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

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This study found that clarithromycin reduced endometriosis symptoms and inflammatory markers more than placebo, but the differences were not statistically significant.

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This double-blinded randomized placebo-controlled trial studied postsurgical endometriotic women in Shiraz, Iran, assigning participants immediately after surgery to receive clarithromycin 500 mg daily for 6 months (n=120) or placebo (n=169). Serum inflammatory markers (CRP, TNF-α, and IL-10) and clinical pain symptoms (dysmenorrhea, dyschezia, dyspareunia, and non-menstrual pain) were assessed at baseline and at 3 and 6 months. Both groups showed decreases in pain symptoms and inflammatory marker levels versus baseline, but the real and placebo groups did not show significant between-group differences, with reported reductions not depending on time. This paper centrally about endometriosis — it tests whether clarithromycin after surgery improves inflammatory markers and clinical manifestations in endometriosis patients.

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Abstract

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. Similar content being viewed by others

References

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Iran J Nurs Midwifery Res 17(2 Suppl 1):S115 Funding This study was financially supported by Shiraz University of Medical Sciences, Shirza, Iran (Grant No.: 91-01-01-4809). Author information Authors and Affiliations Contributions SA: project administration, methodology. TP: conceptualization, validation, writing—review and editing. EA: software, validation, writing—original draft. GD: data curation, formal analysis. Corresponding author Ethics declarations Conflict of interest All authors declare that they have no conflict of interest on publishing this study. Ethical approval All of the protocols and experimental procedures of this study were approved by the local Ethics Committee of Shiraz University of Medical Sciences, Shiraz, Iran (Code: IR.sums.rec.1394.S744) which were in complete accordance with the ethical regulations of human studies set by the Helsinki Declaration (2014). Informed consent Informed consent was obtained from all the patients who participated in this study. Additional information Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Rights and permissions About this article Cite this article Alborzi, S., Poordast, T., Askary, E. et al. 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. Arch Gynecol Obstet 299, 1305–1312 (2019). https://doi.org/10.1007/s00404-019-05057-4 Received: Accepted: Published: Version of record: Issue date: DOI: https://doi.org/10.1007/s00404-019-05057-4

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Condition tags

mesh:D004715endometriosis

MeSH descriptors

Anti-Bacterial Agents Biomarkers Clarithromycin Endometriosis Adult Anti-Bacterial Agents Anti-Bacterial Agents Biomarkers Clarithromycin Clarithromycin Double-Blind Method Endometriosis Endometriosis Female Follow-Up Studies Humans Middle Aged

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