Objective:

Uterine fibroids affect at least 30 percent of women during their reproductive years. Symptoms associated with fibroids have a significant impact on quality of life. Fibroids are the leading indication for hysterectomy and result in more than $2 billion in annual hospital charges. This report presents an assessment of the literature on the benefits, risks, and costs of the management of symptomatic and asymptomatic uterine fibroids in women aged 20 to 55.

Search Strategy:

Published literature on the management of uterine fibroids was identified in MEDLINE, CINAHL, CancerLit, EMBASE, HealthSTAR, and the Cochrane Library for 1975 through 2000. Medical subject headings terms used included "leiomyoma," "fibroids," "hysterectomy," and "myomectomy."

Selection Criteria:

Empirical study designs considered included controlled trials, prospective trials with historical controls, prospective or retrospective cohort studies, and medium to large case series. Studies of these types and review articles were included if the study population included women with uterine fibroids and data were provided on one or more of the key research questions. Studies were excluded if the article did not present original research or a relevant review, the patient population did not include women with uterine fibroids, or the study design was a single case report or small case series with fewer than 20 subjects.

Data Collection and Analysis:

Paired reviewers independently screened each abstract and article. Two reviewers also performed the data abstraction. Included studies were graded for internal and external validity. Supplemental data were collected from the Nationwide Inpatient Sample and from Duke University Medical Center.

Main Results:

The overall quality of the literature on the management of fibroids is poor. Inconsistency in reporting the severity of symptoms, uterine and fibroid anatomy, and response to treatments prevented meaningful comparison of studies for most questions. The researchers found almost no evidence to support the effectiveness of commonly recommended medical treatments. However, there was consistent evidence from randomized trials that preoperative use of gonadotropin-releasing hormone agonist therapy reduces estimated blood loss and may facilitate the surgical approach by reducing uterine size; the clinical significance of these effects is unclear.

Prospective studies consistently show that the outcomes of hysterectomy up to 2 years after surgery are favorable for most symptomatic women, although up to 12 percent of women develop new symptoms after surgery. Placing these results in the context of other treatments, such as myomectomy, medical therapy, or no intervention, is impossible because of significant differences in the severity of preintervention disease.

There are almost no data to allow estimation of the overall costs of fibroids to the economy.

Research priorities should include methodologically rigorous studies of the effectiveness of nonsurgical treatments and development of standard measures of disease severity.

Conclusions:

The available evidence on the management of uterine fibroids is of poor quality. Patients, clinicians, and policymakers do not have the data they need to make truly informed decisions about appropriate treatment. Given the prevalence of this condition and its substantial impact on women's lives, obtaining these data should be a high research priority.