SYMPTOMATIC TREATMENT OF NEUROLATHYRISM WITH TOLPERIZONE HCL (MYDOCALM) - A RANDOMIZED DOUBLE-BLIND AND PLACEBO-CONTROLLED DRUG TRIAL

The efficacy and safety of oral Tolperisone HCL was evaluated in doubl e blind, placebo-controlled, randomized trial in 72 patients with neur olathyrism in stages I, II, and III of the disease at Kolla Duba Healt h 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 subj ective complaints such as muscle cramps,: heaviness of the legs, start le attacks, flexor spasms and repeated falls;, An overall subjective i mprovement 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 an kle clonus were significantly reduced in tolperisone HCL group (P valu es = 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 e ffects like muscle pain, generalized body-weakness and, dizziness were recorded in patients taking the drug but all were minor and self limi ted, none requiring discontinuation of treatment. It is concluded that tolperisone is a well tolerated and efficacious drug for symptomatic treatment of neurolathyrism.