Heavy menstrual bleeding-related quality of life does not vary at 6 to 12 months based on the use of the levonorgestrel intrauterine system (LNG-IUS) vs combined oral contraceptives (COCs), according to a recent study published in the American Journal of Obstetrics & Gynecology.
Takeaways
- Quality of life related to heavy menstrual bleeding (HMB) does not significantly differ between the use of the levonorgestrel intrauterine system (LNG-IUS) and combined oral contraceptives (COCs) at 6 to 12 months, as per a recent study in the American Journal of Obstetrics & Gynecology.
- Up to 30% of women experience HMB, which can have a substantial impact on their physical and emotional well-being. LNG-IUS and COCs are common treatments for HMB, but little data exists comparing their effectiveness.
- The study compared the effects of a 52-mg LNG-IUS with 30- or 35-μg ethinyl estradiol COCs on bleeding-related quality of life in women with HMB. Eligible participants were aged 18 to 51 years, seeking HMB treatment, not pregnant, and meeting specific criteria.
- Both LNG-IUS and COCs resulted in a significant reduction in Menstrual Bleeding Questionnaire scores after 12 months compared to baseline. The SF-36 Mental Component Summary scores favored the LNG-IUS group at 12 months.
- The study concluded that both LNG-IUS and COCs are effective in improving HMB-related quality of life, with minor adverse events reported in the COC group.
Up to 30% of women experience heavy menstrual bleeding (HMB), significantly impacting their physical and emotional quality of life. HMB is commonly treated throughLNG-IUSand COCs in US women. However, there is little data comparing the efficacy of these methods.
To evaluate changes in bleeding-related quality of life from 52-mg LNG-IUS vs 30- or 35-μg ethinyl estradiol COCs, investigators conducted a randomized clinical trial. Participants included individuals with self-reported HMB from hemostatic disorders or ovulatory disorders.
Eligibility criteria included being aged 18 to 51 years, seeking HMB treatment, being nonpregnant, being able to read and write in English or Spanish, not having a copper intrauterine device, not planning pregnancy in the next 12 months, and not having an endometrial ablation or a delivery in the past 6 months.
Contraindications to either COCs or LNG-IUS were reported on standardized forms by participants’ gynecologic care providers. Providers also measured a patient’s most likely etiology of HMB based on clinical laboratory testing, clinical history, and other clinical evaluations.
In the LNG-IUS group, participants received a 52-mg device, which a gynecologic care provider inserted using standard procedures. In the COC group, participants received a monophasic pill with 30 or 35 μg of ethinyl estradiol to be taken cyclically.
Participants completed a questionnaire at baseline with data on demographic and clinical characteristics, as well as additional questionnaires at 6 weeks and 3, 6, and 12 months. The Menstrual Bleeding Questionnaire (MBQ), the 36-Item Short Form Survey (SF-36), the EuroQol EQ-5D, and the Work Productivity and Activity Impairment Questionnaire were included in study forms.
Investigators measured the mean changes in score on the MBQ from the treatment visit to 6 months and 12 months. There are 20 questions on bleeding heaviness, bleeding irregularity, pain, and bleeding impact or worry about quality of life included in the MBQ.Scores ranged from 0 to 75, with higher scores indicating worse quality of life.
Treatment failure was also measured as a coprimary outcome. Health-related quality of life was the secondary outcome of the analysis, measured using the SF-36 and EQ-5D.
There were 24 women included in the LNG-IUS group and 31 in the COC group. Participants were aged a median 31 years and had a median body mass index of 29.3 kg/m2.
Similar pretreatment bleeding characteristics and HMB treatment histories were observed between both groups. Continued LNG-IUS use at 6 weeks was observed in 75% of the LNG-IUS group, compared to continued COC use in 96.8% of the COC group.
Both groups saw an approximately halved MBQ score after 12 months compared to pretreatment. In the LNG-IUS group, pretreatment and 12-month MBQ scores were 33.2 and 14.3, respectively. In the COC group, these scores were 32.9 and 15.8, respectively. Reductions in MBQ score began as early as 6 weeks.
The change in SF-36 Physical Component Summaryscores did not significantly differ between the LNG-IUS and COC group at 6 and 12 months of follow-up in the intention-to-treat or per-protocol analyses. However, the change in SF-36 Mental Component Summary scores significantly differed from the treatment visit to 12 months in favor of the LNG-IUS group.
EQ-5D scores did not significantly change in either group. Major adverse events ending treatment were not reported in the LNG-IUS group, but 1 participant with new-onset migraine headaches and 1 with deep vein thrombosis were reported in the COC group. These results indicated both LNG-IUS and COCs are effective for treating HMB-related quality of life.
Reference
Matteson KA, Valchin J, Raker CA, Clark MA. A randomized trial comparing the 52-mg levonorgestrel system with combination oral contraceptives for treatment of heavy menstrual bleeding. American Journal of Obstetrics & Gynecology. 2023;229(5):532.E1-532.E13. doi:10.1016/j.ajog.2023.07.049
