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Q In women with heavy menstrual bleeding, what are the relative efficacy, safety, and acceptability of surgical and medical treatments?
Clinical impact ratings GP/FP/Primary care ★★★★★★☆ Gynaecology ★★★★★★☆ Endocrine ★★★★★★☆
Cochrane Central Register of Controlled Trials (issue 3, 2005), Cochrane Menstrual Disorders and Subfertility Group trial register, Medline, CINAHL, EMBASE/Excerpta Medica, Current Contents, Biological Abstracts, PsycINFO (September 2005), relevant journals, conference abstracts, reference lists, pharmaceutical companies, and experts.
Study selection and assessment:
randomised controlled trials (RCTs) that compared surgical treatment (hysterectomy, resection, or ablation) with medical treatment (oral drugs or the levonorgestrel intrauterine system [LNG-IUS]) for heavy menstrual bleeding in women of reproductive age (mean age 41–44 y). 8 RCTs (n = 821) met the selection criteria. Excluded were studies involving postmenopausal or intermenstrual bleeding; irregular menses; or pathological or iatrogenic causes of bleeding. 2 reviewers independently assessed included trials for methodological quality.
control of menstrual bleeding (amenorrhoea or improvement to an acceptable level), satisfaction with treatment, need for additional treatment, and improvement in quality of life.
Surgical treatment resulted in better control of bleeding and less need for further surgical treatment than medical treatment (table). Satisfaction with treatment was greater with surgery than with oral medications, but did not differ between surgery and LNG-IUS (table). Quality of life improved after all types of treatment. At 4–6 months, the extent of improvement was greater with surgery than with oral medications, but by 2 years (when >50% of women in the medical group had undergone surgery), there were few differences between groups. The surgery and LNG-IUS groups did not differ for most quality of life measures for up to 5 years. Adverse effects were less likely with surgical treatment.
Surgery is more effective than oral or intrauterine medical treatment in reducing heavy menstrual bleeding. The levonorgestrel intrauterine system provides patient satisfaction and improvement to quality of life similar to that of surgery.
The overuse of surgical treatment for idiopathic menorrhagia has been a cause of concern because of possible adverse clinical and economic consequences. Surgical interventions are frequently used, mainly as second line treatments when medical treatment fails. LNG-IUS, unlike oral drugs, can be considered as an alternative to ablation or hysterectomy. The review by Marjoribanks et al provides evidence of the value of surgery compared with these 2 types of medical intervention.
The interpretation of the evidence, however, does not seem straight forward. What is the logic in aggregating the data for heterogeneous surgical treatments? Second generation ablation techniques have recently been recommended in preference to hysterectomy, as they are less costly and result in only marginally fewer quality adjusted life years.1 Why present different types of adverse events as a composite outcome? Such measures may invalidate inferences about effectiveness, particularly when insufficient power exists to discern an effect for individual events.2 Moreover, for a meaningful comparison, outcome measures have to be applicable to all trial arms.
The aim of management of a chronic and disabling benign condition such as menorrhagia is to improve the sufferers’ quality of life. Well developed generic and disease specific life quality measures are required to assess this outcome and to focus on aspects of health unique to menorrhagia.
Although clinically sound conclusions are limited in light of these methodological concerns, it is safe to infer from the review by Marjoribanks et al that LNG-IUS is an effective therapy to attempt before embarking on surgical treatment for menorrhagia. Whether it should be considered the first line of treatment over oral medication is currently being addressed by the ECLIPSE trial (www.eclipse.bham.ac.uk).
For correspondence: MsJ Marjoribanks, University of Auckland, Auckland, New Zealand.
Source of funding: no external funding.
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