Quality of life and costs of levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of menorrhagia: a 10-year randomized controlled trial.

OBJECTIVE Menorrhagia is a common problem impairing the quality of life (QOL) of many women. Both levonorgestrel-releasing intrauterine system (LNG-IUS) and hysterectomy are effective treatment modalities but no long-term comparative studies of QOL and costs exist. The objective of this study was to compare QOL and costs of LNG-IUS or hysterectomy in the treatment of menorrhagia during 10-year follow-up. STUDY DESIGN A total of 236 women, aged 35-49 years, referred for menorrhagia to 5 university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 10 years. The main outcome measures were health-related QOL (HRQOL), psychosocial well-being, and cost-effectiveness. RESULTS A total of 221 (94%) women were followed for 10 years. Although 55 (46%) women assigned to the LNG-IUS subsequently underwent hysterectomy, the overall costs in the LNG-IUS group ($3423) were substantially lower than in the hysterectomy group ($4937). Overall, levels of HRQOL and psychosocial well-being improved during first 5 years but diminished between 5 years and 10 years and the improved HRQOL returned close to the baseline level. There were no significant differences between LNG-IUS and hysterectomy groups. CONCLUSION Both LNG-IUS and hysterectomy improved HRQOL. The improvement was most striking during the first 5 years. Although many women eventually had hysterectomy, LNG-IUS remained cost-effective.

[1]  A. Coulter,et al.  Outcomes of referrals to gynaecology outpatient clinics for menstrual problems: an audit of general practice records , 1991, British journal of obstetrics and gynaecology.

[2]  A. S. Silva Filho,et al.  A randomized prospective trial comparing the levonorgestrel-releasing intrauterine system with thermal balloon ablation for the treatment of heavy menstrual bleeding. , 2010, Contraception.

[3]  L. Hallberg,et al.  Menstrual blood loss and iron deficiency. , 2009, Acta medica Scandinavica.

[4]  J. Guest,et al.  Cost-utility of levonorgestrel intrauterine system compared with hysterectomy and second generation endometrial ablative techniques in managing patients with menorrhagia in the UK , 2007, Current medical research and opinion.

[5]  K. Jordan,et al.  An epidemiological survey of symptoms of menstrual loss in the community. , 2004, The British journal of general practice : the journal of the Royal College of General Practitioners.

[6]  P. Jacobs,et al.  Work Loss Associated With Increased Menstrual Loss in the United States , 2002, Obstetrics and gynecology.

[7]  R Gray,et al.  Hysterectomy, endometrial destruction, and levonorgestrel releasing intrauterine system (Mirena) for heavy menstrual bleeding: systematic review and meta-analysis of data from individual patients , 2010, BMJ : British Medical Journal.

[8]  S. Grénman,et al.  Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: randomized trial 5-year follow-up. , 2004, JAMA.

[9]  T O Jefferson,et al.  Guidelines for authors and peer reviewers of economic submissions to the BMJ , 1996, BMJ.

[10]  E. Steinberg,et al.  Costs and charges associated with three alternative techniques of hysterectomy , 1996, The New England journal of medicine.

[11]  V. Sung,et al.  A systematic review comparing hysterectomy with less-invasive treatments for abnormal uterine bleeding. , 2012, Journal of minimally invasive gynecology.

[12]  J. Davidson,et al.  A longitudinal study of the effects of menopause on sexuality. , 1985, Maturitas.

[13]  K Rickels,et al.  Short form of depression inventory: cross-validation. , 1974, Psychological reports.

[14]  K. Dickersin,et al.  Hysterectomy, endometrial ablation and Mirena® for heavy menstrual bleeding: a systematic review of clinical effectiveness and cost-effectiveness analysis. , 2011, Health technology assessment.

[15]  C. Sherbourne,et al.  The RAND 36-Item Health Survey 1.0. , 1993, Health economics.

[16]  S. Grénman,et al.  The effect of hysterectomy or levonorgestrel-releasing intrauterine system on cardiovascular disease risk factors in menorrhagia patients: a 10-year follow-up of a randomised trial. , 2011, Maturitas.

[17]  S. Grénman,et al.  Quality of life and cost-effectiveness of levonorgestrel-releasing intrauterine system versus hysterectomy for treatment of menorrhagia: a randomised trial , 2001, The Lancet.

[18]  H. Fernandez,et al.  Economic evaluation of three surgical interventions for menorrhagia. , 2003, Human Reproduction.

[19]  J. You,et al.  A cost-utility analysis of hysterectomy, endometrial resection and ablation and medical therapy for menorrhagia. , 2006, Human reproduction.

[20]  T. Roberts,et al.  Hysterectomy, endometrial ablation, and levonorgestrel releasing intrauterine system (Mirena) for treatment of heavy menstrual bleeding: cost effectiveness analysis , 2011, BMJ : British Medical Journal.

[21]  A. Gafni,et al.  The 'NICE' Approach to Technology Assessment: An Economics Perspective , 2004, Health care management science.

[22]  A. Lethaby,et al.  Surgery versus medical therapy for heavy menstrual bleeding. , 2016, The Cochrane database of systematic reviews.

[23]  S. Grénman,et al.  Combined laboratory and diary method for objective assessment of menstrual blood loss , 1998, Acta obstetricia et gynecologica Scandinavica.

[24]  M A Koopmanschap,et al.  The impact of indirect costs on outcomes of health care programs. , 1994, Health economics.

[25]  S. Grénman,et al.  A randomized controlled trial of hysterectomy or levonorgestrel-releasing intrauterine system in the treatment of menorrhagia-effect on FSH levels and menopausal symptoms. , 2004, Human reproduction.

[26]  D. Sarlos,et al.  Robotic versus laparoscopic hysterectomy: a review of recent comparative studies , 2011, Current opinion in obstetrics & gynecology.

[27]  P. Yuen,et al.  Health Status Function after Treatment with Thermal Balloon Endometrial Ablation and Levonorgestrel Intrauterine System for Idiopathic Menorrhagia: A Randomized Study , 2006, Gynecologic and Obstetric Investigation.

[28]  S. Grénman,et al.  The effect of hysterectomy or levonorgestrel‐releasing intrauterine system on lower urinary tract symptoms: a 10‐year follow‐up study of a randomised trial , 2010, BJOG : an international journal of obstetrics and gynaecology.

[29]  A. Williams EuroQol : a new facility for the measurement of health-related quality of life , 1990 .

[30]  L. Mattsson,et al.  A Swedish version of the Women's Health Questionnaire , 1993, Acta obstetricia et gynecologica Scandinavica.

[31]  J. Trussell,et al.  Cost-effectiveness of treatments for dysfunctional uterine bleeding in women who need contraception. , 2006, Contraception.

[32]  L. Dennerstein,et al.  The Menopause and Sexual Functioning: A Review of the Population-Based Studies , 2003, Annual review of sex research.

[33]  A. Coulter,et al.  Quality of life and patient satisfaction following treatment for menorrhagia. , 1994, Family practice.

[34]  R. Hurskainen,et al.  Cost‐effectiveness and quality of life associated with heavy menstrual bleeding among women using the levonorgestrel‐releasing intrauterine system , 2011, International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics.