A newly reported clinical trial found that patients experiencing mild migraine attacks achieved significant pain relief with a homeopathic preparation of ginger and the herb feverfew. However, this was a small study with numerous limitations and potential sources of bias.
Writing in the journal Headache, from the American Headache Society, researchers report a multi-center trial involving subjects meeting International Headache Society criteria for migraine with or without aura and experiencing 2-6 migraines per month; 77% were female, 87% Caucasians, mean age 41 years [Cady et al. 2011]. They were randomized 3:1 to receive either a sublingual feverfew/ginger product or a matching placebo, and were instructed to treat with study medication at the earliest recognition of migraine.
In total, 60 subjects treated 208 evaluable attacks of migraine during a 1-month period; 45 treated 163 attacks with sublingual feverfew/ginger and 15 subjects treated 58 attacks with the sublingual placebo preparation. Evaluable pain diaries were completed for 151 attacks of migraine in the population using feverfew/ginger and 57 attacks for those attacks treated with placebo.
At 2 hours, 32% of subjects receiving active medication and 16% of subjects receiving placebo were completely pain-free (P = .02). Also at 2 hours, 63% of subjects receiving feverfew/ginger found some pain relief (pain-free or only mild headache) versus 39% for placebo (P = .002). Pain level improvements on a 4-point (0-3) pain scale for those receiving feverfew/ginger versus placebo were -0.24 versus -0.04, respectively (P = .006). Feverfew/ginger was generally well tolerated with some oral numbness and nausea being the most frequently occurring adverse events.
COMMENTARY: Therapeutic needs of migraineurs vary considerably between patients and even from one headache episode to another. While the “triptan” class of drugs is considered a “gold standard” of migraine therapy, these do have limitations and many patients are seeking therapeutic alternatives. The authors conclude that the sublingual feverfew/ginger treatment appears safe and effective as a first-line abortive treatment for a population of migraineurs who frequently experience mild headache prior to the onset of more severe headache.
Feverfew, which is derived from a flowering plant, Tanacetum parthenium, has long been considered a remedy for headaches. The feverfew/ginger product tested in this trial is described by the authors as “homeopathic,” indicating that “there is no clear scientific or allopathic explanation of its mechanism of action.” The product costs $29.95 USD for a few sublingual-dose packets, and is most likely not covered by insurance plans, which could be a concern for some patients.
The authors present their investigation as a “pilot study,” probably since enrollment was small and the study was statistically underpowered. At the time of treatment, the average pain severity on the 0-to-3 scale was 1.41 for those receiving active treatment and 1.67 in the placebo group; both representing mild levels of pain and a statistically significant imbalance between groups at the outset that might have distorted differences in outcomes. And, as noted above, the mean difference of post-treatment pain-improvement ratings between groups of just 0.20 might be considered of questionable clinical significance.
Preliminary trials such as this can be useful for generating data that aid in designing larger, appropriately powered studies with a potential for yielding valid results. However, the quality of evidence in this present study is low and whether its presentation merits a 9-page journal article, as is the case here, is debatable.
This study was funded by PuraMed Bioscience, which makes the feverfew/ginger product, the lead researcher received past research grants from the company, and one of the other named authors is the Chairman/CEO of the company. Therefore, the potential for vested commercial interests and bias in conducting the study, as well as its interpretation and the reporting of results, must be cautiously considered.
REFERENCE: Cady RK, Goldstein J, Nett R, et al. A Double-Blind Placebo-Controlled Pilot Study of Sublingual Feverfew and Ginger (LipiGesic™M) in the Treatment of Migraine. Headache. 2011; online ahead of print, June 1 [article here].
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7 comments:
You are correct but too polite in your criticism of this research. It seems that this study is nothing more than an infomercial for the sponsor’s feverfew product, under the guise of a journal article. I wonder what sort of incentives might have been offered to the American Headache Society, which controls the journal, for them to publish the study. Why did you even bother reporting on this article?
Thank you for the comment (above); there are much worse things we can be accused of than being correct and polite. We felt it was worthwhile reporting on the Headache journal article because (a) migraineurs are always looking for new remedies and we thought this might be of interest (albeit of questionable value), and (b) this study somewhat typifies the potential biases and quality issues that are pervading the pain literature these days. Readers need to be very cautious about accepting what they see in the journals or news media and our role in these UPDATES has been to at least point toward some avenues of more critical interpretation.
It seems to me the company is using the word "homeopathy" quite incorrectly. Homeopathic remedies are highly diluted and to my knowledge would not be able to cause numbness and nausea. Homeopathic remedies also disclose the level of potency for each remedy.
Yes... we agree that their use of the term "homeopathic" in the article did not fit the usual interpretation. Essentially, the product is simply an herbal remedy. --SBL
I have taken Feverfew for a number of years now for my migraines, and I have found they do work.
Although I do get the odd migraine they can be severe with vomiting.
I still take Feverfew to this day.
I'd like to point out that the potential biases and quality issues mentioned in regards to this study are pervasive in studies of prescription medications as well. The vast majority of studies of prescription drugs are paid for by the company that makes the medication, carried out by researchers who have financial ties to those companies, and published in journals supported by pharmaceutical advertisements.
These issues are rarely mentioned in reports on prescription studies funded by the company making the medication, but are mentioned in almost every report on studies of herbal medications or supplements funded by the company that makes them.
I agree with Ms. Burnett (above) that conflict of interest biases are not unique to studies of alternative therapies (eg, herbs, supplements, etc). Any reputable journal posts such information as a part of the respective article (if one looks closely). Unfortunately, mass media and other commenters on such research often overlook (or ignore) those sources of bias. -- SBL
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