Double-blind, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for the treatment of palmar hyperhidrosis.

摘要: 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 Drug Administration for use in treatment cervical dystonia United States December 2000, has subsequently been used effectively an off-label indication to treat hyperhidrosis. There are sparse data, however, literature evaluating safety efficacy BTX-B palmar hyperhidrosis. Objective We evaluated Myobloc bilateral This was double-blind, randomized, placebo-controlled study report on Myobloc. Methods Twenty participants (10 men, 10 women) diagnosed with were injected either (5,000 U per palm) or 1.0 mL vehicle (100 mM NaCl, succinate, 0.5 mg/mL human albumin) into palms (15 Myobloc, 5 placebo). The followed until sweating returned baseline levels. main outcome measures safety, versus placebo, duration effect. Results A significant difference found response at day 30, as determined participant assessments, between 15 3 placebo. action, calculated 17 who received injections completed study, ranged from 2.3 4.9 months, mean 3.8 months. single most reported adverse event dry mouth throat, which 18 20 participants. profile also included indigestion heartburn (60%), excessively hands muscle weakness decreased grip strength (50%). Conclusion proved be efficacious had rapid onset, responding within 1 week. action mouth, heartburn, hands, weakness, strength. MYOBLOC WAS PROVIDED FOR THIS STUDY BY ELAN PHARMACEUTICALS.