The fibroid growth study: determinants of therapeutic intervention

Abstract

Aims: The demographics, ethnicity, symptoms, lifestyle characteristics, and treatment outcomes are analyzed in participants of a study designed to evaluate uterine leiomyoma growth and correlate symptoms and outcomes in a clinically relevant population of women (Fibroid Growth Study).

Methods: Women included in the Fibroid Growth Study (FGS) completed a medical history and physical examination, underwent T1-weighted and T2-weighted magnetic resonance image (MRI) scans, provided urine and blood samples at each scheduled MRI, and responded to an initial extensive telephone-administered questionnaire followed by abbreviated monthly questionnaire updates. Summary scores were developed to quantify stress, pain, and bleeding. The Wilcoxin test was used for statistical comparisons between study participant characteristics and tumor-related characteristics.

Results: Participants included 116 premenopausal women, ranging in age from 20 to 54 years; 48% were black women, 41% were white women, 10% were women of other or multiple racial backgrounds, and 1% did not self-identify. Over 90% of participants had multiple leiomyomas, and nearly a third had more than 10. Black women were younger and had more fibroids, but no differences were found in the proportions of black and white women choosing an intervention; 44% of black women and 40% of white women chose intervention during the study.

Conclusions: There was no correlation between number of leiomyomas or uterine size and choosing treatment. However, women who opted for treatment were more symptomatic, with higher bleeding and pain scores, compared with the women with no intervention. Consequently, our study suggests that once women are symptomatic, black and white women choose surgery as a treatment method for the same reasons and at about the same rates. Moreover, our data suggest that bleeding and pain, not the size or multiplicity of fibroids, determine the choice for intervention. Therefore, aggressive management of pain and bleeding may be effective in reducing the need for surgical intervention.

FIG. 1.

Comparisons of clinical symptoms in FGS participants before and after treatment. Symptom scales were calculated by summing assigned values to specific questionnaire responses and converting the sums to a 100-point scale. Stress, pain, bleeding problems, and amount of bleeding were identified as significant factors related to treatment in the overall FGS population. These symptoms are further compared prior to and after treatment in the subset of participants (n = 20) who had treatment and were available for a follow-up questionnaire after treatment.