Naproxen, acetaminophen et migraine

By Rachael Myers Lowe


NEW YORK (Reuters Health) - Migraine sufferers may be able to get
sufficient relief without turning to prescription drugs, according to
two new studies.


The studies, published in the latest issue of the journal
Headache, conclude that naproxen (marketed as Aleve) and acetaminophen
(Tylenol) effectively decreased or eliminated pain and reduced migraine
recurrence and migraine-associated symptoms to a degree defined as a
"desirable outcome" of migraine therapy by the International Headache
Society.


Migraine headache affects as many as 28 million Americans and
costs the U.S. economy an estimated $24 billion every year.


About three-quarters of people who suffer from migraines report
more than one migraine a month. The symptoms -- pain, light and noise
sensitivity, nausea -- can last from 4 to 72 hours and often lead to
missed days from school or work.


Researchers from Thailand analyzed four well-designed previous
studies of naproxen at doses of 500 to 825 milligrams for treatment of
acute moderate to severe migraines involving 2,168 patients.


Led by Chuthamanee Suthisisand of Mahidol University in Bangkok,
the authors concluded that naproxen effectively reduced headache
intensity, pain and symptoms within 2 hours of taking it - defined by
the International Headache Society as a desirable outcome.


When compared to other drugs known as triptans, naproxen did as
well as the prescription drug frovatriptan (marketed as Frova) but did
not offer the same clinical benefits as almotriptan (marketed as Axert)
and zolmitriptan (marketed as Zomig).


However, because of side effects, not all patients can take
triptans, and naproxen offers those patients a non-prescription
alternative,
Still, the authors found that naproxen "appears to be inferior" to
aspirin in treating migraines. Suthisisand said the science suggests
1,000 milligrams of aspirin is the best of several treatments that
include naproxen and acetaminophen for acute moderate to severe migraine
episodes, as long as patients can tolerate potential gastrointestinal
side effects.


Although the Thai team acknowledged that the quality of studies
such as theirs depends on the quality of the original studies, they said
they were confident the studies they reviewed were high-quality.


In the second study, researchers from McNeil Consumer Healthcare,
the makers of Tylenol, randomly assigned 378 migraine sufferers to
either 1000 milligrams of Tylenol or a dummy pill.


In the 90-day trial, the researchers, led by Mary Jane Prior,
found that the Tylenol group began to benefit within an hour of taking
the medication. At 2 hours, 52 percent of the acetaminophen group
reported that their pain was reduced to mild or no pain, compared to 32
percent of the dummy pill group.


The team also reported a benefit for severe pain sufferers, but
they could not determine whether that was due to chance, given the small
number of patients in the trial.


The study also found that acetaminophen offered "significantly
larger" relief than placebo from nausea and noise sensitivity at 2 hours
and nausea, light and noise sensitivity and functional impairment at 6
hours.


The study, the authors concluded, adds to earlier clinical
evidence supporting acetaminophen's use to treat migraine.


"When effective," the authors wrote, "acetaminophen provides
consumers with a non-prescriptive, lower cost alternative to costly
prescription migraine drugs."


Acetaminophen is not currently approved by the FDA as a migraine
treatment except as part of an aspirin or aspirin and caffeine compound.
McNeil Consumer Healthcare declined to say whether they were applying
to the FDA for approval of acetaminophen for use in migraine.


SOURCE: Headache, March 2010.