Treatment of diabetic microangiopathy and edema with total triterpenic fraction of Centella asiatica: A prospective, placebo-controlled randomized study

The aim of this study was to demonstrate in a prospective, placebo-controll ed, randomized study, whether total triterpenic fraction of Centella assiat ica (TTFCA) is effective in improving the microcirculation in diabetic micr oangiopathy and neuropathy. Patients with severe diabetic microangiopathy, neuropathy, and edema; patients with microangiopathy without neuropathy; an d healthy subjects were included. Microangiopathy was defined by laser Dopp ler and capillary filtration (rate on ankle swelling). Inclusion criteria w ere increase in resting flux and rate of ankle swelling; decrease in venoar teriolar response (VAR) and alteration in flux increase with temperature. P atients were randomized: the treatment group received TTFCA (tablets, 60 mg twice daily for 12 months); those in the placebo group received similar ta blets. Healthy controls were followed up as a reference, Groups were compar able; there were no dropouts. There were no differences in the treatment an d placebo groups at inclusion. Treatment was well tolerated; no side effect s were reported. No variations were observed in normals at 12 months. In th e neuropathy A-group, decreases (p < 0.05) in RF and RAS were observed in t he two treatment groups. The decrease in RAS was associated with a decrease in edema (p < 0.05) in both treatment groups. The differences in flux (38% ) and in VAR (38%) were associated with a decrease (28%) in the rate of ank le swelling (p < 0.05). In patients without neuropathy (B-group) the decrea se in flux was 22%, the VAR increased 22.7%, and the RAS decreased 9.5% at 12 months. The variations in normals and the progressive deterioration obse rved in untreated patients in both groups indicates the difference between treatment and placebo. In conclusion, the decrease in capillary filtration and edema is associated with symptomatic improvement. The action on edema i s beneficial for the evolution of neuropathy, The effects of TTFCA on flux, RAS, and edema are important in early stages of microangiopathy to avoid p rogression to clinical stages.