OBJECTIVE: To compare the levonorgestrel intrauterine system (LNG-IUS) with hysterectomy in patients with adenomyosis and to study the effects of both treatments on quality of life (QOL). DESIGN: Prospective randomized clinical trial. SETTING:Women's health teaching and research hospital. PATIENT(S): Eighty-six patients (43 patients for each group) were enrolled, but only 75 women continued the study. INTERVENTION(S): Women interpreted as having adenomyosis on transvaginal ultrasound and magnetic resonance imaging were assigned to receive either LNG-IUS or hysterectomy. MAIN OUTCOME MEASURE(S): Clinical measures of menstrual bleeding as number of used pads/day during menstruation, hemoglobin levels, and health-related QOL variables were assessed. Each woman was followed up for 1 year after treatment. RESULT(S): LNG-IUS increased the hemoglobin levels at the sixth month and first year of the treatment to the comparable levels with hysterectomy. When pretreatment and post-treatment QOL scores of groups were compared, three of the five mean domain scores (physical, environmental, environmental-TR) were increased in patients treated with hysterectomy, while in patients managed with LNG-IUS, all five mean domain scores were increased. CONCLUSION(S): It seems that LNG-IUS demonstrates significant and comparable improvements in hemoglobin levels to hysterectomy in treating adenomyosis-associated menorrhagia during the first year. Although both treatments lead to improvements in health-related QOL, LNG-IUS seems to have superior effects on psychological and social life. It may be a promising alternative therapy to hysterectomy.
RCT Entities:
OBJECTIVE: To compare the levonorgestrel intrauterine system (LNG-IUS) with hysterectomy in patients with adenomyosis and to study the effects of both treatments on quality of life (QOL). DESIGN: Prospective randomized clinical trial. SETTING:Women's health teaching and research hospital. PATIENT(S): Eighty-six patients (43 patients for each group) were enrolled, but only 75 women continued the study. INTERVENTION(S): Women interpreted as having adenomyosis on transvaginal ultrasound and magnetic resonance imaging were assigned to receive either LNG-IUS or hysterectomy. MAIN OUTCOME MEASURE(S): Clinical measures of menstrual bleeding as number of used pads/day during menstruation, hemoglobin levels, and health-related QOL variables were assessed. Each woman was followed up for 1 year after treatment. RESULT(S): LNG-IUS increased the hemoglobin levels at the sixth month and first year of the treatment to the comparable levels with hysterectomy. When pretreatment and post-treatment QOL scores of groups were compared, three of the five mean domain scores (physical, environmental, environmental-TR) were increased in patients treated with hysterectomy, while in patients managed with LNG-IUS, all five mean domain scores were increased. CONCLUSION(S): It seems that LNG-IUS demonstrates significant and comparable improvements in hemoglobin levels to hysterectomy in treating adenomyosis-associated menorrhagia during the first year. Although both treatments lead to improvements in health-related QOL, LNG-IUS seems to have superior effects on psychological and social life. It may be a promising alternative therapy to hysterectomy.
Authors: Magdalena Bofill Rodriguez; Sofia Dias; Vanessa Jordan; Anne Lethaby; Sarah F Lensen; Michelle R Wise; Jack Wilkinson; Julie Brown; Cindy Farquhar Journal: Cochrane Database Syst Rev Date: 2022-05-31
Authors: K J Neis; W Zubke; T Römer; K Schwerdtfeger; T Schollmeyer; S Rimbach; B Holthaus; E Solomayer; B Bojahr; F Neis; C Reisenauer; B Gabriel; H Dieterich; I B Runnenbaum; W Kleine; A Strauss; M Menton; I Mylonas; M David; L-C Horn; D Schmidt; P Gaß; A T Teichmann; P Brandner; W Stummvoll; A Kuhn; M Müller; M Fehr; K Tamussino Journal: Geburtshilfe Frauenheilkd Date: 2016-04 Impact factor: 2.915
Authors: Klaus J Neis; Wolfgang Zubke; Mathias Fehr; Thomas Römer; Karl Tamussino; Monika Nothacker Journal: Dtsch Arztebl Int Date: 2016-04-08 Impact factor: 5.594