Hysterectomy, endometrial ablation and Mirena® for heavy menstrual bleeding: a systematic review of clinical effectiveness and cost-effectiveness analysis

• Published in: Health technology assessment (Winchester, England) England), 2011-04, Vol.15 (19), p.iii-252
• Main Authors: Bhattacharya, S, Middleton, L J, Tsourapas, A, Lee, A J, Champaneria, R, Daniels, J P, Roberts, T, Hilken, N H, Barton, P, Gray, R, Khan, K S, Chien, P, O'Donovan, P, Cooper, K G, Abbott, J, Barrington, J, Bongers, M Y, Brun, J-L, Busfield, R, Clark, T J, Cooper, J, Corson, S L, Dickersin, K, Dwyer, N, Gannon, M, Hawe, J, Hurskainen, R, Meyer, W R, O'Connor, H, Pinion, S, Sambrook, A M, Tam, W H, van Zon-Rabelink, I A A, Zupi, E
• Format: Article
• Language: English
• Subjects: Contraceptive Agents, Female - adverse effects; Contraceptive Agents, Female - economics; Contraceptive Agents, Female - therapeutic use; Cost-Benefit Analysis; endometrial ablation; Endometrial Ablation Techniques - adverse effects; Endometrial Ablation Techniques - economics; Endometrial Ablation Techniques - methods; Female; Humans; hysterectomy; Hysterectomy - adverse effects; Hysterectomy - economics; Hysterectomy - methods; Levonorgestrel - adverse effects; Levonorgestrel - economics; Levonorgestrel - therapeutic use; Menorrhagia - drug therapy; Menorrhagia - economics; Menorrhagia - surgery; menstrual bleeding; mirena; Patient Satisfaction; Postoperative Complications - epidemiology; Quality-Adjusted Life Years; systematic review; Time; Treatment Outcome
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta15190

The aim of this project was to determine the clinical effectiveness and cost-effectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and Mirena® (Bayer Healthcare Pharmaceuticals, Pittsburgh, PA, USA) for the treatment of heavy menstrual bleeding. Individual patient data (IPD) meta-analysis of existing randomised controlled trials to determine the short- to medium-term effects of hysterectomy, EA and Mirena. A population-based retrospective cohort study based on record linkage to investigate the long-term effects of ablative techniques and hysterectomy in terms of failure rates and complications. Cost-effectiveness analysis of hysterectomy versus first- and second-generation ablative techniques and Mirena. Data from women treated for heavy menstrual bleeding were obtained from national and international trials. Scottish national data were obtained from the Scottish Information Services Division. Women who were undergoing treatment for heavy menstrual bleeding were included. Hysterectomy, first- and second-generation EA, and Mirena. Satisfaction, recurrence of symptoms, further surgery and costs. Data from randomised trials indicated that at 12 months more women were dissatisfied with first-generation EA than hysterectomy [odds ratio (OR): 2.46, 95% confidence interval (CI) 1.54 to 3.93; p = 0.0002), but hospital stay [WMD (weighted mean difference) 3.0 days, 95% CI 2.9 to 3.1 days; p < 0.00001] and time to resumption of normal activities (WMD 5.2 days, 95% CI 4.7 to 5.7 days; p < 0.00001) were longer for hysterectomy. Unsatisfactory outcomes associated with first- and second-generation techniques were comparable [12.2% (123/1006) vs 10.6% (110/1034); OR 1.20, 95% CI 0.88 to 1.62; p = 0.2). Rates of dissatisfaction with Mirena and second-generation EA were similar [18.1% (17/94) vs 22.5% (23/102); OR 0.76, 95% CI 0.38 to 1.53; p = 0.4]. Indirect estimates suggested that hysterectomy was also preferable to second-generation EA (OR 2.32, 95% CI 1.27 to 4.24; p = 0.006) in terms of patient dissatisfaction. The evidence to suggest that hysterectomy is preferable to Mirena was weaker (OR 2.22, 95% CI 0.94 to 5.29; p = 0.07). In women treated by EA or hysterectomy and followed up for a median [interquartile range (IQR)] duration of 6.2 (2.7-10.8) and 11.6 (7.9-14.8) years, respectively, 962/11,299 (8.5%) women originally treated by EA underwent further gynaecological surgery. While the risk of adnexal surgery was similar in both gro