3) Steiner TJ, Joseph R, Hedman C et al. Metoprolol in the prophylaxis of
migraine: parallel-groups comparison with placebo and dose-ranging follow-up.
Headache. 1988; 28:15-23
|
論文抄録
|
88 patients in need of prophylactic treatment for classical, common or mixed migraine of at least 2
years' duration were admitted to a double-blind placebo-controlled trial of the beta1-selective adrenoceptor
blocker, metoprolol. All patients initially took placebo for I month, during which 29 were excluded
principally because of failure to reattend or placebo-response making active treatment unnecessary. The
remaining 59 patients were randomised to continued placebo or metoprolol 50 mg b.i.d. for 2 months.
Patients after this time subjectively categorizing their responses as less than optimal changed,
double-blindly, from placebo to metoprolol 50 mg b.i.d., or from metoprolol 50 mg b.i.d. to 100 mg b.i.d., for
a further follow-up period of up to 3 months.
Placebo response was 40% overall, and often occurred after the first month. In the first double-blind
comparative period metoprolol reduced attack frequency significantly, and more than placebo. Severity of
attacks still occurring was not altered by either treatment. Other measures of illness were altered
consistently with these principal findings. Consistent improvements also were seen in patients switching
from initial placebo therapy to metoprolol 50 mg b.i.d. for the further follow-up period, and those changing
to the higher dose of metoprolol showed statistically significant further improvements, and clinically
important improvements overall. Side-effects were minor and reversible.
This study gives supportive evidence of the value of metoprolol in preventing migraine attacks and
suggests that individual dosage titration can substantially enhance its efficacy. Side-effects do not
significantly impede its use and other evidence suggests that beta1-selective blockers are to be preferred
over non-selective in migraine therapy.
|
文献 PubMed−ID
|
PM:3277926 |
エビデンスレベル
|
Ib
|
文献タイトル (日本語)
|
メトプロロールによる片頭痛予防療法:プラセボとの比較と容量依存性
の追跡
|
目的
|
β遮断薬 メトプロロールが容量依存的に片頭痛の発作回数・程度を抑制可能か否かを検討
|
研究デザイン
|
二重盲検プラセボ対照試験 (a double-blind placebo-controlled trial)
|
研究施設
|
The Princess Margaret Clinic for treatment of migraine
|
対象患者
|
少なくとも 2年の罹病期間がある古典型片頭痛,普通型片頭痛患者で,予防療法が必要な18歳〜64歳までの88例.
|
介入
|
1ヶ月のプラセボによる観察期間の後,治療不要となった29症例を除外 (Baseline period).
59例はランダムに50mg×2回/日の偽薬またはメトプロロールを2ヶ月間投与 (Double-blind period).
治療効果が不十分な場合には,盲検下に偽薬はメトプロロール 50mg×2回に増量,メトプロロール50mg×2回は100mg×2回に増量し,最高3ヵ月の追跡調査期間を設定 (Follow-up period).
|
主要評価項目とそれに用いた統計学的手法
|
頭痛日記に片頭痛発作の有無, 片頭痛発作の重症度, 急性期治療薬の使用数を記録
|
結果
|
最初の 1ヶ月間でのプラセボ効果は40%に認められた.
Double-blind period においてメトプロロールは偽薬より有意に発作頻度を減少させたが,頭痛発作の重症度は治療により変化しなかった.
Follow-up period に偽薬治療からメトプロロールに切り替えた患者にも改善がみられ,高用量のメトプロロール変更群も統計学的に有意なさらなる改善がみられた.
副作用は軽度で可逆性であった.
|
結論
|
メトプロロールには片頭痛発作予防効果がある.
患者毎に用量設定をすることで実質的な有効性を強化することができる.
副作用は問題にならず,片頭痛治療において選択的β 1遮断薬が,非選択的β遮断薬より好まれる可能性が示唆された.
|
コメント
|
中規模の良質な RCT.
|
備考
|
Publication Types:
・Clinical Trial
・Controlled Clinical Trial
MeSH Terms:
・Adult
・Clinical Trials
・Dose-Response Relationship, Drug
・Double-Blind Method
・Female
・Follow-Up Studies
・Humans
・Male
・Metoprolol/administration & dosage*
・Middle Aged
・Migraine/prevention & control*
・Research Support, Non-U.S. Gov't
Substances:
・Metoprolol
|
作成者
|
竹島多賀夫
|