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GYN: Chance of Surgery 50% After Conservative TxFrom: art fougner, md (evsono@pipeline.com)Fri Apr 30 09:53:33 2004
Patrice G.W. Norton Contributing Writer Women with an unsatisfactory response to first-line medical therapy for excessive uterine bleeding who undergo further conservative therapy stand about a 50% chance of ultimately needing a hysterectomy, results of two randomized trials suggest. The clinical implications of this finding will vary among patients and their physicians, Dr. Roy M. Pitkin of the University of California, Los Angeles, and Dr. James R. Scott of the University of Utah, Salt Lake City, said in an editorial accompanying the studies (JAMA 291[12]:1503-04, 2004). “Does it mean that surgery will likely be necessary eventually anyway, so perhaps better sooner than later, sparing the woman continued symptoms? Or does it mean that there is a 50% chance of avoiding the hysterectomy and these odds are worth taking to avoid a major operation?” they wrote, noting that additional randomized trials with longer follow-up are still needed. In the first study, Finnish investigators found that use of intrauterine hormonal therapy provided improved quality of life and was 40% less expensive than hysterectomy at a 5-year follow-up (JAMA 291[12]:1456-63, 2004). In the second study, hysterectomy was superior in terms of health-related quality of life at 6 months, compared with a variety of oral or injectable hormone regimens. A total of 17 women in the medical treatment group later requested and received hysterectomy, however. By the end of the 2-year study, most differences between the hysterectomy and medical groups were no longer statistically significant in an intention-to-treat analysis, said Miriam Kuppermann, Ph.D., of the University of California, San Francisco, and her associates (JAMA 291[12] 1447-55, 2004). Both trials found a relatively high proportion of women in the control groups who eventually underwent hysterectomy: 42% in the Finnish trial and 53% in the U.S. trial. The Finnish study included 236 women aged 35-49 years with complaints of menorrhagia. They were randomly assigned to receive hysterectomy or insertion of an intrauterine device that gradually releases 20 µg of levonorgestrel every 24 hours over 5 years. The levonorgestrel group had 115 women available for follow-up and the hysterectomy group had 114, said Dr. Ritva Hurskainen of the University of Helsinki and associates. After 5 years, the groups had no substantial difference in terms of the primary outcome of health-related quality of life as measured by the 5-Dimensional EuroQol (EQ-5D). No significant differences were found in psychological well-being or in patient satisfaction between the treatment groups. Moreover, 94% of women in the levonorgestrel group and 93% in the hysterectomy group were satisfied or very satisfied. Although 50 women in the levonorgestrel group eventually underwent hysterectomy, the direct and indirect costs, discounted by 3% per year, were substantially lower in the levonorgestrel group. The mean discounted total cost per subject was $2,817 in the levonorgestrel group and $4,660 for the hysterectomy group after 5 years. The U.S. study included 63 premenopausal women aged 30-50 years who had abnormal uterine bleeding for a median of 4 years. They were dissatisfied with medical treatments, including medroxyprogesterone acetate, and were randomly assigned to receive hysterectomy or expanded medical treatment with estrogen and/or progesterone and/or prostaglandin synthetase inhibitors. At 6 months, women in the hysterectomy group had greater improvement in the primary outcome of mental health, as measured by the Mental Component Summary of the 36-Item Short-Form Health Survey, than women in the medicine group (8 vs. 2 on a 0-100 scale, respectively). They also reported much greater improvements in secondary outcomes, including symptom resolution and satisfaction with degree of symptom relief, pelvic problem interference with sex, sexual desire, and health distress. At the end of the 2-year follow-up period, the improvements were maintained in the hysterectomy group and significant improvements in seven secondary outcomes were noted in the medical treatment group. Between-group differences were no longer significant except that improved sexual desire was much greater for those in the hysterectomy group. Dr. Kuppermann and her associates noted that their study—the first randomized trial comparing hysterectomy with oral medical treatment—was limited by its small size and the high rate of crossing over to hysterectomy by women in the medicine group.
-- art fougner, md ich bin ein New Yorker
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