Facts after Mirena and NovaSures: Which to Use To control Your Period: Ablation, IUD, OCs or MBPs?
"Menorrhagia or heavy menstrual bleeding is a common gynecologic problem that constitutes a frequent indication for surgical intervention," write Andrew M. Kaunitz, MD, from the Department of Obstetrics and Gynecology at the University of Florida College of Medicine–Jacksonville, and colleagues. They write that although hysterectomy has traditionally been the most common surgical treatment, resulting in complete cessation of menstrual bleeding and high levels of satisfaction, "it may not be the most appropriate method for some women, especially those who wish to retain their fertility, and is associated with substantial surgical risks and costs." During the past 2 decades, endometrial ablation has been used increasingly in the management of heavy menstrual bleeding, offering a less invasive surgical alternative to hysterectomy but not eliminating the perioperative or long-term risks associated with surgery. "Moreover, recurrence of symptoms, necessitating repeat treatment or hysterectomy, may occur," explain the study authors, who go on to say that oral pharmacologic therapies offer another option but are considered less effective than surgical approaches. "In contrast, the [LNG-IUS] is generally considered the most effective first-line medical therapy for the reduction of menstrual blood loss and in the overall management of heavy menstrual bleeding," write the authors. "Indeed, the LNG-IUS has been advocated as an effective alternative to surgery." Although the benefits of the LNG-IUS in reducing menstrual bleeding are well characterized, uncertainty exists whether it reduces bleeding as effectively as endometrial ablation, with past comparison studies between the 2 treatments yielding conflicting results. As these studies typically involved fewer than 50 participants per treatment group, statistical power was limited in detecting differences in efficacy, according to the authors. "We therefore conducted a systematic review of the literature and meta-analysis to more precisely compare the effectiveness of the LNG-IUS and endometrial ablation in reducing heavy menstrual bleeding." In this study, the investigators searched MEDLINE and EMBASE for randomized controlled trials comparing LNG-IUS with endometrial ablation in the treatment of heavy menstrual bleeding up to January 2009. Restricting their search to those trials in which menstrual blood loss was reported using pictorial blood loss assessment chart scores at baseline and after intervention, they identified 6 trials (3 conducted in Western Europe and 1 each in New Zealand, Egypt, and Turkey) with a total of 390 women. Of these participants, 196 women were treated with the levonorgestrel intrauterine system and 194 women received endometrial ablation. In addition, 3 of the 6 trials used first-generation endometrial ablation (manual hysteroscopy,), and the other 3 used second-generation endometrial ablation (thermal balloon). The primary study outcome was menstrual blood loss estimated with the pictorial bleeding assessment chart scores. A secondary outcome was treatment failures in both study groups, including unacceptable bleeding profile, persistent/recurrent heavy bleeding, major change in allocated treatment, and removal of LNG-IUS or repeated surgery. Overall results showed that both treatment modalities were associated with similar reductions in menstrual blood loss after 6 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). Treatment failures did not appear to significantly differ between groups, at 21.2% for LNG-IUS compared with 17.9% for endometrial ablation (relative risk, 1.40; 95% CI, 0.89 - 2.20). "However, our analysis had less than 80% power to detect a difference of 10 percentage points in [the treatment failures]," explain the authors. Both treatments were also generally associated with similar improvements in quality of life in the 5 studies that reported this outcome. Although no major complications occurred with either treatment in any of the trials, "In general, the sample size of the studies was too small to adequately assess adverse events," write the study authors. However, in the 2 studies that analyzed the occurrence of adverse events using statistical methods, non serious adverse events were more frequently reported in the LNG-IUS group than in the endometrial ablation group (P < .05). Finally, although a separate analysis was performed for the different endometrial ablation procedures used in the selected trials, overall findings did not change. Limitations of the study include the small overall numbers of trial participants and follow-up duration lasting no more than 3 years in any of the trials, which limited the investigators' ability to assess long-term efficacy and safety outcomes. "Although limited statistical power limits the robustness of these findings, our meta-analysis indicates that at 6, 12, and 24 months, the LNG-IUS is at least as effective as endometrial ablation in reducing menstrual blood loss," the authors conclude. "We believe that the results...represent a valid comparison of the efficacy of LNG-IUS compared with both first- and second-generation endometrial ablation techniques. In women choosing between insertion of a LNG-IUS and endometrial ablation, the need for contraception, risk of future pregnancy complications, and future ability to conceive, if desired, should be considered." Maria Isabel Rodriguez, MD, clinical fellow in family planning at the University of California, San Francisco, and author of the Medscape blog "Reproductive Write," told Medscape Ob/Gyn & Women's Health that overall, she found this to be an important review. "I think it was very well done and offers an improvement in understanding how the [LNG-IUS] can be used in noncontraceptive methods." Dr. Rodriguez was not involved with the article. "Menorrhagia, or heavy menstrual bleeding, is one of the most common gynecologic complaints there are, affecting anywhere from 10% to 20% of women," said Dr. Rodriguez. "It's a really common reason why women see gynecologists in all stages in life. And this study offers women a new choice." She continued: "There are many different ways that endometrial ablation can be done. Sometimes it can be done in the clinic or in an outpatient setting, but most of the time, it's done in an operating room and is often expensive. The [LNG-IUS] can be inserted in the office in under 3 minutes, typically. So women can avoid a more invasive procedure that's also a lot more affordable, (bloggers note: and now with Obamacare the Mirena may be covered at 100% whether you have a large out of pocket deductable) I think it's a great first step to try." "One of the major limitations, and the authors addressed it, is that in doing this systematic review, there are just small numbers of women in studies of these types done to date," said Dr. Rodriguez. "In addition, I think some more long-term follow-up for safety outcomes would be great to have. Nonetheless, there's great data to show that up to 2 years, there's no difference in terms of outcomes between the 2 interventions. So I think it just makes sense for women to consider the LNG-IUS, especially if they're close to menopause anyway." Dr. Kaunitz has been a consultant to and has been on scientific advisory boards for Bayer Schering Pharma AG, the maker of the LNG-IUS. Two of the other study authors have also disclosed financial relationships with Bayer Schering Pharma AG. A complete description of their disclosures is available in the original article. Dr. Rodriguez has disclosed no relevant financial relationships. Obstet Gynecol. 2009;113:1104-1116.