- pharmaceutical treatment should be considered where no structural or histological abnormality is present, or for fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity
- if history and investigations indicate that pharmaceutical treatment is appropriate and either hormonal or non-hormonal treatments are acceptable, then NICE have suggested that treatments should be considered in the following order:
- levonorgestrel-releasing intrauterine system [LNG IUS] should be considered 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
- 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
- note that progestogen-only contraception may suppress menstruation, which could be beneficial to women with HMB
- 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 required taking into account any investigations the woman has already had and
- alternative treatment choices, including:
- pharmacological options not already tried
- surgical options:
- second-generation endometrial ablation
- hysterectomy
- for women with submucosal fibroids, consider hysteroscopic removal
- Treatments for women with fibroids of 3 cm or more in diameter
- consider referring women to specialist care to undertake additional investigations and discuss treatment options for fibroids of 3 cm or more in diameter
- or 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:
- hormonal:
- LNG-IUS[1]
- combined hormonal contraception[3]
- cyclical oral progestogens
- uterine artery embolisation
- surgical:
- An MRHA alert stated (1): Advice for healthcare professionals:
- Esmya (ulipristal acetate) for uterine fibroids:
- contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. The licence for Esmya has been suspended to protect public health while a safety review is conducted following a further case of liver injury requiring transplant
- contact patients currently being treated with Esmya as soon as possible and stop their treatment; discuss alternative treatment options for uterine fibroids as appropriate
- do not start any new patients on Esmya
- advise recent users to seek immediate medical attention if they develop signs and symptoms of liver injury (nausea, vomiting, malaise, right hypochondrial pain, anorexia, asthenia or jaundice)
- perform liver function tests 2–4 weeks after stopping Esmya as recommended in the product information
- report suspected adverse drug reactions without delay to the Yellow Card Scheme
- there are no concerns with emergency contraceptive ellaOne (ulipristal acetate 30mg single dose) at this time
- pretreatment with a gonadotrophin-releasing hormone analogue[4] before hysterectomy and myomectomy should be considered if uterine fibroids are causing an enlarged or distorted uterus
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
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.
[1] At the time of publication (November 2018), not all LNG-IUSs have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Prescribing guidance: prescribing unlicensed medicines for further information.
[2] At the time of publication (November 2018), NSAIDs do not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Prescribing guidance: prescribing unlicensed medicines for further information.
[3] At the time of publication (November 2018), not all combined hormonal contraceptives have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Prescribing guidance: prescribing unlicensed medicines for further information.
[4] At the time of publication (November 2018), not all gonadotrophin-releasing hormone analogues have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Prescribing guidance: prescribing unlicensed medicines for further information.
Notes:
- if menorrhagia/heavy menstrual bleeding (HMB) coexists with dysmenorrhoea, the use of NSAIDs should be preferred to tranexamic acid
- with respect to NSAIDs and/or tranexamic acid
- ongoing use of NSAIDs and/or tranexamic acid is recommended for as long as it is found to be beneficial by the woman
- if there is no improvement in symptoms within 3 menstrual cycles then use of NSAIDs and/or tranexamic acid should be stopped
- NICE suggest that danazol should not be used routinely for the treatment of HMB
- danazol
- competitively binds sex hormones to their receptors and inhibits their production by direct enzymatic action
- given orally
- may cause endometrial atrophy in older women
Reference:
- NICE (August 2016). Heavy menstrual bleeding
- NICE (November 2018) Heavy menstrual bleeding
- MHRA (March 18th 2020). Esmya (ulipristal acetate): suspension of the licence due to risk of serious liver injury