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Adaption and Application of the Four Phase Trials to Traditional Chinese Medicines
Joint Authors
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2013, Issue 2013 (31 Dec. 2013), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2013-08-20
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
Four phases of trial are widely used in testing drugs, surgery, and diagnosis in Western medicine (WM).
The staged testing process helps protect patients from unnecessary harms and control costs while assessing safety and efficacy.
In this paper we adapt the four phase trials for traditional Chinese medicine (TCM).
As TCM has been used in humans for thousands of years and there has been good preliminary clinical evidence on safety and efficacy for many of its therapies, in most cases its evaluation can start directly in humans, and preclinical laboratory research can be conducted in phase 4 trials after the efficacy is firmly demonstrated.
Furthermore, unlike investigational drugs, TCM therapies are various in the certainty of their safety and efficacy and thus should not enter the evaluation process at the same stage.
Unlike in WM, clarifying and refining PICO (patients, intervention, comparator, and outcome) are an important part of evaluation of newly designed TCM therapies.
The incommensurability between WM and TCM causes additional difficulties in TCM trials regarding defining and choosing PICO, for which some suggestions are made.
Observational studies seem to have a greater role in evaluation for TCM although the efficacy must be confirmed with randomized trials.
American Psychological Association (APA)
Di, M. Y.& Tang, Jin Ling. 2013. Adaption and Application of the Four Phase Trials to Traditional Chinese Medicines. Evidence-Based Complementary and Alternative Medicine،Vol. 2013, no. 2013, pp.1-10.
https://search.emarefa.net/detail/BIM-447853
Modern Language Association (MLA)
Di, M. Y.& Tang, Jin Ling. Adaption and Application of the Four Phase Trials to Traditional Chinese Medicines. Evidence-Based Complementary and Alternative Medicine No. 2013 (2013), pp.1-10.
https://search.emarefa.net/detail/BIM-447853
American Medical Association (AMA)
Di, M. Y.& Tang, Jin Ling. Adaption and Application of the Four Phase Trials to Traditional Chinese Medicines. Evidence-Based Complementary and Alternative Medicine. 2013. Vol. 2013, no. 2013, pp.1-10.
https://search.emarefa.net/detail/BIM-447853
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-447853