title: Double-blind, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for the treatment of palmar hyperhidrosis.
abstract: BACKGROUND
  Palmar hyperhidrosis is a problem of unknown etiology that affects patients both socially and professionally. Botulinum toxin type B (Myobloc), approved by the Food and Drug Administration for use in the treatment of cervical dystonia in the United States in December 2000, has subsequently been used effectively in an off-label indication to treat hyperhidrosis. There are sparse data, however, in the literature evaluating the safety and efficacy of BTX-B for the treatment of palmar hyperhidrosis.
  
  
  OBJECTIVE
  We evaluated the safety and efficacy of Myobloc in the treatment of bilateral palmar hyperhidrosis. This was a double-blind, randomized, placebo-controlled study to report on the safety and efficacy of Myobloc.
  
  
  METHODS
  Twenty participants (10 men, 10 women) diagnosed with palmar hyperhidrosis were injected with either Myobloc (5,000 U per palm) or a 1.0 mL vehicle (100 mM NaCl, 10 mM succinate, and 0.5 mg/mL human albumin) into bilateral palms (15 Myobloc, 5 placebo). The participants were followed until sweating returned to baseline levels. The main outcome measures were safety, efficacy versus placebo, and duration of effect.
  
  
  RESULTS
  A significant difference was found in treatment response at day 30, as determined by participant assessments, between 15 participants injected with Myobloc and 3 participants injected with placebo. The duration of action, calculated in the 17 participants who received Myobloc injections and completed the study, ranged from 2.3 to 4.9 months, with a mean duration of 3.8 months. The single most reported adverse event was dry mouth or throat, which was reported by 18 of 20 participants. The adverse event profile also included indigestion or heartburn (60%), excessively dry hands (60%), muscle weakness (60%), and decreased grip strength (50%).
  
  
  CONCLUSIONS
  Myobloc proved to be efficacious for the treatment of palmar hyperhidrosis. Myobloc had a rapid onset, with most participants responding within 1 week. The duration of action ranged from 2.3 to 4.9 months, with a mean of 3.8 months. The adverse event profile included dry mouth, indigestion or heartburn, excessively dry hands, muscle weakness, and decreased grip strength.
authors.affiliation: Department of Dermatology and Cutaneous Surgery/Division of Cosmetic Dermatology, University of Miami, Miami, Florida, USA. lsb@derm.net
authors.forename: Leslie
authors.initials: L
authors.lastname: Baumann
authors.forename: Anele
authors.initials: A
authors.lastname: Slezinger
authors.forename: Monica
authors.initials: M
authors.lastname: Halem
authors.forename: Justin
authors.initials: J
authors.lastname: Vujevich
authors.forename: Karin
authors.initials: K
authors.lastname: Mallin
authors.forename: Carlos
authors.initials: C
authors.lastname: Charles
authors.forename: Lucy K
authors.initials: LK
authors.lastname: Martin
authors.forename: Laura
authors.initials: L
authors.lastname: Black
authors.forename: Joy
authors.initials: J
authors.lastname: Bryde
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001905:Botulinum Toxins / Q000009:adverse effects / Q000627:therapeutic use*; D019274:Botulinum Toxins, Type A; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006945:Hyperhidrosis / Q000188:drug therapy*; D008297:Male; D008666:Metalloendopeptidases / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life
chemical_list: C096323:rimabotulinumtoxinB; D008666:Metalloendopeptidases; D001905:Botulinum Toxins; D019274:Botulinum Toxins, Type A