Progestogen-releasing intrauterine systems for heavy menstrual bleeding

• Published in: Cochrane database of systematic reviews 2020-06, Vol.6 (6), p.CD002126-CD002126
• Main Authors: Bofill Rodriguez, Magdalena, Lethaby, Anne, Jordan, Vanessa
• Format: Article
• Language: English
• Subjects: Antifibrinolytic Agents - administration & dosage; Antifibrinolytic Agents - therapeutic use; Contraceptives, Oral - administration & dosage; Contraceptives, Oral - therapeutic use; Endometrium - surgery; EXCESSIVE MENSTRUAL BLEEDING; Female; Gynaecology; Humans; Hysterectomy; Intrauterine Devices, Medicated; Levonorgestrel - administration & dosage; Levonorgestrel - therapeutic use; Mefenamic Acid - administration & dosage; Mefenamic Acid - therapeutic use; Menorrhagia - drug therapy; Menorrhagia - surgery; Norethindrone - administration & dosage; Norethindrone - therapeutic use; Progesterone - administration & dosage; Progesterone - therapeutic use; Quality of Life; Randomized Controlled Trials as Topic; Tranexamic Acid - administration & dosage; Tranexamic Acid - therapeutic use; Treatment Outcome
• ISSN: 1469-493X
• DOI: 10.1002/14651858.CD002126.pub4

Heavy menstrual bleeding (HMB) impacts the quality of life of otherwise healthy women. The perception of HMB is subjective and management depends upon, among other factors, the severity of the symptoms, a woman's age, her wish to get pregnant, and the presence of other pathologies. Heavy menstrual bleeding was classically defined as greater than or equal to 80 mL of blood loss per menstrual cycle. Currently the definition is based on the woman's perception of excessive bleeding which is affecting her quality of life. The intrauterine device was originally developed as a contraceptive but the addition of progestogens to these devices resulted in a large reduction in menstrual blood loss: users of the levonorgestrel-releasing intrauterine system (LNG-IUS) reported reductions of up to 90%. Insertion may, however, be regarded as invasive by some women, which affects its acceptability. To determine the effectiveness, acceptability and safety of progestogen-releasing intrauterine devices in reducing heavy menstrual bleeding. We searched the Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL (from inception to June 2019); and we searched grey literature and for unpublished trials in trial registers. We included randomised controlled trials (RCTs) in women of reproductive age treated with LNG-IUS devices versus no treatment, placebo, or other medical or surgical therapy for heavy menstrual bleeding. Two authors independently extracted data, assessed risk of bias and conducted GRADE assessments of the certainty of evidence. We included 25 RCTs (2511 women). Limitations in the evidence included risk of attrition bias and low numbers of participants. The studies compared the following interventions. LNG-IUS versus other medical therapy The other medical therapies were norethisterone acetate, medroxyprogesterone acetate, oral contraceptive pill, mefenamic acid, tranexamic acid or usual medical treatment (where participants could choose the oral treatment that was most suitable). The LNG-IUS may improve HMB, lowering menstrual blood loss according to the alkaline haematin method (mean difference (MD) 66.91 mL, 95% confidence interval (CI) 42.61 to 91.20; 2 studies, 170 women; low-certainty evidence); and the Pictorial Bleeding Assessment Chart (MD 55.05, 95% CI 27.83 to 82.28; 3 studies, 335 women; low-certainty evidence). We are uncertain whether the LNG-IUS may have any effect on women's satisfaction up to one year