The effectiveness of the mirena coil (levonorgestrel-releasing intrauterine system) in menorrhagia
Stewart A, Cummins C, Gold L, Jordan R, Phillips W
Record ID 32001000996
Menorrhagia (heavy blood loss during menstruation) constitutes a considerable problem for many women, resulting in much discomfort, anxiety and disruption in the lives of sufferers. Where no organic pathology is present, the term dysfunctional uterine bleeding is used.The number and cost of consultations and treatments produce a substantial burden to the NHS.
Surgical procedures such as hysterectomy and endometrial resection are often used to treat menorrhagia, but these can be costly, traumatic, risky and sometimes unnecessary.
Menorrhagia can also be treated with drugs, although the effectiveness of some drug therapies is uncertain. The drugs used have a range of undesirable side effects, and may
need to be used for long periods. Norethisterone, a drug commonly used to treat menorrhagia, has been shown to be ineffective for treating this condition.
The levonorgestrel-releasing intrauterine system (LNG-IUS, trade name MIRENA) was developed primarily as a contraceptive device, and is licensed only for this purpose at present.
Its use has been associated with a reduction in menstrual blood loss which might eventually exceed 90%, as well as having other benefits and comparatively few side effects. The device is licensed for five years effective contraceptive use in the UK.
This review assesses the effectiveness of the LNG-IUS for menorrhagia, by evaluating studies where subjects have confirmed menorrhagia.
The included studies (both RCTs and case series) show that use of the LNG-IUS can significantly reduce menstrual blood loss in women with confirmed menorrhagia. Althoughvariations within and between the studies meant that percentage MBL reductions could not be combined in meta-analysis, each reported a statistically significant difference between baseline and final MBL with the LNG-IUS, ranging from 74% to 97% overall.The LNG-IUS has proved more effective at reducing MBL than either tranexamic acid (considered the most effective drug therapy) (p<0.01) or flurbiprofen (p<0.001) in the studiesincluded in this review. High dose norethisterone is shown to have a similar effect to LNGIUS (difference not significant – p=0.56). While patient satisfaction and quality of life were greater with the LNG-IUS when compared to drug treatments, its efficacy was slightly inferior to endometrial resection in two studies (statistically significantly so in one study).Two studies showed that a large proportion of patients on the waiting list for surgery for menorrhagia cancelled their operations after receiving the LNG-IUS. This has implicationsfor hospital waiting lists for hysterectomy and endometrial resection.In the primary care setting, the LNG-IUS is also cheaper per cycle than several medical alternatives, making it a treatment that should be considered for suitable women. Its use may be especially cost-effective in primary care, although not all GPs provide contraceptive services, and those who do may need some additional training in insertion technique.To allow more reliable conclusions to be drawn, further research comparing the LNG-IUS to other treatments for menorrhagia is indicated. This should ideally include larger numbers of randomly selected patients, involve several centres and patient follow-up for at least 2 years, and use generic outcome measures such as SF36, SF12 or EQ-5D, so that existing outcome data can be compared to data on surgery. The manufacturers of the LNG-IUS have confirmed that further trials are underway, in preparation for their UK license application for its use in the treatment of menorrhagia and hormone replacement therapy. No results are expected in the near future, however. One of the trials reported here 132 will provide follow-up data to three years on the relative effectiveness of LNG-IUS and endometrial resection in the near future.
English language abstract:
An English language summary is available
- Intrauterine Devices
West Midlands Health Technology Assessment Collaboration
Elaena Donald-Lopez, West Midlands Health Technology Assessment Collaboration, Department of Public Health and Epidemiology, University of Birmingham, Edgbaston, Birmingham B15 2TT Tel: +44 121 414 7450; Fax: +44 121 414 7878
University of Birmingham