[Clinical trials and evaluation of Chinese patent medicine for chronic obstructive pulmonary disease].

Abstract

The clinical randomized controlled trials(RCTs) of Chinese patent medicine in the treatment of chronic obstructive pulmonary disease(COPD) were reviewed and analyzed to provide references for clinical research, guideline development, policy formulation, and quality improvement of clinical evidence. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, EMbase were searched for RCTs of Chinese patent medicine for COPD as a source of clinical evidence from database inception to December 31, 2019. The publication time, sample size, intervention and control measures, course of treatment, outcome indicators, and methodological quality of the trials were analyzed and evaluated. A total of 733 RCTs of Chinese patent medicine for COPD were included, among which 228 RCTs had a sample size higher than 100, accounting for 31.1% of total RCTs. Eighty-eight Chinese patent medicines were involved, including 40 oral medicines and 48 injections. A total of 327 RCTs mentioned intervention and control measures(Chinese patent medicine + conventional treatment vs conventional treatment), accounting for 43.0%. In addition, 94.40% of the RCTs reported the course of treatment, and 53.20% of the RCTs determined 8-14 d as the intervention course. The evaluation indicators adopted were numerous, among which physicochemical indicators(70.57%) and symptoms/signs(24.35%) were the most frequently employed. The operation of allocation concealment and blinding was not standard. Registration and the procedure related to ethics were mostly missing. The results indicate that there are prominent methodological problems in the clinical trials of Chinese patent medicine in the treatment of COPD, affecting the reliability and practicability of the trials. It is necessary to further standardize the design, implementation, and quality control of clinical trials of Chinese patent medicine in the treatment of COPD, highlight the clinical value of Chinese patent medicine for COPD, and improve the quality of evidence.

• Authors: Chao-Nan Feng, Hai-Yin Hu, Zhao-Chen Ji, Xiao-Yu Qiang, Zhe Chen, Yi Ou, Lu-Jia Cao, Jun-Hua Zhang
• Journal: Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica (Zhongguo Zhong Yao Za Zhi) Vol. 47 Issue 9 Pg. 2351-2357 (May 2022) ISSN: 1001-5302 [Print] China
• PMID: 35531683 (Publication Type: Journal Article)

Chemical References

• Drugs, Chinese Herbal
• Nonprescription Drugs

Topics

• China
• Clinical Trials as Topic
• Drugs, Chinese Herbal (therapeutic use)
• Humans
• Medicine, Chinese Traditional
• Nonprescription Drugs (therapeutic use)
• Pulmonary Disease, Chronic Obstructive (drug therapy)
• Reproducibility of Results