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Issues for Research
Following are highlights of a May 1994 AHCPR conference on research issues in the
effectiveness of hysterectomy and alternative therapies for common non-cancerous uterine
conditions. The full report of the conference is available from the AHCPR Publications
Clearinghouse. Call toll free 800-358-9295. Order AHCPR Pub. No. 95-0067 (July 1995).
Hysterectomy is the most common nonpregnancy-related major surgery performed on women
in the United States. In 1995, approximately 590,000 women in this country will undergo the
procedure. Surgical removal of the uterus, and frequently the ovaries, is widely accepted both
by medical professionals and the public as appropriate treatment for uterine cancer, and for
various common non-cancerous uterine conditions that can produce often disabling levels of
pain, discomfort, uterine bleeding, emotional distress, and related symptoms. Yet, while
hysterectomy can alleviate uterine problems, less invasive treatments are available.
Most women who undergo hysterectomy are between the ages of 35 and 54, with the highest
age-specific rate for women 35 to 44 years of age. Overall, fibroids account for approximately
one-third of all hysterectomies performed in the United States. Endometriosis is the second
most common condition leading to hysterectomy, accounting for 18 percent. Hysterectomy
rates also are correlated with a number of non-clinical characteristics of patients, such as
socioeconomic status, and with provider variables, such as physician training.
Health services research findings since the 1970s have highlighted wide, unexplained
variations in rates of hysterectomy in different parts of the United States, and much higher
rates in the United States compared with other Western countries. There is no way, however,
to determine from these studies which rate is right.
Thus, AHCPR initiated work to identify specific research opportunities related to the outcomes
of hysterectomy and its alternatives, and to encourage such research. The conference had a
dual purpose: to assess the state of the science, and to identify the most important areas for
The current scientific literature is weak and incomplete. Studies containing original data
typically are small, observational studies; the few which compare treatments focus on one type
of hysterectomy versus another type (e.g., abdominal versus vaginal surgery). Outcomes
addressed in these studies are limited almost exclusively to traditional endpoints, such as
mortality, complications of surgery, and other physician assessments. These studies confirm
that the risk of mortality is low; however, complications are common occurrences.
Very few studies provide information about the effects of hysterectomy on the symptoms that
led women to seek treatment in the first place or on the long-term outcomes that contribute to
the patient's quality of life. Reports often lack enough data about study design, sample size,
patient characteristics, reasons for treatment, and other information critical to interpreting and
weighing the results.
Even the best studies beg the critical question: For non-cancerous uterine conditions, what
treatment is most effective? Only a few, preliminary studies have compared the outcomes of
hysterectomy with other treatment alternatives and considered outcomes from the patient's
Alternatives to hysterectomy fall into three general categories: conservative surgical
management; pharmacologic therapies (hormonal and nonhormonal); and other strategies,
including psychosocial support and therapy, and watchful waiting. There has been little
research on how physicians or their patients choose among available treatments. Potential
applications of these treatments are summarized in the following table:
Alternatives to Hysterectomy for Common Non-Cancerous Uterine Conditions
|GnRH(a) agonists with add-back therapy
Excision of endometrial ablation
Resection of cul-de-sac obliteration
Uterosacral nerve ablation
|GnRH(a) agonists with add-back therapy
Lifestyle change(nutrition, exercise)
|| Anterior or posterior colporrhaphy
Laparoscopic or vaginal suspension techniques
Periurethral injections of GAX(b), collagen, fat, silicon, etc.
||Dilation and curettage
Luteinizing hormone agonists
|| Watchful waiting
|Chronic pelvic pain
Uterosacral nerve ablation
GnRH(a) agonists with add-back therapy
Trigger point injections
(a) Gonadotropin-releasing hormone.
(b) Experimental treatment.
(c) Nonsteroidal anti-inflammatory drugs.
The research needs identified by AHCPR's conferees address the scarcity of attempts to prove
the effectiveness of hysterectomy, the methodological weaknesses in much of the clinical
research that has been done, and the limited attention to outcomes important to patients.
AHCPR is particularly interested in supporting randomized clinical trials designed to answer
important questions about effectiveness and relative effectiveness. Studies addressing related
issues, such as methodological and epidemiological topics, also are encouraged as appropriate
submissions for AHCPR's program of research on medical effectiveness.
All Non-Cancerous Uterine Conditions:
- Evidence regarding the effectiveness and relative effectiveness of hysterectomy and
alternative treatments is seriously lacking. Prospective randomized studies are needed
comparing hysterectomy with watchful waiting, and comparing different treatment
strategies (surgical, pharmacologic, psychological, and combinations thereof).
- A broad range of patient outcomes need assessment. Typically, symptoms are what drive
women to treatment for non-cancerous uterine conditions. Thus, in addition to traditional
clinical endpoints, it is critical to understand the effects of treatment (or time) on the
presenting symptoms and development of new symptoms, and to measure the value of
particular outcomes to individual women.
- Assessment of multiple outcomes require basic methodological work to validate existing
measures or develop new measures. Measures need to be validated and standardized so that
the findings of different studies can be compared and, possibly, to permit aggregation of
results from small studies.
- Epidemiologic studies, especially large, prospective, community-based cohort studies, are
needed to determine the incidence and prevalence of uterine problems, their natural history,
and the factors that place some women at high risk.
- Important variables influencing patients' and providers' perceptions and expectations of
different treatments are poorly understood. Research is needed to explain how physician-patient interaction affects treatment decisions.
- Management of asymptomatic fibroids—when, if, or how to treat.
- Importance of fibroid size. Published criteria generally recommend surgical removal of
fibroids if and when they reach the size of the uterus at 12-weeks gestation, and this has
become usual practice. Studies are needed to determine how changes in fibroid size
influence patients' functional status and quality of life. The scientific literature does not
provide adequate evidence to support the recommendation/practice of hysterectomy at 12-weeks gestational size.
- Formation of leiomyosarcoma. With the possibility of malignant change in fibroids, rapid
growth in the size of the uterus or fibroids is often used as justification for hysterectomy.
The scientific basis for this practice is inadequate.
- Mechanisms of hormone ablation, add-back (norethindrone) therapy, and fibroid growth in
the absence of estrogen. Investigations in hormonal therapies and management need to
address receptor content.
- Etiology of fibroids, the mechanisms that influence their growth, and reasons for
apparently higher rates in black women relative to white women.
- Determine what attributes of patient, provider, and treatment predict relief of pain, cost,
health status, functional status, and health-related quality of life.
- Develop techniques and methods that are less invasive than laparoscopy for diagnosing
endometriosis, e.g., imaging techniques and/or blood-serum markers.
- Investigate the relationship between endometriosis and dysmenorrhea, and between
endometriosis and non-cyclic chronic pelvic pain.
- Investigate the biologic etiology of endometriosis and how various growth factors as well
as the immune system affect the initiation and progress of the disease.
Pelvic Prolapse/Urinary Dysfunction:
- No scientific evidence was found favoring hysterectomy as the best alternative for
managing pelvic prolapse. In fact, the studies containing original data were all conducted in
women who experienced prolapse subsequent to hysterectomy.
- For uterine prolapse, determine the effectiveness, relative to hysterectomy, of non-surgical
treatments including the use of pessaries, estrogen, and exercises to strengthen the pelvic
- For urinary stress incontinence, determine the relative effectiveness of available treatments.
Panelists recommended a prospective clinical trial, with minimum 5-year followup, to
determine the effectiveness of surgical and nonsurgical treatments for urinary stress
Dysfunctional Uterine Bleeding and Chronic Pelvic Pain:
- For dysfunctional bleeding, compare the outcomes of alternative treatments, including
medical treatments, surgical alternatives (endometrial ablation and hysterectomy), and
- For the management of chronic pelvic pain, evaluate the effectiveness of hysterectomy,
surgical procedures other than hysterectomy (lysis of pelvic adhesions, etc.), medical
therapies (trigger point injections, etc.), and non-traditional therapies, such as biofeedback.
- Investigate the effectiveness of imaging methods commonly used to diagnose the cause of
chronic pelvic pain.