title: Efficacy of Botulinum Toxin B Injection for Raynaud's Phenomenon and Digital Ulcers in Patients with Systemic Sclerosis.
abstract: The efficacy and safety of botulinum toxin B (BTX-B) for treatment of Raynaud's phenomenon and digital ulcers in patients with systemic sclerosis was assessed. A total of 45 patients with systemic sclerosis who had Raynaud's phenomenon were blinded and divided randomly into 4 groups: a no-treatment control group, and 3 treatment groups, using 250, 1,000 or 2,000 international units (U) of BTX-B injections in the hand with more severe symptoms. Four weeks after injection, pain/numbness visual analogue scale scores and Raynaud's score in the groups treated with 1,000 and 2,000 U BTX-B were significantly lower than in the control group and the group treated with 250 U BTX-B. These beneficial effects were sustained until 16 weeks after the single injection. At 4 weeks after injection skin temperature recovery in the group treated with 2,000 U BTX-B was significantly improved. The numbers of digital ulcers in the groups treated with 1,000 and 2,000 U BTX-B were significantly lower than in the control group. In conclusion, 1,000 and 2,000 U BTX-B injections significantly suppressed the activity of Raynaud's phenomenon and digital ulcers in patients with SSc without serious adverse events.
authors.affiliation: Department of Dermatology, Gunma University Graduate School of Medicine, 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan. smotegi@gunma-u.ac.jp.
authors.forename: Sei-Ichiro
authors.initials: SI
authors.lastname: Motegi
authors.forename: Akihito
authors.initials: A
authors.lastname: Uehara
authors.forename: Kazuya
authors.initials: K
authors.lastname: Yamada
authors.forename: Akiko
authors.initials: A
authors.lastname: Sekiguchi
authors.forename: Chisako
authors.initials: C
authors.lastname: Fujiwara
authors.forename: Sayaka
authors.initials: S
authors.lastname: Toki
authors.forename: Yuki
authors.initials: Y
authors.lastname: Date
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Nakamura
authors.forename: Osamu
authors.initials: O
authors.lastname: Ishikawa
mesh_terms: D065087:Acetylcholine Release Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007267:Injections; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011928:Raynaud Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D012595:Scleroderma, Systemic / Q000150:complications*; D016037:Single-Blind Method; D012881:Skin Temperature / Q000187:drug effects; D012883:Skin Ulcer / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
chemical_list: D065087:Acetylcholine Release Inhibitors; C096323:rimabotulinumtoxinB; D019274:Botulinum Toxins, Type A