A sublingual preparation of feverfew and ginger is safe, well-tolerated, and an effective first-line treatment for mild headaches to prevent a more serious attack, a new study has found.
With about half of those with migraine managing their headaches without medical supervision and with many of them reluctant to take triptans, the "gold standard" of migraine treatment, this homeopathic remedy is a welcome additional treatment, according to lead study author Roger K. Cady, MD, director of the Headache Care Center, Springfield, Missouri.
Although he's averse to comparing the feverfew-ginger product directly to a triptan, Dr. Cady said he would go so far as to say the two treatments "are not dissimilar.
"I'm not going to say that this is doing the same thing that a triptan does, but a significant number of people [in the study] found relief and restoration of function; basically, they had improvement in all the associated symptoms as well as pain."
The study was published online in Headache, the journal of the American Headache Society.
The study, conducted at three headache centers in the United States, included 60 patients aged 13 to 60 years (one withdrew after becoming pregnant, leaving 59 included in the analysis). These subjects met criteria for International Headache Society migraine with or without aura, had migraines for more than a year, and had had between two and six attacks per month during the previous three months. Subjects also had to differentiate migraine from nonmigraine.
Researchers randomly assigned these patients on a 3:1 ratio to receive LipiGesic M, a combination of ginger and feverfew, which is made from a flowering plant, or a matching placebo that had a similar taste. At baseline, there was a modest randomization imbalance; the average severity of headache for those in the treatment group was 1.41 on a scale of 0 to 3 compared with 1.67 for those receiving placebo.
Participants were asked to treat all migraine attacks over one month and were encouraged to initiate treatment when the headache was mild and likely to be more disabling if left untreated. They were also asked to keep detailed headache diaries.
The study found that at two hours after dosing, 32.19% of the treatment group reported being pain free compared with 15.79% of those taking placebo (P = .02). The feverfew group rated 63.70% of the attacks as having no or mild pain vs 38.60% for the placebo group.
Disabling Headache Features
Feverfew-ginger was also statistically superior to placebo in eliminating disabling features of headaches, including their pulsating nature, worsening with activity, and accompanying light sensitivity, sound sensitivity, and nausea.
|Disabling Headache Features by Treatment|
|Feature ||Feverfew-Ginger, % ||Placebo, % ||PValue|
|Worsening with activity||36.2||39.7||.015|
The treatment was well tolerated, with adverse events comparable to those of placebo, except for oral numbing (six in the active vs. none in the placebo group) and nausea (ten in the active vs. three in the placebo group).
On the Patient Perception of Migraine Questionnaire, there was a statistical superiority for feverfew-ginger over placebo in the total score that rates efficacy, functionality, ease of use, cost, and "bothersomeness" (mean of 57.59 vs. 40.05).
The mechanism of action of the feverfew-ginger product is not clear, although one small study suggested that it may interact with nitrous oxide, an important regulator of vascular tone, said Dr. Cady.
A previous open-label trial tested a water-based feverfew-ginger product, but the one used in the current study was oil based, which, according to Dr. Cady, may improve absorption. An advantage of the sublingual administration is that it's absorbed through the mucosa of the tongue and mouth and avoids going through the gastrointestinal tract, he said.
Some people with migraine are reluctant to take triptans because of concerns about safety and costs. Others are hesitant to take any prescribed medicine unless they're certain they need it.
In any case, many patients are looking for an effective nonprescription medication to use as a first-line treatment. "Patients are inventing all types of ways they might manage their migraine; they may start with an OTC [over-the counter drug]; they may start with ice; they may wish it away; they may do a lot of things before they get to the prescribed medications," said Dr. Cady.
Although migraines should be treated early, this occurs in only about 50% of attacks, said Dr. Cady, who calls this the adherence gap. "Maybe if we gave people a better set of tools, we could close that gap," he said.
A limitation of the study was that because numbness can be associated with ginger, this may have introduced a bias for participants aware of this potential distinction with placebo. But Dr. Cady said he had confidence in the blinding of the study. "Unless you were really a connoisseur of ginger you probably wouldn't be able to tell the difference."
Dr. Cady said he would like to test this product in children because it has a "tremendous safety factor" and there are very few data on the treatment of migraines in children.
According to Russ Mitchell, chief executive officer, PuraMed Bioscience, which developed and markets LipiGesic and which funded this study, the product will be available nationally in some drug stores by the fall. It can be purchased online (www.lipigesic.com) at $29.95 for 6 doses, or enough to treat 3 migraines. At retail stores, the suggested price of a package of 8 doses is $19.95.
Reached for a comment, Marc Wasserman, MD, a neurologist in Flossmoor, Illinois, and a member of the American Academy of Neurology, said the study was well designed although small and not fully randomized due to the higher likelihood of receiving treatment. "It's certainly intriguing enough in its findings to warrant larger studies," he told Medscape Medical News in an email.
Dr. Wasserman said this product is "definitely" something his patients would be interested in. "Sadly, while there are a lot of treatments out there for migraines, the success rate can be low at times in some patients."
He agreed that patients are hesitant to take triptans, partly because of the cost. He pointed out that only one triptan — sumatriptan — is readily available generically but is nevertheless expensive.
Another concern with prescribed medications is perceived adverse effects, such as nausea, fast heartbeat, and risk for stroke. The safety profile of feverfew may be particularly interesting to patients who often regard herbal medications as intrinsically safer or easier to take.
In such an environment, research into alternative medications, like feverfew, butterbur, and magnesium, "is extremely helpful and should be pursued aggressively," said Dr. Wasserman.
Dr. Cady has served as a consultant for Glaxo/Smith/Kline, Merck, and Ortho-McNeil and received research grants from Allergan, Endo Pharmaceuticals, Glaxo/Smith/Kline, Merck, PuraMed Bioscience, and Wyeth. For conflict of interest information on the other authors, please see original article.
Headache. Published online June 1, 2011. Abstract
Pauline Anderson • Medscape Medical News © 2011 WebMD, LLC