Abstract
Journal Scan Archive, February 1998 http://www.ama.assn-org/migraine Posted March 27, 1998 Abstract 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. Commentary This study clearly shows that 2 tablets of an over-the-counter combination analgesic containing acetaminophen, aspirin, and caffeine (Excedrin Extra-Strength) were effective in treating all but the most severe cases of migraine (who were excluded from the trial).1 For patients who have mild to moderate migraine this is important news. A word of caution is needed, however. The study, although convincing and produced in exemplary fashion by a group of well-known headache experts, deals with the treatment of a single headache attack. More study will be needed on the effects of the medication when used for repeated attacks over longer periods of time. As expected, the medication produced minimal adverse effects. Not only was headache relieved promptly, but other migraine symptoms such as nausea, photophobia, and phonophobia as well as the functional disability caused by migraine were also alleviated. Without medical supervision nonresponders may be tempted to take repeated doses of this nonprescription medication, thereby creating possible problems for patients who are allergic to aspirin, who have asthma, or who have bleeding problems (eg, from the gastrointestinal tract). The patients in this study fell into 2 classes: those with intermediate and those with low treatment needs. These are migraineurs who usually respond well to combination or simple analgesics. Easy access to a low-cost effective treatment for recurring headache, however, might further increase the large proportion of patients who never consult a physician for their headaches.2 Medical supervision of migraine is desirable to ensure that patients learn about nonpharmacological treatments and how to protect themselves from attacks. Repeated use of nonprescription analgesics should be supervised; overuse may produce chronic daily headache and rebound headache.3 Patients with chronic headache should always have the benefit of a specific headache diagnosis and supervision by a physician. The "Step Approach" treatment of migraine,4 which advocates the use of simpler analgesics before resorting to more powerful and costly treatments of migraine, will receive a considerable boost from this interesting study. Published literature selected for posting on the JAMA Web sites receives postpublication peer review. Posted abstracts may be accompanied by commentaries prepared for the Web sites that may be selected for republishing in THE JOURNAL. The JAMA Migraine Information Center is made possible by grant support from Zeneca Pharmaceuticals. References 1. Lipton RB, Stewart WF, Ryan Jr RE, Saper J, Silberstein S, Sheftell F. Efficacy and safety of acetaminophen, aspirin, and caffeine in alleviating headache pain: three double-blind, randomized, placebo-controlled trials. Arch Neurol.1998;55:210-217.Google Scholar 2. Linet MS, Stewart WF, Celentano DD, Ziegler D, Sprecher M. An epidemiologic study of headache among adolescents and young adults. JAMA.1989;261:2211-2216.Google Scholar 3. Mathew NT. Migraine transformation and chronic daily headache. In: Cady RK, Fox AW, eds. Treating the Headache Patient. New York, NY: Marcel Dekker; 1994:75-100. 4. Lipton RB, Stewart WF. Clinical applications of zolmitriptan (Zomig, 311C90). Cephalalgia.1997;17(suppl 18):53-59.Google Scholar
Journal
JAMA
– American Medical Association
Published: Apr 22, 1998
Keywords: aspirin,acetaminophen,migraine disorders,caffeine
