Levels of evidence for the accuracy of diagnostic tests (Ia-IV) and for interventions (1++ to 4), and grading of recommendations (A-D), are defined at the end of the "Major Recommendations" field.
In addition to the evidence-based recommendations, the Guideline Development Group (GDG) also identifies best practice based on the experience of the group (D[GPP]).
Impact of Heavy Menstrual Bleeding (HMB) on Women
C - HMB should be recognised as having a major impact on a woman's quality of life, and any intervention should aim to improve this rather than focusing on menstrual blood loss.
D - For clinical purposes, HMB should be defined as excessive menstrual blood loss which interferes with the woman's physical, emotional, social, and material quality of life, and which can occur alone or in combination with other symptoms. Any interventions should aim to improve quality of life measures.
History Taking, Examination and Investigations for HMB
History Taking for HMB
D(GPP) - 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, impact on quality of life and other factors that may determine treatment options (such as presence of comorbidity).
D(GPP) - Clinicians should take into account the range and natural variability in menstrual cycles and blood loss when diagnosing HMB, and should discuss this variation with the woman. If the woman feels that she does not fall within the normal ranges, care options should be discussed.
D(GPP) - 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).
D(GPP) - If the history suggests HMB with structural or histological abnormality, with symptoms such as intermenstrual or post-coital bleeding, pelvic pain and/or pressure symptoms, a physical examination and/or other investigations (such as ultrasound) should be performed.
Measurement of Menstrual Blood Loss
D(GPP) - Measuring menstrual blood loss either directly (alkaline haematin) or indirectly ('pictorial blood loss assessment chart') is not routinely recommended for HMB. Whether menstrual blood loss is a problem should be determined not by measuring blood loss but by the woman herself.
Physical Examination for HMB
D(GPP) - A physical examination should be carried out before all:
- LNG-IUS fittings*
- Investigations for structural abnormalities
- Investigations for histological abnormalities
* See "Long-acting reversible contraception, NICE clinical guideline 30, http://guidance.nice.org.uk/CG30, for more detail. (National Guideline Clearinghouse summary of the NICE guideline Long-acting reversible contraception: the effective and appropriate use of long-acting reversible contraception.)
D(GPP) - Women with fibroids that are palpable abdominally or who have intra-cavity fibroids and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than 12 cm should be offered immediate referral to a specialist.
Laboratory Tests for HMB
C - A full blood count test should be carried out on all women with HMB. This should be done in parallel with any HMB treatment offered.
C - Testing for coagulation disorders (for example, von Willebrand disease) should be considered in women who have had HMB since menarche and have personal or family history suggesting a coagulation disorder.
B - A serum ferritin test should not routinely be carried out on women with HMB.
C - Female hormone testing should not be carried out on women with HMB.
C - Thyroid testing should only be carried out when other signs and symptoms of thyroid disease are present.
Investigations for HMB
D(GPP) - 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.
D(GPP) - Imaging should be undertaken in the following circumstances:
- The uterus is palpable abdominally
- Vaginal examination reveals a pelvic mass of uncertain origin
- Pharmaceutical treatment fails
A - Ultrasound is the first-line diagnostic tool for identifying structural abnormalities.
A - Hysteroscopy should be used as a diagnostic tool only when ultrasound results are inconclusive, for example, to determine the exact location of a fibroid or the exact nature of the abnormality.
D(GPP) - If imaging shows the presence of uterine fibroids then appropriate treatment should be planned based on size, number and location of the fibroids.
A - Saline infusion sonography should not be used as a first-line diagnostic tool.
B - Magnetic resonance imaging (MRI) should not be used as a first-line diagnostic tool.
B - Dilatation and curettage alone should not be used as a diagnostic tool.
D(GPP) - 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.
Education and Information Provision
Education for Women with HMB
A - A woman with HMB referred to specialist care should be given information before her outpatient appointment. The Institute's information for patients ("Understanding NICE guidance") is available from http://www.nice.org.uk/CG044publicinfo. (See also "Patient Resources" field in this summary.)
D(GPP) - Although respect for autonomy, and individual choice, are important for the NHS and its users, they should not have the consequence of promoting the use of interventions that are not clinically and/or cost-effective.
D(GPP) - Women should be made aware of the impact on fertility that any planned surgery or uterine artery embolisation (UAE) may have, and if a potential treatment (hysterectomy or ablation) involves the loss of fertility then opportunities for discussion should be made available.
Women should be given the following information on potential unwanted outcomes.
Table: Potential Unwanted Outcomes of Interventions for HMB
| Intervention |
Potential unwanted outcomes experienced by some women (common = 1 in 100 chance, less common = 1 in 1000 chance, rare = 1 in 10,000 chance, very rare = 1 in 100,000 chance) |
| Levonorgestrel-releasing intrauterine system (LNG-IUS) |
Common: |
irregular bleeding that may last for over 6 months; hormone-related problems such as breast tenderness, acne or headaches, which, if present, are generally minor and transient |
| Less common: |
amenorrhoea |
| Rare: |
uterine perforation at the time of IUS insertion |
| Tranexamic acid |
Less common: |
indigestion; diarrhoea; headaches |
| Nonsteroidal anti-inflammatory drugs (NSAIDs) |
Common: |
indigestion; diarrhoea |
| Rare: |
worsening of asthma in sensitive individuals; peptic ulcers with possible bleeding and peritonitis |
| Combined oral contraceptives (COCs) |
Common: |
mood changes; headaches; nausea; fluid retention; breast tenderness |
| Rare: |
deep vein thrombosis; stroke; heart attacks |
| Oral progestogen (norethisterone) |
Common: |
weight gain; bloating; breast tenderness; headaches; acne (but all are usually minor and transient) |
| Rare: |
depression |
| Injected progestogen |
Common: |
weight gain; irregular bleeding; amenorrhoea; premenstrual-like syndrome (including bloating, fluid retention, breast tenderness) |
| Less common: |
small loss of bone mineral density, largely recovered when treatment is discontinued |
| Gonadotrophin-releasing hormone analogue (GnRH-a) |
Common: |
menopausal-like symptoms (such as hot flushes, increased sweating, vaginal dryness) |
| Less common: |
osteoporosis, particularly trabecular bone with longer than 6 months' use |
| Endometrial ablation |
Common: |
vaginal discharge; increased period pain or cramping (even if no further bleeding); need for additional surgery |
| Less common: |
infection |
| Rare: |
perforation (but very rare with second-generation techniques) |
| Uterine artery embolisation (UAE) |
Common: |
persistent vaginal discharge; post-embolisation syndrome – pain, nausea, vomiting and fever (not involving hospitalisation) |
| Less common: |
need for additional surgery; premature ovarian failure, particularly in women over 45 years old; haematoma |
| Rare: |
haemorrhage; non-target embolisation causing tissue necrosis; infection causing septicaemia |
| Myomectomy |
Less common: |
adhesions (which may lead to pain and/or impaired fertility); need for additional surgery; recurrence of fibroids; perforation (hysteroscopic route); infection |
| Rare: |
haemorrhage |
| Hysterectomy |
Common: |
infection |
| Less common: |
intra-operative haemorrhage; damage to other abdominal organs, such as the urinary tract or bowel; urinary dysfunction – frequent passing of urine and incontinence |
| Rare: |
thrombosis (DVT and clot on the lung) |
| Very rare: |
death |
| (Complications are more likely when hysterectomy is performed in the presence of fibroids) |
| Oophorectomy at the time of hysterectomy |
Common: |
menopausal-like symptoms |
Choice
Choice for Women with HMB
D(GPP) - A woman with HMB should be given the opportunity to review and agree any treatment decision. She should have adequate time and support from healthcare professionals in the decision-making process.
D(GPP) - A woman with HMB and/or her doctor should have the option of gaining a second medical opinion where agreement on treatment options for HMB is not reached.
Pharmaceutical Treatments for HMB
D(GPP) - 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.
D(GPP) - The healthcare professional should determine whether hormonal contraception is acceptable to the woman before recommending treatment (for example, she may wish to conceive).
If history and investigations indicate that pharmaceutical treatment is appropriate and either hormonal or non-hormonal treatments are acceptable, treatments should be considered in the following order:*
- Levonorgestrel-releasing intrauterine system (LNG-IUS) provided long-term (at least 12 months) use is anticipated **,+ [A]
- Tranexamic acid [A] or nonsteroidal anti-inflammatory drugs (NSAIDs) [A] or combined oral contraceptives (COCs) [B]
- Norethisterone (15 mg) daily from days 5 to 26 of the menstrual cycle, or injected long-acting progestogens.**,^ [A]
D(GPP) - If hormonal treatments are not acceptable to the woman, then either tranexamic acid or NSAIDs can be used.
D(GPP) - Women offered an LNGIUS should be advised of anticipated changes in the bleeding pattern, particularly in the first few cycles and maybe lasting longer than 6 months. They should therefore be advised to persevere for at least 6 cycles to see the benefits of the treatment.+
D(GPP) - If pharmaceutical treatment is required while investigations and definitive treatment are being organised, either tranexamic acid or NSAIDs should be used.
D(GPP) - When HMB coexists with dysmenorrhoea, NSAIDs should be preferred to tranexamic acid.
D(GPP) - Ongoing use of NSAIDs and/or tranexamic acid is recommended for as long as they are found to be beneficial by the woman.
D(GPP) - Use of NSAIDs and/or tranexamic acid should be stopped if it does not improve symptoms within three menstrual cycles.
D - When a first pharmaceutical treatment has proved ineffective, a second pharmaceutical treatment can be considered rather than immediate referral to surgery.
B - Use of a gonadotrophin-releasing hormone analogue could be considered prior to surgery or when all other treatment options for uterine fibroids, including surgery or uterine artery embolization (UAE), are contraindicated. If this treatment to be used for more than 6 months or if adverse effects are experienced then hormone replacement therapy (HRT) "addback" therapy is recommended.**
A - Danazol should not be routinely used for the treatment of HMB.
A - Oral progestogens given during the luteal phase only should not be used for the treatment of HMB.
A - Etamsylate should not be used for the treatment of HMB.
* World Health Organization "Pharmaceutical eligibility criteria for contraceptive use" (WHOMEC) apply. These criteria can be used to assess the individual's suitability for particular contraceptives. This allows informed decision making by the woman prior to the start of treatment. [http://www.ffprhc.org.uk/admin/uploads/298_UKMEC_200506.pdf]
** Check the Summary of Product Characteristics for current licensed indications. Informed consent is needed when using outside the licensed indications. This should be discussed and documented in the notes.
+ See "Long-acting reversible contraception," NICE clinical guideline 30, http://guidance.nice.org.uk/CG30, for more detail. (National Guideline Clearinghouse summary of the NICE guideline Long-acting reversible contraception: the effective and appropriate use of long-acting reversible contraception.)
^ In adolescents and women older than 40 years, refer to Committee on Safety of Medicines (CSM) advice issued in November 2004. Go to www.mhra.gov.uk and search for Depo-Provera.
Surgery as First-Line Treatment for HMB
Surgery as First-Line Treatment for HMB in Secondary Care
A - Endometrial ablation may be offered as an initial treatment for HMB after full discussion with the woman of the risks and benefits and of other treatment options.
D(GPP) - Hysterectomy should not be used as a first-line treatment solely for HMB.
Non-Hysterectomy Surgery for HMB
Endometrial Ablation/Resection
C - Endometrial ablation should be considered where bleeding is having a severe impact on a woman's quality of life, and she does not want to conceive in the future.
A - Endometrial ablation may be offered as an initial treatment for HMB after full discussion with the woman of the risks and benefits and of other treatment options.
D(GPP) - Women must be advised to avoid subsequent pregnancy and on the need to use effective contraception, if required, after endometrial ablation.
A - Endometrial ablation should be considered in women who have a normal uterus and also those with small uterine fibroids (less than 3 cm in diameter).
A - In women with HMB alone, with uterus no bigger than a 10 week pregnancy, endometrial ablation should be considered preferable to hysterectomy.
D(GPP) - All women considering endometrial ablation should have access to a second-generation ablation technique.
A - Second-generation ablation techniques should be used where no structural or histological abnormality is present. The second-generation techniques recommended for consideration are as follows. Providers should ensure that when purchasing any of these they buy the least expensive available option:* ** # +
- Impedance-controlled bipolar radiofrequency ablation (formerly NICE interventional procedure guidance 104)
- Fluid-filled thermal balloon endometrial ablation (TBEA) (formerly NICE interventional procedure guidance 6)
- Microwave endometrial ablation (MEA) (formerly NICE interventional procedure guidance 7)
- Free fluid thermal endometrial ablation (formerly NICE interventional procedure guidance 51)
D(GPP) - In TBEA, endometrial thinning is not needed.
A - In MEA, scheduling of surgery for postmenstrual phase is an alternative to endometrial thinning.
D(GPP) - First-generation ablation techniques (for example, rollerball endometrial ablation [REA] and transcervical resection of the endometrium [TCRE]) are appropriate if hysteroscopic myomectomy is to be included in the procedure.
* NICE have produced "Fluid-filled thermal balloon and microwave endometrial techniques for heavy menstrual bleeding. NICE technology appraisal guidance 78" on TBEA and MEA.
** This clinical guideline supersedes the following NICE interventional procedure guidances: "Balloon thermal endometrial ablation. IPG 6," "Microwave endometrial ablation. IPG 7," "Free fluid endometrial ablation. IPG 51" and "Impedance-controlled bipolar radiofrequency ablation for menorrhagia. IPG 104." However, "Endometrial cryotherapy for menorrhagia. NICE interventional procedure guidance 157" is not covered by this guideline.
# Reference should be made to the limits on uterus size given by the manufacturer of the endometrial ablation device.
+ It is recommended that the Medicines and Healthcare products Regulatory Agency (MHRA) safety notices on endometrial ablation should be followed (MDA [1998] SN 9812 "Devices used for endometrial ablation achieved by thermal means," and MDA [1999] SN 1999(18) "Devices used for endometrial ablation").
Dilatation and Curettage
C - Dilatation and curettage should not be used as a therapeutic treatment.
Further Interventions for Uterine Fibroids Associated with HMB
D(GPP) - For women with large fibroids and HMB, and other significant symptoms such as dysmenorrhoea or pressure symptoms, referral for consideration of surgery or uterine artery embolisation (UAE) as first-line treatment can be recommended.
(See "Uterine artery embolisation for the treatment of fibroids," NICE interventional procedure guidance 94, http://guidance.nice.org.uk/IPG94.)
C - UAE, myomectomy or hysterectomy should be considered in cases of HMB where large fibroids (greater than 3 cm in diameter) are present and bleeding is having a severe impact on a woman's quality of life.
D(GPP) - When surgery for fibroid-related HMB is felt necessary then UAE, myomectomy and hysterectomy must all be considered, discussed and documented.
C - Women should be informed that UAE or myomectomy will potentially allow them to retain their fertility.
D - Myomectomy is recommended for women with HMB associated with uterine fibroids and who want to retain their uterus.
B - UAE is recommended for women with HMB associated with uterine fibroids and who want to retain their uterus and/or avoid surgery.
(See "Uterine artery embolisation for the treatment of fibroids," NICE interventional procedure guidance 94,
http://guidance.nice.org.uk/IPG94.)
D(GPP) - Prior to scheduling of UAE or myomectomy, the uterus and fibroid(s) should be assessed by ultrasound. If further information about fibroid position, size, number and vascularity is required, MRI should be considered.
A - 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.
(Check the Summary of Product Characteristics for current licensed indications. Informed consent is needed when using outside the licensed indications. This should be discussed and documented in the notes.)
D(GPP) - If a woman is being treated with gonadotrophin-releasing hormone analogue and UAE is then planned, the gonadotrophin-releasing hormone analogue should be stopped as soon as UAE has been scheduled.
Hysterectomy
C - Hysterectomy should not be used as a first-line treatment solely for HMB. Hysterectomy should be considered only when:
- Other treatment options have failed, are contraindicated or are declined by the woman
- There is a wish for amenorrhoea
- The woman (who has been fully informed) requests it
- The woman no longer wishes to retain her uterus and fertility
D(GPP) - Women offered hysterectomy should have a full discussion of the implication of the surgery before a decision is made. The discussion should include: sexual feelings, fertility impact, bladder function, need for further treatment, treatment complications, the woman's expectations, alternative surgery and psychological impact.
C - Women offered hysterectomy should be informed 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.
D(GPP) - Women should be informed about the risk of possible loss of ovarian function and its consequences, even if their ovaries are retained during hysterectomy.
D(GPP) - Individual assessment is essential when deciding route of hysterectomy. The following factors need to be taken into account:
- Presence of other gynaecological conditions or disease
- Uterine size
- Presence and size of uterine fibroids
- Mobility and descent of the uterus
- Size and shape of the vagina
- History of previous surgery
A - 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.
D(GPP) - Under circumstances such as morbid obesity or the need for oophorectomy during vaginal hysterectomy, the laparoscopic approach should be considered, and appropriate expertise sought.
D(GPP) - When abdominal hysterectomy is decided upon then both the total method (removal of the uterus and the cervix) and subtotal method (removal of the uterus and preservation of the cervix) should be discussed with the woman.
Removal of Ovaries at the Time of Hysterectomy
Oophorectomy
D(GPP) - Removal of healthy ovaries at the time of hysterectomy should not be undertaken.
D(GPP) - Removal of ovaries should only be undertaken with the express wish and consent of the woman.
D(GPP) - Women with a significant family history of breast or ovarian cancer should be referred for genetic counselling prior to a decision about oophorectomy.
(See "The classification and care of women at risk of familial breast cancer in primary, secondary and tertiary care," NICE clinical guideline 41, http://guidance.nice.org.uk/CG41, for more detail.)
D(GPP) - In women under 45 considering hysterectomy for HMB with other symptoms that may be related to ovarian dysfunction (for example, premenstrual syndrome), a trial of pharmaceutical ovarian suppression for at least 3 months should be used as a guide to the need for oophorectomy.
D(GPP) - If removal of ovaries is being considered, the impact of this on the woman's well-being and, for example, the possible need for hormone replacement therapy (HRT) should be discussed.
D(GPP) - Women considering bilateral oophorectomy should be informed about the impact of this treatment on the risk of ovarian and breast cancer.
Competencies
Competencies
Training
D(GPP) - All those involved in undertaking surgical or radiological procedures to diagnose and treat HMB should demonstrate competence (including both technical and consultation skills) either during their training or in their subsequent practice.
D(GPP) - The operative competence of healthcare professionals who are acquiring new skills in procedures to diagnose and treat HMB should be formally assessed by trainers through a structured process such as that defined within training schemes of the Post-graduate Medical Education and Training Board (PMETB), the Royal Colleges and/or the Society and College of Radiographers (SCoR).
D(GPP) - Training programmes must be long enough to enable healthcare professionals to achieve competency in complex procedures when these are appropriate (for example, operations for fibroids that are large or in an awkward position, or using laparoscopic techniques). These training programmes will usually be located in units with a particular interest and sufficient workload to allow experience of these procedures.
Maintenance
D(GPP) - Maintenance of surgical, imaging or radiological skills requires a robust clinical governance framework including audit of numbers, decision making, case-mix issues and outcomes of all treatments at both individual operator and organisational levels. These data should be used to demonstrate good clinical practice.
D(GPP) - Established healthcare professionals should be able to demonstrate that their training, experience and current practice meets or exceeds the standards laid out for newly trained professionals.
Governance
D(GPP) - If a healthcare professional lacks competence to undertake a procedure then they should refer the woman to a professional with the appropriate skill. Organisations that commission services should be responsible (through service specification based on robust audit data) for identifying and contracting professionals with appropriate skills.
Definitions:
Levels of Evidence for Intervention Studies
| Level |
Source of Evidence |
| 1++ |
High-quality meta-analyses, systematic reviews of randomised controlled trials (RCTs) or RCTs with a very low risk of bias |
| 1+ |
Well-conducted meta-analyses, systematic reviews of RCTs or RCTs with a low risk of bias |
| 1− |
Meta-analyses, systematic reviews of RCTs or RCTs with a high risk of bias |
| 2++ |
High-quality systematic reviews of case–control or cohort studies; high-quality case–control or cohort studies with a very low risk of confounding bias or chance and a high probability that the relationship is causal |
| 2+ |
Well-conducted case–control or cohort studies with a low risk of confounding bias or chance and a moderate probability that the relationship is causal |
| 2− |
Case–control or cohort studies with a high risk of confounding bias or chance and a significant risk that the relationship is not causal |
| 3 |
Non-analytical studies (for example, case reports, case series) |
| 4 |
Expert opinion, formal consensus |
Levels of Evidence for Studies of the Accuracy of Diagnostics Tests
| Level |
Type of Evidence |
| Ia |
Systematic reviews (with homogeneity)a of level-1 studiesb |
| Ib |
Level-1 studiesb |
| II |
Level-2 studiesc; systematic reviews of level-2 studies |
| III |
Level-3 studiesd; systematic reviews of level-3 studies |
| IV |
Consensus, expert committee reports or opinions and/or clinical experience without explicit critical appraisal; or based on physiology, bench research or 'first principles' |
a Homogeneity means there are no or only minor variations in the directions and degrees of results between individual studies that are included in the systematic review.
b Level-1 studies are studies that use a blind comparison of the test with a validated reference standard (gold standard) in a sample of patients that reflects the population to whom the test would apply.
c Level-2 studies are studies that have only one of the following:
- Narrow population (the sample does not reflect the population to whom the test would apply)
- Use a poor reference standard (defined as that where the 'test' is included in the 'reference', or where the 'testing' affects the 'reference')
- The comparison between the test and reference standard is not blind
- Case–control studies
d Level-3 studies are studies that have at least two or three of the features listed above.
Classification of Recommendations
|
Class
|
Evidence
|
|
A
|
At least one meta-analysis, systematic review, or randomised controlled trial (RCT) that is rated as 1++, and is directly applicable to the target population, or
A systematic review of RCTs or a body of evidence that consists principally of studies rated as 1+, is directly applicable to the target population and demonstrates overall consistency of results, or
Evidence drawn from a National Institute for Health and Clinical Excellence (NICE) technology appraisal.
|
|
B
|
A body of evidence that includes studies rated as 2++, is directly applicable to the target population and demonstrates overall consistency of results, or
Extrapolated evidence from studies rated as 1++ or 1+.
|
|
C
|
A body of evidence that includes studies rated as 2+, is directly applicable to the target population and demonstrates overall consistency of results, or
Extrapolated evidence from studies rated as 2++.
|
|
D
|
Evidence level 3 or 4, or
Extrapolated evidence from studies rated as 2+, or
Formal consensus.
|
|
D(GPP)
|
A good practice point (GPP) is a recommendation for best practice based on the experience of the Guideline Development Group.
|
