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Comparison of effectiveness and safety between granules and decoction of Chinese herbal medicine: a systematic review of randomized clinical trials.
J Ethnopharmacol. 2012 Apr 10; 140(3):555-67.JE

Abstract

BACKGROUND

The clinical use of Chinese herbal medicine granules is gradually increasing. However, there is still no systematic review comparing the effectiveness and safety of granules with the more traditional method of herbal decoctions.

METHOD

A literature search was conducted using China National Knowledge Infrastructure Databases (CNKI), Chinese Science and Technology Periodical Database (VIP), China Biomedical Database web (CBM), Wanfang Database, PubMed, and the Cochrane Library until March 10, 2011. Clinical controlled trials (CCTs) including randomized trials (RCTs) comparing the effectiveness and safety between Chinese herbal medicine granules and decoction were included. Two authors conducted the literature searches, and extracted data independently. The assessment of methodological quality of RCTs was based on the risk of bias from the Cochrane Handbook, and the main outcome data of trials were analyzed by using RevMan 5.0 software. Risk ratio (RR) or mean difference (MD) with a 95% confidence interval (CI) were used as effect measure.

RESULTS

56 clinical trials (n=9748) including 42 RCTs and 14 CCTs were included, and all trials were conducted in China and published in Chinese literature. 40 types of diseases and 15 syndromes of traditional Chinese medicine (TCM) were reported. Granules were provided by pharmaceutical companies in 13 trials. The included RCTs were of generally low methodological quality: 7 trials reported adequate randomization methods, and 2 of these reported allocation concealment. 10 trials used blinding, of which 5 trials used placebo which were delivered double blind (blinded participants and practitioners). 98.2% (55/56) of studies showed that there was no significant statistical difference between granules and decoctions of Chinese herbal medicine for their effectiveness. No severe adverse effects in either group were reported.

CONCLUSIONS

Due to the poor methodological quality of most of the included trials, it is not possible to reach a definitive conclusion whether both Chinese herbal medicine granules and decoctions have the same degree of effectiveness and safety in clinical practice, but this preliminary evidence supports the continued use of granules in clinical practice and research. Standardization of granules and further more rigorous pharmacological, toxicological and clinical studies are needed to demonstrate the equivalence with decoctions.

Authors+Show Affiliations

Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Review
Systematic Review

Language

eng

PubMed ID

22343092

Citation

Luo, Hui, et al. "Comparison of Effectiveness and Safety Between Granules and Decoction of Chinese Herbal Medicine: a Systematic Review of Randomized Clinical Trials." Journal of Ethnopharmacology, vol. 140, no. 3, 2012, pp. 555-67.
Luo H, Li Q, Flower A, et al. Comparison of effectiveness and safety between granules and decoction of Chinese herbal medicine: a systematic review of randomized clinical trials. J Ethnopharmacol. 2012;140(3):555-67.
Luo, H., Li, Q., Flower, A., Lewith, G., & Liu, J. (2012). Comparison of effectiveness and safety between granules and decoction of Chinese herbal medicine: a systematic review of randomized clinical trials. Journal of Ethnopharmacology, 140(3), 555-67. https://doi.org/10.1016/j.jep.2012.01.031
Luo H, et al. Comparison of Effectiveness and Safety Between Granules and Decoction of Chinese Herbal Medicine: a Systematic Review of Randomized Clinical Trials. J Ethnopharmacol. 2012 Apr 10;140(3):555-67. PubMed PMID: 22343092.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of effectiveness and safety between granules and decoction of Chinese herbal medicine: a systematic review of randomized clinical trials. AU - Luo,Hui, AU - Li,Qing, AU - Flower,Andrew, AU - Lewith,George, AU - Liu,Jianping, Y1 - 2012/02/09/ PY - 2011/09/17/received PY - 2012/01/22/revised PY - 2012/01/22/accepted PY - 2012/2/21/entrez PY - 2012/2/22/pubmed PY - 2012/8/2/medline SP - 555 EP - 67 JF - Journal of ethnopharmacology JO - J Ethnopharmacol VL - 140 IS - 3 N2 - BACKGROUND: The clinical use of Chinese herbal medicine granules is gradually increasing. However, there is still no systematic review comparing the effectiveness and safety of granules with the more traditional method of herbal decoctions. METHOD: A literature search was conducted using China National Knowledge Infrastructure Databases (CNKI), Chinese Science and Technology Periodical Database (VIP), China Biomedical Database web (CBM), Wanfang Database, PubMed, and the Cochrane Library until March 10, 2011. Clinical controlled trials (CCTs) including randomized trials (RCTs) comparing the effectiveness and safety between Chinese herbal medicine granules and decoction were included. Two authors conducted the literature searches, and extracted data independently. The assessment of methodological quality of RCTs was based on the risk of bias from the Cochrane Handbook, and the main outcome data of trials were analyzed by using RevMan 5.0 software. Risk ratio (RR) or mean difference (MD) with a 95% confidence interval (CI) were used as effect measure. RESULTS: 56 clinical trials (n=9748) including 42 RCTs and 14 CCTs were included, and all trials were conducted in China and published in Chinese literature. 40 types of diseases and 15 syndromes of traditional Chinese medicine (TCM) were reported. Granules were provided by pharmaceutical companies in 13 trials. The included RCTs were of generally low methodological quality: 7 trials reported adequate randomization methods, and 2 of these reported allocation concealment. 10 trials used blinding, of which 5 trials used placebo which were delivered double blind (blinded participants and practitioners). 98.2% (55/56) of studies showed that there was no significant statistical difference between granules and decoctions of Chinese herbal medicine for their effectiveness. No severe adverse effects in either group were reported. CONCLUSIONS: Due to the poor methodological quality of most of the included trials, it is not possible to reach a definitive conclusion whether both Chinese herbal medicine granules and decoctions have the same degree of effectiveness and safety in clinical practice, but this preliminary evidence supports the continued use of granules in clinical practice and research. Standardization of granules and further more rigorous pharmacological, toxicological and clinical studies are needed to demonstrate the equivalence with decoctions. SN - 1872-7573 UR - https://www.unboundmedicine.com/medline/citation/22343092/Comparison_of_effectiveness_and_safety_between_granules_and_decoction_of_Chinese_herbal_medicine:_a_systematic_review_of_randomized_clinical_trials_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-8741(12)00044-X DB - PRIME DP - Unbound Medicine ER -