Treatment of symptomatic uterine fibroids: van der Kooij et al Kristen A. Matteson, MD, MPH; George A. Macones, MD, MSCE, Associate Editor The article below summarizes a roundtable discussion of a study published in this issue of the Journal in light of its methodology, relevance to practice, and implications for future research. Article discussed: van der Kooij SM, Hehenkamp WJK, Volkers NA, et al. Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5-years outcome from the randomized EMMY trial. Am J Obstet Gynecol 2010;203:105.e1-13. The full discussion appears at www.AJOG.org, pages e1-6. DISCUSSION QUESTIONS  How does the study contribute to knowledge in the field?  What was the research question?  What type of study was this?  What statistical methods were used?  What data are in the tables?  What did the authors conclude?  How does this study apply to your clinical practice? P atients with symptomatic uterine fibroids often present with heavy menstrual bleeding and pelvic pressure. Classically, only surgical treatments were available: hysterectomy or myomectomy. While hysterectomy is the definitive treat- ment—nearly all patients experience amenorrhea, and most report diminished pelvic pressure—it is a major surgical pro- cedure with possible morbidity and neces- sary recovery time. Uterine artery emboli- zation (UAE), first described 15 years ago, has garnered increased attention in recent years as a treatment for symptomatic uter- ine fibroids. Previous publications from the EMbolization versus hysterectoMY (EMMY) trial indicate that compared with hysterectomy, UAE was associated with an equal rate of major complications but a shorter hospital stay and a faster return to usual daily activities. The latest study of EMMY participants, by van der Kooji and colleagues, examined how patients who underwent UAE instead of hysterectomy were faring at the 5-year postprocedure mark. The data were discussed at this month’s meeting of the Journal Club. Prospecting for gold Given the prevalence of uterine leiomyo- mas and the substantial number of hysterectomies performed for this indi- cation, development of less invasive treatments is an enticing prospect. How- ever, any new procedure must be com- pared to hysterectomy to establish whether its efficacy and side-effect pro- file are favorable enough to deem it a fea- sible alternative. Randomized controlled trials (RCTs) are the preferred study de- sign when weighing a new medication or device against a so-called gold standard. Recruitment of patients into surgical/ procedural RCTs can be quite challeng- ing, though, as patients often have pre- conceived notions about the type of intervention they desire. This study’s 51% participation rate prior to random- ization likely reflected the difficulty of enrolling patients in a study where a the- oretical flip of a coin decided whether the patient would have a major surgical pro- cedure or a less common, less familiar radiologic procedure. Nonetheless, as long as the sample size is adequate, randomization of partici- pants to an intervention controls for both known and unknown confounders by producing groups with similar base- line characteristics. In this study, for in- stance, without the randomization pro- cess, factors such as prior treatment, number and volume of fibroids, and du- ration of symptoms could have affected the results. If this study had been de- signed as a cohort study, it would be pos- sible for patients to be preferentially as- signed to a specific treatment based on factors such as uterine size, and this could have introduced additional bias into the study. Proving noninferiority van der Kooji et al devised a noninferior- ity RCT. That is, the overall objective was to show that UAE was not worse than hysterectomy with respect to alleviating menorrhagia. In contrast, an equiva- lence study is intended to show that a new intervention is not worse or better than the standard by more than a pre- specified margin. In previous analyses of this trial, the authors stated that this de- sign was chosen because UAE could not prove superior to hysterectomy. 1 One aspect of their most recent investigation was a bit unconventional in that the main outcome, avoidance of hysterec- From the Department of Obstetrics and Gynecology, Women and Infants Hospital, Warren Alpert Medical School of Brown University, Providence RI: Moderator Kristen A. Matteson, MD, MPH Assistant Professor Discussants Maureen G. Phipps, MD, MPH Associate Professor Christina A. Raker, ScD Statistician Beth Cronin, MD Fourth-Year Resident Laura Holman, MD Third-Year Resident 0002-9378/free © 2010 Published by Mosby, Inc. doi: 10.1016/j.ajog.2010.05.025 See related article, page 105 Journal Club www. AJOG.org 186 American Journal of Obstetrics & Gynecology AUGUST 2010