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Efficacy of transdermal scopolamine for sialorrhea in patients with amyotrophic lateral sclerosis

Revista Cogent Medicine
Año 2017
Enlaces DOI www.cochranelibrary.com

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Background: Sialorrhea, the excessive flow of saliva from the mouth, causes distress in about half of patients with amyotrophic lateral sclerosis (ALS). Treatments of sialorrhea in ALS include systemic anticholinergic drugs, amitriptyline, botulinum toxin injection, and salivary gland radiotherapy, although each has limitations. Scopolamine transdermal patches have been used to prevent motion sickness since the 1980s but have also been used to treat sialorrhea in oropharyngeal disease, cerebral palsy, and Parkinson’s disease. To date, no blinded, controlled studies of sialorrhea in ALS have been reported. Methods: A crossover, double-blind comparative study was conducted by randomly assigning patients to receive scopolamine or placebo patches for 1 week. Results: A total of 10 patients (three males and seven females; mean age 71.6 years) were enrolled. The mean volume of daily oral suction was decreased with scopolamine treatment. However, there were no significant differences between scopolamine and placebo in terms of a visual analogue scale of sialorrhea severity and difficulty, and the saliva item of the ALS Functional Rating Scale-Revised (ALSFRS-R). Conclusions: Our findings suggest that scopolamine patches might decrease saliva production and relieve sialorrhea in some patients with ALS. However, these findings were not statistically significant for all patients.

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Enhanced Bulbar Function in Amyotrophic Lateral Sclerosis: The Nuedexta Treatment Trial.

Revista Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics
Año 2017
Enlaces Pubmed DOI PubMed Central

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The goal of this randomized, blinded, crossover clinical trial was to determine whether Nuedexta (dextromethorphan and quinidine) enhanced speech, swallowing, and salivation in patients with ALS. Sixty patients with amyotrophic lateral sclerosis (ALS) received either Nuedexta or placebo for 28 to 30 days, followed by a 10 to 15-day washout period. Subsequently, patients were switched to the opposite treatment arm for the remaining days of the trial. The primary endpoint was a reduction in the self-report Center for Neurologic Study Bulbar Function Scale (CNS-BFS) score. The rater-administered ALS Functional Rating Scale Revised was the principal secondary endpoint. The CNS-BFS score improved with active treatment, decreasing from a mean of 59.3 in the placebo arm of the trial to 53.5 during the drug-treatment arm (p < 0.001). Each of the individual domains of bulbar function interrogated by the CNS-BFS responded to treatment with Nuedexta as follows: salivation: 15.8 versus 14.3 (p = 0.004); speech: 24.6 versus 22.2 (p = 0.003); swallowing: 18.9 versus 17.1 (p = 0.009). Similarly, the bulbar component of the ALS Functional Rating Scale Revised improved with active treatment (p = 0.003), although the drug did not affect the motor and respiratory components of this scale. This study is unique for several reasons. Firstly, it was driven by patient reports of improved speech and swallowing while taking Nuedexta for control of emotional lability. Secondly, the study was conducted over a short duration (70 days), and thirdly, a self-report scale was selected as the principle outcome measure. Considering the importance of bulbar functions, these results, if confirmed, point to an additional use of Nuedexta as an adjunct to the management of ALS.

Estudio primario

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Botulinum toxin-A injections vs radiotherapy for drooling in ALS.

Revista Acta neurologica Scandinavica
Año 2016
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OBJECTIVES: Botulinum neurotoxin (BoNT) injections in the salivary glands and radiotherapy (RT) on these glands are commonly used to alleviate severe drooling in patients with amyotrophic lateral sclerosis (ALS). This study compares BoNT type A with RT based on patient-rated evaluations. MATERIALS & METHODS: A prospective randomized controlled pilot study to compare RT (n = 10; on the parotid and the posterior part of the submandibular glands) with BoNT-A treatment (n = 10; in the parotid glands only, because of the risk of increasing oropharyngeal weakness) in patients with ALS. The primary outcome was the drooling status (burden of drooling), and our secondary interests were the degree of salivation, global change of drooling after treatment, and level of satisfaction with the treatment and negative experiences. RESULTS: There were no statistically significant between-treatment differences for the drooling status after treatment. Only at twelve weeks more saliva reduction was achieved by RT (P = 0.02). Patients treated with RT also described more transient negative experiences (like pain in mandible) directly after treatment. Subgroup analysis showed that patients with very severe dysphagia (no oral intake) were less satisfied and experienced a lower global change of drooling after treatment. CONCLUSIONS: This pilot study showed no significant difference in the burden of drooling between the treatments. However, with RT more saliva reduction was achieved, including negative experiences directly after treatment, but without the risk of decreasing oropharyngeal function. In addition, patients with very severe dysphagia do not seem to benefit from either treatment.

Estudio primario

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Radiotherapy treatment of sialorrhea in patients with amyotrophic lateral sclerosis requiring non-invasive ventilation.

Revista Journal of neurology
Año 2015
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Radiation therapy for hypersalivation: a prospective study in 50 amyotrophic lateral sclerosis patients.

Revista International journal of radiation oncology, biology, physics
Año 2014
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PURPOSE: This study aimed to evaluate the efficiency and the tolerance of radiation therapy (RT) on salivary glands in a large series of amyotrophic lateral sclerosis (ALS) patients with hypersalivation. METHODS AND MATERIALS: Fifty ALS patients that had medically failure pretreatment were included in this prospective study. RT was delivered through a conventional linear accelerator with 6-MV photons and 2 opposed beams fields including both submandibular glands and two-thirds of both parotid glands. Total RT dose was 10 Gy in 2 fractions (n=30) or 20 Gy in 4 fractions (n=20). RT efficacy was assessed with the 9-grade Sialorrhea Scoring Scale (SSS), recently prospectively validated as the most effective and sensitive tool to measure sialorrhea in ALS patients. RESULTS: At the end of RT, all patients had improved: 46 had a complete response (92% CR, SSS 1-3) and 4 had a partial response (8% PR, SSS 4-5). A significant lasting salivary reduction was observed 6 months after RT completion: there was 71% CR and 26% PR, and there was a significant SSS reduction versus baseline (P<10(-6)). There was no grade 3 to 4 toxicity, and most side effects (34%) occurred during RT. Nine patients (18%) underwent a second salivary gland RT course, with a 3-months mean delay from the first RT, resulting in a SSS decrease (-77%). Both RT dose regimens induced a significant SSS decrease with no significant toxicity. There were, however, more patients with CR/PR in the 20-Gy protocol (P=.02), and 8 of 9 patients (89%) receiving a second RT course had previously been treated within the 10-Gy protocol. CONCLUSION: Radiation therapy of 20 Gy in 4 fractions is an efficient and safe treatment for ALS patients with sialorrhea. A shorter RT course (10 Gy in 2 fractions) may be proposed in patients in poor medical condition.

Estudio primario

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Salivary glands radiotherapy to reduce sialorrhea in amyotrophic lateral sclerosis: dose and energy.

Revista Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique
Año 2013
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PURPOSE: This retrospective study evaluated the effectiveness of salivary gland radiotherapy for reducing sialorrhea in patients with amyotrophic lateral sclerosis (ALS). PATIENTS AND METHODS: From August 2001 to February 2008, 21 patients with amyotrophic lateral sclerosis (six men, 15 women; mean age 61.2 years, range 39-81) received external beam radiotherapy for sialorrhea (evaluation by the ALS Functional Rating Scale). All patients had previously received pharmacological treatments with unsatisfactory results or side effects. The mean dose was 19.1Gy (range 3-48), delivered in five fractions (range 1-16) on 17 days (range 1-77). Eight patients received 3D-conformal and 13 received 2D-conformal radiotherapy. Clinical target volumes included the parotids and submandibular glands (18 patients), submandibular glands and one parotid (one patient), or parotids (two patients). Thirteen patients were treated with 5.5-6MV photons and eight were treated with 6-15MeV electrons. A satisfactory salivary response was defined as complete or partial improvement. The median follow up was 10.4 months (range 0.4-26). One patient was lost to follow up. RESULTS: A positive response was observed in 65% of patients during a mean of 7 months (range 1-23). Four patients (20%) treated with photons and no patients treated with electrons experienced acute toxicity. Half (50%) the patients treated with photons and 87.5% of patients treated with electrons responded positively (P=0.09). Positive responses were more common with a high total dose (≥16Gy; 78.6%) than a low total dose (<16Gy; 33%; P=0.07). No differences were observed in tolerance (P=0.27). Age and sex did not impact the response. CONCLUSION: Salivary gland radiotherapy effectively reduced sialorrhea in patients with amyotrophic lateral sclerosis. An adequate compromise between toxicity and efficiency was achieved with 3D-conformal radiotherapy delivered with electrons to parotids and submandibular glands in a total dose of 16Gy or more (mean: 20Gy in five fractions).

Estudio primario

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Clinical Trial Nuedexta in Subjects With ALS

Registro de estudios clinicaltrials.gov
Año 2013
Enlaces Registro de estudios

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The purpose of this study is to determine whether Nuedexta is effective in the treatment of symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral Sclerosis (ALS).

Estudio primario

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Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patients

Autores
Revista UMIN000011494
Año 2013

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Volume matters: the influence of different botulinum toxin-A dilutions for sialorrhea in amyotrophic lateral sclerosis.

Revista Muscle & nerve
Año 2013
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INTRODUCTION: We aimed to determine the effect of different botulinum toxin-A (BTX-A) dilutions on the treatment efficacy and side effects for amyotrophic lateral sclerosis (ALS) related sialorrhea. METHODS: Ten patients were enrolled in the study. BTX-A dilution for Group A was 100 U in 1 ml of saline, whereas the dilution for Group B was 100 U in 2 ml of saline. Both groups received 20 U of BTX-A in each parotid gland, and assessments were made by means of the Drooling Impact Scale, items 1 and 3 of the ALS functional rating scale, and visual analog scales for drooling and swallowing function. RESULTS: Although both groups exhibited a similar improvement in drooling, Group B had a mild but significant deterioration in bulbar function that was not evident in Group A. CONCLUSIONS: These results suggest that BTX-A has a safer profile when reconstituted with 1 ml instead of 2 ml of saline.

Estudio primario

No clasificado

Botulinum toxin type B for sialorrhoea in children with cerebral palsy: a randomized trial comparing three doses

Revista Developmental medicine and child neurology
Año 2011
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AIM: The aim of the present study was to evaluate the efficacy and safety of three doses of botulinum toxin type B (BoNT‐B) in reducing persistent sialorrhoea in children with cerebral palsy (CP). METHOD: Children with CP and refractory sialorrhoea were randomized to one of four groups: a control group and three experimental groups receiving a low (1500 mouse units [MU]), medium (3000 MU), or high (5000 MU) dose of BoNT‐B respectively, into bilateral salivary glands. Drooling was measured using the Thomas‐Stonell rating scale, and the weight and the number of bibs used per day were counted in all children at baseline, 4, and 12 weeks after BoNT‐B injection. RESULTS: Twenty‐seven children (15 males, 12 females; mean age 7 y 10 mo, SD 1 y 6 mo; range 5‐15 y) were randomized into a control (seven children: four males, three females) and experimental groups receiving low (six children: four males, two females), medium (seven children: four males, three females), and high (seven children: three males, four females) doses of BoNT‐B respectively. All children had mixed neurological disorders consisting of spastic paraparesis, tetraparesis, dystonic movements, and ataxia. Gross Motor Function Classification System levels ranged from III to V, and all children had moderate or severe intellectual disability. Estimated means with their standard errors (SEM) of drooling were at baseline, 4, and 12 weeks respectively, as follows: control group, 12.1 (2.1), 11.9 (2.1), 11.8 (2.2), p for trend 0.992; low dose group, 13.8 (2.3), 11.4 (2.3), 13.9 (2.3), p for trend 0.952; medium dose group, 13.9 (2.1), 6.7 (2.1), 7.1 (2.1) p for trend 0.008; and for the high dose group 14.4 (2.1), 5.0 (2.1), 5.6 (2.1), p for trend 0.002. Side effects included dense saliva, xerostomia, and difficulty in swallowing, and were more frequent in the high‐dose group. INTERPRETATION: A 3000 MU injection of BoNT‐B into the salivary glands significantly improved the frequency and severity of sialorrhoea in children with CP. The lower dose was ineffective, and the higher dose produced no greater benefit and more side effects.