Abstract: Objectives: To evaluate the therapeutic outcome of local (L) versus oral (O) progestins for management
of simple endometrial hyperplasia (SEH). Patients & Methods: The study included 84 multiparous women with
mean age of 41.7±4.7 years; 68 were pre- and 16 were post-menopausal women presented by abnormal uterine
bleeding (AUB). Patients were divided into two equal groups: Group O received norethisterone acetate (NET) (15
mg/day as continuous oral dose for 3 months) and Group L assigned to Levonorgestrel-releasing intrauterine system
(LNG-IUS) insertion. Primary outcome was to define number of responders after 3 months (Phase I). Responders
were continuously followed-up, while non-responders in each group received the program assigned for the other
group for another 3-months (Phase II) and all non-responders after Phase II were assigned for hysterectomy.
Secondary outcome was the duration and severity of menstrual bleeding and the occurrence of spotting during
duration of cycle. Patients’ satisfaction at the end of the study period was evaluated. Results: Primary outcome of
Phase I was 73.8% in group L and 57.1% in group O with significantly higher frequency of responders in group L.
During Phase II, 72.2% patients responded to LNG-IUS compared to 63.6% response to NET therapy and 9 patients
(10.7%) had hysterectomy. Both therapeutic regimens significantly reduced duration and heaviness of blood loss
with significant reduction at 6-m compared to 3-m and in group L compared to group O. Throughout follow-up
period of 15.3±4.2 months, no case progressed to atypical EH or carcinoma. At the end of follow-up, the frequency
of higher satisfaction grades was significantly higher in group L compared to group O. Conclusion: LNG-IUS is
safe and efficient therapeutic modality for SEH in women with AUB. LNG-IUS significantly reduced hysterectomy
rate and duration and severity of bleeding with high satisfaction rates. LNG-IUS could be used as prophylactic
therapy as no patient progressed to atypia or cancer. |
