Analysis of outcome indicators in clinical trials on Chinese medicine as adjuvant therapy for severe pneumonia.
10.19540/j.cnki.cjcmm.20220523.501
- Author:
Kai XIE
1
;
Sheng-Nan GUAN
1
;
Hui JING
1
;
Chen-Xi ZHANG
1
;
Hai-Feng WANG
1
Author Information
1. the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province &Education Ministry of China, Henan University of Chinese Medicine Zhengzhou 450000, China.
- Publication Type:Journal Article
- Keywords:
core outcome set;
randomized controlled trial;
severe pneumonia;
traditional Chinese medicine
- MeSH:
Humans;
Medicine, Chinese Traditional;
Drugs, Chinese Herbal/therapeutic use*;
Quality of Life;
Combined Modality Therapy;
Pneumonia/drug therapy*
- From:
China Journal of Chinese Materia Medica
2022;47(20):5642-5653
- CountryChina
- Language:Chinese
-
Abstract:
This study analyzed the outcome indicators in randomized controlled trial(RCT) on Chinese medicine as adjuvant therapy for severe pneumonia in the past years, laying a foundation for the design of clinical trials on and construction of core outcome set(COS) for severe pneumonia. To be specific, related RCT was retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, Chinese Clinical Trial Registry, and ClinicalTrials.gov(from January 1,2011 to April 9,2022). Then data in the trials were extracted, and the quality of included RCT was assessed according to Cochrane handbook, followed by descriptive analysis of the use of outcome indicators. A total of 11 833 articles were screened out, and finally 34 RCTs were included(2 were protocols). The included trials involved 109 outcome indicators with emergence frequency of 320, which were mainly classified into 9 categories: physicochemical indicators(54, frequency 167), time to achieve the efficacy(15, frequency 38), clinical effective rate(10, frequency 36), quality of life(11, frequency 35), symptoms and signs(7, frequency 18), traditional Chinese medicine(TCM) syndrome(4, frequency 13), safety(3, frequency 8), economic evaluation(1, frequency 1), other indicators(4, frequency 4). The indicators with high frequency followed the order: total effective rate, arterial oxygen partial pressure, C-reactive protein, white blood cell count, arterial blood carbon dioxide partial pressure. A total of 5 articles(14.71%) reported the main outcome indicators and 11 articles(32.35%) adopted the efficacy on TCM syndromes as the outcome indicator. There are many problems in the selection of outcome indicators in RCT on the treatment of severe pneumonia with Chinese medicine, mainly manifested as the disregard of clinical endpoint indicators, the inappropriate selection of surrogate indicators, and the non-standard evaluation criteria for the efficacy on TCM syndrome. It is suggested that the evaluation system for the efficacy of Chinese medicine on severe pneumonia should be established in accordance with the method for international COS to improve the quality of clinical trials.
