AIMTo evaluate the effect of silymarin on the serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma glutamyl transpeptidase (γGT) in patients with liver diseases.METHODSA systematic review with meta-analysis of ramdomized and controlled clinical trials was performed, evaluating the effects of sylimarin in patients with hepatic diseases, published by January 31, 2016. Clinical trials were sought on the basis of The Cochrane Central Register of Controlled Trials in the Cochrane Library, PubMed/Medline, Scopus, Web of Science, Lilacs and Clinical Trials. The trials with adult and elderly patients of both sexes, with Liver Diseases who took oral silymarin supplementation, as extract or isolated, as well as Silymarin combined with other nutrients, were included. The trials should provide information about the intervention, such as dosages and detailing of the product used, besides the mean and standard deviation of serum levels of ALT, AST and γGT of the baseline and at the end of the intervention.RESULTSAn amount of 10904 publications were identified. From those, only 17 were included in the systematic review and 6 in the meta-analysis, according to the used selection criteria. In this meta-analysis, the results indicated a reduction of 0.26 IU/mL (95%CI: -0.46-0.07, P = 0.007) at the level of ALT and 0.53 IU/mL (95%CI: -0.74-0.32, P = 0.000) at the serum levels of AST after using the silymarin, both, statistically significant, but with no clinical relevance. There was no significant change in the γGT levels. Subgroup analyzes were also performed for the biochemical markers in relation to the type of intervention, whether silymarin isolated or associated with other nutrients and the time of intervention (whether ≥ 6 mo or < 6 mo). Significant differences were not found. The evaluated studies presented a high degree of heterogeneity and low methodological quality in the carried out analysis.CONCLUSIONSilymarin minimally reduced, but without clinical relevance, the serum levels of ALT and AST. It is necessary to carry out studies with more appropriate methodological designs.

Context Nonalcoholic fatty liver disease (NAFLD) is estimated to affect approximately 25% of the adult population, making it one of the most common chronic liver diseases worldwide and a major public health problem. Still, there is no consensus on the most appropriate nutritional intervention for disease treatment. Objective To systematize and synthesize the results of randomized controlled trials that have evaluated the effect of dietary interventions with different, quantitative, macronutrient compositions on hepatic steatosis attenuation, serum levels of alanine aminotransferase, aspartate aminotransferase, lipid profile, glucose metabolism markers, and anthropometric parameters of adults and the elderly (age ≥ 60 years) with NAFLD. Data Sources MEDLINE databases via PubMed, Embase, Science Direct, LILACS, Web of Science, ClinicalTrials.gov, and Cochrane Library were searched. Randomized controlled trials that compared interventions as diets with values ≤ 45% or 20% of the total daily energy intake from carbohydrates or lipids, respectively, compared with dietary reference intakes, were included. Data Extraction Risk of bias was assessed through the Cochrane Collaboration tool. The meta-analysis was only performed to evaluate the effect of carbohydrate-modified diets on the outcome variables. The number of participants and mean values and respective standard deviations of the outcome variables were extracted and used to calculate weighted mean differences and their respective 95%CIs. Results The search strategy resulted in 21 146 studies, of which 10 were retained for qualitative analysis and 6 were included in the meta-analysis. From the analysis of 10 studies were identified 8 articles in which low-calorie diets were evaluated and 3 interventions that used an isocaloric diet. Only 3 studies were classified as having low risk of bias. Conclusion The observed effects on hepatic steatosis, serum alanine aminotransferase and aspartate aminotransferase levels, parameters of lipid and glucose metabolism, and anthropometric variables were mostly related to a hypocaloric diet. The use of reduced macronutrient interventions had no efficacy. Systematic Review Registration PROSPERO registration no. CRD42018088824.

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

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