Our Review Summary
This WebMD story covers a conference presentation about a drug called gabapentin that may help to treat hot flashes. On the plus side, it included a footnote at the end of the article calling attention to the preliminary nature of such conference reports, which usually have undergone very limited peer review. This seems to be an efficient way for health reporters to alert readers to this problem without interrupting the flow of their stories.
On the downside, this story failed to include some basic information about the studies being covered, including how many patients were involved, how long they were treated and followed, and how big of a benefit was seen. It also failed to address costs and didn’t fully explain whether the drug is currently available for treatment of hot flashes.
Why This Matters
As the story points out, hormone therapy is currently the only FDA-approved treatment for hot flashes. However, many women are reluctant to take hormones due the increased risk of breast cancer and stroke associated with their use. Developing effective nonhormonal alternatives is an important research priority.
The slow-release gabapentin discussed here isn’t commercially available, so cost information may not be readily available. Nevertheless, the story quotes sources at the manufacturer who could have been asked about the likely cost of the new formulation. At the very least, the story could have told us about the cost of standard gabapentin, with the caveat that the new slower-release form would certainly be more expensive.
The story provides the absolute number of women who experienced a “significant improvement in hot flash symptoms” in the treatment group and placebo group—a description which comes close to meeting our standard. However, to be judged truly satisfactory, we think the story should have also told us what the researchers mean by “significant” and how this was measured. Sometimes, a benefit can be “significant” in the statistical sense but not make much difference in how people feel in the real world.
Harms and side effects are a primary emphasis of the story and are adequately addressed. The story quantifies the incidence of the two major side effects associated with gabapentin use, daytime sleepiness and dizziness, and provides the occurrence rate in the placebo group for comparison.
The article focuses on two studies that are scheduled to be presented at a conference. We were very pleased to see a disclaimer at the end of this story about the limited peer review to which conference papers are subjected.
The story also made it clear that these were placebo-controlled trials that used relevant clinical endpoints, thus meeting some of the key requirements for this criterion. On the other hand, the article failed to provide some basic but important details about the design of the two studies that are at the heart of the story. Examples:
· We never learn how many women were included in either study.
· We learn the dosage provided in the first study (which failed to show a benefit for the drug), but not the second (which did show a benefit).
· We learn how long second study was (12 weeks), but not the first.
· We learn how the researchers defined a benefit in the first study (number of hot flashes per day), but for the second study the result is described as a “significant reduction in symptoms,” which is imprecise and might mean something different than in the first study.
In addition, a major question raised by the story is why gabapentin was effective in one study but not the other. We were disappointed that the story didn’t provide any possible explanations for the discrepancy.
We’re on the fence with this one. In general, a story needs to provide some kind of description of the size of a study to be judged satisfactory on this criterion, but the story does provide readers with enough information to meet our main requirement.
This article did not engage in disease-mongering.
The article is up-front about where this information is coming from and the potential conflicts the sources may have. Still, the story relies heavily on comments from company representatives or researchers involved with the study. The only comment from a truly independent observer doesn’t address the research itself and is about the general need for non-hormonal treatments for hot flashes. A close one, but we’ll call it satisfactory.
The story mentions low-dose hormone replacement therapy, which is one option for particularly bothersome hot flashes. It could have also mentioned lifestyle changes such as keeping cool and avoiding dietary triggers, which are useful approaches for some women. The story also notes that almost half the women in the placebo arm of one of the trials reported improvement. It would have been helpful to readers to highlight that fact and put the drug results in context with the fact that women feel better after a few weeks even without any treatment. On balance, the story does enough to fulfill the criterion.
The oblique reference to this drug perhaps being "one step closer to becoming the first approved nonhormonal treatment for menopause-related hot flashes" is likely to leave many readers unsure about whether this drug is not yet available or whether it is just not approved specifically for treatment of hot flashes.
The standard formul gabapentin, which is approved for treatment of seizures and pain, can be prescribed off label for treatment of hot flashes even though it isn’t FDA approved for this use. (In fact, Pfizer has recently been slapped with large fines for promoting unapproved off-label uses of the drug.) However, the slow-release form of the drug discussed here is not available commercially. Although it calls the new drug "experimental," the story doesn’t explicitly address the availability of the immediate-release vs. slow-release forms of the drug. The article should have been clearer that the FDA has not approved this new slow release form, and that it is not available.
The story makes it clear the studies involved an extended release version of the drug, which has previously been studied in an immediate-release formulation. It does not oversell the novelty of the drug or the research. However, it appears that some of these results were released a year ago. (See Clinical results section of Depomed corporate web page
with 2009 announcement of Breeze 1 and 2 trial results.) The story does not explain what is new about the latest announcement.
This story includes interviews with multiple sources and is clearly not based entirely on a press release.
Total Score: 7 of 10 Satisfactory