Doxycycline vs levofloxacin combined with tinidazole for treating chronic endometritis: a randomized controlled trial.

Abstract

The spontaneous cure rate of chronic endometritis is very low, and doxycycline alone or a combination of levofloxacin and tinidazole are the 2 most widely used antibiotic regimens for treating chronic endometritis. However, there is currently no consensus regarding the optimal antibiotic regimen. This study aimed to assess the effectiveness and safety of doxycycline alone and levofloxacin combined with tinidazole as antibiotic therapies for chronic endometritis. In this parallel randomized controlled trial comparing 2 antibiotic therapies for chronic endometritis, 172 patients with chronic endometritis diagnosed using CD138 were randomly divided into treatment and control groups. Levofloxacin combined with tinidazole was administered to the treatment group, whereas doxycycline alone was administered to the control group. Repeated hysteroscopy and endometrial biopsies were performed during the first menstrual proliferative period after antibiotic therapy to evaluate the resolution of chronic endometritis. The one-course cure rate for chronic endometritis, based on the conversion of CD138 expression from positive to negative, and the incidence of adverse reactions were compared between the groups. A total of 160 patients were enrolled, with 79 in the treatment group and 81 in the control group. After one course of antibiotic therapy, there was no difference in the chronic endometritis cure rate between the groups (84.8% vs 77.8%) (P=.255). In the subgroup analysis based on chronic endometritis severity, there were no differences between the groups regardless of whether chronic endometritis was mild (88.9% vs 83.7%) (P=.464) or severe (79.4% vs 68.8%) (P=.322). In the intent-to-treat analysis (n=172), the cure rates were 77.9% (67/86) and 73.3% (63/86) in the treatment and control groups, respectively, showing no difference between the groups (P=.595). The incidence of adverse reactions was significantly higher in the treatment group (11.6% vs 2.3%, P=.032) in the safety analysis. The 2 antibiotic therapy regimens were effective and safe for treating chronic endometritis. The study did not find a statistically marked difference in cure rate between the 2 antibiotic therapy groups. Doxycycline alone is recommended as the first-line treatment because of the lower incidence of adverse reactions.