Dr Sarah Gray, Chair of the working party guideline, presents a summary of guidance that will help practitioners to offer women effective care and avoid unnecessary referrals
Read this article to learn more about:
- advice from the working party guideline on assessment and management of uterine fibroids
- when intervention and treatment for uterine fibroids is needed or not
- referral and subsequent shared-care arrangements.
* The development of the working party guideline on which this article is based was supported by a grant from Gedeon Richter (UK) Ltd. The guideline was developed by MGP Ltd, the publishers of Guidelines in Practice, and the working party was convened by them. The content of the working party guideline and this article is independent of and not influenced by the commercial sponsorship
F ibroids (leiomyomata) are monoclonal smooth muscle tumours of the uterus. They are not found before puberty but become increasingly common through reproductive life and generally regress after menopause. There is little UK-based prevalence data, but an American study1 has shown that:
- approximately 60% of black women have detectable fibroids by the age of 35 years; this increases to approximately 80% by 50 years of age
- approximately 40% of white women have detectable fibroids by the age of 35 years; this increases to 70% by 50 years of age.
The overwhelming majority of fibroids are benign, with less than 1:1000 being malignant (leiosarcoma). It is not thought that malignant transformation occurs,2 as benign and malignant lesions are of different aetiology. Fibroid formation is influenced via oestrogen and progesterone receptors, yet this relationship is not simple and pregnancy appears to be protective. 3 Hormonal contraception has not been shown to affect growth, but this might occur in some women on hormone replacement therapy (HRT), and it has been suggested that this relates to progesterone type and dose.4,5 Diabetes, obesity, and hypertension may be associated with increased risk of fibroid formation but the evidence is inconsistent. 3,6 The increased incidence in Afro-Caribbean women indicates that genetic factors are relevant.2 Fibroids are classified (see Figure 1, below) according to:7
- number—as they can be multiple and hence have a significant effect on uterine size even if individual fibroids are small
- size—with those <3 cm in diameter less likely to have significant clinical effect
- location within the uterus:
- subserosal fibroids—develop towards the outer surface of the uterus and, if large or pedunculated, project into the peritoneal cavity. These will usually present with bulk or pressure effects
- intramural fibroids—develop within the uterine wall increasing the bulk of the uterus. These can present with bleeding and/or bulk effects
- submucosal fibroids—develop towards the cavity of the uterus and cause distortion unless very small. They will usually present with bleeding problems.
Presenting symptoms fall into the following categories:
- bleeding problems, particularly heavy menstrual bleeding (HMB), although these are non-specific and bleeding may also occur with other identifiable causes or without obvious pathological explanation
- symptoms due to pressure or bulk—this may affect bladder or bowel function or cause a sensation of something pressing down, bloating, or fullness. Again these are non-specific and there are many other possible explanations for such symptoms
- acute pain and bleeding attributable to torsion of pedunculated fibroids or degeneration. Degeneration can occur after menopause or after a period of rapid growth such as in pregnancy.8 Again, the differential diagnosis is wide
- indirect discovery during investigation of infertility or obstetric complications
- none—the majority of fibroids are asymptomatic.
There is therefore a classical management conundrum for general practice:
- symptoms are non-specific
- fibroids may be present but be asymptomatic
- how do you work this out?
- what do you need to do?
- what can you do?
- what is best for the patient?
The challenge presented to primary care is therefore to identify when fibroids are the cause of the patient's symptoms and to manage these appropriately. New options and guidance are available that enable more conservative yet effective management. Equally, it is important to understand when fibroids are an incidental finding and to provide appropriate reassurance and advice. This can potentially save unnecessary referrals, with associated anxiety and cost to the patient, and also avoid secondary care costs.
Current NICE guidance focuses on heavy menstrual bleeding (HMB) rather than on the management of uterine fibroids.9,10 Inconsistency of management of the symptoms of HMB has been shown across England and Wales, even where this is the only factor.11 Given that fibroids can cause a variety of symptoms or none at all, there is even more variability in their management, and many GPs are unsure how to manage patients with fibroids in primary care, tending to refer them to secondary care.
A working party was convened in 2014 to develop a guideline on the assessment and management of uterine fibroids in primary care7 to improve the quality and consistency of care across the UK. This guideline aimed to give primary care healthcare professionals (HCPs) the confidence to:
- assess a woman's risk of fibroids
- initiate medical management in low-risk patients
- understand and explain the relevance of ultrasound findings in order to avoid unnecessary referrals.
Diagnosis in primary care
The guideline group7 considered it important for primary care clinicians both to be aware of the potential for fibroids to be an explanation for the patient's symptoms, and to be able to explore the differential diagnosis.
To explore the presenting complaint, it is important to ask questions about:8
- the nature, extent, and impact of bleeding
- pain associated with bleeding
- symptoms of pelvic pressure.
Some suggested questions are included in Box 1 (see below). Medical, family, and social history are also important. In the process of history-taking, the clinician should be looking for factors that will affect clinical decision making. These can be regarded as: strong risk factors that definitely trigger investigation or referral; moderate risk factors that may do so; and alerts that will alter management (see Box 2, below).
Box 1: History taking for diagnosis of fibroids
- Tell me about your periods:
- how often do they come and are they regular?
- for how many days do you bleed?
- how heavy is the bleeding? What protection is needed on a bad day?
- what happens at night? Do you have to get up to change protection?
- how much of an impact does your period have on your daily activities?
- Are your periods painful?
- how bad is the pain?
- how long does pain start before the bleeding and how long does it last for?
- for how long has pain been a problem?
- Do you bleed between your periods or after having sex?
- Do you have pain during or after having sex?
- Have you noticed any changes to your bladder and bowel?
- do you have any feeling of something pressing down or disruption to bladder or bowels?
- do you feel swollen or bloated?
- does your bladder frequently fill up and need emptying?
- do you have problems passing urine?
- do you have constipation?
Box 2: Factors that will affect decision making7
- Strong risk of gynaecological pathology—refer any of these:
- intermenstrual bleeding—that is not cyclical
- postcoital bleeding
- postmenopausal bleeding
- Moderate risk factors for endometrial hyperplasia—consider number and strength of factors and refer if cumulative:
- age >45 years with HMB
- polycystic ovarian syndrome with few periods
- family history of ovarian/breast cancer with the presence of high-risk (e.g. BRCA) genes
- tamoxifen use
- Alerts that may alter management:
- vaginal discharge (may indicate other problems including pelvic inflammatory disease and acute necrotising fibroids)
- multiple sexual partners (risk factor for ascending infection)
- not attending for cervical screening (risk factor for cervical pathology)
- recent uterine intervention/event, including termination and miscarriage
- contraceptive method as this may explain the bleeding pattern12
- anticoagulants (e.g. warfarin), which can increase bleeding.
- HMB=heavy menstrual bleeding
Abdominal, pelvic bimanual, and speculum examination should be performed if there is a possibility of fibroid disease, both to assess the uterus and other pelvic organs and to exclude visible pathology such as cervical polyps.
A full blood count should be arranged for all women presenting with or identified as having HMB, to identify whether there is haematological impact. The following investigations should also be considered:6
- tests for clotting disorders in women whose bleeding has been heavy from menarche
- hormone—follicle-stimulating hormone, luteinising hormone, prolactin, oestradiol, and thyroid tests are not needed unless there are other indications
- tests should be ordered to exclude sexually transmitted infections if women are identified to be at risk
- cervical cytology should be arranged if the woman's cervical screening is not up to date
- ultrasound will identify structural changes such as fibroids, but should only be organised where there is clinical indication and after examination.
Imaging is used to detect structural anomalies such as fibroids, polyps, cysts, etc. Endometrial thickness is unreliable in premenopausal women, although gross changes in endometrial appearance may be helpful. A combination of transabdominal and transvaginal ultrasound is often performed:
- transabdominal ultrasound allows a wider field view, increased depth, and the ability to examine other organs if necessary. It is better for pedunculated subserosal fibroids that extend into the abdominal cavity and for very large fibroids
- transvaginal ultrasound offers better resolution for visualising smaller fibroids and their relationship to the endometrial cavity—polyps may be difficult to differentiate from small pedunculated fibroids. It also allows for more accurate assessment of the endometrium. Patients should be counselled prior to transvaginal scanning so they know what to expect
- magnetic resonance imaging is not recommended as first-line imaging.
When referring the woman for imaging, enough clinical information should be provided on the request so that the sonographer can interpret appropriately (this should include the start date of the last menstrual period). Box 3 (see below) gives information on how to interpret an ultrasound report.
In order to assess for any rapid increase in uterine/fibroid size, compare the scans with any previous ultrasound images. The GP may need to do this if the scans have been performed at different hospitals.
Box 3: How to use an ultrasound report
Look out for the following on the ultrasound report:
- the overall dimensions of the uterus (LS x AP x TS)
- the location and size of the fibroids (not always possible if they are large and multiple)
- whether fibroids encroach upon the endometrial cavity
- whether the endometrial cavity is distorted (helpful if considering the intrauterine system)
- the appearance of the endometrium (e.g. normal, cystic, polyps. Thickness is unreliable in women who are still menstruating)
- size and appearance of the ovaries (not always visible when large fibroids are present).
If HMB is identified as a component of the presentation, interim mitigating management should be offered while the patient is further evaluated. The principle is to do something to help, 10 and either or both of a non-steroidal anti-inflammatory drug (NSAID) and tranexamic acid can be offered.
If after evaluation medical management is appropriate, the options available should be discussed with the patient to enable her to make an informed decision regarding what she would like to start with. She should be offered a review and the option to change her treatment at 3 months. The list below provides some pointers toward clinical decision-making. These are not exhaustive and the final choice will depend on the profile and preferences of the individual woman.
For more information, refer to Figure 1,7 above, Table 17 below, formulary guidance (e.g. www.bnf.org), any relevant drug summary of product characteristics, and references here and in the guideline.7
|Treatment||Contraceptive effect||Effect on pain||Effect on bleeding||Fibroid volume||Special consideration|
|NSAID||No. Fertility preserved||Helpful||Reduction shown in HMB||Not evaluated|
|Tranexamic acid||No. Fertility preserved||No effect||Reduction shown in HMB||Not evaluated|
|LNG-IUS||Yes, reversed on removal||Usually helpful||Significant reduction but may take 6 months||No conclusive evidence|
|CHC||Yes, reversed on stopping||Usually helpful||Not evaluated|
|High-dose oral progestogen||No, but not recommended if trying to conceive||Usually helpful||Reduction shown in HMB if used on days 5-26 of each cycle (15 mg norethisterone or 20-30 mg/day medroxyprogesterone acetate||Not evaluated|
|High-dose injected progestogen||Yes, and will take up to a year before fertility returns after last injection||Usually helpful||Reduction, with high incidence of amenorrhoea with continuous use||Not evaluated|
|Ulipristal acetate (5 mg)||No. Additional non-hormonal contraception required in women at risk of pregnancy||Yes, effective within first cycle||Rapid reduction in bleeding, with many achieving amenorrhoea within 7-10 days||Significant reduction of 36%-42% by 3 months|
|GnRH analogues||No. Additional non-hormonal contraception required in all women at risk of pregnancy||Yes, gradual reduction||Gradual reduction up to 30 days to achieve amenorrhoea||Significant reduction of 53% by 3 months|
- interim management and treatment option
- moderate effect on bleeding—may be enough
- will help pain and is often useful in young women soon after menarche
- can be used if trying to conceive as it is started at onset of bleeding.
- interim management and treatment option
- moderate effect on bleeding—may be enough
- does not help pain, but may be useful in anovulatory bleeding close to menopause
- can be used if the woman is trying to conceive as it is started at onset of bleeding.
Hormonal treatment options
Levonorgestrel 20 μg/24 h intrauterine system (LNG-IUS)
- treatment option that also provides contraception
- highly effective at reducing blood loss and also usually the pain associated with bleeding
- change is progressive over about 6 months
- can be offered to women of all ages, regardless of parity
- minimal systemic progestogenic side-effects
- seek specialist advice if the fibroid significantly distorts the uterine cavity or is >3 cm.
Combined hormonal contraception
- treatment option
- moderately to highly effective (this may vary with the regimen used) at reducing blood loss and usually the pain associated with bleeding
- will provide cycle control, predictability of bleeding, and contraception
- the woman's cardiovascular risk profile should be evaluated and additional risks associated with use of oestrogen considered.
High-dose progesterone for 3 weeks (e.g. norethisterone 15 mg daily)
- treatment option
- moderately effective at reducing blood loss and usually the pain associated with bleeding
- will provide cycle control and predictability of bleeding
- limited by progestogenic side effects so not suitable for long-term use, but may be useful in anovulatory bleeding close to menopause
- the woman's cardiovascular risk profile should be evaluated and additional thrombotic risks associated with use considered
- short duration of use only during the luteal phase (e.g. days 19–26) is not effective and should not be offered.
High-dose injectable progesterone
- treatment option (recommended by NICE CG44 but not licensed 9)*
- highly effective at reducing blood loss and usually the pain associated with bleeding
- will ablate cycle and residual bleeding will be unpredictable
- may be limited by progestogenic side-effects such as bloating, breast tenderness, or mood change
- potential effect on bone metabolism should be considered.
Ulipristal acetate (selective progesterone receptor modulator)
- treatment option only where fibroids identified (local formulary may state that it must be initiated by a specialist)
- 3-month course, which may be repeated once
- rapid and highly effective at reducing blood loss and pain associated with fibroids
- highly effective in reducing volume of fibroids and pressure effect
- few associated menopausal symptoms.
Gonadotropin-releasing hormone agonist
- treatment option only where fibroids identified (specialist initiated)
- usually use limited to 6 months due to effects on bone metabolism—add-back HRT may be considered
- progressively effective over about 3 months at reducing blood loss and pain associated with fibroids
- progressively effective in reducing volume of fibroids and pressure symptoms
- significant associated menopausal symptoms.
A treatment review should be conducted with the patient after 3 months to determine whether the treatment has led to a satisfactory improvement in symptoms (as judged by the woman). This will allow for changes, if necessary, or addition of a further medical option.
NICE CG44 on heavy menstrual bleeding provides guidance on surgical decision making and this can be used within primary care to guide the decision on whether, when, and where to refer.8 This, however, will only be necessary in a minority of cases. If the decision is taken to refer the woman to secondary care (see Figure 16), the GP should discuss possible specialist management options in outline with the patient prior to referral so that she can express a preference and she can then be referred appropriately. She should be offered a patient information sheet or directed to useful support organisations and websites (for example, www.britishfibroidtrust.org.uk; www.patient.co.uk/health/fibroids-leaflet) so that she can participate in the discussion regarding her further management.
Working with secondary care
In order to facilitate referral to secondary care, the GP should ensure that:
- ahead of referral, as a minimum, the patient has been examined, medical treatment initiated, and an ultrasound scan requested
- if a specific type of interventional procedure is desired, refer the woman to a specific service based on local commissioning arrangements
- the referral letter should provide sufficient information for the receiving clinician to act upon.
Following referral, if the secondary care specialist requests follow-on prescribing, the primary care professional should check that the patient has been appropriately counselled in secondary care and that they will review the treatment plan. If taking prescribing responsibility, the clinician signing the prescription should ensure they understand the treatment being authorised. The dose and frequency should be specified by the specialist, especially if the drug is being used off-licence. Contact the initiator to clarify if these instructions are not explicit.
Fibroids are common and may or may not be a problem to the woman herself. If they are not, then no intervention is required as the risk of malignant change is small. There is no certainty that growth will occur or problems develop. Women can be counselled and reassured in the primary care setting. The patient should, however, feel confident to consult her GP again if her symptoms change.
In making a clinical decision to treat fibroids, the impact of the condition and the patient's health and background should be weighed against the treatment being considered. Most heavy bleeding can be effectively managed with pharmaceutical options and, increasingly, we are also seeing the bulk effects of fibroids managed medically. While the latter is not generally initiated in primary care, shared-care arrangements may lead to requests to issue prescriptions. Good medical practice requires that if that is the case, whoever signs the prescription should be confident to take responsibility and that they understand the product involved.
Assessment and management of fibroids is neither complex nor difficult, and following a simple set of decision-making guides should increase primary care practitioners' confidence. This will then avoid unnecessary referral, enable effective management when this is needed, but reassurance where it is not, to the benefit both of the patient and the health economy.
- Fibroids may be asymptomatic and an incidental finding
- Presentation of symptoms to primary care is most commonly associated with heavy bleeding and/or problems arising from uterine bulk
- Examine the patient
- Consider possible risks of other pathology and refer if indicated
- Check a full blood count if bleeding is heavy
- Ultrasound imaging will provide necessary information about number, size, and location of fibroids
- Manage heavy bleeding whether or not the patient is investigated or referred
- Discuss all management options with the patient— though be aware that no action may be indicated
- Most pharmaceutical options can be offered and provided in the primary care setting without a specialist opinion
- If referring, consider the most likely option to be chosen and refer appropriately.
GP commissioning messages
written by Dr David Jenner, NHS Alliance GMS contract/PBC Lead
- Uterine fibroids are common and are often associated with HMB. They can usually be managed in primary care
- Commissioners should:
- consider using articles like this to create primary care pathways for the management of HMB and uterine fibroids, with identified investigations and referral triggers
- ensure they have local enhanced services in place to incentivise IUS insertions for HMB in primary care (IUSs for contraception are the responsibility of Public Health to commission
- Clinical commissioning groups and referral management centres could define a minimum data set to be included in referrals, to:
- ensure referrals are appropriate
- capture key information
- To support GPs, auto-consultation or problem-orientated templates can be designed and added to practice software systems to guide GPs through the required elements of a pathway and prompt accurate history taking and discussion with the patient
- Tariff costs for gynaecology outpatients: £131 (new), £80 (follow up); ultrasound (outpatient) £44–£56.a
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- Haney A. Clinical decision making regarding leiomyomata: what we need in the next millenium. Environ Health Perspect 2000; 108 (Suppl. 5): 835–839.
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- NICE. Heavy menstrual bleeding. Clinical guideline 44. NICE, 2007. Available at: www.nice.org.uk/cg044
- NICE. Heavy menstrual bleeding. Quality Standard 47. NICE, 2013. Available at: www.nice.org.uk/guidance/qs47
- Royal College of Obstetricians and Gynaecologists. National heavy menstrual bleeding audit. Second annual report. RCOG Press, 2012. Available at: bit.ly/RCOG_2012
- Faculty of Sexual & Reproductive Healthcare Clinical Guidance. Management of unscheduled bleeding in women using hormonal contraception. FSRH: 2009. Available at: bit.ly/FSRH_09
- General Medical Council. Good practice in prescribing and managing medicines and devices. London: GMC, 2013. Available at: www.gmc-uk.org/guidance/ethical_guidance/14316.asp (accessed 23 January 2015).