Fibroids are common and can cause bothersome symptoms such as pain, bleeding, and pressure in some women. However, they are also benign and deciding about how or whether to treatment them depends on how much a woman is bothered by her symptoms, feels about the pros and cons of different treatments, and whether she wishes to conserve her fertility. There are many different safe and viable treatments available, ranging from medications to minimally invasive procedures to surgery. Women who make a fully-informed decision about treatment in conjunction with their doctor are likely to be satisfied with their treatment so long as their choice matches their goals and what’s important to them.
Even with so many options, it would be welcome news that a drug may not just treat the symptoms but actually might reduce the size of fibroids. A new study presented at this week’s European Society of Human Reproduction and Embryology shows that EllaOne, currently available as an emergency contraceptive in Europe (but not in the US), may shrink fibroids and reduce symptoms relative to placebo. However, the results should be greeted cautiously. This was a small, short study and the full results have not been evaluated. More research is needed to confirm them and answer many outstanding questions.
Whilet EllaOne may be shown to be very helpful to women with fibroids in the future, these results are premature at best.
The story does not describe costs of the drug.
The story states that 80 to 95% of women have no bleeding after taking the drug. However, that leaves a lot of open questions about the effectiveness of the drug. For example, how long does this benefit last? What about other symptoms of fibroids like abdominal pain and pressure? The story repeatedly mentions that the drug shrinks fibroids. By how much? Is that difference clinically meaningful? In other words, can women perceive an improvement in bulk symptoms (pain, pressure) as a result of the decreased fibroid size? Do the fibroids grow back?
The story mentions the potential harm of elevated liver function test results. However, it does not explain that women commonly experience abdominal pain, headaches and nausea with this drug.
The story does not critically appraise the current study. This was a small study (57 patients) with a short follow-up time. The results have also yet to be fully evaluated and have only been presented at a scientific conference.
The story verges on disease mongering by exaggerating the seriousness of fibroids. While it is true that up to 80% of women may have fibroids, only about 20% of women will have symptoms that are bothersome enough that they would seek treatment. Fibroids in of themselves are benign and are not problematic unless they cause symptoms and treatment should only be initiated if a woman is bothered by them. Symptoms of fibroids also most often go away after menopause. However, this story leaves the impression that all women with fibroids should be treated.
The story quoted multiple independent experts.
The story mentions Lupron and Uterine Artery Embolization as alternatives to EllaOne but fails to mention many other safe and effective options that are currently available. For example, oral contraceptives (which are not approved for fibroids but are commonly used for that indication) can help reduce bleeding and cramping associated with fibroids. Likewise, the Mirena IUD often stops bleeding altogether. NSAIDs can also be used for pain. Myomectomy, surgery to remove fibroids, preserves fertility. By not mentioning these options, the story leaves the reader with the impression that there are few viable alternatives.
The story clearly states that EllaOne is available for emergency contraception only in Europe but is being considered for approval in the US.
The story clearly describes that this drug is not new, but has previously only been used as an emergency contraceptive in Europe.
Because the story quotes several indepdent experts, the reader can assume that the story did not rely on a press release as the sole source of information.
Systematic, Criteria-Driven
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