M. Vray et Jr. Attali, RANDOMIZED STUDY OF GLIBENCLAMIDE VERSUS TRADITIONAL CHINESE TREATMENT IN TYPE-2 DIABETIC-PATIENTS, Diabete et metabolisme, 21(6), 1995, pp. 433-439
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 Eleven patients were withdrawn for administrative r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.