Background: Most women who have dysfunctional uterine bleeding are offered surgical intervention when medical therapy is unsuccessful. Dickersin and colleagues compared the two principal surgical therapies, hysterectomy and endometrial ablation, in a multicenter randomized controlled trial.
The Study: The 25 participating U.S. and Canadian centers enrolled 237 eligible women between 1998 and 2001. Participants were premenopausal, at least 18 years of age, and had a history of at least six months of excessive or unpredictable menstruation that had been refractory to medical therapy for at least three months. Women were excluded from the study if they were pregnant, refused surgery, wished to preserve fertility, or had undergone bilateral oophorectomy.
Following initial data collection and screening, women were randomly assigned to undergo hysterectomy or endometrial ablation. In addition to routine surgical follow-up, participants completed telephone interviews three, six, and 12 months after surgery, and then every six months for at least 24 months and up to five years. The telephone interviews addressed demographic information, experience of vaginal bleeding, sexual function, general health symptoms (including pain, sleep disturbances, fatigue, and urinary problems), health-related quality of life, employment, and ability to conduct daily work and leisure activities. The interviews also covered health professional visits, treatments, and out-of-pocket costs of any gynecologic problems. The interviewers were blinded to the surgical treatment allocation.
The primary outcomes measured one year after surgery were the effect of the procedure on bleeding, pain, fatigue, and the principal symptom identified by the woman as her reason for undergoing surgery. Secondary outcomes included changes in quality of life, surgical complications, additional surgery, and resource utilization.
Results: The 123 women randomized to receive endometrial ablation were comparable with the 114 assigned to receive a hysterectomy in all significant respects. Around 85 percent of each group were younger than 45 years, 76 percent were white, about one half had not completed high school, and less than 30 percent were of normal or low body mass index. About 42 percent of the women were smokers. The average parity was 2.5. For 85 percent of participants, the major problem was excessive or abnormal bleeding, and the average duration of the bleeding was 6.6 to 7.6 years. Twenty participants did not receive the assigned therapy (14 endometrial ablation and six hysterectomy).
The intention-to-treat analysis at one year indicated that women reported less bleeding and less pelvic and bodily pain following hysterectomy. These differences were still apparent at 48 months. Changes in fatigue were similar for both groups. The major presenting problem was resolved by 12 months after surgery for 87.9 percent of women assigned to endometrial ablation and 93.2 percent of those assigned to hysterectomy. By 48 months, 85 percent of those assigned to endometrial ablation and 98 percent of hysterectomy participants reported that the major problem was resolved. Also after 48 months, 48.9 percent of the endometrial ablation group and 56.9 percent of the hysterectomy group reported being “very or mostly satisfied” with the results of the surgery.
The groups reported similar results on primary outcomes. Only at the six-month follow-up were pain and fatigue reported significantly more frequently by women assigned to endometrial ablation than hysterectomy. Also at six months, the women who had endometrial ablation and reoperation reported more pain than those who had endometrial ablation and no reoperation, and those who had hysterectomy. Adverse effects were significantly more frequent following hysterectomy than endometrial ablation (40.6 percent of participants compared with 10.9 percent).
Conclusion: The authors conclude that endometrial ablation and hysterectomy effectively resolved the principal problem and that benefit persists for at least 48 months. Hysterectomy was more effective than endometrial ablation in resolving bleeding but was associated with more adverse effects. By 60 months after initial treatment, 34 of the 110 women originally treated with endometrial ablation underwent a reoperation. Thirty-two had hysterectomy, and two had repeat endometrial ablation.