This story covers an analysis of a small study about a potential drug to treat hot flashes associated with menopause, called MLE4901.
The story contains no independent sources and doesn’t stretch beyond what’s in a news release. What’s more, it omits the fact that the compound studied here won’t be used in future trials because of its potential to harm the liver.
More than half of midlife women experience frequent hot flashes that can last several years, disrupting sleep and eroding their quality of life, according to one federally-funded study.
While estrogen therapy is the most effective treatment option, it often isn’t prescribed for long periods and may present cardiovascular and breast cancer risks. Better treatment options would be welcome, but news stories shouldn’t stir up excitement about therapies that haven’t been proven both safe and effective.
The story doesn’t mention how much this therapy might cost or how it might compare to the current standard treatment, hormone replacement therapy. According to the website CostHelper, hormone replacement therapy costs $10 to $85 per month for patients without insurance.
The story said women who took MLE4901 — who had been experiencing at least seven hot flashes per day — “had the frequency of their hot flashes reduced by 72 percent and the severity of hot flashes decreased by 38 percent. This improvement started as early as three days after first taking the drug and relief continued for the whole month of treatment.”
These are relative risk reductions. It would have been more informative to state how often women typically had hot flashes before treatment, and how often they had them afterward, using absolute numbers. Similarly, the story does not state what sort of scale was used to rate the severity of the hot flashes. Rather than describe the benefit as a 38% reduction, the story could have stated the typical severity of hot flashes on that scale before and after treatment. Also, what were the changes in the placebo group? More: Reporting the findings: Absolute vs relative risk.
It also says, “Sleep and concentration improved after three days, too, which was an added bonus. The researchers noted that those improvements could have been related to the reduction in hot flashes.”
The story would have been more informative had it quantified both the number of women who experienced improvements after three days — since that was the key finding — and their improvements in sleep and concentration, since that’s a benefit many women would care about.
The story states that a “previous study on MLE4901 was associated with liver toxicity in a few participants, which resolved when they stopped taking it. They hope slightly modifying the drug may improve that side effect.”
That harm should have been mentioned higher in the story, rather in the second-to-last paragraph.
In addition, the story doesn’t say anything about what adverse effects were observed in this particular study — that information should have been included.
The story does some things right, mentioning this was a “small study” involving 37 women who had at least seven hot flashes per day. The groups received either MLE4901 twice a day for 4 weeks, or a placebo pill on the same schedule. Two weeks later the groups swapped their treatments.
However, it doesn’t explore whether the women in the study were representative of the “millions” the story claimed might be helped by such a drug. For example, it’s unclear how many women in menopause have at least seven hot flashes per day, which seems like a very high number.
More importantly, the story is misleading when it states that “larger studies” on MLE4901 are underway. According to a news release, the “specific compound” tested in this trial “will not be taken further in trials, due to side effects that may affect liver function. However, two very similar drugs, which also block NKB but do not appear to carry these side effects have entered larger patient trials, with one such trial launched in the US last year.”
It remains to be seen whether the “similar drugs” will have the same effect.
The lead of the story refers to “millions of women in menopause who suffer with hot flashes.” The story later states, “About 70 percent of postmenopausal women experience vasomotor symptoms -— the familiar hot flashes — which, in some cases, last for years.
However, it’s far from clear how many women might stand to benefit from this type of drug. As mentioned under Quality of Evidence, the story doesn’t make clear how many women experience the high frequency of hot flashes of those who were in this study.
The story uses only quotes in a news release and contains no independent sources. Two of the authors of the study are employees of Millendo Therapeutics, which has licensed the rights to the compound. Two other authors are listed on a patent related to this method of treatment.
The story does the minimum by mentioning the current standard treatment, hormone replacement therapy. It states: “The previous ‘go to’ therapy was supplemental estrogen, which proved to have side effects like blood clots or even breast cancer.”
While it’s laudable to bring up estrogen replacement and its drawbacks, it also misleading to call it a “previous go to,” since it’s still the standard therapy for menopausal symptoms.
Also, the story doesn’t say whether this drug has been compared to hormone replacement in terms of effectiveness.
Also, the story doesn’t mention other therapies such as low-dose antidepressants and lifestyle changes that might relieve hot flashes.
The story states states: “Larger studies on MLE4901 are underway in the U.S. and U.K. that will help gain an understanding of the drug’s safety and effectiveness. Like any new drug, safety and effectiveness have to be proven to the FDA before the drug can be offered in the U.S.”
The story quotes a researcher who says “this new analysis confirms the beneficial effect is obtained very quickly — within just three days.”
That’s backed by the conclusion of the analysis itself, which reads that the drug “rapidly relieves (hot flashes) without the need for estrogen exposure.”
The story appears to be based entirely from a news release. This quote is taken directly from the news release without attribution:
The potential for this drug class to really improve many of the symptoms of the menopause, such as hot [flashes], difficulty sleeping, weight gain, and poor concentration, is huge,” lead author Dr. Julia Prague of the Imperial College London. “To see the lives of our participants change so dramatically and so quickly was so exciting, and suggests great promise for the future of this new type of treatment.”