Hysterectomy, endometrial ablation and Mirena for heavy menstrual bleeding

a systematic review of clinical effectiveness and cost-effectiveness analysis

Siladitya Bhattacharya, Lee Middleton, A Tsourapas, Amanda Jane Lee, R Champaneria, JP Daniels, T Roberts, NH Hilken, P Barton, R Gray, KS Khan, P Chien, P O'Donovan, K Cooper

Research output: Book/ReportCommissioned Report

59 Citations (Scopus)

Abstract

Objective: The aim of this project was to determine the clinical effectiveness and costeffectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and Mirena® (Bayer Healthcare Pharmaceuticals, Pittsburgh, PA, USA) for the treatment of heavy menstrual bleeding.
Design: Individual patient data (IPD) meta-analysis of existing randomised controlledtrials to determine the short- to medium-term effects of hysterectomy, EA and Mirena. A population-based retrospective cohort study based on record linkage to investigate the long-term effects of ablative techniques and hysterectomy in terms of failure rates and complications. Cost-effectiveness analysis of hysterectomy versus first- and secondgeneration ablative techniques and Mirena.
Setting: Data from women treated for heavy menstrual bleeding were obtained from national and international trials. Scottish national data were obtained from the Scottish Information Services Division.
Participants: Women who were undergoing treatment for heavy menstrual bleeding were included.
Interventions: Hysterectomy, first- and second-generation EA, and Mirena.
Main outcome measures: Satisfaction, recurrence of symptoms, further surgery
and costs.
Results: Data from randomised trials indicated that at 12 months more women were dissatisfied with first-generation EA than hysterectomy [odds ratio (OR): 2.46, 95% confidence interval (CI) 1.54 to 3.93; p = 0.0002), but hospital stay [WMD (weighted mean difference): 3.0 days, 95% CI 2.9 to 3.1; p < 0.00001] and time to resumption of normal activities (WMD: 5.2 days, 95% CI 4.7 to 5.7; p < 0.00001) were longer for hysterectomy.
Unsatisfactory outcomes associated with first- and second-generation techniques were comparable [12.2% (123/1006) vs 10.6% (110/1034); OR: 1.20, 95% CI 0.88 to 1.62; p = 0.2). Rates of dissatisfaction with Mirena and second-generation EA were similar [18.1% (17/94) vs 22.5% (23/102); OR: 0.76, 95% CI 0.38 to 1.53; p = 0.4]. Indirect estimates suggested that hysterectomy was also preferable to second-generation EA (OR: 2.32, 95% CI 1.27 to 4.24; p = 0.006) in terms of patient dissatisfaction. The evidence to suggest that hysterectomy is preferable to Mirena was weaker (OR: 2.22, 95% CI 0.94 to 5.29; p = 0.07).
In women treated by EA or hysterectomy and followed up for a median [interquartile range (IQR)] duration of 6.2 (2.7–10.8) and 11.6 (7.9–14.8) years, respectively, 962/11,299 (8.5%) women originally treated by EA underwent further gynaecological surgery. While the risk of adnexal surgery was similar in both groups [adjusted hazards ratio 0.80 (95% CI 0.56 to 1.15)], women who had undergone ablation were less likely to need pelvic floor repair [adjusted hazards ratio 0.62 (95% CI 0.50 to 0.77)] and tension-free vaginal tape surgery for stress urinary incontinence [adjusted hazards ratio 0.55 (95% CI 0.41 to 0.74)]. Abdominal hysterectomy led to a lower chance of pelvic floor repair surgery [hazards ratio 0.54 (95% CI 0.45 to 0.64)] than vaginal hysterectomy. The incidence of endometrial cancer following EA was 0.02%. Hysterectomy was the most cost-effective treatment. It dominated firstgeneration EA and, although more expensive, produced more quality-adjusted life-years (QALYs) than second-generation EA and Mirena. The incremental cost-effectiveness
ratios for hysterectomy compared with Mirena and hysterectomy compared with secondgeneration ablation were £1440 per additional QALY and £970 per additional QALY, respectively.
Conclusions: Despite longer hospital stay and time to resumption of normal activities, more women were satisfied after hysterectomy than after EA. The few data available suggest that Mirena is potentially cheaper and more effective than first-generation ablation techniques, with rates of satisfaction that are similar to second-generation techniques. Owing to a paucity of trials, there is limited evidence to suggest that hysterectomy is preferable to Mirena. The risk of pelvic floor surgery is higher in women treated by hysterectomy than by ablation. Although the most cost-effective strategy, hysterectomy may not be considered an initial option owing to its invasive nature and higher risk of complications. Future research should focus on evaluation of the clinical effectivesness
and cost-effectiveness of the best second-generation EA technique under local anaesthetic versus Mirena and types of hysterectomy such as laparoscopic supracervical hysterectomy versus conventional hysterectomy and second-generation EA.
Funding: The National Institute for Health Research Health Technology
Assessment programme.
Original languageEnglish
Place of PublicationSouthampton
PublisherPrepress Projects Ltd
Number of pages252
Volume15
Edition19
ISBN (Print)1366-5278
DOIs
Publication statusPublished - Apr 2011

Fingerprint

Endometrial Ablation Techniques
Levonorgestrel
Hysterectomy
Cost-Benefit Analysis
Hemorrhage
Confidence Intervals
Odds Ratio
Pelvic Floor
Quality-Adjusted Life Years
Costs and Cost Analysis
Length of Stay

Keywords

  • Heavey Menstrual Bleeding
  • Endometrial Ablation
  • Hysterectomy

Cite this

Hysterectomy, endometrial ablation and Mirena for heavy menstrual bleeding : a systematic review of clinical effectiveness and cost-effectiveness analysis. / Bhattacharya, Siladitya; Middleton, Lee; Tsourapas, A; Lee, Amanda Jane; Champaneria, R; Daniels, JP; Roberts, T; Hilken, NH; Barton, P; Gray, R; Khan, KS; Chien, P; O'Donovan, P; Cooper, K.

19 ed. Southampton : Prepress Projects Ltd, 2011. 252 p.

Research output: Book/ReportCommissioned Report

Bhattacharya, S, Middleton, L, Tsourapas, A, Lee, AJ, Champaneria, R, Daniels, JP, Roberts, T, Hilken, NH, Barton, P, Gray, R, Khan, KS, Chien, P, O'Donovan, P & Cooper, K 2011, Hysterectomy, endometrial ablation and Mirena for heavy menstrual bleeding: a systematic review of clinical effectiveness and cost-effectiveness analysis. vol. 15, 19 edn, Prepress Projects Ltd, Southampton. https://doi.org/10.3310/hta15190
Bhattacharya, Siladitya ; Middleton, Lee ; Tsourapas, A ; Lee, Amanda Jane ; Champaneria, R ; Daniels, JP ; Roberts, T ; Hilken, NH ; Barton, P ; Gray, R ; Khan, KS ; Chien, P ; O'Donovan, P ; Cooper, K. / Hysterectomy, endometrial ablation and Mirena for heavy menstrual bleeding : a systematic review of clinical effectiveness and cost-effectiveness analysis. 19 ed. Southampton : Prepress Projects Ltd, 2011. 252 p.
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abstract = "Objective: The aim of this project was to determine the clinical effectiveness and costeffectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and Mirena{\circledR} (Bayer Healthcare Pharmaceuticals, Pittsburgh, PA, USA) for the treatment of heavy menstrual bleeding. Design: Individual patient data (IPD) meta-analysis of existing randomised controlledtrials to determine the short- to medium-term effects of hysterectomy, EA and Mirena. A population-based retrospective cohort study based on record linkage to investigate the long-term effects of ablative techniques and hysterectomy in terms of failure rates and complications. Cost-effectiveness analysis of hysterectomy versus first- and secondgeneration ablative techniques and Mirena. Setting: Data from women treated for heavy menstrual bleeding were obtained from national and international trials. Scottish national data were obtained from the Scottish Information Services Division. Participants: Women who were undergoing treatment for heavy menstrual bleeding were included. Interventions: Hysterectomy, first- and second-generation EA, and Mirena. Main outcome measures: Satisfaction, recurrence of symptoms, further surgery and costs. Results: Data from randomised trials indicated that at 12 months more women were dissatisfied with first-generation EA than hysterectomy [odds ratio (OR): 2.46, 95{\%} confidence interval (CI) 1.54 to 3.93; p = 0.0002), but hospital stay [WMD (weighted mean difference): 3.0 days, 95{\%} CI 2.9 to 3.1; p < 0.00001] and time to resumption of normal activities (WMD: 5.2 days, 95{\%} CI 4.7 to 5.7; p < 0.00001) were longer for hysterectomy. Unsatisfactory outcomes associated with first- and second-generation techniques were comparable [12.2{\%} (123/1006) vs 10.6{\%} (110/1034); OR: 1.20, 95{\%} CI 0.88 to 1.62; p = 0.2). Rates of dissatisfaction with Mirena and second-generation EA were similar [18.1{\%} (17/94) vs 22.5{\%} (23/102); OR: 0.76, 95{\%} CI 0.38 to 1.53; p = 0.4]. Indirect estimates suggested that hysterectomy was also preferable to second-generation EA (OR: 2.32, 95{\%} CI 1.27 to 4.24; p = 0.006) in terms of patient dissatisfaction. The evidence to suggest that hysterectomy is preferable to Mirena was weaker (OR: 2.22, 95{\%} CI 0.94 to 5.29; p = 0.07). In women treated by EA or hysterectomy and followed up for a median [interquartile range (IQR)] duration of 6.2 (2.7–10.8) and 11.6 (7.9–14.8) years, respectively, 962/11,299 (8.5{\%}) women originally treated by EA underwent further gynaecological surgery. While the risk of adnexal surgery was similar in both groups [adjusted hazards ratio 0.80 (95{\%} CI 0.56 to 1.15)], women who had undergone ablation were less likely to need pelvic floor repair [adjusted hazards ratio 0.62 (95{\%} CI 0.50 to 0.77)] and tension-free vaginal tape surgery for stress urinary incontinence [adjusted hazards ratio 0.55 (95{\%} CI 0.41 to 0.74)]. Abdominal hysterectomy led to a lower chance of pelvic floor repair surgery [hazards ratio 0.54 (95{\%} CI 0.45 to 0.64)] than vaginal hysterectomy. The incidence of endometrial cancer following EA was 0.02{\%}. Hysterectomy was the most cost-effective treatment. It dominated firstgeneration EA and, although more expensive, produced more quality-adjusted life-years (QALYs) than second-generation EA and Mirena. The incremental cost-effectiveness ratios for hysterectomy compared with Mirena and hysterectomy compared with secondgeneration ablation were £1440 per additional QALY and £970 per additional QALY, respectively. Conclusions: Despite longer hospital stay and time to resumption of normal activities, more women were satisfied after hysterectomy than after EA. The few data available suggest that Mirena is potentially cheaper and more effective than first-generation ablation techniques, with rates of satisfaction that are similar to second-generation techniques. Owing to a paucity of trials, there is limited evidence to suggest that hysterectomy is preferable to Mirena. The risk of pelvic floor surgery is higher in women treated by hysterectomy than by ablation. Although the most cost-effective strategy, hysterectomy may not be considered an initial option owing to its invasive nature and higher risk of complications. Future research should focus on evaluation of the clinical effectivesness and cost-effectiveness of the best second-generation EA technique under local anaesthetic versus Mirena and types of hysterectomy such as laparoscopic supracervical hysterectomy versus conventional hysterectomy and second-generation EA. Funding: The National Institute for Health Research Health Technology Assessment programme.",
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AU - Lee, Amanda Jane

AU - Champaneria, R

AU - Daniels, JP

AU - Roberts, T

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N2 - Objective: The aim of this project was to determine the clinical effectiveness and costeffectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and Mirena® (Bayer Healthcare Pharmaceuticals, Pittsburgh, PA, USA) for the treatment of heavy menstrual bleeding. Design: Individual patient data (IPD) meta-analysis of existing randomised controlledtrials to determine the short- to medium-term effects of hysterectomy, EA and Mirena. A population-based retrospective cohort study based on record linkage to investigate the long-term effects of ablative techniques and hysterectomy in terms of failure rates and complications. Cost-effectiveness analysis of hysterectomy versus first- and secondgeneration ablative techniques and Mirena. Setting: Data from women treated for heavy menstrual bleeding were obtained from national and international trials. Scottish national data were obtained from the Scottish Information Services Division. Participants: Women who were undergoing treatment for heavy menstrual bleeding were included. Interventions: Hysterectomy, first- and second-generation EA, and Mirena. Main outcome measures: Satisfaction, recurrence of symptoms, further surgery and costs. Results: Data from randomised trials indicated that at 12 months more women were dissatisfied with first-generation EA than hysterectomy [odds ratio (OR): 2.46, 95% confidence interval (CI) 1.54 to 3.93; p = 0.0002), but hospital stay [WMD (weighted mean difference): 3.0 days, 95% CI 2.9 to 3.1; p < 0.00001] and time to resumption of normal activities (WMD: 5.2 days, 95% CI 4.7 to 5.7; p < 0.00001) were longer for hysterectomy. Unsatisfactory outcomes associated with first- and second-generation techniques were comparable [12.2% (123/1006) vs 10.6% (110/1034); OR: 1.20, 95% CI 0.88 to 1.62; p = 0.2). Rates of dissatisfaction with Mirena and second-generation EA were similar [18.1% (17/94) vs 22.5% (23/102); OR: 0.76, 95% CI 0.38 to 1.53; p = 0.4]. Indirect estimates suggested that hysterectomy was also preferable to second-generation EA (OR: 2.32, 95% CI 1.27 to 4.24; p = 0.006) in terms of patient dissatisfaction. The evidence to suggest that hysterectomy is preferable to Mirena was weaker (OR: 2.22, 95% CI 0.94 to 5.29; p = 0.07). In women treated by EA or hysterectomy and followed up for a median [interquartile range (IQR)] duration of 6.2 (2.7–10.8) and 11.6 (7.9–14.8) years, respectively, 962/11,299 (8.5%) women originally treated by EA underwent further gynaecological surgery. While the risk of adnexal surgery was similar in both groups [adjusted hazards ratio 0.80 (95% CI 0.56 to 1.15)], women who had undergone ablation were less likely to need pelvic floor repair [adjusted hazards ratio 0.62 (95% CI 0.50 to 0.77)] and tension-free vaginal tape surgery for stress urinary incontinence [adjusted hazards ratio 0.55 (95% CI 0.41 to 0.74)]. Abdominal hysterectomy led to a lower chance of pelvic floor repair surgery [hazards ratio 0.54 (95% CI 0.45 to 0.64)] than vaginal hysterectomy. The incidence of endometrial cancer following EA was 0.02%. Hysterectomy was the most cost-effective treatment. It dominated firstgeneration EA and, although more expensive, produced more quality-adjusted life-years (QALYs) than second-generation EA and Mirena. The incremental cost-effectiveness ratios for hysterectomy compared with Mirena and hysterectomy compared with secondgeneration ablation were £1440 per additional QALY and £970 per additional QALY, respectively. Conclusions: Despite longer hospital stay and time to resumption of normal activities, more women were satisfied after hysterectomy than after EA. The few data available suggest that Mirena is potentially cheaper and more effective than first-generation ablation techniques, with rates of satisfaction that are similar to second-generation techniques. Owing to a paucity of trials, there is limited evidence to suggest that hysterectomy is preferable to Mirena. The risk of pelvic floor surgery is higher in women treated by hysterectomy than by ablation. Although the most cost-effective strategy, hysterectomy may not be considered an initial option owing to its invasive nature and higher risk of complications. Future research should focus on evaluation of the clinical effectivesness and cost-effectiveness of the best second-generation EA technique under local anaesthetic versus Mirena and types of hysterectomy such as laparoscopic supracervical hysterectomy versus conventional hysterectomy and second-generation EA. Funding: The National Institute for Health Research Health Technology Assessment programme.

AB - Objective: The aim of this project was to determine the clinical effectiveness and costeffectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and Mirena® (Bayer Healthcare Pharmaceuticals, Pittsburgh, PA, USA) for the treatment of heavy menstrual bleeding. Design: Individual patient data (IPD) meta-analysis of existing randomised controlledtrials to determine the short- to medium-term effects of hysterectomy, EA and Mirena. A population-based retrospective cohort study based on record linkage to investigate the long-term effects of ablative techniques and hysterectomy in terms of failure rates and complications. Cost-effectiveness analysis of hysterectomy versus first- and secondgeneration ablative techniques and Mirena. Setting: Data from women treated for heavy menstrual bleeding were obtained from national and international trials. Scottish national data were obtained from the Scottish Information Services Division. Participants: Women who were undergoing treatment for heavy menstrual bleeding were included. Interventions: Hysterectomy, first- and second-generation EA, and Mirena. Main outcome measures: Satisfaction, recurrence of symptoms, further surgery and costs. Results: Data from randomised trials indicated that at 12 months more women were dissatisfied with first-generation EA than hysterectomy [odds ratio (OR): 2.46, 95% confidence interval (CI) 1.54 to 3.93; p = 0.0002), but hospital stay [WMD (weighted mean difference): 3.0 days, 95% CI 2.9 to 3.1; p < 0.00001] and time to resumption of normal activities (WMD: 5.2 days, 95% CI 4.7 to 5.7; p < 0.00001) were longer for hysterectomy. Unsatisfactory outcomes associated with first- and second-generation techniques were comparable [12.2% (123/1006) vs 10.6% (110/1034); OR: 1.20, 95% CI 0.88 to 1.62; p = 0.2). Rates of dissatisfaction with Mirena and second-generation EA were similar [18.1% (17/94) vs 22.5% (23/102); OR: 0.76, 95% CI 0.38 to 1.53; p = 0.4]. Indirect estimates suggested that hysterectomy was also preferable to second-generation EA (OR: 2.32, 95% CI 1.27 to 4.24; p = 0.006) in terms of patient dissatisfaction. The evidence to suggest that hysterectomy is preferable to Mirena was weaker (OR: 2.22, 95% CI 0.94 to 5.29; p = 0.07). In women treated by EA or hysterectomy and followed up for a median [interquartile range (IQR)] duration of 6.2 (2.7–10.8) and 11.6 (7.9–14.8) years, respectively, 962/11,299 (8.5%) women originally treated by EA underwent further gynaecological surgery. While the risk of adnexal surgery was similar in both groups [adjusted hazards ratio 0.80 (95% CI 0.56 to 1.15)], women who had undergone ablation were less likely to need pelvic floor repair [adjusted hazards ratio 0.62 (95% CI 0.50 to 0.77)] and tension-free vaginal tape surgery for stress urinary incontinence [adjusted hazards ratio 0.55 (95% CI 0.41 to 0.74)]. Abdominal hysterectomy led to a lower chance of pelvic floor repair surgery [hazards ratio 0.54 (95% CI 0.45 to 0.64)] than vaginal hysterectomy. The incidence of endometrial cancer following EA was 0.02%. Hysterectomy was the most cost-effective treatment. It dominated firstgeneration EA and, although more expensive, produced more quality-adjusted life-years (QALYs) than second-generation EA and Mirena. The incremental cost-effectiveness ratios for hysterectomy compared with Mirena and hysterectomy compared with secondgeneration ablation were £1440 per additional QALY and £970 per additional QALY, respectively. Conclusions: Despite longer hospital stay and time to resumption of normal activities, more women were satisfied after hysterectomy than after EA. The few data available suggest that Mirena is potentially cheaper and more effective than first-generation ablation techniques, with rates of satisfaction that are similar to second-generation techniques. Owing to a paucity of trials, there is limited evidence to suggest that hysterectomy is preferable to Mirena. The risk of pelvic floor surgery is higher in women treated by hysterectomy than by ablation. Although the most cost-effective strategy, hysterectomy may not be considered an initial option owing to its invasive nature and higher risk of complications. Future research should focus on evaluation of the clinical effectivesness and cost-effectiveness of the best second-generation EA technique under local anaesthetic versus Mirena and types of hysterectomy such as laparoscopic supracervical hysterectomy versus conventional hysterectomy and second-generation EA. Funding: The National Institute for Health Research Health Technology Assessment programme.

KW - Heavey Menstrual Bleeding

KW - Endometrial Ablation

KW - Hysterectomy

U2 - 10.3310/hta15190

DO - 10.3310/hta15190

M3 - Commissioned Report

SN - 1366-5278

VL - 15

BT - Hysterectomy, endometrial ablation and Mirena for heavy menstrual bleeding

PB - Prepress Projects Ltd

CY - Southampton

ER -