Ⅲ-9

緊張型頭痛にボツリヌス療法は有効か

 

6) Schulte-Mattler WJ, Krack P . Treatment of chronic tension-type
  headache with botulinum toxin A: a randomized, double-blind,
  placebo-controlled multicenter study. Pain 2004 May;109(1-2):110-4
論文抄録
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) 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 under 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.
文献 PubMed-ID

PMID: 15082132

エビデンスレベル

Ib

文献タイトル (日本語)

ボツリヌス毒素 A による慢性緊張型頭痛の治療:無作為二重盲検プラセボ対照多施設試験

目的
ボツリヌス毒素の緊張型頭痛に対する有用性に関する科学的な検証
研究デザイン
多施設無作為二重盲検プラセボ対照交差試験 ( Randomized, double-blind, placebo-controlled multicenter study )
研究施設
Department of Neurology, University of Regensburg
研究期間
18 週
対象患者

112 名の慢性緊張型頭痛患者
(診断は国際頭痛分類を厳守して実施し,片頭痛を併せ持った場合は除外)

介入
500 マウス単位のボツリヌス毒素( Dysport )またはプラセボ
主要評価項目とそれに用いた
統計学的手法

頭痛日記を記録し,治療前 6 週と治療後 12 週の頭痛カーブ下面積を測定し,主要な効果測定とした.二次的な効果測定は,頭痛日数,鎮痛剤の服用日数,夜間睡眠時間,および Beck Depression Inventory スコアにより測定した.
結果

いかなる項目においても実薬群とプラセボ群に有意差はなかった.実薬群の患者 7 名において眼劔,頸部,あるいはその両方の鈍麻を生じ,今回の検討で用いられた以上の用量を頭痛の治療に使用することは妥当とはいえない可能性が示された.

結論
統計的には慢性緊張型頭痛に対するボツリヌス毒素 A の効果は臨床的に有意な効果をもたないという結論を十分支持しうるものであった.
コメント
対象も多く,研究デザイン,測定項目も優れたもの.
備考

Publication Types:
*Clinical Trial
*Multicenter Study
*Randomized Controlled Trial

MeSH Terms:
*Adult
*Animals
*Area Under Curve
*Botulinum Toxin Type A/therapeutic use*
*Comparative Study
*Dose-Response Relationship, Drug
*Double-Blind Method
*Female
*Humans
*Male
*Mice
*Middle Aged
*Neuromuscular Agents/therapeutic use*
*Pain Measurement/drug effects
*Placebos
*Prospective Studies
*Research Support, Non-U.S. Gov't
*Retrospective Studies
*Tension Headache/drug therapy*
*Time Factors
*Treatment Outcome

作成者
平田幸一