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Claims that uterine fibroid procedure ‘restores fertility’ aren’t backed by evidence

Uterine fibroid embolization helps restore fertility

Our Review Summary

The news release describes a research study that assessed pregnancy rates in women with uterine fibroids after they’d undergone a treatment called uterine fibroid embolization (UFE). UFE involves injecting an agent into the uterine arteries to block the blood supply to the uterus and fibroids which causes the fibroids to shrink and die.

The research set out to determine whether either of two types of UFE — conventional and partial — is viable for treating uterine fibroids while preserving fertility. But the release suggests that all of the women who became pregnant after the procedure did so because the fibroids were treated. However, it’s unclear whether the fibroids caused infertility (they don’t always) or whether their removal made pregnancy possible.

The release could have spelled out potential harms from the procedure a lot more clearly than it did.

 

Why This Matters

The release misleadingly associates uterine fibroids with infertility. Fibroids are very common and often do not cause symptoms such as bleeding or pain. If they do cause symptoms, treatment options include medication, surgery and uterine artery embolization (UAE). Some cases of infertility can be caused by fibroids, but (contrary to the release) it is not well known how often fibroids are the root cause.

The release quotes the study, but the study itself misstates the extent to which fibroids are known to cause infertility. The quote that 1-in-4 women with fibroids have problems with fertility is based on a classic study published in 1981, and is inaccurate to boot. Other authors citing the same reference conclude that fibroids account for 1-2 percent of infertility, according to UpToDate, the gold standard online medical text. Because of the uncertainty of the effects of fibroids on fertility, women found to have fibroids who desire a future pregnancy are generally counseled not to postpone pregnancy, since fertility declines with age — but they are NOT advised to have treatment in the absence of other symptoms, unless the fibroids have particular features such as their location that are likely to prevent pregnancy.

The conventional treatment for women with uterine fibroids is myomectomy. Though UFE is a less invasive procedure than myomectomy, its use remains controversial because its effects on fertility are unknown.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The costs of the three treatments considered — conventional UFE, partial UFE, myomectomy — are not discussed in the news release.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The news release does a good job providing absolute numbers in describing the trial results:

After an average follow-up of almost six years, 149 of the 359 women, or 41.5 percent, had become pregnant one or more times, and 131 gave birth to a total of 150 babies. It was the first pregnancy for more than 85 percent of the women who gave birth.

The procedures had a clinical success rate of approximately 79 percent for fibroid-related symptoms.

However, to understand the actual benefits, we’d need to know more about the women who were treated with UAE.  This study enrolled women who had fibroids and/or adenomyosis (a different condition) that apparently caused symptoms, and had not become pregnant after a year of unprotected sex; it offered them the option of UAE, even though its fertility effects were not well understood at the time of the study. There is no information on whether these women had fibroids as the cause of their failure to conceive after a year.  Thus, the pregnancy rates achieved after UAE are difficult to interpret.

The release would also have been more informative had it broken down pregnancy rates by full or partial UAE.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release cites concerns that UFE “may cause inadequate blood flow to the endometrium, or lining of the uterus, and the ovaries” as the reason the procedure isn’t more widely used. This is a bit hard to interpret by the layperson and it isn’t until later in the release that we learn this essentially means there are risks of infertility associated with conventional UFE.

The release should have spelled out the known complications, which, in addition to infertility, include pelvic pain, fever and vaginal discharge, all of which are usually temporary. Death from an embolism (an artery blocked by blood or an air bubble or some other foreign body) following the procedure has been reported but is extremely rare.

Also, one of the reported findings is fairly misleading:

Complication rates were 14.6 percent for partial UFE and 23.1 percent for conventional UFE.

The original research article discloses that this observed difference is not significantly significant.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

There is little in the news release describing what kind of study was undertaken. A reading of the original research article reveals that the findings are based on a retrospective, observational cohort study (one that establishes a link between risk factors and health outcomes but can’t establish cause and effect). It isn’t until the last line of the news release that we learn the researchers next plan to conduct “a randomized study comparing the results of partial and conventional UFE.”

Does the news release commit disease-mongering?

Not Satisfactory

Disease mongering is the most serious shortcoming of this release. The cited statistic that “one out of every four women with fibroids has problems related to fertility” inflates the causal relationship between fibroids and infertility. The more relevant statistic would be the percentage of infertile women who have fibroids.

The release disease mongers because it makes it sound like all women with fibroids are at high risk of infertility, and thus, should receive treatment. In reality, UFE and related procedures are generally reserved for women with fibroids who have symptoms such as bleeding and pain.

The concern is that readers will infer that all women with fibroids who wish to optimize future fertility need treatment for the fibroids — regardless of whether they are causing bothersome symptoms — and that the use of UFE will be extended to treating women with fibroids but without symptoms who hope for a future pregnancy. That’s a very large group indeed, since fibroids are so common.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

Funding sources were not mentioned. The research article states there were no conflicts of interest to disclose.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release discusses the different alternatives for treating uterine fibroids. It at first leads the reader to anticipate a study comparing UFE to myomectomy, but it turns out that the study is much more about comparing conventional UFE to partial UFE. The hypothesis that partial UFE may help reduce the risks of infertility compared to conventional UFE could have been given more discussion.

It is not clear why the lack of difference between conventional and partial UFE is not highlighted in the study abstract or the release.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

There is no explicit discussion of UFE’s availability, but as conventional UFE is described as such, its availability is implicit.

Does the news release establish the true novelty of the approach?

Satisfactory

The release doesn’t make an outward claim of novelty. However, there is novelty here in that there is little published evidence on fertility rates after UFE and this adds to the body of available research.

Total Score: 5 of 10 Satisfactory

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