This story reports a new study of an established treatment: the medicated IUD used not to prevent pregnancy, but to treat heavy menstrual bleeding. But the story falls short on several of our key criteria.
Researchers found that a hormone-containing IUD is more effective than usual medical treatments for heavy menstrual bleeding. While the study was sound, the way the findings are reported doesn’t provide the reader with a useful way of understanding how effective the treatment was.
Heavy menstrual bleeding is a common problem, and a number of medical treatments are available. The benefits of Mirena IUD have been demonstrated in short-term studies, and the FDA has approved it to treat heavy periods. This study added to the existing information by comparing Mirena directly with other common treatments and looking at its effectiveness for a period of two years. The story does not make clear that this was a new study of an established treatment.
There was no mention of costs even though the Mirena’s website has it at about $800 (a significant number of insurers will pay for it).
The story stated that women using Mirena improved 32.7 points compared with 21.4 points on a symptom scale. Unfortunately, it’s not clear what symptoms were being measured.
The symptom scale reports a combined score that represents the effect of heavy menstrual bleeding on physical and mental health, daily life, and other areas. Researchers like scales because they are easier to work with statistically, but they don’t measure something we can understand intuitively. This rating is a tough call because the researchers themselves used a quantitative, validated measure that is virtually meaningless to readers (and confusing to doctors).The best we can say is that the story accurately reported the findings, but the outcome measure was difficult to interpret. And health care stories often need to do more than regurgitate what researchers report, but to offer some interpretation.
The explanation of side effects was not satisfactory. There are a list of side effects on the manufacturer’s website that were not mentioned in the story.
As correctly stated in the story, the most common side effect of Mirena is irregular bleeding. Since the purpose of the study was to compare overall effectiveness and side effects of Mirena vs. other medical therapies, it was adequate to the study’s purpose to simply state that serious adverse effects were no different between the groups. But the story provides little detail provided about adverse effects of the other therapies, as well as Mirena. It would be useful to the reader to have a better sense of the kinds of side effects associated with both types of treatment.
The story makes clear that this was randomized trial, allowing higher confidence in its findings. The story did discuss how the findings for the IUD group could be influenced by the fact the Mirena yields a 100% compliance but didn’t discuss how this biased results.
The story states that heavy menstrual bleeding makes up about 20% of all office visits in the US and UK. What the story failed to state was the actual prevalence of this condition in the population (which is about 5%).
Borderline call, but we’ll give the story the benefit of the doubt.
There is another doctor who does not appear to be affiliated with the study quoted in the story.
The study discussed the usual treatment for heavy menstrual bleeding, but what is not clear is if the side effects from using Mirena are different from the current medications. Inadequate discussion of alternatives and comparisons overall.
We are only told that the IUD is “sold under the brand name Mirena.”
We’ll give the story the benefit of the doubt, although it didn’t discuss anything about how widespread is the use of this IUD.
The story did not do a good job of making clear that what was novel about this study was that it was a large randomized trial and that it followed women for 2 years, whereas earlier studies only went up to 12 months.
The story did not appear to rely on a press release.