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
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.
| Item Type: |
Article
|
| Keywords: |
General practice; Levonorgestrel Intrauterine system; Medical treatment; Menorrhagia; Menstrual; Primary health care |
| Schools/Departments: |
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Primary Care |
| Identification Number: |
10.3399/bjgp16X687577 |
| Depositing User: |
Eprints, Support
|
| Date Deposited: |
11 Aug 2016 13:21 |
| Last Modified: |
13 Oct 2017 20:34 |
| URI: |
http://eprints.nottingham.ac.uk/id/eprint/35818 |
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