Estudios primarios incluidos en esta revisión sistemática

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Estudio primario

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Revista American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
Año 2011
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Estudio primario

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Revista Amyotrophic lateral sclerosis : official publication of the World Federation of Neurology Research Group on Motor Neuron Diseases
Año 2010
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Botulinum toxin type A (BoNT/A) has been proposed as an alternative treatment for sialorrhoea in patients with amyotrophic lateral sclerosis (ALS). In an open-label prospective study, BoNT/A was injected into the parotid glands bilaterally using anatomic landmarks in 26 ALS patients with bulbar symptoms. Two weeks after injection the severity of sialorrhoea and the related disability were evaluated subjectively and objectively. A group of healthy subjects acted as controls for saliva production. Patients also underwent electrophysiological tests to evaluate possible toxin effects in the nearby non-injected muscles by comparing the amplitude of compound motor action potentials (cMAPs) elicited by electrical stimulation and recorded from the orbicularis oculi and masseter muscles. After BoNT/A injections, of the 26 patients treated, 23 reported that the severity of sialorrhoea improved and the disabling symptoms diminished. Cotton roll weight also decreased after BoNT/A injection, suggesting a reduction in saliva production. Two patients complained of dry mouth. BoNT/A injection left the cMAP amplitude unchanged, suggesting that botulinum toxin does not significantly affect the non-injected facial and masticatory muscles. In conclusion, intraparotid anatomically-guided BoNT/A injection is an effective, easy, and safe treatment for sialorrhoea in patients with bulbar symptoms related to ALS.

Estudio primario

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Revista Muscle & nerve
Año 2009
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Veinte pacientes con ELA con sialorrea refractarios al tratamiento médico se inscribieron en este estudio doble ciego, aleatorizados para recibir U 2500 de la toxina botulínica tipo B (BTxb) o placebo dentro de las glándulas parótidas y los submandibulares bilaterales con guía electromiográfica. Los pacientes que recibieron BTxb informó una impresión global de mejoría del 82% a las 2 semanas en comparación con el 38% de los que recibieron placebo (P <0,05). Este efecto significativo se mantuvo en 4 semanas. A las 12 semanas, el 50% de los pacientes que recibieron BTxb siguieron informando de mejora en comparación con el 14% de los que recibieron placebo. No hubo efectos adversos significativos, incluyendo la disfagia, en el grupo BTxb, y no hubo un aumento significativo en la tasa de disminución de la capacidad vital.

Estudio primario

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Revista Amyotroph Lateral Scler.
Año 2008
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Estudio primario

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Revista Journal of neurology
Año 2008
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BACKGROUND: Sialorrhea 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. OBJECTIVES: To evaluate the efficacy and safety of BTX type B in the treatment of sialorrhea in patients with bulbar-onset ALS. METHODS: Open-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. RESULTS: Sixteen 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. CONCLUSIONS: Anatomic guided BTX type B injections seem effective and safe to treat sialorrhea in bulbar-onset ALS.

Estudio primario

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Revista European journal of neurology
Año 2007
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Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder. Sialorrhea is a frequent problem in ALS patients with bulbar symptoms, because of progressive weakness of oral, lingual and pharyngeal muscles. This prospective study aimed to investigate the putative effect of palliative single-dose radiotherapy on problematic sialorrhea in patients with ALS. Twenty patients with ALS and problematic drooling were included; 14 were given radiotherapy with a single fraction of 7.5 Grey (Gy). Five patients were treated with botulinum toxin A (BTX-A) injections (20 U) into the parotid glands; two of these were later given radiotherapy. Symptom assessment, clinical examination and measurements of salivary flow (ml/min) were performed before and after treatment (1-2 weeks, 3 months). Salivary secretion was significantly reduced after radiation treatment, with a mean reduction of 60% (1 week) and 51% (2 weeks). Three months post-treatment, 21% reduction of the salivary secretion was observed compared with salivation before treatment. Mean salivary flow was not reduced after BTX-A treatment in five patients. No serious side-effects were observed with either of the two treatment modalities. Single-dose radiotherapy (7.5 Gy) significantly reduces sialorrhea and is an effective and safe palliative treatment in patients with ALS.

Estudio primario

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Revista Parkinsonism & related disorders
Año 2007
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Sialorrhea is frequent and invalidating in patients with amyotrophic lateral sclerosis (ALS) or Parkinson's disease (PD). Botulinum toxin (BTX) emerged as an alternative to traditional treatments. We evaluated efficacy and tolerability of ultrasound-guided BTX-B injections in parotids and submandibular glands in 18 patients with ALS or PD. At 1 week, both objective (cotton rolls weight) and subjective evaluations (dedicated clinical scales) documented sialorrhea reduction (p<0.01). ALS patients reported shorter benefit duration (p<0.001) and higher prevalence of viscous saliva (seven vs one patients), possibly due to different pattern of autonomic involvement. BTX-B seems efficacious in reducing sialorrhea in ALS and PD but the risk-benefit ratio might differ between these two conditions. This might have implications for clinical practice.

Estudio primario

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Autores Verma A , Steele J.
Revista Muscle Nerve.
Año 2006
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Estudio primario

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Revista Amyotroph Lateral Scler.
Año 2005
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Estudio primario

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Revista J Clin Neuromuscul Dis.
Año 2005
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