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Bhattacharya S, Middleton LJ, Tsourapas A, et al.; the International Heavy Menstrual Bleeding Individual Patient Data Meta-analysis Collaborative Group. Hysterectomy, Endometrial Ablation and Mirena® for Heavy Menstrual Bleeding: A Systematic Review of Clinical Effectiveness and Cost-Effectiveness Analysis. Southampton (UK): NIHR Journals Library; 2011 Apr. (Health Technology Assessment, No. 15.19.)

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Hysterectomy, Endometrial Ablation and Mirena® for Heavy Menstrual Bleeding: A Systematic Review of Clinical Effectiveness and Cost-Effectiveness Analysis.

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6Conclusion

This study has produced data on the clinical effectiveness and cost-effectiveness of different modalities of treatment of HMB and highlighted the risk of further surgery following EA and hysterectomy. It has also exposed gaps in the literature – especially with regards to the clinical effectiveness of Mirena in comparison with EA and hysterectomy and long-term follow-up data in women using it for HMB.

Despite a longer hospital stay and time to resumption of normal activities, more women were satisfied after hysterectomy than after first-generation EA. In the absence of head-to-head trials, indirect estimates suggest that hysterectomy is also preferable to second-generation EA in terms of patient satisfaction. Dissatisfaction rates were comparable between first- and second-generation techniques, although second-generation techniques were cheaper, quicker and associated with faster recovery and fewer complications. There are few comparisons of Mirena versus more invasive procedures. The few data available suggest that Mirena is potentially cheaper and more effective than first-generation ablation techniques with rates of satisfaction that are similar to first- and second-generation techniques. Owing to a paucity of trials, evidence to suggest that hysterectomy is preferable to Mirena is currently so limited that definitive conclusions cannot yet be made.

A quarter of women undergoing EA as an initial treatment are likely to face further gynaecological surgery (mainly repeat ablation or hysterectomy) for persistent menstrual problems. However, hysterectomy is more likely to lead to future surgery for stress urinary incontinence. Thus, in comparison with hysterectomy, the lower morbidity associated with EA needs to be balanced against the chance of repeat surgery for the same symptoms, although the risk of long-term pelvic floor problems may be less.

The cost-effectiveness analysis identified the strategy of opting for hysterectomy as the most cost-effective one. Hysterectomy is both cheaper as well as more effective than first-generation EA. In comparison with second-generation EA and Mirena, hysterectomy costs more but produces more QALYs. The ICER for hysterectomy is £1440 per additional QALY compared with Mirena and £970 per additional QALY compared with second-generation EA. These results suggest that hysterectomy would be considered the most cost-effective strategy in light of the acceptable thresholds used by NICE, which tends to accept new technologies if the ICER is within £20,000 per additional QALY.

Our review provides evidence that hysterectomy reduces dissatisfaction compared with EA and this information should be used as part of a consultation with women making a choice about treatment options when initial drug treatment fails to control HMB. EA is satisfactory for a very high proportion of women, but, if complete cessation of bleeding is sought, then hysterectomy may be offered. A decision to opt for hysterectomy needs also to take into account the invasive nature of the procedure and its potential for short- and long-term morbidity in some women. Relatively few trials have evaluated the evidence of effectiveness of Mirena. These are small, imprecise and have relatively high levels of compliance. Thus, we concur with a recent NICE recommendation that women should be offered Mirena before more invasive procedures. We have highlighted the benefits and risks associated with the three broad strategies for the treatment of HMB, and, while supportive of the existing NICE guideline on this subject, our results underline the need for a degree of flexibility in accommodating women's preferences. Hysterectomy may be the most cost-effective strategy, but, owing to its invasive nature and higher risk of complications, is considered a final option by gynaecological experts and consumers who are swayed by other considerations such as ease of access to treatment, degree of invasiveness, long-term consequences and patient autonomy.

© 2011, Crown Copyright.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK99732

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