Abstract
Introduction
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.
Conclusion
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.
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References
Dones I. Intrathecal baclofen for the treatment of spasticity. Acta Neurochir Suppl. 2007;97:185–188.
Saulino M, Jacobs BW. The pharmacological management of spasticity. J Neurosci Nurs. 2006;38:456–459.
Brennan PM, Whittle IR. Intrathecal baclofen therapy for neurological disorders: a sound knowledge base but many challenges remain. Br J Neurosurg. 2008;22:508–519.
Rietman JS, Geertzen JH. Efficacy of intrathecal baclofen delivery in the management of severe spasticity in upper motor neuron syndrome. Acta Neurochir Suppl. 2007;97:205–211.
Nance PW. A comparison of clonidine, cyproheptadine and baclofen in spastic spinal cord injured patients. J Am Paraplegia Soc. 1994;17:150–156.
Bass B, Weinshenker B, Rice GP, et al. Tizanidine versus baclofen in the treatment of spasticity in patients with multiple sclerosis. Can J Neurol Sci. 1988;15:15–19.
Bose K. The efficacy and safety of eperisone in patients with cervical spondylosis: results of a randomized, double-blind, placebo-controlled trial. Methods Find Exp Clin Pharmacol. 1999;21:209–213.
Cabitza P, Randelli P. Efficacy and safety of eperisone in patients with low back pain: a double blind randomized study. Eur Rev Med Pharmacol Sci. 2008;12:229–235.
Beltrame A, Grangiè S, Guerra L. Clinical experience with eperisone in the treatment of acute low back pain. Minerva Med. 2008;99:347–352.
Sartini S, Guerra L. Open experience with a new myorelaxant agent for low back pain. Adv Ther. 2008;25:1010–1018.
Rodriguez Boronat E, Colomer Rusinyol F, Ferrer Bosch F, Viladot Pericé R. Myorelaxant effects of eperisone and diazepam in the treatment of acute spinal muscle contracture: a comparative study. J Anaesthesiol Clin Pharmacol. 2008;24:285–290.
Tanaka K, Kaneko T, Yamatsu K. Effects of 4′-ethyl-2-methyl-3-piperidinopropiophenone on experimental contracture and spinal cord activities [in Japanese]. Folia Pharmcol Jpn. 1981;77:511–520.
Mano T, Miyaoka T. Effects of muscle relaxant E.M.P.P. on afferent discharges of muscle spindle in man — an microneurographic analysis [in Japanese]. No To Shinkei. 1981;33:237–241.
Grassi C, Passatore M. Spontaneous sympathetic command to skeletal muscles; functional implications. Funct Neurol. 1990;5:227–232.
Iwase S, Mano T, Saito M, Ishida G. Effect of a centrally-acting muscle relaxant, eperisone hydrochloride, on muscle sympathetic nerve activity in humans. Funct Neurol. 1992;7:459–470.
Sakai Y, Matsuyama Y, Nakamura H, et al. The effect of muscle relaxant on the paraspinal muscle blood flow: a randomized controlled trial in patients with chronic low back pain. Spine. 2008;33:581–587.
Ishizuki M, Yanagisawa M. Antinociceptive effects of tizanidine, diazepam and eperisone in isolated spinal cord-tail preparations of newborn rat. Pain. 1992;48:101–106.
Bresolin N, Zucca C, Pecori A. Efficacy and tolerability of eperisone in patients with spastic palsy: a cross-over, placebo-controlled dose-ranging trial. PECONIC. Eur Rev Med Pharmacological Sci. 2009. In press.
Pandyan AD, Johnson GR, Price CI, Curless RH, Barnes MP, Rodgers H. A review of the properties and limitations of the Ashworth and modified Ashworth scales as measures of spasticity. Clin Rehabil. 1999;13:373–383.
Russell DJ, Rosenbaum PL, Avery LM, Lane M. Gross Motor Function Measure (GMFM-66 & GMFM-88) User’s Manual. London: Mac Keith Press; 2002.
Tariq M, Akhtar N, Ali M, Rao S, Badshah M, Irshad M. Eperisone compared to physiotherapy on muscular tone of stroke patients: a prospective randomized open study. J Pak Med Assoc. 2005;55:202–204.
Pedersen E. Spasticity: Mechanism, Measurement, Management. Springfield, IL: Charles C. Thomas; 1969.
Hsieh JT, Wolfe DL, Miller WC, Curt A. SCIRE Research Team. Spasticity outcome measures in spinal cord injury: psychometric properties and clinical utility. Spinal Cord. 2008;46:86–95.
Macdonell RA, Talalla A, Swash M, Grundy D. Intrathecal baclofen and the H-reflex. J Neurol Neurosurg Psychiatry. 1989;52:1110–1112.
Dario A, Tomei G. A benefit-risk assessment of baclofen in severe spinal spasticity. Drug Saf. 2004;27:799–818.
Hoving MA, van Raak EP, Spincemaille GH, Palmans LJ, Sleypen FA, Vles JS. Dutch Study Group on Child Spasticity. Intrathecal baclofen in children with spastic cerebral palsy: a double-blind, randomized, placebo-controlled, dose-finding study. Dev Med Child Neurol. 2007;49:654–659.
Van Schaeybroeck P, Nuttin B, Lagae L, Schrijvers E, Borghgraef C, Feys P. Intrathecal baclofen for intractable cerebral spasticity: a prospective placebocontrolled, double-blind study. Neurosurgery. 2000;46:603–609.
Biering-Sørensen F, Nielsen JB, Klinge K. Spasticity assessment: a review. Spinal Cord. 2006;44:708–722.
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Bresolin, N., Zucca, C. & Pecori, A. Efficacy and tolerability of eperisone and baclofen in spastic palsy: a double-blind randomized trial. Adv Therapy 26, 563–573 (2009). https://doi.org/10.1007/s12325-009-0031-8
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DOI: https://doi.org/10.1007/s12325-009-0031-8