- Email: [email protected]
RCOG guidelines on menorrhagia—Time for an update?
ARTICLE IN PRESS Current Obstetrics & Gynaecology (2005) 15, 382–386
www.elsevier.com/locate/curobgyn
RCOG guidelines on menorrhagia—Time for an update? Alison M. Sambrook, Kevin Cooper Aberdeen Royal Infirmary, Foresterhill Rd, Aberdeen AB25 2ZB, UK
KEYWORDS Menorrhagia; Surgery
Summary Menorrhagia or heavy menstrual bleeding is a common and debilitating condition, and affects work, family and social life. Investigations and management should be evidence based. When management options are discussed there should be the flexibility to provide an acceptable solution for each individual woman. & 2005 Elsevier Ltd. All rights reserved.
Introduction
Indications
The Royal College of Obstetricians and Gynaecologists (RCOG) published guidelines on the management of menorrhagia in 1998. They covered both primary and secondary care. The aim was to provide general practitioners and gynaecologists with recommendations for improving the quality of care provided to women with menorrhagia or heavy menstrual bleeding (HMB). The guidelines were developed using the best available evidence at the time, but as new evidence becomes available the guidelines are due to be revised. The National Institute for Clinical Excellence (NICE) guidelines on HMB are due for publication April 2007 in collaboration with the RCOG.
One in 20 women in the UK aged 30–49 years will consult their general practitioners each year regarding heavy periods, with a substantial number of these women being referred onto secondary care. Objective menorrhagia or HMB is measured menstrual blood loss of 80 mL or more per cycle. In practice most women are investigated and treated with the subjective complaint of HMB without formal menstrual loss measurements being performed once they are referred into secondary care.
Corresponding author. Tel.: +44 1224 559945.
E-mail address: [email protected] (A.M. Sambrook).
Investigations The aim of investigations is to exclude any serious pathology and treat any underlying medical conditions. Risk factors for endometrial cancer such as obesity, polycystic ovarian syndrome, tamoxifen usage and unopposed oestrogen therapy must be borne in mind both in primary and secondary care settings.
0957-5847/$ - see front matter & 2005 Elsevier Ltd. All rights reserved. doi:10.1016/j.curobgyn.2005.09.001
ARTICLE IN PRESS RCOG guidelines on menorrhagia—Time for an update?
Menstrual blood loss measurements Objective menstrual blood loss measurements are rarely performed outside clinical research. The alkaline haematin method is a useful research tool, but women on the whole find it inconvenient and distasteful to collect soiled sanitary wear for analysis. The PBAC or pictorial blood loss assessment chart has been used as an alternative. However, there have been difficulties with validation, and there is evidence that it offers no benefit in the objective diagnosis of menorrhagia. More commonly the diagnosis of HMB is based on the woman’s subjective assessment of her periods. This in turn will be affected by a woman’s perception of what is normal, and tolerance of her menstrual symptoms. Women in the year 2005 are more likely to be employed outside the home than in the 1960s. The number of children in a family has reduced from an average of six in the 1850s to less than two in the 1990s. Few women currently breast feed for long periods of time and life expectancy has increased. It can be surmised that a woman in the year 2005 is likely to be troubled by a greater number of menstrual cycles in her adult life.
383
when abnormalities are detected. This allows the clinician to distinguish between polyps and fibroids. Routine hysteroscopy is unsupported by clinical evidence.
Endometrial sampling This should be considered for all women with persistent HMB. The most commonly used device in the UK is the Pipelle sampler. It has been shown to be as effective as D&C for excluding endometrial carcinoma and endometrial hyperplasia. The combination of transvaginal ultrasound and pipelle biopsy reduces false-negative results from blind sampling with further investigations should symptoms persist despite negative investigations. Sampling of the endometrium is still critical after a normal hysteroscopy, as the procedure has a low sensitivity for endometrial hyperplasia.
Oral drug treatments These can be subdivided into hormonal and nonhormonal methods.
Blood tests
Non-hormonal
Full blood count, but not serum ferritin, is an essential baseline investigation. Anaemia may be readily treatable with the alleviation of symptoms. A low haemoglobin makes objective menorrhagia more likely, but a normal haemoglobin of 412 g/dL does not preclude it. Endocrine investigations such as progesterone, oestradiol, leutinising hormone (LH) and follicle stimulating hormone (FSH) in women with regular menstrual cycles are of little value. Thyroid function and coagulation studies should only be considered if there are suggestive features in the history or examination findings. Inherited bleeding disorders often go unrecognised in the gynaecology setting. Mild forms may be a significant underlying factor in women presenting with HMB, especially mild von Willebrand’s disease. There is an argument for routine testing as the prevalence in a menstrual clinic may be as high as 17%.
Anti-fibrinolytics such as tranexamic acid reduce menstrual loss by inhibiting the action of plasminogen activators, which cause the breakdown of blood clots. Anti-fibrinolytics do not generally relieve menstrual cramps, but can reduce blood loss by 40–50%. Mefenamic acid, a non-steroidal anti-inflammatory drug (NSAID), also relieves menstrual cramps. The mode of action is upon the production of prostaglandin. NSAIDs reduce the menstrual flow by 33–55%.
Investigation of the uterine cavity In secondary care the ideal one-stop menstrual disorders clinic has transvaginal ultrasound available for investigation of the uterine cavity and the pelvis in general, with outpatient hysteroscopy
Hormonal Oral contraceptives are an effective treatment for HMB, reducing menstrual loss by 40%. Many women once their families are complete are reluctant to take hormonal medication on a long-term basis for non-contraceptive reasons. This can limit their usage in a menstrual disorders clinic. They can be safely used until the age of 50 in women with no contraindications. Long-cycle progestogens are effective in the treatment of menorrhagia when given as a dose of 5 mg three times daily from day 5 to day 26 of the cycle. They reduce menstrual loss by 87%, but offer reduced satisfaction with treatment when compared with the Mirena coil.
ARTICLE IN PRESS 384 Second-line drug treatments, such as gestrinone, danazol and gonadotophin-releasing hormone analogues, are all effective in reducing blood loss. The problem with these preparations is that their side effects limit long-term usage. They should probably be restricted to preparation of the endometrium before surgery, shrinkage of fibroids, or whilst a definitive treatment is being considered.
Progesterone-releasing IUD The progesterone releasing IUD has provided gynaecologists with a simple and effective outpatient treatment for HMB. The most widely available device Mirena has been extensively evaluated in randomised controlled trials (RCTs) against hysterectomy, transcervical endometrial resection (TCRE) and thermal balloon endometrial ablation (TBEA). It has been demonstrated to reduce menstrual blood loss by 94% after 3 months and is well tolerated by the majority of women. Hormonal side effects include weight gain, breast tenderness and bloating; the devices may occasionally be expelled spontaneously. These negative effects can be outweighed by the fact it is an effective and reversible treatment; after removal fertility returns rapidly.
Surgical treatments Uterine artery embolisation NICE issued guidance in October 2004 confirming that this procedure is safe for routine use; however, although there is symptomatic benefit in the shortterm, long-term effects and the effect upon fertility are not known. We are awaiting the results of RCTs such as the REST (Randomised Trial of Embolisation versus Surgical Treatment for Fibroids) study.
A.M. Sambrook, K. Cooper ectomy. Women undergoing resection or ablation have a significantly shorter hospital stay, less analgesia, shorter recovery time, and a reduced time to return to work than those who undergo hysterectomy of either abdominal or vaginal route. A randomised comparison of medical treatment versus TCRE revealed that a policy of offering immediate TCRE to women referred to a gynaecologist for heavy menstrual loss resulted in higher satisfaction, better menstrual status and greater improvements in health-related quality of life than medical treatment in the short, medium and longterm. In this study immediate TCRE did not lead to an increase in the number of hysterectomies. It was concluded that all eligible women seeking treatment for heavy periods should be offered an effective endometrial ablative technique.
Second-generation techniques Second-generation techniques employ different energy sources to cause endomyometrial destruction. They are blind in nature, not being performed under direct hysteroscopic vision with the exception of the HydroTherm AblatorTM. They therefore, avoid the risks of fluid distension media. They were developed to be easier to learn and perform than first-generation techniques. Some techniques may be performed under local anaesthesia. For all methods, the woman should have no desire to retain her fertility. The uterus should be of 12-week size or less. The ability to cope with intra-cavity pathology, such as sub-mucus fibroids, varies between techniques. The two in most widespread usage in the UK are microwave (MEATM) and TBEA, and are currently undergoing comparison in an independently funded RCT. NICE have an ongoing programme of evaluation for second-generation ablative techniques.
First-generation endometrial ablation techniques
Hysterectomy
First-generation endometrial ablation techniques were developed 20 years ago as an alternative procedure to hysterectomy. They were designed to remove or destroy the entire thickness of the endometrium and superficial myometrium (endometrial ablation) whilst leaving the uterus intact. The three first-generation endometrial ablation techniques, laser ablation, TCRE and rollerball endometrial ablation, have been extensively evaluated against both medical treatments and hyster-
This is the only method where amenorrhoea can essentially be guaranteed, (with the exception of a subtotal hysterectomy). A large-scale audit of the procedure by abdominal, vaginal and laparoscopic routes has been performed. It is usually performed as an elective procedure, but not without a significant complication rate. Value and eVALuate give complication rates of between 3.5% and 11% for major complications and 8.59–27% for minor complications.
ARTICLE IN PRESS RCOG guidelines on menorrhagia—Time for an update?
Patient issues HMB can have significant adverse effects on quality of life: work, social life and family life are all affected by HMB. Increased levels of depression, anxiety and sexual problems are all reported in women with HMB. It is important when considering treatment options to actively collaborate with the
385
woman. The first-line treatment for HMB is considered to be medical therapy. It is not universally effective and can give rise to unpalatable side effects. Patient preference for a particular treatment must be taken into account when deciding upon management. In a partially randomised patient preference trial, it was demonstrated that women who preferred medical treatment were
Confirm no change to history of regular cycles especially no IMB or PCB (C) Abdominal,bimanual and speculum examinations (C) Perform full blood count (B), consider TFT and coagulation tests if history indicates Transvaginal ultrasound
abnormal
normal Endometrial biopsy (C) normal
Endometrial biopsy (C) + Hysteroscopy (A)
Abnormal − Outside scope of guidelines
normal
Discuss options with patient
Drug treatments (A)
Remove endometrial polyps / submucosal fibroids hysteroscopically (No evidence for effectiveness) Offer concurrent endometrial ablation
and provide information
Reassure
abnormal
Progestogen releasing IUD (A)
Endometrial ablation (A)
OCP Tranexamic acid Mefenamic acid
Figure 1 Management in secondary care.
Hysterectomy (A) if no other method suitable/ acceptable
ARTICLE IN PRESS 386 significantly more likely to find the treatment acceptable and to wish to continue with it than those who were randomised to medical treatment. They still, however, had poorer results with respect to bleeding score, pain score, haemoglobin increase, satisfaction with treatment, and wishing to continue with the same treatment than those patients preferring or who were randomised to TCRE.
A.M. Sambrook, K. Cooper feel this is most suitable for them. Fig. 1 suggests an alternative algorithm for the treatment of HMB in women with no desire for further fertility. In those women wishing to have children treatment options are limited to oral medication or the LNG-IUS. Practice points
Summary HMB is an important issue in women’s health. Satisfaction with treatment and improvement in quality of life should be thought of as the primary goal of treatment. Over 8000 hysterectomies are still performed annually in the UK for HMB. In a review of surgical versus medical treatment it was concluded that women undergoing endometrial ablation to those fitted with a LNG-IUS reported similar rates of satisfaction and quality of life. There was no significant difference in bleeding between the two groups at 3 years. A hysterectomy is still the definitive treatment for HMB, but it does not appear to offer any improvement in satisfaction and quality of life over LNG-IUS or endometrial ablation. Not all clinical trials set out to measure these outcomes, but chose surrogate outcomes such as amenorrhoea. The only treatment for HMB that can guarantee this is hysterectomy, which is a major surgical procedure with attendant risks and complications attached. From a health services viewpoint, resources are limited. It is important that the cost-effectiveness of treatments is considered in the equation. RCTs without health economics components are of limited value. Involving the individual woman in the decisionmaking process is invaluable. Once referred into secondary care women should be able to opt for a surgical treatment as a first-line approach if they
Conservative surgical treatments should not be withheld in an effort to pursue medical therapy; if eligible all options should be discussed. LNG-IUS is an effective treatment for heavy menstrual bleeding. Second-generation endometrial ablation techniques continue to undergo further evaluation, not all techniques are equally suitable for all women.
Further Reading 1. Royal College of Obstetricians and Gynaecologists. Guideline on the management of menorrhagia in secondary care. RCOG press; 1998. 2. Royal College of Obstetricians and Gynaecologists. The initial management of menorrhagia. RCOG press; 1998. 3. Marjoribanks J, Lethaby A, Farquhar C. Surgery versus medical therapy for heavy menstrual bleeding. Cochrane Database Syst Rev 2003(2):CD003855. 4. Lethaby A, Hickey M. Endometrial destruction techniques for heavy menstrual bleeding: a Cochrane review. Hum Reprod 2002;17(11):2795–806. 5. Cooper KG, Jack SA, Parkin DE, Grant AM. Five-year follow up of women randomised to medical management or transcervical resection of the endometrium for heavy menstrual loss: clinical and quality of life outcomes. BJOG 2001;108(12): 1222–8. 6. National Institute for Clinical Excellence—interventional procedures programme www.nice.org.uk.
www.elsevier.com/locate/curobgyn
RCOG guidelines on menorrhagia—Time for an update? Alison M. Sambrook, Kevin Cooper Aberdeen Royal Infirmary, Foresterhill Rd, Aberdeen AB25 2ZB, UK
KEYWORDS Menorrhagia; Surgery
Summary Menorrhagia or heavy menstrual bleeding is a common and debilitating condition, and affects work, family and social life. Investigations and management should be evidence based. When management options are discussed there should be the flexibility to provide an acceptable solution for each individual woman. & 2005 Elsevier Ltd. All rights reserved.
Introduction
Indications
The Royal College of Obstetricians and Gynaecologists (RCOG) published guidelines on the management of menorrhagia in 1998. They covered both primary and secondary care. The aim was to provide general practitioners and gynaecologists with recommendations for improving the quality of care provided to women with menorrhagia or heavy menstrual bleeding (HMB). The guidelines were developed using the best available evidence at the time, but as new evidence becomes available the guidelines are due to be revised. The National Institute for Clinical Excellence (NICE) guidelines on HMB are due for publication April 2007 in collaboration with the RCOG.
One in 20 women in the UK aged 30–49 years will consult their general practitioners each year regarding heavy periods, with a substantial number of these women being referred onto secondary care. Objective menorrhagia or HMB is measured menstrual blood loss of 80 mL or more per cycle. In practice most women are investigated and treated with the subjective complaint of HMB without formal menstrual loss measurements being performed once they are referred into secondary care.
Corresponding author. Tel.: +44 1224 559945.
E-mail address: [email protected] (A.M. Sambrook).
Investigations The aim of investigations is to exclude any serious pathology and treat any underlying medical conditions. Risk factors for endometrial cancer such as obesity, polycystic ovarian syndrome, tamoxifen usage and unopposed oestrogen therapy must be borne in mind both in primary and secondary care settings.
0957-5847/$ - see front matter & 2005 Elsevier Ltd. All rights reserved. doi:10.1016/j.curobgyn.2005.09.001
ARTICLE IN PRESS RCOG guidelines on menorrhagia—Time for an update?
Menstrual blood loss measurements Objective menstrual blood loss measurements are rarely performed outside clinical research. The alkaline haematin method is a useful research tool, but women on the whole find it inconvenient and distasteful to collect soiled sanitary wear for analysis. The PBAC or pictorial blood loss assessment chart has been used as an alternative. However, there have been difficulties with validation, and there is evidence that it offers no benefit in the objective diagnosis of menorrhagia. More commonly the diagnosis of HMB is based on the woman’s subjective assessment of her periods. This in turn will be affected by a woman’s perception of what is normal, and tolerance of her menstrual symptoms. Women in the year 2005 are more likely to be employed outside the home than in the 1960s. The number of children in a family has reduced from an average of six in the 1850s to less than two in the 1990s. Few women currently breast feed for long periods of time and life expectancy has increased. It can be surmised that a woman in the year 2005 is likely to be troubled by a greater number of menstrual cycles in her adult life.
383
when abnormalities are detected. This allows the clinician to distinguish between polyps and fibroids. Routine hysteroscopy is unsupported by clinical evidence.
Endometrial sampling This should be considered for all women with persistent HMB. The most commonly used device in the UK is the Pipelle sampler. It has been shown to be as effective as D&C for excluding endometrial carcinoma and endometrial hyperplasia. The combination of transvaginal ultrasound and pipelle biopsy reduces false-negative results from blind sampling with further investigations should symptoms persist despite negative investigations. Sampling of the endometrium is still critical after a normal hysteroscopy, as the procedure has a low sensitivity for endometrial hyperplasia.
Oral drug treatments These can be subdivided into hormonal and nonhormonal methods.
Blood tests
Non-hormonal
Full blood count, but not serum ferritin, is an essential baseline investigation. Anaemia may be readily treatable with the alleviation of symptoms. A low haemoglobin makes objective menorrhagia more likely, but a normal haemoglobin of 412 g/dL does not preclude it. Endocrine investigations such as progesterone, oestradiol, leutinising hormone (LH) and follicle stimulating hormone (FSH) in women with regular menstrual cycles are of little value. Thyroid function and coagulation studies should only be considered if there are suggestive features in the history or examination findings. Inherited bleeding disorders often go unrecognised in the gynaecology setting. Mild forms may be a significant underlying factor in women presenting with HMB, especially mild von Willebrand’s disease. There is an argument for routine testing as the prevalence in a menstrual clinic may be as high as 17%.
Anti-fibrinolytics such as tranexamic acid reduce menstrual loss by inhibiting the action of plasminogen activators, which cause the breakdown of blood clots. Anti-fibrinolytics do not generally relieve menstrual cramps, but can reduce blood loss by 40–50%. Mefenamic acid, a non-steroidal anti-inflammatory drug (NSAID), also relieves menstrual cramps. The mode of action is upon the production of prostaglandin. NSAIDs reduce the menstrual flow by 33–55%.
Investigation of the uterine cavity In secondary care the ideal one-stop menstrual disorders clinic has transvaginal ultrasound available for investigation of the uterine cavity and the pelvis in general, with outpatient hysteroscopy
Hormonal Oral contraceptives are an effective treatment for HMB, reducing menstrual loss by 40%. Many women once their families are complete are reluctant to take hormonal medication on a long-term basis for non-contraceptive reasons. This can limit their usage in a menstrual disorders clinic. They can be safely used until the age of 50 in women with no contraindications. Long-cycle progestogens are effective in the treatment of menorrhagia when given as a dose of 5 mg three times daily from day 5 to day 26 of the cycle. They reduce menstrual loss by 87%, but offer reduced satisfaction with treatment when compared with the Mirena coil.
ARTICLE IN PRESS 384 Second-line drug treatments, such as gestrinone, danazol and gonadotophin-releasing hormone analogues, are all effective in reducing blood loss. The problem with these preparations is that their side effects limit long-term usage. They should probably be restricted to preparation of the endometrium before surgery, shrinkage of fibroids, or whilst a definitive treatment is being considered.
Progesterone-releasing IUD The progesterone releasing IUD has provided gynaecologists with a simple and effective outpatient treatment for HMB. The most widely available device Mirena has been extensively evaluated in randomised controlled trials (RCTs) against hysterectomy, transcervical endometrial resection (TCRE) and thermal balloon endometrial ablation (TBEA). It has been demonstrated to reduce menstrual blood loss by 94% after 3 months and is well tolerated by the majority of women. Hormonal side effects include weight gain, breast tenderness and bloating; the devices may occasionally be expelled spontaneously. These negative effects can be outweighed by the fact it is an effective and reversible treatment; after removal fertility returns rapidly.
Surgical treatments Uterine artery embolisation NICE issued guidance in October 2004 confirming that this procedure is safe for routine use; however, although there is symptomatic benefit in the shortterm, long-term effects and the effect upon fertility are not known. We are awaiting the results of RCTs such as the REST (Randomised Trial of Embolisation versus Surgical Treatment for Fibroids) study.
A.M. Sambrook, K. Cooper ectomy. Women undergoing resection or ablation have a significantly shorter hospital stay, less analgesia, shorter recovery time, and a reduced time to return to work than those who undergo hysterectomy of either abdominal or vaginal route. A randomised comparison of medical treatment versus TCRE revealed that a policy of offering immediate TCRE to women referred to a gynaecologist for heavy menstrual loss resulted in higher satisfaction, better menstrual status and greater improvements in health-related quality of life than medical treatment in the short, medium and longterm. In this study immediate TCRE did not lead to an increase in the number of hysterectomies. It was concluded that all eligible women seeking treatment for heavy periods should be offered an effective endometrial ablative technique.
Second-generation techniques Second-generation techniques employ different energy sources to cause endomyometrial destruction. They are blind in nature, not being performed under direct hysteroscopic vision with the exception of the HydroTherm AblatorTM. They therefore, avoid the risks of fluid distension media. They were developed to be easier to learn and perform than first-generation techniques. Some techniques may be performed under local anaesthesia. For all methods, the woman should have no desire to retain her fertility. The uterus should be of 12-week size or less. The ability to cope with intra-cavity pathology, such as sub-mucus fibroids, varies between techniques. The two in most widespread usage in the UK are microwave (MEATM) and TBEA, and are currently undergoing comparison in an independently funded RCT. NICE have an ongoing programme of evaluation for second-generation ablative techniques.
First-generation endometrial ablation techniques
Hysterectomy
First-generation endometrial ablation techniques were developed 20 years ago as an alternative procedure to hysterectomy. They were designed to remove or destroy the entire thickness of the endometrium and superficial myometrium (endometrial ablation) whilst leaving the uterus intact. The three first-generation endometrial ablation techniques, laser ablation, TCRE and rollerball endometrial ablation, have been extensively evaluated against both medical treatments and hyster-
This is the only method where amenorrhoea can essentially be guaranteed, (with the exception of a subtotal hysterectomy). A large-scale audit of the procedure by abdominal, vaginal and laparoscopic routes has been performed. It is usually performed as an elective procedure, but not without a significant complication rate. Value and eVALuate give complication rates of between 3.5% and 11% for major complications and 8.59–27% for minor complications.
ARTICLE IN PRESS RCOG guidelines on menorrhagia—Time for an update?
Patient issues HMB can have significant adverse effects on quality of life: work, social life and family life are all affected by HMB. Increased levels of depression, anxiety and sexual problems are all reported in women with HMB. It is important when considering treatment options to actively collaborate with the
385
woman. The first-line treatment for HMB is considered to be medical therapy. It is not universally effective and can give rise to unpalatable side effects. Patient preference for a particular treatment must be taken into account when deciding upon management. In a partially randomised patient preference trial, it was demonstrated that women who preferred medical treatment were
Confirm no change to history of regular cycles especially no IMB or PCB (C) Abdominal,bimanual and speculum examinations (C) Perform full blood count (B), consider TFT and coagulation tests if history indicates Transvaginal ultrasound
abnormal
normal Endometrial biopsy (C) normal
Endometrial biopsy (C) + Hysteroscopy (A)
Abnormal − Outside scope of guidelines
normal
Discuss options with patient
Drug treatments (A)
Remove endometrial polyps / submucosal fibroids hysteroscopically (No evidence for effectiveness) Offer concurrent endometrial ablation
and provide information
Reassure
abnormal
Progestogen releasing IUD (A)
Endometrial ablation (A)
OCP Tranexamic acid Mefenamic acid
Figure 1 Management in secondary care.
Hysterectomy (A) if no other method suitable/ acceptable
ARTICLE IN PRESS 386 significantly more likely to find the treatment acceptable and to wish to continue with it than those who were randomised to medical treatment. They still, however, had poorer results with respect to bleeding score, pain score, haemoglobin increase, satisfaction with treatment, and wishing to continue with the same treatment than those patients preferring or who were randomised to TCRE.
A.M. Sambrook, K. Cooper feel this is most suitable for them. Fig. 1 suggests an alternative algorithm for the treatment of HMB in women with no desire for further fertility. In those women wishing to have children treatment options are limited to oral medication or the LNG-IUS. Practice points
Summary HMB is an important issue in women’s health. Satisfaction with treatment and improvement in quality of life should be thought of as the primary goal of treatment. Over 8000 hysterectomies are still performed annually in the UK for HMB. In a review of surgical versus medical treatment it was concluded that women undergoing endometrial ablation to those fitted with a LNG-IUS reported similar rates of satisfaction and quality of life. There was no significant difference in bleeding between the two groups at 3 years. A hysterectomy is still the definitive treatment for HMB, but it does not appear to offer any improvement in satisfaction and quality of life over LNG-IUS or endometrial ablation. Not all clinical trials set out to measure these outcomes, but chose surrogate outcomes such as amenorrhoea. The only treatment for HMB that can guarantee this is hysterectomy, which is a major surgical procedure with attendant risks and complications attached. From a health services viewpoint, resources are limited. It is important that the cost-effectiveness of treatments is considered in the equation. RCTs without health economics components are of limited value. Involving the individual woman in the decisionmaking process is invaluable. Once referred into secondary care women should be able to opt for a surgical treatment as a first-line approach if they
Conservative surgical treatments should not be withheld in an effort to pursue medical therapy; if eligible all options should be discussed. LNG-IUS is an effective treatment for heavy menstrual bleeding. Second-generation endometrial ablation techniques continue to undergo further evaluation, not all techniques are equally suitable for all women.
Further Reading 1. Royal College of Obstetricians and Gynaecologists. Guideline on the management of menorrhagia in secondary care. RCOG press; 1998. 2. Royal College of Obstetricians and Gynaecologists. The initial management of menorrhagia. RCOG press; 1998. 3. Marjoribanks J, Lethaby A, Farquhar C. Surgery versus medical therapy for heavy menstrual bleeding. Cochrane Database Syst Rev 2003(2):CD003855. 4. Lethaby A, Hickey M. Endometrial destruction techniques for heavy menstrual bleeding: a Cochrane review. Hum Reprod 2002;17(11):2795–806. 5. Cooper KG, Jack SA, Parkin DE, Grant AM. Five-year follow up of women randomised to medical management or transcervical resection of the endometrium for heavy menstrual loss: clinical and quality of life outcomes. BJOG 2001;108(12): 1222–8. 6. National Institute for Clinical Excellence—interventional procedures programme www.nice.org.uk.