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Prescrire Int. 2014 May;23(149):130-5.

Bleeding associated with uterine leiomyomas. Tailor treatment to the individual patient.

[No authors listed]


Uterine leiomyomas are benign, often asymptomatic, tumours of the uterus. When they are symptomatic, the most frequent symptom is heavy, prolonged menstrual bleeding, which stops at menopause. When this blood loss causes iron-deficiency anaemia, iron supplementation is justified. Various treatments aimed at reducing uterine blood loss are proposed for women with leiomyoma-related bleeding. As of late 2013, what is the harm-benefit balance of these treatments? To answer this question, we reviewed the available data using the standard Prescrire methodology. Hysterectomy (removal of the uterus) is the most radical treatment for the clinical manifestations of uterine leiomyomas. Serious complications sometimes occur. Nine randomised trials including a total of 1553 patients found no advantage in leaving the cervix intact. Randomised trials in about 4500 patients showed that the vaginal approach is preferable to an open abdominal or laparoscopic approach: in particular, it resulted in fewer infections and less bleeding. Myomectomy (selective removal of uterine leiomyomas) is another surgical option, especially when the patient wishes to preserve her fertility. Its evaluation is mainly based on noncomparative case series. As with hysterectomy, it exposes patients to the risk of serious complications. Symptoms recur in 4% to 27% of cases.The reintervention rate is 4% to 20%. Injections of the gonadorelin agonists leuprorelin or triptorelin reduce bleeding associated with leiomyomas, according to several randomised trials. They have not been demonstrated to reduce the need for transfusion or to facilitate subsequent surgery for leiomyomas.The harm-benefit balance of prolonged use of these drugs is unfavourable, due to their numerous adverse effects. The oral progesterone receptor antagonist ulipristal reduces excessive bleeding, but has not been demonstrated to facilitate subsequent surgery.The effects on the endometrium of taking ulipristal for more than 3 months are unknown. The progesterone antagonist mifepristone reduced bleeding in small randomised trials, but increased the incidence of endometrial hyperplasia. The levonorgestrel-releasing intrauterine device has mainly been evaluated in non-comparative studies, which suggest that it reduces menstrual bleeding in women with leiomyomas. The risk of expulsion of the device in women with leiomyomas appears to be about 20%. Its main adverse effects are rare cases of acne, depression, headache, weight gain and breast tenderness. Very little evaluation data is available on oral progestins in this situation. A progestin, such as norethisterone, taken from the 5th to the 26th day of the menstrual cycle seems to reduce menstrual blood loss and has a contraceptive effect. Oral progestins expose women to an increased risk of venous thromboembolism and possibly increase the risk of breast cancer. Their harm-benefit balance seems less favourable than that of the levonorgestrel-releasing intrauterine device. The thrombotic risk associated with tranexamic acid is unclear, but deserves serious consideration given the drug's uncertain efficacy. In practice, the treatment should be chosen with the patient, based on various factors, including severity of symptoms, age, desire to preserve fertility or the uterus, characteristics of the leiomyomas, and patient preference. As of late 2013, when drug treatment is considered useful in postponing surgery or while awaiting menopause, the levonorgestrel-releasing intrauterine device is the first choice. Oral progestins are another alternative, although their adverse effects are unclear when taken for several months. It is better to avoid exposing patients to the other available drugs, and to choose iron supplementation for women who develop anaemia.

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