The Use of Traditional Chinese Patent Medicine for Chronic Hepatitis B Should Be Questioned: A Systematic Review and Meta-analysis of RCTs

Tao Zhan¹, Xing Wei¹, Xing-ping Dai^{1, 2}*, Ze-qi Chen¹, and Dong-sheng Wang¹

1.       Institute of Integrated Medicine and Key Unit of SATCM for Traditional Chinese Medicine Gan, Xiangya Hospital, Central South University, Changsha, 410008, PR. China

2.       Institute of Clinical Pharmacology, Hunan Key Laboratory of Pharmacogenetics, Central South University, Changsha, Hunan 410078, PR. China

 

BACKGROUND/AIM: Traditional Chinese patent medicine (TCPM) is widely used for the treatment of chronic hepatitis B (CHB) in China. Based on the relevant clinical trials conducted in the world we performed a systematic review on the available randomized controlled trials (RCTs) to assess the efficacy and safety of TCPM for CHB.

METHODS: We extensively retrieved the reports of RCTs on traditional Chinese medicine (TCM) for CHB and screened those with an experimental TCPM that is registered officially and approved for standardized manufacturing by the government of P.R. China. Cochrane systematic review methods were applied, which mainly included a process of assessing the quality of included trials and a meta-analysis of extracted data.

RESULTS: One hundred thirty eight available RCTs on 61 types of TCPM, involving 16393 patients, were included according to the criteria we designed. Few trials correctly reported methods of randomization. Only one trial on Fu Zheng Hua Yu capsules was assessed as “good quality”, which was multi-center, randomized, double blind and positive-controlled. The methodological quality of included trials was generally “poor”. Some trials on 27 TCPM reported more or less anti-viral effect of TCPM. Other claimed beneficial aspects included the improvement on liver function, liver fibrosis, symptoms of CHB and rare adverse events when applying TCPM. 7 drugs (Dan Shen agents, Da Huang Zhe Chong pills/capsules, Shuang Hu Qing Gan granules, An Luo Hua Xian pills, Ye Xia Zhu capsules, Huang Qi injection, Fu Zheng Hua Yu capsules) had relatively more studies (>5) and patient numbers.

CONCLUSIONS: Because of the poor methodological quality of the included studies, the main outcomes of RCTs on current registered TCPM could possibly be of much bias. The evidence is too weak to recommend TCPM for the treatment of CHB. However, there’re still potentially benefits of these assessed drugs. Further well-designed RCTs are required to evaluate the efficacy and safety of TCPM for CHB.

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