㈼−2- 8
アセトアミノフェンは片頭痛治療に有効か

 

1) Lipton RB, Baggish JS, Stewart WF, Codispoti JR, Fu M. Efficacy and
　 safety of acetaminophen in the treatment of migraine: results of a
　 randomized, double-blind, placebo-controlled, population-based
　 study. Arch Intern Med. 2000 Dec 11-25;160(22):3486-92.
論文抄録
BACKGROUND: Although most persons with migraine treat their headaches with over-the-counter medication, systematic data on the safety and efficacy of widely used treatment, including acetaminophen, are sparse. METHODS: This is a randomized, double-blind, placebo-controlled study comparing oral acetaminophen, 1000 mg (two 500-mg Extra Strength Tylenol tablets), with identical placebo in the treatment of a single acute migraine attack. Eligible subjects met International Headache Society diagnostic criteria for migraine with or without aura. Patients who usually required bed rest with their headaches or who vomited more than 20% of the time were excluded. MAIN OUTCOME MEASURES: The percentage of subjects who, at 2 hours after dosing, experienced a change in baseline pain intensity from severe or moderate pain to mild or no pain (headache response); and pain intensity difference from baseline at the 2-hour postmedication assessment. RESULTS: The headache response rate 2 hours after dosing was 57.8% in the acetaminophen group and 38.7% in the placebo group (P =.002). Pain-free rates at 2 hours were 22.4% in the acetaminophen group and 11.3% in the placebo group (P =.01). The mean pain intensity difference from baseline 2 hours after dosing was 1.08 in the acetaminophen group and 0.73 in the placebo group (P<.001). At 2 hours, other migraine headache characteristics, such as functional disability (P =.002), photophobia (P =.02), and phonophobia (P =.08), were significantly improved after treatment with acetaminophen vs placebo. CONCLUSIONS: Acetaminophen was highly effective for treating pain, functional disability, photophobia, and phonophobia in a population-based sample of persons with migraine, excluding the most disabled persons with migraine. The drug also had an excellent safety profile and was well tolerated. Arch Intern Med. 2000;160:3486-3492.
文献 PubMed−ID
PMID: 11112243 ㈵ b
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アセトアミノフェンの効果と安全性：無作為二重盲検プラセボ対照，一般住民に基づいた試験結果
研究デザイン
無作為二重盲検プラセボ対照試験
研究施設
Baltimore と Catonsville の研究施設
研究期間
1998年３月11日〜1998年８月10日
対象患者
18歳以上の片頭痛患者351例，1-6回／月の頻度で，未治療の場合，中等度以上の痛みのあるもの
介入
寝こんだり， 50％以上の時間日常生活が傷害される患者，発作の20％以上に嘔吐を伴う患者を除いた．
試験薬は中等度以上の痛みに使用．
主要評価項目とそれに用いた
統計学的手法
投与２時間後に重度または中等度の頭痛が軽度または頭痛なしとなった割合
副次結果：投与前と投与２時間後の痛みの程度の差，痛み消失，機能的支障度，悪心，嘔吐，光過敏，音過敏，嘔吐の有無の経時的程度
χ 2 test, Fisher exact test
結果

アセトアミノフェン 1000mg投与群（57.8%）はプラセボ（38.7%）と比較して２時間後の頭痛改善度に有意差がみられた(p=0.002)．さらに投与前の痛みが重度の患者での投与２時間後の改善率(50.9%)もプラセボ(27%)に比し高率であった（ p=0.008）が中等度の痛みでは有意差がなかった．２時間後の痛み消失はアセトアミノフェン22.4%，プラセボ11.3%で，有意差あり．投与前後の痛みの程度の差，レスキュー薬使用状況，機能的支障度の改善，光過敏消失，音過敏消失もアセトアミノフェン投与群が有意に優れていたが，悪心の改善度にはプラセボとの差がなかった．患者の全体的印象はアセトアミノフェンで優れていた．重篤な有害事象はなかった．
結論
多くの片頭痛をもつ人々にとってアセトアミノフェンは安全で，経済的な治療オプションである．
コメント
一般住民を対象とした良質なＲＣＴ
作成者
五十嵐久佳

 

2) Larsen BH, Christiansen LV , Andersen B, Olesen J. Randomized
　 double-blind comparison of tolfenamic acid and paracetamol in
　 migraine. Larsen BH, Christiansen LV , Andersen B, Olesen J.
論文抄録
In a double-blind cross-over study we compared tolfenamic acid with paracetamol in out-patients with common migraine (migraine without aura). Each patient was treated during (at least) 4 attacks with one of the following alternatives: tolfenamic acid 200 mg, tolfenamic acid 400 mg, paracetamol 500 mg or paracetamol 1000 mg in a randomized sequence. The same sequence of treatments was applied to (preferably) 4 more attacks. Dosage was repeated after 2 h if the attack had not abated. Escape medication was allowed after 4 h if the treatment was inefficient. A total of 83 patients were admitted to the study, but 3 dropped out, while 10 completed less than 4 attacks. Seventy completed 4 attacks, and 58 completed all 8. The total number of attacks treated was 545. We found a significant superiority of tolfenamic acid over paracetamol with regard to effect on pain after 2 h (p less than 0.01), patients' global evaluation (p less than 0.001), and use of escape medication (p less than 0.02). The trend was the same for duration of attacks, confinement to bed during attack and nausea, but the results were not statistically significant. There was no significant difference between the smaller and the larger dose of either drug nor between the need for escape medication, although the trend favoured tolfenamic acid. Side effects were few. Tolfenamic acid is evidently valuable in treatment of migraine.
文献 PubMed−ID
2375249
エビデンスレベル
㈵ b
文献タイトル (日本語)
片頭痛におけるトルフェナム酸とパラセタモールの無作為二重盲検比較試験
目的
トルフェナム酸とパラセタモールの効果を比較する
研究デザイン
二重盲検，交差試験
研究施設
Department of Neurology, Rigshospitalet, Copenhagen , Denmark .
対象患者
前兆のない片頭痛患者 83例（外来患者）
介入
少なくとも４回の発作をトルフェナム酸 200mg，400mg，パラセタモール500mg，1000mgで治療
結果
服用２時間後の痛みの改善，患者の全体的評価，レスキュー薬使用状況はトルフェナム酸使用群がパラセタモール使用群より有意に優れていた．発作持続時間，発作中の寝込み，悪心についても同様であったが有意差はなかった．各薬剤とも用量による差はなかった．
結論
トルフェナム酸は片頭痛治療効果がある．
作成者
五十嵐久佳

 

3) MacGregor EA, Wilkinson M, Bancroft K. Domperidone plus
　 paracetamol in the treatment of migraine. Cephalalgia. 1993
　 Apr;13(2):124-7.
論文抄録
This study was designed to evaluate the safety and efficacy of domperidone in combination with paracetamol in the treatment of migraine. Severity of headache, duration of migraine attack and overall efficacy of treatment were amongst the variables assessed in a randomized, double-blind, three-way cross-over comparison of 1 g paracetamol plus either domperidone 30 mg, domperidone 20 mg or placebo, taken at onset of headache. Forty-six patients attending the City of London Migraine Clinic completed the study. A significant difference was observed in the duration of the migraine attack: a median of 17.5 h with paracetamol alone was reduced to 12.0 h with the addition of domperidone 20 mg, and to 12.0 h with domperidone 30 mg. No significant adverse events were reported. A reduction in pain intensity and nausea was noted but this was not statistically significant. It was concluded that domperidone shortens the duration of a migraine attack and may help reduce headache and associated symptoms.
 
Publication Types:
Clinical Trial
Randomized Controlled Trial
 
PMID: 8495454 [PubMed - indexed for MEDLINE
 
文献 PubMed−ID
8495454
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ドンペリドンプラスパラセタモール
目的
片頭痛治療におけるドンペリドンとパラセタモールの組み合わせの安全性と効果を評価する
研究デザイン
無作為，二重盲検，プラセボ対照，交差試験
研究施設
City of London Migraine Clinic , UK .
対象患者
46例の片頭痛患者
介入
ドンペリドン 30mg＋パラセタモール1g
ドンペリドン 20mg＋パラセタモール1g
プラセボ＋パラセタモール 1g
上記薬剤をそれぞれ１回の片頭痛発作の痛み開始時に治療薬を服用するよう指示
主要評価項目とそれに用いた統計学的手法
痛みの強さを４段階で示し，痛み開始時，服用後 30分，１，２，４，８，２４時間の痛みの程度の合計，頭痛改善度，随伴症状の改善度，頭痛持続時間，治療に対する患者の総合評価
結果
片頭痛持続時間はドンペリドン併用群（ 30mg 12.2時間，20mg 12.0時間）はプラセボ(17.5時間)に比し短かった（30mg p=0.019, 20mg p=0.001）．痛みの強さ，悪心の改善はドンペリドン併用群で優れていたが，プラセボとの有意差はみられなかった．重篤な副作用はなかった．
結論
ドンペリドンは片頭痛発作を短縮させ，副作用が少ない．
作成者
五十嵐久佳

 

4) Dowson A, Ball K, Haworth D. Comparison of a fixed combination of
　 domperidone and paracetamol (Domperamol) with sumatriptan 50 mg
　 in moderate to severe migraine: a randomised UK primary care
　 study. Curr Med Res Opin. 2000;16(3):190-7.

論文抄録

Migraine is a common and debilitating condition routinely managed in primary care. A number of treatment options--both acute and prophylactic--are currently available but may differ in terms of efficacy, tolerability and cost. The aim of this study was to compare the effectiveness and tolerability of a fixed combination of domperidone and paracetamol (Domperamol; Servier), which has anti-nauseant and anti-emetic activity, with sumatriptan 50 mg in moderate to severe migraine. To do this, 120 patients were recruited from 23 primary care practices throughout the UK and were enrolled into the six-month trial. Patients were randomised at entry to one of the comparator regimens (used to treat their first migraine attack) and then crossed over to the alternative treatment for their second attack. Detailed diary cards were completed for each attack using a scale of pain severity. At two hours and four hours post-dose, the two treatments showed comparable efficacy (< or = 15% difference) in relieving headache and reducing nausea and vomiting. Both were well tolerated and there were no serious adverse effects. In the management of migraine patients typically seen in routine general practice, this trial showed that the effects of Domperamol and sumatriptan 50 mg were broadly comparable. Since Domperamol is considerably less expensive than sumatriptan (and other triptans), a first-line role for this agent appears appropriate.

文献 PubMed−ID

11191009

エビデンスレベル

㈵ b

文献タイトル (日本語)

中等度〜重度の片頭痛におけるドンペリドンとパラセタモールの合剤（ドンペラモール）とスマトリプタン 50mgの比較：無作為英国プライマリケアの研究

目的

ドンペラモール（ドンペリドン 10mgとパラセタモーム500mg）とスマトリプタン50mgの効果と忍容性を比較する

研究デザイン

多施設，無作為，二重盲検，ダブルダミー，プラセボマッチング交叉試験

研究施設

英国の 23のプライマリ・ケア医

対象患者

120例の片頭痛患者
中等度〜重度の片頭痛発作

主要評価項目とそれに用いた統計学的手法

服用２時間後に痛みが重度または中等度から軽度またはなし
Mainland-Gart test

結果

２時間後の頭痛改善率はドンペラモール 36.4%，スマトリプタン33.3%，４時間後は49.2%と41.9%．悪心・嘔吐改善率，忍容性に差はなかった．

結論

ドンペリドンとパラセタモール（アセトアミノフェン）の合剤はトリプタンより安価であり，第一選択薬となりうる．

作成者

五十嵐久佳

 

5) Lipton RB, Stewart WF, Ryan RE Jr, Saper J, Silberstein S, Sheftell
　 F. Efficacy and safety of acetaminophen, aspirin, and caffeine in
　 alleviating migraine headache pain: three double-blind, randomized,
　 placebo-controlled trials. Arch Neurol. 1998 Feb;55(2):210-7.

論文抄録

OBJECTIVE: To assess the effectiveness of the nonprescription combination of acetaminophen, aspirin, and caffeine in alleviating migraine headache pain. DESIGN: Three double-blind, randomized, parallel-group, single-dose, placebo-controlled studies. SETTING: Private practice, referral centers, and general community. PATIENTS: Migraineurs with moderate or severe headache pain who met International Headache Society diagnostic criteria for migraine with aura or without aura. The most severely disabled segment of migraineurs, including those whose attacks usually required bed rest, or who vomited 20% or more of the time, were excluded. Of the 1357 enrolled patients, 1250 took study medication and 1220 were included in the efficacy-evaluable data set. INTERVENTION: Two tablets of the nonprescription combination of acetaminophen, aspirin, and caffeine or placebo taken orally as a single-dose treatment of 1 eligible acute migraine attack. Main Outcome Measures: Pain intensity difference from baseline; percentage of patients with pain reduced to mild or none. RESULTS: Significantly greater reductions in migraine headache pain intensity 1 to 6 hours after dose were seen in patients taking the acetaminophen, aspirin, and caffeine combination than in those taking placebo in each of the 3 studies. Pain intensity was reduced to mild or none 2 hours after dose in 59.3% of the 602 drug-treated patients compared with 32.8% of the 618 placebo-treated patients (P< .001; 95% confidence interval [CI], 55%-63% for drug, 29%-37% for placebo); at 6 hours after dose, 79% vs 52%, respectively, had pain reduced to mild or none (P<.001; 95% CI, 75%-82% vs 48%-56%). In addition, by 6 hours after dose, 50.8% of the drug-treated patients were pain free compared with 23.5% of the placebo-treated patients (P<.001; 95% CI, 47%-55% for drug, 20%-27% for placebo). Other migraine headache characteristics, such as nausea, photophobia, phonophobia, and functional disability, were significantly improved 2 to 6 hours after treatment with the acetaminophen, aspirin, and caffeine combination compared with placebo (P< or =.01). CONCLUSIONS: The nonprescription combination of acetaminophen, aspirin, and caffeine was highly effective for the treatment of migraine headache pain as well as for alleviating the nausea, photophobia, phonophobia, and functional disability associated with migraine attacks. This drug combination also has an excellent safety profile and is well tolerated.

文献 PubMed−ID

9482363

エビデンスレベル

㈵ｂ

文献タイトル (日本語)

片頭痛の痛み緩和におけるアセトアミノフェン・アスピリン・カフェイン配合薬の効果と安全性：３つの二重盲検，無作為，プラセボ対照試験

目的

片頭痛の痛み緩和における非処方薬アセトアミノフェン・アスピリン・カフェイン配合薬の効果を評価する

研究デザイン

３つの二重盲検，無作為，平行，単回投与，プラセボ対照試験

研究施設

Department of Neurology, Albert Einstein College of Medicine, Montefiore Headache Unit, Bronx, NY 10467, USA.

研究期間

1995年８月１７日〜1996年７月２２日

対象患者

18歳以上の片頭痛患者で1-6回／月の頻度．痛みは中等度以上だが，寝込むほどの痛みや発作の20%以上は嘔吐するような患者は除外．

介入

２錠のアセトアミノフェン・アスピリン・カフェイン配合薬，もしくはプラセボを１回の急性片頭痛発作に投与

主要評価項目とそれに用いた統計学的手法

投与前との痛みの程度の差，痛みが軽度またはなしとなった患者の割合
χ 2 test

結果

アセトアミノフェン・アスピリン・カフェイン配合薬は服用１〜６時間後に片頭痛の痛みを有意に軽減した．服用２時間後に痛みの強さが軽度〜なしとなったものは，治療薬では 602例中５９．３％，プラセボでは618例中32.8％（p<0.001;95%CI, 55-63% 治療薬, 29-37%プラセボ）．服用６時間後は79%対52%(p<0.001;95%CI, 75-82% 治療薬，48-56%プラセボ)．
服用６時間後までに頭痛消失したものは，治療薬群では 50.8%，プラセボ23.5%(p<0.001;95%CI,47-55%治療薬，20-27%プラセボ)．
悪心，光過敏，音過敏，機能的障害は治療群で有意に改善した．

結論

非処方薬アセトアミノフェン・アスピリン・カフェイン配合薬は片頭痛の痛み，随伴症状改善に有効であり，極めて安全性が高い．

作成者

五十嵐久佳