Changes in thermal sensation in diabetic patients after treatment with gangliosides.

Thirty diabetic patients (mean age (+/- SD) 45.7 +/- 11.4 years, mean duration of diabetes 7.5 +/- 7.0 years, 17 insulin-dependent), were given 3 months of placebo injections followed by either 3-4 or 6 months injections of 100 mg mixed gangliosides (Cronassial) every weekday intramuscularly in a double-blind placebo-controlled study. There was an improvement of 0.77 +/- 1.25(10) degrees C and 0.65 +/- 1.05(10) degrees C in the thermal thresholds of the Cronassial treated group after 13-19 weeks and greater than 20 weeks respectively (p less than 0.22 from change of 0.04 +/- 0.59 degrees C in group treated with placebo. Compared to those with normal thresholds, patients with abnormal thermal thresholds (greater than 1.2 degrees C) improved significantly after Cronassial treatment for 13-19 weeks (-1.13 +/- 1.72(12) vs. 0.03 +/- 0.45(16) degrees C, p less than 0.006) and for greater than 20 weeks (-1.83 +/- 1.46(6) vs. 0.06 +/- 0.59(11), p less than 0.004) but this may have been related to the fact that the degree of improvement in thermal sensation was correlated with the initial thermal threshold (r = -0.80(28), p less than 0.001). There were no significant changes in electrophysiological measurements or vibration thresholds. Gangliosides are known to increase nerve sprouting and dendritogenesis and their effects in diabetic patients may be more easily seen using tests of small fibre function.

RCT Entities:   Population Interventions Outcomes