Drugs Log

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, Suthisisand told Reuters Health by email.

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.

Naproxen
Brand names: Aleve, Anaprox, Comfort Pac with Naproxen, EC-Naprosyn, Leader Naproxen Sodium, Midol Extended Relief, Naprelan, Naprosyn

What is naproxen?
Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.
Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

Naproxen may also be used for other purposes not listed in this medication guide.

Important information about naproxen

Naproxen can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use naproxen. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking naproxen. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to naproxen (such as ibuprofen or ketoprofen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, or ketoprofen. Do not drink alcohol while taking naproxen. Alcohol can increase the risk of stomach bleeding caused by naproxen. Avoid prolonged exposure to sunlight. Naproxen can make your skin more sensitive to sunlight, and a sunburn may result.