A Systematic Review Comparing Hysterectomy with Less-Invasive Treatments for Abnormal Uterine Bleeding

Article Outline

• Abstract
• Materials and Methods
  • Data Source
  • Study Selection and Data Extraction
• Results
  • Hysterectomy Versus Endometrial Ablation (Table 2)
  • Bleeding Control (Critical Importance)
  • Quality of Life (Critical Importance)
  • Pain (Critical Importance)
  • Sexual Health (High Importance)
  • Satisfaction (High Importance)
  • Additional Treatment (Moderate Importance)
  • Hysterectomy Versus the Levonorgestrel-intrauterine System (Table 3)
  • Bleeding Control (Critical Importance)
  • Quality of Life Measures (Critical Importance)
  • Pain (Critical Importance)
  • Sexual Health (High Importance)
  • Satisfaction (High Importance)
  • Additional Treatment (Moderate Importance)
  • Hysterectomy Versus Medications (Table 4)
  • Bleeding Control (Critical Importance)
  • Quality of Life Measures (Critical Importance)
  • Pain (Critical Importance)
  • Sexual Health (High Importance)
  • Satisfaction (High Importance)
  • Additional Treatment (Moderate Importance)
  • Adverse Events
• Discussion
• Acknowledgments
• References
• Copyright

Abstract 

Study Objective

To compare hysterectomy with less-invasive alternatives for abnormal uterine bleeding (AUB) in 7 clinically important domains.

Design

Systematic review.

Setting

Randomized clinical trials comparing bleeding, quality of life, pain, sexual health, satisfaction, need for subsequent surgery, and adverse events between hysterectomy and less-invasive treatment options.

Patients

Women with AUB, predominantly from ovulatory disorders and endometrial causes.

Interventions

Systematic review of the literature (from inception to January 2011) comparing hysterectomy with alternatives for AUB treatment. Eligible trials were extracted into standardized forms. Trials were graded with a predefined 3-level rating, and the strengths of evidence for each outcome were evaluated with the Grades for Recommendation, Assessment, Development and Evaluation system.

Measurements and Main Results

Nine randomized clinical trials (18 articles) were eligible. Endometrial ablation, levonorgestrel intrauterine system, and medications were associated with lower risk of adverse events but higher risk of additional treatments than hysterectomy. Compared to ablation, hysterectomy had superior long-term pain and bleeding control. Compared with the levonorgestrel intrauterine system, hysterectomy had superior control of bleeding. No other differences between treatments were found.

Conclusion

Less-invasive treatment options for AUB result in improvement in quality of life but carry significant risk of retreatment caused by unsatisfactory results. Although hysterectomy is the most effective treatment for AUB, it carries the highest risk for adverse events.

Keywords: Abnormal uterine bleeding, Dysfunctional uterine bleeding, Hysterectomy, Systematic review

Abnormal uterine bleeding (AUB) affects up to 30% of women during their reproductive years 1, 2, 3, 4. AUB has a substantial impact on women’s quality of life, associated loss of productivity, and major health care costs 5, 6, 7, 8. AUB is a symptom of several different underlying conditions, which have been newly classified by the International Federation of Gynecology and Obstetrics (FIGO) Menstrual Disorders Group 9, 10. Under this system, causes of AUB are classified as polyps, adenomyosis, leiomyomas (AUB-L), malignancy and premalignant conditions, coagulopathy (AUB-C), ovulatory disorders (AUB-O), endometrial disorders (AUB-E), iatrogenic, and “not classified.” Because of confusion surrounding the term “dysfunctional uterine bleeding” (DUB), this term is not included in the naming system, and women who were formerly described as having “DUB” generally fit into the ovulatory disorders and endometrial hemostatic disorders categories if coagulopathy has been excluded 9, 10. Although hysterectomy is considered the “definitive” treatment for AUB regardless of cause, less-invasive options are increasingly available, including medical therapy, the levonorgestrel intrauterine system (LNG-IUS), and endometrial ablation. Better characterization of the relative efficacy of these alternatives compared with hysterectomy will improve patient counseling, facilitate informed decision-making, and reduce the burden of unnecessary procedures on both the patient and the health care system.

The Systematic Review Group of the Society of Gynecologic Surgeons (SGS SRG) performed a systematic review of randomized control trials (RCTs) comparing hysterectomy with other treatment modalities for women with AUB presumed caused by ovulatory (AUB-O) or endometrial dysfunction (AUB-E) under this new FIGO classification system. The objective of this study was to determine the relative efficacy of less-invasive treatments compared with hysterectomy for bleeding control, change in quality of life, pain, sexual health, patient satisfaction, additional needed treatments, and adverse events. The systematic review was conducted with the goal of producing an evidence-based guideline on decision-making around hysterectomy for AUB-O and AUB-E.

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Materials and Methods 

Data Source 

The SGS SRG, including gynecologic surgeons and systematic review methodologists, performed a systematic search to identify RCTs comparing treatments for AUB in women with ovulatory disorders (AUB-O), endometrial hemostatic dysfunction (AUB-E), or myomas (AUB-L). A working document defining parameters for a literature search was created [11]. We searched Medline from 1950 to January 14, 2011, for English-language human randomized clinical trials. We included search terms for AUB, menorrhagia, myomas, hysterectomy, myomectomy, uterine artery embolization, ablation, intrauterine devices, medical therapies, RCTs, and related terms. Details of the full search were reported in a previous publication [12].

Study Selection and Data Extraction 

We included RCTs that compared hysterectomy (via any route) with endometrial ablation, LNG-IUS, or medical therapies as treatments of AUB caused by presumed ovulatory disorders (AUB-O) or endometrial hemostatic dysfunction (AUB-E), and reported an outcome of interest. We excluded RCTs that included only participants with AUB attributed to myomas (AUB-L), although studies that included women with AUB-L in addition to AUB-O and AUB-E were not excluded. This review was conducted as part of a broader systematic review that addressed all treatments for AUB caused by ovulatory disorders (AUB-O), endometrial hemostatic dysfunction (AUB-E), or myomas (AUB-L).

Data from studies were extracted by members of the SRG, most of whom had experience from a prior systematic review 13, 14. Individual extractions were confirmed by a second member, and discrepancies were resolved by consensus among all members of the SRG. Complete details on the definitions of variables of interest, outcome classification, and coding have been published [12]. In brief, 114 outcomes were identified and ranked as “critical,” “important,” and “low-importance” for clinical decision-making. Using a ballot system all members of the SGS SRG used a structured process (explained in detail in a previous publication of the review group) to grade the importance of each outcome with a scale suggested by the Grades for Recommendation, Assessment, Development and Evaluation (GRADE) Working Group 12, 15, 16. “Critical” and “important” outcomes were organized into 7 overarching domains considered in this review (bleeding, quality of life, pain, sexual health, patient satisfaction, need for subsequent surgical treatment, and adverse events) [12]. Adverse events were categorized as “major” (need for urgent reoperation/conversion to another surgery [hysterectomy or laparotomy], cystotomy, ureteral injury, bowel injury, pelvic or vaginal vault hematoma, death, myocardial infarction/cardiorespiratory event, deep vein thrombosis/thromboembolism, pulmonary embolus/thromboembolic event, stroke, admission to the intensive care unit, and “other”) and “minor” (wound infection, pelvic infection/cuff cellulitis, febrile morbidity, “other infection” [which included urinary tract infection, pneumonia, other infections], wound hematoma/wound rupture [which also included wound hematoma/seroma and unspecified hematomas]), need for transfusion, readmission without reoperation, fluid overload, uterine perforation, ileus obstruction, and nonurgent surgery presumed caused by complications from the initial procedure. Reoperations that were not presumed caused by complications from the initial procedure were not reliably reported (for example, subsequent surgery for ovarian cysts or adhesions) and therefore not included.

We assessed the methodologic quality of each study using predefined criteria from a 3-category system modified from the Agency for Healthcare Research and Quality [15]. Studies were graded as good (A), fair (B), or poor (C) quality on the basis of the likelihood of biases and the completeness of reporting. Grades for different outcomes could vary within the same study. We decided a priori that meta-analyses would be performed only when 3 or more trials used similar interventions and outcome definitions. To grade the overall strength of evidence, we followed the GRADE system, with 4 ratings: high, moderate, low, and very low [16]. As part of a public vetting process, the review and guidelines were presented for public comment at the 36th SGS Annual Scientific Meeting April 2010 and posted on the SGS website, where public comments were solicited for 4 weeks.

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Results 

The literature search identified 5503 citations. Screening of citations and potentially relevant full-text articles resulted in 117 eligible articles (115 which were extracted) and 81 distinct RCTs relevant to the broader review (Fig. 1). This review is based on the 18 articles from 9 trials that directly compared hysterectomy with another intervention and met our eligibility criteria (Table 1).

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• Fig. 1 

  Study selection process.

Table 1. Summary of studies, comparators, and primary outcomes

Study (Study quality rating)a	No.	Mean age (y)	Hysterectomy	Comparator	Primary outcomes (Time), Sample size and power summary
Hysterectomy vs. Ablation
Gannon [17]b United Kingdom	54	40	TAH	TCER (pretreated with IM MPA)	Unclear primary outcome (12 mo), power, and sample size unclear
Dwyer [18]b United Kingdom	196	40	TAH	TCER	Satisfaction (4 mo), needed 100 per group to detect a 10% difference β = 0.1, α = 0.05
Sculpher [19]b United Kingdom	155				Satisfaction (2.8 y), power, and sample size unclear
Pinion [20]b United Kingdom	204	40	Hysterectomy (87 TAH, 12 TVH)	TCER or laser endometrial ablation (pretreated with GnRH analog)	Satisfaction (12 mo), needed 160 per group to detect a 20% difference β = 0.2, α = 0.05
Alexander [21]b United Kingdom	204			TCER or laser endometrial ablation (pretreated with GnRH analog)	Psychosocial outcomes (12 mo), power and sample size unclear
Aberdeen [22]b United Kingdom	151			TCER or laser endometrial ablation (pretreated with GnRH analog)	Satisfaction (4.8 y), power and sample size unclear, may be same as study by Pinion et al. [20]
Corsignani [23]b Italyb	92	46	TVH	TCER or rollerball ablation	Satisfaction (2 y), needed 43 per group to detect a 25% difference β = 0.2, α = 0.05
Zupi [24]c Italy	181	43	LASH	TCER (pretreated with GnRH analog)	HRQoL: SF-36, (2 y), sample size not calculated for this outcome. Needed 90 per group to detect a 50% difference in satisfaction, β = 0.2, α = 0.05
Dickersin [25]b USA	237	NR	Hysterectomy (30 TAH, 70 TVH, 18 laparoscopic)	Endometrial ablation (hysteroscopic with coagulation or vaporization or nonresectocopic with thermal balloon)	Problem solved, resolution of primary complaint, bleeding, pain, and fatigue measured by SF-36 (12 mo), Needed 121 per group to detect a 7.4 point difference in MCS, 9 point difference in pain, and a 10 point difference in general health and energy, β = 0.1, α = 0.05. Sample size for bleeding based on Ruta scale score, but data on Ruta scale score. Not included in study.
O’Connor [26]b United Kingdomd	202	40	Hysterectomy (28 TAH, 28 TVH)	TCER (pretreated, mixed)	Satisfaction rate and subsequent re-operation (2 y), needed 200 total (2:1 ablation to hysterectomy ratio) to detect a 15% difference in “rate of further gynecologic surgery, β = 0.1, α = 0.05”
Hysterectomy vs LNG-IUSd (All studies conducted in Finland)
Hurskainen [27]c	236	43	Hysterectomy (21 TAH, 30 TVH, 56 laparoscopic)	LNG- IUS	EuroQol-5D (12 mo), needed 115 per group to detect a 7.5% difference in score, β = 0.2, α = 0.05
Hurskainen [28]c	236				EuroQol-5D (12 mo), power and sample size needed for multivariable logistic regression unclear
Hurskainen [29]c	232				EuroQol-5D (5 y), needed 115 per group to detect a 7.5% difference in score, β = 0.2, α = 0.05
Halmesmaki [30]c	232				McCoy sex scale scores (5 y), power and sample size not reported
Heliövaara-Peippo [31]c	232				Likert scores on back/abdominal pain (5 y) Power and sample size not reported
Heliövaara-Peippo [32]c	221				Lower urinary tract symptoms (10 y), retrospective power calculation showed 164 hysterectomy group and 71 in LNG-IUS group would give 80% power to detect a 15% difference in symptoms with α = 0.05
Hysterectomy vs medication All studies conducted in USA
Kuppermann [33]c	63	41 years	Hysterectomy (10 TAH, 18 TVH)	Medical therapye	Mental health score of SF-36 (2 y), needed 30 per group to detect a 6.8 unit difference with β = 0.1, α = 0.05
Learman [34]b					“Clinical outcomes” (2 y), power and sample size not reported

IM MPA = Intramuscular medroxyprogesterone acetate; HRQoL = health-related quality of life; MOS SF-36 = Medical Outcomes Study–Short-Form 36; TCER = transcervical resection of endometrium; LASH = laparoscopic supracervical hysterectomy.

Table 2. Summary of data comparing ablation to hysterectomy

Outcome	Study, year	Length of follow-up (mo)	Ablation	Hysterectomy	Summary of findings
Bleeding control (7 studies, n = 1167)					Summary: Moderate quality evidence showed no difference; outcome of critical importance
Amenorrheaa					6 of 7 trials evaluated amenorrhea as an outcome in the ablation group. Amenorrhea rates ranged from 13%-64%, and hypomenorrhea rates ranged from 24%–77%
	Gannon 1991 [17]	12	16/25 (64%)	Only measured in ablation arm
	Dwyer 1993 [18]	4	13/99 (13%)
	Pinion 1994 [20]	12	21/96 (22%)
	Aberdeen 1999 [22]	48	33/73 (45%)
	Corsignani 1997 [23]	24	8/41 (20%)
	O’Connor 1997 [26]	12	48/104 (46%)
		36	11/54 (21%)
Hypomenorrheaa
	Dwyer 1993 [18]	4	76/99 (77%)	Only measured in ablation arm
	Pinion 1994 [20]	12	59/96 (61%)
	Aberdeen 1999 [22]	48	29/73 (40%)
	Corsignani 1997 [23]	24	10/41 (24%)
“Excessive” bleedinga
Amount
	Dickersin 2007 [25]	12	10/107 (9%)	3/103 (3%)	Proportion of patients with “excessive” bleeding appears greater in ablation group than the hysterectomy group, although statistical testing was not performed for this outcome
		48	7/47 (15%)	0/51 (0%)
Unpredictability		12	6/107 (6%)	1/103 (1%)
		48	5/47 (11%)	0/51 (0%)
Duration		12	19/107 (18%)	1/103 (1%)
		48	8/47 (17%)	0/51 (0%)
Frequency		12	16/107 (15%)	2/103 (2%)
		48	5/47 (11%)	0/51 (0%)
Quality of Life (6 studies, n = 1116)					Summary: Moderate quality evidence showed no difference; outcome of critical importance No difference in SF-36 physical component, mental component, or emotional scores. No difference in EuroQol5D scores. Findings of some studies suggest greater SF-36 dimension scores for pain, general health, vitality, and social function for hysterectomy group compared to ablation group. Pinion found better health in the hysterectomy group 1 year after surgery. Other studies found no difference in “General Health Questionnaire” score (Dwyer), Hospital Anxiety and Depression Scores (Alexander).
SF-36 (Pain)b
	Sculpher 1996 [19]	33	73.2	83.1c
	Corsignani 1997 [23]	24	69.6	75.9
	Zupi 2003 [24]	24	58.6	60.1
SF-36 (General Health)b
	Sculpher 1996 [19]	33	74.4	79.7
	Corsignani 1997 [23]	24	61.3	71.2
	Zupi 2003 [24]	24	59.6	69.4c
SF-36 (Vitality)b
	Sculpher 1996 [19]	33	60.8	62.3
	Corsignani 1997 [23]	24	52.3	63.6c
	Zupi 2003 [24]	24	61.0	72.3
SF-36 (Social Function)b
	Sculpher 1996 [19]	33	84.4	90.4
	Corsignani 1997 [23]	24	70.1	80.4d
	Zupi 2003 [24]	24	67.3	88.5c
Health much better compared with 1 year ago?	Pinion 1994 [20]	12	46/96 (48%)	65/89 (73%)c
Pain (5 studies, n = 818)					Summary: Low quality evidence favored hysterectomy; outcome of critical importance
Improve Dysmenorrheaa	Dwyer 1993 [18]	4	53/85 (62%)	81/84 (96%)e
Pelvic pain presenta					Dickerson et al found a higher proportion in the ablation group reported “moderate/severe” pain 2 years post-operatively. Statistical testing was not performed for most comparisons, though it appears that more participants in the ablation groups than hysterectomy groups reported pelvic pain at follow-up
	Sculpher 1996 [19]	33	46/72 (64%)	13/70 (19%)e
	Aberdeen 1999 [22]	48	14/77 (18%)	10/68 (15%)
	Zupi 2003 [24]	24	9/38 (24%)	2/39 (5%)e
	Dickersin 2007 [25]	24	30/106 (28%)	7/107 (7%)c
Sexual Health (5 studies, n = 879)					Summary: Low quality evidence showed no difference; outcome of high importance
Return to sexual activityf
	Dwyer 1993 [18]	4	3 wks	6 wksc	Participants in the ablation group reporter faster return to sexual activity. No differences in sexual satisfaction or sexual rating between groups.
	Zupi 2003 [24]	24	3 wks	3 wks
	O’Connor 1997 [26]	24	4 wks	6 wksc
Increased sexual satisfaction
	Dwyer 1993 [18]	4	19/85 (22%)	12/81 (15%)
	Aberdeen 1999 [22]	48	19/69 (28%)	22/69 (32%)
Sexual Rating Scaleg	Corsignani 1997 [23]	24	44.8	48.5
Satisfaction (5 studies, n = 935)					Summary: Very low quality evidence showed no difference; outcome of high importance
Satisfieda
	Sculpher 1996 [19]	33	65/82 (79%)	69/73 (95%)c	Most participants randomized to either ablation or hysterectomy were satisfied. One study showed statistically greater satisfaction among the hysterectomy group compared with the ablation group.
	Aberdeen 1999 [22]	48	69/73 (95%)	67/72 (93%)
	Corsignani 1997 [23]	24	33/38 (87%)	37/39 (95%)
	Dickersin 2007 [25]	48	53/107 (50%)	54/103 (52%)
	O’Connor 1997 [26]	12	90/104 (87%)	42/46 (91%)
		24	74/86 (86%)	36/38 (94%)
		36	46/54 (75%)	27/28 (96%)
Additional Treatment (7 studies, n = 1167)					Summary: Moderate quality evidence favored hysterectomy; outcome of moderate importance
Repeat ablationa
	Sculpher 1996 [19]	33	10/88 (11%)	N/A hysterectomy arm	At 1 to 4 years after surgery, 2% to 19% of the ablation groups had undergone repeat ablation
	Gannon 1991 [22]	12	4/25 (16%)
	Aberdeen 1999 [23]	48	19/102 (19%)
	Dickersin 2007 [25]	48	2/110 (2%)
	O’Connor 1997 [26]	24	14/119 (12%)
Hysterectomy				N/A hysterectomy arm	At 1 to 4 years after surgery, 10% to 29% of the ablation groups had undergone a hysterectomy
	Sculpher 1996 [19]	33	18/88 (20%)
	Aberdeen 1999 [22]	48	24/102 (24%)
	Corsignani 1997 [23]	24	4/41 (10%)
	Dickersin 2007 [25]	48	32/110 (29%)
	O’Connor 1997 [26]	24	12/119 (10%)
“Further surgical needs”	Zupi 2003 [24]	24	12/89 (14%)	1/92 (1%)

Table 3. Summary of data comparing LNG-IUS with hysterectomy

Outcome	Study	Length of follow-up (mo)	LNG-IUS	Hysterectomy	Summary of results
Bleeding control					Summary: Moderate quality evidence favored hysterectomy; outcome of critical importance
Amenorrheaa	Hurskainen [29]	12	41/81 (51%)	Only measured LNG-IUS arm	Data were analyzed “as treated”. Included only women with the LNG-IUS still in situ.
Oligomenorrheaa	Hurskainen [29]	60	43/57 (75%)
Quality of life					No differences in change in any quality of life scores (Before treatment − After treatment) between LNG-IUS and hysterectomy groups
Change in SF-36 score	Hurskainen [29]				Summary: Moderate quality evidence showed no difference; outcome of critical importance
Physical health		60	−1.4	−2.0
Mental health			8.4	8.1
Physical role function			8.9	8.9
Pain			12.8	13.4
General health			3.6	4.4
Vitality			9.4	10.0
Social function			8.7	9.0
Emotional role			16.2	12.9
EuroQol-5Db	Hurskainen [29]	60	0.08	0.10
STAIc	Hurskainen [29]	60	−2.4	1.9
BDId	Hurskainen [29]	60	−1.2	−1.4
Pain					Summary: Moderate quality evidence showed no difference; outcome of critical importance
Lower abdominal paina	Heliövaara-Peippo [31]	6	35/114 (31%)	19/103 (18%)	Greater proportion of LNG-IUS group with lower abdominal pain at 12 months. No difference in proportion with lower abdominal pain at 6 months and 5 years. No difference in back pain between groups at any time point.
		12	33/111 (30%)	15/108 (14%)e
		60	18/116 (16%)	17/113 (15%)
Back paina	Heliövaara-Peippo [31]	6	40/114 (35%)	31/104 (30%)
		12	46/111 (41%)	32/109 (29%)
		60	44/116 (38%)	41/113 (36%)
Sexual Health					Summary: Moderate quality evidence showed no difference; outcome of high importance
McCoy Sex Scale Scoreg	Halmesmaki [30]	6	23.87	24.51	Compared with hysterectomy, the LNG-IUS group reported more sexual problems at 6 months (p =.03); however, this effect was not seen at 12 months or 5 years. No differences were found in sexual problems at other time points or in satisfaction scores at any time point.
		12	23.25	24.25
		60	22.8	23.95f
Sexual problemsh		6	4.25	3.83
		12	4.2	4.1
		60	4.48	4.38
Satisfaction with partneri
		6	16.23	16.47
		12	15.95	16.62
		60	15.95	16.62
Satisfaction					Summary: Moderate quality evidence showed no difference; outcome of high importance
Very/mostly satisfied	Hurskainen [29]	60	93%	94%	Both treatment options resulted in high satisfaction rates.
Additional Treatment					Summary: Moderate quality evidence favored hysterectomy; outcome of moderate importance At 5 years after randomization, 42% of patients in the LNG-IUS group had undergone subsequent hysterectomy.
Hysterectomy
	Hurskainen [29]	12	24/119 (20%)	N/A
		60	50/119 (42%)

EuroQol = European quality of life scale; STAI = State-Trait Anxiety Inventory; BDI = Beck Depression Index.

All data from one RCT (several publications) with a total of 236 participants.

Table 4. Summary of data comparing medications to hysterectomy

Outcome	Study	Length of follow-up (mo)	Medicationsa	Hysterectomya	Summary of results
Bleeding control (Not reported)
Quality of life summaryb
Change in SF-36 score	Kuppermann [33]	24			No differences in change in any quality of life scores (pretreatment minus post-treatment) between medication and hysterectomy groups
Physical Health			9	7
Mental health			4	7
Pain summaryc
Pelvic pain	Learman [34]	24	−1.8	−2.2	No difference in pelvic pain and lower back pain between groups
Lower back pain			−1.3	−1.7
Sexual health summaryd
Change in SF-36 score: sexual satisfaction	Kuppermann [33]	24	18	17	No difference in sexual satisfaction between groups
Satisfaction summaryd
Change in SF-36 score satisfaction with symptom level	Kuppermann [33]	24	46	40	No difference in satisfaction with treatment between groups in intention to treat analyses
Additional treatmente
Hysterectomy	Kuppermann [33]	24	17/32 (53%)	N/A
Trachelectomy for persistent bleeding			N/A	1/31 (3.2%)	At 2 years follow-up, 53% of the group randomized to medication had undergone subsequent hysterectomy

All data from one RCT with a total of 63 participants.

Hysterectomy Versus Endometrial Ablation (Table 2) 

Seven RCTs (6 rated as “B” quality and 1 rated as “A” quality) with 1167 women compared hysterectomy with endometrial ablation, with follow-up from 4 to 48 months 17, 18, 19, 20, 21, 22, 23, 24, 25, 26. Two of the 7 trials included women with submucous myomas (AUB-L-SM) 23, 26. In the hysterectomy arm of these 7 trials, 49% (n = 395) had a total abdominal hysterectomy (TAH), 26% (n = 206) had a TVH, and 25% (n = 199) had a laparoscopic approach to hysterectomy. All trials utilized resectoscopic methods of endometrial ablation [4 used resection only, one resection or laser (20), one resection or rollerball (23), and one electrodessication or thermal balloon (25)]. Overall quality of the evidence for these studies was low to moderate for each outcome domain. The heterogeneity in specific outcomes reported precluded meta-analyses for this comparison.

Bleeding Control (Critical Importance) 

Seven studies reported bleeding outcomes. Amenorrhea rates for the endometrial ablation groups ranged from 13–64%, versus an implied 100% following hysterectomy in most studies (one study reported one woman who had bleeding following hysterectomy) [25]. Because of the heterogeneity of outcomes measures between studies comparing hysterectomy and ablation (different questionnaires), there were insufficient data to systematically compare bleeding control outcomes other than amenorrhea for the evidence profiles. The strength of evidence was moderate that bleeding is better controlled following hysterectomy than ablation.

Quality of Life (Critical Importance) 

Six studies evaluated quality of life. Overall, studies showed significant improvement above baseline in quality of life scores after treatment with both ablation and hysterectomy. Several studies found no difference between treatment arms in scores on various validated quality of life assessment tools 18, 19, 21, 24, 25. However, these studies were not powered to detect differences in quality of life scores, thus lack of statistical significance does not confirm no difference in effect. Three studies found statistically significant differences in various Short-form 36 (SF-36) dimensions favoring hysterectomy: pain [19], general health 23, 24, vitality 23, 24, and social function [24]. It should be noted that 2 of these 3 studies compared ablation specifically to minimally invasive methods of hysterectomy (the Zupi et al hysterectomies were laparoscopic supracervical hysterectomy and the Croisignani et al. hysterectomies were TVH) 23, 24. The strength of evidence was moderate, revealing no difference between hysterectomy and ablation in postoperative quality of life.

Pain (Critical Importance) 

Five trials assessed pain beyond the immediate postoperative period 18, 19, 22, 24, 25. Improvement in “dysmenorrhea” was more prevalent in the hysterectomy group than the ablation group at 4 months after procedure [18]. Three studies found pelvic pain was less prevalent in the hysterectomy group (5% to 19%) than the ablation group (24% to 64%) at 2 to 3 years follow-up, although only one study tested this statistically and found a significant difference 19, 24, 25. One study found no difference in the proportion experiencing pain at 4 years [22]. The strength of evidence on pain beyond the postoperative period was low and favored hysterectomy over ablation.

Sexual Health (High Importance) 

Five trials reported comparisons of sexual health outcomes 18, 22, 23, 24, 26. These studies showed no difference in overall effect on sexual satisfaction and sexual health rating, although only one study used a validated questionnaire [23]. The quality of evidence for sexual health was low and revealed no difference in the effect of hysterectomy compared with ablation.

Satisfaction (High Importance) 

Five trials compared general satisfaction between ablation and hysterectomy and four of which defined satisfaction rate as the primary outcome 18, 19, 20, 22, 23, 25, 26. Outcome measures varied among studies. Most women in both treatment arms reported being satisfied with their treatment option (50% to 95% for ablation, 52% to 96% for hysterectomy) at 1 to 4 years of follow-up. Three trials found no differences in satisfaction between the hysterectomy and ablation group 23, 25, 26. Two trials found significantly greater satisfaction after hysterectomy than ablation. One trial reported more women “very satisfied” 1 year after hysterectomy (88% vs 78%, p <.05), but no significant difference at 4.8 years, possibly because of reduced statistical power caused by dropouts. Another study found that at 4 months, 95% of the hysterectomy group was “quite satisfied” or “very satisfied” compared with 79% of the ablation group (p =.002) [19]. Overall, the quality of evidence was very low for satisfaction outcomes that were not different between hysterectomy and ablation.

Additional Treatment (Moderate Importance) 

The need for additional treatment after endometrial ablation, with either repeat ablation or hysterectomy, was reported as an outcome in 7 trials 17, 18, 19, 20, 22, 23, 24, 25, 26. At 1 to 4 years follow-up, 16% to 42% of participants assigned to ablation had undergone an additional surgical treatment for bleeding, with 10% to 29% treated with hysterectomy. Overall, the quality of evidence regarding additional treatments was moderate and favored hysterectomy over ablation.

Hysterectomy Versus the Levonorgestrel-intrauterine System (Table 3) 

One “A” quality RCT (with 6 publications) compared hysterectomy with LNG-IUS 27, 28, 29, 30, 31, 32. A total of 236 women with heavy menstrual bleeding were followed for 6 months to 10 years after treatment. In the hysterectomy group, 20% (n = 21) had a TAH, 28% (n = 30) had a total vaginal hysterectomy (TVH), and 52% (n = 56) had a laparoscopic approach to hysterectomy. Women with submucous myomas and women with “irregular bleeding” as a main complaint were excluded; 49% of participants had uterine fibroids. Overall quality of the evidence for these studies was moderate for each outcome domain.

Bleeding Control (Critical Importance) 

The proportion of participants who reported amenorrhea or oligomenorrhea with the LNG-IUS still “in situ” was 51% (41/81) at 12 months and 75% (43/57) at 5 years. Women who discontinued use of the LNG-IUS (n = 50 [42%]) did so because of intermenstrual bleeding (70%) and heavy bleeding (30%). Overall, the evidence favored hysterectomy over LNG-IUS for bleeding control.

Quality of Life Measures (Critical Importance) 

Both the European quality of life scale–5D and the SF-36 were used to measure quality of life 27, 28, 29. Overall, the evidence revealed no differences in quality of life outcomes between hysterectomy and LNG-IUS.

Pain (Critical Importance) 

At 6 and 12 months follow-up, a greater proportion of participants in the LNG-IUS group reported lower abdominal pain. At 12 months, this difference was statistically significant (30% LNG-IUS vs 14% hysterectomy, p =.02). No difference was found at 5 years [31]. Overall, the evidence on pain revealed no differences between hysterectomy and LNG-IUS.

Sexual Health (High Importance) 

Sexual function was compared between LNG-IUS and hysterectomy at 6 months, 1 year, and 5 years with McCoy sex scale scores [30]. Compared with hysterectomy, the LNG-IUS group reported more sexual problems at 6 months (p =.03); however, this effect was not seen at 12 months or 5 years. No differences were found in sexual problems at other time points or in sexual satisfaction scores at any time point. Overall, evidence for sexual health revealed no differences between hysterectomy and LNG-IUS.

Satisfaction (High Importance) 

Satisfaction rates at 5 years were very high for both the LNG-IUS group (93%) and the hysterectomy group (94%) [29]. Overall, the evidence regarding satisfaction showed no difference in satisfaction between LNG-IUS and hysterectomy.

Additional Treatment (Moderate Importance) 

Among women randomized to LNG-IUS, 20% had undergone hysterectomy by 12 months, 42% by 5 years, and 46% by 10 years. Overall, the evidence on additional treatments favored hysterectomy over LNG-IUS.

Hysterectomy Versus Medications (Table 4) 

One RCT (rated as “A” or “B” quality for different outcomes) compared hysterectomy with medical therapy in 63 women with AUB presumably from AUB-E or AUB-O. The participants were followed up for 2 years 33, 34. In the hysterectomy group 36% (n = 10) had a TAH, and 64% (n = 18) had a TVH. The trial did not mandate a specific medication regimen, and therapies used in this study included combined oral contraceptive pills (38%), cyclic progestin (16%), continuous progestin (6%), conjugated estrogen with progestin (25%), and conjugated estrogen alone (6%); 53% received a prostaglandin synthetase inhibitor, usually with a hormonal therapy. Overall quality of the evidence for these studies was low to very low for each outcome domain.

Bleeding Control (Critical Importance) 

Measures of bleeding control were not reported for this trial.

Quality of Life Measures (Critical Importance) 

No differences were found in the change of any SF-36 scores between medication and hysterectomy groups [33]. Overall, the quality of evidence for quality of life measures was low and revealed no differences between hysterectomy and medications.

Pain (Critical Importance) 

No differences were found in pain between groups [34]. Overall, the quality of evidence for pain outside the postoperative period was very low and revealed no differences between hysterectomy and medications.

Sexual Health (High Importance) 

No differences were found in SF-36 sexual satisfaction scores between groups [33]. Overall, the quality of evidence on sexual health outcomes was low and revealed no differences between hysterectomy and medications.

Satisfaction (High Importance) 

No differences were found in change in satisfaction with symptom level between groups [33]. Overall, the quality of evidence for satisfaction was low and revealed no differences between hysterectomy and medications.

Additional Treatment (Moderate Importance) 

At 2-year follow-up, 53% of the group randomized to medication had “crossed-over” to the hysterectomy group [33]. One patient in the hysterectomy arm required a trachelectomy 15 months after hysterectomy for persistent bleeding. Although “additional treatment” can be inferred from “crossed-over” to hysterectomy, it was not specifically assessed nor reported as an explicit “outcome” for this study. Therefore an evidence profile was not generated.

Adverse Events 

Adverse events are listed in Table 5; however, reporting of adverse events was not standardized across studies, and not all studies presented data on each adverse event listed. We combined the hysterectomy arms of all 9 trials (ablation vs hysterectomy, LNG-IUS vs hysterectomy, and medications vs hysterectomy) to obtain the complication totals for hysterectomy. In total, there were 57 “major” complications and 225 “minor” complications in the hysterectomy group that consisted of 724 patients. Rates/proportions are reported for each individual complication and not the composite of “major” and “minor” complications because one patient could have multiple complications and artificially inflate the overall complication rate. The most common “major” complication was pelvic or vaginal vault hematoma (n = 28, 3.9%), with urinary tract injuries (n = 7 [1% for cystotomy] and n = 1 [0.1% for ureteral injuries]), and bowel injuries (n = 2 [0.3%]) being present but uncommon.

Table 5. Adverse events for hysterectomy, ablation, LNG-IUS, and mediations

	Hysterectomya	Ablation	LNG-IUS	Medications
Total n	724	579	116	32
Number of studies	9	7	1	1
“Major” complications (no.)b	57	7	1	0
Additional intraoperative procedures or urgent reoperationc	13 (1.8%)	6 (1%)	0	None reported
Cystotomyd	7 (1%)	0	0	None reported
Ureteral injury	1 (0.1%)	0	0	None reported
Bowel injury	2 (0.3%)	0	0	None reported
Pelvic hematoma or vaginal vault hematoma	28 (3.9%)	1 (0.2%)	0	None reported
“Cardiorespiratory event”e	3 (0.4%)	0	0	None reported
Deep vein thrombosis or thromboembolism	0	0	1 (0.9%)	None reported
“Thromboembolic event”e	2 (0.3%)	0	0	None reported
Otherf	1 (0.1%)	0	0	None reported
“Minor” complications (number)b	225	69	0	0
Infection
Wound infection	46 (6.4%)	0	No minor complications reported	No minor complications reported
Pelvic infection or cuff cellulitisg	25 (3.5%)	10 (1.7%)
Febrile morbidity	37 (5.1%)	4 (0.7%)
Other infectionh	64 (8.8%)	18 (3.1%)
Wound hematoma or wound rupturei	25 (3.5%)	5 (0.9%)
Need for transfusion	17 (2.4%)	4 (0.7%)
Readmission not reoperation	4 (0.6%)	3 (0.5%)
Uterine perforation	0	8 (1.4%)
Fluid overload	0	23 (4.0%)
Ileus or obstruction	5 (0.7%)	1 (0.2%)
Nonurgent surgery presumed caused by complications from initial procedurej	2 (0.3%)	1 (0.2%)

For the studies comparing ablation to hysterectomy, adverse events were reported in 7 studies (n = 1167). In patients randomized to ablation, there were a total of 7 major complications and 69 minor complications. The most common “major” complication was conversion to a different surgery or urgent re-operation, but this occurred in only 1% of patients (n = 6). The most common “minor” complication was fluid overload, which occurred in 4% of patients (n = 23). Two studies statistically compared adverse events between hysterectomy and ablation groups. One found no significant differences in complications between ablation and hysterectomy [24]. The second found no different in intraoperative complications, but a higher rate of complications in the hysterectomy group before (p <.001) and after discharge (p =.004) [26]. There appears to be a trend to a higher rate of major and minor complications for hysterectomy than for ablation. Overall, the quality of evidence regarding adverse events was moderate and favored ablation over hysterectomy for minimizing adverse events.

One study compared the LNG-IUS with hysterectomy. In this study, one major complication (a recurrent thromboembolic event) occurred in the LNG-IUS group (1%) and no minor complications. There were 12 major complications and 32 minor complications among patients undergoing hysterectomy in this study, and the authors reported that 30% of participants in the hysterectomy group had “postoperative complications.” Overall, the evidence for adverse events was moderate quality and favored LNG-IUS over hysterectomy.

In the 1 trial that compared medications to hysterectomy, there were no reported complications in the medication group. In the hysterectomy group, there were 3 major complications and 1 minor complication. Overall, the quality of evidence for adverse events was low and favored medication over hysterectomy.

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Discussion 

Designing and interpreting research on AUB treatment is challenging. Many different treatment modalities are available, and AUB is associated with a wide spectrum of symptoms. Our review provides a concise assessment of the efficacy of less-invasive options for managing AUB, predominantly from ovulatory dysfunction or endometrial hemostatic dysfunction, as compared with hysterectomy within 7 important clinically relevant outcome domains. Despite the high prevalence of AUB and a variety of available treatments, we found only 9 RCTs reported in 18 articles that compared hysterectomy directly with other “less-invasive” treatment options. We identified important trade-offs between the relative benefits and harms of hysterectomy and endometrial ablation, LNG-IUS, and medications.

Regardless of the comparator, hysterectomy was favored over other options for elimination of bleeding symptoms and need for additional treatment. Hysterectomy was also favored over ablation for pelvic pain resolution outside of the immediate post-operative period. However, these superior outcomes were achieved with the tradeoff of higher risks of adverse events. Although hysterectomy is more efficacious for treatment of many AUB symptoms, we found less-invasive options including endometrial ablation and LNG-IUS to be comparable to hysterectomy in achieving outcomes related to patient satisfaction and quality of life improvement. Consistent with our finding, a previous meta-analysis of individual patient data from 17 trials (6 that compared hysterectomy with ablation, 1 that compared hysterectomy with LNG-IUS, 3 that compared ablation with LNG-IUS, and 7 that compared ablation techniques) concluded that patients undergoing hysterectomy were more satisfied than patients undergoing endometrial ablation. However, satisfaction rates were very high for both groups, and absolute differences were small [35].

A limitation to our comparison of hysterectomy versus endometrial ablation is that all of the RCTs identified involved resectoscopic endometrial ablation techniques, which, while still used, have largely been replaced by a number of nonresectoscopic ablation techniques. Thus the applicability of the available trials to current practice is unclear. However, 2 recent reviews comparing non-resectoscopic to resectoscopic endometrial ablation techniques found no difference in amenorrhea rates, satisfaction rates, and rates of additional surgical interventions 35, 36.

Because of the limited body of evidence comparing medical therapies with hysterectomy, we are unable to make definitive conclusions on the relative effectiveness of individual medical therapy compared with hysterectomy. Many different medication types were used in the “medication arm” of the one RCT that directly compared medications to hysterectomy, which may help with the broad comparison of “medication vs hysterectomy” but did not allow direct comparison of individual medical therapies to hysterectomy in terms of effectiveness. Most of the data concerning effectiveness of medical therapies are derived from RCTs comparing specific medications to either placebo or each other, which were outside of the scope of our review. Given that medications arguably represent the “least-invasive” alternative to hysterectomy, the lack of evidence in this area highlights the importance of future research.

For this review, we chose to include only evidence from RCTs that compared hysterectomy with uterine-preserving treatments. Although this reduced the body of evidence, use of the hysterectomy comparison arm as a prerequisite for study inclusion provided a means to standardize populations across trials and to reduce the clinical heterogeneity and selection bias that stems from recruitment for treatments with varying interventional risks. However, we were challenged by the inconsistency across studies in the definitions of the study populations. There are multiple causes of AUB, and although we reviewed trials of treatment of women with AUB presumed caused by ovulatory dysfunction or endometrial hemostatic dysfunction (AUB-O or AUB-E), it was not always clear how the studies identified the cause of bleeding, especially whether they investigated possible coagulopathy as a cause. Additionally, 2 of the studies comparing ablation to hysterectomy included patients with submucous myomas (AUB-L-SM), which could affect bleeding and treatment effectiveness. Another obstacle is that the term “DUB,” which was used in most of these trials, is used inconsistently by clinicians, researchers, and experts on AUB [9]. This is why an expert group from FIGO has recommended discontinued use of the terms “dysfunctional uterine bleeding” and “DUB” and why we have not used these terms throughout this article.

In addition to the small number of trials, this review was limited by lack of consistency in the eligibility criteria of individual trials and the extensive heterogeneity of studied outcomes. As discussed in greater detail in a previous publication [12], the extreme heterogeneity in specific outcomes across trials limited the interpretability of their conclusions. Likewise, the sparseness of data made it difficult to come to definitive conclusions about the efficacy of hysterectomy versus alternative treatments or to rank treatments. A clear example of this challenge was studying the efficacy in bleeding control. For most women seeking treatment for AUB, a reduction in their amount of bleeding to an acceptable level or a “normalization of menses” by their personal standards would likely constitute a satisfactory outcome. Unfortunately, amenorrhea was the only outcome that was reported in a consistent fashion across studies, allowing direct comparisons between hysterectomy and other treatments. We could not compare treatments in terms of “reduction in bleeding” or “normalization of menses.” Studies tended to report overall patient satisfaction with their interventions, but it is unclear how this may correlate with “satisfaction” with their menstrual bleeding. There is a need to standardize and validate outcome measures that are responsive to important symptoms from AUB 12, 37 and to use them consistently going forward.

We generated clinical practice guidelines for the treatment of AUB-O and AUB-E on the basis of our systematic review (see accompanying article). Because limitations in the current body of literature comparing hysterectomy to other options allowed us to make only “weak” recommendations, we offer suggestions to address these shortcomings with additional higher quality research. Treatments not yet compared against hysterectomy, such as newer endometrial ablation techniques, need to be studied in appropriate trials before we can confidently appraise their relative value. Additionally, although some studies used minimally invasive approaches to hysterectomy, overall most hysterectomies for the ablation comparisons were performed abdominally (49%). It is possible that outcomes may vary by method of hysterectomy, and the studies involved in this review did not stratify results by hysterectomy type. Given emphasis on increasing the proportion of hysterectomies performed by minimally invasive approaches (total vaginal hysterectomy and laparoscopic and robotic approaches to hysterectomy), the outcomes of these methods need to be more clearly studied relative to non-hysterectomy options for AUB [38]. Also, studies looking at outcomes of treatment for women with AUB should be powered to detect a meaningful difference in symptoms related to bleeding and disease-specific quality of life [39].

In summary, in comparing hysterectomy with the “less-invasive” options of endometrial ablation, LNG-IUS, and medications, we identified tradeoffs between treatment effectiveness and risk of serious adverse events. Given the many options available for the treatment of AUB, it is important that clinicians are aware of the relative advantages and disadvantages of each option and are able to discuss this with patients seeking treatment for AUB. Each patient should receive counseling about the efficacy, as well as burden and risk of each management option in the context of her disease manifestations to facilitate an informed choice on the basis of the available evidence.

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Acknowledgments 

We acknowledge the work and contributions of the following Society for Gynecologic Surgeons Systematic Review Group Members: Rebecca G. Rogers, MD, Katrin Uhlig, MD, MS, James C. Lukban, DO, Michelle Y. Morrill, MD, Miles Murphy, MD, MSPH, Lior Lowenstein, MD, MS, Mamta M. Mamik, MD, Diego Illanes, MD, Oz Harmanli, MD, Blair Washington, MD, Matthew Barber, MD, Karl Tamussino, MD, Scott Smilen, MD, Rajiv Gala, MD, and Linda Bradley, MD.

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