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12/21/2000

Acetaminophen Alleviates Migraine Symptoms

Kate Traynor

New research shows that acetaminophen safely relieves the symptoms of some moderate to severe migraine episodes.

Researchers reported in the Dec. 11/25 Archives of Internal Medicine (PDF) that 58 percent of adults who used acetaminophen during a migraine attack had mild pain or none at all within two hours of taking the drug. In contrast, just 39 percent of the migraine sufferers who used a placebo attained this level of pain relief.

Twenty-two percent of the acetaminophen users and 11 percent of the adults who took placebo were completely free of migraine pain after two hours. After six hours, 46 percent of acetaminophen users and 28 percent of placebo users were free of pain.

Acetaminophen controlled pain best when used by people—40 percent of all the study participants—who described their headaches as severe. Of this group, 51 percent of the acetaminophen users and 27 percent of placebo users had mild or no pain two hours after taking the study medication.

Among the remaining 60 percent of the study enrollees, the likelihood of their having mild or no pain at two hours was the same for patients in both treatment groups.

A total of 351 adults 18 years of age and older agreed to participate in the study, which ran from March 11 through Aug. 10, 1998. Fifty-eight men and 231 women took the medication assigned to them.

The study participants—adults in the Baltimore area—were initially contacted by telephone using a random-digit dialing system. People considered potentially eligible for the study were in good health but had at least one migraine episode, with or without aura, every two months.

Adults whose migraine episodes typically occurred more than six times per month were ineligible for the study. People who normally required bed rest or had to reduce their daily activities by 50 percent during a migraine attack could not participate in the study. Migraine sufferers who typically vomited during more than one in five migraine episodes were also ineligible.

People who were considered likely candidates for the study were asked to visit a clinic, where they were given physical and neurological evaluations. Among the eligible participants, 176 were randomly assigned to the acetaminophen group and 175 to the placebo group.

Each study enrollee took home a single dose of the assigned medication. The drugs—two 500-mg tablets of Extra Strength Tylenol or two placebo tablets—were identical in appearance and free of brand designation.

Study participants were given a diary and asked to record data describing a single, subsequent migraine headache of at least moderate pain intensity.

When the study enrollees had a new migraine attack, they were asked to take their assigned medication and refrain from using additional drugs for at least two hours. Thirty-two percent of placebo users and 15 percent of acetaminophen users took some form of "rescue" medication within six hours of their assigned study drug.

Acetaminophen users were more likely than placebo users to be free of photophobia or "functional disability"—a measure of the ability to perform normal work—two or six hours after taking their medication. Patients in the acetaminophen group reported fewer episodes of phonophobia than did placebo users two hours after taking the drug. The frequency of complete relief from nausea was similar in both groups at two and six hours.

Fifty-two percent of acetaminophen users and 28 percent of patients in the placebo group rated their assigned medication as "good" or "excellent."

No serious adverse events occurred during the study. Digestive disturbances including nausea were the most commonly reported adverse events, occurring at the same frequency in both treatment groups. The research team noted that their patients’ nausea and vomiting were likely attributable to the migraine headache, not the study medications.

The researchers said that the results of this study can be generalized to many migraine sufferers in the general population, especially people likely to use nonprescription drugs to control their symptoms. Many people, noted the researchers, use nonprescription drugs to treat migraine symptoms despite the fact that few of these remedies have been approved for the treatment of migraine headaches.

This study was funded by the McNeil Consumer Healthcare Co., the manufacturer of Tylenol products.