Oral Chinese Patent Medicines for Endometriosis: A Scoping Analysis of Clinical Evidence
10.13422/j.cnki.syfjx.20252122
- VernacularTitle:口服中成药治疗子宫内膜异位症临床研究证据的概况性分析
- Author:
Xiaojun BU
1
;
Zhiran LI
2
;
Shan HUANG
3
;
Ruihua ZHAO
2
;
Xing LIAO
4
;
Weiwei SUN
2
Author Information
1. Graduate School, Beijing University of Chinese Medicine, Beijing 100029,China
2. Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053,China
3. Medical College of Qinghai University, Xining 810000,China
4. Center for Evidence-based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700,China
- Publication Type:Journal Article
- Keywords:
scoping analysis;
rational drug use;
oral Chinese patent medicines;
clinical research;
endometriosis
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(21):186-197
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo systematically retrieve, analyze, and summarize the basic information and clinical research evidence of Chinese patent medicines (CPMs) for endometriosis via a scoping review method. MethodsCPMs indicated for EM were identified from three major drug lists, CNKI, clinical guidelines, and textbooks. Relevant clinical studies were retrieved from eight Chinese and English databases from inception to April 1, 2025. Key data from included studies were extracted to analyze characteristics of CPMs and their clinical evidence. ResultsA total of 18 CPMs were included, among which those with blood-activating and stasis-resolving effects accounted for the highest proportion. Constituent herbs predominantly exhibited sweet, bitter, and pungent flavors, with tropism to the liver and spleen meridians. Daily treatment costs varied substantially across CPMs. The 438 included studies involved 13 CPMs, among which Guizhi Fuling capsules/pills, Sanjie Zhentong capsules, and Dan'e Fukang soft extract/granules were the most extensively studied. Randomized controlled trials (RCTs) were the predominant study design. The most common comparison was between CPMs combined with Western medicine and Western medicine alone. The largest number of studies reported a sample size of 51-100 cases. The high-frequency outcome indicators covered 10 domains, including clinical response rate, adverse reactions, female hormone levels, serum CA125 levels, and recurrence status. ConclusionMultiple oral CPMs demonstrate efficacy in EM management, yet inadequate safety profiles persist in drug labeling. The annual number of clinical studies on oral CPMs for endometriosis showed an overall increasing trend. However, clinical research has shortcomings including uneven distribution of CPMs, small sample sizes, and suboptimal methodological rigor. Future efforts should focus on updating drug indications and safety information in package inserts, conducting high-quality clinical research, and generating more robust evidence to support the clinical use of oral CPMs for EM.