E Montané1, A Vallano, J R Laporte. 1. Unitat d'Assaigs Clínics i Farmacoepidemiologia, Servei de Farmacologia Clínica, Pg Vall d'Hebron, no 119-129, Hospital Universitari Vall d'Hebron, 08035 Barcelona, Spain. eme@icf.uab.es
Abstract
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.
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.