P-077 - A retrospective analysis on the benefits of an over-the-counter combination of aspirin, acetaminophen, and caffeine (AAC) in menstrual migraine.

Abstract Title: A retrospective analysis on the benefits of an over-the-counter combination of aspirin, acetaminophen, and caffeine (AAC) in menstrual migraine.


Background: Migraine affects approximately 15% of the general population globally. It is generally an episodic headache disorder that produces a wide spectrum of pain and associated disability. Women are three times more likely than men to experience migraine headache. More than 60% of women with migraine experience attacks that occur in association with the menstrual periods. Although some women experience migraine exclusively during the perimenstrual period, others have attacks both during the perimenstrual period and at other times of the month. Menstrual migraine is thought to be more severe and disabling and less responsive to non-drug treatments than is non-menstrual migraine.

Purpose/Objectives: Since menstrual migraine is an important health issue for women, we wanted to examine whether the aspirin, acetaminophen, and caffeine (AAC) combination is more effective than placebo in relieving menstruation associated migraine and improving the quality of life (QoL) of patients.


Methods: The study population selected for this analysis were adapted from a pooled analysis of women associated with menstrual migraine [Clin Therapeutics 21(3) 475, 1999]. A total of 185 women with menstrual associated migraine, of which 85 took one dose of AAC (aspirin/acetaminophen/caffeine – 250 mg/250 mg/65 mg) and 100 took placebo were included in this analysis.

The data was analyzed using SAS Windows version 9.4. All post-rescue medication severity scores were assigned either the baseline value or the last recorded value whichever was most severe. Post-rescue medication pain relief scores were classified as “no relief”.

Results: It was observed that the intensity of the headache pain was reduced to mild or none (1) within 30 min in 20% of AAC treated vs 10% of placebo treated patients. Within 1 hour, this was 40% of AAC treated vs 14% of placebo treated patients (p< =0.001), and the pain relief lasted for at least six hours.

The quality of life (able to perform all or usual activities with minimal or no additional effort) also improved within 1 hour in 48.2% of AAC treated vs 28% of placebo treated patients (p< =0.005), and within 3 hour in 68.2% of AAC treated vs 40% of placebo treated patients (p< =0.001).

In addition, in terms of relative change (%) difference, there was a 19% improvement in QoL with a 24.6% reduction in pain intensity with AAC within 1 hour. At 3 hours the QoL scores improved to 38.1% with a reduction in pain intensity of 41.1%, which lasted for 6 hours with AAC treated patients.

Conclusions/Implications for future research and/or clinical care: This post- hoc pooled analysis provides evidence that a single dose of AAC provides significant benefits in relieving menstrual migraine associated pain and improves quality of life of patients in their ability to perform usual activities with minimal or no additional effort. This research supports the use of AAC as an effective treatment for women who experience menstrual migraine.


References: Silberstein SD, et al. Treatment of menstruation-associated migraine with the nonprescription combination of acetaminophen, aspirin, and caffeine: Results from three randomized, placebo-controlled studies. Clin Therapeutics. 1999;21(3):475-491.