This story takes a narrowly-focused trial and pumps it up to look like a grand medical advance.
A year ago, the American Journal of Cardiology featured a more noteworthy trial on red yeast rice. It was a multi-year randomized controlled trial of a red yeast rice extract involving nearly 5,000 heart attack patients that reported a reduction in coronary events… but for some reason ABC News decided to highlight red yeast rice using a brief, small trial that was narrowly focused on the side effects reported by participants who could not tolerate statin treatment.
The researchers of this small trial reported in the Annals of Internal Medicine pointed out the need for larger and longer studies that measure actual heart health outcomes (not just lab measurements of cholesterol) – and an accompanying editorial said physicians should not prescribe red yeast rice supplements to their patients. But this story did not tell viewers about those caveats.
The story also perpetuates the widespread confusion between cholesterol lab tests and actual health outcomes. The story concludes by saying “an ancient supplement might just be the answer,” but this story can’t even get the question right.
Costs are not mentioned in this story.
A letter written in response to an earlier publication by the same group of researchers notes that generic statin pills may cost as little as $4 per month at certain pharmacies, whereas red yeast rice supplements may cost 10 times as much at the studied dose.
Is Red Yeast Rice a Suitable Alternative for Statins?
Mayo Clinic Proceedings November 2008 vol. 83 no. 11 p.1294
This story focused on the reduction of cholesterol levels, as if that result were the ultimate goal. There was no mention of heart attacks, blocked coronary arteries, or any other real health outcome. As mentioned earlier, this story continues the widespread confusion of cholesterol levels with actual health or illness.
The story did highlight that the trial focused on people who discontinued statin treatment because of side effects, but the narrow scope of the trial was overshadowed by broader and inappropriate claims of treatment efficacy.
The story featured an unrepresentative anecdote. The only participant interviewed said his cholesterol level dropped from 221 (mg/dL) to 135. However, the story did not mention that the average reduction was far smaller (from 245 mg/dL to 209 mg/dL over 24 weeks.)
Two other points left out of the story:
– those taking placebo pills also saw some reduction in cholesterol, though it was smaller than in the active treatment arm,
– there was a partial rebound in cholesterol levels between measurements taken at 12-weeks and those taken at 24-weeks. The story reported only the (more dramatic) 12-week results. And then it used only percentage figures, not absolute numbers.
At first glance, it appears this story does deals with potential harms by noting that the “biggest problem with red yeast rice is that unlike statin drugs, it’s not regulated,” thus leaving consumers uncertain about strength or purity of supplements.
There are two major flaws with that angle. First, the biggest problem with recommending red yeast rice based on this study is that the study wasn’t designed to provide evidence that those taking the supplements received any real health benefits. Second, the proposed solution to questions about supplement safety and effective is the old saw: “Ask your doctor.”
However, because supplements are not independently monitored, no one, including a physician, can offer any assurances that a particular brand or source is safe.
An editorial in the Annals of Internal Medicine pointed out case reports indicating that any product that lowers cholesterol (including red yeast rice) may cause muscle pain and damage. The editorial author goes on to council physicians against recommending red yeast rice: “The U.S. Food and Drug Administration continues to warn against inconsistent and possibly toxic formulations of red yeast rice, and we should not prescribe it until it has been standardized and tested further.
The story quoted a researcher saying there were a “very small number of side effects.” It did not point out that 4 out of 29 (14%) participants stopped taking red yeast rice supplements; two because of “intolerable” muscle pain, one because of dizziness and one because of loose stools. One participant in the placebo arm stopped taking the pills after reporting intolerable muscle pain.
Other trials and case reports in the medical literature link red yeast rice and extracts to hepatitis and kidney damage. The variability of strength and purity of supplements is also documented.
This story overinflates the results of the study.
In the journal article abstract, the authors caution that, “The study was small, was single-site, was of short duration, and focused on laboratory measures.” Then in the discussion they write, “A larger, multicenter trial with longer follow-up is needed to determine whether red yeast rice offers a safe and effective solution for this unmet medical need and to evaluate its effects on cardiovascular outcomes.”
Viewers heard neither of these important caveats.
The TV story did not give viewers information on how to find the original journal article.
Like so many news reports, this one treats elevated cholesterol as a disease, not just a marker of coronary artery disease risk. Indeed, nowhere does the story even mention coronary artery disease or heart disease of any kind; lowering measurements of blood cholesterol levels are treated as the ultimate goal.
This confusion of a lab test result with an actual health outcome then leads the story to proclaim that red yeast rice “just might be the answer,” without ever making clear that this study was neither long enough nor large enough to provide any answers about whether people taking red yeast rice live longer or healthier.
We‘ll give the story the benefit of the doubt on this criterion since a second source was interviewed – a physician who was not an author of the journal article. However, the story offered no information about expertise of the (apparently) independent source. And the quote used did not address the trial that was just published.
While the story does feature statin treatment, it makes no mention of diet, physical activity or other lifestyle measures that not only can reduce cholesterol levels, but actually improve health in numerous ways.
Other substances that can reduce cholesterol, such as niacin and fish oil, are not mentioned.
This story notes that red yeast rice is available as a food and a supplement. It also notes that the quality of these products, including strength and purity, is not regulated or independently monitored.
Viewers of this report would have no idea that several studies of red yeast rice for lowering cholesterol have been published over the past decade.
The online version of the story (http://abcnews.go.com/WNT/MedicineCuttingEdge/story?id=7846751) notes that, “Research published last year in the American Journal of Cardiology showed that heart attack patients in China who took a red yeast rice supplement daily were 45 percent less likely to have another attack within five years.” But this study, which was far larger, longer, and focused on more important outcomes, was not mentioned in the TV report.
The new information provided by the trial is that over a six-month period a selected group of people who could not tolerate statin treatment were mostly able to tolerate red yeast rice supplements. But in the TV story, that limited scope was overwhelmed by promises of an alternative method to lower cholesterol.
The story did not appear to be based only on a news release.