This news release about a brand of peppermint oil used to treat symptoms of irritable bowel syndrome (IBS) disguises the company sponsorship of the only published trial of the product and appears intended to fool readers into believing that independent researchers concluded this brand is superior to other, less-costly brands of peppermint oil. Claims of benefits are vague. Harms are missing. Conflicts of interest are hidden. Two short sentences buried in a 20-thousand-word review of IBS published by Nature are misused to claim independent support for the company’s product.
Irritable bowel syndrome is a serious condition that plagues millions. Those who suffer its effects yearn for effective treatments and no doubt would rush to try an over-the-counter product that was recommended by independent experts. However, this release slyly disguises a brief citation of a single company-sponsored trial as a pillar of an international review of IBS. It fails to mention that there is no evidence IBgard is any better than other forms of peppermint oil. The release leaves out any mention of company involvement and funding in the single trial of the product.
The news release by the maker of IBgard notes that its product is available at “CVS/pharmacy, Walgreens and Rite Aid” and other stores, but it neglected to tell readers that the recommended doses would cost up to four times as much as generic peppermint oil capsules, with a monthly cost that could exceed $100 (6 capsules/day). (CVS lists IBgard at $22.99 for 48 capsules, or 63 cents each vs. 15 cents each for generic capsules.)
The news release does not quantify the benefits of IBgard or generic peppermint oil. It makes vague statements about benefits or effectiveness without specifying what they are:
“The published data showed that IBgard® demonstrated a statistically significant reduction in the Total IBS Symptom Score (TISS) in as early as 24 hours and at four weeks. The TISS represents a composite score of eight individual IBS symptoms.”
Which symptoms were reduced? By how much were they reduced? How many patient volunteers were involved in the study? The release doesn’t say.
A strength of the release is the inclusion of information on number-needed-to-treat (NNT). But lack of comparability in the outcomes measured in different studies makes comparison of NNT across treatments difficult. The release tries to make such comparisons nonetheless.
The release does not mention any harms, even though the trial of IBgard that is highlighted in the release specifically tracked adverse events including indigestion, flatulence and reflux. The article summarizing that trial knocked other brands of peppermint oil capsules for causing heartburn, nausea, anal burning and “dose-dumping,” which is the sudden release, rather than slow release, of the drug in the capsule.
This release not only fails to explain the quality of the Nature review article it highlights, it seriously misleads readers by disguising company-sponsored research. The release states that the panel of researchers that wrote the Nature article stated “peppermint oil…is beneficial in reducing IBS symptoms.” Actually, the Nature article merely quoted a five-year-old Cochrane review that briefly noted a handful of trials showing some benefits from peppermint oil, while criticizing the quality of those studies, including that none adequately concealed whether participants were receiving the active treatment or a placebo. Then the release claims that the Nature article authors concluded (emphasis added) that “A novel formulation of peppermint oil, designed to cause sustained release in the small bowel, was superior to placebo in causing a reduction in total symptoms.” Actually, that quote is merely a citation of the trial of IBgard funded and managed by the manufacturer and its own consultants. This section of the release conceals the source of the cited evidence and portrays the praise as coming from an independent source.
The news release states that “one in six Americans experience Irritable Bowel Syndrome (IBS).” That estimate is about twice as high as the range cited in the Nature article (between 5-10 percent or 1-in-20 to 1-in-10). The release does say that only doctors can diagnose IBS and that IBgard should be used only under medical supervision, even though this product and other brands of peppermint oil capsules are available without a prescription.
The estimate of prevalence is inflated, but it is true that IBS should be diagnosed by a medical professional. Other more serious conditions such as inflammatory bowel disease (ulcerative colitis and Crohn’s) can mimic IBS symptoms.
The news release fails to reveal that the trial of IBgard it highlights was funded by the manufacturer, IM HealthScience, and authored by two employees and a consultant. The release does not reveal that the expert it quotes, Brooks Cash, M.D., is the company consultant.
The Nature review highlighted in the release refers to several other IBS treatments, including some drugs such as otilonium bromide and hyoscine, that act to reduce spasm, as does peppermint oil. The release doesn’t note these alternatives or several other drug, nutrition and behavioral approaches to managing IBS.
The release notes that IBgard is for sale without a prescription at many pharmacies and other stores.
The release implies that IBgard capsules are superior to other brands. However, the only trial it cites compared the company’s product to placebo, not other peppermint oil products, so any claims of novelty or superiority remain untested.
The release improperly portrays citations of a single, company-sponsored trial as the “Latest in growing scientific and medical recognition of IBgard as an effective, safe, and well-tolerated option in the management of IBS.”
This bullet point at the top of the release also goes overboard in suggesting that peppermint oil is the best treatment for IBS: “Builds on a previous review article where the lead author cited peppermint oil as the most effective option in management of IBS.”
There is growing appreciation of the potential benefits of peppermint oil, but not of IBgard per se.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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