is crucial for advancing TCM clinical research and will have a profound impact on the field.
aplastic anemiarandomized controlled trialoutcome measurestraditional Chinese medicinecore outcome set
万方数据
维普
