Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care
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...
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| Format: | Article |
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Royal College of General Practitioners
2016
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| Online Access: | https://eprints.nottingham.ac.uk/35818/ |
| _version_ | 1848795167955353600 |
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| author | Kai, Joe Middleton, Lee Daniels, Jane Pattison, Helen Tryposkiadis, Konstantinos Gupta, Janesh |
| author_facet | Kai, Joe Middleton, Lee Daniels, Jane Pattison, Helen Tryposkiadis, Konstantinos Gupta, Janesh |
| author_sort | Kai, Joe |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T19:27:47Z |
| format | Article |
| id | nottingham-35818 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:27:47Z |
| publishDate | 2016 |
| publisher | Royal College of General Practitioners |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-358182024-08-15T15:20:39Z https://eprints.nottingham.ac.uk/35818/ Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care Kai, Joe Middleton, Lee Daniels, Jane Pattison, Helen Tryposkiadis, Konstantinos Gupta, Janesh 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. Royal College of General Practitioners 2016-10-10 Article PeerReviewed Kai, Joe, Middleton, Lee, Daniels, Jane, Pattison, Helen, 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 General practice; Levonorgestrel Intrauterine system; Medical treatment; Menorrhagia; Menstrual; Primary health care http://bjgp.org/content/early/2016/10/10/bjgp16X687577 doi:10.3399/bjgp16X687577 doi:10.3399/bjgp16X687577 |
| spellingShingle | General practice; Levonorgestrel Intrauterine system; Medical treatment; Menorrhagia; Menstrual; Primary health care Kai, Joe Middleton, Lee Daniels, Jane Pattison, Helen Tryposkiadis, Konstantinos Gupta, Janesh Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care |
| title | Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care |
| title_full | Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care |
| title_fullStr | Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care |
| title_full_unstemmed | Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care |
| title_short | Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care |
| title_sort | usual medical treatments or levonorgestrel-ius for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care |
| topic | General practice; Levonorgestrel Intrauterine system; Medical treatment; Menorrhagia; Menstrual; Primary health care |
| url | https://eprints.nottingham.ac.uk/35818/ https://eprints.nottingham.ac.uk/35818/ https://eprints.nottingham.ac.uk/35818/ |