The efficacy and safety of oral
Tolperisone HCL was evaluated in double blind, placebo-controlled, randomized trial in 72 patients with
neurolathyrism in stages I, II, and III of the disease at Kolla Duba Health Centre of Dembia District of North Gondar between January and April 1995. Taken orally daily for 12 weeks,
tolperisone HCL (
Mydocalm) in a dose of 150 milligrams (mgs) twice daily significantly improved subjective complaints such as
muscle cramps, heaviness of the legs, startle attacks, flexor
spasms and repeated falls. An overall subjective improvement was observed in 75% of the patients on
tolperisone HCL and 39% of the placebo group (P = 0.002). When objectively assessed
spastic muscle tone in the abductors, stiffness of Achilles and spontaneous ankle clonus were significantly reduced in
tolperisone HCL group (P values = 0.001, 0.04, and 0.0001, respectively). Walking ability and speed of walking was also significantly improved. The
drug is most effective in relieving symptoms of stage I and stage II disease. Some adverse effects like
muscle pain, generalized body weakness and
dizziness were recorded in patients taking the
drug but all were minor and self limited, none requiring discontinuation of treatment. It is concluded that
tolperisone is a well tolerated and efficacious
drug for symptomatic treatment of
neurolathyrism.