㈼−2- 7
アスピリンは片頭痛治療に有効か

 

1) Lange R, Schwarz JA, Hohn M. Acetylsalicylic acid effervescent 1000
　 mg (Aspirin) in acute migraine attacks; a multicentre, randomized,
　 double-blind, single-dose, placebo-controlled parallel group study.
　 Cephalalgia. 2000 Sep;20(7):663-7.
論文抄録
In this multicentre, randomized, double-blind, single-dose study a total of 374 patients generally suffering from migraine attacks suitable for treatment with non-prescription drugs, received either oral acetylsalicylic acid effervescent 1000 mg (ASAE) or effervescent placebo for the treatment of an acute migraine attack. Of the 343 patients fulfilling the criteria for efficacy analysis 169 patients took acetylsalicylic acid and 174 placebo. Response rates (reduction of headache severity from severe or moderate to mild or no pain at 2 h after administration) were 55.0% for acetylsalicylic acid and 36.8% for placebo (P < 0.001). Twenty-nine percent of patients in the active treatment group were pain-free after 2 h compared with 16.7% in the placebo group (P = 0.007). No headache recurred within 24 h post-dose in 84.6% of patients in the active group and in 85.1% of patients in the placebo group. Effervescent placebo reduced nausea and vomiting to the same degree as the active drug. Adverse events of acetylsalicylic acid (8.3%) were generally mild or moderate and comparable to those of placebo (2.9%). This study shows that oral ASAE is safe and effective for the treatment of acute migraine attacks.
文献 PubMed−ID

11128825

エビデンスレベル

㈵ b

文献タイトル (日本語)
急性期片頭痛発作におけるアセチルサリチル酸 1000mg（アスピリン）；多施設，無作為，二重盲検，単回投与，プラセボ対照並行試験
研究デザイン
多施設無作為二重盲検プラセボ対照並行試験
研究施設
ドイツの 36の医療施設
研究期間
1998年４月〜1998年９月
対象患者
343例の片頭痛患者
介入
痛みの強さが中等度以上で，発作開始後６時間以内に服用．調査施設受診後２ヶ月以内に試験薬服用．
主要評価項目とそれに用いた
統計学的手法
服用２時間後の頭痛改善率（中等度〜重度の頭痛が軽度〜頭痛なしに減少），２時間後の頭痛消失率
Fisher's exact test
結果

アセチルサリチル酸 1000mg投与では２時間後の改善率は55.0％，（プラセボ36.8% p<0.001），２時間後の頭痛消失率は29%‘プラセボ16.7% p<0.007)で，プラセボに比し有意に高値を示した．有害事象は8.3%で軽度〜中等度であった．
結論
経口アセチルサリチル酸は安全で有効な片頭痛急性期治療薬である．
作成者
五十嵐久佳

 

2) MacGregor EA, Dowson A, Davies PT. Mouth-dispersible aspirin in
　 the treatment of migraine: a placebo-controlled study. Headache.
　 2002 Apr;42(4):249-55.

論文抄録

OBJECTIVE: To compare the efficacy of mouth-dispersible aspirin 900 mg and placebo in the treatment of migraine. BACKGROUND: Aspirin is widely accepted as an effective therapy for migraine. Previous studies have indicated that gastric stasis and delayed gastric emptying, which occur during migraine attacks, delay aspirin absorption. Mouth-dispersible formulations are considered to be more quickly absorbed than solid formulations and, therefore, may be more effective in treating migraine. DESIGN: Randomized, double-blind, placebo-controlled, crossover study in four specialized migraine clinics in the United Kingdom . METHODS: One hundred one patients diagnosed with migraine (according to the International Headache Society diagnostic criteria) participated in the study. Patients received either single doses of mouth-dispersible aspirin (3 x 300 mg) or placebo for moderate pain in the treatment of two migraine attacks. Rescue medication could be taken after 2 hours, if required. The primary efficacy parameter was response to therapy at 2 hours posttreatment. Other efficacy parameters were response to treatment, pain-free, and pain intensity at all other time points. Functional disability, nausea, vomiting, photophobia, phonophobia, symptom relief, patient and investigator global evaluation, use of rescue medication, headache recurrence, and palatability and convenience were also recorded. RESULTS: Of 101 patients, 73 took both treatments. At 2 hours, 48% of patients taking mouth-dispersible aspirin responded, compared to only 19% taking placebo (P =.0005). Mouth-dispersible aspirin was significantly better than placebo for response to treatment (P<.05) and pain intensity difference (P<.01) at all time points from 30 minutes posttreatment; for pain-free (P<.05) and use of rescue medication (P<.01) from 3 hours posttreatment; for headache recurrence (P<.05); and for patients' and investigators' global evaluations of efficacy (P =.0001 in both cases). CONCLUSIONS: Mouth-dispersible aspirin 900 mg is effective compared with placebo for the treatment of moderate migraine head pain, with relief seen from as early as 30 minutes after taking medication.

文献 PubMed−ID

12010380

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口腔内分解性アスピリンープラセボ対照試験

目的

片頭痛治療に対する口腔内分解性アスピリン 900mgとプラセボとの比較

研究デザイン

無作為，二重盲検，２期間，プラセボ対照交差試験

研究施設

英国の４つの片頭痛クリニック

対象患者

IHS診断基準を満たす18歳以上の片頭痛患者101例 　1-6回/月の頻度

介入

片頭痛発作のほとんどで嘔吐する患者は除外した．
口腔内分解性アスピリ 300mg３錠とプラセボを２回の片頭痛発作に使用．頭痛が中等度に達したときに服用．

主要評価項目とそれに用いた統計学的手法

投与２時間後の頭痛改善度（痛みの強さが軽度またはなし）
two-tailed test

結果

アスピリンは２時間後の改善度は 48％で，プラセボ(19%)に比し高い反応性あり．痛みの強さの変化，痛み消失，レスキュー薬使用，再発，患者・観察者の効果の評価すべてで良好であった．

結論

口腔内分解性アスピリン 900mgは中等度の片頭痛の痛みに有効であり，服用30分後に改善がみられる．

作成者

五十嵐久佳

 

3) Nebe J, Heier M, Diener HC. Low-dose ibuprofen in self-medication
　 of mild to moderate headache: a comparison with acetylsalicylic acid
　 and placebo. Cephalalgia. 1995 Dec;15(6):531-5.

論文抄録

A double-blind, threefold crossover, double-dummy trial was performed, investigating the efficacy of 200 mg ibuprofen compared with 500 mg acetylsalicylic acid and placebo in patients who usually treated their headaches with over-the-counter drugs. Ninety-five patients suffering from mild to moderate migraine or episodic tension-type headache were included. Seventy-seven patients entered the intention-to-treat analysis and 65 completed all three treatments. For the main response criterion, a minimum 50% decrease of headache intensity on a visual analogue scale at 1 h after treatment, ibuprofen was significantly superior to acetylsalicylic acid and placebo. This was true for migraine attacks and tension-type headache episodes. Towards the end of the observation period (150 min), the differences between ibuprofen and acetylsalicylic acid were no longer significant. In conclusion, ibuprofen was at least equivalent to acetylsalicylic acid and superior to placebo.

文献 PubMed−ID

8706118

エビデンスレベル

㈵ b

文献タイトル (日本語)

軽度〜中等度の頭痛の自己治療における低用量イブプロフェン：アセチルサリチル酸，プラセボとの比較

研究デザイン

二重盲検，３期間，交差，ダブルダミー試験

研究施設

Department of Neurology, University of Essen , Germany .

対象患者

軽度〜中等度の片頭痛もしくは反復発作性緊張型頭痛があり，市販薬で治療している非外来通院患者 95例．18-70歳．１−６回/月の頻度．

介入

イブプロフェン 200mg，アセチルサリチル酸500mg，プラセボ

主要評価項目とそれに用いた統計学的手法

VASで服用１時間後に頭痛の強さが50％以下に低下
Two-sided Mc-Nemar test

結果

服用１時間後にイブプロフェンはアセチルサリチル酸，プラセボに比し，有意に頭痛を改善した (31%,15%, 5%)．服用150分後ではイブプロフェンとアセチルサリチル酸には有意差はなかった．

結論

イブプロフェンは少なくともアセチルサリチル酸と同等の頭痛改善効果を示し，プラセボに優る．

作成者

五十嵐久佳

 

4) Boureau F, Joubert JM, Lasserre V, Prum B, Delecoeuillerie G.
　 Double-blind comparison of an acetaminophen 400 mg-codeine 25
　 mg combination versus aspirin 1000 mg and placebo in acute
　 migraine attack. Cephalalgia. 1994 Apr;14(2):156-61.

論文抄録

The purpose of this study was to compare the efficacy and tolerance of a single dose of the acetaminophen 400 mg-codeine 25 mg combination (ACC) aspirin 1000 mg (A) and a placebo (P) for the treatment of acute migraine attack. The study design was randomized, multicentre, double-blind and double dummy with cross-over on three periods. Of the 198 patients who had three attacks 29.8%, 52.3% and 49.7% had recorded the complete or almost complete disappearance of the pain at 2 h after P, A and ACC respectively. When compared with the placebo, the difference was significant for the A and ACC. When complete disappearance of pain at 2 h was used as a criterion, no significant difference was observed. These results enabled the sensitivity of the evaluation criteria suggested for clinical trials of migraine attack to be discussed.

文献 PubMed−ID

8062355

エビデンスレベル

㈵ b

文献タイトル (日本語)

急性期片頭痛発作におけるアセトアミノフェン 400mgとコデイン25mgの合剤とアスピリン1000mg，プラセボの二重盲検比較試験

目的

急性期片頭痛発作治療におけるアセトアミノフェン 400mg・コデイン25mg配合薬１条とアスピリン1000mg，プラセボの効果と認容性を比較する

研究デザイン

無作為，多施設，二重盲検，ダプルﾀﾞﾐｰ，３期間交差試験

研究施設

フランスの 50 の施設，観察者は片頭痛専門家でほとんどはフランス片頭痛学会の会員から募集された神経内科医．

対象患者

前兆のない片頭痛患者 198例，18〜65歳，2-6回/月の頻度

介入

各治療薬を２回ずつ３期に分けて使用

主要評価項目とそれに用いた統計学的手法

服用２時間後の完全またはほぼ完全な痛みの消失（痛みの程度がなし，または軽度）．
Chi-squre test

結果

服用２時間後の完全もしくはほぼ完全な痛みの消失は，プラセボ (P)29.8％，アスピリン(A)52.3％，アセトアミノフェン・コデイン(ACC)49.7％で，両治療薬はプラセボに比し有意な改善を示したが，両治療薬間には差はなかった．２時間後の痛みの完全消失を基準とした場合は，P11.1%，A22.0%，ACC18.4%で有意差はみられなかった．治療前後の痛みの強さの差による比較ではアスピリンはACCより有意に効果がみられた（Tukey test delta=6.37）．レスキュー薬使用，発作終了時の患者評価による痛み改善の割合，患者の好みは両治療薬ともプラセボとの間に有意差がみられたが，両治療薬間には差はなかった．

結論

アスピリンとアセトアミノフェン・コデインの効果に差はなかった．

作成者

五十嵐久佳

 

5) Diener HC, Eikermann A, Gessner U, Gobel H, Haag G, Lange R,
　 May A, Muller-Schwefe G, Voelker M. Efficacy of 1,000 mg
　 effervescent acetylsalicylic acid and sumatriptan in treating
　 associated migraine symptoms. Eur Neurol. 2004;52(1):50-6. Epub
　 2004 Jul 05.

論文抄録

Recently a new effervescent acetylsalicylic acid (ASA) tablet with high buffering capacity has been developed. In this double-blind, 3-arm, multicenter, parallel-group study, 433 patients were treated either with 1,000 mg effervescent ASA or 50 mg encapsulated sumatriptan or placebo. The primary endpoint was the percentage of patients with complete remission of the 3 accompanying symptoms nausea, photophobia and phonophobia within 2 h after intake of the study drug. 43.8% of patients treated with ASA, 43.7% of patients treated with sumatriptan and 30.9% of patients treated with placebo showed complete remission of all 3 accompanying symptoms (p < 0.05 for ASA and sumatriptan vs. placebo). Both active treatments were superior to placebo regarding the individual symptoms photophobia and phonophobia, but not for nausea. The percentage of patients with reduction in headache severity from moderate or severe to mild or no pain (secondary objective) was 49.3% for ASA, 48.8% for sumatriptan and 32.9% for placebo. All active treatments were superior to placebo (p < 0.05). 25.3, 24.4 and 14.5% of patients treated with ASA, sumatriptan or placebo were pain free at 2 h. Drug-related adverse events were reported in 3.9, 4.7 and 6.7% of patients treated with placebo, ASA or sumatriptan. The study showed that administration of effervescent ASA leads to remission of the migraine symptoms nausea, photophobia and phonophobia, reduces migraine headache and is comparable to sumatriptan.

文献 PubMed−ID

15240983

エビデンスレベル

㈵ b

文献タイトル (日本語)

1000mgアセチルサリチル酸とスマトリプタンの片頭痛随伴症状治療効果

研究デザイン

二重盲検多施設並行試験

研究施設

ドイツの 42のプライマリケア医または神経内科医の施設

研究期間

2001年６月〜2002年12月

対象患者

433例の片頭痛患者，18-65歳，1-6回/月の頻度

介入

スマトリプタンはゼラチンカプセルでコーティングした．
中等度または重度の片頭痛の痛みで発作開始６時間以内に服用．

主要評価項目とそれに用いた統計学的手法

３つの随伴症状である悪心，光過敏，音過敏が服用２時間以内に完全寛解する割合
χ 2 tset

結果

アセチルサリチル酸 1000mg（43.7％），スマトリプタン50mg（43.7%）はプラセボ（30.9%）に比し，全随伴症状が有意に寛解した．個々の項目では，光過敏，音過敏は２つの治療薬はプラセボに比し優れていたが，悪心は有意差がなかった．頭痛の改善，２時間後の頭痛消失率とも２つの治療薬はプラセボより優れていた．

結論

アセチルサリチル酸は片頭痛の随伴症状である悪心・光過敏・音過敏を寛解，痛みを減少させ，その効果はスマトリプタンと同等である．

作成者

五十嵐久佳

 

6) Chabriat H, Joire JE, Danchot J, Grippon P, Bousser MG. Combined
　 oral lysine acetylsalicylate and metoclopramide in the acute
　 treatment of migraine: a multicentre double-blind placebo-controlled
　 study. Cephalalgia. 1994 Aug;14(4):297-300.

論文抄録

This multicentre, double-blind, randomized, placebo-controlled, parallel study was designed to evaluate the efficacy of combined oral lysine acetylsalicylate and metoclopramide (LAS-MCP) in the acute treatment of migraine attacks. A total of 266 patients, 18-65 years old, with two to six attacks of migraine with or without aura (IHS criteria) per month were included. The patients had to treat two migraine attacks with LAS-MCP (1620 mg lysine acetylsalicylate--the equivalent of 900 mg aspirin--combined with 10 mg metoclopramide) or placebo. The main outcome measure was headache relief (reduction in headache severity from grade 3 or 2--severe or moderate--to grade 1 or 0--mild or none) 2 h after treatment. LAS-MCP was superior to placebo for headache relief (56% vs 28%) and for the following secondary outcome measures: complete headache relief (18% vs 7%; p < 0.001), nausea (28% vs 44%; p < 0.001), vomiting (3% vs 11%; p = 0.001), use of rescue medication (47% vs 68%; p < 0.001), global efficacy judged as good or excellent (32% vs 14%; p < 0.001). The tolerability was considered as good in 94% of treated attacks in both groups. Combined oral lysine acetylsalicylate and metoclopramide is an effective and well-tolerated acute treatment of migraine attacks.

文献 PubMed−ID

7954760

エビデンスレベル

㈵ b

著者名

Chabriat H, Joire JE, Danchot J, Grippon P, Bousser MG.

雑誌名 ,出版年 巻: 頁

Cephalalgia. 1994 Aug;14(4):297-300.

目的

リジンアセチルサリチル酸とメトクロプラミド配合薬（ LAS-MCP）の片頭痛発作急性期治療効果を評価する．

研究デザイン

多施設二重盲検プラセボ対照並行試験

対象患者

266例の片頭痛患者　18-65歳　１ヶ月に２〜６回の前兆のある片頭痛または前兆のない片頭痛発作があるもの

介入

２回の片頭痛発作を治療
LAS-MCP(リジンアセチルサリチレート1620mg（アスピリン900mg相当）とメトクロプラミド10mg配合薬)またはプラセボを１回ずつ

主要評価項目とそれに用いた統計学的手法

頭痛改善；治療２時間後に頭痛の強さの程度が３または２（重度または中等度）から１または０（軽度または頭痛なし）

結果

LAS-MCPはプラセボに比し有意に頭痛を改善した（56%対28%）．副次的結果として，頭痛完全寛解（ 18% 対 7%; p < 0.001 ），悪心（ 28% 対 44%; p < 0.001 ） ，嘔吐（ 3% 対 11%; p = 0.001 ） ，レスキュー薬使用（ 47% 対 68%; p < 0.001 ） ，全体的評価（ 32% 対 14%; p < 0.001 ） においても LAS-MCPはプラセボより有意に優れていた．いずれのグループも忍容性は高かった．

結論

リジンアセチルサリチレート・メトクロプラミド配合薬は急性期片頭痛発作に有効で安全性が高い．

作成者

五十嵐久佳

 

7) Tfelt-Hansen P, Olesen J. Effervescent metoclopramide and aspirin
　(Migravess) versus effervescent aspirin or placebo for migraine
　 attacks: a double-blind study. Cephalalgia. 1984 Jun;4(2):107-11.

論文抄録

Aspirin 650 mg and metoclopramide 10 mg in an effervescent preparation (Migravess) were compared with effervescent aspirin 650 mg (Alka-Seltzer) and placebo for common migraine attacks with a double-blind cross-over design. One hundred and eighteen patients with common migraine were entered. Eighty-five patients completed all three forms of treatment, eleven completed two, and six completed one. Medicine was taken when patients were sure they had a migraine attack and not just interval headache. After each form of treatment, they mailed a report form to the investigators. Additional medication was allowed after 2 h and was taken for 79/95 placebo treated attacks, 63/92 Migravess treated attacks, and 51/86 aspirin treated attacks (p less than 0.01). Aspirin was significantly better than placebo for pain but not quite significant for nausea. Migravess was significantly better than placebo for pain and for nausea. There was no significant difference between aspirin and Migravess with regard to analgesic effectiveness (p = 0.33) or to antinausea effect (p = 0.18).

文献 PubMed−ID

6375873

エビデンスレベル

㈵ b

文献タイトル (日本語)

片頭痛発作にたいする発泡性メトプロプラミド＋アスピリン（ Migravess）と発泡性アスピリン，プラセボの効果：二重盲検試験

目的

可溶性メトクロプラミド＋アスピリンは可溶性アスピリン単体やプラセボより効果があるか否かを検証する．

研究デザイン

二重盲検，交差試験

研究施設

Copenhagen acute headache clinic, Denmark

対象患者

118例の片頭痛患者　22-67歳，1-6回／月の頻度

介入

試験薬は２錠ずつ服用
Migravess ；アスピリン325mg，メトクロプラミド5mg，mクエン酸850mg，炭酸水素ナトリウム1180mg
アスピリン錠；アスピリン 325mg，クエン酸850mg，炭酸水素ナトリウム1180mg
プラセボ錠；クエン酸 900mg，炭酸水素ナトリウム1300mg，フメル酸160mg）
片頭痛と確信できた時点で家庭で服用

主要評価項目とそれに用いた統計学的手法

痛みの強さ：４段階（ 0=痛みなし，1=軽度　2=中等度　3=重度）
試験薬服用後の頭痛と悪心の改善度（悪化＝ 1　不変＝２　軽減＝３　完全消失＝４）

結果

アスピリンはプラセボに比し，痛みを有意に改善したが，悪心は有意差がなかった． Migravessはプラセボに比し痛みと悪心の両方に効果が優れていた．鎮痛効果，抗悪心効果についてアスピリンとMigravessに有意な差はみられなかった．

結論

Migravess２錠投与は発泡性アスピリン単体と同等もしくは片頭痛の悪心に対してのみわずかに優れていた．メトクロプラミドの量を増やすことが推奨される．

作成者

五十嵐久佳

 

8) The Oral Sumatriptan and Aspirin plus Metoclopramide Comparative
　 Study Group. A study to compare oral sumatriptan with oral aspirin
　 plus oral metoclopramide in the acute treatment of migraine. Eur
　 Neurol. 1992;32(3):177-84.

論文抄録

In a double-blind, placebo-controlled study, the efficacy, safety and tolerability of 100 mg oral sumatriptan, given as a dispersible tablet, was compared with that of 900 mg oral aspirin plus 10 mg oral metoclopramide in the acute treatment of migraine. A total of 358 patients treated up to three migraine attacks within 3 months, recording clinical information on a diary card. In attack 1, headache relief after 2 h, defined as a reduction in severity from severe or moderate pain to mild or no pain, was recorded in 56% (74/133) of patients who took sumatriptan and 45% (62/138) of patients who took aspirin plus metoclopramide (p = 0.078). This analysis of the primary efficacy end point was not statistically significant. However, for attacks 2 and 3 (secondary end points), headache relief was achieved in 58 versus 36% of patients (p = 0.001) and 65 versus 34% of patients (p less than 0.001), respectively. Relief from nausea, vomiting, photophobia and phonophobia was similar in both treatment groups. Rescue medication was required by fewer patients treated with sumatriptan than by those who received aspirin plus metoclopramide (attack 1, 34 versus 56%, p less than 0.001; attack 2, 32 versus 51%, p = 0.001, and attack 3, 35 versus 54%, p = 0.001). Sumatriptan also produced a faster improvement and resolution of migraine attacks. Comparing the sumatriptan and aspirin plus metoclopramide treatment groups, complete resolution of the attack occurred within 6 h in 32 versus 19% (attack 1), 35 versus 23% (attack 2) and 32 versus 20% of patients (attack 3).(ABSTRACT TRUNCATED AT 250 WORDS)

文献 PubMed−ID

1317294

文献タイトル (日本語)

片頭痛急性期治療における経口スマトリプタンと経口アスピリン＋メトクロプラミドの比較試験

研究デザイン

二重盲検，ダブルダミー，無作為化，並行試験

研究施設

８カ国の神経内科，プライベートクリニック，一般開業医の計 37施設

対象患者

358例の片頭痛患者　18-65歳，１ヶ月に1-6回の中等度または重度の片頭痛発作

介入

スマトリプタン 100mgとアスピリン900mg＋メトクロプラミド10mg
３ヶ月以内に３回

主要評価項目とそれに用いた統計学的手法

１回目の発作における服用２時間後の頭痛改善度（重度または中等度→軽度または頭痛なし）
Mantel-Haenszel χ2-test

結果

服用２時間後の頭痛改善度はスマトリプタン 56%，アスピリン＋メトクロプラミド45%で有意差なし．２回目，３回目の発作では頭痛改善度は有意差あり（58%対36% p=0.001，65%対34% p<0.001）．悪心，嘔吐，光過敏，音過敏の改善度は両治療薬で同等．レスキュー薬使用はスマトリプタン群で少なかった(発作１；34%対56%, p<0.001，発作２；32%対51% p=0.001，発作３；35%対54%,p=0.001)．スマトリプタンは片頭痛発作をより速く改善した．スマトリプタンとアスピリン+メトクロプラミドの６時間以内の発作完全消失は発作１（32%対19%），発作２（35%対23%）発作３（32%対20%）であった．患者による評価はスマトリプタンのほうが優れていた（66% 対45% p<0.001）．

結論

スマトリプタンはアスピリン＋メトクロプラミドに比し，片頭痛改善により有効であり，効果がはやい．

作成者

五十嵐久佳

 

9) Tfelt-Hansen P, Henry P, Mulder LJ, Scheldewaert RG, Schoenen J,
　 Chazot G. The effectiveness of combined oral lysine acetylsalicylate
　 and metoclopramide compared with oral sumatriptan for migraine.
　 Lancet. 1995 Oct 7;346(8980):923-6.

論文抄録

Aspirin is commonly used to treat migraine attacks, although sumatriptan, a much more expensive treatment, is also effective. We compared a combination of lysine acetylsalicylate (equivalent to 900 mg aspirin) and 10 mg metoclopramide (LAS+MTC) with oral sumatriptan (100 mg) and placebo in 421 patients with migraine. LAS+MTC was as effective as sumatriptan with a decrease of headache from severe or moderate to mild or none of 57% and 53%, respectively, for the first migraine attack treated. Both treatments were better than placebo (success rate 24%, p < 0.0001). LAS+MTC was significantly more effective in the treatment of nausea than sumatriptan (p < 0.0001) and was better tolerated (adverse events in 18% and 28%, respectively, p < 0.05). LAS+MTC is as effective as sumatriptan in the treatment of migraine attacks. It is also much cheaper.

文献 PubMed−ID

7564725

エビデンスレベル

㈵ b

文献タイトル (日本語)

片頭痛における経口リジンアセチルサリチレート・メトクロプラミド配合薬と経口スマトリプタンの効果の比較

目的

リジンアセチルサリチレート（アスピリン 900mgと同等）とメトクロプラミド10mg配合薬（LAS＋MTC）とスマトリプタン100mgの効果の比較

研究デザイン

多施設　無作為プラセボ対照試験

研究施設

Denmark .

対象患者

421例の片頭痛患者

結果

LAS＋MTCは頭痛の程度が中等度〜重度→軽度〜頭痛なしとなる率がスマトリプタンと同等であり，いずれの治療薬もプラセボに比し有意に改善率が高かった．LAS＋MTCはスマトリプタンに比し有意に悪心を改善した．

結論

LAS＋MTCはスマトリプタンと同等の片頭痛発作治療効果を有し，より安価である．

作成者

五十嵐久佳

 

10) Geraud G, Compagnon A, Rossi A; COZAM Study Group.
　 Zolmitriptan versus a combination of acetylsalicylic acid and
　 metoclopramide in the acute oral treatment of migraine: a double-
　 blind, randomised, three-attack study. Zolmitriptan versus a
　 combination of acetylsalicylic acid and metoclopramide in the acute
　 oral treatment of migraine: a double-blind, randomised, three-attack
　 study.

論文抄録

This multicentre, randomised, double-blind study compared oral zolmitriptan 2.5 mg with a combination of oral acetylsalicylic acid 900 mg and metoclopramide 10 mg as acute anti-migraine therapy for 3 migraine attacks. In total, 666 patients took at least one dose of study medication (326 took zolmitriptan and 340 took acetylsalicylic acid plus metoclopramide). The percentage of patients with a 2-hour headache response after the first dose for all 3 attacks (the primary end point) was 33.4% with zolmitriptan and 32.9% with acetylsalicylic acid plus metoclopramide [odds ratio 1.06, 95% confidence interval (CI) 0.77-1.47; p = 0.7228]. For the majority of secondary end points, the two treatments demonstrated comparable efficacy. However, post hoc analysis showed that significantly more patients receiving zolmitriptan were free of pain 2 h after the first dose in all 3 attacks compared with patients receiving acetylsalicylic acid plus metoclopramide (10.7 vs. 5.3%; odds ratio 2.19, 95% CI 1.23-4.03; p = 0.0095). In addition, post hoc analysis showed that the overall 2-hour pain-free response rate was consistently higher with zolmitriptan (34.6%) than with acetylsalicylic acid plus metoclopramide (27.9%) (odds ratio 1.40, 95% CI 1.09-1.78; p = 0.007). Both treatments reduced migraine-associated nausea, vomiting, phonophobia and photophobia. There were no important inter-group differences with respect to the onset of meaningful migraine relief, the frequency of headache recurrence, the usage or efficacy of a second dose of medication or the use of escape medication. However, at the last attack, the proportion of patients who expressed overall satisfaction with the treatment was significantly higher in the zolmitriptan group, i.e. 83.7%, versus 75.0% with acetylsalicylic acid plus metoclopramide (p = 0.0346). Both agents were well tolerated. Adverse events were reported by 40.8% (133/326) of zolmitriptan-treated patients and 29.1% (99/340) of those treated with acetylsalicylic acid plus metoclopramide. The incidence of withdrawals due to adverse events was very low with both zolmitriptan (0.9%) and the combination regimen (1.5%); the latter percentage included 1 patient who withdrew from the study due to phlebitis, which was classified as a serious adverse event. This study showed that zolmitriptan is effective and well tolerated for the acute treatment of moderate to severe migraine. Zolmitriptan was at least as effective as acetylsalicylic acid plus metoclopramide in achieving a 2-hour headache response, but significantly more effective than the combination therapy for other end points, including the 2-hour pain-free response. Copyright 2002 S. Karger AG, Basel

文献 PubMed−ID

11844897

エビデンスレベル

㈵ b

文献タイトル (日本語)

片頭痛急性期経口治療におけるゾルミトリプタンとアセチルサリチル酸＋メトクロプラミドの比較

目的

急性期蛍光片頭痛治療薬として，ｿﾞﾙﾐﾄﾘﾌﾟﾀﾝとアセチルサリチル酸＋メトクロプラミドの効果を比較する

研究デザイン

多施設，無作為化，二重盲検試験

対象患者

666例の片頭痛患者　18-65歳　1-6/月の頻度

介入

ゾルミトリプタン 2.5mg
アセチルサリチル酸 900mg＋メトクロプラミド10mg
ダブルダミー
 

主要評価項目とそれに用いた統計学的手法

３回の片頭痛発作における服用２時間後の頭痛改善率 

結果

2時間後の頭痛改善率は両治療薬群で有意差がなかったが，２時間後の頭痛消失率はゾルミトリプタンが優れていた（34.6%対27.9% p=0.007）．両治療薬とも悪心，嘔吐，光過敏，音過敏を改善した．患者の全般的満足度はゾルミトリプタンが高かった（83.7%対75.0% p=0.00346）．両治療薬とも忍容性が高かった．

結論

ゾルミトリプタンは中等度〜重度の片頭痛発作急性期治療薬として有効で忍容性が高い．

作成者

五十嵐久佳

 

11) Le Jeunne C, Gomez JP, Pradalier A, Titus i Albareda F, Joffroy A,
　 Liano H, Henry P, Lainez JM, Geraud G. Comparative efficacy and
　 safety of calcium carbasalate plus metoclopramide versus
　 ergotamine tartrate plus caffeine in the treatment of acute migraine
　 attacks. Eur Neurol. 1999 Jan;41(1):37-43. Related Articles, Links

論文抄録

This randomized, double-blind, double-dummy, multicenter, parallel-group study aimed at comparing the efficacy and safety of calcium carbasalate (equivalent to 900 mg aspirin) plus metoclopramide 10 mg (CM) with ergotamine tartrate 1 mg plus caffeine 100 mg (EC) administered in the treatment of 2 acute migraine attacks. A total of 296 patients fulfilling the International Headache Society diagnostic criteria for migraine were enrolled. In total, one or two migraine attacks were treated in 268 and 235 patients, respectively. The primary endpoint for the first treated attack was headache relief, with intensity decreasing from moderate or severe to mild or absent 2 h after drug intake. Usual secondary efficacy endpoints were assessed. A superiority of CM over EC was observed for both treated attacks for the main endpoint: success in 54 versus 36%, p = 0.003 for the first attack and 60 versus 44%, p = 0.02 for the second attack. CM was also significantly superior to EC during the first attack for complete headache relief (20 vs. 8%, p = 0.006), nausea (42 vs. 63%, p = 0. 007) and willingness to take the drug again (90 vs. 80%, p = 0.043). The global efficacy evaluation, rated by the investigators, was significantly more favorable to CM for both attacks (p = 0.001 for the first attack and p = 0.02 for the second). The patients' evaluation was significant for the first attack (p = 0.002). The global incidence of adverse events was 45% higher with EC, though not significant (32 vs. 22%, p = 0.075). They were most often unspecific and mild to moderate in intensity. Gastrointestinal side effects were significantly less frequent with CM than EC (7 vs. 21%, p = 0.001). Thus, CM is more effective and has a better gastrointestinal safety than EC in the acute treatment of migraine attacks.

文献 PubMed−ID

9885327

エビデンスレベル

㈵ b

文献タイトル (日本語)

急性片頭痛発作治療におけるカルシウムカバサレート＋メトクロプラミドとエルゴタミン＋カフェインの効果と安全性の比較

研究デザイン

無作為化，二重盲検，ダブルダミー，多施設，平行試験

対象患者

296例の片頭痛患者

介入

カルシウムカルバサレート（アスピリン 900mgと同等）＋メトクロプラミド10mg（CM）
エルゴタミン 1mg＋カフェイン100mg（EC）
２回の発作に使用

主要評価項目とそれに用いた統計学的手法

服用２時間後の頭痛改善率（痛みの強さが中等度または重度→軽度またはなし） 

結果

２時間後の改善率は CMがECより有意に高かった（１回目；54%対36% p=0.003，２回目；60%対44% p=0.02）．痛みの完全消失率についてもCMはECより有意に高かった（20％対8% p = 0.006) ．悪心，薬剤再服用の意思に関しても CM が優れていた．観察者による全体的効果の評価は CM で高かった．

作成者

五十嵐久佳

 

12) Diener HC, Bussone G, de Liano H, Eikermann A, Englert R, Floeter
　 T, Gallai V, Gobel H, Hartung E, Jimenez MD, Lange R, Manzoni GC,
　 Mueller-Schwefe G, Nappi G, Pinessi L, Prat J, Puca FM, Titus F,
　 Voelker M; EMSASI Study Group. Placebo-controlled comparison of
　 effervescent acetylsalicylic acid, sumatriptan and ibuprofen in the
　 treatment of migraine attacks. Cephalalgia. 2004 Nov;24(11):947-54.

論文抄録

Acetylsalicylic acid (ASA) in combination with metoclopramide has been frequently used in clinical trials in the acute treatment of migraine attacks. Recently the efficacy of a new high buffered formulation of 1000 mg effervescent ASA without metoclopramide compared to placebo has been shown. To further confirm the efficacy of this new formulation in comparison with a triptan and a nonsteroidal anti-inflammatory drug (ibuprofen) a three-fold crossover, double-blind, randomized trial with 312 patients was conducted in Germany , Italy and Spain . Effervescent ASA (1000 mg) was compared to encapsulated sumatriptan (50 mg), ibuprofen (400 mg) and placebo. The percentage of patients with reduction in headache severity from moderate or severe to mild or no pain (primary endpoint) was 52.5% for ASA, 60.2% for ibuprofen, 55.8% for sumatriptan and 30.6% for placebo. All active treatments were superior to placebo (P < 0.0001), whereas active treatments were not statistically different. The number of patients who were pain-free at 2 h was 27.1%, 33.2%, 37.1% and 12.6% for those treated with ASA, ibuprofen, sumatriptan or placebo, respectively. The difference between ASA and sumatriptan was statistically significant (P = 0.025). With respect to other secondary efficacy criteria and accompanying symptoms no statistically significant differences between ASA and ibuprofen or sumatriptan were found. Drug-related adverse events were reported in 4.1%, 5.7%, 6.6% and 4.5% of patients treated with ASA, ibuprofen sumatriptan or placebo. This study showed that 1000 mg effervescent ASA is as effective as 50 mg sumatriptan and 400 mg ibuprofen in the treatment of migraine attacks regarding headache relief from moderate/severe to mild/no pain at 2 h. Regarding pain-free at 2 h sumatriptan was most effective.

文献 PubMed−ID

15482357

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発泡性アセチルサリチル酸，スマトリプタン，イブプロフェンのプラセボ対照比較試験

目的

アセチルサリチル酸とメトプロプラミドの配合薬の効果をトリプタン， NSAIDと比較する

研究デザイン

３期間，交叉，二重盲検，無作為試験

研究施設

Department of Neurology, University Essen , Germany .

対象患者

312例の片頭痛患者

介入

発泡性アセチルサリチル酸 1000mg
スマトリプタン 50mg
イブプロフェン 400mg

主要評価項目とそれに用いた統計学的手法

頭痛の強度が中等度または重度→軽度またはなし，となった割合

結果

頭痛改善率はアセチルサリチル酸 52.5%，イブプロフェン60.2%，スマトリプタン55.8%，プラセボ30.6%で，治療薬はいずれもプラセボより有意に高率であった (p<0.0001)が，治療群間では差が無かった．２時間後の頭痛消失率はアセチルサリチル酸 27.1%,イブプロフェン 33.2%, スマトリプタン37.1%，プラセボ12.6%であった．アセチルサリチル酸とスマトリプタンの間に有意差がみられた(P = 0.025)．随伴症状の改善は治療群間で差がなく，有害事象は治療群とプラセボ間に差がなかった．

結論

発泡性アセチルサリチル酸 1000ｍｇは投与２時間後の頭痛改善率はスマトリプタン50mg，イブプロフェン400mgと同等で，２時間後の頭痛消失率はスマトリプタンが最も優れていた．

作成者

五十嵐久佳