• Journal of neurology · Apr 2008

    Clinical Trial

    Botulinum toxin type-B improves sialorrhea and quality of life in bulbaronset amyotrophic lateral sclerosis.

    • João Costa, Maria Luz Rocha, Joaquim Ferreira, Teresinha Evangelista, Miguel Coelho, and Mamede de Carvalho.
    • Serviço de Neurologia (Piso 7), Hospital de Santa Maria, Av. Prof. Egas Moniz, 1649-035 Lisboa. joaoncosta@sapo.pt
    • J. Neurol. 2008 Apr 1; 255 (4): 545-50.

    BackgroundSialorrhea is a disabling problem in bulbaronset amyotrophic lateral sclerosis (ALS). Botulinum toxin (BTX) type A and B have been proposed as alternatives to traditional treatments.ObjectivesTo evaluate the efficacy and safety of BTX type B in the treatment of sialorrhea in patients with bulbar-onset ALS.MethodsOpen-label prospective study of BTX type B injections in parotids (1000 U) and submandibular (250 U) glands using anatomic landmarks. Primary outcome was rate of responders (improvement > 50% on visual analogue scales (VAS) of severity and disability of sialorrhea) 1 month post-treatment. Other outcomes included subjective (drooling and quality of daily living questionnaires) and objective (cotton roll weights and number of paper handkerchiefs used) evaluations. Safety evaluations included questionnaires regarding brain stem symptoms.ResultsSixteen ALS patients were included. At 1 month the rate of responders was 75% with a mean reduction of 70% in severity and disabling VASs. Fifteen patients (94 %) reported some benefit with drooling reduction. In objective measurements there was a reduction over 60 % in saliva production and in the number of handkerchiefs used. Onset of effect occurred within 3 days. Most patients reported better quality of living. The most frequent side-effects were viscous saliva, local pain, chewing weakness and respiratory infection. There were no changes in blood pressure or cardiac rate. At 3 months, there was still a positive effect in all outcomes. All patients except one manifested their willingness to repeat treatment.ConclusionsAnatomic guided BTX type B injections seem effective and safe to treat sialorrhea in bulbar-onset ALS.

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