Federally-Funded Study Shows More Women Can Avoid Hysterectomy for Common Problem
Posted Nov 30 2008 12:20pm
CYPRESS, CA -- December 28, 2007 -- The minimally invasive procedure endometrial ablation is as effective as hysterectomy in solving dysfunctional uterine bleeding (DUB), according to a new federally-funded study published in the Journal of Obstetrics and Gynecology.
Dysfunctional uterine bleeding is abnormal bleeding which cannot be attributed to abnormalities of the female reproductive system, pharmacological interaction, intrauterine contraception, or bleeding disorders. It is also referred to menometrorrhagia.
The condition affects up to a third of all women at some point during their reproductive years, usually women over age 30. It is characterized by extremely heavy, erratic menstrual bleeding and is often accompanied by fatigue, pelvic pain and decreased quality of life. The excessive blood loss in DUB can provoke iron deficiency anemia.
"This is a very important study, proving that a minimally invasive procedure -- endometrial ablation -- can solve the problem of excessive bleeding as well as hysterectomy," commented Franklin D. Loffer, MD, Executive Vice President/Medical Director of AAGL, the professional organization dedicated to the advancement of minimally-invasive gynecologic surgery. "Women should always be offered the least invasive, effective approach to solving her medical problems."
While hysterectomy has a long history of use to cure DUB, newer, less invasive procedures have become available in recent years. These have stirred controversy over whether hysterectomy is overused, particularly for conditions such as DUB for which more conservative approaches may be just as effective and cause fewer complications.
The new study, Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (StopDUB) was a multicenter, randomized, controlled trial in the U.S. and Canada involving 237 women at 25 treatment centers. The primary complaint causing women to seek surgery was excessive bleeding that had not been mitigated by medical therapy. These women were randomly assigned to receive either hysterectomy or endometrial ablation, a minimally invasive technique that removes only the lining of the uterus (the lining cells are responsible for the bleeding), not the entire organ.
The primary measure of success in the study was women's satisfaction with their treatment, rather than just a clinical endpoint. After 3 years of follow-up, the vast majority of patients in both groups (93-95%) reported that their problem was solved. The secondary endpoints of pain and fatigue were also similar between the hysterectomy group and the endometrial ablation group.
"Using women's satisfaction as the study goal, rather than clinical endpoints alone, was very astute from our perspective, because the most important outcome is the woman's opinion, not the doctor's," said Dr. Loffer. "Our view at AAGL is always patient-focused: how much pain will there be, how much trauma, how much time lost, what impact on the quality of life? These are the measures that count."
Advantages of the less invasive procedure include shorter hospital stays (hours instead of days), less blood loss, fewer complications and quicker recovery. In many cases endometrial ablation causes menstrual periods to become much lighter and more regular, rather than eliminating them altogether. Many women consider this to be a satisfactory outcome and would prefer to have normal periods rather than lose their uterus.
"Both endometrial ablation and hysterectomy are effective treatments in women with dysfunctional uterine bleeding. However, hysterectomy was associated with about four times more adverse events and six times as many postoperative infections," said Malcolm Munro, MD, an investigator in the StopDUB Research Group at the David Geffen School of Medicine, University of California Los Angeles. Dr. Munro is also an advisor to the AAGL.
The American College of Obstetricians and Gynecologists (ACOG) recommends that treatment for menorrhagia begin with the least invasive therapy. But, for some women, endometrial ablation may not solve their problem.
"In this study about two thirds of women were able to avoid hysterectomy by having an endometrial ablation procedure while about a third of the patients who had received endometrial ablation ended up having a hysterectomy several years later. This rate is comparable to that seen in other studies," said Munro.
About 600,000 hysterectomies are performed annually in the U.S., making it the second most common major surgery performed on women of reproductive age. There is controversy about how many of these hysterectomies are really necessary. Clearly, 120,000 hysterectomies performed each year for DUB (without uterine pathology) are amenable to endometrial ablation. Moreover, many patients with uterine fibroids and abnormal bleeding can be treated via endometrial ablation. Fibroids account for 40% of hysterectomies each year.
While some doctors may look for anemia as a diagnostic indicator for DUB, in the StopDUB study women's perception of their problem was the main criterion, supported by clinical measures of excess duration, amount, or unpredictability of flow. "We felt that women should not have to be anemic in order to seek help and have their problem taken seriously," said Munro.
"Based on our results, it is reasonable to recommend that women should select the type of surgery they want for DUB, based on their preferences and situations," concluded Munro.