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
Introduction Malnutrition is strongly associated with negative outcomes in aged populations with cancer. Several studies have compared the outcomes of nutritional-screening tools, but knowledge specifically covering older adult patients with cancer remains limited. The aim of this study was to compare the outcomes of two tools, the Patient-Generated Subjective Global Assessment (PG-SGA) versus the Mini Nutritional Assessment (MNA) for this population. Method Cross-sectional study with 432 participants who consented to participate and were enrolled at admission to medical and surgical wards of a tertiary referral hospital. The participants’ nutritional statuses were simultaneously assessed using the PG-SGA and the MNA, and the outcomes compared using the kappa statistical test. The Receiver Operating Characteristic Curve (ROC) was employed to calculate the MNA sensitivity, specificity, positive and negative predictive values, and was compared with PG-SGA. Results Prevalence of good nourishment was observed in 62.5% and 61.1% of the participants, as detected by PG-SGA and MNA, respectively. Both tools concurred moderately (kappa = 0.453). Importantly, there were significant differences in the diagnosis of malnutrition (7.6% vs. 4.6%, p = 0.000). The MNA showed sensitivity of 72.2% and specificity of 75.9% in detecting good nourishment for the population investigated. Conclusion The MNA may not present greater sensitivity, possibly due to a lack of coverage of gastrointestinal symptoms. It is a quick and efficient tool for nutritional assessment of older adult patients with cancer, but as it is more specific than sensitive, caution is recommended when identifying borderline or early malnourished individuals of this population.
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