Update information

Update information

November 2018: References to ulipristal acetate (Esmya) were reinstated after the European Medicines Agency completed its review on the use of Esmya for uterine fibroids, and more information on shared decision making and monitoring for side effects has been included. The accompanying visual summary has also been updated.

The recommendations are marked as:

  • [Nov 2018] if the evidence was reviewed in November 2018

  • [2018, amended Nov 2018] if the evidence was reviewed in 2018, but changes were made to the recommendation wording in November 2018 that changed the meaning

  • [2007, amended 2018, amended Nov 2018] if the evidence was reviewed in 2018, but changes were made to the recommendation wording in March 2018 and November 2018 that changed the meaning.

March 2018: This guideline is an update of NICE guideline CG44 (published January 2007) and replaces it.

New recommendations have been added on investigations for heavy menstrual bleeding (HMB) and management.

The recommendations are marked as:

  • [2018] if the evidence was reviewed in 2018

  • [2016] if the evidence was reviewed in 2016

  • [2007] if the evidence was reviewed in 2007

  • [2007, amended 2018] if the evidence was reviewed in 2007, but changes were made to the recommendation wording in 2018 that changed the meaning.

References to ulipristal acetate (Esmya) were removed from this guideline because the European Medicines Agency was reviewing the use of Esmya for uterine fibroids and had introduced temporary safety measures.

Amended recommendation wording (change to meaning)

Recommendation in 2007 guideline

Recommendation in current guideline

Reason for change

Initially, a history should be taken from the woman. This should cover the nature of the bleeding, related symptoms that might suggest structural or histological abnormality (see recommendation 1.2.4), impact on quality of life and other factors that may determine treatment options (such as presence of comorbidity). (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] (1.2.1)

Symptoms related to HMB have been added here instead of cross-referencing to a later recommendation for clarity. 'Persistent' was added because occasional intermenstrual bleeding is quite common but if it is persistent it might indicate an underlying problem.

'Structural abnormality' has been replaced by 'uterine cavity abnormality' because this is a more precise term.

Adenomyosis has been added, because diagnosis and treatment of this condition is now covered in the guideline update.

Fibroids have been added to include fibroids outside the uterine cavity.

Previous treatment for HMB was added because it is important to know if any treatment has failed previously.

If the history suggests HMB without structural or histological abnormality, pharmaceutical treatment can be started without carrying out a physical examination or other investigations at initial consultation in primary care, unless the treatment chosen is levonorgestrel-releasing intrauterine system (LNG IUS) (see recommendation 1.2.6). (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] (1.2.3)

To avoid repetition and to add clarity 'structural or histological abnormality' was replaced by 'other related symptoms (see recommendation 1.2.1)'.

The verb has been changed to 'consider' in line with current NICE style and the management recommendations.

'Or other investigations at initial consultation in primary care' has been taken out to avoid overlap with another recommendation (1.3.2) that covers investigation.

Text has been moved to clarify the meaning.

If the history suggests HMB with structural or histological abnormality, with symptoms such as intermenstrual or postcoital bleeding, pelvic pain and/or pressure symptoms, a physical examination and/or other investigations (such as ultrasound) should be performed. (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] (1.2.4)

List of symptoms has been taken out and added to an earlier recommendation instead (see recommendation 1.2.1).

The verb has been changed to 'offer' in line with current NICE style.

'And/or other investigations (such as ultrasound) should be performed' has been taken out because this section covers physical examination and investigations are covered in section 1.3.

If appropriate, a biopsy should be taken to exclude endometrial cancer or atypical hyperplasia. Indications for a biopsy include, for example, persistent intermenstrual bleeding, and in women aged 45 and over, treatment failure or ineffective treatment. (1.2.13)

Consider endometrial biopsy at the time of hysteroscopy for women who are at high risk of endometrial pathology, such as:

• women with persistent intermenstrual or persistent irregular bleeding, or women with infrequent heavy bleeding who are obese or have polycystic ovary syndrome

• women taking tamoxifen

• women for whom treatment for HMB has been unsuccessful. [2007, amended 2018] (1.3.10)

The committee amended this recommendation to reflect current practice by:

• using the verb 'consider' for consistency with current style

• specifying endometrial biopsy for clarity

• adding 'at the time of hysteroscopy', for consistency with the updated recommendations about diagnosis

• changing 'hyperplasia' for 'pathology' for consistency with other recommendations

• removing the age cut-off, because it is no longer relevant

• amending the groups of women who are at higher risk of endometrial pathology, to ensure that women at risk are correctly identified and offered appropriate investigations.

Pretreatment before hysterectomy and myomectomy with a gonadotrophin-releasing hormone analogue for 3 to 4 months should be considered where uterine fibroids are causing an enlarged or distorted uterus. (1.7.8)

Pretreatment with gonadotrophin-releasing hormone analogue before hysterectomy and myomectomy should be considered if uterine fibroids are causing an enlarged or distorted uterus. [2007, amended 2018] (1.5.17)

Ulipristal acetate was added as a pretreatment, reflecting the 2016 recommendations on ulipristal acetate, but was removed before publication. See information on EMA review and temporary safety measures.

The length of treatment was deleted, because this would depend on the agent.

Taking into account the need for individual assessment, the route of hysterectomy should be considered in the following order: first line vaginal; second line abdominal. (1.8.6)

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] (1.5.18)

The comparison between different routes of hysterectomy was out of the scope of the protocol. The committee agreed the old recommendation is no longer valid, because the laparoscopic route is usually preferable. However, they agreed to place the emphasis on women's choice.

Removal of ovaries should only be undertaken with the express wish and consent of the woman. (1.9.2)

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] (1.5.20)

The committee did not review removal of ovaries with hysterectomy, but agreed it is essential to specify that a full discussion of risks and benefits is needed.

Where dilatation is required for non-hysteroscopic ablative procedures, hysteroscopy should be used immediately prior to the procedure to ensure correct placement of the device. (1.2.21)

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] (1.5.22)

The recommendation has been amended by the committee to reflect the latest guidance from the Medicines and Healthcare products Regulatory Agency (MHRA).

ISBN: 978-1-4731-2777-7

  • National Institute for Health and Care Excellence (NICE)