Progesterone/progestogen releasing intrauterine systems versus either placebo or any other medication for heavy menstrual bleeding

Abstract

Background: Heavy menstrual bleeding (HMB) is an important cause of ill health in women and it accounts for 12% of all gynaecology referrals in the UK. Heavy menstrual bleeding is clinically defined as greater than, or equal to, 80mls blood loss per menstrual cycle but women may complain of excessive bleeding when their blood loss is less than 80ml. Hysterectomy is often used to treat women with this complaint but medical therapy may be a successful alternative. The intrauterine coil device was originally developed as a contraceptive but the addition of uterine relaxing hormones, or progestogens, to these devices resulted in a large reduction in menstrual blood loss. Case studies of 2 types of progesterone/progestogen releasing systems, Progestasert and Mirena, report reductions of up to 90% and dysmenorrhoea may be improved. Insertion, however, may be regarded as invasive by some women affecting its acceptability as a treatment and frequent intermenstrual bleeding and spotting is likely during the first few months.

Objectives: To determine the effectiveness and acceptability of progesterone/progestogen-releasing intrauterine devices in achieving a reduction in heavy menstrual bleeding.

Search strategy: All studies which might describe randomised controlled trials of progesterone/progestagen-releasing intrauterine devices for the treatment of heavy menstrual bleeding were obtained by electronic searches of the MEDLINE 1966-1999, EMBASE 1980-1999 databases and the Cochrane Library. Companies producing progestogen releasing intrauterine devices and experts in the field were contacted for information on published and unpublished trials.

Selection criteria: Randomised controlled trials in women of reproductive age treated with progesterone/progestogen-releasing intrauterine devices versus no treatment, placebo, or other medical or surgical therapy for heavy menstrual bleeding within either the primary care, family planning or specialist clinic setting were eligible for inclusion. Women with postmenopausal bleeding, intermenstrual or irregular bleeding, or pathological causes of heavy menstrual bleeding were excluded.

Data collection and analysis: Potential trials were independently assessed by three reviewers and five trials met the criteria for inclusion in the review. The reviewers extracted the data independently and data were pooled where appropriate. Odds ratios for dichtomous outcomes and weighted mean differences for continuous outcomes were estimated from the data. The primary outcome was reduction in menstrual blood loss but incidence of side effects, changes in quality of life and satisfaction and acceptability measures were also assessed.

Main results: Progesterone/progestogen-releasing intrauterine systems have not been compared to placebo or no treatment. Progestasert has been compared to a number of different medical therapies in one small study but no conclusions can be made about effectiveness. The levonorgestrel-releasing intrauterine device (LNG IUS) has been compared to oral cyclical norethisterone (NET) administered on days 5-26 in one trial and was significantly more effective although there was a large reduction from baseline in both groups and these differences were not perceived by the women undergoing the treatment. Some side effects were more common in the LNG IUS group but a significantly greater proportion of women in this group were satisfied and willing to continue with their treatment. In one trial of women awaiting hysterectomy where the LNG IUS was compared with a control group taking their existing medical therapy, a higher proportion of the women in the former group cancelled their planned surgery after 6 months of treatment. The levonorgestrel-releasing intrauterine device has been compared to a surgical procedure (transcervical resection of the endometrium (TCRE)) in two trials. (ABSTRACT TRUNCATED)