O Istre1, B Trolle. 1. Department of Obstetrics and Gynecology, Central Hospital of Hedmark County, Hamar, Norway. oistre@c2i.net
Abstract
OBJECTIVE: Treatment of menorrhagia with levonorgestrel intrauterine system (LNG IUS) and transcervical resection. DESIGN: An open, therapeutic, randomized study. SETTING:Central county hospital specializing in hysteroscopy. PATIENT(S): Two parallel groups of 30 subjects each. INTERVENTION(S): Thirty patients had a LNG IUS inserted within the first 7 days of menses; 29 patients underwentendometrial resection. MAIN OUTCOME MEASURE(S): A 12-month follow-up of menstrual blood loss and adverse events were evaluated. RESULT(S): LNG IUS group: 13 patients reported one or more pelvic adverse events, bleeding disorders (n = 6), abdominal pain (n = 4), breast tenderness (n = 3), headache, acne (n = 2), and mood changes (n = 1). Six patients discontinued treatment because of irregular bleeding (n = 3), pain (n = 2), and acne (n = 1). In both groups, general feeling of genital health increased with Visual Analogue Scale score. Nine patients reported adverse events. This included pelvic pain indicating inflammation (n = 4), bleeding (n = 3), vaginitis (n = 1), and ulceration (n = 1). Treatment success at 12 months was achieved in 20 (67%) of the 30 patients in the LNG IUS group and in 26 (90%) of the 29 patients in the transcervical resection group. Adverse events were more often reported in the LNG IUS group. CONCLUSION(S): Both treatments effectively reduced the menstrual blood loss. Furthermore, the LNG IUS treatment is reversible and has no operative hazards.
RCT Entities:
OBJECTIVE: Treatment of menorrhagia with levonorgestrel intrauterine system (LNG IUS) and transcervical resection. DESIGN: An open, therapeutic, randomized study. SETTING: Central county hospital specializing in hysteroscopy. PATIENT(S): Two parallel groups of 30 subjects each. INTERVENTION(S): Thirty patients had a LNG IUS inserted within the first 7 days of menses; 29 patients underwent endometrial resection. MAIN OUTCOME MEASURE(S): A 12-month follow-up of menstrual blood loss and adverse events were evaluated. RESULT(S): LNG IUS group: 13 patients reported one or more pelvic adverse events, bleeding disorders (n = 6), abdominal pain (n = 4), breast tenderness (n = 3), headache, acne (n = 2), and mood changes (n = 1). Six patients discontinued treatment because of irregular bleeding (n = 3), pain (n = 2), and acne (n = 1). In both groups, general feeling of genital health increased with Visual Analogue Scale score. Nine patients reported adverse events. This included pelvic pain indicating inflammation (n = 4), bleeding (n = 3), vaginitis (n = 1), and ulceration (n = 1). Treatment success at 12 months was achieved in 20 (67%) of the 30 patients in the LNG IUS group and in 26 (90%) of the 29 patients in the transcervical resection group. Adverse events were more often reported in the LNG IUS group. CONCLUSION(S): Both treatments effectively reduced the menstrual blood loss. Furthermore, the LNG IUS treatment is reversible and has no operative hazards.