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

Abstract

BACKGROUND The spontaneous cure rate of chronic endometritis (CE) is very low, and doxycycline alone or a combination of levofloxacin and tinidazole are the two most widely used antibiotic regimens for treating CE. However, there is currently no consensus regarding the optimal antibiotic regimen. OBJECTIVE This study aimed to assess the effectiveness and safety of doxycycline alone and levofloxacin combined with tinidazole as antibiotic therapies for CE. STUDY DESIGN In this parallel randomized controlled trial (RCT) comparing two antibiotic therapies for CE, 172 patients with CE 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 CE. The one-course cure rate for CE, based on the conversion of CD138 expression from positive to negative, and the incidence of adverse reactions were compared between the groups. RESULTS 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 CE cure rate between the groups (84.8% vs. 77.8%) (P = 0.255). In the subgroup analysis based on CE severity, there were no differences between the groups, regardless of whether CE was mild (88.9% vs. 83.7%) (P = 0.464) or severe (79.4% vs. 68.8%) (P = 0.322). 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 = 0.595). The incidence of adverse reactions was significantly higher in the treatment group (11.6% vs. 2.3%) (P < 0.05) in the safety analysis. CONCLUSION The two antibiotic therapy regimens were effective and safe for treating CE. The study did not find a statistically significant difference in cure rate between the two antibiotic therapy groups. Doxycycline alone is recommended as the first-line treatment because of the lower incidence of adverse reactions.