Sialorrhea In Patients Research Articles

Botulinum toxin type A for the treatment of sialorrhoea in amyotrophic lateral sclerosis: A clinical and neurophysiological study

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.

Botulinum toxin B as an effective and safe treatment for neuroleptic-induced sialorrhea

Severe sialorrhea is a common, potentially stigmatizing and disabling side-effect of neuroleptic drugs such as clozapine. Sialorrhea also occurs in neurological disorders such as Parkinson's disease (PD). For neurological diseases, several studies have demonstrated botulinum toxin type B to be a safe and effective treatment. To evaluate the treatment effects, tolerance, and duration of treatment-induced effects of botulinum toxin type B (Neurobloc) in the context of neuroleptic-induced sialorrhea (group 1) or PD-associated drooling (group 2) in a double-blind, placebo-controlled trial. Nine patients (four from group 1; five from group 2) with severe sialorrhea received injections into the salivary glands with either botulinum toxin type B or placebo and were followed over 16 weeks. We found large effect sizes for improvement of sialorrhea in patients treated with botulinum toxin type B, whereas the improvement of sialorrhea in those receiving placebo was only small. No patient reported any side effects. Reduction of sialorrhea lasted for 8 to 16 weeks after a single injection. Like for PD, botulinum toxin type B represents an effective and safe treatment for neuroleptic-induced sialorrhea with a treatment effect of 8 to 16 weeks.

Differentiated botulinum toxin treatment of sialorrhea in 15 patients suffering from Parkinson's disease, MSA, PSP, and brain injury in early childhood

The question is as follows: Is it possible to apply specific approaches with BoNT for the various diseases that can cause sialorrhea? We examined 15 patients who were seriously affected by sialorrhea. Three diagnostic groups were involved: Parkinson's disease (PD) ( n =8), brain injury in early childhood (BI) ( n =5) and two patients with MSA and PSP, respectively. Our first step was BoNT treatment of parotid glands (PG); if this did not show adequate results, submandibular glands (SM) and sublingual (SL) glands were injected as well. All of the PD patients experienced reduced salivation after only one injection into their PG. None of these cases showed the required subjective benefits; the actual reduction was still inadequate. Subsequent injection of only the SM resulted in clearly reduced salivation in all of the 8 patients. In the group of patients with BI, treating only the PG, or the SM, respectively, did not produce adequate results. Injecting both salivary glands finally resulted in beneficial effects for the patients. Additional injections into the SL did not lead to any further improvement. Successful BoNT treatment of sialorrhea in patients with PD (predominantly production at rest) can be accomplished with injections into only the SM. Patients with BI will need injections into the PG and the SM.

Safety and efficacy of Myobloc ® (botulinum toxin type B) for sialorrhea in Parkinson's disease (PD) patients

Background : Botulinum toxin type B (BoNT/B) reduces saliva production and may be helpful for PD patients with sialorrhea. Objective : To determine the safety, tolerability, and efficacy of BoNT/B for treating sialorrhea in patients with PD. Methods : Up to 60 patients will be recruited in a phase II double-blind, placebo-controlled, single-treatment, dose escalation study, and randomized 3:1 to 1 of 4 dose groups (1500, 2500, 3500 U or placebo). Patients will receive 250 U into each submandibular gland; parotid gland injections will vary from 500 to 1500 U. The initial 4-week period of this 20-week study will primarily assess the safety and preliminary efficacy of BoNT/B. Safety, tolerability, and duration of action will be assessed over 20 weeks. Safety will be evaluated by the frequency and intensity of adverse events (AEs), particularly those that indicate a compromised airway, and discontinuations due to AEs. Efficacy will be evaluated using patient and investigator ratings on the Drooling Frequency and Severity Scale, the Investigator's Clinical Global Impression of Change scale, and by saliva flow rate. Results : Two blinded safety monitoring board reviews have concluded there are no safety issues; ongoing reviews are expected to show BoNT/B to be well tolerated. Demographics will be presented.

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

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. To evaluate the efficacy and safety of BTX type B in the treatment of sialorrhea in patients with bulbar-onset ALS. 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. 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. Anatomic guided BTX type B injections seem effective and safe to treat sialorrhea in bulbar-onset ALS.

Radiotherapy to the salivary glands as treatment of sialorrhea in patients with parkinsonism

This study investigated retrospectively the long-term efficacy and safety of radiotherapy (RT) to the major salivary glands as treatment of sialorrhea in patients with parkinsonism. Twenty-eight patients received a bilateral dose of 12 Gy to the parotid and part of the submandibular glands between 2001 and 2006. Severity of sialorrhea and adverse events were assessed at 1 and 6 months post-RT and finally in the first quarter of 2007. Item 6 of the activities of daily living-section of the Unified Parkinson's Disease Rating Scale was used as primary endpoint. Quality of life (QoL) pre- and post-RT was investigated using a shortened Parkinson's Disease Questionnaire-8. Sialorrhea had improved significantly at 1 month post-RT and this effect was maintained for at least 1 year. Most frequent adverse events were loss of taste and a dry mouth; however, 75% of these adverse events were transient. QoL had improved significantly on the long term. The clinical global impression scores at the final follow-up showed that 80% of patients were satisfied. It was concluded that RT is an effective and safe treatment of sialorrhea on the long term in patients with parkinsonism.

Radiotherapy reduces sialorrhea in amyotrophic lateral sclerosis

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.

Treatment of sialorrhoea in patients with Parkinson??s disease: best current evidence

(1) Sialorrhoea is a common condition in patients with Parkinson's disease that has a negative impact on patient quality of life. (2) Traditionally, muscarinic antagonists have been the pharmacological agents of choice for the treatment of sialorrhoea; however, these agents are frequently associated with adverse events in patients with Parkinsonian disorders. (3) Recent studies suggest that botulinum toxin injection is currently the most effective treatment option for Parkinsonian-related sialorrhoea.

Validation of a new scale for the evaluation of sialorrhea in patients with Parkinson's disease

Sialorrhea is common in Parkinson disease (PD), affecting approximately 70% to 75% of patients. Several tools for measuring saliva volume or production exist, but none are designed specifically for assessing sialorrhea-related discomfort. The objective of this study was to develop and validate a clinical scale for subjective evaluation of sialorrhea in PD. In Phase I, internal consistency of the Sialorrhea Clinical Scale for PD (SCS-PD) was established in 39 PD patients. In Phase II, scale validity was proven through saliva volume measurements obtained in 49 PD patients and 27 healthy volunteers. Internal consistency estimated using Cronbach's alpha was 0.78, indicating none of the original seven items tested needed to be removed. Twenty-one patients complaining of sialorrhea (63%) studied during Phase II, showed higher SCS-PD scores but no differences in saliva volume. SCS-PD scores showed significant correlation with saliva volume (r = 0.41; P = 0.004) and with total Unified Parkinson's Disease Rating Scale Part III (UPDRS III) scores (r = 0.70). Furthermore, saliva volume showed inverse relation to age in PD patients as well as in controls (r = -0.3 and r = -0.4; P < 0.05), but SCS-PD scores did not. The SCS-PD scale showed good internal consistency and validity, providing support for its use in routine clinical sialorrhea-related discomfort evaluation.

Botulinum Toxin A in the Treatment of Sialorrhea in Children with Cerebral Palsy

Sialorrhea is commonly associated with many neurological and systemic conditions. For children and young adults with cerebral palsy, sialorrhea may cause embarrassment and social isolation. Current medical management used for sialorrhea is unsatisfactory. Preliminary studies in adults with sialorrhea have demonstrated that botulinum toxin A as an effective treatment; however, no studies have defined the optimal dose and the duration of botulinum toxin A's effects on sialorrhea in patients with cerebral palsy. We present four patients with cerebral palsy who received botulinum toxin A treatment for sialorrhea. Under ultrasound guidance, body weight-related dosage of botulinum toxin A was injected bilaterally into the parotid glands. All four patients reported distinct improvement within the first 2 weeks following toxin injection. Duration of the toxin's effect varied from 16 to 20 weeks. There were no therapeutic side effects.

Botulinum toxin treatment of sialorrhea: comparing different therapeutic preparations

In recent years, a number of potential new therapeutic indications of botulinum toxin injections have emerged, amongst which sialorrhea has attracted considerable attention. Based on open-label and controlled studies, botulinum toxin can be used to improve sialorrhea in patients with Parkinson's disease, parkinsonian syndromes, motor neuron disease and cerebral palsy. The toxin can be injected blindly based on anatomic landmarks of the salivary glands, or localization can be facilitated by use of ultrasound guidance. There are few reported adverse effects. However, many more carefully designed, controlled studies are still required to address the specific questions related to selection of patients, the optimal injection technique, the appropriate dose of botulinum toxin and its long-term effects.

Botulinum toxin B reduces sialorrhoea in patients with Parkinson's disease,

Botulinum toxin B reduces sialorrhoea in patients with Parkinson's disease,

Ultrasound-guided versus ‘blind’ intraparotid injections of botulinum toxin-A for the treatment of sialorrhoea in patients with Parkinson’s disease

Objective: To investigate the efficacy and safety of intraparotid botulinum toxin-A (BTX-A) injections into parotid gland using ultrasound-guided versus nonguided techniques for the treatment of sialorrhoea in patients with Parkinson’s disease (PD). Methods: 15 patients with PD and sialorrhoea were included and divided into two groups. Group A patients ( n=8) were injected with BTX-A using ultrasound guidance. Group B patients ( n=7) were injected with BTX-A without ultrasound guidance. Saliva secretion was assessed quantitatively at baseline and at weeks 1, 4, and 12. Patients and/or caregivers also assessed the saliva secretion using visual analog scale (VAS). Results: All patients except one reported subjective improvement in sialorrhoea at the first week. Group A patients showed significantly higher rate of saliva reduction at the first week, whereas in Group B the reduction was not statistically significant from baseline at the first week ( P>0.05). Comparisons of quantitative saliva assessments at each follow-up visit also showed that ultrasound-guided injections were superior to blind injections for saliva reduction. VAS scores showed an improvement in the mean rate of saliva secretion in each group at first week ( P<0.05). Two patients suffered from dry mouth in mild severity lasting 1 month. Conclusion: Intraparotid BTX-A injections using ultrasound guidance may be an effective, easy, and safe treatment for parkinsonian sialorrhoea.

Sialorrhea in amyotrophic lateral sclerosis: a hypothesis of a new treatment - botulinum toxin A injections of the parotid glands

The inhibitory action of botulinum toxin is not confined to the neuromuscular junction. The toxin has long been known to block all the autonomic cholinergic fibers, including the major secretomotor parasympathetic fibers to salivary glands. The parotids are the largest of the salivary glands and their selective chemodenervation with botulinum toxin A is likely to result in substantial reduction of saliva production. Injection of the parotid glands with botulinum toxin is proposed as an new treatment for sialorrhea in patients with amyotrophic lateral sclerosis and other neurological diseases.