Efficacy and safety of traditional chinese medicine for diabetes: a double-blind, randomised, controlled trial.

Linong Ji,Xiaolin Tong,Yingli Chen,Yizhong Wang,Hongmei Li,Huimin Zhou,Gangyi Yang,Hongjie Yang,Yanbin Gao,Guang Ning,Lili Zhang,Qifu Li,Min Liu,Zhongai Zhang,Yan Li,Quanmin Li,Haoming Tian,Hongyuan Wang,Guo X ,Zhou Zhang ,Sanjoy K Paul

doi:10.1371/journal.pone.0056703

Abstract

BackgroundTreatment of diabetes mellitus with Traditional Chinese Medicine has a long history. The aim of this study is to establish the safety and efficacy of traditional Chinese medicine combined with glibenclamide to treat type 2 diabetes mellitus.MethodsIn a controlled, double blind, multicentre non-inferiority trial, 800 patients with unsatisfactory glycemic control (fasting glucose 7–13 mmol/L and HbA1c 7–11%) were randomly assigned to receive Xiaoke Pill, a compound of Chinese herbs combined with glibenclamide, or Glibenclamide in two study groups – drug naive group, and patients previously treated with metformin monotherapy (metformin group). Outcome measures at 48 weeks were the incidence and rate of hypoglycemia, mean difference in HbA1c, and proportion of patients with HbA1c<6.5%.FindingsIn drug naïve group, the total hypoglycemia rate and the mild hypoglycemic episode in the Xiaoke Pill arm were 38% (p = 0.024) and 41% (p = 0.002) less compared to Glibenclamide arm; in Metformin group, the average annual rate of hypoglycemia was 62% lower in Xiaoke Pill arm (p = 0.003). Respective mean changes in HbA1c from baseline were −0.70% and −0.66% for Xiaoke Pill and Glibenclamide, with a between-group difference (95% CI) of −0.04% (−0.20, 0.12) in the drug naïve group, and those in metformin group were −0.45% and −0.59%, 0.14% (−0.12, 0.39) respectively. The respective proportions of patients with a HbA1c level <6.5% were 26.6% and 23.4% in the drug naïve group and 20.1% and 18.9% in the metformin group.InterpretationIn patients with type 2 diabetes and inadequate glycaemic control, treatment with Xiaoke Pill led to significant reduction in risk of hypoglycemia and similar improvements in glycemic control after 48 weeks compared to Glibenclamide.Trial RegistrationChinese Clinical Trial Register number, ChiCTR-TRC-08000074

Highlights

Treatment of diabetes mellitus with Traditional Chinese Medicine (TCM) has a long history of more than 2,000 years in China [1]
The median (IQR) duration of diabetes in metformin group was 3 (1.0, 6.3) years; based on Mann-Whitney U tests, no significant differences were observed in the baseline variables between the two treatments in two study groups (Table 1)
Our study showed that Xiaoke Pill is associated with reduced risk of hypoglycemia and has similar glucose-lowing efficacy as compared with glibenclamide

Summary

Introduction

Treatment of diabetes mellitus with Traditional Chinese Medicine (TCM) has a long history of more than 2,000 years in China [1]. Diabetes has been described as ‘‘Xiaoke (wastingthirst)’’ in Traditional Chinese Medicine [2,3]. Large-scale, direct comparison of TCM and well established allopathic glucose lowering drugs in terms of safety (such as hypoglycemia: one of the most common symptoms during treatment of diabetes) and efficacy has been lacking [9,10,11,12]. Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history. The aim of this study is to establish the safety and efficacy of traditional Chinese medicine combined with glibenclamide to treat type 2 diabetes mellitus

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Results

Conclusion