The San Antonio Breast Cancer Symposium typically generates extensive media coverage of new research studies. However, not all of the studies presented are of the same caliber and some will never undergo the peer review that will lead them to be published in a medical journal. This means reporters needs to be at the top of their game when evaluating the news releases they receive about studies that will be presented at the meeting.
This story from HealthDay does many things right — it covers costs, side effects, study limitations, and more. This earned it five stars from us. However, we do think the story would have been even stronger if it had better emphasized a key fact: The overall reduction in hot flashes was roughly 28 to 23 in the drug group and 28 to 25 in the placebo group. That’s not much, and raises eyebrows in light of a physician in the story calling it “game-changing.”
Many breast cancer treatments are known to cause hot flashes. Some premenopausal women have treatments that put them into immediate menopause; others enter menopause naturally while they are being treated for breast cancer; and still others are postmenopausal and find the drugs used to treat their breast cancer cause their hot flashes to return or become more frequent. Hot flashes and night sweats can affect quality of life, and it would be great if there was an easy way to control them without using menopausal hormone therapy which has never been recommended for women with breast cancer as it is known to increase breast cancer risk.
However, as multiple studies have shown, many drugs over the years rarely perform much better than a placebo–as was the case in this study of oxybutynin. Yet, this study got widespread play as game-changing.
Using the lead researcher as a source, the article states that most insurers cover oxybutynin; that a month’s supply can range from $21 to $42; and that the cost could be less, depending on the type of insurance a patient has.
Kudos to HealthDay for explicitly addressing cost.
The article reports that the study found the women on oxybutynin had an average of five fewer hot flashes per week, while those on the placebo had three fewer. It’s not clear if the benefit was the same for both doses. The story explains that this was from a group 150 women who experienced at least 28 hot flashes a week. This is enough information to glean the magnitude of benefit.
But, the story could have used more context: The drug resulted in five fewer hot flashes a week. That’s not even one less hot flash per day. And those on the placebo, which costs nothing and has no side effects, has three fewer hot flashes a week. That’s a difference of two hot flashes a week–which seems like a really low bar.
The article says that side effects included constipation, mild diarrhea, dry mouth, dry eyes, episodes of confusion and difficulty urinating. It’s not noted if these side effects were seen in both the low-dose and high-dose groups. There is also no indication of which side effects were most common or how many women experienced them.
Importantly, though, the article does note that the long-term effects of the drug aren’t known and that oxybutynin is in a class of drugs that “have been linked with mental decline” and that previous studies have found “the drugs may raise the risk for problems with short-term memory, reasoning and confusion, and may also hike the risk for dementia among older patients.”
Information on ClincalTrials.gov about the trial suggests this study evaluated two doses in an effort to find an effective dose with fewer side effects.
The concluding paragraph of the article states that the study was scheduled to be presented at the San Antonio Breast Cancer Symposium and that “studies presented at meetings are usually considered preliminary until peer-reviewed for publication in a medical journal.”
It’s important to note this. But the wording also indicates that the article was written before the presentation was even given and the the reporter never saw the researcher’s data or slides or heard any questions the audience may have asked regarding the findings.
It’s indisputable that many women going through menopause experience hot flashes and that side effects of many breast cancer treatments include hot flashes, in some cases because the treatment puts a woman into immediate menopause. They result from fluctuations in women’s hormones.
The article quotes Dr. Alice Police, regional director of breast surgery at the Northwell Health Cancer Institute in Sleepy Hollow, NY, who was not affiliated with the study. We did not detect any conflicts of interest that should have been disclosed.
The article makes it sound like the only option for treating hot flashes is menopausal hormone therapy. But, in fact, there are other ways to treat hot flashes that are currently recommended. These include drugs used for other purposes as well as non-drug options like mind-body approaches.
The article states that the drug, which is approved to treat incontinence, is readily available.
This is the first time that a drug is this class has been shown to have an effect on hot flashes, and so is newsworthy for this reason. That could have been more explicit in the story, though.
The article included original comments not found in the news release.