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Journal of Chinese Integrative Medicine ›› 2006, Vol. 4 ›› Issue (3): 225-232.doi: 10.3736/jcim20060302

• Review • Previous Articles     Next Articles

Improving the quality of randomized controlled trials in Chinese herbal medicine, Part Ⅲ: Quality control of Chinese herbal medicine used in randomized controlled trials

Kelvin S.Y. Leung1, Zhao-xiang Bian1, David Moher2, Simon Dagenais2, You-ping Li3, Liang Liu1, Tai-xiang Wu3, Jiang-Xia Miao4   

  1. 1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China
    2. Children’s Hospital of Eastern Ontario Research Institute, Ottaw;
  • Online:2006-05-31 Published:2006-05-15

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Objective

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.

Methods

A search of the Cochrane Library was conducted to identify RCTs of CHM. Quality control information reported in those RCTs was then assessed independently.

Results

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.

Conclusion

The overall quality of reporting of RCTs of CHM was poor, reflecting the need for improvements in reporting future clinical trials in this area. Recommendations: 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.

Key words: Randomized controlled trial, Chinese herbal medicine, Quality control

CLC Number: 

  • R-3

"

Preparation form Definition
Capsule Herbs inside hard or soft gelatin envelope
Decoction Liquid extract made by slowly boiling herbs in water
Granule Raw herb powder or herb extract compressed into solid form
Injection Administration of extracted herbs with a needle, usually subcutaneously, intramuscularly, or intravenously
Oral liquid Herbs soaked in solvent such as alcohol to extract active ingredient(s), then distilled to reduce solvent
Pill Solid round form of herbs ground into fine powder and mixed with liquid and binding agent such as honey, paste, or flour
Powder Herbs ground into fine dry powder
Sachet Dried or powdered herbs prepared in individual bags as a single dose administration, added to water prior to consumption
Syrup Herbs mixed with thick liquid such as honey, sugar, or glycerin
Tablet Herbs mixed with excipients and pressed into solid form
Tea Herbs steeped in hot water

"

Preparation form of CHM Trials reported (%)
Decoction 76 (42.9)
Injection 34 (19.2)
Capsule 22 (12.4)
Oral liquid 12 (6.8)
Pill 8 (4.5)
Tablet 8 (4.5)
Granule 6 (3.4)
Sachet 4 (2.3)
Tea 3 (1.7)
Powder 2 (1.1)
Syrup 1 (0.6)
Unclear 1 (0.6)
Total 177 (100)
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