Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding

Autor: Jan Willem van der Steeg, Diana S. Massop-Helmink, Lucet F. van der Voet, Patrick M. M. Bossuyt, Heleen P. Eising, Pleun Beelen, Theodoor E. Nieboer, Janny H. Dekker, Sjors F.P.J. Coppus, Ruben G. Duijnhoven, Marlies Y. Bongers, Ellen R. Klinkert, Marjolein Y. Berger, Marian J van den Brink, Anne Timmermans, Joke M. Schutte, Nienke Mak, Nicol A. C. Smeets, Peggy M.A.J. Geomini, Sebastiaan Veersema, Malou C. Herman, Marchien van Baal, Ben W.J. Mol, Hannah S. van Meurs
Přispěvatelé: Obstetrics and Gynaecology, APH - Amsterdam Public Health, Epidemiology and Data Science, APH - Methodology, APH - Personalized Medicine, APH - Aging & Later Life, RS: GROW - R4 - Reproductive and Perinatal Medicine, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Life Course Epidemiology (LCE), Damage and Repair in Cancer Development and Cancer Treatment (DARE)
Jazyk: angličtina
Rok vydání: 2021
Předmět:
medicine.medical_treatment
0302 clinical medicine
Obstetrics and gynaecology
Quality of life
Levonorgestrel
030212 general & internal medicine
IUS
SCALE
Netherlands
030219 obstetrics & reproductive medicine
Obstetrics
Intrauterine Devices
Medicated
Obstetrics and Gynecology
WOMEN
General Medicine
Middle Aged
intrauterine device
Treatment Outcome
Contraceptive Agents
Hormonal
Patient Satisfaction
Retreatment
Endometrial ablation
THERMAL BALLOON ABLATION
Female
TRIAL
5-YEAR FOLLOW-UP
Sexual Health
medicine.drug
Adult
medicine.medical_specialty
RESECTION
Intrauterine device
Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18]
03 medical and health sciences
All institutes and research themes of the Radboud University Medical Center
Patient satisfaction
Mirena
menorrhagia
medicine
Humans
Endometrial Ablation Techniques
Pregnancy
business.industry
excessive uterine bleeding
medicine.disease
NovaSure
Menstrual bleeding
Increased risk
Quality of Life
business
Sexual function
Zdroj: American journal of obstetrics and gynecology, 224(2), 187.e1-187.e10. Mosby Inc.
American Journal of Obstetrics and Gynecology, 224
American Journal of Obstetrics and Gynecology, 224(2), 187.e1-187.e10. MOSBY-ELSEVIER
American Journal of Obstetrics and Gynecology, 224(2). MOSBY-ELSEVIER
American Journal of Obstetrics and Gynecology, 224, 2
ISSN: 0002-9378
Popis: Heavy menstrual bleeding (HMB) can negatively influence physical activity, work productivity, and sexual life and therefore has a major impact on women's quality of life (QoL). The National Institute for Health and Care Excellence guidelines recommend the levonorgestrel-releasing intrauterine system (LNG-IUS) as the treatment of first choice for HMB. Surgical treatments for treating HMB in women without future pregnancy wish include endometrial ablation (EA) and hysterectomy. Because of potentially biased studies and conflicting results on bleeding scores, satisfaction, and reintervention rate, there is no consensus on the efficacy of LNG-IUS versus EA. This multicenter, randomized controlled, noninferiority trial aimed to compare the effectiveness of the LNG-IUS system with EA in women with HMB. This study was performed between 2012 and 2016 in 26 hospitals in the Netherlands. Women were considered eligible if they had a diagnosed HMB with a Pictorial Blood Loss Assessment Chart (PBAC) score exceeding 150 points, were older than 34 years, had no pregnancy wish, and had no abnormal cervix cytology in the past 5 years. Participants were randomized in a 1:1 ratio to either the LNG-IUS or EA cohort. The LNG-IUS cohort had implantation of the device containing a total of 52 mg of levonorgestrel, releasing 20 μg/d. The EA intervention was performed with a bipolar radiofrequency device either in the office under local anesthetics or in the operating room under general or spinal anesthesia. The primary study outcome was menstrual blood loss at 24 months after randomization in PBAC, measured by participants through standardized questionnaires. Participants completed questionnaires before treatment and at 3, 6, 12, and 24 months after randomization. The primary analysis was an intention-to-treat analysis with a hypothesis that LNG-IUS would be noninferior to EA. Noninferiority of the LNG-IUS protocol would be established if the upper limit of the 95% confidence interval (CI) for the difference in PBAC score did not exceed the predetermined noninferiority margin of 25 points with P < 0.05. A total of 270 participants were randomized to initial treatment with LNG-IUS (n = 132) or treatment with EA (n = 138) between April 2012 and January 2016. A total of 247 participants (91%) reported PBAC scores at 24 months. The mean PBAC score was 64.8 in the LNG-IUS group compared with 14.2 in the EA group (mean difference, 50.5; 95% CI, 4.3-96.7). Noninferiority of LNG-IUS could not be demonstrated (noninferiority, P = 0.87). At 3 months of follow-up, 60% of women in the LNG-IUS group had reached a PBAC score of less than 75 points compared with 83% of women in the EA group (relative risk, 0.72; 95% CI, 0.59-0.87). The LNG-IUS was removed in 49 women (39%), and those in the LNG-IUS cohort were more likely to receive a surgical or drug reintervention within 24 months compared with women in the EA group (35% vs 20%; relative risk, 1.77; 95% CI, 1.17-2.68). There was no statistically significant difference in participant satisfaction and QoL between the cohorts. This study found that both the LNG-IUS and EA protocols for HMB led to a large decrease in menstrual blood loss, with LNG-IUS resulting in an increased risk of needing additional treatment and EA achieving a greater decrease in blood loss, with comparable QoL and satisfaction scores. Noninferiority of LNG-IUS compared with EA could not be demonstrated.
Databáze: OpenAIRE
Externí odkaz: