Look at LNG IUS for menorrhagia treatment
(Editor's note: This article discusses off-label use of the levonorgestrel intrauterine system.)
Your next patient is a 35-year-old mother of two who is experiencing ongoing heavy menstrual bleeding (menorrhagia). Recently remarried, she says she may want to have a child in the future with her new partner. What are your treatment options?
Consider use of the levonorgestrel intrauterine system (Mirena LNG IUS, Berlex Laboratories, Montville, NJ). A new systematic review of scientific studies indicates that while use of conservative surgery reduces blood loss more than the IUS, the two treatments appear about equal in terms of patient satisfaction.1
For women who experience menorrhagia, heavy blood loss often interferes with daily activities and can lead to anemia. Defined as total menstrual blood loss of more than 80 ml/cycle, menorrhagia affects 15% to 20% of American women.2
Treatment for heavy menstrual bleeding often has led to hysterectomy; menstrual disorders are one of the leading indications for the procedure.3 How does use of the LNG IUS compare with hysterectomy for treatment of menorrhagia?
Jane Marjoribanks, co-author of the current review and researcher at the University of Auckland in New Zealand, points to a randomized comparison of the LNG IUS with hysterectomy.4 In that study, there was no significant difference between the groups in quality-of-life scores at one or five years, she notes.
"Hysterectomy, by definition, stopped all bleeding," notes Marjoribanks. "In the intrauterine system arm, 68% of women still had the device in place at one year." Of these, more than half had nil or negligible bleeding while the rest, which included one woman with ongoing menorrhagia, had a mean loss of only 13 ml per cycle (range 1-92 ml), she says.
With use of the LNG-IUS, surgery is avoided, and the woman gains the advantage of contraception without losing the possibility of fertility, observes Irving Sivin, senior scientist at the New York-based Population Council. The Population Council served as a co-developer of the device along with Leiras, a Finnish pharmaceutical firm.
The LNG IUS also is effective in protecting against fibroid development, notes Sivin. In a six-country study conducted by the Population Council that compared the IUS and the Copper T 380A IUD (ParaGard IUD, Barr Pharmaceuticals, Pomona, NY) over seven years, one of 1,125 women using an IUS developed fibroids, compared with 14 of 1,121 women using the copper IUD.5
The Mirena IUS was approved by the Food and Drug Administration (FDA) in December 2000. Its current approved indication is solely for contraception, so use of the device for treatment of menorrhagia would be considered an off-label application.
When used off-label in women with menorrhagia, including women with fibroids, use of the progestin-releasing IUS often leads to adequate reduction in menstrual blood loss, says Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville. In addition, insertion of the progestin-IUS is done in the office, does not involve a major anesthetic, is safer, fully reversible, and costs much less than more invasive therapies including endometrial ablation, he states.
"For this reason, for many women with menorrhagia, use of the progestin-IUS represents a first-line therapeutic approach in my practice," states Kaunitz. "If the IUS works, great; if not, then it becomes appropriate to consider more invasive therapies."
Clinicians may opt to treat menorrhagia with nonsteroidal anti-inflammatory drugs, oral progestins, or oral contraceptives. However, if these approaches prove ineffective, women may seek surgical alternatives to hysterectomy that remove or destroy the lining of the uterus using an electric loop, laser, hot water balloon, ultrasound, or other device. These procedures have fewer risks of serious complications and often can be done on an outpatient basis.6
Since menorrhagia is a common reason for seeking medical attention, providers should weigh the outcomes and costs to provide the most appropriate care.7 The levonorgestrel-releasing IUS improves health-related quality of life significantly at relatively low cost.4
References
- Marjoribanks J, Lethaby A, Farquhar C. Surgery versus medical therapy for heavy menstrual bleeding. Cochrane Database Syst Rev 2006, 2:CD003855.
- The LNG-IUS and menorrhagia treatment. Contraception Report 2003; 14:13-15.
- Farquhar C, Steiner C. Hysterectomy rates in the United States 1990- 1997. Obstet Gynecol 2002; 99:229-234.
- Hurskainen R, Teperi J, Rissanen P, et al. Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: Randomized trial 5-year follow-up. JAMA 2004; 291:1,456-1,463.
- Sivin I, Stern J. Health during prolonged use of levonorgestrel 20 µg/d and the Copper TCu 380A intrauterine contraceptive devices: A multicenter study. Fertil Steril 1994; 61:70-77.
- Nagrani R, Bowen-Simpkins P, Barrington JW. Can the levonorgestrel intrauterine system replace surgical treatment for the management of menorrhagia? Br J Obstet Gynaecol 2002; 109:345-347.
- Hurskainen R, Paavonen J. Levonorgestrel-releasing intrauterine system in the treatment of heavy menstrual bleeding. Curr Opin Obstet Gynecol 2004; 16:487-490.
Resource
The Population Council, in cooperation with the United Nations Population Fund, will host the Fifth International Symposium on Intrauterine Devices (IUDs) and Systems for Women's Health Oct. 27-28, 2006, at the American Conference Centers in New York City. Thirty-six international scientists will present data and analyses of new information on a range of biomedical issues relating to IUDs and intrauterine systems in the symposium, the first one held since 1992. Space for the conference will be limited. To register on-line, go to the Population Council web site, www.popcouncil.org, and click on the symposium link on the opening page. The registration fee is $375. Continuing education credits are available.
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