History

1.2.1.

Take a history from the woman that covers:

• the nature of the bleeding
• related symptoms, such as persistent intermenstrual bleeding, pelvic pain and/or pressure symptoms, that might suggest uterine cavity abnormality, histological abnormality, adenomyosis or fibroids
• impact on her quality of life
• other factors that may affect treatment options (such as comorbidities or previous treatment for HMB). [2007, amended 2018]

1.2.2.

Take into account the range and natural variability in menstrual cycles and blood loss when diagnosing HMB, and discuss this variation with the woman. If the woman feels that she does not fall within the normal ranges, discuss care options. [2007]

1.2.3.

If the woman has a history of HMB without other related symptoms (see recommendation 1.2.1), consider pharmacological treatment without carrying out a physical examination (unless the treatment chosen is levonorgestrel-releasing intrauterine system [LNG IUS]). [2007, amended 2018]

Note that this is an off-label use for some LNG-IUSs. See NICE’s information on prescribing medicines.

Physical examination

1.2.4.

If the woman has a history of HMB with other related symptoms (see recommendation 1.2.1) offer a physical examination. [2007, amended 2018]

1.2.5.

Carry out a physical examination before all investigations or LNG-IUS fittings. [2007]

Note that this is an off-label use for some LNG-IUSs. See NICE’s information on prescribing medicines.

Laboratory tests

1.2.6.

Carry out a full blood count test for all women with HMB, in parallel with any HMB treatment offered. [2007]

1.2.7.

Testing for coagulation disorders (for example, von Willebrand’s disease) should be considered for women who:

• have had HMB since their periods started and
• have a personal or family history suggesting a coagulation disorder. [2007]

1.2.8.

Do not routinely carry out a serum ferritin test for women with HMB. [2007]

1.2.9.

Do not carry out female hormone testing for women with HMB. [2007]

1.2.10.

Do not carry out thyroid hormone testing for women with HMB unless other signs and symptoms of thyroid disease are present. [2007]

Before starting investigations

1.3.1.

Consider starting pharmacological treatment for HMB without investigating the cause if the woman’s history and/or examination suggests a low risk of fibroids, uterine cavity abnormality, histological abnormality or adenomyosis. [2018]

1.3.2.

If cancer is suspected, see the NICE guideline on suspected cancer: recognition and referral. [2007]

Investigations

1.3.3.

Take into account the woman’s history and examination when deciding whether to offer hysteroscopy or ultrasound as the first-line investigation. [2018]

Other diagnostic tools

1.3.16.

Do not use saline infusion sonography as a first-line diagnostic tool for HMB. [2007]

1.3.17.

Do not use MRI as a first-line diagnostic tool for HMB. [2007]

1.3.18.

Do not use dilatation and curettage alone as a diagnostic tool for HMB. [2007]

Levonorgestrel-releasing intrauterine system (LNG-IUS)

1.4.3.

Explain to women who are offered an LNG-IUS:

• about anticipated changes in bleeding pattern, particularly in the first few cycles and maybe lasting longer than 6 months
• that it is advisable to wait for at least 6 cycles to see the benefits of the treatment. [2007]

Note that this is an off-label use for some LNG-IUSs. See NICE’s information on prescribing medicines.

Impact of treatments on fertility

1.4.4.

Explain to women about the impact on fertility that any planned surgery or uterine artery embolisation may have, and if a potential treatment (hysterectomy or ablation) involves loss of fertility then opportunities for discussion should be made available. [2007]

1.4.5.

Explain to women that uterine artery embolisation or myomectomy may potentially allow them to retain their fertility. [2007]

Endometrial ablation

1.4.6.

Advise women to avoid subsequent pregnancy and use effective contraception, if needed, after endometrial ablation. [2007]

Hysterectomy

1.4.7.

Have a full discussion with all women who are considering hysterectomy about the implications of surgery before a decision is made. The discussion should include:

• sexual feelings
• impact on fertility
• bladder function
• need for further treatment
• treatment complications
• her expectations
• alternative surgery
• psychological impact. [2007]

1.4.8.

Inform women about the increased risk of serious complications (such as intraoperative haemorrhage or damage to other abdominal organs) associated with hysterectomy when uterine fibroids are present. [2007]

1.4.9.

Inform women about the risk of possible loss of ovarian function and its consequences, even if their ovaries are retained during hysterectomy. [2007]

Treatments for women with no identified pathology, fibroids less than 3 cm in diameter, or suspected or diagnosed adenomyosis

1.5.2.

Consider an LNG-IUS as the first treatment for HMB in women with:

• no identified pathology or
• fibroids less than 3 cm in diameter, which are not causing distortion of the uterine cavity or
• suspected or diagnosed adenomyosis. [2018]

Note that this is an off-label use for some LNG-IUSs. See NICE’s information on prescribing medicines.

1.5.3.

If a woman with HMB declines an LNG-IUS or it is not suitable, consider the following pharmacological treatments:

• non-hormonal:

  –

  tranexamic acid

  –

  NSAIDs (non-steroidal anti-inflammatory drugs)

• hormonal:

  –

  combined hormonal contraception

  –

  cyclical oral progestogens. [2018]

Note that this is an off-label use for NSAIDs and some combined hormonal contraceptives. See NICE’s information on prescribing medicines.

1.5.4.

Be aware that progestogen-only contraception may suppress menstruation, which could be beneficial to women with HMB. [2018]

1.5.5.

If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, consider referral to specialist care for:

• investigations to diagnose the cause of HMB, if needed (see section 1.3) taking into account any investigations the woman has already had and
• alternative treatment choices, including:

  –

  pharmacological options not already tried (see recommendations 1.5.2 and 1.5.3)

  –

  surgical options:

  ◇

  second-generation endometrial ablation

  ◇

  hysterectomy. [2018]

1.5.6.

For women with submucosal fibroids, consider hysteroscopic removal. [2018]

Treatments for women with fibroids of 3 cm or more in diameter

1.5.7.

Consider referring women to specialist care to undertake additional investigations and discuss treatment options for fibroids of 3 cm or more in diameter. [2018]

1.5.8.

If pharmacological treatment is needed while investigations and definitive treatment are being organised, offer tranexamic acid and/or NSAIDs. [2007]

Note that this is an off-label use for NSAIDs. See NICE’s information on prescribing medicines.

1.5.9.

Advise women to continue using NSAIDs and/or tranexamic acid for as long as they are found to be beneficial. [2007]

Note that this is an off-label use for NSAIDs. See NICE’s information on prescribing medicines.

1.5.10.

For women with fibroids of 3 cm or more in diameter, take into account the size, location and number of fibroids, and the severity of the symptoms and consider the following treatments:

• pharmacological:

  –

  non-hormonal:

  ◇

  tranexamic acid

  ◇

  NSAIDs

  –

  hormonal:

  ◇

  LNG-IUS

  ◇

  combined hormonal contraception

  ◇

  cyclical oral progestogens

  ◇

  ulipristal acetate (this is only indicated for some premenopausal women; see recommendations 1.5.11 and 1.5.12 for more information) [amended 2021]

• uterine artery embolisation for fibroids
• surgical:

  –

  myomectomy

  –

  hysterectomy.

Note that this is an off-label use for NSAIDs and some LNG-IUSs. See NICE’s information on prescribing medicines. [2018]

1.5.11.

Only think about ulipristal acetate for the intermittent treatment of moderate to severe symptoms of uterine fibroids in premenopausal women if:

• surgery and uterine artery embolisation for fibroids are not suitable, for example, because the risks to a woman outweigh the possible benefits, or
• surgery and uterine artery embolisation for fibroids have failed, or
• the woman declines surgery and uterine artery embolisation for fibroids.

See the MHRA drug safety update on ulipristal acetate. [2021]

1.5.12.

Discuss with the woman the risks and possible benefits of intermittent treatment with ulipristal acetate.

• Advise that ulipristal acetate can be associated with serious liver injury leading to liver failure, and the signs and symptoms to look out for.
• Measure liver function before starting ulipristal acetate, monthly for the first 2 courses and once before each new treatment course when clinically indicated.
• If there is no underlying liver injury, and surgery and uterine artery embolisation for fibroids are unsuitable or have failed, consider ulipristal acetate 5 mg (up to 4 courses) for premenopausal women with heavy menstrual bleeding and fibroids of 3 cm or more in diameter, particularly if the haemoglobin level is 102 g per litre or below.
• If a woman shows signs and symptoms of liver failure, stop ulipristal acetate and perform liver function tests urgently. [2021]

1.5.13.

Be aware that the effectiveness of pharmacological treatments for HMB may be limited in women with fibroids that are substantially greater than 3 cm in diameter. [2018, amended 2020]

1.5.14.

Prior to scheduling of uterine artery embolisation or myomectomy, the woman’s uterus and fibroid(s) should be assessed by ultrasound. If further information about fibroid position, size, number and vascularity is needed, MRI should be considered. [2007]

1.5.15.

Consider second-generation endometrial ablation as a treatment option for women with HMB and fibroids of 3 cm or more in diameter who meet the criteria specified in the manufacturers’ instructions. [2018]

1.5.16.

If treatment is unsuccessful:

• consider further investigations to reassess the cause of HMB (see section 1.3), taking into account the results of previous investigations and
• offer alternative treatment with a choice of the options described in recommendation 1.5.10. [2018]

1.5.17.

Pretreatment with a gonadotrophin-releasing hormone analogue before hysterectomy and myomectomy should be considered if uterine fibroids are causing an enlarged or distorted uterus. [2007, amended 2020]

Note that this is an off-label use for some gonadotrophin-releasing hormone analogues. See NICE’s information on prescribing medicines.

Route and method of hysterectomy

1.5.18.

When discussing the route of hysterectomy (laparoscopy, laparotomy or vaginal) with the woman, carry out an individual assessment and take her preferences into account. [2007, amended 2018]

1.5.19.

Discuss the options of total hysterectomy (removal of the uterus and the cervix) and subtotal hysterectomy (removal of the uterus and retention of the cervix) with the woman. [2007, amended 2018]

Removal of ovaries (oophorectomy) with hysterectomy

1.5.20.

Only remove ovaries with hysterectomy with the express wish and informed consent of the woman, after discussion of all associated risks and benefits. [2007, amended 2018]

Dilatation and curettage

1.5.21.

Do not offer dilatation and curettage as a treatment option for HMB. [2007]

1.5.22.

If dilatation is needed for non-hysteroscopic endometrial ablation:

• confirm that there is no evidence of uterine perforation or false passage
• use hysteroscopy before inserting the ablation device, to establish the condition of the uterus
• ultrasound may be used to ensure correct uterine placement of the ablation device; if the device uses a balloon, keep this inflated during the ultrasound scan. [2007, amended 2018]

Why this is important

There is no consensus about the best test-and-treat strategy for women with HMB, and empiric pharmacological treatment is often initiated as a first treatment without investigation. Parameters of diagnostic accuracy give useful information about a test’s ability to detect a condition (or the absence of a condition). But accurate diagnosis does not automatically result in a better overall outcome for the woman, because this also depends on treatment decisions after the diagnosis is made. However, it is thought that optimal treatment depends on accurate diagnosis of the underlying pathology causing HMB.

In the absence of clinical trials, decision analytical economic models evaluating all possible outpatient testing algorithms have indicated that using ultrasound or hysteroscopy for initial diagnostic testing for women with HMB are the most effective diagnostic strategies. Pelvic ultrasound has been most commonly used because it has been more widely available and is considered less intrusive than hysteroscopy. However, advances in technology mean that the hysteroscopy is well tolerated in the outpatient setting, and it can potentially be performed outside the traditional hospital environment in a community setting. Moreover, in contrast with ultrasound, hysteroscopy allows concomitant treatment of intrauterine pathologies such as submucosal fibroids and endometrial polyps. It also facilitates the fitting of levonorgestrel-releasing intrauterine systems (LNG-IUS).

A test-and-treat randomised controlled trial with cost-effectiveness analysis could help to answer the crucial question of whether hysteroscopy improves outcomes for women and results in more effective use of NHS resources.

Why this is important

Many women use LNG-IUS as the first-line pharmacological treatment for HMB, but it is not acceptable to all women. Combined oral contraceptives have also been shown to be effective for treating HMB, but their use is contraindicated in some women. Other progestogens used for contraception have far fewer contraindications than combined contraceptives, but their effectiveness as a treatment for HMB has not been studied.

A randomised controlled trial or cohort prospective observational study could compare the effectiveness of progestogens with other pharmacological treatments for HMB.

Why this is important

Adenomyosis is common, and the symptoms cause significant morbidity, including restriction of daily activities. A wide range of incidences have been suggested, but most studies report a prevalence of between 20 and 35%. Despite this, there is little evidence about the impact of adenomyosis on symptoms of HMB or the best treatment for this condition. Optimising treatment can lead to better patient satisfaction and the avoidance of unnecessary investigations and treatments. In order to do this, a better understanding of the impact of adenomyosis in causing HMB, pain and subfertility is needed.

A prospective clinical registry would allow long-term clinical outcomes such as patient satisfaction and re-intervention for refractory symptoms, to be recorded after pharmacological and uterine-sparing surgical treatments for women with adenomyosis.

Why this is important

HMB is thought to be caused by submucosal fibroids in around 15% of women. Such fibroids are amenable to minimally invasive surgical removal (‘hysteroscopic myomectomy’), avoiding the need for surgical incision. Non-comparative data have reported improvement in HMB symptoms and the avoidance of further pharmacological or surgical treatment in 70 to 80% of women treated with hysteroscopic myomectomy.

Specific hysteroscopic surgical skills are necessary to optimise surgical success and minimise complications. However, recent advances in endoscopic technologies have made hysteroscopic myomectomy potentially safer and more feasible.

A randomised controlled trial comparing this technique with long-term pharmacological therapy or more invasive surgical intervention would provide information on long-term outcomes.

Why this is important

With the wider availability of high-resolution transvaginal pelvic ultrasound, adenomyosis and fibroids have been recognised as 2 of the most common uterine pathologies in women presenting with HMB. Pharmacological treatments appear to be less effective in the presence of these conditions, making referral to specialist care for surgery more likely.

Second-generation endometrial ablation is a minimally invasive, uterine-sparing surgical procedure, but its effectiveness in women with adenomyosis or uterine fibroids is unclear. Thus women with these conditions may be denied second-generation endometrial ablation and undergo unnecessary invasive surgery such as hysterectomy. On the other hand, women may be subjected to ineffective second-generation endometrial ablation that delays more effective treatment such as hysterectomy. It is therefore important to evaluate the effectiveness of second-generation endometrial ablation in women with these conditions, and a cohort controlled study is suggested as the best approach for doing this.

Why the committee made the recommendations

How the 2018 recommendations might affect practice

Why the committee made the recommendations

The committee emphasised the importance of talking to the woman about her needs and preferences when deciding on treatments for HMB. This includes any plans for pregnancy and whether she wants to retain her uterus or fertility. The committee also highlighted that the cause of HMB and other symptoms should be taken into account. This is to ensure that the most appropriate management strategy is offered to the woman.

How the 2018 recommendations might affect practice

The committee noted that the recommendations should reinforce current best practice and help to reduce variation in clinical practice for the treatment of HMB.

In current practice, hysterectomy is a second-line treatment strategy for heavy menstrual bleeding, for which women need to have tried first-line treatment strategies, and for these to be unsuccessful, before being offered a hysterectomy. Offering hysterectomy as a first-line treatment option may result in an increase in hysterectomies. However, only a small group of women are expected to choose the procedure as first-line treatment.

For full details of the evidence and the committee’s discussion see evidence review B: management of heavy menstrual bleeding.