Status of Outcome Index in Randomized Controlled Trials of Traditional Chinese Medicine for Treatment of Tic Disorder in Children
10.13422/j.cnki.syfjx.20241023
- VernacularTitle:中药治疗儿童抽动障碍随机对照试验结局指标的现状分析
- Author:
Yujing CHEN
1
;
Hui LIU
1
;
Qianfang FU
1
;
Haihong YAN
2
;
Ping RONG
1
Author Information
1. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine， Tianjin 300381， China
2. Shanxi Children's Hospital， Taiyuan 030013， China
- Publication Type:Journal Article
- Keywords:
children with tic disorder;
traditional Chinese medicine;
randomized controlled trial;
outcome index;
core index set
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(20):103-110
- CountryChina
- Language:Chinese
-
Abstract:
This study analyzed the outcome index and related design elements of randomized controlled trials （RCTs） of traditional Chinese medicine （TCM） in the treatment of children with tic disorder （TD） in the past ten years， so as to provide a basis for the construction of the core index set of TCM in the treatment of children with TD. Eight databases were searched， including four English databases （PubMed， Web of Science， Embase， and Cochrane Library） and four Chinese databases， including China National Knowledge Infrastructure （CNKI）， Wanfang Database， VIP Database， and China Biology Medicine disc （CBMdisc）， as well as ClinicalTrials.gov and China Clinical Trial Registry. The search time was limited to from January 1， 2013 to October 29， 2023. RCTs on the TD in children treated with TCM were collected. Two researchers independently conducted literature screening， data extraction， and literature quality evaluation and summarized clinical outcome indexes and related trial design elements through qualitative analysis. A total of 67 RCTs were included， including 63 outcome indexes， with a total frequency of 348 times. The related outcome indexes could be divided into six categories： 12 symptom/sign indexes with a frequency of 134 （38.5%）， seven TCM symptom/syndrome indexes with a frequency of 31 （8.9%）， 33 physical and chemical examination indexes with a frequency of 97 （27.9%）， four safety indexes with a frequency of 67 （19.3%）， three long-term prognostic indexes with a frequency of 14 （4.0%）， and one kind of quality-of-life evaluation index （0.3%）. Currently， the RCTs research design of TCM in the treatment of TD in children has not yet formed a unified standard， and there are many problems in the quality of methodology， which reduces the authenticity and reliability of clinical conclusions. There are problems with clinical outcome indexes， such as significant quantity differences， unclear primary and secondary outcome indexes， unreasonable alternative indexes， non-standard TCM syndrome types and TCM evaluation indexes， lack of economic evaluation indexes， and less attention to long-term prognostic indexes and safety indexes. It is suggested that the researchers should design a more rigorous trial scheme and reasonably design the outcome index which is in line with the clinical trial efficacy evaluation of TCM， so as to construct the core index set with the characteristics of TCM for the treatment TD in children.
