See nonsurgical options for abnormal bleeding

A new Agency for Healthcare Research and Quality (AHRQ) review of available evidence reveals that women who have problematic irregular or heavy cyclic menstrual bleeding have several safe and effective nonsurgical treatment options.1 The variety of effective options suggests that many women can address symptom relief and contraceptive or fertility desires. (See the full report at http://1.usa.gov/12BbERZ.)

“We were really pleasantly surprised that there was a body of literature of good and fair quality that affirmed a lot of the clinical care that we do,” says Katherine Hartmann, MD, PhD, professor of obstetrics and gynecology and director of women’s health research at Vanderbilt University in Nashville. “There are good choices based on women’s childbearing desires, their metabolic circumstances, and their preferences, as well as what they are comfortable with using.”

Clinicians are familiar with abnormal uterine bleeding. It is among the most common gynecologic complaints of reproductive-age women in ambulatory care settings. It is estimated to affect 11-13% of reproductive-age women at any given time.1

Prevalence increases with age. About one-quarter of women ages 36-40 experience such bleeding.2,3 Women usually consult a clinician when the amount, timing, or other characteristics of their bleeding have changed from their individual norm. Population norms for menstrual bleeding, as established by fifth and 95th percentiles, include:

• frequency of menses within a 24- to 38-day window;

• regularity (cycle-to-cycle variation) within 2-20 days;

• duration of flow from four to eight days;

• blood loss volume from 5 to 80 ml.4-8

What works?

The new review takes a look at nonsurgical options to treat abnormal bleeding, with an emphasis on interventions that are accessible to and within the scope of usual practice for primary care practitioners in any clinical care setting. Contraceptive and noncontraceptive effective treatment options are available for women who have problematic, irregular, or heavy cyclic menstrual bleeding.

The review team found a high strength of evidence that combined oral contraceptives can improve menstrual regularity for women with irregular bleeding patterns. The use of metformin, a drug commonly used to treat diabetes, is supported by moderate strength of evidence for improving cycle regularity especially among women with polycystic ovary syndrome, reviewers note.

Multiple interventions for heavy cyclic bleeding are supported by evidence that they reduce menstrual blood loss, the research team states. Strong evidence suggests that combined oral contraceptives are effective, while moderate strength of evidence indicates that the levonorgestrel intrauterine device (IUD), nonsteroidal anti-inflammatory drugs (NSAIDs), and tranexamic acid reduce bleeding relative to baseline, decrease total volume of bleeding when comparisons are made across treatment groups, and decrease days of bleeding per cycle, the team notes.

In direct comparisons, research indicates the levonorgestrel IUD is superior to NSAIDs, tranexamic acid is superior to NSAIDs, and tranexamic acid combined with an NSAID was superior to tranexamic acid alone. Results from combined oral contraceptives and NSAID comparisons suggest comparable effectiveness, the research team notes.

“Not all women will benefit from these interventions,” the researchers state. “Across agents data are sparse to evaluate long-term improvements and risk of harms.”

New data in

Clinicians will want to add a just-published study to the new body of evidence on effective abnormal bleeding options, says Robert Hatcher, MD, MPH, professor emeritus of gynecology and obstetrics at Emory University School of Medicine in Atlanta. In a randomized study of women who presented to primary care providers in the United Kingdom with excessive menstrual bleeding, the levonorgestrel intrauterine system was more effective than other medical treatments, such as tranexamic acid, NSAID, combined oral contraceptives, progestin-only pill, and the contraceptive injection, in reducing the effect of heavy menstrual bleeding on quality of life.9

Researchers randomized 571 women with menorrhagia to treatment with levonorgestrel IUD or usual medical treatment, which includes tranexamic acid, mefenamic acid, combined oral contraceptives, mini-pills, or the contraceptive injection. Researchers identified the primary outcome as the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS). The scale used scores from 0 to 100, with lower scores indicating greater severity) and was assessed over two years. Secondary outcomes included general quality-of-life and sexual-activity scores and surgical intervention.

Researchers report scores improved from baseline to six months in the levonorgestrel-IUD group and the usual-treatment group (mean increase, 32.7 and 21.4 points, respectively; P < 0.001 for both comparisons). The improvements were maintained over a two-year period but were significantly greater in the levonorgestrel-IUD group than in the usual-treatment group (mean between-group difference, 13.4 points; 95% confidence interval, 9.9 to 16.9; P less than 0.001).9

Improvements in all MMAS domains (practical difficulties, social life, family life, work and daily routine, psychological well-being, and physical health) were significantly greater in the levonorgestrel-IUD group than in the usual-treatment group, and these improvements also were true for seven of the eight quality-of-life domains, researchers note. At two years, more of the women still were using the levonorgestrel-IUD than were undergoing the usual medical treatment (64% vs. 38%, P less than 0.001).9

References

1. Hartmann KE, Jerome RN, Lindegren ML, et al. Primary Care Management of Abnormal Uterine Bleeding. Rockville, MD: Agency for Healthcare Research and Quality. March 2013.

2. Liu Z, Doan QV, Blumenthal P, et al. A systematic review evaluating health-related quality of life, work impairment, and healthcare costs and utilization in abnormal uterine bleeding. Value Health 2007; 10(3):183-194.

3. Marret H, Fauconnier A, Chabbert-Buffet N, et al. Clinical practice guidelines on menorrhagia: management of abnormal uterine bleeding before menopause. Eur J Obstet Gynecol Reprod Bio 2010; 152(2):133-137.

4. Belsey EM, Pinol AP. Menstrual bleeding patterns in untreated women. Task Force on Long-Acting Systemic Agents for Fertility Regulation. Contraception 1997; 55(2):57-65.

5. Fritz MA, Speroff L. Clinical gynecologic endocrinology and infertility. Eighth ed. Philadelphia: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2011.

6. Hallberg L, Hogdahl AM, Nilsson L, et al. Menstrual blood loss — a population study. Variation at different ages and attempts to define normality. Acta Obstet Gynecol Scand 1966; 45(3):320-351.

7. Manzoli L, De Vito C, Marzuillo C, et al. Oral contraceptives and venous thromboembolism: a systematic review and meta-analysis. Drug Saf 2012; 35(3):191-205

8. Treloar AE, Boynton RE, Behn BG, et al. Variation of the human menstrual cycle through reproductive life. Int J Fertil 1967; 12(1 Pt 2):77-126.

9. Gupta J, Kai J, Middleton L, et al. Levonorgestrel intrauterine system versus medical therapy for menorrhagia. N Engl J Med 2013; 368(2):128-137.