This news release from Georgetown University Medical Center does a thorough job laying out the main points of a resveratrol phase II clinical trial. It reasonably talks about the study’s findings and design, while cautioning readers on how researchers must pursue further studies before recommending the drug.
Given this cautious overall framing, we view the release’s omissions as relatively minor. One concern is that the release could have put the potential benefits and the harms into better perspective. For example, readers aren’t told how much levels of the biomarker (Abeta40) would normally decrease in Alzheimer’s patients and how this compares to what was found in the study. Readers also don’t know how many patients suffered from side effects from the concentrated supplement. It would also be interesting to know what existing Alzheimer’s drugs already on the market can do and how resveratrol might compare.
But for the most part, this news release – including its use of language – was appropriately tempered and very informative, hitting home the message that these research findings are preliminary.
Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills. It is a condition associated with aging, since most symptoms appear when people hit their mid-60s. Estimates vary, but experts suggest that more than 5 million Americans may have Alzheimer’s, according to the National Institute on Aging.
Many of these treatments concentrate not on reversing the disease, but on helping people maintain mental function, manage behavioral symptoms, and slow or delay disease progression. In addition, drugs on the market help only some patients and may be effective for only a limited amount of time.
Consequently, any research highlighting a new drug candidate that prevents Alzheimer’s or delays its onset would be newsworthy for both patients and clinicians. Since Alzheimer’s is also a complex disease, having a variety of treatment options would also prove to be beneficial.
Although resveratrol is found in some foods, it was tested here as an investigational new drug. This means that it is not available commercially in 1-gram pills. The news release points out this fact, which is why we rate this Not Applicable.
The news release does a good job explaining how Abeta40 levels were stabilized in patients taking resveratrol in its purified form, pointing out that those “treated with increasing doses of resveratrol over 12 months showed little or no change” in the biomarker.
But we wish the news release could have quantified, or at least provided some indication as to the importance of, the decrease in Abeta40 seen in patients with worsening dementia. How big is the decline in levels? And is there a significant difference between that level and the baseline point?
It would also have been great to see the caveat noted later in the piece (“A decrease in Abeta40 is seen as dementia worsens and Alzheimer’s disease progresses; still, we can’t conclude from this study that the effects of resveratrol treatment are beneficial,” Turner explains.) mentioned sooner in the release. By talking about this biomarker in the lead sentence, the clear implication is that the finding suggests a benefit — only several paragraphs later do we learn that this isn’t necessarily the case.
The news release mentions resveratrol’s most common side effects, which include nausea, diarrhea and weight loss. It would have been helpful to know how commonly these effects occurred. It also lists loss of brain volume as an effect, but states it could interpreted as either a benefit (since it could have reduced inflammation) or harm.
The news release does a thorough job describing the context, significance and design of the study. It mentions the resveratrol clinical trial was a “randomized, phase II, placebo-controlled, double blind study in patients with mild to moderate dementia due to Alzheimer’s disease.” It talks about why the researchers chose to study resveratrol (because it activates compounds known as sirtuins) and why the study is significant (the trial was the largest, longest and highest dose trial of resveratrol in humans to date).
But as noted above, we can almost always find suggestions for improvement. The study’s primary objective was to determine whether resveratrol was safe and tolerated at the 1-gram oral dose – not to see whether it was effective in the treatment of dementia in people with Alzheimer’s. The release might have briefly explained the purpose of a phase II trial, as we felt this was not clear enough in the news release.
In addition, the fact that resveratrol levels stabilize in these patients does not necessarily translate into better health, like prolonged life and better cognitive function. The use of the patient anecdote and of the word “cure” in one of the comments could give readers the wrong impression. The news release could have been a bit clearer when cautioning readers on extrapolating surrogate markers to primary outcomes, even though Turner is quoted as saying, “…still, we can’t conclude from this study that the effects of resvertrol treatment are beneficial.”
But again, we applaud the release’s overall careful characterization of the study, including that the findings “cannot be used to recommend resveratrol.” In a couple of instances, the release calls for further research.
There is no disease mongering in the news release. And the news release did a nice job bringing in a patient/family story, though it might have been helpful to describe the symptoms associated with mild Alzheimer’s to place this story in context.
The news release discloses the funding source, which was the National Institute on Aging. The study’s principal investigator R. Scott Turner, according to the disclosure statement attached to the original journal article, states he has received research support from Ceregene, Eli Lilly, Merck, Biogen Idec, Toyama, Elan/Transition Therapeutics and Pfizer, as well as the NIH and the DOD. The news release doesn’t list these disclosures, and says only that that Dr. Turner “reports no personal financial interests related to the study.”
We’d argue that it would have been better to list those disclosures in the news release, since they were deemed important enough to include the journal manuscript. But since we couldn’t easily find any indication that these companies are developing resveratrol-based drugs — which would be a clear conflict of interest — we’ll give the benefit of the doubt and rule this Satisfactory.
It would have been helpful to know what standard treatments for Alzheimer’s are and how resveratrol could compare with these drugs in the future. According to the National Institute on Aging, several other drugs on the market – like Donepezil (Aricept®), rivastigmine (Exelon®), and galantamine (Razadyne®) – may help slow down cognitive decline, but do not change the underlying disease process. The release could have discussed the lack of great treatments, further supporting the importance of this work.
The news release states resveratrol is not available commercially in the 1-gram oral form.
The news release sends a clear message in the first paragraph on what this clinical trial brings to the existing body of knowledge. “The study Turner led… is the largest, longest and highest dose trial of resveratrol in humans to date,” it states.
The release also does a nice job of mentioning other research applications of resveratrol.
The news release uses appropriate, neutral language and steers clear (for the most part) of sensational wording. The only potential deviation comes from the patient family quote, where the quoted individual talks about wanting to find a “cure.” The release in no way suggests that resveratrol might be such a cure, however we’re not sure that the quotation adds much in the way of value to the release.