Gangliosides in the treatment of diabetic neuropathy: A randomized, double-blind, placebo-controlled, dose-finding study

A mixture of the four major gangliosides derived from neural tissues was administered intramuscularly at two different doses, 40 mg and 100 mg a day, for 4 consecutive weeks to 268 patients with diabetic neuropathy in a double-blind, placebo-controlled study. The patients were scored 2 wk before starting the trial, just prior to the treatments, at the end of the dosing period, and after a 4-weeks washout. Both neurological signs and symptoms, and instrumental parameters (vibratory perception threshold and conduction velocity of the sural nerve) improved considerably in the drug-treated patients. The improvement was dose-dependent for many parameters, and persisted for the 4-wk follow-up. However, also those parameters that did not show any clinically important difference between the two doses were shown to be significantly different from the placebo group at any time point. The drug tolerability was always very good, as demonstrated by the extremely small number of adverse events and the high patient compliance.