The impact of metronidazole on pain persistence after fertility-sparing endometriosis surgery: METROFERT randomized study - 24/12/24
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. |
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This study was funded by University of Louisville, United States. |
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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. |
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Trial registration number: NCT04554693 (NCT04554693). |
Vol 232 - N° 1
P. 106.e1-106.e9 - janvier 2025 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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