EXECUTIVE SUMMARY
Clinicians can inform patients with heavy menstrual bleeding that they can potentially improve their bleeding-related quality of life by using either a levonorgestrel intrauterine device (IUD) or combined oral contraceptives.
- Researchers studied the patients’ reported quality of life and found both were equally positive at six months and 12 months after initiating contraception with the levonorgestrel IUD or the combined oral contraceptives.
- Women with heavy menstrual bleeding talk about how they change their daily activities to avoid public areas and sometimes wear black clothing around the days they expect their periods to start.
- Bleeding can lead to increased anxiety and negatively affect their quality of life.
Women with concerns about menstrual bleeding could improve their bleeding-related quality of life (QoL) with either the levonorgestrel intrauterine device (IUD) system or combined oral contraceptives at six or 12 months, new research shows.1
“For the study, patients were instructed to take combined oral contraceptive pills cyclically so they would have menstrual bleeding monthly,” says Kristen A. Matteson, MD, MPH, lead study author and a professor of obstetrics and gynecology at the University of Massachusetts Chan Medical School. “In other studies, it’s shown to have significant reduction of blood flow, and it’s effective for reducing blood loss, but those studies are small and limited.”
The results of Matteson’s study suggest that clinicians could counsel patients on both approaches to improving their experience with menstrual bleeding. “Patients can be counseled that at 12 months post-treatment, the [negative] impact of bleeding and quality of life is reduced by nearly half for individuals treated with a [levonorgestrel] IUD or combined oral contraceptives,” Matteson says. Both methods are good options for improving bleeding-related QoL for people with heavy menstrual bleeding, she adds.
Clinicians also could help patients understand that the two methods are very different, and there may be additional reasons why a person would choose one contraceptive over another. For example, the levonorgestrel IUD might be a better choice if the patient is focusing on blood loss or does not want to have to remember to take a pill each day.
Matteson and colleagues found that investigators could not detect a statistically significant difference in bleeding related to QoL between people randomized to receive the levonorgestrel IUD and those randomized to receive combined contraceptives.
“I’m not saying they’re equivalent. It’s not powered to detect that,” Matteson explains. “The study was designed to find a difference, and we failed to find that difference.”
Creating an Outcome Measure
Matteson has been interested in patients’ experiences with bleeding and their assessment of QoL related to menstrual bleeding for at least two decades. When Matteson was working toward her master of public health degree in 2004, she participated in research classes that asked students to propose a clinical trial.
“Where I got stuck was, I couldn’t find an outcome measure that reflected what patients were telling me in clinical practice,” Matteson explains. “I couldn’t find a measure that reflected interference with the quality of life and stress they were experiencing.”
Matteson spent several years developing a questionnaire about how bleeding interfered with patients’ daily life. “This trial was designed to measure differences in the impact in quality of life,” she says. “In the U.S., levonorgestrel IUD and combination oral contraceptives are the most commonly used for treating heavy menstrual bleeding. This study was designed to focus on differences in bleeding related to quality of life, which I would assert is the most important thing when you’re trying to treat someone with heavy menstrual bleeding.”
The QoL tool she designed and published about seven years ago can be used by clinicians to assess how much bleeding affects patients’ lives. It was modified and validated for use in adolescents in another published study.
“I never copyrighted it. My goal was to create something others could use,” Matteson says. “When investigators reach out to me, I send them the tool and scoring method. I think it’s important we embrace patient-centered outcomes in clinical trials.”
For instance, Matteson’s research does not use clinical experience as a measure of whether the hormonal IUDs or pills were better for reducing patients’ bleeding patterns.
“That makes the same mistake that researchers make all the time — the misconception that we know better than our patients with their lived experiences,” Matteson explains. “We conducted focus groups, cognitive interviews, and validated the instrument to make sure it was measuring what we thought it was measuring.”
The experiences of patients with menstrual bleeding are the most important measure of the symptom’s impact. “I’m not a person who is suffering from the symptom. How can I know best how it’s impacting my patients if I’m not including them in a conversation?” Matteson asks.
In developing the framework to think about how bleeding affected patients’ quality of life, Matteson was most interested in their sense of worry and the concept of fear of social embarrassment. “These led to anxiety and behavior change,” she says. “In other questionnaires, they focused on leaking and staining events and how often that happened in public settings. What I learned in focus group settings is if someone has suffered from heavy menstrual bleeding for a long time, they don’t have those episodes anymore because they modify their entire life to avoid those episodes.”
Women mentally prepare for bleeding. They predict their bleeding and when it will be heavy. They make plans, such as bringing extra clothing.
“It’s this pervasive worry and stress that causes menstruators to live a different life,” Matteson says. “I heard people say, ‘I wear black clothes,’ but that didn’t come up in our group. Participants had social embarrassment and avoided situations where they could be subjected to social embarrassment and bleeding they could not contain.”
For example, they would avoid shopping and any other activity where it could take them a long time to get to a restroom. They described elaborate tactics to avoid bleeding heavily in public, changing their behavior in anticipation of their period.
The most striking finding for both the levonorgestrel IUD and the combined oral contraceptives groups was that bleeding-related QoL increased and menstrual bleeding questionnaire scores significantly decreased, beginning at the six-week follow-up.
“There were similar changes in those randomized to IUD and combined oral contraceptives,” Matteson notes. “There are a lot of factors that go into patient decision-making, and this study contributes evidence that they’re both good options in terms of their effectiveness to improve quality of life to improve heavy bleeding.”
REFERENCE
- Matteson KA, Valcin J, Raker CA, Clark MA. A randomized trial comparing the 52-mg levonorgestrel system with combination oral contraceptives for treatment of heavy menstrual bleeding. Am J Obstet Gynecol 2023;S0002-9378(23)00521-5.
Women with concerns about menstrual bleeding could improve their bleeding-related quality of life with either the levonorgestrel intrauterine device system or combined oral contraceptives at six or 12 months, new research shows.
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