WASHINGTON — Oral medroxyprogesterone acetate and oral contraceptives are equally effective in stopping nongestational acute uterine bleeding, according to a small randomized controlled trial presented at the annual meeting of the American College of Obstetricians and Gynecologists.
Cessation of bleeding occurred in 88% of the women randomized to oral contraceptives and in 76% of the women randomized to medroxyprogesterone. The mean time to cessation in the oral contraceptive group was 3.2 days vs. 3.8 days in the medroxyprogesterone group, reported Dr. Malcolm G. Munro, professor of obstetrics and gynecology at the University of California, Los Angeles, and chairman of the abnormal uterine bleeding working group for Kaiser Permanente, Southern California.
Women with nongestational acute uterine bleeding are seen frequently, and yet there has been a paucity of research on how best to treat them. Oral contraceptives are the most commonly used treatment in North America, but their efficacy for this indication has not been scientifically tested, Dr. Munro said. “There's never been a case report, a series, or a comparative trial. To my knowledge, the use of some type of combination oral contraceptives is based on a textbook that espouses this as being a treatment, and probably because it seems to work reasonably well, people perceive that a lot of research has been done in the area, but that is not the case.”
Currently, treatment options have been surgical therapy (D&C) or medical therapy with gonadal steroids, estrogen alone, progestins alone, or a combination estrogen-progestin formulation, Dr. Munro said.
He noted that only two studies of acute uterine bleeding have been reported in the literature. The first, a study of unopposed estrogen given intravenously in 32 women, was published in the early 1980s, and the second, a study of medroxyprogesterone acetate in 24 women, was published in 1997. “This is the sum total of the research, so clinicians need to know there's hardly any research in this area.”
In an open-label trial, Dr. Munro and his colleagues at Kaiser Permanente randomized 40 women with acute uterine bleeding, defined as excessively heavy or prolonged bleeding that was not related to pregnancy, to receive either medroxyprogesterone acetate, 20 mg three times a day for 7 days, and then 20 mg a day for 3 weeks, or combination oral contraceptive treatment with norethindrone (1 mg) and ethinyl estradiol (35 mcg) in one tablet three times a day for 7 days, followed by one tablet a day for 3 weeks.
At the end of the study, 33 of the original 40 patients remained, and in these patients both treatments were “roughly equivalent” with respect to efficacy, time to bleeding cessation, and nausea. Patient satisfaction in both groups was high, Dr. Munro reported.
“The degree of nausea was statistically even between the two but there was a trend toward more nausea in the oral contraceptive group, and this trend may have been significant if we had a larger sample size,” commented Dr. Munro.
One patient in the oral contraceptive group required an emergency procedure, compared with none in the medroxyprogesterone acetate group. “All of the women in the study had been bleeding for more than 10 days. They were the type of patient who is often taken to the operating room. At the very least, they needed emergent intervention, and only one required an emergent intervention in this study,” he added.
This study, although small, provides some support for clinicians who have been using oral contraceptives in some type of multidose format, feeling that it is the right thing to do, Dr. Munro noted. “And for those clinicians who are wedded to the notion of inpatient therapy, our results let them know that there are a couple of medical alternatives that may be effective.”
'People perceive that a lot of research has been done in the [OC] area, but that is not the case.' DR. MUNRO