Thursday, July 26, 2012

LipiGesic M -- Quack Medicine

I've written before about my own migraine headaches, so you won't be surprised that I noticed this ad from Wednesday's Star Tribune:

Newspaper ad with picture of four pretty women and headline Her migraine was stopped dead in its tracks
(Click to enlarge.)

Not even counting its use of a bunch of pretty women, the ad is clearly deceptive when it claims the product stops a migraine "dead in its tracks." The only efficacy study, sited on its own website, was funded by the company itself. It claims the study was double-blind and placebo controlled, but given the clear incentive to cook the data books, I'd say it's not worth the pixels it's not printed on. The study had 45 people in the treatment group and 15 in the placebo group; 32 percent of the treatment group reported complete pain relief in two hours, vs. 16 percent in the placebo group. Does that sound like stopping a migraine dead in its tracks?

What is LipiGesic M, anyway? According to the site, it's a homeopathic formulation of feverfew (Pyrethrum parthenium, also known as Tanacetum parthenium) and ginger (Zingiber), the feverfew diluted 3X (1/1000th of the original strength) and the ginger 2X (1/100th of the original).

There are two problems with that formulation. First, like homeopathic remedies in general, it's diluted. So basically you're taking a lot of whatever it's diluted with (usually alcohol or water) and just about none of the "active" ingredient. Lots of people have shown the illogic of that approach to creating medications. The LipiGesic M formulation is relatively undiluted, compared to many homeopathic products, but it's still quite diluted.

It's good that it's diluted, though, because the second problem is that Tanacetum is a known abortifacient. (If you've read the Game of Thrones books, you may remember the plot point about Tansy, another of the plant's common names.) Feverfew consumption is also not recommended for people who are allergic to ragweed...which is just about anyone who has allergies.

It sounds like the part of feverfew that's pharmacologically significant is an oil called thujone. The amount of thujone in any particular feverfew plant varies greatly, and isn't controllable by varying the growing conditions. According to herbs2000.com, "...thujone is [a] toxic amalgam which has the aptitude to bring about convulsions as well as psychotic consequences in humans."

LipiGesic M is sold by a company called PuraMed BioScience. Oooh, sounds like a trustworthy group to me. A site called zestinvest.com is pretty critical of their business bonafides, including these nuggets:

  • The company had $30,000 in sales last year, while the 2 executives paid themselves $180,000 and enormous quantities of stock (which they have to dump in order to get their money). Source: annual report
  • The company has a track record of paying bills, such as those from consultants, by issuing large amounts of shares for as little as $0.15 per share. Source: annual report.
  • The company has marketed as an “independent study” a study of its main product, LipiGesic, that it funded. The CEO was one of the researchers. The CEO paid himself in shares for conducting the research on LipiGesic. Source: press releases and the company’s annual report.
  • LipiGesic is based on feverfew, which is a kind of daisy that anybody can grow. Yet, the company is trying to sell LipiGesic in packaging that only contains 6 doses for between $20-$30. Source: company site and Web searches.
  • Feverfew is associated with side-effects, including rebound headaches and miscarriages. The company doesn’t, or didn’t until recently, warn about side-effects. Source: Web research; company Web site.
  • Many of the insiders were previously involved with Quigly Inc.’s product, Cold-EEZE. The nasal spray version of that product destroyed the sense of smell of some users, resulting in a class-action lawsuit. The officers were also sued by shareholders for unjustly enriching themselves at shareholder expense.
PuraMed is incorporated in Minnesota, but its headquarters is near Wausau, Wis., so it has a local connection. Great.

Please do me a favor and don't buy this over-the-counter dreck. If you have migraines, see a doctor. There are legitimately tested medications that can help.
 _______

Update: I contacted Dr. Harriet Hall, of Science-Based Medicine and SkepDoc.info, to see if she had any information on LipiGesic M. She hadn't heard of it specifically, but had this to say:
There is some evidence that feverfew helps with migraines and that ginger can relieve pain, but only in substantial doses, not in these homeopathic dilutions. This study falls in the category of preliminary studies that are essentially meaningless unless they are later replicated and validated with other evidence. As Ioannidis pointed out, half of all published studies are false, and those based on improbable remedies are even more likely to be false.

1 comment:

Eric Yarnell said...

Tanacetum parthenium is NOT tansy and has not been shown to be abortifacient; you have it confused with Tanacetum vulgare. And also you're trying to have your cake and eat it too: if highly diluted Tanacetum parthenium can't have any anti-migraine activity, then how can it also be held responsible for adverse effects seen at pharmacological doses? Anyhow, while I agree with you that the plausibility of homeopathy is extremely low, I believe it is an error to argue this trial was complete garbage based solely on the sample size and funding by the product maker (which are problems, and widespread ones throughout medical research, but they don't completely invalidate the results). Rather this trial should be viewed as preliminary (not a basis for practitioners to recommend this treatment or for patients to take it) and provide support for conduct of a larger trial funded by a third party to confirm (or deny) its results. There have been other implausible treatments (even penicillin itself at the time it was introduced) that turned out to be beneficial with time and many plausible treatments (e.g arthroscopic knee surgery) that were ultimately shown ineffective.