Article Text

Viusid, a nutritional supplement, increases survival and reduces disease progression in HCV-related decompensated cirrhosis: a randomised and controlled trial
  1. Eduardo Vilar Gomez1,
  2. Yoan Sanchez Rodriguez2,
  3. Ana Torres Gonzalez2,
  4. Luis Calzadilla Bertot2,
  5. Enrique Arus Soler1,
  6. Yadina Martinez Perez3,
  7. Ali Yasells Garcia3,
  8. Maria del Rosario Abreu Vazquez4
  1. 1Department of researches, National Institute of Gastroenterology, Havana, Cuba
  2. 2Department of Hepatology, National Institute of Gastroenterology, Havana, Cuba
  3. 3Department of Gastroenterology, National Institute of Gastroenterology, Havana, Cuba
  4. 4Department of Biostatistics, National Institute of Gastroenterology, Havana, Cuba
  1. Correspondence to Professor Eduardo Vilar Gomez; vilar{at}infomed.sld.cu

Abstract

Objectives Viusid is a nutritional supplement with recognised antioxidant and immunomodulatory properties which could have beneficial effects on cirrhosis-related clinical outcomes such as survival, disease progression and development of hepatocellular carcinoma (HCC). This study evaluated the efficacy and safety of viusid in patients with HCV-related decompensated cirrhosis.

Design A randomised double-blind and placebo-controlled study was conducted in a tertiary care academic centre (National Institute of Gastroenterology, Havana, Cuba). The authors randomly assigned 100 patients with HCV-related decompensated cirrhosis to receive viusid (three oral sachets daily, n=50) or placebo (n=50) during 96 weeks. The primary outcome of the study was overall survival at 96 weeks, and the secondary outcomes included time to disease progression, time to HCC diagnosis, time to worsening of the prognostic scoring systems Child–Pugh and Model for End-Stage Liver Disease, and time to a new occurrence or relapse for each one of the main clinical complications secondary to portal hypertension at 96 weeks.

Results Viusid led to a significant improvement in overall survival (90%) versus placebo (74%) (HR 0.27, 95% CI 0.08 to 0.92; p=0.036). A similar improvement in disease progression was seen in viusid-treated patients (28%), compared with placebo-treated patients (48%) (HR 0.47, 95% CI 0.22 to 0.89; p=0.044). However, the beneficial effects of viusid were wholly observed among patients with Child–Pugh classes B or C, but not among patients with Child–Pugh class A. The cumulative incidence of HCC was significantly reduced in patients treated with viusid (2%) as compared with placebo (12%) (HR 0.15, 95% CI 0.019 to 0.90; p=0.046). Viusid was well tolerated.

Conclusions The results indicate that treatment with viusid leads to a notable improvement in overall clinical outcomes such as survival, disease progression and development of HCC in patients with HCV-related decompensated cirrhosis.

Trial registration number http://ClinicalTrials.gov (NCT00502086).

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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Footnotes

  • Correction notice The “To cite: …” information and running footer in this article have been updated with the correct volume number (volume 1).

  • To cite: Vilar Gomez E, Sanchez Rodriguez Y, Torres Gonzalez A, et al. Viusid, a nutritional supplement, increases survival and reduces disease progression in HCV-related decompensated cirrhosis: a randomised and controlled trial. BMJ Open 2011;1:e000140. doi:10.1136/bmjopen-2011-000140

  • Funding This work was supported in part by a grant from Catalysis Laboratories, Spain.

  • Competing interests None.

  • Ethics approval Ethics approval was provided by the ethics committee and the institutional review board of the National Institute of Gastroenterology.

  • Contributions The authors were collectively responsible for the study design, data collection, statistical analysis and interpretation of data, the writing of the manuscript and the decision to submit the manuscript for publication. EVG was involved in the study concept and design, acquisition of data, analysis and interpretation of data, drafting of the manuscript, critical revision of the manuscript for important intellectual content and statistical analysis, and obtained funding. YSR was involved in the study concept and design, acquisition of data, analysis and interpretation of data, critical revision of the manuscript for important intellectual content and drafting of the manuscript. ATG was involved in the study concept and design, acquisition of data, analysis and interpretation of data, and drafting of the manuscript. LCB was involved in the study concept and design, acquisition of data, analysis and interpretation of data, drafting of the manuscript, and critical revision of the manuscript for important intellectual content. EAS was involved in the study concept and design, critical revision of the manuscript for important intellectual content and drafting of the manuscript. YMP was involved in the study concept and design, acquisition of data, analysis and interpretation of data, and drafting of the manuscript. AYG was involved in the study concept and design, acquisition of data, analysis and interpretation of data, drafting of the manuscript and critical revision of the manuscript for important intellectual content. MdRAV was involved in the study concept and design, acquisition of data, analysis and interpretation of data, drafting of the manuscript, critical revision of the manuscript for important intellectual content and statistical analysis. All authors approved the final draft submitted.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The permission to share data of this clinical trial was denied by the ethic committee of the National Institute of Gastroenterology.

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