Department of Nutrition Sciences, Federal University of Bahia, Bahia, 32 Araújo Pinho Street, Canela, Salvador, Bahia, 40.110-150, Brazil.
Gastrohepatology Service, Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Bahia, Brazil.
Trials. 2023 Mar 10;24(1):177. doi: 10.1186/s13063-023-07210-6.
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.
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.
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.
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.
非酒精性脂肪性肝病（NAFLD）是全球最常见的肝脏疾病之一。NAFLD 的药物治疗仍然有限。水飞蓟素是从水飞蓟中提取的一种化合物，传统上被用作民间医学中治疗肝脏疾病的草药补充剂。有人提出，水飞蓟素可能具有保肝和抗炎作用。本试验旨在评估水飞蓟素补充剂在辅助治疗成年 NAFLD 患者中的疗效。
这是一项在门诊接受治疗的成年 NAFLD 患者的随机双盲安慰剂对照临床试验。参与者被随机分为干预（I）组或对照（C）组。两组均服用相同的胶囊，并随访 12 周。I 组每天服用 700mg 水飞蓟素+8mg 维生素 E+50mg 磷脂酰胆碱，C 组每天服用 700mg 麦芽糊精+8mg 维生素 E+50mg 磷脂酰胆碱。患者在研究开始和结束时进行计算机断层扫描（CT）扫描和血液检查。所有参与者每月进行面对面咨询和每周电话联系。主要结局评估为通过上腹部 CT 获得的肝脏和脾脏之间衰减系数的差异来评估 NAFLD 阶段的变化。
本研究的结果可能提供关于水飞蓟素是否可作为 NAFLD 管理或治疗的辅助治疗的宝贵意见。关于水飞蓟素的疗效和安全性的数据可能为进一步的试验和可能在临床实践中的应用提供更多的基础。
本研究已获得巴西萨尔瓦多巴伊亚州教授埃德加·桑托斯大学医院综合大楼研究伦理委员会的批准，协议号为 2.635.954。该研究按照巴西法规中规定的涉及人类的研究指南和监管标准进行。试验注册 - ClinicalTrials.gov：NCT03749070。2018 年 11 月 21 日。
