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

Abstract

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.

Keywords:

• ALS
• sialorrhea
• scopolamine
• transdermal patch

Public interest statement

Sialorrhea is mentally and socially stressful for patients with amyotrophic lateral sclerosis (ALS), not only in early stage disease but also in advanced stages with ventilator and tube feeding. Several treatments are available to control sialorrhea but none are without limitations. Some studies have previously indicated the efficacy of scopolamine patches for preventing motion sickness in reducing sialorrhea without severe side effects in patients following otorhinolaryngology/oral surgery, with cerebral palsy, and with Parkinson’s disease, although the numbers of patients were small. To date, no blinded controlled studies of scopolamine in ALS have been reported. We conducted a double-blind, crossover study in 10 patients with ALS to evaluate the efficacy and safety of scopolamine patches. The daily oral suction volume of saliva appeared to decrease with scopolamine treatment, although the effect was not statistically significant. Our findings suggest that scopolamine patches represent an optional treatment for sialorrhea.

Competing Interests

The authors declare no competing interest.

Additional information

Notes on contributors

Kiyomi Odachi

Our team is based at three hospitals, Mie University Hospital, National Mie Hospital, and Matsusaka Central General Hospital. Each hospital provides treatments and care for the patients in the hospitals and at the patients’ home. We thank the patients who participated in our study, their care providers, visiting nurses, and the ward nurses.