Randomized double-blind study of botulinum toxin type B for sialorrhea in ALS patients

Muscle Nerve. 2009 Feb;39(2):137-43. doi: 10.1002/mus.21213.


Twenty ALS patients with sialorrhea refractory to medical therapy were enrolled in this double-blind, randomized study to receive either 2,500 U of botulinum toxin type B (BTxb) or placebo into the bilateral parotid and submandibular glands using electromyographic guidance. Patients who received BTxb reported a global impression of improvement of 82% at 2 weeks compared to 38% of those who received placebo (P < 0.05). This significant effect was sustained at 4 weeks. At 12 weeks, 50% of patients who received BTxb continued to report improvement compared to 14% of those who received placebo. There were no significant adverse events, including dysphagia, in the BTxb group, and there was no significant increase in the rate of decline of vital capacity.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Amyotrophic Lateral Sclerosis / complications*
  • Anti-Dyskinesia Agents / therapeutic use*
  • Botulinum Toxins / therapeutic use*
  • Botulinum Toxins, Type A
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Sialorrhea / drug therapy*
  • Sialorrhea / etiology*
  • Time Factors
  • Young Adult


  • Anti-Dyskinesia Agents
  • rimabotulinumtoxinB
  • Botulinum Toxins
  • Botulinum Toxins, Type A