Document Detail


Levonorgestrel intrauterine system versus medical therapy for menorrhagia.
MedLine Citation:
PMID:  23301731     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Menorrhagia is a common problem, yet evidence to inform decisions about therapy is limited. In a pragmatic, multicenter, randomized trial, we compared the levonorgestrel-releasing intrauterine system (levonorgestrel-IUS) with usual medical treatment in women with menorrhagia who presented to their primary care providers.
METHODS: We randomly assigned 571 women with menorrhagia to treatment with levonorgestrel-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined estrogen-progestogen, or progesterone alone). The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) (ranging from 0 to 100, with lower scores indicating greater severity), assessed over a 2-year period. Secondary outcomes included general quality-of-life and sexual-activity scores and surgical intervention.
RESULTS: MMAS scores improved from baseline to 6 months in both the levonorgestrel-IUS group and the usual-treatment group (mean increase, 32.7 and 21.4 points, respectively; P<0.001 for both comparisons). The improvements were maintained over a 2-year period but were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group (mean between-group difference, 13.4 points; 95% confidence interval, 9.9 to 16.9; P<0.001). Improvements in all MMAS domains (practical difficulties, social life, family life, work and daily routine, psychological well-being, and physical health) were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group, and this was also true for seven of the eight quality-of-life domains. At 2 years, more of the women were still using the levonorgestrel-IUS than were undergoing the usual medical treatment (64% vs. 38%, P<0.001). There were no significant between-group differences in the rates of surgical intervention or sexual-activity scores. There were no significant differences in serious adverse events between groups.
CONCLUSIONS: In women with menorrhagia who presented to primary care providers, the levonorgestrel-IUS was more effective than usual medical treatment in reducing the effect of heavy menstrual bleeding on quality of life. (Funded by the National Institute of Health Research Health Technology Assessment Programme; ECLIPSE Controlled-Trials.com number, ISRCTN86566246.).
Authors:
Janesh Gupta; Joe Kai; Lee Middleton; Helen Pattison; Richard Gray; Jane Daniels;
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  368     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-10     Completed Date:  2013-01-17     Revised Date:  2014-03-14    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  128-37     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN86566246
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MeSH Terms
Descriptor/Qualifier:
Adult
Antifibrinolytic Agents / adverse effects,  therapeutic use
Contraceptive Agents, Female / administration & dosage,  adverse effects,  therapeutic use*
Estrogens / adverse effects,  therapeutic use
Female
Follow-Up Studies
Humans
Intrauterine Devices, Medicated*
Levonorgestrel / administration & dosage,  adverse effects,  therapeutic use*
Mefenamic Acid / adverse effects,  therapeutic use
Menorrhagia / drug therapy*,  surgery
Middle Aged
Progestins / adverse effects,  therapeutic use
Quality of Life*
Severity of Illness Index
Sexual Behavior
Tranexamic Acid / adverse effects,  therapeutic use
Grant Support
ID/Acronym/Agency:
02/06/02//Department of Health
Chemical
Reg. No./Substance:
0/Antifibrinolytic Agents; 0/Contraceptive Agents, Female; 0/Estrogens; 0/Progestins; 367589PJ2C/Mefenamic Acid; 5W7SIA7YZW/Levonorgestrel; 6T84R30KC1/Tranexamic Acid
Investigator
Investigator/Affiliation:
Joe Kai / ; Janesh Gupta / ; Jane Daniels / ; Lee Middleton / ; Richard Gray / ; Helen Pattison / ; J Gupta / ; Joe Kai / ; Jane Daniels / ; Lee Middleton / ; Richard Gray / ; Helen Pattison / ; Laura Gennard / ; Lisa Leighton / ; Enid Darby / ; Laura Gross / ; Robert Hills / ; Hemi Soneja / ; Sheetal Madari / ; Susan Snoxall / ; Lucy Ingram / ; Jackie Ingram / ; Pamela Whatmough / ; Gail Prileszky / ; Catherine Warlow / ; Oonagh Pickering / ; Susan Sargent / ; Stirling Bryan / ; Tracey Roberts / ; Sabina Sanghera / ; Yemisi Takwoingi / ; Nicholas Hilken / ; Jim Thornton / ; Irwin Nazareth / ; Klim McPherson / ; Elaine Nicholls / ; Bill Mackenzie / ; Andrew Prentice / ; Jayne Fountain / ; Mary Ann Lumsden / ; Amanda Farrin / ; Nick Freemantle / ; R P Kulshrestha / ; S Kulshrestha / ; K O'Brien / ; W Coulson / ; J Craig / ; L Descals / ; A Kownacki / ; E Montague / ; B McKenzie / ; C A Spooner / ; N Sanganee / ; I P Collier / ; S J Cope / ; A Goodwin / ; L J Sheldrake / ; C Hanly / ; R Rajesh / ; S Hutchon / ; T Bingham / ; J K Gupta / ; J Ingram / ; L Ingram / ; H Soneja / ; S Madari / ; R Pettinger / ; C Sadler / ; M Brown / ; J Chaffey / ; V Cowan / ; L Brain / ; H S Pabla / ; H Godridge / ; M E Horner / ; P D Horton / ; M F McGhee / ; M McGrath / ; K R Sumner / ; G J Ward-Campbell / ; S Williams / ; P Madhavan / ; L Brewin / ; A Glenchcliffe / ; D J Young / ; K Heslington / ; D Hunt / ; N Saikia-Varman / ; M Jones / ; L Kavi / ; L Kidd / ; J Kai / ; N Zaman / ; A Piracha / ; K Ladha / ; M Morris / ; K O'Neill / ; J N Patel / ; J E Waddell / ; P G Beighton / ; F H Cole / ; R M Edwards / ; A Thompson / ; J Ayres / ; J Davies / ; T L Poltock / ; M Smith / ; H Talbot / ; A J Cuthbert / ; S Horwell / ; C Jenkins / ; G Sinha / ; Kim Weaver / ; B Goodwin / ; R P Patel / ; S E Debenham / ; A D Cartmill / ; S Parker / ; E Pennington / ; S J Pennington / ; G B Young / ; S Butler / ; P A Hamilton / ; L Warhad / ; J Elliott / ; E Lawrence / ; J North / ; C I Elliott / ; S Jerome / ; P A Shipman / ; R Bagchi / ; N Sheerin / ; C Blackwall / ; V Divers / ; J Siddall / ; H J Parle / ; S Read / ; S K Patodi / ; S Amis / ; S Moloney / ; H H Leung / ; H U Obi / ; M Sidhu / ; N Ahmed / ; S R Carter / ; W Davies / ; H Harvey / ; K Khanna / ; P F Rice / ; L Shapiro / ; J Stone / ; T Parkin / ; J M Craig / ; P J Moss / ; V Steele / ; J E Cartwright / ; M G Edward / ; C Harrison / ; R Francis / ; P Hassall / ; C E Lloyd / ; J Haynes / ; S Budh-Raja / ; V P Budh-Raja / ; S P Patel / ; J H Redferne / ; S Deb / ; A Lancaster / ; M C Powell / ; J Wragg / ; D C O'Brien / ; S Milner / ; D W Taylor / ; D Davies / ; A K Tangri / ; C Tangri / ; S Amer / ; G Prileszky / ; C Warlow / ; P Whatmough / ; C H Duncan / ; W Bower / ; S Irani / ; S Rajput / ; V K Rajput / ; K Young / ; R E Cooper / ; K Chin / ; D Scott / ; J Stacey / ; C Dadd / ; K G Joshi / ; K Sundar / ; C R M Broomhead / ; M P Clarke / ; E Sangha / ; Janet Wood / ; B Fitzgerald-Jones / ; G R Harley-Mason / ; A D Coward / ; C M Coward / ; J Pash / ; H M Little / ; A G Macdonald / ; J P Williams / ; J Marshall / ; H McBride / ; K A Watson / ; S N Clay / ; S A Walker / ; J Billington / ; H Griffiths / ; R Mehta / ; C J Emslie / ; S S Bath / ; W Chiam / ; K R Gordon / ; M Latthe / ; D K Nandi / ; V A Lilford / ; G Smith / ; E Godfrey / ; S Griffiths / ; C Porter / ; M S Baird / ; C Crombie / ; D O'Donnell / ; V Horton / ; R E Kelsey / ; J D Fletcher / ; F Hall / ; C Lenton / ; M P Allen / ; J Heanue / ; J H McDonnell / ; J Hancock / ; B L Pattni / ; S T Banerjee / ; S Pate /
Comments/Corrections
Comment In:
Evid Based Med. 2013 Dec;18(6):e57   [PMID:  23635841 ]
N Engl J Med. 2013 Jan 10;368(2):184-5   [PMID:  23301736 ]

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