A Double-Blind Controlled Trial of Tolperisone Hydrochloride in Hemiplegic Patients:with Reference to Rehabilitation

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Tolperisone hydrochloride (Muscalm) is a new muscle relaxant which mainly inhibits the multisynaptic spinal reflexes.<BR>A multiclinic double-blind controlled trial of Tolperisone in hemiplegic patients as performed from the point of view of rehabilitation. Three participating centers and 15 observers were contributed to the trial.<BR>Of the 93 patients started on the trial, 6 patients dropped out for various reasons. The remaining 87 patients, 60 males and 27 females, were included in the analysis. Randomization assigned 43 patients to Tolperisone and 44 to placebo. Tolperisone, in a dosage of 300 mg per day, was administered during a 6-week period.<BR>Tolperisone was significantly effective compared with placebo in evaluating the spasticity (muscle resistance, reflex and stretch reflex), whereas it was not significantly better than placebo in evaluating the function (gait, balance and ADL). No serious side-effect was encountered.<BR>From the whole assessment, however, it was suggested that Tolperisone, a new muscle relaxant, was also an useful supplementary drug for the successful rehabilitation of hemiplegic patients.
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