Article type
Year
Abstract
Background: The prevalence of type 2 diabetes mellitus (T2DM) in adults was about 9.0% and Chinese herbal medicines (CHMs) have been widely used for treatment of T2DM in China. The State Food and Drug Administration of China (SFDA) is in charge of approval of CHMs on the market.
Objectives: To obtain the number of approved CHMs for T2DM, and to describe evidence on randomized clinical trials (RCTs) and assess the methodological quality of RCTs.
Methods: We searched Chinese pharmacopeia, essential drug lists, and relevant government websites for approved CHMs for T2DM. We searched four major Chinese biomedical databases for RCTs investigating CHMs for treatment of T2DM until August 2011. The methodological quality was evaluated by the risk of bias tool of the Cochrane Collaboration.
Results: Ninety-four herbal formulae (149 in different formulations) had been approved for treatment of T2DM by the SFDA between 1990 and 2011. The formulations included capsules, granules, tablets, pills, oral liquids, herbal tea, powders, dripping pills, mixture (He ji), adhesive plaster, liquid extract, and herbal injection. In total, 41 RCTs were identified on approved CHMs for T2DM. The methodological quality of the 41 RCTs was generally poor in terms of risk of bias. 17 of 94 CHMs were listed in Chinese Pharmacopeia. 22 of 94 CHMs were tested in RCTs, among which three formulae (Jinqi Jiangtang tablet, Tang Mai Kang granules, Tianmai Xiaoke tablets) were tested in more than three RCTs, respectively. Four herbal formulae were listed in Chinese essential drugs with two formulae were tested in RCTs. 41 formulae were listed as healthcare insurance drugs, and among them nine formulae were tested in RCTs.
Conclusions: Substantial numbers of herbal formulae have been approved by the SFDA in China for T2DM. However, evidence from RCTs is very limited, and the quality of the RCTs is poor.
Objectives: To obtain the number of approved CHMs for T2DM, and to describe evidence on randomized clinical trials (RCTs) and assess the methodological quality of RCTs.
Methods: We searched Chinese pharmacopeia, essential drug lists, and relevant government websites for approved CHMs for T2DM. We searched four major Chinese biomedical databases for RCTs investigating CHMs for treatment of T2DM until August 2011. The methodological quality was evaluated by the risk of bias tool of the Cochrane Collaboration.
Results: Ninety-four herbal formulae (149 in different formulations) had been approved for treatment of T2DM by the SFDA between 1990 and 2011. The formulations included capsules, granules, tablets, pills, oral liquids, herbal tea, powders, dripping pills, mixture (He ji), adhesive plaster, liquid extract, and herbal injection. In total, 41 RCTs were identified on approved CHMs for T2DM. The methodological quality of the 41 RCTs was generally poor in terms of risk of bias. 17 of 94 CHMs were listed in Chinese Pharmacopeia. 22 of 94 CHMs were tested in RCTs, among which three formulae (Jinqi Jiangtang tablet, Tang Mai Kang granules, Tianmai Xiaoke tablets) were tested in more than three RCTs, respectively. Four herbal formulae were listed in Chinese essential drugs with two formulae were tested in RCTs. 41 formulae were listed as healthcare insurance drugs, and among them nine formulae were tested in RCTs.
Conclusions: Substantial numbers of herbal formulae have been approved by the SFDA in China for T2DM. However, evidence from RCTs is very limited, and the quality of the RCTs is poor.