title: Randomized double-blind study of botulinum toxin type B for sialorrhea in ALS patients.
abstract: 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.
authors.affiliation: University of Texas Health Science Center, 7703 Floyd Curl Drive, Mail Code 7883, San Antonio, Texas 78229-3900, USA. jacksonce@uthscsa.edu
authors.forename: Carlayne E
authors.initials: CE
authors.lastname: Jackson
authors.forename: Gary
authors.initials: G
authors.lastname: Gronseth
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Rosenfeld
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Barohn
authors.forename: Richard
authors.initials: R
authors.lastname: Dubinsky
authors.forename: C Blake
authors.initials: CB
authors.lastname: Simpson
authors.forename: April
authors.initials: A
authors.lastname: McVey
authors.forename: Pamela P
authors.initials: PP
authors.lastname: Kittrell
authors.forename: Ruth
authors.initials: R
authors.lastname: King
authors.forename: Laura
authors.initials: L
authors.lastname: Herbelin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000690:Amyotrophic Lateral Sclerosis / Q000150:complications*; D018726:Anti-Dyskinesia Agents / Q000627:therapeutic use*; D001905:Botulinum Toxins / Q000627:therapeutic use*; D019274:Botulinum Toxins, Type A; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D012798:Sialorrhea / Q000188:drug therapy* / Q000209:etiology*; D013997:Time Factors; D055815:Young Adult
chemical_list: D018726:Anti-Dyskinesia Agents; C096323:rimabotulinumtoxinB; D001905:Botulinum Toxins; D019274:Botulinum Toxins, Type A