Progestogens or progestogen-releasing intrauterine systems for uterine fibroids

Uterine fibroids are common premenopausal benign uterine tumours. Treatment of uterine fibroids includes surgery, medical treatment, or both. Progestogens can be administered by various routes such as orally and by injection. Depot medroxyprogesterone acetate (DMPA is a synthetic progesterone hormone given by intramuscular injection that may inhibit uterine fibroid growth. The progestogen-releasing (levonorgestrel) intrauterine system (LNG-IUS) is a device placed inside the uterus that releases the hormone progesterone and can cause endometrial suppression. In this review, three randomised controlled studies were included. Two randomised controlled studies included 131 women and evaluated the beneficial and harmful effects of the LNG-IUS compared with hysterectomy or a low dose combined oral contraceptive (COC). However, the results were from only one study that compared 29 women with an LNG-IUS versus 29 women with COC for treating uterine fibroids. The LNG-IUS appeared to reduce menstrual blood loss and increase haemoglobin levels in premenopausal women with uterine fibroids. Reduction of fibroid size was not significant. In one study that included 56 women treated with preoperative oral progestogens (lynestrenol) compared with gonadotropin-releasing hormone (GnRH) agonist, the uterine fibroid size was not different. There was no randomised controlled study of DMPA to treat uterine fibroids. The included studies were of poor quality and had small numbers of participants. Indeed, the authors did not recommend the use of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids. More high quality randomized controlled studies evaluating progestogens or progestogen-releasing intrauterine systems for treating uterine fibroids that have an adequate sample size are needed.

Authors' conclusions: 

Progestogen-releasing intrauterine systems appear to reduce menstrual blood loss in premenopausal women with uterine fibroids. Oral progestogens did not reduce fibroid size or fibroid- related symptoms. However, there was a methodological limitation and the one included study with data had a small sample size. This evidence is insufficient to support the use of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids.

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Background: 

Uterine fibroids are the most common premenopausal benign uterine tumours. Fibroids can cause symptoms including heavy menstrual bleeding, pelvic pressure and pain. Progestogens can be administered by various routes. Intramuscular injection of depot medroxyprogesterone acetate (DMPA) has dual actions (stimulatory or inhibitory) on fibroid cell growth. Progestogen-releasing intrauterine systems (IUS) decrease menstrual blood loss associated with fibroids by inducing endometrial atrophy and reduction of uterine fibroid size. Currently, their effectiveness for the treatment of uterine fibroids has not been evaluated.

Objectives: 

To determine the effectiveness of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids.

Search strategy: 

We searched the Menstrual Disorders and Subfertility Group Specialised Register (inception to 17 August 2012), CENTRAL (inception to 17 August 2012) and Database of Abstracts of Reviews of Effects (DARE) in The Cochrane Library, MEDLINE (inception to 17 August 2012), Ovid EMBASE (1 January 2010 to 17 August 2012), Ovid PsycINFO (inception to 17 August 2012), CINAHL database, and trials registers for ongoing and registered trials.

Selection criteria: 

All identified published or unpublished randomised controlled trials (RCTs) assessing the effect of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids.

Data collection and analysis: 

We assessed all potentially eligible studies identified as a result of the search strategy. Two review authors extracted data from each included study using an agreed form and assessed the risk of bias. We resolved discrepancies through discussion.

Main results: 

This review included three studies. However, data for progestogen-releasing intrauterine systems were available from only one study that compared 29 women with a levonorgestrel (LNG)-IUS versus 29 women with a combined oral contraceptive (COC) for treating uterine fibroids. There was a significant reduction of menstrual blood loss (MBL) in women receiving the LNG-IUS compared to the COC using the alkaline hematin test (mean difference (MD) 77.5%, 95% CI 71.3% to 83.67%, 58 women) and a pictorial assessment chart (PBAC) (MD 34.5%, 95% CI 14.9% to 54.1%, 58 women). The reduction in uterine fibroid size was significantly greater in the leuprorelin group at 16 weeks compared to the progestogen lynestrenol group (MD -15.93 mm, 95% CI -18.02 to -13.84 mm, 46 women). There was no RCT evaluating the effect of DMPA on uterine fibroids.

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