Original ContributionSilybin combined with phosphatidylcholine and vitamin E in patients with nonalcoholic fatty liver disease: A randomized controlled trial
Graphical abstract
Research Highlights
► Currently there is no effective therapy for nonalcoholic fatty liver disease, except for lifestyle modification. ► Realsil treatment for 12 months improves liver enzymes, insulin resistance, and liver histology. ► HCV patients in the Realsil group showed improvements in fibrogenesis markers.
Section snippets
Trial design
The trial was conducted at 11 Italian and 2 Romanian centers. Protocol and patient consent forms were designed by the coordinating center and reviewed by all participating centers. The protocol conformed to ethical guidelines of the 1975 Declaration of Helsinki and was approved by the Institutional Review Board at each participating center. All patients gave informed written consent. The trial was registered with the European Clinical Trials Database (EudraCT, Ref. 2005-000860-24). No
Results
The trial took place from 13 June 2005 to 10 October 2008 and enrolled 180 patients with histologically proven NAFLD; 36 were HCV positive. Overall, 91 patients received RA and 88 received P. Forty-one patients were prematurely withdrawn (22 and 19 from the RA and P groups, respectively), with 138 patients available for PP analysis (69 in each group). Reasons for discontinuation were physician's decision (n = 5), patient's decision (n = 21), AEs (n = 10), or other (n = 5). AEs were generally transient
Discussion
This is the first study to systematically assess the effects of silybin in NAFLD patients, with and without HCV infection. Patients treated for 12 months with RA, an oral complex containing silybin, phosphatidylcholine, and vitamin E, exhibited improvements in levels of transaminases and γGT, insulin resistance, and several aspects of liver histology. These improvements were similar to those noted in patients treated with pioglitazone and vitamin E [4], [31]. However, in our study, body weight
Acknowledgments
We thank Gardiner-Caldwell Communications for general editing and styling assistance, which was funded by the Istituto Biochimico Italiano Lorenzini S.p.a, Italy. This study was funded by a grant from the Istituto Biochimico Italiano, Lorenzini S.p.a., Italy. The manuscript was written by the lead and corresponding author and was approved by all authors, who assume responsibility for the completeness of the data and the overall content of the article. This article was approved by the ethics
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