㈼−2- 9 |
NSAIDsは片頭痛治療に有効か |
論文抄録 |
OBJECTIVE: To evaluate the efficacy and safety of ibuprofen, 200 mg and 400 mg, compared with placebo and each other for the treatment of pain of migraine headache. BACKGROUND: Migraine headache is a common illness with significant social and economic impact. DESIGN: Randomized, placebo-controlled, double-blind trial of 6 hours' treatment duration. METHODS: Fifteen investigators at 17 private practice and referral centers in the United States participated in this study of 660 outpatient adults aged 18 to 84 years with migraine headache of moderate to severe intensity. Each patient was randomly assigned to a single dose of study medication: ibuprofen 200 mg (n = 216) or 400 mg (n = 223), or placebo (n = 221). The percentage of patients with a reduction in baseline headache intensity from severe or moderate to mild or none 2 hours after treatment and the headache pain intensity difference from baseline at 2 hours were the primary efficacy measures. Secondary outcomes included other measures of pain relief, severity differences from baseline for migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability, and percentage of patients with migraine-associated symptoms reduced to none. RESULTS: Significantly (P < or = .006) more patients treated with ibuprofen, 200 mg or 400 mg, reported mild to no pain after 2 hours (41.7% and 40.8%, respectively), compared with those treated with placebo (28.1%). The mean pain intensity difference from baseline measured at 2 hours was significantly (P < or = .001) greater for patients treated with ibuprofen 200 mg or 400 mg (0.68 and 0.65, respectively), compared with those treated with placebo (0.39). Statistically significant differences in favor of both doses of ibuprofen over placebo were observed for mean pain intensity difference at 1 hour after treatment. In patients with severe baseline pain intensity, ibuprofen, 400 mg, was significantly (P < or = .048) superior to placebo for the primary efficacy end points, while ibuprofen, 200 mg, was not. Ibuprofen, 200 mg and 400 mg, were statistically significantly more effective than placebo for all clinically important secondary pain relief outcomes. Mean severity changes of migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability at 2 and 6 hours were significantly (P < or = .03) in favor of both doses of ibuprofen over placebo, and results for the percentage of patients with symptoms reduced to none consistently, although less often statistically significant, favored ibuprofen. No statistically significant differences in adverse events were found among treatment groups. CONCLUSIONS: Ibuprofen at doses of 200 mg and 400 mg is an efficacious, cost-effective, well-tolerated, single-ingredient nonprescription treatment for pain of migraine headache. In addition, while not always statistically significant, ibuprofen provided a beneficial effect on associated symptoms of migraine including nausea, photophobia, phonophobia, and functional disability. |
文献 PubMed−ID |
11554954 |
エビデンスレベル |
㈵ b |
文献タイトル (日本語) |
片頭痛治療におけるイブプロフェン市販薬の効果:無作為対照試験 |
目的 |
片頭痛治療におけるイブプロフェン 200mg、400mgの効果と安全性を評価する |
研究デザイン |
無作為、プラセボ対照、二重盲検試験 |
研究施設 |
15名の観察者、17の診療所 米国 |
研究期間 |
1998年3月〜1998年7月 |
対象患者 |
頭痛の強さが中等度〜重度の 660例の外来片頭痛患者 18〜84歳 |
介入 |
1回の片頭痛発作に使用 |
主要評価項目とそれに用いた 統計学的手法 |
服用2時間後に頭痛の強さが重度または中等度→軽度または頭痛なしに改善した患者の割合 |
結果 |
イブプロフェン 200mg(41.7%)、400mg(40.8%)群はプラセボ群(28.1%)に比し2時間後に頭痛が改善した患者が有意に多かった(p< or =0.006)。服用前と2時間後の痛みの強さの差の平均はイブプロフェン200mg(0.68)、400mg(0.65)群でプラセボ群(0.39)より有意に大きかった(p < or =0.001)。 |
結論 |
イブプロフェン 200mg、400mgは片頭痛の痛みに有効で、経済効果がよく、忍容性が高い単一成分非処方治療薬である。また常に有意さがみられたわけではないが、片頭痛の随伴症状や機能支障度に対しても効果がみられた。 |
コメント |
市販薬の効果を示した良質な RCT |
作成者 |
五十嵐久佳 |