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Kai, Joe and Middleton, Lee and Daniels, Jane and Pattison, Helen and Tryposkiadis, Konstantinos and Gupta, Janesh (2016) Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care. British Journal of General Practice, 66 (653). e861-e870. ISSN 1478-5242

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Abstract

Background: Heavy menstrual bleeding (HMB) is a common, chronic problem burdening women and health services. However long-term evidence on treatment in primary care is lacking.

Aim: To assess the effectiveness of commencing levonorgestrel intra-uterine system (LNG-IUS) or usual medical treatments for women presenting with HMB in general practice.

Design: Pragmatic, multicentre, parallel, open-label randomised controlled trial

Setting: 63 primary care practices

Methods: 571 women, aged 25-50, 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, work and family life; scores from 0 -100). Secondary outcomes included surgical intervention (endometrial ablation/hysterectomy), general quality-of-life, sexual-activity and safety.

Results: At five 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% CI: -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%; HR: 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 heavy menstrual bleeding can be successfully initiated in primary care with long-term benefit for women, and with only modest need for surgery.

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