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Efficacy of silymarin in patients with Non-Alcoholic Fatty Liver Disease – The Siliver trial: a study protocol for a randomized controlled clinical trial

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Avelar, C.R., Nunes, B.V.C., Sassaki, B.S., Vasconcelos, M.S., Oliveira, L.P.M., Lyra, A.C., Bueno, Allain ORCID: https://orcid.org/0000-0002-9456-8558 and Jesus, R.P. (2023) Efficacy of silymarin in patients with Non-Alcoholic Fatty Liver Disease – The Siliver trial: a study protocol for a randomized controlled clinical trial. Trials, 24 (177). ISSN 1745-6215

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Official URL: https://doi.org/10.1186/s13063-023-07210-6

Abstract

Background: Non-Alcoholic Fatty Liver Disease (NAFLD) is one of the most prevalent liver diseases globally. Pharmacological treatments for NAFLD are still limited. Silymarin, a compound extracted from Silybum marianum, is an herbal supplement traditionally used in folk medicine for liver disorders. It has been proposed that silymarin may possess hepatoprotective and anti-inflammatory properties. The present trial aims to assess the efficacy of silymarin supplementation in the adjuvant treatment of NAFLD in adult patients.
Method: This is a randomized double-blind placebo-controlled clinical trial recruiting adult NAFLD patients in therapy on an outpatient basis. Participants are randomized to an Intervention (I) or Control (C) group. Both groups receive identical capsules and are followed for 12 weeks. I receives 700mg of silymarin + 8mg vitamin E + 50mg phosphatidylcholine daily, whilst C receives 700mg maltodextrin + 8mg vitamin E + 50mg phosphatidylcholine daily. Patients undergo a computerized tomography (CT) scan and blood tests at the beginning and end of the study. Monthly face-to-face consultations and weekly telephone contact are carried out for all participants. The primary outcome assessed will be change in NAFLD stage, if any, assessed by the difference in attenuation coefficient between liver and spleen, obtained by upper abdomen CT.
Discussion: The results of this study may provide a valuable opinion on whether silymarin can be used as adjuvant therapy for the management or treatment of NAFLD. The data presented on efficacy and safety of silymarin may provide more foundation for further trials and for a possible use in clinical practice.
Trial registration: This study has been approved by the Research Ethics Committee of the Professor Edgard Santos University Hospital Complex, Salvador BA, Brazil, under protocol 2.635.954. The study is carried out according to guidelines and regulatory standards for research involving humans, as set out in Brazilian legislation. Trial registration - clinicaltrials.gov: NCT03749070.

Item Type:	Article
Additional Information:	This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Uncontrolled Discrete Keywords:	Clinical trial, Silymarin, Non-alcoholic fatty liver disease, randomized controlled trial
Subjects:	R Medicine > R Medicine (General)
Divisions:	College of Health, Life and Environmental Sciences > School of Science and the Environment
Depositing User:	Allain Bueno
Date Deposited:	13 Mar 2023 12:51
Last Modified:	13 Mar 2023 12:51
URI:	https://eprints.worc.ac.uk/id/eprint/12808

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