Clinical Trials and Evaluation of Chinese Patent Medicine in the Treatment of Stroke(2021-2022)
Objective:This study collected,collated,analyzed,and evaluated randomized controlled trials(RCTs)of Chinese patent medicine in the treatment of stroke published in 2021 and summarized clinical evidence of Chinese patent medicine in the treatment of stroke at different stages,providing references for follow-up research and evidence transformation and application.Methods:Based on the included literature in the Traditional Chinese Medicine(TCM)Clinical Evidence Database System(EVDS),CNKI,CBM,CSPD,Cochrane Library,PubMed,and EMbase were searched for RCTs of Chinese patent medicine in the treatment of stroke published in 2021,and statistical analysis was conducted.Results:The search yielded eligible RCTs from 147 papers,of which 67(45.58%)were RCTs with a sample size of more than 100 cases.A total of 51 kinds of Chinese patent medicine were involved,in-cluding 25 kinds of oral Chinese patent medicine and 26 kinds of TCM injections.A total of 16 intervention/control cases were in-cluded in RCTs,and among them,"Chinese patent medicine+Western medicine+conventional treatment"and"Western medicine+conventional treatment"were the most common(91 papers,61.90%).Among the 147 RCTs included,only one did not report a specific course of treatment,and the intervention duration was 14 days in 63.95%of the studies.There were still some problems in the overall methodology quality of research,especially the low risk rate of less than 5%in items including allocation concealment,blindness,and other biases.In addition,research registration and sample size estimation were rarely reported.Conclu-sion:The reports of RCTs of Chinese patent medicine in the treatment of stroke published in 2021 are significantly insufficient in randomization method,allocation concealment,bias implementation(blind application),and other biases.
Chinese patent medicineStrokeRandomized controlled trialsEvidence-based medicineTraditional Chinese medi-cineEvidence reportAnnual report