New analysis eyes use of LNG IUS for menorrhagia
(Editor's note: This story discusses off-label use of the levonorgestrel intrauterine system.)
A new review indicates the levonorgestrel intrauterine system (LNG-IUS, Mirena, Bayer HealthCare Pharmaceuticals; Wayne, NJ) appears as effective as endometrial ablation in reducing heavy menstrual bleeding.1 Based on the meta-analysis of six randomized clinical trials, the efficacy of the levonorgestrel intrauterine system in the management of heavy menstrual bleeding appears to have similar therapeutic effects to that of endometrial ablation up to two years after treatment, reports the new review.1
"Although use of the LNG-IUS to treat heavy menstrual bleeding represents off-label use, a substantial [body of] literature, including our systematic review and meta-analysis, supports the efficacy of the LNG IUS in this clinical setting," says Andrew Kaunitz, MD, professor and associate chair in the Obstetrics and Gynecology Department at the University of Florida College of Medicine — Jacksonville and lead author of the review. "For selected women with heavy menstrual bleeding, medical management, including the LNG-IUS, should be considered prior to proceeding with surgery."
The most common surgical treatment for heavy menstrual bleeding has been hysterectomy.2 However, it might not be the most appropriate option for women who wish to retain their fertility, and it is associated with substantial surgical risks and costs.2 Endometrial ablation, a medical procedure that removes the lining of the uterus, has increased in use as a treatment for menorrhagia; however, it is not recommended for women who wish to preserve their fertility.
Menorrhagia is common
Heavy menstrual bleeding is a common gynecologic problem, accounting for about 20% of gynecologic primary care visits.2 Contraceptive Technology defines menorrhagia as menstrual periods that occur at regular intervals but are marked by prolonged bleeding (more than seven days) or excessive blood loss (more than 80 cc).3 (For idiopathic menorrhagia, consider bleeding disorders in your differential. See the box below for information on new guidance regarding bleeding disorders.)
Nonsurgical treatment options for menorrhagia include oral pharmacological therapies such as nonsteroidal anti-inflammatory agents, tranexamic acid, oral contraceptives, progestins in short or long courses, and danocrine. However, research indicates these are less effective than surgical approaches.4
How can you talk with women about menorrhagia? The National Association of Nurse Practitioners in Women's Health (NPWH) has just developed a tool kit for counseling women on the treatment of heavy menstrual bleeding, says Susan Wysocki, RNC, NP, the organization's president and CEO. In addition, NPWH is offering a continuing education program on the subject. Both materials will be made available at the organization's web site, www.npwh.org.
To perform the current meta-analysis, researchers looked at trials in which menstrual blood loss was reported using pictorial blood loss assessment chart scores at baseline and after intervention. Six trials were identified, with a total of 390 women included in the research; 196 women were treated with the levonorgestrel intrauterine system and 194 women received endometrial ablation. Three of the six trials used manual hysteroscopy for endometrial ablation. The others used the thermal balloon approach. Primary study outcome was menstrual blood loss estimated with the pictorial bleeding assessment chart (PBAC) scores. Secondary outcome was treatment failures in both study groups, including unacceptable bleeding profile, persistent or recurrent heavy bleeding, major change in allocated treatment, and removal of LNG IUS or repeated surgery.
Inclusion criteria for the six studies were:
- menorrhagia refractory to medical therapy5;
- women ages 25-50 with self-described heavy menstrual bleeding (HMB), a regular cycle occurring every three to six weeks, and no future plans for pregnancy6;
- women age 38 or older referred for hysterectomy due to menorrhagia (confirmed by PBAC 100 or greater), normal cervical cytology within the previous year, normal uterine cavity upon examination7;
- women ages 40-50 scheduled to undergo hysterectomy for menorrhagia (PBAC 100 or greater) with no wish for pregnancy8;
- women ages 30-49 referred for surgical treatment of HMB (PBAC more than 75): 11 and 13 women randomized, respectively, to LNG-IUS or endometrial resection. Had failed oral medical management, expressed no further desire for children, had a normal uterine cavity9;
- women ages 40 and older with menorrhagia (PBAC greater than 150 for two consecutive cycles) and no further pregnancy plans, who refused or did not respond to medical treatment.10
The researchers report both of the treatment modalities were associated with similar reductions in menstrual blood loss after:
- six months (weighted mean difference, –31.96 pictorial blood loss assessment chart score [95% confidence interval (CI), –65.96 to 2.04]);
- 12 months (weighted mean difference, 7.45 pictorial blood loss assessment chart score [95% CI, –12.37 to 27.26]);
- and 24 months (weighted mean difference, –26.70 pictorial blood loss assessment chart score [95% CI, –78.54 to 25.15]).
"In addition, both treatments were generally associated with similar improvements in quality of life in five studies that reported this as an outcome," the researchers note. "No major complications occurred with either treatment modality in these small trials."
References
- Kaunitz AM, Meredith S, Inki P, et al. Levonorgestrel-releasing intrauterine system and endometrial ablation in heavy menstrual bleeding: A systematic review and meta-analysis. Obstet Gynecol 2009; 113:1,104-1,116.
- Nicholson WK, Ellison SA, Grason H, et al. Patterns of ambulatory care use for gynecologic conditions: A national study. Am J Obstet Gynecol 2001; 184:523-530.
- Nelson AL, Baldwin S. "Menstrual Disorders and Related Concerns." In: Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 19th revised edition. New York City: Ardent Media; 2007.
- Marjoribanks J, Lethaby A, Farquhar C. Surgery versus medical therapy for heavy menstrual bleeding. Cochrane Database Syst Rev 2006; (2):CD003855.
- Barrington JW, Arunkalaivanan AS, Abdel-Fattah M. Comparison between the levonorgestrel intrauterine system (LNG-IUS) and thermal balloon ablation in the treatment of menorrhagia. Eur J Obstet Gynecol Reprod Biol 2003; 108:72-74.
- Busfield RA, Farquhar CM, Sowter MC, et al. A randomised trial comparing the levonorgestrelintrauterine system and thermal balloon ablation for heavy menstrual bleeding. BJOG 2006; 113:257-263.
- Crosignani PG, Vercellini P, Mosconi P, et al. Levonor-gestrel-releasing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional uterine bleeding. Obstet Gynecol 1997; 90:257-263.
- Malak K, Shawki O. Management of menorrhagia with the levonorgestrel intrauterine system versus endometrial resection. Gynecol Surg 2006; 3:275-280.
- Rauramo I, Elo I, Istre O. Long-term treatment of menorrhagia with levonorgestrel intrauterine system versus endometrial resection. Obstet Gynecol 2004; 104:1,314-1,321.
- Soysal M, Soysal S, Ozer S. A randomized controlled trial of levonorgestrel releasing IUD and thermal balloon ablation in the treatment of menorrhagia. Zentralbl Gynakol 2002; 124:213-219.
Guidance issued on bleeding disorders Don't forget to factor in the possibility of a bleeding disorder when a patient presents with menorrhagia, particularly in teenagers and younger women. About 25% of women with heavy menstruation may have an undiagnosed bleeding disorder.1 An international expert consortium has just issued guidance on signs that may signal the presence of a bleeding disorder in women.1 [Editor's note: Free access to the article is available at the American Journal of Obstetrics & Gynecology, www.ajog.org/article/S0002-9378(09)00410-4/abstract.] Although the majority of women who present with menorrhagia do not have a bleeding disorder, consortium participants identified more than a dozen symptoms that suggest further evaluation for the condition, including:
The most common inherited bleeding disorder is von Willebrand disease.1 Common criteria for medical diagnosis include a family history of bleeding, a personal history of bleeding and laboratory tests that indicate the lack of the von Willebrand factor protein, which is essential for clotting. A hematologic evaluation of the patient's platelet number and function and her coagulation factor profile should be assessed in collaboration with a hematologist.1 Once treated, these women can expect to have normal periods and go through childbirth safely. Reference
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