A double blind placebo controlled trial of mixed gangliosides in diabetic peripheral and autonomic neuropathy.

Twenty-six patients with signs or symptoms of diabetic neuropathy who also had motor or sensory neurophysiological abnormalities, were intensively studied in the first double-blind, placebo controlled trial of a ganglioside mixture in the U.K. (Cronassial, Fidia Farmaceutici, Abano Terme, Italy; 6 weeks of 20 mg daily intramuscularly). Diabetes control was good in both groups and there was no deterioration in either group during the course of the trial. Of the five neurophysiological parameters measured - the motor nerve compound action potential, motor nerve conduction velocity and minimum f wave latency of the common peroneal nerve and the sensory action potential and conduction velocity of the sural nerve - only the mean motor nerve action potential and conduction velocity increased though the changes were not significant. Four patients showed improvements of greater than 1.0 mV after treatment with Cronassial while none of the placebo group did so (p less than 0.05). Of the four patients who showed dramatic improvements in motor nerve action potentials, three also showed improvements in motor nerve conduction velocity. There were no significant changes in three tests of autonomic function after Cronassial therapy (orthostatic tilt reactions, single deep breath and Valsalva maneuver). Four patients in the Cronassial group (not those showing neurophysiological improvement) but only one in the placebo group reported marked improvements in their symptomatic complaints after treatment. We conclude that Cronassial is a promising new drug for the treatment of diabetic peripheral neuropathy with clear benefits for some patients.

RCT Entities:   Population Interventions Outcomes