Efficacy of Chinese Herbal Medicine Compared with Metformin for Glucose Regulation and Cardiovascular Risk Factors in Patients with Type 2 Diabetes with Dyslipidaemia: A Multicenter, Randomised Clinical Trial
Authors: Lian Fengmei , Tian Jiaxing , Jin De , Piao Chunli , Guo Hailong , Zhang Jun , Li Liping , Wu Shentao , Guo Meizhen , Hong Yuzhi , Pu Weirong , Lang Suping , Yu Xiaotong , Xu Lipeng , Wu Shengping , Tong Xiaolin 
Published: June 2021

Abstract
Background: Previous studies have showed that traditional Chinese medicine can regulate glycaemia, bodyweight, lipids, and blood pressure in populations with various different cardiovascular risk factors. Yet no studies have established the benefits of traditional Chinese medicine in patients with type 2 diabetes with dyslipidaemia and abdominal obesity. We aimed to assess the efficacy and safety of the Jiangtangtiaozhi decoction (known as JTTZF), a Chinese herbal medicine, on glycaemia, lipids, and weight variables, compared with metformin. Methods: We did a randomised, multicenter, clinical trial in nine research centres in China. Adult patients (aged 18-70 years old) with type 2 diabetes and dyslipidaemia (defined as triglyceride 1.70-5.65 mmol/L-1) inadequately controlled by diet and exercise were enrolled. Patients were randomly allocated (1:1) via a computer-generated randomisation sequence to receive JTTZF (30g, twice per day) or metformin (0.25 g, three times a day) for 48 consecutive weeks. Patients were treated with gliclazide sustained-release tablets once per day when their HbA1c was more than 7% after 24 weeks. If their triglyceride was more than 5.65 mmol/L-1, bezafibrate was given twice a day. Patients and clinicians were masked to group assignment. The primary endpoint was change from baseline to week 48 of mean HbA1c in each treatment group. Secondary endpoints included lipid concentrations (ie, triglyceride, total cholesterol, LDL, and HDL), waist circumference, bodyweight, and BMI. Analyses were done in the per-protocol population who complied with the protocol and had no violations. Percentages of patients that reached HbA1c targets (<7·0%) and lipid targets (triglyceride <1·7 mmol/L, total cholesterol <5·7 mmol/L) were also assessed. Ethical approval was granted by the Guang’anmen Hospital Medical Ethics Commission in Beijing, China. Informed patient consent was given by all participants. This study is registered with ClinicalTrials.gov, number NCT01471275.Results: Between Nov 25, 2011, and Jun 27, 2013, we randomly assigned 450 patients to either JTTZF (n=225) or to metformin (n=225). 378 patients were included in the per-protocol analysis (201 patients in the JTTZF group and 177 patients in the metformin group). At week 48, JTTZF reduced mean HbA1c to 7.30% (SD 1.21, -0.94% from baseline) and metformin reduced mean HbA1c to 7.23% (SD 1.15, -1.00% from baseline; p=0.55 for difference between groups). 46% of patients attained the HbA1c goal in the JTTZF group and 41% in the metformin group. Compared with metformin, JTTZF did not significantly reduce mean concentrations of triglycerides (-0.87 mmol/L, SD 2.73 in the JTTZF group vs -0.53 mmol/L, 2.33 in the metformin group; p=0.19), total cholesterol (-0.53 mmol/L, 1.36 vs -0.39 mmol/L, 1.27; p=0.324), LDL (-0.45 mmol/L, 1.00 vs -0.33 mmol/L, 0.82; p=0.204), and HDL (-0.08 mmol/L, 0.43 vs -0.06 mmol/L, 0.27; p=0.54). More patients in the JTTZF than the metformin group reached targets for triglycerides (42% vs 28%, p=0.007) and total cholesterol (78% vs 69%, p=0.047). After 48 weeks, compared with metformin, JTTZF decreased mean waist circumference (-4.15 cm, SD 5.41 vs -2.95 cm, 5.70; p=0.036), bodyweight (-2.72 kg, SD 4.29 vs -1.75 kg, 4.31; p=0.029), and BMI (-0.99 kg/m², SD 1.55 vs -0.62 kg/m², SD 1.59; p=0.021). Serious adverse events were reported in four (2%) of 225 patients in the JTTZF group and in six (3%) of 225 patients in the metformin group. No severe hypoglycaemia was reported in either group.Conclusions: JTTZF showed improvements in several cardiovascular risk factors compared with metformin. JTTZF might be a promising alternative treatment for patients with type 2 diabetes.Trial registration Clinicaltrials.gov Identifier: NCT01471275