Research eyes IUS use for menstrual bleeding

Many women may experience excessive menstrual bleeding, but for those with extreme menstrual bleeding (menorrhagia), such 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%-20% of American women.1

As a clinician, you may opt to treat menorrhagia with nonsteroidal anti-inflammatory drugs, progestins, or oral contraceptives. However, if these approaches prove ineffective, women may seek endometrial resection or ablation or undergo a hysterectomy.2

Just-published research compares outcomes, quality-of-life issues, and costs of the levonorgestrel-releasing intrauterine system (LNG-IUS, Mirena, Berlex Laboratories, Montville, NJ) vs. hysterectomy in the treatment of menorrhagia.3 While the Mirena IUS is approved solely for contraceptive use in the United States, several countries also have granted regulatory clearance for use of the device for treatment of menorrhagia. U.S. clinicians have used the Mirena IUS for this noncontraceptive approach on an off-label basis; however, the company is looking at an indication for the device. According to Berlex spokeswoman Kimberly Schillace, the company is in talks with the Food and Drug Administration to determine what would be required to obtain regulatory approval for the new indication.

Treatment of menorrhagia with the LNG-IUS is not new; it has been studied since the device’s development, says Elof Johansson, MD, vice president of the New York City-based Population Council. The LNG-IUS was co-developed and tested by the Population Council and the Finnish pharmaceutical company Leiras. German pharmaceutical company Schering, Berlex’s parent company, markets the device worldwide. Public health officials have looked at use of the device in developing countries, where an estimated 45% of nonpregnant women are considered anemic.4 Use of the LNG-IUS offers a viable approach; women with menorrhagia using the device reported up to 96% reduction in blood loss at 12 months.5

Look at the study

In the new study, Finnish researchers evaluated the outcomes of 236 women with an average age of 43 years who were referred to five Finnish hospitals for treatment of menorrhagia between 1994 and 2002. The study participants were randomized to treatment with the LNG-IUS or hysterectomy, and they were monitored for five years.

Of the 117 women initially randomized to hysterectomy, intraoperative complications occurred in four women, and postoperative complications were noted in 33 (30%). Of the 117 participants who received LNG IUS insertion, 50 (42%) ultimately underwent hysterectomy. Of the 57 (48%) IUS recipients who continued with the IUS in place at five years, 75% reported amenorrhea or oligomenorrhea. Two women had the IUS removed after developing mood symptoms, one due to recurrent thromboembolic disease and one was due to a benign ovarian cyst. No expulsions or perforations were reported.

Notwithstanding the initial IUS recipients who ultimately underwent hysterectomy, the five-year overall costs were estimated to be substantially lower in the group randomized to IUS insertion. By providing improvement in patients’ health-related quality of life at relatively low cost, the LNG-IUS may offer another choice for the patient and may decrease costs by preventing surgery, researchers conclude.

One limitation of the study is that it did not report on standardized pre-randomization assessment of the menorrhagia, says Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville. It would be important to know, for instance, what percentage of participants had been diagnosed with intramural fibroids, adenomysosis, or intracavitary lesions prior to randomization, he notes. This information may have provided insight into the reasons women ultimately underwent hysterectomy, he observes.

Weigh the options

In Kaunitz’s practice, a growing number of patients with benign conditions associated with heavy bleeding are choosing to try the progestin-releasing IUS. Clinicians and patients should be aware, however, that use of this intrauterine device to treat menorrhagia represents off-label use and that expulsion rates have been observed to be higher in women with fibroids than in other women,6 Kaunitz notes. Not all women with menorrhagia will achieve therapeutic success with an IUS, but the IUS does represent an office-based, minimally invasive approach to treatment, says Kaunitz.

"This study clarifies that use of the progestin-releasing intrauterine system indeed can successfully treat menorrhagia in a substantial proportion of women who otherwise will need surgical intervention," Kaunitz observes.

References

1. The LNG-IUS and menorrhagia treatment. Contraception Report 2003; 14:13-15.

2. 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.

3. 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.

4. Trieman K, Liskin L, Kols A, et al. IUDs — an update. Population Reports 1995; B:8.

5. Milsom I, Andersson K, Andersch B, et al. A comparison of flurbiprofen, tranexamic acid, and a levonorgestrel-releasing intrauterine contraceptive device in the treatment of idiopathic menorrhagia. Am J Obstet Gynecol 1991; 164: 879-883.

6. Hidalgo M, Bahamondes L, Perrotti M, et al. Bleeding patterns and clinical performance of the levonorgestrel-releasing intrauterine system (Mirena) up to two years. Contraception 2002; 65:129-132.