Efficacy and tolerability of eperisone and baclofen in spastic palsy: a double-blind randomized trial.
BACKGROUND
Few trials have compared different central muscle relaxants in the treatment of spastic palsy. This head-to-head phase 3 trial compares oral eperisone, a central muscle relaxant with a promising activity in spasticity therapy, and oral baclofen.


METHODS
Patients (>18 years) with moderate to severe spastic palsy were eligible in this double-blind, randomized study; they received eperisone 300 mg/ day or baclofen 60 mg/day for 6 weeks. The efficacy evaluations included: functional analysis (Pedersen's scale, muscular tone, joint range of motion, 10-meter walking time); physiological and pathological reflexes; and electromyography (Hmax/Mmax amplitude ratio and the Wartenberg test). Physicians and patients globally assessed treatment efficacy.


RESULTS
Both eperisone (n=40) and baclofen (n=40) significantly improved functionality of lower limbs versus baseline (eperisone: -9.1%, P<0.01; baclofen: -8.3%, P<0.05), but only eperisone improved this parameter in the upper limbs (-7.8%, P<0.01 vs. -6.3%, P=NS). Both drugs reduced muscular tone from week 2. Only eperisone improved the joint range of motion (-32.5%, P<0.01 vs. -14.6%, P=NS). Both treatments reduced the 10-meter walking time (eperisone: -20.2%, P<0.01; baclofen: -24.0%, P<0.01); this effect was evident at week 2 with eperisone only. Both drugs improved reflexes. Eperisone and baclofen decreased the Hmax/Mmax amplitude ratio (eperisone: -30.0%, baclofen: -18.6%; P<0.01 for both). Eperisone increased the number of leg oscillations at the Wartenberg test (P<0.05) while baclofen increased the velocity of leg falling (P<0.01). For tolerability, no differences were observed between eperisone and baclofen in any parameters. Eperisone was judged as "good" by a higher number of physicians and patients than baclofen. Eighteen adverse events, most of mild intensity, were reported with eperisone and 27 with baclofen.


CONCLUSIONS
Eperisone 300 mg/day and baclofen 60 mg/day, administered orally, are effective and well-tolerated drugs in the treatment of spastic palsy. However, eperisone might be associated with some additional clinical benefits when compared with baclofen.
Bresolin
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Institute of Clinical Neurology, University of Milan, IRCCS Ospedale Maggiore Policlinico, Via F. Sforza, 35, 20122, Milan, Italy. nereo.bresolin@unimi.it
Zucca
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Pecori
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D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D001418:Baclofen / Q000494:pharmacology / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004576:Electromyography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009125:Muscle Relaxants, Central / Q000494:pharmacology / Q000627:therapeutic use*; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D011427:Propiophenones / Q000494:pharmacology / Q000627:therapeutic use*; D016059:Range of Motion, Articular / Q000187:drug effects; D012018:Reflex / Q000187:drug effects; D012021:Reflex, Abnormal / Q000187:drug effects; D012720:Severity of Illness Index; D016896:Treatment Outcome; D016138:Walking
D009125:Muscle Relaxants, Central; D011427:Propiophenones; C030848:eperisone; D001418:Baclofen