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Hindi Research Article
The Efficacy Evaluation of Danggui Buxue Tang (DBT) on Menopausal Symptoms: Clinical Trial Protocol Design and Considerations
King-Fai Cheng1,2, Eliza LY Wong3 and Ping-Chung Leung1,2*1Institute of Chinese Medicine, The Chinese University of Hong Kong, Hong Kong, P.R. China
2State Key Laboratory of Phytochemistry and Plant Resources in West China, Hong Kong, P.R. China
3The Chinese University of Hong Kong, Hong Kong, P.R. China
- *Corresponding Author:
- Ping-Chung Leung
Centre for Clinical Trials on Chinese Medicine
5/F, The CUHK Hong Kong Jockey Club School of Public Health Building
Prince of Wales Hospital
Shatin, NT, Hong Kong, P.R. China
Tel: (852)22528868
Fax: (852)26325441
E-mail: pingcleung@cuhk.edu.hk
Received date: November 17, 2014; Accepted date: January 12, 2015; Published date: January 16, 2015
Citation: Cheng K, Wong ELY, Leung P (2015) The Efficacy Evaluation of Danggui Buxue Tang (DBT) on Menopausal Symptoms: Clinical Trial Protocol Design and Considerations. J Community Med Health Educ 5:330. doi: 10.4172/2161-0711.1000330
Copyright: © 2015 Cheng K, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
Background: Almost two third women experience hot flushes after menopause. Conventional treatment is the use of oestrogen replacement therapy or hormone replacement therapy (HRT). Although HRT is considered the most effective treatment for hot flushes, it may increase the risk of breast cancer and thromboembolic disease. Danggui Buxue Tang (DBT) is a combination of Danggui 當æ¸ (Radix Angelicae Sinensis) and Huangqi 黃芪 (Radix Astragali), which has been reported in ancient Chinese medicinal literature to relieve blood deficiency in female. The aims of the clinical studies were to proof the efficacy and to find out the optimal dose of DBT for menopausal symptoms. Methods/Design: The clinical studies were consisted of two stages. Stage I was designed as a single-center, randomized, double blind, placebo-controlled parallel study. Eligible subjects were randomized to one of two groups: DBT or placebo. Stage II was designed as a multiple-dose escalation clinical trial to look for the optimum dose for menopausal women. Eligible subjects were randomized to one of three dosage groups: low, middle and high dose. Results: Through the well-designed and well-conducted clinical trials, we found that in stage I trial, in analysis by severity of flushes, there was a significant reduction in the number of mild hot flushes in DBT group but not in the placebo group. In stage II trial, there were significant reduction in hot flushes and night sweats in high and middle dose groups after 3 months treatment, however, no significant changes were seen in low dose group. Conclusion: Our experiences suggested that it was feasible to perform a well-designed TCM clinical trial although there were challenges had to deal with, such as placebo preparation, outcome/endpoints determination and batch-to-batch consistency of the study medication.
