Tranexamic acid

Hysterectomy is a common surgical procedure that provides definitive treatment for menorrhagia. However, many women prefer to continue medical therapy for several years because hysterectomy is irreversible and associated with surgical risks. No randomized controlled trials have compared medical and surgical treatment of menorrhagia in women who did not have a strong preference or medical indications for either strategy. Learman and colleagues compared the outcome of these two treatment strategies in 63 premenopausal women referred to four teaching hospitals in the United States because of symptomatic menorrhagia.

Study participants were 30 to 50 years of age and reported abnormal menstrual flow lasting more than seven days each month or sufficient flow to cause anemia for at least two months. Women who were older than 45 years were tested for menopause by measuring follicle-stimulating hormone level and also were tested for endometrial hyperplasia or carcinoma before being enrolled in the study. Exclusion criteria included coagulopathies, other causes of anemia, endocrine conditions, pelvic pathology, desire for pregnancy, and recent use of oral contraceptives or long-acting hormonal therapies.

A total of 413 women initially began the trial and were given cyclic medroxyprogesterone acetate for 10 to 14 days per month. Patients who were dissatisfied with this regimen were invited to participate in the comparison trial of hysterectomy and extended medical therapy. Patients assigned to medical therapy received a combined oral contraceptive plus a prostaglandin inhibitor, but variations in the actual regimen were permitted. Patients were followed every three months for two years to assess health status, beliefs and attitudes, gynecologic and urinary symptoms, and other relevant symptoms, such as back pain and sexual function.

On entry to the study, both groups reported multiple pelvic symptoms and low satisfaction with their current health status and symptom management. The median duration of abnormal bleeding symptoms was three to four years. Initially, 29 of the 32 women assigned to medical treatment received hormonal therapy, but only 17 of these women also received a prostaglandin inhibitor. Within two years, 17 of these women had undergone a hysterectomy.

Of the 31 women assigned to hysterectomy, 28 had the surgery. Most of these women (86 percent) required a one- to two-day hospitalization. Two patients had perioperative complications and three required readmission because of late complications. After six months, women in the hysterectomy group reported significantly greater improvements in pelvic pain, breast pain, urinary urgency, and sensation of incomplete bladder emptying than women receiving medical treatment. They also reported nonstatistically significant improvements in pelvic or bladder pressure and lower back pain compared with women treated medically.

By two years, the most significant differences recorded between the groups were hot flushes and incomplete bladder emptying. Women who remained on medical treatment showed significant improvements from baseline in pelvic pain, pelvic or bladder pressure, and stress incontinence symptoms. Women who crossed over to hysterectomy reported significant improvements in bleeding; pelvic, back, or breast pain; and urinary frequency and urgency. Conversely, women who crossed over from medicine to hysterectomy had more days lost from usual activities and more days in bed than women who remained on medical therapy.

The authors conclude that hysterectomy may be the better treatment option for women who seek relief of symptoms such as bleeding, pelvic pain, breast pain, lower back pain, and bladder symptoms. Conversely, medical therapy can provide substantial improvements in symptoms with fewer overall days of restricted activities in the short term for women who do not want to have a hysterectomy.

ANNE D. WALLING, M.D.

Learman LA, et al. Hysterectomy versus expanded medical treatment for abnormal uterine bleeding: clinical outcomes in the medicine or surgery trial. Obstet Gynecol May 2004;103:824-33.

EDITOR'S NOTE: Deciding on the optimal treatment strategy for an individual woman with menorrhagia can be challenging for several reasons. Although the medical literature is difficult to assess objectively, about one third of patients are reported to have strong personal preferences for a specific therapy. The options are much wider than suggested in this article. A review (1) in the BMJ Best Treatments series (http://www.besttreatments.org) concluded that nonsteroidal anti-inflammatory drugs (NSAIDs), tranexamic acid, hysterectomy (after failure of medical therapy), and endometrial thinning before hysteroscopic surgery are "treatments that work," and that endometrial destruction (after failure of medical therapy) is a "treatment likely to work."

"Treatments that need further study" include ethamsylate, oral contraceptives, intrauterine progesterones, gonadotropin-releasing hormone (GnRH), and myomectomy. One of the more interesting facts found in this review is that women adequately treated with NSAIDs reported a 25 to 50 per-cent reduction in bleeding, but in the above study, only a small proportion of the women assigned to treatments including NSAIDs actually took them. Although hysterectomy is the definitive therapy for menorrhagia (and the leading indication for the more than 600,000 hysterectomies performed in the United States per year), studies that followed patients for more than two years after hysterectomy or endometrial ablation found no significant difference between the groups in satisfaction at longer follow-up. Women treated by endometrial ablation were calculated to have a mean reduction in operating time of 23 minutes and returned to work 4.5 weeks sooner than women undergoing hysterectomy.--A.D.W.

REFERENCE

(1.) Popovic JR, Kozak LJ. National hospital discharge survey: annual summary 1998. National Center for Health Statistics. Vital Health Stat 2000;13:1-194.

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