Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Mar 10;24(1):177.
doi: 10.1186/s13063-023-07210-6.

Efficacy of silymarin in patients with non-alcoholic fatty liver disease - the Siliver trial: a study protocol for a randomized controlled clinical trial

Camila Ribeiro de Avelar  1 , Beatriz Vieira Coelho Nunes  2 , Betina da Silva Sassaki  2 , Mariana Dos Santos Vasconcelos  2 , Lucivalda Pereira Magalhães de Oliveira  2 , André Castro Lyra  3 , Allain Amador Bueno  4 , Rosângela Passos de Jesus  2
Affiliations

Efficacy of silymarin in patients with non-alcoholic fatty liver disease - the Siliver trial: a study protocol for a randomized controlled clinical trial

Camila Ribeiro de Avelar et al. Trials. .

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, while 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 the 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. November 21, 2018.

Keywords: Clinical trial; Non-alcoholic fatty liver disease; Silymarin; randomized controlled trial.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flowchart
See this image and copyright information in PMC

References

    1. Cerit M, Şendur HN, Cindil E, Erbaş G, Yalçın M, Cerit E, et al. Quantification of liver fat content with ultrasonographic attenuation measurement function: correlation with unenhanced multidimensional computerized tomography. Clin Imaging. 2020;65:85–93. doi: 10.1016/j.clinimag.2020.04.028. - DOI - PubMed
    1. Dan AA, Kallman JB, Wheeler A, Younoszai Z, Collantes R, Bondini S, et al. Health-related quality of life in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2007;26(6):815–820. doi: 10.1111/j.1365-2036.2007.03426.x. - DOI - PubMed
    1. Beaton MD, Chakrabarti S, Levstik M, Speechley M, Marotta P, Adams P. Phase II clinical trial of phlebotomy for non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2013;37(7):720–729. doi: 10.1111/apt.12255. - DOI - PubMed
    1. Nseir W, Hellou E, Assy N. Role of diet and lifestyle changes in nonalcoholic fatty liver disease. World J Gastroenterol. 2014;20(28):9338–9344. doi: 10.3748/wjg.v20.i28.9338. - DOI - PMC - PubMed
    1. Fresneda S, Abbate M, Busquets-Cortés C, López-González A, Fuster-Parra P, Bennasar-Veny M, et al. Sex and age differences in the association of fatty liver index-defined non-alcoholic fatty liver disease with cardiometabolic risk factors: a cross-sectional study. Biol Sex Differ. 2022;13:64. doi: 10.1186/s13293-022-00475-7. - DOI - PMC - PubMed

Publication types

Associated data