Trends and quality assessment of randomized controlled trials of western medicine for tic disorders in China
YANG Jing
WANG Ping-ping
YU Dan
HUANG Liang
ZHANG Ling-li
YANG Chun-song
Abstract：Objective: To systematically evaluate the current status of randomized controlled trials (RCTs) focusing on drug therapy for tic disorders in China and provide evidences for the development of clinical trails in China. Methods: A comprehensive and systematic literature search was carried out to collect all RCTs focusing on TDs drug therapy in 6 databases including the PubMed, Embase and four Chinese Databases. The quality of the literature was evaluated by the Cochrane bias risk assessment tool. Results: A total of 84 RCTs and 6562 patients were included in this study, among which male patients were totally 4640. A small quantity of RCTs had been published in the past 19 years. Among all the enrolled RCTs, only 2.4% (2/84) of RCTs involved sample size. 4.8% (4/84) of RCTs were multicenter studies involving two to eight centers. 29.8%(25/84) of RCTs were performed in teaching hospitals. For drug therapy, typical antipsychotics, atypical antipsychotics, antiepileptic drugs and alpha-2 adrenergic agonists were involved in 14.3% (12/84) of RCTs, 45.2% (38/84) of RCTs, 28.6% (24/84) of RCTs and 6.0% (5/84) of RCTs respectively. Only 3.6% (3/84) of RCTs used a placebo control while 96.4% (81/84) of RCTs used a positive drug control. 20.3% (17/84) of RCTs correctly stated random grouping methods, in which only 3.6% (3/84) of RCTs stated complete blind allocation plans. 7.1%(6/84) of RCTs was correctly blinded. Conclusion: In recent years, the number of high-quality RCTs remains scarce in China, which were mainly focusing on atypical antipsychotic agonists (risperidone, aripiprazole and quetiapine) and antiepileptic drugs (topiramate). Most published RCTs had small samples, no multicenters and low quality. We must pay more attentions to improve the study design and quality of RCTs on drug therapy for tic disorders in China.
Keywords：Tic disorderDrug therapyRandomized controlled trialQuality assessment
Publication Date：2018-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：5( 181-185 )