November 16, 2013

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PRESS RELEASE Edison, New Jersey, USA, November 4th, 2013

Tocomin SupraBioÒ Improves Liver Stiffness Measurement In Patients With Non-Alcoholic Fatty Liver Disease

November 4th, 2013 – New Jersey, USA –At the recently concluded Asian Pacific Association for the Study of the Liver (APASL), a research team of medical doctors from the Philippines, led by Dr. Marilyn Arguillas shows that supplementation with Tocomin SupraBio® patented and bio-enhanced full spectrum palm tocotrienol/tocopherol complex (manufactured by Carotech) at 100mg daily for 3 months significantly reduces liver stiffness in patients with non-alcoholic fatty liver disease (NAFLD).

Dr. Marilyn Arguillas used non-invasive Transient Elastography (FibroScan) to measure liver stiffness among NAFLD patients. Liver Stiffness Measurement (LSM) is routinely used to determine the hepatic fibrosis stage in NAFLD patients.

“The development of fibrosis marks the connection between fatty liver disease and end-stage liver disease,” Dr. Arguillas said in a newspaper interview.

The study involved 67 patients for three months. Patients were divided into two groups (treatment group and control group). Both groups were placed under Lifestyle Modification Advice Group (LMAG), which included nutritional counseling and advice on exercise. The Treatment group, however, was also placed on 100mg of mixed tocotrienol (containing Tocomin SupraBio®) daily for 3 months.

After 3 months, 57% of all patients (n=38) showed decrease in their liver stiffness measurement, but 43% (n=29) did not improve. 79% of those who improved were from the Treatment group and 21% from LMAG alone. Out of the 29 patients who did not improve, 23 patients or 79% are from LMAG alone and only 6 patients or 21% from Treatment group.

The study shows that lifestyle modification and exercise together with supplementation of tocotrienol (Tocomin SupraBio®) had a significant effect on the improvement of liver stiffness measure

NAFLD often coexists with metabolic syndrome especially type 2 diabetes and obesity. It is reported to be an independent risk factor for cardiovascular disease and affects approximately 30% of the population in Western countries. Recently, the University of Hong Kong reported that a staggering 40% of healthy Hong Kong population have non-alcoholic fatty liver disease, with majority of them not aware of the condition.

In an earlier animal study[1], Japanese researchers reported that simultaneous intake of tocotrienols with alpha-tocopherol synergistically inhibited lipid accumulation, inflammation and fibrosis in the liver, which further underscores the importance of tocotrienols and tocopherols in reducing the severity or risk of NAFLD.

“Human studies using Tocomin SupraBio® have previously shown that tocotrienols improve liver conditions in NAFLD and end stage liver disease and that alpha-tocopherol works in a synergistic manner with tocotrienols in exerting these liver protective effects. We are pleased to learn of this latest study from the Philippines, which further supports hepatoprotective benefits of Tocomin SupraBio®,” says WH Leong, Vice President of Carotech Inc.

“To date, there is no drug or therapeutic agent that could cure NAFLD. This study shows that supplementation of Tocomin SupraBio® at 100mg daily coupled with life style modification for 3 months have significant benefits in reducing liver stiffness, hence minimizing risk of progressing to NASH, as well as other NAFLD-related diseases including obesity, diabetes, and cardiovascular disease (metabolic syndrome),” added WH Leong.

Sources: “The Effect of Vitamin E (Mixed Tocotrienol) on the Liver Stiffness measurement Measured by Transient Elastography (FibroScan) among NAFLD Patients”, presented at APASL Liver Week, Singapore, June 7th, 2013.

About Carotech

Carotech, incorporated in 1990, is the first and largest producer of natural full spectrum tocotrienol/tocopherol complex (Tocomin® & Tocomin SupraBio®), natural mixed carotene complex (Caromin®), phytosterol complex (Stelessterol™), red palm oil concentrate (Spectra™) in the world via its patented technology.

Carotech is the only GMP-Certified tocotrienol producer in the world. Its laboratory is accredited with ISO/ISE 17025 accreditation.

Tocomin SupraBio® is a patented (US Patent No. 6,596,306) self emulsifying palm tocotrienol complex that ensures optimal tocotrienols oral absorption.

Carotech manufactures these products under the tradenames: Tocomin®, Tocomin SupraBio®, Caromin®, Stelessterol™ and Spectra™.

Carotech’s branded ingredients are 100% Non-GMO, Kosher and Halal certified.

Websites: www.carotech.net and www.tocotrienol.org

Contacts:

Mr. WH Leong, Vice President, Carotech, Australia Tel : +61 (03) 9801 3881 E-mail: info@caro-bf.com

Dr. Sharon Ling, Carotech, Europe Tel : +44 (0) 1296 623 214 Email : sling@caro-bf.com

Mr. Bryan See, Carotech Inc, USA Tel : +1 (732) 906 1901 Email: klsee@caro-bf.com


[1] Yachi R, et al., 2013. Effects of tocotrienol on tumor necrosis factor-alpha/D-galactosamine-induced steatohepatitis in rats. J. Clin. Biochem. Nutr., 52(2), pp. 146-153.

Source Carotech INC.

Also See: The Effect of Vitamin E (Mixed Tocotrienol) on the Liver Stiffness Measurement Measured by Transient Elastography (FibroScan) among NAFLD Patients

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Abstract

Speaker: Eduward E.J. Thendiono

Author: Eduward Jansen Thendiono, Marylin Arguillas

Affiliation: Internal Medicine, Davao Doctors Hospital, Davao City, Philippines

Session: Distinguished Posters - NAFLD

Date: Friday - June 07, 2013 13:30-14:00

Location: Exhibition Hall

Subtopic: Clinical

Topic: NAFLD

Introduction: Vitamin E has been shown to slow down progression or cause regression of fibrosis stage among NAFLD patients. Transient Elastography (FibroScan) is a non-invasive tool that has been used to determine the stage of fibrosis among NAFLD patients and may be used for treatment monitoring.

Methods: NAFLD patients diagnosed by ultrasound who met the inclusion criteria were enrolled in the study. Liver Stiffness Measurement (LSM) was measured by FibroScan at base line and at the end of 3 months. A change in the LSM was the primary objective. Chi Square analysis was used to measure the change of LSM pre and post treatment. P value less than 0.05 was considered significant.

Patients were assigned to either the Life style Modification Advice Group (LMAG)—with nutritional counseling and advise to exercise—or the Treatment Group (Vitamin E as Mixed Tocotrienol 100 mg daily for 3 months plus lifestyle modification advise).

Result: Fifty-seven percent (38/67) of patients enrolled in both arms of the study improved --with decrease in their LSM measurements -- but 43% (29 of 67) did not.

Of those who improved 79% (30 / 38) were from the Treatment Group (Vitamin E) and 21% (8 / 38) were from the LMAG.

Twenty -nine (29) patients did not improve: 79% (23/29) from LMAG and only 6/29 (21%) from the Treatment Group. Chi-square analysis showed that treatment with Vitamin E had a significant effect (p= < 0.05) on improvement of LSM.

Conclusion: Vitamin E (mixed Tocotrienol) 100 mg daily for 3 months could decrease the LSM among NAFLD patients.

Source

Journal of Gastroenterology and Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

Clinical Hepatology

Álvaro Mena*, José D Pedreira, Ángeles Castro, Soledad López, Pilar Vázquez,  Eva Poveda

DOI: 10.1111/jgh.12432

This article is protected by copyright. All rights reserved.

This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/jgh.12432

Publication History
Accepted manuscript online: 13 NOV 2013 05:42AM EST
Manuscript Accepted: 16 SEP 2013

Keywords: HBV;  inactive carriers;  metabolic syndrome; fibrosis;  FibroScan

Abstract\

Background and Aim

There are few data of fibrosis development in chronic hepatitis B (CHB) patients classified as inactive carriers. The aim of this study is to determinate the prevalence of significant fibrosis and probable cirrhosis measured by FibroScan in real inactive CHB carriers and investigate the relationship with virological, epidemiological and metabolic factors.

Methods

Cross-sectional cohort study including CHB inactive carriers. Liver stiffness measurement was performed with transient elastography (FibroScan). Significant fibrosis (≥F2) was defined as stiffness >7.5 kPa, and probable cirrhosis as >11.8 kPa. Factors associated with significant fibrosis were explored with univariate and multivariate adjusted logistic regression analyses.

Results

96 CHB inactive carriers were analyzed. Of them, 24 (25%) had significant fibrosis and 7 (7%) probable cirrhosis; mean stiffness was 6.2±2.3 kPa.

Of them, 24% had metabolic syndrome, with higher FibroScan value than those without (8.4 kPa vs 5.5 kPa, p<0.001).

Factors associated with significant fibrosis were (odds ratio, 95% confidence interval, p value): central obesity (7.1, 1.8-27.9, 0.005), elevated fasting glucose (4.3, 1.3-27.9, 0.036), reduced HDL-cholesterol (5.2, 1.2-23.6, 0.032) and elevated triglycerides (6.2, 1.4-28.3, 0.019). Factors as age, sex, transaminases, HBV-DNA or genotype were not related with liver fibrosis.

The presence of metabolic syndrome has a 69% of positive predictive value and 89% of negative predictive value for significant fibrosis.

Conclusion

Different components of metabolic syndrome are associated with fibrosis development in CHB inactive carriers. In the absence of metabolic syndrome, significant fibrosis is uncommon in this population.

Source

Hepatology International

November 2013

Mamun Al-Mahtab, Sheikh Mohammad Fazle Akbar, Julio Cesar Aguilar, Md. Helal Uddin, Md. Sakirul Islam Khan, Salimur Rahman

Citations

Abstract

Purpose

The safety and clinical efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (HBsAg/HBcAg) were evaluated in patients with chronic hepatitis B (CHB).

Methods

Eighteen patients with CHB were administered a vaccine containing 100 μg of HBsAg and 100 μg of HBcAg. The vaccine was administered ten times at 2-weekly intervals, the first five times via the nasal route only and the subsequent five times via both nasal and subcutaneous routes. The safety and efficacy of this therapeutic approach were assessed by periodic assessment of the patients’ general condition, viral kinetics, and biochemical parameters during treatment and 24 and 48 weeks after therapy. The production of cytokines by peripheral blood mononuclear cells (PBMC) and antigen-pulsed dendritic cells (DC) was evaluated to assess the immunomodulatory effects of the HBsAg/HBcAg vaccine in CHB patients.

Results

The HBsAg/HBcAg vaccine was safe in all patients. No flare of HBV DNA or alanine aminotransferase (ALT) was recorded in any patient. Sustained HBV DNA negativity and persistently normalized ALT were detected in 9 (50 %) and 18 (100 %) patients with CHB, respectively. PBMC and HBsAg/HBcAg-pulsed DCs from HBsAg/HBcAg-vaccinated CHB patients produced significantly higher levels of various cytokines [interleukin 1β (IL-1β), IL-6, IL-8, IL-12, and tumor necrosis factor α (TNF-α)] than those from control unvaccinated CHB patients (p < 0.05) after stimulation with HBsAg/HBcAg in vitro.

Conclusion

HBsAg/HBcAg vaccine seems a safe and efficient therapeutic approach for patients with CHB.

Mamun Al-Mahtab and Sheikh Mohammad Fazle Akbar contributed equally to this study

Source

Journal of Viral Hepatitis

Early View (Online Version of Record published before inclusion in an issue)

Original Article

A. Striki1, S. Manolakopoulos1,*, M. Deutsch1, M. Mela2, M. Kalafateli3, M. Schini1, O. Anagnostou1, C. Triantos3, I. Andreadis1, I. Ketikoglou4, G. Papatheodoridis1, D. Pectasides1

Article first published online: 13 NOV 2013

DOI: 10.1111/jvh.12197

© 2013 John Wiley & Sons Ltd

Abstract

Keywords: chronic hepatitis C;  cirrhosis;  infection's hazard;  leucopenia;  neutropenia;  pegylated interferon-a

Summary

Peginterferon-alpha (PegIFNa) frequently causes neutropenia, mainly due to bone marrow suppression. The aim of this study was to explore factors that are associated with infections during antiviral treatment. We analysed data from 275 chronic hepatitis C (CHC) patients with compensated liver disease who underwent 318 courses of PegIFNa and ribavirin. Neutropenia was defined as neutrophils <1000 cells/μL. Mean leucocytes count significantly decreased from baseline to treatment nadir (7081 ± 2182 vs 3293 ± 1331 cells/μL,P < 0.001), while neutropenia was observed in 32% during treatment. Thirty-one infections were observed. The incidence rate for infection was assessed at 1.46 infections per 100 person-months of therapy. The hazard rate for infection did not correlate with the neutrophils' nadir or the decrease in white blood cells. In multivariate Cox's regression analysis, cirrhosis was the only factor that was significantly associated with the occurrence of infection. Our data show that the development of bacterial infections during treatment with PegIFNa and ribavirin in patients with compensated CHC is not associated with reduction or the nadir of white cells or neutrophil counts. Baseline cirrhosis is the only factor related with infection during treatment. The common practice of dose adjustment or discontinuation of interferon should be revised; careful assessment of liver damage before therapy and close monitoring during therapy are essential in all patients receiving interferon-based regimes, to minimize the detrimental consequences of infections.

Source