Efficacy and safety of acetaminophen in the treatment of migraine: Results of a randomized, double-blind, placebo-controlled, population-based study

Richard B. Lipton, Jeffrey S. Baggish, Walter F. Stewart, Joseph R. Codispoti, Min Fu

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)3486-3492
Number of pages7
JournalArchives of Internal Medicine
Volume160
Issue number22
StatePublished - Dec 11 2000

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Acetaminophen
Migraine Disorders
Placebos
Safety
Headache
Pain
Population
Hyperacusis
Photophobia
Therapeutics
Migraine without Aura
Migraine with Aura
Bed Rest
Disabled Persons
Tablets
Outcome Assessment (Health Care)
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Internal Medicine

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Efficacy and safety of acetaminophen in the treatment of migraine : Results of a randomized, double-blind, placebo-controlled, population-based study. / Lipton, Richard B.; Baggish, Jeffrey S.; Stewart, Walter F.; Codispoti, Joseph R.; Fu, Min.

In: Archives of Internal Medicine, Vol. 160, No. 22, 11.12.2000, p. 3486-3492.

Research output: Contribution to journalArticle

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abstract = "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.",
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N2 - 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.

AB - 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.

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