Effects of clarithromycin on inflammatory markers and clinical manifestations in postsurgical follow-up of patients with endometriosis: a double-blinded randomized placebo-controlled clinical trial.

PURPOSE: Studies showed anti-inflammatory and immunomodulatory effects of macrolide antibiotics such as clarithromycin in endometriosis. Therefore, the present study aims to investigate the therapeutic efficacy of clarithromycin in patients with endometriosis.

METHODS

This was a double-blinded randomized placebo-controlled trial conducted on endometriotic women during March 2016-2017 in Dena Hospital, Shiraz, Iran. Immediately after surgery, the patients were randomly divided into clarithromycin (real) (n = 120) and placebo group (n = 169). The real group received 500 mg of clarithromycin everyday for 6 months and the placebo group received the placebo. The serum levels of tumor necrosis factor-alpha (TNF-α), interleukin-10 (IL-10), Erythrocyte sedimentation rate (ESR) and C-reactive protein as well as clinical symptoms at baseline and 3 and 6 months of post-surgery were compared within and between groups.

RESULTS

The scores of dysmenorrhea, dyschezia, dyspareunia, and non-menstrual pain significantly decreased in both real and placebo groups compared with the baseline values. However, the real group showed greater reductions compared with the placebo group (p < 0.001). Similarly, the serum levels of CRP, TNF-α, and IL-10 decreased in both groups compared with the baseline values, but the real group showed greater reductions. Interestingly, the reductions in the clinical symptoms and serum levels did not significantly differ between the real and placebo groups. Moreover, the reductions in the studied variables showed no dependence on the time.

CONCLUSION

Clarithromycin may be an appropriate treatment in endometriotic patients. However, the non-significant differences between the real and placebo groups necessitate further studies on the therapeutic efficacy of clarithromycin.