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The impact of metronidazole on pain persistence after fertility-sparing endometriosis surgery: METROFERT randomized study - 24/12/24

Doi : 10.1016/j.ajog.2024.07.006 
Amira Quevedo, MD a, , Shivani Parikh, MD b, Jonathan Reinstine, MD c, Petra Chamseddine, MD d, Jeremy T. Gaskins, PhD e, Cathy Whalen, PharmD f, Shan Biscette, MD, MBA g, Resad Paya Pasic, MD, PhD b
a Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville, FL 
b Department of Obstetrics and Gynecology, University of Louisville, Louisville, KY 
c Department of Obstetrics and Gynecology, Norton Women's and Children's Hospital, Louisville, KY 
d Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology, Henry Ford Health, Detroit, MI 
e Department of Bioinformatics & Biostatistics, University of Louisville, Louisville, KY 
f James Graham Brown Cancer Center, University of Louisville, Louisville, KY 
g Department of Obstetrics and Gynecology, Atrium Health, Charlotte, NC 

Corresponding author: Amira Quevedo, MD.

Abstract

Background

Recent studies have shown that a disrupted microbiome is associated with endometriosis. Despite endometriosis affecting 1 in 10 reproductive-aged women, there is a lack of innovative and nonhormonal long-term effective treatments. Studies have reported an approximately 20% to 37.5% persistence of pain after fertility-sparing endometriosis surgery. Metronidazole has been shown to decrease inflammatory markers and the size of endometriosis lesions in animal studies.

Objective

To determine if modulating the microbiome with oral metronidazole for 14 days after fertility-sparing endometriosis surgery decreases pain persistence postoperatively.

Study Design

This was a randomized, multicenter, placebo-controlled, double-blind trial. Individuals 18 to 50 years old were prospectively randomized to placebo vs oral metronidazole for 14 days immediately after endometriosis fertility-sparing excision surgery. The primary outcome was binary, subjective pain persistence at 6 weeks postoperatively. Secondary outcomes included quality of life, sexual function, and endometriosis-associated pain scores according to the Endometriosis Health Profile-5, Female Sexual Function Index, and a visual analog scale.

Results

One hundred fifty-two participants were approached from October 2020 to October 2023 to enroll in the study. Sixty-four participants were excluded either because they did not meet inclusion or exclusion criteria or because they declined to participate. Eighty-eight participants were randomized in a 1:1 ratio to receive either the oral placebo or metronidazole after endometriosis excision surgery; 18.2% of participants were lost to follow-up or discontinued treatment and this was not significantly different between the 2 arms, yielding a final cohort of 72 participants. Baseline demographics of the 2 study groups were similar. There was no statistically significant improvement in the primary outcome of binary subjective pain persistence between the metronidazole group compared to placebo (84% vs 88%, P=.74) at 6 weeks postoperatively. Further, no significant differences between treatments were detected in the secondary outcomes.

Conclusion

A postoperative 14-day regimen of oral metronidazole immediately after fertility-sparing endometriosis surgery was not associated with any significant differences between treatment groups in the persistence of endometriosis-related pain symptoms compared to placebo at 6 weeks.

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Key words : dysmenorrhea, endometriosis, fertility, metronidazole, microbiome, pain


Plan


 S.B. is a proctor for Intuitive Surgical. R.P.P. is a speaker for Cooper Surgical. A.Q., S.P., J.R., P.C., J.T.G., and C.W. report no conflict of interest.
 This study was funded by University of Louisville, United States.
 Cite this article as: Quevedo A, Parikh S, Reinstine J, et al. The impact of metronidazole on pain persistence after fertility-sparing endometriosis surgery: METROFERT randomized study. Am J Obstet Gynecol 2025;232:106.e1-9.
 Trial registration number: NCT04554693 (NCT04554693).


© 2024  Publié par Elsevier Masson SAS.
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Vol 232 - N° 1

P. 106.e1-106.e9 - janvier 2025 Retour au numéro
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