Clinical Evidence Profile of Eleven Expensive Chinese Patent Medicines： A Scoping Analysis
10.13422/j.cnki.syfjx.20241430
- VernacularTitle:11种名贵中成药临床研究证据的概况性分析
- Author:
Yajing LI
1
;
Miaomiao LI
2
;
Le ZHANG
1
;
Wenya WANG
1
;
Hui ZHAO
3
;
Xing LIAO
1
Author Information
1. Center for Evidence-Based Chinese Medicine， Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Science， Beijing 100700， China
2. Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Science， Beijing 100700， China
3. China Center for Evidence-Based Traditional Chinese Medicine， Beijing 100700， China
- Publication Type:Journal Article
- Keywords:
expensive Chinese patent medicines;
clinical evidence;
scoping analysis;
randomized controlled trial;
rational administration
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(2):227-238
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveThis study employed the scoping review method to systematically retrieve and analyze the basic information and clinical research evidence of expensive Chinese patent medicines （CPMs）， aiming to provide a basis for future related research and clinical applications. MethodsEight Chinese and English databases were systematically searched for the clinical research evidence on expensive CPMs. ResultsEleven expensive CPMs （Angong Niuhuang Wan， Jufang Zhibao Wan， Suhexiang Wan， Pien Tze Huang， Niuhuang Qingxin Wan， Qinggong Shoutao Wan， Compound Realgar Natural Indigo Tablets， Xihuang Wan， Dingkun Wan， Babao Wan， and Guilingji Capsules） were selected. A total of 365 related studies were included in this review， comprising 331 clinical studies （of which 291 were randomized controlled trials）， 30 systematic reviews and Meta-analyses， 3 expert consensus， and 1 rapid health technology assessment. Among the 11 CPMs， 2（Angong Niuhuang Wan and Jufang Zhibao Wan） had a daily price over 500 yuan. The famous and precious Chinese medicinal materials involved included Moschus （frequency of 7）， Bovisc Alculus （7）， and Borneol （5）. The dosage forms included pills， capsules， oral liquid， tablets， and lozenges. The diseases treated by these CPMs mainly included malignant tumors， cerebrovascular diseases， gynecological diseases， and hepatobiliary system diseases. The sample sizes of the clinical studies were mainly concentrated within the range of 51-100 cases， and the main control form was CPM + basic Western medicine treatment vs. basic Western medicine treatment. The 331 clinical studies reported a total of 44 adverse events occurred， of which 36 were determined to be adverse reactions. ConclusionThe scarcity of raw materials leads to the high prices of expensive CPMs. The difficulty of conducting clinical research and the critical and severe cases treated lead to a lack of clinical research evidence with large sample sizes. The uneven distribution of existing studies， incomplete information on medicine package， and non-standard clinical research designs remain to be addressed in the future.
