Treatment Of Sialorrhea In Patients Research Articles

Examining the Role of Sublingual Atropine for the Treatment of Sialorrhea in Patients with Neurodevelopmental Disabilities: A Retrospective Review.

Sialorrhea is common in children with neurodevelopmental disabilities (NDD) and is reported in >40% of children with cerebral palsy (CP). It causes a range of complications, including significant respiratory morbidity. This single-center retrospective chart review aims to document sublingual atropine (SLA) utilization to guide further study in establishing its role in secretion management for children with NDD. A chart review was completed for patients with NDD ≤ 22 years of age treated with SLA at a free-standing children's hospital between 1 January 2016 and 1 June 2021. Descriptive statistics were generated to summarize findings. In total, 190 patients were identified, of which 178 met inclusion criteria. The average starting dose for SLA was 1.5 mg/day, or 0.09 mg/kg/day when adjusted for patient weight. Eighty-nine (50%) patients were prescribed SLA first line for secretion management while 85 (48%) patients tried glycopyrrolate prior to SLA. SLA was used after salivary Botox, ablation, and/or surgery in 16 (9%) patients. This study investigates SLA as a potential pharmacologic agent to treat sialorrhea in children with NDD. We identify a range of prescribing patterns regarding dosing, schedule, and place in therapy, highlighting the need for further evidence to support and guide its safe and efficacious use.

Effectiveness of the pharmacological treatments for sialorrhea in patients with Parkinson's disease: a systematic review and network meta-analysis.

The present systematic review and network meta-analysis of randomized control trials (RCTs) aimed to establish whether there are evidence-based differences in the pharmacological agents used to manage sialorrhea in patients with Parkinson's disease (PD). The authors searched the databases: MEDLINE via PubMed, EMBASE, Scopus, Web of Science, and Cochrane Library for clinical trials. Unpublished trials were searched on clinicaltrials.gov and the Brazilian Clinical Trials Registry. Means and standard deviations of changes in the salivary flow or drooling reported by participants due to the interventions were recorded. The authors analyzed 13 RCTs. Compared to the placebo, types A and B of the botulinum toxin effectively reduced the salivary flow and the severity or frequency of drooling. However, the network meta-analysis did not differentiate between the botulinum toxin types. Ipratropium bromide and glycopyrrolate did not differ from the placebo. Indirect evidence showed that ipratropium had similar results to those obtained with both types of botulinum toxin. The CINeMA approach estimated the quality of the evidence as very low for all comparisons. The best treatment for sialorrhea in patients with PD is not fully elucidated yet. Therefore, more well-conducted randomized clinical trials are required to increase the level of evidence. There needs to be more evidence defining the best intervention to treat sialorrhea in patients with PD. However, botulinum toxin types A and B seem to reduce sialorrhea in patients effectively.

IncobotulinumtoxinA in the treatment of sialorrhea in patients with infantile cerebral palsy

Sialorrhea is a severe medical problem that is difficult to treat, which can lead to serious complications. In almost all cases, chronic sialorrhea is accompanied by a restriction of the child's contacts with peers, socialization difficulties, and a significant decrease in the quality of life. Nowadays, botulinum therapy can be an effective tool that significantly reduces sialorrhea manifestation.Oblective: to evaluate the effectiveness of Xeomin (incobotulinumtoxinA) in the treatment of sialorrhea in patients with spastic infantile cerebral palsy (ICP).Patients and methods. We enrolled 24 children with ICP (14 (58.3%) females, and 10 (41.7%) males) with various disease forms: 4 (16.6%) — with spastic hemiparesis, 6 (25.0%) — with spastic diplegia, and 14 (58.3%) — with spastic quadriparesis. IncobotulinumtoxinA injections were performed bilaterally in the parotid and submandibular salivary glands under ultrasound control at a total dose of 40-100 U (min 1.3, max 4.5 U/kg of body weight). IncobotulinumtoxinA. The Drooling Impact (DIS) and the Global Impression of Change Scale (GICS) were used 1, 3 and 6 months after IncobotulinumtoxinA injections to assess treatment effectiveness.Results and discussion. Botulinum toxin therapy resulted in a significant decrease in saliva discharge from the oral cavity 1 and 3 months after IncobotulinumtoxinA injections, which was demonstrated by a reduction in mean DIS score from 78.6±9.6 (min 62, max 95 points; 95% CI 74.6—82.7) to 48.7±6.7(min 25, max 61 points; 95% CI45.8—51.6) and 52.7±8.5points (min 22, max 65; 95% CI49.1—56.3), respectively, as well as an increase in delta GICSscore up to +1.3+0.8(min 0, max 3points; 95% CI 1.0—1.6) and +1.0+0.7points (min 0, max 3points; 95% CI 0.8—1.3), respectively. Adverse events were observed in 4patients (16.6%), which were classified as mild in 3 patients (did not require special treatment and completely stopped within six days) and moderate in 1 patient (also did not require special treatment and completely stopped within three weeks).Conclusion. In the majority (79.1%) of patients with ICP, it is possible to achieve high efficiency in reducing sialorrhea and this effect persists for at least 3 months.

Cost-Effectiveness of IncobotulinumtoxinA in the Treatment of Sialorrhea in Patients with Various Neurological Conditions.

IntroductionSialorrhea is a common and debilitating symptom associated with neurological conditions, which can result in considerable physical and psychosocial complications. In Australia, management options are limited and further impeded by the lack of approved treatments. Whilst there is emerging evidence for the efficacy and tolerability of botulinum toxin (BoNT) for the treatment of sialorrhea in patients with neurological conditions, the cost-effectiveness of the treatment is yet to be established.ObjectivesTo evaluate the cost-effectiveness of incobotulinumtoxinA for the treatment of chronic troublesome sialorrhea caused by various neurological conditions from the Australian healthcare perspective.MethodsA Markov state transition model was developed to perform a cost-utility analysis comparing incobotulinumtoxinA with standard of care (SoC). The model consisted of a hypothetical cohort of patients transiting between three severity-based health states, defined according to the Drooling Severity and Frequency Scale (DSFS), in 16-weekly cycles over 5 years. All clinical and utility inputs were sourced from a single placebo-controlled randomised clinical trial. Only direct healthcare costs were considered, and potential indirect costs such as carer’s time and lost productivity were ignored. The primary outcome measure was the incremental cost per quality-adjusted life-year (QALY). Univariate and probabilistic sensitivity analyses were conducted.ResultsThe model demonstrated that proportionally more patients spent time in less severe sialorrhea health states in the incobotulinumtoxinA arm. For example, over the 5-year period, patients receiving incobotulinumtoxinA were estimated to spend 1.6 years with minimal or no sialorrhea, while no patients achieved this level of improvement under SoC. IncobotulinumtoxinA was shown to have an incremental cost per QALY gained of A$23,445 when compared with SoC.ConclusionsThe quality of life (QoL) of patients with sialorrhea caused by neurological conditions was considerably compromised. IncobotulinumtoxinA was shown to successfully alleviate sialorrhea and it was demonstrated to be a cost-effective intervention when compared with SoC alone.

Onabotulinum Toxin A Injections Into the Salivary Glands for Spinal Muscle Atrophy Type I: A Prospective Case Series of 4 Patients.

The aim of the study was to investigate the safety and efficacy of onabotulinum toxin A injection to the salivary glands under ultrasound guidance for the treatment of sialorrhea in patients with spinal muscular atrophy type I. Prospective case series with four patients with spinal muscular atrophy type I who received onabotulinum toxin A injection to parotid and submandibular glands for sialorrhea as part of clinical care. All four patients received validated surveys for measuring drooling, including objective measures of number of bib changes, and number of mouth wipes before injection and 4-6 wks after injection. Research was limited to survey completion. Scales included the Drooling Severity and Frequency Scale and the Drooling Impact Scale as well as a new scale used in our clinic, the Posterior Drooling Scales looking at coughing/choking and number of aspiration pneumonias. There were no adverse events. All four patients showed clinically significant improvements. The improvement in drooling using the Drooling Impact Scale was statistically significant (paired t test, t = 3.243, P = 0.048). All patients improved with number of mouth wipes. Ultrasound-guided onabotulinum toxin A injections to the salivary glands may be a safe and effective method of decreasing drooling in patients with spinal muscular atrophy type I.

The role of radiation therapy in the management of sialorrhea: A systematic review.

Up to 80% of patients with Parkinson disease and 30% of patients with amyotrophic lateral sclerosis (ALS) suffer from sialorrhea. Patients who fail medical and surgical therapy should be considered for external beam radiation therapy (EBRT). In this study, we conduct a systematic review to determine the dose and techniques used that result in greatest efficacy and lowest toxicity for the administration of EBRT in patients with Parkinson disease or ALS-associated sialorrhea. This review included 216 patients from four prospective and six retrospective studies published from 1998 to 2014, with ALS or Parkinson disease who were treated with electron or photon EBRT for sialorrhea. A total of 216 patients were treated with EBRT from 10 studies. The indication for EBRT was failure of alternative medical treatment in all ALS patients. For patients with Parkinson disease, EBRT was the primary mode of treatment in 68% of cases. Overall, 176 (81%) of 216 patients treated with EBRT for sialorrhea reported symptomatic improvement from baseline. The most common target was the inferior two-thirds of the bilateral parotid glands and the entire bilateral submandibular glands. The total number of patients who experienced short-term toxicity was 86 of 216 patients (40%). The total number of patients who experienced long-term toxicity was 24 of 207 (12%). EBRT is an effective treatment for sialorrhea in patients suffering from ALS or Parkinson disease. Treatment to the bilateral submandibular glands and caudal parotid glands is the most common field arrangement.

Effects of Repeated Botulinum Toxin Treatment for Sialorrhea in Patients with Parkinson's Disease.

To evaluate the efficacy and adverse effects of repeated onabotulinumtoxinA (BoNT-A) treatment in patients suffering from Parkinson's disease (PD) with sialorrhea. A retrospective analysis of 16 patients with sialorrhea treated with BoNT-A at our movement disorders outpatient clinic was conducted from February 2009 to September 2013. A patient with adult cerebral palsy and a patient with PD who received only a single application were excluded. BoNT-A was injected into the parotid glands without ultrasound guidance. Pre-treatment sialorrhea severity was quantified according to the Drooling Frequency and Severity Scale (DFSS). The efficacy was evaluated four weeks after BoNT-A injections using DFSS and according to the subjective assessment of the patients and/or caregivers. The mean age of the patients was 70.00±9.82 years and the mean follow-up duration was 18.78±10.37 months. Totally, 37 applications were performed. The mean BoNT-A total dose was 34.35±6.41 units. The mean scores of DFSS before and after injections were 7.00±1.03 and 3.21±0.89, respectively (p<0.001). Efficacy was 100%, and the mean experienced sialorrhea improvement was 71.78±12.95%. We found a significant difference between the first and last application in the mean duration of efficacy (17.28±9.21 weeks and 18.03±9.02 weeks, respectively, p=0.001). We did not observe side effects in this study group. Repeated injections of BoNT-A are safe and effective in treating sialorrhea in patients with PD. Based on our results, it seems that there is a maintenance of efficacy after a three-year period and an increase in the mean duration of efficacy with the number of injections. Further prospective clinical studies with larger number of patients and more longer duration of follow-up are needed to confirm our results.

133. Effects of botulinum toxin on treatment for sialorrhea in patients with cerebral palsy

133. Effects of botulinum toxin on treatment for sialorrhea in patients with cerebral palsy

Sialorrhea in patients with Parkinson's disease: safety and administration of botulinum neurotoxin.

Sialorrhea may present as a troublesome symptom in patients suffering from Parkinson's disease. Current options for treatment include anticholinergic drugs, irradiation, surgery, oral-motor and behavioural therapies, and injection of botulinum neurotoxin (BoNT) in the salivary glands. The aim of this study is to evaluate the safety and administration of BoNT as a treatment for sialorrhea in patients with Parkinson's disease (PD) based on a review of the studies conducted so far in this field. A PubMed search was conducted using the major keywords sialorrhea, botulinum neurotoxin, botulinum toxin and Parkinson's disease. The literature search identified 12 articles, which were selected for further analysis. Few adverse effects were described in the studies included in this present review. Various treatment strategies, including different medication dosages, were applied in the studies. BoNT treatment is safe for sialorrhea in patients with PD. Positive effect is well documented, and there have been relatively few reported adverse effects, which have been mild and transient. Based on this review, a treatment algorithm is proposed. Ultrasound guidance may not be necessary when injecting the parotid gland but may improve the effect and safety of administration, especially when injecting the submandibular glands.

Comparison of Radiotherapy Types in the Treatment of Sialorrhea in Amyotrophic Lateral Sclerosis

Many patients with amyotrophic lateral sclerosis (ALS) develop progressive difficulty swallowing secretions, leading to drooling. Although external beam radiation is considered to be an effective and well-tolerated treatment, the optimum schedule in terms of dose, target, radiation type, and number of fractions is unknown. The aim of this observational study was to define the most effective schedule for salivary gland irradiation and to compare electron and photon radiotherapy. Sixteen patients with ALS (12 females and 4 males) with drooling, enrolled for external radiation of salivary glands between 2002 and 2007, were included. Patients received different treatment protocols according to the decision of their radiotherapist. Efficacy and safety were assessed at 1 and 6 months after treatment by a neurologist and a radiotherapist using a 4-point Likert patient improvement scale, as follows: 0 (no change), 1 (slight improvement), 2 (good improvement), and 3 (very good improvement). Radiotherapy for drooling was shown to be safe and effective in ALS patients with duration of effect expected up to 6 months. Eighty percent of patients felt improved at 1 month and 43% at 6 months after external radiation. Patients with sustained improvement at 6 months were treated with electron therapy (>8 MeV; p = 0.02). Electron-based radiotherapy, delivered as five 4Gy fractions to a total dose of 20 Gy, encompassing the whole of the submandibular gland and sparing the upper part of the parotid gland, can be proposed as a safe and effective schedule for the treatment of sialorrhea in patients with ALS.

Poster 59: Botulinum Boxin Type B as a Treatment of Sialorrhea in Patients With Stroke

Poster 59: Botulinum Boxin Type B as a Treatment of Sialorrhea in Patients With Stroke

Glycopyrrolate for sialorrhea in Parkinson disease

Sialorrhea affects approximately 75% of patients with Parkinson disease (PD). Sialorrhea is often treated with anticholinergics, but central side effects limit their usefulness. Glycopyrrolate (glycopyrronium bromide) is an anticholinergic drug with a quaternary ammonium structure not able to cross the blood-brain barrier in considerable amounts. Therefore, glycopyrrolate exhibits minimal central side effects, which may be an advantage in patients with PD, of whom a significant portion already experience cognitive deficits. To determine the efficacy and safety of glycopyrrolate in the treatment of sialorrhea in patients with PD. We conducted a 4-week, randomized, double-blind, placebo-controlled, crossover trial with oral glycopyrrolate 1 mg 3 times daily in 23 patients with PD. The severity of the sialorrhea was scored on a daily basis by the patients or a caregiver with a sialorrhea scoring scale ranging from 1 (no sialorrhea) to 9 (profuse sialorrhea). The mean (SD) sialorrhea score improved from 4.6 (1.7) with placebo to 3.8 (1.6) with glycopyrrolate (p = 0.011). Nine patients (39.1%) with glycopyrrolate had a clinically relevant improvement of at least 30% vs 1 patient (4.3%) with placebo (p = 0.021). There were no significant differences in adverse events between glycopyrrolate and placebo treatment. Oral glycopyrrolate 1 mg 3 times daily is an effective and safe therapy for sialorrhea in Parkinson disease. This study provides Class I evidence that glycopyrrolate 1 mg 3 times daily is more effective than placebo in reducing sialorrhea in patients with Parkinson disease during a 4-week study.

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.

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.

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.