RESUMO
BACKGROUND: Water extract from Malvastrum coromandelianum (Linn.) Garcke (MC) has been shown to have glucose lowering effect, short- and long-term safety in animal studies. A preliminary study in human reveals safety and its potential use as an adjunctive treatment to antihyperglycemic medications. OBJECTIVE: To investigate the glycemic-lowering efficacy ofMC in type 2 diabetes subjects. MATERIAL AND METHOD: A multicenter randomized, double-blind, placebo-controlled trial was conducted. Seventy-one diabetes subjects, who were treated with either diet control or single oral anti-diabetic drug (sulphonylurea or biguanide) with HbA1C between 6.5-9%, were recruited. Subjects were randomized to take MC tablets in a total dose of 1,200 mg/day or placebo for 12 weeks. Clinical parameters, glycemic control, HOMA-IR and HOMA-ß were assessed. RESULTS: Both MC (n = 34) and placebo (n = 37) groups had comparable baseline characteristics with a mean baseline HbA1C of 7.6 ± 0.82 vs. 7.5 ± 0.8%, respectively. During the study, HbA1C did not differ statistically after 4, 8 and 12 weeks of treatment (7.7 ± 0.97 vs. 7.6 ± 1.0, 7.9 ± 1.09 vs. 7.8 ± 1.03 and 7.8 ± 1.1 vs. 7.6 ± 1.1%, respectively). The body weight, insulin resistance and insulin secretion were also similar between groups (p > 0.05). No episode of hypoglycemia was reported. CONCLUSION: MC in a dosage of 1,200 mg/day does not have glucose lowering efficacy in type 2 diabetes.
