Fibroids (uterine myomatosis, leiomyomas) Search date May 2014 Anne Lethaby and Beverley Vollenhoven ABSTRACT INTRODUCTION: Between 50% and 77% of women may have fibroids, depending on the method of diagnosis used. Fibroids may be asymptomatic, or may present with menorrhagia, pain, mass and pressure effects, infertility, or recurrent pregnancy loss. Risk factors for fibroids include obesity, having no children, and no long-term use of the oral contraceptive pill. Fibroids tend to shrink or fibrose after the menopause. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of surgical/interventional radiological treatments in women with fibroids? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2014 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: Five studies were included. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: magnetic resonance-guided focused ultrasound surgery versus no/sham treatment; magnetic resonance-guided focused ultrasound surgery versus other interventions (hysterectomy, myomectomy, hysteroscopic resection, rollerball endometrial ablation, thermal balloon ablation, thermal myolysis with laser); uterine artery embolisation versus no/sham treatment; uterine artery embolisation versus hysterectomy; uterine artery embolisation versus myomectomy; uterine artery embolisation versus other interventions (magnetic resonance-guided focused ultrasound surgery, hysteroscopic resection, rollerball endometrial ablation, thermal balloon ablation, thermal myolysis with laser).

QUESTIONS What are the effects of surgical/interventional radiological treatments in women with fibroids?. . . . . . . . . . . . . 4 INTERVENTIONS EFFECTS OF SURGICAL/INTERVENTIONAL RADIOLOGICAL TREATMENTS Trade off between benefits and harms Uterine artery embolisation versus hysterectomy (may reduce hospital stay, time to resume normal activities, and need for blood transfusion compared with hysterectomy, but may result in higher rates of future intervention) New . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Uterine artery embolisation versus myomectomy (may reduce recovery time and hospital stay compared with myomectomy, but may result in higher rates of future intervention) New . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Magnetic resonance-guided focused ultrasound surgery versus other interventions (hysterectomy, myomectomy, hysteroscopic resection, rollerball endometrial ablation, thermal balloon ablation, thermal myolysis with laser) New . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Uterine artery embolisation versus no treatment/sham treatment New . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Uterine artery embolisation versus other interventions (magnetic resonance-guided focused ultrasound surgery, hysteroscopic resection, rollerball endometrial ablation, thermal balloon ablation, thermal myolysis with laser) New . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Covered elsewhere in Clinical Evidence

Unknown effectiveness Magnetic resonance-guided focused ultrasound surgery versus no treatment/sham treatment New . . . . . . . 4

Menorrhagia (many women with fibroids experience symptoms of heavy menstrual bleeding). See Menorrhagia.

Key points • Between 50% and 77% of women may have fibroids, depending on the method of diagnosis used. Fibroids may be asymptomatic, or may present with menorrhagia, pain, mass and pressure effects, infertility, or recurrent pregnancy loss. Risk factors for fibroids include obesity, having no children, and no long-term use of the oral contraceptive pill. Fibroids tend to shrink or fibrose after the menopause. • Myomectomy maintains fertility. • We searched for RCT evidence. Overall, we found a limited number of trials with relatively small numbers of participants in the assessment of some outcomes. There is a need for further high-quality RCTs in this field. • We don't know whether magnetic resonance-guided focused ultrasound surgery is beneficial in women with fibroids compared with no treatment/sham treatment, or other procedures (uterine artery embolisation, hysteroscopic resection, rollerball endometrial ablation, myomectomy, hysterectomy, thermal balloon ablation, or thermal myolysis with laser) as we found no studies. • We found no RCT evidence on uterine artery embolisation (UAE) compared with no treatment/sham treatment. • UAE may reduce procedure time, hospital stay, and recovery time compared with hysterectomy, and may reduce the need for blood transfusion. Satisfaction rates may be similar between the two procedures at up to 5 years. ..................... 1 .....................

© BMJ Publishing Group Ltd 2015. All rights reserved.

Clinical Evidence 2015;06:814

Women's health

..................................................

However, UAE seems to be associated with an increased need for future treatment compared with hysterectomy. • UAE may reduce procedure time, hospital stay, and recovery time compared with myomectomy. Satisfaction rates may be similar between the two procedures at up to 2 years. However, UAE may be associated with an increased need for future treatment compared with myomectomy. Myomectomy may increase pregnancy rates compared with UAE in women with fibroids who wish to retain fertility, but evidence was limited, and came from a small sample of women in one RCT. • We don’t know how UAE compares with magnetic resonance-guided focused ultrasound surgery, hysteroscopic resection, rollerball endometrial ablation, thermal balloon ablation, or thermal myolysis with laser, as we found no studies. Clinical context

GENERAL BACKGROUND Fibroids (uterine leiomyomas) are benign tumours of the smooth muscle cells of the uterus. Women with fibroids can be asymptomatic, or may present with menorrhagia, pelvic pain with or without dysmenorrhoea, or pressure symptoms, infertility, and recurrent pregnancy loss. Fibroids are the most common gynaecological tumour.

FOCUS OF THE REVIEW To date, open surgery has been the mainstay of treatment. There are now minimally invasive surgical as well as interventional radiological treatment options. This review will focus on the evidence surrounding the radiological interventions of magnetic resonance-guided focused ultrasound surgery and uterine artery embolisation.

COMMENTS ON EVIDENCE For four of the six comparisons, no evidence was identified for the specified outcomes. For the other two comparisons (uterine artery embolisation [UAE] v hysterectomy and UAE v myomectomy), only one systematic review was identified with three and two RCTs. None of the trials were blinded, which may have influenced some of the outcome estimates. Additional quality concerns included potential selection bias for one trial included in the UAE v hysterectomy comparison and difficulties in generalisability for the UAE v myomectomy comparison (with different participants in the two relevant trials). Where evidence was found, it was generally of low quality.

SEARCH AND APPRAISAL SUMMARY The update literature search for this review was carried out from the date of the last search, June 2009, to May 2014. For more information on the electronic databases searched and criteria applied during assessment of studies for potential relevance to the review, please see the Methods section. Searching of electronic databases retrieved 186 studies. After deduplication and removal of conference abstracts, 68 records were screened for inclusion in the review. Appraisal of titles and abstracts led to the exclusion of 46 studies and the further review of 22 full publications. Of the 22 full articles evaluated, two systematic reviews and three RCTs were added at this update. DEFINITION

Fibroids (uterine leiomyomas) are benign tumours of the smooth muscle cells of the uterus. Women with fibroids can be asymptomatic, or may present with menorrhagia (30%), pelvic pain with or without dysmenorrhoea or pressure symptoms (34%), infertility (27%), and recurrent preg[1] nancy loss (3%). Much of the data describing the relationship between the presence of fibroids and symptoms are based on uncontrolled studies that have assessed the effect of myomectomy [2] on the presenting symptoms. One observational study (142 women) undertaken in the USA suggested that the prevalence of fibroids in infertile women can be as high as 13%, but no direct [3] causal relationship between fibroids and infertility has been established.

INCIDENCE/ PREVALENCE

The reported incidence of fibroids varies from 5.4% to 77.0%, depending on the method of diagnosis used (the gold standard is histological evidence). It is not possible to state the actual incidence of fibroids, because some women with fibroids will not have symptoms, and will therefore not be tested for fibroids. Observational evidence suggests that, in premenopausal women, the incidence [4] [5] [6] of fibroids increases with age, reducing during menopause. On the basis of postmortem [7] examination, 50% of women were found to have these tumours. Gross serial sectioning at 2 mm intervals of 100 consecutive hysterectomy specimens revealed the presence of fibroids in 50/68 (73%) premenopausal women and 27/32 (84%) postmenopausal women. These women were [8] having hysterectomies for reasons other than fibroids. The incidence of fibroids in black women is three times greater than that in white women, based on ultrasound or hysterectomy diagnosis. [9] Submucosal fibroids have been diagnosed in 6% to 34% of women having a hysteroscopy for [10] abnormal bleeding, and in 2% to 7% of women having infertility investigations.

© BMJ Publishing Group Ltd 2015. All rights reserved.

........................................................... 2

Women's health

Fibroids (uterine myomatosis, leiomyomas)

AETIOLOGY/ The cause of fibroids is unknown. Each fibroid is of monoclonal origin and arises independently. [11] [12] RISK FACTORS Factors thought to be involved include the sex steroid hormones oestrogen and progesterone, as well as the insulin-like growth factors, epidermal growth factor, and transforming growth factor. There may also be genetic factors associated with development; certain genes may be switched on or off making an individual more likely to develop these tumours. Risk factors for fibroid growth include nulliparity and obesity. Risk also reduces consistently with increasing number of term pregnancies; women with five term pregnancies have one quarter of the risk of nulliparous [5] women (P

Fibroids (uterine myomatosis, leiomyomas).

Between 50% and 77% of women may have fibroids, depending on the method of diagnosis used. Fibroids may be asymptomatic, or may present with menorrhag...
135KB Sizes 0 Downloads 11 Views