Thinking and practice of key links in design of clinical trial scheme for treatment of influenza with traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20200724.501
- Author:
Zhen-Xuan LI
1
;
Guo-Zhen ZHAO
2
;
Yu-Hong GUO
3
;
Bo LI
4
;
Qing-Quan LIU
3
Author Information
1. Capital Medical University Beijing 100069, China Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing 100010, China.
2. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing 100010, China Beijing University of Chinese Medicine Beijing 100029, China.
3. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing 100010, China.
4. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing 100010, China Beijing Institute of Traditional Chinese Medicine Beijing 100010, China Beijing Hospital of Traditional Chinese Medicine Yanqing Branch, Capital Medical University Beijing 100191, China.
- Publication Type:Journal Article
- Keywords:
evidence-based medicine;
influenza;
trial scheme
- MeSH:
Double-Blind Method;
Drugs, Chinese Herbal/therapeutic use*;
Evidence-Based Medicine;
Humans;
Influenza, Human/drug therapy*;
Medicine, Chinese Traditional;
Randomized Controlled Trials as Topic;
Research Design;
Treatment Outcome
- From:
China Journal of Chinese Materia Medica
2021;46(7):1706-1710
- CountryChina
- Language:Chinese
-
Abstract:
To sort out the key points in "PICOS" design of clinical trial scheme for influenza, and optimize the clinical trial scheme of Chinese patent medicine in the treatment of influenza by strictly following the principle of evidence-based medicine, focusing on the clinical practice of the disease, and highlighting the characteristics of traditional Chinese medicine. "The design of a randomized, double-blind, positive parallel control study of a certain herbal preparation for the treatment of non-severe influenza" was taken as an example in this study, and the key points in the clinical trial design of Chinese patent medicine for the treatment of influenza were specifically discussed from six aspects, including the type of study, object of study, intervention measures, control measures, outcome indicators and frequently asked questions in test design. From methodological suggestions, in the design scheme of clinical trial on efficacy and safety of Chinese patent medicine in the treatment of influenza, the randomized controlled study should be the first choice for type of study; the inclusion criteria should define both the diagnostic criteria of Western medicine and the syndromes of traditional Chinese medicine(TCM); the exclusion criteria should include a comprehensive list of confounding factors and special circumstances lea-ding to bias in the study results; the interventions should be based on a well-defined dosing programme; internationally recognized positive drugs or guidelines should be used as control measures, with median antipyretic time as the main outcome indicator. For the evalua-tion of curative effect, disease symptom scale can be set, and the TCM syndrome scoring scale was carefully used in this study, with time nodes set for the efficacy evaluation standard. The full name of the drugs should be written in the regulations on combined drug use and prohibited drug use.
