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Silymarin in treatment of non-alcoholic steatohepatitis: A randomized clinical trial

机译:水飞蓟素治疗非酒精性脂肪性肝炎:一项随机临床试验

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摘要

>Background: No pharmacologic agents have been approved for the treatment of non-alcoholic steatohepatitis (NASH) that is common in our region. The present study was designed to evaluate the efficacy of silymarin, a known herbal drug, in the treatment of NASH. >Methods: This clinical-trial study was conducted on 64 patients with NASH who were randomly divided as case group (33) and control group (31). Abdominal sonography and persistent elevation in levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.2 times of the upper normal limit within the last six months were selected as inclusion criteria. They were advised to take low-fat, low carbohydrate diet, do regular sport activity to lose weight up to 4 Kg. Patients in the case group received 210 mg/day silymarin orally for 8 weeks and those in the control group received placebo. After 8 weeks, the patients were reevaluated and their AST and ALT levels were measured. This study was registered in the Iranian Registry of Clinical Trial () with registration number ID: IRCT201202159018N1. >Results: The mean age of patients in case and control groups was 43.6±8.3 and 39.4±10.5 years, respectively. Their BMI were 27.4±1.7 and 27.5±1.9, respectively. Their weights were also 79±9.2 and 76.9±9.5 kg, respectively. Serum concentrations of ALT were 91.3±21.3 and 38.4±11.8 in case group before and after the study respectively, whiles the figures were 84.6±23.3 and 52.3±29 in the control group (P=0.026). The same trend was seen for AST (P=0.038). >Conclusion: The patients who had taken silymarin experienced more notable fall in hepatic enzymes.
机译:>背景:尚未批准任何药物用于治疗我们地区常见的非酒精性脂肪性肝炎(NASH)。本研究旨在评估水飞蓟素(一种已知的草药)在NASH治疗中的功效。 >方法:该临床试验研究了64例NASH患者,随机分为病例组(33)和对照组(31)。选择过去六个月内腹部超声检查和持续升高的谷氨酸天冬氨酸转氨酶(AST)和丙氨酸转氨酶(ALT)的水平超过正常上限的1.2倍。建议他们采取低脂,低碳水化合物饮食,定期进行体育锻炼以减轻体重,最高可达4 Kg。病例组的患者口服210mg /天水飞蓟素治疗8周,而对照组则接受安慰剂。 8周后,对患者进行重新评估,并测量其AST和ALT水平。该研究已在伊朗临床试验注册中心()注册,注册号为ID:IRCT201202159018N1。 >结果:病例组和对照组的平均年龄分别为43.6±8.3岁和39.4±10.5岁。他们的BMI分别为27.4±1.7和27.5±1.9。它们的重量也分别为79±9.2 kg和76.9±9.5 kg。研究前后病例组的血清ALT水平分别为91.3±21.3和38.4±11.8,而对照组的血清ALT水平分别为84.6±23.3和52.3±29(P = 0.026)。 AST的趋势相同(P = 0.038)。 >结论:服用水飞蓟素的患者肝酶下降更为明显。

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