Screenshot: TherapeuticsMD
The news release reports the results of a study examining women’s satisfaction with an applicator-free softgel used for vaginal estrogen therapy to treat post-menopausal vaginal dryness that can cause pain during sexual intercourse. The study involved 731 post-menopausal women who used a placebo softgel or one of three containing varying levels of an investigational low-dose estrogen therapy.
The release provides good context on what post-menopausal vaginal dryness is and how often it shows up in women. But the release was weak on describing attributes that readers need to know when assessing this potential new therapy — such as cost, harms, benefits, evidence, and what makes it different from existing estrogen-based treatments.
While the study itself pointed out the softgels’ ability to dissolve quickly as a benefit, the release omitted this but added “elegant” as an abstract, less informative, benefit. Readers would have been better served with a more concrete approach to addressing usefulness.
Numerous studies have shown that as women age, they are more likely to report problems with sexual functioning, including a lack of desire, vaginal dryness and pain during intercourse. These problems are common, by some estimates affecting nearly two-thirds of American women. The result, especially for women for whom sex is painful, is reduced intercourse frequency, which can be distressing to some women and may cause relationship problems for some couples. On the other hand, some health officials argue that changes such as reduced desire and vaginal dryness are naturally occurring aspects of a woman’s life cycle and therefore should not be treated as medical “problems.”
The news release provides no information about how much the softgels might cost.
The release includes next to nothing in the way of numbers to back up its claim. It includes only one measured benefit: the majority of around 700 women or “(85.4 – 92.1 percent) found the product easy to use.” This was based on a post-trial survey, according to the release.
An interesting finding of the survey not mentioned in the news release was that 57% of women were satisfied with the placebo, compared with 69% to 76% of those treated with the active drug. While it is not surprising that the study, which was supported by the pharmaceutical manufacturer, chose not to focus on this result, it would have provided useful context for understanding the product’s impact on symptoms.
Neither the news release nor the original study on which it reported provided any detailed information about the safety of the investigational drug, other than to say that the estrogen product used has been shown to be “safe and effective.”
The product being discussed may offer a lower dose of estrogen than other currently available alternatives, but nonetheless, full disclosure requires some discussion of potential risks.
The purpose of this arm (the “post trial” survey) of a larger trial was to report on the acceptability of the softgel delivery system itself. It tells us that 96% of the trial volunteers (or 731 individuals) responded to the survey. The release would have been more informative had it told us more about the survey instrument — even the basics such as which questions were asked and how many questions were included.
A separate study examined the benefits and risks of the active drug. That was a randomized double-blind study — the highest quality of evidence — involving 731 postmenopausal women aged 40-75. A survey is not in the same category of evidence as a randomized controlled trial.
The news release states that “50 to 70 percent of post-menopausal women” suffer from vaginal dryness and discomfort or painful intercourse. Another reliable source put the prevalence of vulvovaginal atrophy (VVA) at about half of postmenopausal women, although not all of them experience painful intercourse. Nonetheless, most sources suggest this condition may affect 32 million women in the United States. Given that other research shows that more than 90% of those who experience these symptoms find them troubling, it seems reasonable to conclude that it is a legitimate problem, despite being a normal development as women age.
The news release notes that Dr. Sheryl Kingsberg, the study’s first author, has been a consultant for TherapeuticsMD, which manufactures the active ingredient in the softgels, and for a number of other pharmaceutical companies. It did not mention that several of the study’s other authors also have received research support or consulting fees from TherepauticsMD.
This study carries a strong imprint of its funder, the manufacturer. The acknowledgement in the study notes that even the authorship of the paper was contracted out to a professional medical writing firm, which is a practice that is often criticized. The journal manuscript acknowledged it; the news release could have as well.
The news release mentions several other over-the-counter and prescription products used to treat symptoms of VVA, including creams, moisturizers, tablets, vaginal rings and oral drugs. However, it does not explicitly compare the softgels to these products but mentions that women preferred the softgels to them. The only reference to this comparison comes in a quote from the first author, who described the softgels as “a more elegant delivery system that is easier to use and not messy.”
It would have been nice to see the data on how those women who had previously used another product felt the softgels compared.
The news release says nothing about when these softgels might be available.
The news release does not specify how the softgels differ from previously available vaginal tablets. The study itself suggested that the softgels were formulated to dissolve quickly and without vaginal secretions; it’s somewhat surprising that the news release does not mention this and instead just refers to the product as “elegant.”
It would have been helpful to have more description of the softgel delivery system to help the reader understand how it differed from existing tablets, creams, and rings.
As noted, other than perhaps overestimating the percentage of women affected by VVA, especially by painful sexual intercourse, the news release was relatively low key. It quotes Dr. Kingston, the study’s first author, as saying that health professionals “still have to find better ways to educate the millions of women suffering with VVA about the symptoms, however, so that more of them know it is common, decide to discuss treatment with their healthcare professional, and seek symptom relief with appropriate treatment.” Given that health sources generally seem to agree that VVA is common, reduces quality of life for post-menopausal women and remains under-treated, that statement does not seem terribly out of line.
Systematic, Criteria-Driven
Come on, NY Times; you must do better than this. Important research doesn’t need hype and the “breaking news” BS doesn’t help readers or patients. https://www.healthnewsreview.org/2022/03/nyt-proclaims-breaking-news/
Our editorial team was blessed to have Sharon as a contributor during our best years. As this obit states, she was “kind, patient, wise, thoughtful and generous.” Thank you, Sharon; now rest in peace. https://journalism.wisc.edu/news/in-memoriam-sharon-dunwoody-1947-2022/
We’ve written about the hype of liquid biopsies for years (see link in comment below). And now this…. https://www.statnews.com/2022/01/12/medicare-shouldnt-cover-liquid-biopsies-early-cancer-detection/
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