BACKGROUND: The optimal treatment of heavy menstrual bleeding (HMB) remains a challenge for the physician. There is a need for further trials to compare the effectiveness and compliance between a levonorgestrel-releasing intrauterine system (LNG-IUS) and minimally invasive types of hysterectomy, for example, laparoscopic supracervical hysterectomy (LSH), in women with HMB. This article is the first to report a randomized trial aimed at comparing postoperative outcomes and effects on quality of life after LNG-IUS or LSH in women with HMB. METHODS: The trial was performed at Tor Vergata University Hospital, Rome. Seventy-two women requiring treatment for HMB were randomly allocated into two treatment arms: LNG-IUS (n=36) or LSH (n=36). The primary outcome was the comparison of the effects on menstrual bleeding (pictorial blood loss assessment chart [PBAC]) at 12 months after the two procedures. The secondary outcome measures were the quality of life, improvement in bleeding patterns, intensity of postoperative pain, and early postoperative complications. A p<0.05 was considered statistically significant. RESULTS: The PBAC score was significantly reduced in both treatment groups. The Medical Outcomes Survey Short Form 36 (SF-36) score improved in both groups. A more significant improvement in the parameters Role and Mental health was observed after LNG-IUS. CONCLUSIONS:LNG-IUS can be considered as first option for the treatment of HMB unresponsive to drug therapy, and it is particularly suitable for women who want to preserve an acceptable menstrual flow. LSH may be considered the best surgical option in women with HMB unresponsive to any medical treatment.
RCT Entities:
BACKGROUND: The optimal treatment of heavy menstrual bleeding (HMB) remains a challenge for the physician. There is a need for further trials to compare the effectiveness and compliance between a levonorgestrel-releasing intrauterine system (LNG-IUS) and minimally invasive types of hysterectomy, for example, laparoscopic supracervical hysterectomy (LSH), in women with HMB. This article is the first to report a randomized trial aimed at comparing postoperative outcomes and effects on quality of life after LNG-IUS or LSH in women with HMB. METHODS: The trial was performed at Tor Vergata University Hospital, Rome. Seventy-two women requiring treatment for HMB were randomly allocated into two treatment arms: LNG-IUS (n=36) or LSH (n=36). The primary outcome was the comparison of the effects on menstrual bleeding (pictorial blood loss assessment chart [PBAC]) at 12 months after the two procedures. The secondary outcome measures were the quality of life, improvement in bleeding patterns, intensity of postoperative pain, and early postoperative complications. A p<0.05 was considered statistically significant. RESULTS: The PBAC score was significantly reduced in both treatment groups. The Medical Outcomes Survey Short Form 36 (SF-36) score improved in both groups. A more significant improvement in the parameters Role and Mental health was observed after LNG-IUS. CONCLUSIONS: LNG-IUS can be considered as first option for the treatment of HMB unresponsive to drug therapy, and it is particularly suitable for women who want to preserve an acceptable menstrual flow. LSH may be considered the best surgical option in women with HMB unresponsive to any medical treatment.
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