This Article  • Full text  • PDF  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (89)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Headache  • Migraine  • Pain  • Alert me on articles by topic  Social Bookmarking   What's this?

Three Double-blind, Randomized, Placebo-Controlled Trials

Richard B. Lipton, MD; Walter F. Stewart, PhD, MPH; Robert E. Ryan, Jr, MD; Joel Saper, MD; Stephen Silberstein, MD; Fred Sheftell, MD

Arch Neurol. 1998;55:210-217.

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.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.

From the Departments of Neurology, Epidemiology, and Social Medicine, Albert Einstein College of Medicine, Montefiore Headache Unit, Bronx, NY (Dr Lipton); Johns Hopkins School of Public Health, Baltimore, Md (Dr Stewart); Innovative Medical Research, Baltimore (Drs Lipton and Stewart); Department of Otolaryngology, St Louis University School of Medicine, St Louis, Mo (Dr Ryan); Michigan Headache Pain and Neurological Institute, Ann Arbor (Dr Saper); Comprehensive Headache Center, Philadelphia, Pa (Dr Silberstein); and New England Center for Headache, Stamford, Conn (Dr Sheftell).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Caffeine Accelerates Absorption and Enhances the Analgesic Effect of Acetaminophen
Renner et al.
J Clin Pharmacol 2007;47:715-726.
ABSTRACT | FULL TEXT  

A Practical Approach to Headache Treatment
Tucker
Journal of Pharmacy Practice 2007;20:123-136.
ABSTRACT  

An Evidence-Based Update on Nonsteroidal Anti-Inflammatory Drugs
Ong et al.
Clin Med Res 2007;5:19-34.
ABSTRACT | FULL TEXT  

Headache Pain
Gallagher
JAOA: Journal of the American Osteopathic Association 2005;105:S7-S11.
ABSTRACT | FULL TEXT  

Pharmacologic Management of Acute Attacks of Migraine and Prevention of Migraine Headache
Snow et al.
ANN INTERN MED 2002;137:840-849.
ABSTRACT | FULL TEXT  

Migraine -- Current Understanding and Treatment
Goadsby et al.
NEJM 2002;346:257-270.
FULL TEXT  

What Matters Is Not the Differences Between Triptans, but the Differences Between Patients
Saper
Arch Neurol 2001;58:1481-1482.
FULL TEXT  

Efficacy and Safety of Acetaminophen in the Treatment of Migraine: Results of a Randomized, Double-blind, Placebo-Controlled, Population-Based Study
Lipton et al.
Arch Intern Med 2000;160:3486-3492.
ABSTRACT | FULL TEXT  

An international study to assess reliability of the Migraine Disability Assessment (MIDAS) score
Stewart et al.
Neurology 1999;53:988-988.
ABSTRACT | FULL TEXT  

Limitations of Acetaminophen, Aspirin, and Caffeine in Alleviating Migraine
Maizels et al.
Arch Neurol 1998;55:1590-1590.
FULL TEXT  

A non-prescription analgesic alleviated migraine headache pain and symptoms
Gadsby
Evid. Based Nurs. 1998;1:118-118.
FULL TEXT  

Migraine Relief With Acetaminophen, Aspirin, and Caffeine: Abstract and Commentary
Smith
JAMA 1998;279:1310-1310.
FULL TEXT  

A Simple Treatment for Migraine Headaches . . .
Journal Watch Dermatology 1998;1998:19-19.
FULL TEXT  

A Simple Treatment for Migraine Headaches . . .
JWatch Psychiatry 1998;1998:16-16.
FULL TEXT  

A Simple Treatment for Migraine Headaches
JWatch General 1998;1998:3-3.
FULL TEXT