Improving the quality of randomized controlled trials in Chinese herbal medicine, Part Ⅲ: quality control of Chinese herbal medicine used in randomize
- 15 May 2006
- journal article
- Published by Journal of Chinese Integrative Medicine Press in Journal of Chinese Integrative Medicine
- Vol. 4 (3), 225-232
- https://doi.org/10.3736/jcim20060302
Abstract
To discuss quality control of Chinese herbal medicine (CHM) in randomized controlled trials (RCTs), and to provide suggestions for improving this aspect in future clinical study in this therapeutic area. A search of the Cochrane Library was conducted to identify RCTs of CHM. Quality control information reported in those RCTs was then assessed independently. The search yielded a total of 167 RCTs of CHM for a variety of conditions. A total of 11 CHM preparations were used in those RCTs. Only one trial discussed quality control of the CHM interventions used. Issues affecting the safety and efficacy of CHM products used in RCTs were discussed including standardization of raw herbal materials, processing methods, screening for product contamination, and effects of combination products. The overall quality of reporting of RCTs of CHM was poor, reflecting the need for improvements in reporting future clinical trials in this area. To improve quality control of CHM used in RCTs in future, we recommend developing and implementing guidelines such as Good Agricultural Practice (GAP) for Chinese crude drugs, and current Good Manufacturing Practice (GMP) specific to CHM products. Chemical analyses of individual herbs of CHM and combination products are also recommended to provide reference standards for quality control.Keywords
This publication has 8 references indexed in Scilit:
- Improving the quality of randomized controlled trials in Chinese herbal medicine, Part Ⅰ: clinical trial design and methodologyJournal of Chinese Integrative Medicine, 2006
- Acute occupational pesticide‐related illness in the US, 1998–1999: Surveillance findings from the SENSOR‐pesticides programAmerican Journal of Industrial Medicine, 2003
- Adulteration of Chinese herbal medicines with synthetic drugs: a systematic reviewJournal of Internal Medicine, 2002
- Toxic heavy metals and undeclared drugs in Asian herbal medicinesTrends in Pharmacological Sciences, 2002
- Phytomedicines: Back to the FutureJournal of Natural Products, 1999
- Pharmaceutical Fingerprinting: Evaluation of Neural Networks and Chemometric Techniques for Distinguishing among Same-Product ManufacturersAnalytical Chemistry, 1996
- Chinese herbal medicines revisited: a Hong Kong perspectiveThe Lancet, 1993
- Efficacy of traditional Chinese herbal therapy in adult atopic dermatitisThe Lancet, 1992