Nonprescription Medication OK'd for Migraine Headaches
By Barbara Biedrzycki, RN, MSN, AOCN, CRNP
Summary-An estimated 45 million Americans suffer recurrent headaches, of which up to 25 million are believed to be migraine. Most migraineurs are not presently consulting a physician, and about one-third have never been officially diagnosed. Migraine headache has unique diagnostic characteristics and visual and sensory auras that often precede the onset of headache pain. Seventy-nine percent of subjects medicated with a combination of acetaminophen, aspirin, and caffeine reported none or only mild pain six hours after the medication, as compared to only 52% of the placebo subjects. Significant relief from accompanying neurological symptoms was experienced by the medicated group as compared with the placebo group. There were no serious adverse effects. The drug combination has an excellent safety record, is inexpensive, and is available in generic forms.
There was good news for patients and health care providers when the Food and Drug Administration recently approved Excedrin Migraine (Bristol-Meyers Squibb Co., New York City), a safe and inexpensive over-the-counter (OTC) medication for migraine headache. Research indicates that most migraine sufferers are not presently consulting a physician, and about one-third have never been officially diagnosed. Since most migraineurs are not using health care providers for diagnostic and treatment advice, they do not have access to prescription medications.1 An estimated 45 million Americans suffer from recurrent headaches. Up to 25 million of them are believed to have migraine headache.2 Migraine headaches have unique characteristics that distinguish them from cluster and tension-type headaches. Disturbing visual and sensory auras often precede the onset of headache pain.3
The exact pathophysiology of migraine headaches is unknown, although there are three hypotheses:
· vascular - dilatation and distension of extracranial vessels causes pain, and the release of vasoactive peptides lowers the pain threshold;
· neural - neuronal dysfunction results in a lower cerebral threshold against migraine attacks; and
· neurovascular or unified - central neuronal hyperexcitability leads to changes in cerebral vasculature and neural function.3
OTC Drug Effective for Migraine Pain
A study by Lipton at the Albert Einstein College of Medicine, Stewart at the Johns Hopkins School of Public Health, Ryan at the St. Louis University School of Medicine, et al shows that the OTC combination of drugs is highly effective for treating the pain as well as many of the neurologic, sensory, and visual symptoms that accompany migraine headaches.1
Almost 60% of subjects reported mild or no headache pain within two hours after taking the combination medication, compared with only 32.8% of the placebo-treated patients. After six hours, 79% of the medicated patients but only 52% of the placebo patients reported mild to no pain. Additionally, by six hours, more than half of the medication subjects (50.8%) but less than one-quarter of the placebo subjects (23.5%) were pain-free. The study compared the effect of placebo with unbranded Excedrin Extra-Strength tablets (Bristol-Myers Squibb).1
Each Excedrin tablet contains 250 mg of acetaminophen, 250 mg of aspirin, and 65 mg of caffeine, the same formulation that has been available OTC for more than 20 years.2 Earlier studies found caffeine an effective analgesic adjuvant for various pain conditions.4,5,6,7
Study Design
Lipton et al conducted three independent, double-blinded, randomized, parallel-group, single-dose, placebo-controlled research studies to evaluate the effectiveness of the nonprescription combination drug in the treatment of migraine headache pain.3 Eligible patients within the three groups, who totaled 1,357, met both the inclusion and exclusion criteria. Patients were required to:
· meet the International Headache Society's diagnostic criteria for migraine headaches;
· be at least 18 years old and in good health;
· experience headaches at least once every two months.
Patients were excluded if they had more than six headaches a month, were usually incapacitated by the headaches, or vomited 20% of the time they experienced the headache.
The intervention was a single-dose treatment of either two tablets of the nonprescription combination of acetaminophen, aspirin, and caffeine or identical appearing placebo at the onset of one acute self-recognized migraine attack. The patients recorded pain intensity, pain relief, functional disability, nausea, vomiting, photophobia, and phonophobia at 30 minutes, one hour, and two, three, four, and six hours after the dose.1
Study Results
· Pain intensity. Patients taking the drug combination had significantly higher mean pain intensity scores at points one hour to six hours after the dose.
· Pain relief. Significantly more drug-treated patients than placebo-treated patients had no pain to mild pain from one to six hours.
· Functional disability. A higher percentage of patients who took the drug combination were able to perform activities with little or no additional effort.
· Nausea, photophobia, and phonophobia. For all three symptoms, the percentage of patients without symptoms was significantly higher in the drug-treated group than in the placebo group.
· Vomiting. This study excluded subjects who vomited 20% or more of the time but noted that 60% of subjects reported nausea at baseline. Findings revealed the proportion of patients without nausea was significantly higher in drug-treated subjects than in the placebo group.
· Safety. No serious adverse effects were reported in any of the three groups.1
Practice Implications
Pain and symptoms associated with migraine headaches were significantly reduced in the treatment group of this study. Based on the study findings, the combination of acetaminophen, aspirin, and caffeine (marketed as Excedrin Migraine and Excedrin Extra Strength, but also available in generic forms) offers safe, low-cost, readily available, nonprescription relief for migraine photophobia, phonophobia, and functional sufferers.
References
1. Lipton R, Stewart W, Ryan R, et al. Efficacy and safety of acetaminophen, aspirin, and caffeine in alleviating migraine headache pain. Arch Neurol 1998;55:210-217.
2. The National Headache Foundation. National Headache Foundation fact sheet. Chicago. 1997.
3. Excedrin Migraine Product Monograph. Bristol-Meyers Squibb Co., New York City. 1997.
4. Dalessio D. Caffeine as an analgesic adjuvant: Review of the evidence. Headache 1994;34(suppl. 1):10-12.
5. Migliardi J, Armellino J, Freidman M, et al. Caffeine as an adjuvant in tension headache. Clin Pharmacol and Therapeutics 1994;56:576-86.
6. Lipton R, Newman L, Solomon S. Over-the-counter medication and the treatment of migraine. Headache 1994;34:547-548.
7. Laska E, Sunshine A, Mueller F, et al. Caffeine as an analgesic adjuvant. JAMA 1984;251:1711-1718.
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