BACKGROUND:Botulinum toxin type A (BTA) is replacing trihexyphenidyl as the treatment of choice for idiopathic cervical dystonia (ICD), but there has never been a direct comparative study. METHODS: This trial compares the effectiveness of BTA with that of trihexyphenidyl in a prospective, randomized, double-blind design. Sixty-six consecutive patients with ICD were randomized to treatment with trihexyphenidyl tablets plus placebo injection or placebo tablets plus BTA injections. Tablets were administered daily according to a fixed schedule. Dysport or saline was injected under EMG guidance at study entry and again after 8 weeks. Patients were assessed for efficacy at baseline and after 12 weeks by different clinical rating scales. RESULTS:Sixty-four patients completed the study, 32 in each group. Mean dose of BTA was 292 mouse units (first session) and 262 mouse units (second session). Mean dose of trihexyphenidyl was 16.25 mg. The changes on the Disability section of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-Disability) (primary outcome), Tsui Scale, and the General Health Perception Subscale were significantly in favor of BTA. More patients treated with BTA had an improvement of at least three points on the TWSTRS-Disability (14 versus 6) and on the Tsui Scale (23 versus 12). Adverse effects were significantly less frequent in the BTA group. CONCLUSION:BTA is significantly more effective in the treatment of ICD, with less adverse effects.
RCT Entities:
BACKGROUND: Botulinum toxin type A (BTA) is replacing trihexyphenidyl as the treatment of choice for idiopathic cervical dystonia (ICD), but there has never been a direct comparative study. METHODS: This trial compares the effectiveness of BTA with that of trihexyphenidyl in a prospective, randomized, double-blind design. Sixty-six consecutive patients with ICD were randomized to treatment with trihexyphenidyl tablets plus placebo injection or placebo tablets plus BTA injections. Tablets were administered daily according to a fixed schedule. Dysport or saline was injected under EMG guidance at study entry and again after 8 weeks. Patients were assessed for efficacy at baseline and after 12 weeks by different clinical rating scales. RESULTS: Sixty-four patients completed the study, 32 in each group. Mean dose of BTA was 292 mouse units (first session) and 262 mouse units (second session). Mean dose of trihexyphenidyl was 16.25 mg. The changes on the Disability section of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-Disability) (primary outcome), Tsui Scale, and the General Health Perception Subscale were significantly in favor of BTA. More patients treated with BTA had an improvement of at least three points on the TWSTRS-Disability (14 versus 6) and on the Tsui Scale (23 versus 12). Adverse effects were significantly less frequent in the BTA group. CONCLUSION: BTA is significantly more effective in the treatment of ICD, with less adverse effects.
Authors: J J M Kruisdijk; J H T M Koelman; B W Ongerboer de Visser; R J de Haan; J D Speelman Journal: J Neurol Neurosurg Psychiatry Date: 2006-12-21 Impact factor: 10.154
Authors: Alberto Albanese; Francesca Del Sorbo; Cynthia Comella; H A Jinnah; Jonathan W Mink; Bart Post; Marie Vidailhet; Jens Volkmann; Thomas T Warner; Albert F G Leentjens; Pablo Martinez-Martin; Glenn T Stebbins; Christopher G Goetz; Anette Schrag Journal: Mov Disord Date: 2013-06-15 Impact factor: 10.338
Authors: D M Simpson; A Blitzer; A Brashear; C Comella; R Dubinsky; M Hallett; J Jankovic; B Karp; C L Ludlow; J M Miyasaki; M Naumann; Y So Journal: Neurology Date: 2008-05-06 Impact factor: 9.910
Authors: Patrick Hogan; P David Charles; Maureen Wooten Watts; Janice M Massey; Tamara Miller; John Mackowiack Journal: Curr Ther Res Clin Exp Date: 2004-03