Treatment of chronic tension-type headache with botulinum toxin A: a randomized, double-blind, placebo-controlled multicenter study

Schulte-Mattler, Wilhelm J. and Krack, Paul (2004) Treatment of chronic tension-type headache with botulinum toxin A: a randomized, double-blind, placebo-controlled multicenter study. PAIN, 109 (1-2). pp. 110-114. ISSN 0304-3959

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Abstract

A beneficial effect of botulinum toxin on tension-type headache was reported in open-label studies but scientifically rigorous clinical studies are lacking. Therefore we conducted a prospective, multicenter, randomized, double-blind, placebo-controlled trial. Multiple pericranial muscles of 112 patients with chronic tension-type headache were treated either with 500 mouse units of botulinum toxin (Dysport((R))) or with placebo. The diagnoses were made strictly following the International Headache Society criteria. Co-existence of migraine was an exclusion criterion. Injections were made following a fixed scheme and not adjusted to the patient's symptoms. Patients kept a headache diary that was used to calculate the area tinder the headache curve of 6 weeks before and 12 weeks after the treatment as the main effect measure. Secondary effect measures were the number of days with headache, the number of days with intake of analgesics, the duration of the nocturnal sleep, and the Beck Depression Inventory score. There were no significant differences between the verum group and the placebo group in any of these variables. Seven patients of the verum group had transient weakness of the eyelids, the neck, or both, indicating that a higher dose than used in this Study does not seem sensible for the treatment of headache. The statistical power of the study was high enough to warrant the conclusion that there is no clinically significant effect of botulinum toxin A on chronic tension-type headache. (C) 2004 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Item Type: Article
Uncontrolled Keywords: INJECTIONS; botulinum toxin; placebo-controlled study; tension-type headache; therapy
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Neurologie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 21 Jul 2021 05:57
Last Modified: 21 Jul 2021 05:57
URI: https://pred.uni-regensburg.de/id/eprint/37717

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