Effect of silymarin on Interleukin-6 level and size of endometrioma lesions in women with ovarian endometriosis: a randomized, double-blind placebo-controlled trial

Negin Mirzaei, Shahideh Jahanian Sadatmahalleh, Safoura Rouholamin, Malihe Nasiri
In: Research Square · 2022 · doi:10.21203/rs.3.rs-1632161/v1 · W4280575401
preprint OA: green CC0 ⤵ 1 in-corpus citation
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⚙ AI-generated summary by claude@2026-06, 2026-06-09 ⓘ

This trial found that silymarin significantly reduced endometrioma lesion volume, interleukin-6 levels, and pain in women with endometriosis compared to placebo over 12 weeks.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-09 ⓘ

This paper reports a randomized, double-blind, placebo-controlled phase II trial in 70 reproductive-age women with ovarian endometriosis/endometriomas confirmed by transvaginal ultrasonography, who were already receiving dienogest and then randomized to add silymarin (280 mg/day) or placebo for 12 weeks. Outcomes assessed before and after treatment included serum interleukin-6 (IL-6) levels, 3D ultrasound endometrioma volume, pain, sexual function (FSFI), and quality of life, with measurements performed at baseline and after the intervention. The silymarin group showed significant reductions in endometrioma volume, IL-6, and pain compared with baseline, while quality of life and FSFI did not improve substantially (with nonsignificant between-group differences). This paper is centrally about endometriosis—specifically testing silymarin’s effects on IL-6 and endometrioma lesion size in women with ovarian endometriosis.

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Abstract

Abstract Objective: To study the effect of silymarin on interleukin-6 (IL-6) level, size of endometrioma lesion, pain, sexual function, and quality of life (QoL) in women diagnosed with endometriosis.Materials and methods: This randomized, double-blind placebo-controlled clinical trial was performed on 70 women with endometriosis which was divided into two groups of intervention and control. The intervention was 140 mg silymarin (or matching placebo) administered twice daily for 12 weeks. The volume of endometrioma lesions, IL-6, pain, sexual function, and QoL were analyzed before and after the intervention.Results: The means of endometrioma volume (P =0.04), interleukin-6 (P = 0.002), and pain (P 0.05).Conclusion: Silymarin significantly reduced interleukin-6 levels, sizes of endometrioma lesions, and pain-related symptoms.The trial has been registered in the Iranian Registry of Clinical Trials (IRCT20150905023897N5) on 4 th February 2020 (04/02/2020) (https://en.irct.ir/trial/42215) and the date of initial participant enrollment was 2 nd March 2020 (02/03/2020).

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endometriosisendometrioma

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