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Oral antispastic drugs in nonprogressive neurologic diseases

A systematic review

From Unitat d’Assaigs Clínics i Farmacoepidemiologia (Drs. Montané and Laporte), Fundació Institut Català de Farmacologia (Drs. Montané, Vallano, and Laporte), Servei de Farmacologia Clínica, Hospital Universitari Vall d’Hebron (Drs. Vallano and Laporte), and Universitat Autònoma de Barcelona (Drs. Montané, Vallano, and Laporte), Barcelona, Spain.

Address correspondence and reprint requests to Dr. Eva Montané, Servei de Farmacologia Clínica, Pg Vall d’Hebron, n° 119-129, Hospital Universitari Vall d’Hebron, 08035 Barcelona, Spain; e-mail: eme{at}icf.uab.es

Objective: To assess the efficacy of oral drugs in the treatment of spasticity in patients with nonprogressive neurologic disease (NPND).

Methods: Systematic review of double-blind randomized controlled trials of antispastic oral drugs in the treatment of spasticity in NPND. Data sources: Electronic MEDLINE, PubMed, Cochrane Library, and hand searches.

Results: Twelve studies (469 patients) were included (6 on stroke, 3 on spinal cord diseases, and 3 on cerebral palsy). Tizanidine was assessed in four trials (276 patients, 142 exposed), dantrolene in four (103, 93), baclofen in three (70, 55), diazepam in two (127, 76), and gabapentin in one (28, all exposed). Most trials were of small size, of short duration, and their methodologic quality was inadequate. Ten trials were controlled with placebo and only two were direct comparisons between drugs. Efficacy outcome variables were heterogeneous. Only four reports described the magnitude of the antispastic effect. The incidence of adverse drug effects (drowsiness, sedation, and muscle weakness) was high.

Conclusion: Evidence on the efficacy of oral antispastic drugs in NPND is weak and does not include evaluation of patients’ quality of life. If any, efficacy is marginal. Adverse drug reactions were common. Better methodologic instruments are needed for the evaluation of antispastic treatment.

Received March 23, 2004. Accepted in final form May 28, 2004.

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