RANDOMIZED STUDY OF GLIBENCLAMIDE VERSUS TRADITIONAL CHINESE TREATMENT IN TYPE-2 DIABETIC-PATIENTS

The purpose of this study was to evaluate the efficacy of a traditiona l Chinese treatment(TCT) based on three plants in association with a s ulfonylurea, glibenclamide (2.5 mg x 3/d). A 2 x 2 factorial design wa s adopted for this multicentre randomized double-blind trial involving 4 groups [A = placebo (P) TCT + P glibenclamide; B = P TCT + verum gl ibenclamide; C = verum TCT + P glibenclamide; D = verum TCT + verum gl ibenclamide]. Patients included were type 2 diabetic outpatients, 40-7 0 years of age, treated by diet alone or oral anti-diabetic drugs. End point criteria evaluated were HbA1, blood glucose and plasma insulin ( at fasting, and 1 and 2 h after a test meal). At each visit, a clinica l examination was performed, and a questionnaire on side effects and a ssociated symptoms was completed. The dose was reduced by half in the case of hypoglycaemia. The 216 patients were recruited in 5 centres [S hanghai (1) = 48, Shanghai (2) = 40, Beijing = 40, Canton = 42, Chengd u = 46 and randomized into treatment groups A, B, C, D (56, 56, 50 and 54 respectively). Eleven patients were withdrawn for administrative r easons. In patients treated with glibenclamide, a significant increase in weight and insulinaemia was observed, together with a significant decrease in blood glucose values; in those receiving TCT, blood glucos e values were significantly decreased only 2 h after the test meal. A synergistic effect on blood glucose was observed when both treatments were given. Hypoglycaemia occurred in 19 patients (all in the two veru m glibenclamide groups). This first multicentre controlled trial showe d that the 3 Chinese plants tested were well-tolerated and effective i n Type 2 diabetes as indicated by a significant synergistic effect in association with a sulfonylurea.