Objective
To compare the effect of hysterectomy versus expanded medical treatment on health-related quality of life in premenopausal women with abnormal uterine bleeding (AUB).
Results
In this multicenter, randomized, controlled trial involving 63 women 30 to 50 years of age in whom medical therapy with medroxyprogesterone acetate had failed, those randomized to hysterectomy had greater improvement at 6 months in Mental Component Survey scores (8 vs 2; P = .04). They also had greater improvement in symptom resolution (75 vs 29; P <.001 symptom satisfaction vs>P <.001 interference with sex vs>P = .003), sexual desire (21 vs 3; P = .01), health distress (33 vs 13; P = .009), sleep problems (13 vs 1; P =. 03), overall health (12 vs 2; P = .006), and satisfaction with health (31 vs 14; P = .01).
Expert commentary
This study is one of the first randomized studies to compare the effects of surgery versus medical management on quality of life. Unfortunately, participants were included only after 1 course of medical therapy had failed. Thus, although investigators avoided potential skewing of the results by excluding patients who responded easily to treatment, they also caused selection bias.
It also is likely that some of the patients randomized to medical therapy were frustrated after failing 1 course of therapy, which caused a large crossover group: 17 of 32 women in the medical-therapy group eventually underwent hysterectomy. A more accurate outcome may have resulted if all women initially presenting with AUB had been included.
Shortcomings
Sample size was small, and did not reach the projected numbers even after the target sample size was officially decreased. Again, if investigators had randomized any patient initially presenting with AUB, more women might have been willing to participate. If the reason for the low numbers is that more women wanted to undergo surgical treatment after failing therapy with medroxy-progesterone acetate, researchers could have implemented a 2:1 randomization scheme to encourage higher enrollment in the study.
Although performing surgery without attempting medical therapy does not reflect typical management, it might have provided insight into whether medical management is worthwhile and yielded information on which option truly does lead to better quality of life.
Further, researchers compared each patient’s quality-of-life scores to her baseline, which, in the medicine group, was after a mean of 4 years of treatment. Therefore, one would expect less of a difference between scores in the medicine group, since all women were already refractory to medroxyprogesterone acetate at the beginning of the study.
The large crossover from the medical management group makes it difficult to decipher what the outcome of the study really is, despite the intragroup analysis. This leads me to conclude that, at some point, most patients get tired of trying medications and want a guaranteed fast cure.
No data on effects of hysterectomy route
One area that should have been addressed and subanalyzed: whether the type of hysterectomy (36% abdominal versus 64% vaginal) had any effect on short- or longterm outcomes.
Ablation option not included
There is also another treatment option that was not addressed: endometrial ablation. This surgery typically has a quicker recovery than hysterectomy and should correct the bleeding faster than medical management. It would be interesting to see the differences in quality-of-life and sexual-function outcomes with this option, compared with the others.
Bottom line
Until these issues have been thoroughly evaluated, women with AUB should initially be treated with medical therapy. Based on the preliminary screening study for this trial, medroxyprogesterone acetate appears to effectively control most patients’ symptoms. However, when medical therapy fails, the physician should explain to the patient that the improved short-term outcome seen with hysterectomy does not necessarily translate into significant long-term quality-of-life outcomes, as this study points out. The final decision between medical management and hysterectomy thus should fall to the individual patient.