Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care

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Kai, Joe ; Middleton, Lee ; Daniels, Jane ; Pattison, Helen ; Tryposkiadis, Konstantinos ; Gupta, Janesh (2016)
  • Publisher: Royal College of General Practitioners
  • Journal: The British Journal of General Practice, volume 66, issue 653, pages e861-e870 (issn: 0960-1643, eissn: 1478-5242)
  • Related identifiers: doi: 10.3399/bjgp16X687577, pmc: PMC5198650
  • Subject: levonorgestrel intrauterine system | medical treatment | menorrhagia | general practice | menstrual | primary health care | Research

Background: Heavy menstrual bleeding (HMB) is a common, chronic problem affecting women and health services. However, long-term evidence on treatment in primary care is lacking. Aim: To assess the effectiveness of commencing the levonorgestrel-releasing intrauterine system (LNG-IUS) or usual medical treatments for women presenting with HMB in general practice. Design and setting: A pragmatic, multicentre, parallel, open-label, long term, randomised controlled trial in 63 primary care practices across the English Midlands. Method: In total, 571 women aged 25–50 years, with HMB were randomised to LNG-IUS or usual medical treatment (tranexamic/mefenamic acid, combined oestrogen–progestogen, or progesterone alone). The primary outcome was the patient reported Menorrhagia Multi-Attribute Scale (MMAS, measuring effect of HMB on practical difficulties, social life, psychological and physical health, and work and family life; scores from 0 to 100). Secondary outcomes included surgical intervention (endometrial ablation/hysterectomy), general quality of life, sexual activity, and safety. Results: At 5 years post-randomisation, 424 (74%) women provided data. While the difference between LNG-IUS and usual treatment groups was not significant (3.9 points; 95% confidence interval = −0.6 to 8.3; P = 0.09), MMAS scores improved significantly in both groups from baseline (mean increase, 44.9 and 43.4 points, respectively; P<0.001 for both comparisons). Rates of surgical intervention were low in both groups (surgery-free survival was 80% and 77%; hazard ratio 0.90; 95% CI = 0.62 to 1.31; P = 0.6). There was no difference in generic quality of life, sexual activity scores, or serious adverse events. Conclusion: Large improvements in symptom relief across both groups show treatment for HMB can be successfully initiated with long-term benefit and with only modest need for surgery.
  • References (26)
    26 references, page 1 of 3

    Shapley M, Jordan K, Croft PR. An epidemiological survey of symptoms of menstrual loss in the community.Br J Gen Pract 2004; 54(502): 359-363.

    National Institute for Health and Care Excellence.Heavy menstrual bleeding: assessment and management. Clinical guideline [CG44]. 2007.https://www.

    nice.org.uk/guidance/cg44 (acessed 23 Sep 2016).

    McCormick A, Fleming D, Charlton J, Royal College of General Practitioners, Great Britain. Office of Population Censuses and Surveys.Morbidity statistics from general practice: fourth national study 1991-1992. 1995. http://www.

    worldcat.org/title/morbidity-statistics-from-general-practice-fourth-nationalstudy-1991-1992/oclc/32250603 (acessed 23 Sep 2016).

    Lethaby AE, Cooke I, Rees M. Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding.Cochrane Database Syst Rev 2005; 19(4): CD002126.

    Garside R, Britten N, Stein K. The experience of heavy menstrual bleeding: a systematic review and meta-ethnography of qualitative studies.J Adv Nurs 2008; 63(6): 550-562.

    Royal College of Obstetricians & Gynaecologists. National Heavy Menstrual Bleeding Audit. Final report July 2014.A national audit to assess patient outcomes and experiences of care for women with heavy menstrual bleeding in England and Wales. https://www.rcog.org.uk/globalassets/documents/ guidelines/research--audit/national_hmb_audit_final_report_july_2014.pdf (accessed 15 Sep 2016).

    Warner PE, Critchley HO, Lumsden MA,et al. Menorrhagia II: is the 80-mL blood loss criterion useful in management of complaint of menorrhagia?Am J Obstet Gynecol 2004; 190(5): 1224-1229.

    Warner PE, Critchley HO, Lumsden MA,et al. Menorrhagia: measured blood loss, clinical features, and outcome in women with heavy periods: a survey with follow-up data. Am J Obstet Gynecol 2004; 190(5): 1216-1223.

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