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Br J Gen Pract. 2016 Dec;66(653):e861-e870. Epub 2016 Oct 10.

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

Author information

  • 1Faculty of Medicine & Health Sciences, School of Medicine, University of Nottingham, Nottingham.
  • 2Birmingham Clinical Trials Unit, University of Birmingham, Birmingham.
  • 3School of Life and Health Sciences, Aston University, Birmingham.

Abstract

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.

KEYWORDS:

general practice; levonorgestrel intrauterine system; medical treatment; menorrhagia; menstrual; primary health care

PMID:
27884916
PMCID:
PMC5198650
DOI:
10.3399/bjgp16X687577
[PubMed - in process]
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