NICE heavy menstrual bleeding guidance highlights the importance of a woman's quality of life and keeping the patient informed, explains Dr Mark Shapley

C onsiderable advances have been made in the management of heavy menstrual bleeding (HMB) over recent years, with the introduction of the levonorgestrel-releasing intrauterine system (LNG-IUS), and improved surgical techniques for endometrial ablation. Although hysterectomy numbers are falling, there are concerns that rates may still be too high, but not at a high enough level to enable gynaecologists to achieve and maintain surgical competence.

These developments highlighted the need to update the guidelines on menorrhagia produced by the Royal College of Obstetricians and Gynaecologists (RCOG) in 1998.1 In January 2007, the NICE guideline on HMB2, 3 was published.

How prevalent is heavy menstrual bleeding?

Community surveys have shown a prevalence of HMB of between 4% and 52%, depending on the definition (see below).4,5 Consultation rates with GPs indicate that about 5% of women will consult the doctor each year with HMB.6 It is, therefore, a condition that is commonly encountered in primary care.

What is heavy menstrual bleeding?

There are two methods of defining HMB: within a psychosocial model of healthcare, based on the woman's reported symptoms; or within a biomedical model based on the direct or indirect measurement of the volume of menstrual blood loss.

This has caused considerable controversy, but the NICE guideline has favoured the psychosocial model, focusing on the impact the condition has on a woman's quality of life. According to NICE, 'HMB is defined as excessive menstrual loss that interferes with a woman's physical, social, emotional and/or material quality of life. It can occur alone or with other symptoms. Any interventions should aim to improve quality of life measures.'2 It is an important problem for women, affecting all aspects of well-being, including feelings of femininity, fertility, and sexuality.

How robust is the evidence?

One of the difficulties in producing recommendations is the lack of studies in primary care. There is no evidence on history taking and physical examination.3 The evidence base improves for investigations, but the majority of studies on HMB are based on interventions within secondary care populations. The lowest level of evidence in the NICE classification is Grade D [GPP] (good practice point) and is based on expert opinion provided by the experiences of the members of the guideline development group. It is this level that applies to most of the recommendations for primary care, with the exception of therapy.

History taking

Patients often present to their GP with a disorganised history of illness and multiple symptoms.7 Part of the role of the primary care clinician is to define the presenting condition so that the appropriate guideline for management may be used. Once the problem has been established, it is important to detect symptoms that may indicate other significant pathology requiring action, as well as initiate pharmaceutical treatment.

The red flag symptoms are:2

  • intermenstrual bleeding—the recommendations concerning this symptom are derived from the NICE guideline on referral for suspected cancer8
  • postcoital bleeding—this has a greater association with sexually transmitted disease than with cervical cancer9
  • pelvic pain—suggestive of pelvic inflammatory disease and endometriosis
  • pressure symptoms such as bladder disturbance and a feeling of fullness in the abdomen or pelvis—these raise the possibility of the presence of large fibroids.

There may also be other factors present that will determine treatment options, such as fertility and the need for contraception, the need for opportunistic cervical screening, age, and likelihood of the onset of the menopause.

Patient-centred care

Patient representatives were present within the guideline development group and it was clear that there is a need for clinicians to provide holistic and personalised care. They must respect the right of a woman to be involved in the decision-making process and recognise the feelings of fear, anxiety, and vulnerability that she may have, as well as the presence of ambivalence (positive and negative feelings resulting in difficulties in expressing a clear opinion).

Physical examination

It is a principle of primary care that a procedure should only be undertaken if it will change the management of the case. It is important to take a good medical history at presentation to exclude red flag symptoms, which may indicate a significant structural or histological abnormality. If there are no such symptoms, and the woman does not request a pelvic examination, there is no need to perform one prior to initiating pharmaceutical treatment, except in the circumstances listed in Box 1.

Box 1: Indications for pelvic examination

  • Red flag symptoms — intermenstrual bleeding, postcoital bleeding, pelvic pain, and pressure symptoms
  • Before LNG-IUS fitting
  • Prior to referral for structural investigation
  • Prior to undertaking histological investigation or referring the patient for investigation elsewhere
  • In the case of failure of treatment
HMB=heavy menstrual bleeding; LNG-IUS=levonorgestrel-releasing intrauterine system

Investigations

It is clinically difficult to diagnose anaemia and, therefore, it is recommended that all women with HMB have a full blood count.2 There is no need to undertake routine testing for ferritin levels or perform hormone analysis (sex or thyroid, unless other signs and symptoms of thyroid disease are present).

Tests for coagulation disorders (such as von Willebrand's disease) should be undertaken in women who have had HMB since menarche, and who have a family history suggestive of a coagulation disorder. They may also have a personal history of a bleeding tendency (such as recurrent epistaxis or bleeding post-operatively, including after dental extraction).

The first-line investigation for structural abnormalities is a transvaginal ultrasound scan (see Box 2).

Immediate referral to a specialist should be offered: if the scan shows intracavity fibroids, if the uterine length is greater than 12 cm, or if the uterus is palpable abdominally. At referral, pharmaceutical therapy should be initiated or changed but it is unlikely to be beneficial and surgical treatment of the fibroids will probably be needed. Saline ultrasonography and magnetic resonance imaging are not recommended on health economic analysis.

Investigation for histological abnormality is aimed at excluding the diagnosis of endometrial hyperplasia with cytological atypia or endometrial cancer. Heavy menstrual bleeding has a poor positive predictive value for these conditions in primary care populations. The NICE guideline suggests that endometrial biopsy need only be undertaken in women with persistent intermenstrual bleeding, or in women aged 45 years and over, in whom medical treatment has failed or is ineffective.2 There is no recommendation as to how the biopsy should be taken (whether by endometrial sample or hysteroscopy), except that it should not be done by dilatation and curettage, which has a higher complication rate than endometrial sampling and is less accurate than hysteroscopy.

Box 2: Indications for a transvaginal ultrasound scan

  • The uterus is palpable abdominally
  • Vaginal examination reveals a mass of uncertain origin
  • Failed pharmaceutical treatment

Pharmaceutical treatment

The NICE guideline2, 3 is generally the same as the RCOG 1998 guideline,1 except that use of the LNG-IUS has been given much greater emphasis in the former. Two systematic reviews10, 11demonstrated the effectiveness of the LNG-IUS, and economic modelling showed it to be the most cost-effective pharmaceutical method, provided long-term use was anticipated.3 It should be considered first in women in whom hormonal treatment is acceptable.2

Tranexamic acid, non-steroidal anti-inflammatory drugs, and the combined oral contraceptive pill should be given equal second consideration. The first two drugs should be given equal first consideration in women who do not wish to use hormones. High-dose norethisterone (15 mg daily from days 5 to 26 of the menstrual cycle), or long-acting progestogens (depot medroxyprogesterone acetate 150 mg every 12 weeks) is the third option in women for whom hormonal treatment is acceptable.

Other pharmaceutical treatments are not recommended because they are either ineffective (e.g. low-dose oral progestogens given during the luteal phase), or there is a high incidence of side-effects (e.g. danazol).3

Surgical treatment

In women with small fibroids (less than 3 cm in diameter), or who have none, treatment by endometrial ablation should be considered first. It should, however, be remembered that the woman should have completed her family (the procedure increases the risk of placenta accreta). She will need to use contraception following the surgery (it is not a method of contraception).

For women with large fibroids (greater than 3 cm in diameter) uterine artery embolisation, myomectomy, and hysterectomy should be considered. The first two techniques will enable the woman to retain her uterus and potentially her fertility. If a hysterectomy is decided upon, the vaginal route should be considered before the abdominal approach as it carries a lower complication rate and faster recovery time.3

Summary

The NICE guideline2,3 puts the woman at the centre of care and emphasises that good care is underpinned by respect and information. There is an excellent patient information booklet on understanding the guidance available free from the NICE website.12 Primary care trusts, in combination with practice-based commissioners, must now develop care pathways to meet the needs of women.

NICE implementation tools

NICE has developed the following tools to support implementation of its guideline on the management of urinary incontinence in women. They are now available to download from the NICE website: www.nice.org.uk.

Implementation advice
The implementation advice document contains suggested actions for implementing the guideline. It aims to help implementers identify recommendations in the guideline that are not part of current practice, and should be used alongside the costing report and template.

Slide set
The slides are aimed at supporting organisations to raise awareness of the guidelines at a local level and can be edited to cater for local audiences. They do not cover all the recommendations from the guideline but contain key messages, and should be used in conjunction with the Quick Reference Guide.

Costing tools
National cost reports and local cost templates for the guideline have also been produced. Costing reports are estimates of the national cost impact arising from implementation based on assumptions about current practice, and predictions of how it might change following implementation of the guideline. Costing templates are spreadsheets that allow individual NHS organisations and local health economies to estimate the costs of implementation taking into account local variation from the national estimates, and they quickly assess the impact the guideline may have on local budgets.

Audit criteria
The audit criteria and audit reporting template have been developed to assist NHS trusts to determine whether the service is implementing, and is in compliance with, the clinical guideline. Users can cut and paste the criteria into their own programmes or they can use the template provided.

Practice-based commissioing take home messages

  • Modern developments offer more non-surgical options to manage HMB
  • Key tariff prices:1
      • total hysterectomy = £2633
      • non-surgical treatment of fibroids (admitted) = £460
      • gynaecology outpatient attendance = £138 (new), £76 (follow-up)
  • As HMB is a common condition, savings could be easily produced by a local GPwSI seeing patients and offering non-surgical treatments (e.g. LNG-IUS for HMB) and undercutting the tariff price
  • Gynaecology was one of the six areas identified in the White Paper that seeks to move more work out of hospitals into the community2

1 www.dh.gov.uk/paymentbyresults
2 Department of Health. Our Health, Our Care, Our Say: a new direction for community services. London: Department of Health, 2006

HMB=heavy menstrual bleeding; LNG-IUS=levonorgestrel-releasing intrauterine system

  • Modern developments offer more non-surgical options to manage HMB
  • Key tariff prices:1
      • total hysterectomy = £2633
      • non-surgical treatment of fibroids (admitted) = £460
      • gynaecology outpatient attendance = £138 (new), £76 (follow-up)
  • As HMB is a common condition, savings could be easily produced by a local GPwSI seeing patients and offering non-surgical treatments (e.g. LNG-IUS for HMB) and undercutting the tariff price
  • Gynaecology was one of the six areas identified in the White Paper that seeks to move more work out of hospitals into the community2
  1. Royal College of Obstetricians and Gynaecologists. The initial management of menorrhagia. Evidence-based Guidelines, No 1. London: RCOG, 1998.
  2. National Institute for Health and Care Excellence. Heavy menstrual bleeding. Clinical guideline 44. London: NICE, 2007.
  3. National Collaborating Centre for Women's and Children's Health. Heavy Menstrual Bleeding. London: Royal College of Obstetricians and Gynaecologists, 2007.
  4. Harlow S, Campbell O. Epidemiology of menstrual disorders in developing countries: a systematic review. BJOG 2004; 111 (1): 6–16.
  5. Shapley M, Jordan K, Croft P. An epidemiological survey of symptoms of menstrual loss in the community. Br J Gen Pract 2004; 54 (502): 359–363.
  6. Office of Population Census and Surveys. Morbidity Statistics from General Practice. Fourth National Morbidity Study 1991–92. London: HMSO, 1995.
  7. Balint M. The doctor, his patient and the illness. Second edition. London: Pitman Medical, 1965.
  8. National Institute for Health and Care Excellence. Referral guidelines for suspected cancer. Clinical guideline 27. London: NICE, 2005.
  9. Shapley M, Jordan J, Croft P. A systematic review of postcoital bleeding and risk of cervical cancer. Br J Gen Pract 2006; 56: 453–460.
  10. Stewart A, Cummins C, Gold L et al. The effectiveness of the levonorgestrel-releasing intrauterine system in menorrhagia: a systematic review. BJOG 2001; 108 (1): 74–86.
  11. Lethaby A, Cooke I, Rees M. Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding. Cochrane Database Syst Rev 2005; (4): CD002126.
  12. National Institute for Health and Care Excellence. Heavy menstrual bleeding: Understanding NICE guidance CG44. London: NICE, 2007.G