Is Outpatient Diagnostic Hysteroscopy More Useful Than Endometrial Biopsy Alone for the Investigation of Abnormal Uterine Bleeding in Unselected Premenopausal Women? A Randomised Comparison

Abstract

This article presents the results of a randomized, controlled trial comparing diagnostic hysteroscopy and endometrial biopsy in the evaluation of abnormal uterine bleeding. Between August 1996 and October 1999, premenopausal women who were referred to the Aberdeen Royal Infirmary for evaluation of abnormal uterine bleeding were offered the opportunity to participate in the trial. The study subjects were randomly assigned to have endometrial biopsy, which was performed at the first visit using a 3-mm flexible Pipelle, or hysteroscopy in a dedicated hysteroscopy clinic within 2 weeks of their initial clinic visit. There were a total of 370 final study participants. Hysteroscopy was not possible in 28 patients; 19 of these women were evaluated with endometrial biopsy. Cervical stenosis prevented endometrial biopsy in 11 patients, and 6 were unable to tolerate the pain associated with the procedure. The results of a patient questionnaire completed after the evaluation procedure found no significant difference in patient acceptability of either method. The results of the McGill Pain Assessment Questionnaire showed that patients found neither procedure much more uncomfortable than a regular gynecological examination. No endometrial atypia was found in any patient by endometrial biopsy. Of the 178 women who underwent hysteroscopy, a normal endometrial cavity was seen in 123, uterine fibroids were diagnosed in 21, a congenital abnormality was found in 2, and 1 was not evaluable. Further clinical investigation was carried out in nine women under general anesthesia, one of whom was found to have a polyp. Four of the women who were unable to complete endometrial biopsy underwent hysteroscopy under general anesthesia. A submucosal fibroid was found in one, and the findings were normal in the other three. In the 178 patients who underwent hysteroscopy, 11 were diagnosed with endometrial polyps, and 22 were diagnosed with uterine fibroids. There was no statistically significant difference in the rate of uterine abnormality between women with irregular bleeding patterns and those with regular patterns. Hysteroscopic findings had no influence on subsequent management of patients. There were no directed resections for fibroids or polyps identified by diagnostic hysteroscopy, and endometrial ablation or resection was performed only at the patient's request. Not all women with endometrial polyps or fibroids received further treatment. Five percent of the hysteroscopy group and 4% of the endometrial biopsy group underwent hysterectomy. At follow-up 6 months to 1 year after evaluation of abnormal bleeding, 11% women, equally represented in both groups, had changed their treatment program, either by stopping medication or undergoing endometrial ablation.