High-dose aspirin for migraines
Posted by medconsumers on April 14, 2010
This is the most satisfying pharmaceutical research story to report: A cheap non-prescription drug—aspirin—has been shown to be almost as good as the popular, high-priced prescription drug. People who suffer migraine headaches usually take the prescription drug Imitrex, which is expensive even when purchased in its generic form (sumatriptan). Nearly the same degree of relief, however, can be received from a single high dose of aspirin (1,000 mg)…and with fewer adverse effects. The aspirin vs placebo and the aspirin vs Imitrex studies are part of a new review from the Cochrane Collaboration. It is based on 13 studies with a combined total of 4,222 participants.
More than half of the people who took high-dose aspirin experienced pain relief within two hours of taking high-dose aspirin. And many said that it lasted 24 hours. One in four went from “moderate or severe pain” to “no pain” within two hours after a single 1,000 mg aspirin dose. And one in two said their pain went down to “pain no worse than mild pain.” High-dose aspirin also reduced the nausea and vomiting experienced during a migraine headache. These findings came from trials that had randomly assigned people to take high-dose aspirin or a placebo as soon as the migraine began. The addition of a 50 mg dose of the gut-protecting prescription drug called Reglan (generic name: metoclopramide) reduced the nausea and vomiting symptoms, though it had no effect on pain relief; a 100-mg dose was only slightly better at alleviating pain within two hours.
Then there are the studies that compared people taking an oral dose of Imitrex (100 mg) plus Reglan with people taking high-dose aspirin with or without Reglan. Imitrex had a small advantage over aspirin in terms of more pain relief at two hours. Adverse reactions to high-dose aspirin were not an issue, but adverse effects occurred slightly more often in people taking Imitrex.
This Cochrane review, entitled “Aspirin with or without an anti-emetic for acute migraine in adults” was conducted by Varo Kirthi and colleagues at the University of Oxford, U.K.
For more information:
Migraine drugs are usually taken on a short-term basis but be aware that chronic use of Reglan can have severe adverse effects. Last year, the FDA ordered a “black box” warning for Reglan’s label (click here for an example of a drug label). Chronic use should be avoided because it can cause a movement disorder called tardive dyskinesia, which is more likely to occur in the elderly, especially elderly women. Tardive dyskinesia is described as involuntary, repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, etc. It is rarely reversible, according to the label, and there is no treatment.
Why it is so common to learn of a new adverse effects long after a drug received FDA approval was explained in a recent commentary entitled, “The missing voice of patients in drug-safety reporting” for The New England Journal of Medicine (click here). During the clinical trials required by the FDA for new drug approval, the study participants are not asked about symptoms they have while taking a drug. Incredibly, the side effects reported in these trials are based on the physicians’ and nurses’ impressions of the trial participants’ adverse drug reactions. These impressions become the initial source of side effect warnings in the FDA-approved drug label. This New England Journal of Medicine commentary cites “a substantial body of evidence,” showing that physicians “systematically downgrade the severity of patients’ symptoms” and that “patients’ self-reports capture side effects that physicians miss.”
Maryann Napoli, Center for Medical Consumers(c)ISSN 2155-1480