A. Melka et al., SYMPTOMATIC TREATMENT OF NEUROLATHYRISM WITH TOLPERIZONE HCL (MYDOCALM) - A RANDOMIZED DOUBLE-BLIND AND PLACEBO-CONTROLLED DRUG TRIAL, Ethiopian medical journal, 35(2), 1997, pp. 77-91
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.