Chronic illness impacts each and everyone of us either directly or indirectly. We all know a loved one that is suffering from some form of debilitating chronic illness. Our goal is to optimize the health of people suffering from chronic illness.

Chronic Fatigue Syndrome/Fibromyalgia (CFS/FMS)

Chronic Fatigue Syndrome is a common condition in Canada and North America, with an estimated 30,000 Canadians with CFS and 442,200 Canadians with Fibromyalgia. But, given the difficulty in diagnosis, and many who suffer without seeking treatment, this is probably an underestimate. The cause of CSF/FMS is unknown, but elements of these syndromes suggest a viral origin. Commonly implicated viruses are members of the herpes virus family, such as the Epstein-Barr Virus (EBV), but this virus is not consistently found in CFS patients. Thus, CFS/FMS may be the result of a chronic inflammatory reaction to various viral infections rather than due to a specific viral cause.

Some patients with CFS/FMS have evidence of a chronic viral infection as seen in their cytokine profile, such as increased endogenous interferon production, elevated levels of tumor necrosis factor (TNF-alpha) and O-A2’-5’ synthetase, and increased IL-4 and IL-15.

These elevated cytokine levels suggest the presence of an inflammatory response and its associated oxidative stress. As in the NRG HCV study, natural products (i.e. nutraceuticals) could be used to decrease the oxidative stress in these patients. Relief of oxidative stress may decrease FMS symptoms, even though there is no claim of an antiviral effect. At NRG we are committed to advancing nutraceutical-based theories and protocols.

Viral Hepatitis and Inflammation

Currently more than 670 million people globally suffer from chronic liver disease in the form of Hepatitis B or C. Worldwide, these viral hepatitis infections cause significant morbidity and mortality, as an estimated 170 million to 200 million suffer with chronic hepatitis C infection, and an estimated 360 million to 400 million carry the hepatitis B virus. These are two very distinct viruses have different mechanisms of replication and susceptibility to antiviral agents. Chronic hepatitis B infection can lead to cirrhosis or hepatocellular carcinoma, which is one of the most common causes of fatal cancer in the world. Chronic hepatitis C infection can also lead to cirrhosis, end-stage liver disease, and hepatocellular carcinoma (HCC). An estimated 600,000 – 700,000 people die each year from cirrhosis due to HCV infection, and an additional 500,000 that will die from HCC from HBV or HCV. In North America and Western Europe, hepatitis C is the most common cause of end-stage liver disease resulting in liver transplantation.

Before the Harvoni therapy was available, treatment for hepatitis C was pegylated interferon and ribavirin. However, interferon treatment did not cure Hepatitis C and 100% of patients with hepatitis C virus who underwent liver transplantation suffered re-infection of their transplanted liver, even when treated with pegylated interferon and ribavirin. Trials using mice with human livers (chimeric mice) showed that the NRG liver protocol could reverse fibrosis, even though the viral load was unaffected. Thus, the viral load appears to be a less significant factor than controlling inflammation in restoring patient health and liver function.

CFS/FMS and Liver Inflammation Clinical Trial Considerations:

The NRG studies on chimeric mice infected with hepatitis C and treated with anti-inflammatory neutraceuticals imply that HCV produces much of its damage by the immune system’s inflammatory response. Therefore, future NRG studies will focus on showing that NAFLD/NASH, Alcoholic Fibrosis/Cirrhosis, and CFS are likewise inflammation-based. Therefore, by inhibiting the inflammatory response we can slow or even stop disease progression at a cellular level. Intervention with anti-inflammatory neutraceuticals may return quality of life to those affected by these diseases.

If the pilot study for NASH and these other inflammatory conditions shows benefit, we intend to follow it by a double-blind, placebo-controlled study, with sufficient numbers to demonstrate statistical significance.

CFS Pilot Study

In the CFS Pilot Study, we will select 5 patients with classical symptoms of CFS and compare their objective and subjective markers before and after treatment. We will measure the cytokine levels of these patients as our objective indicators, and record their quality of life assessments as the subjective reflection of their disease/wellness state. The anti-inflammatory/anti-oxidant therapy will be administered, and measurements taken at baseline, and after 3 and 6 months of treatment.

CFS Clinical Trial

If the pilot study suggests that these patients would benefit from this treatment, then a placebo-controlled double-blind study would be designed. This study would include a minimum of 60 patients; 30 will receive the antioxidant/anti-inflammatory treatment and 30 will receive the placebo treatment. The study would include consultation and collaboration with the CFS Society of Alberta and Dr. Klein in Calgary. Patients entering the study must have elevated cytokines or evidence of immune activation. Cytokine assays will be performed at a reference laboratory such as Redpath. Nutraceutical Research Group conducts its clinical research under the direction of Dr. Lorne Tyrrell at the University of Alberta.

Non-Invasive Testing in Chronic Hepatitis Therapy Studies:

Liver fibrosis is the main predictor of the progression of chronic hepatitis C, and its assessment by liver biopsy (LB) can help determine therapy. However, biopsy is an invasive procedure with several limitations. A new, non-invasive medical device based on transient elastography has been designed to measure liver stiffness. The aim of this study was to investigate the use of liver stiffness measurement (LSM) in the evaluation of liver fibrosis in patients with chronic hepatitis C.

As an example of the testing methods used by NRG in its clinical studies, we have used elastography as the instrument for evaluating the progress of pilot study volunteers in the testing of the efficacy of its formulas developed to ameliorate various liver conditions. To that end, we note the study proving the equivalency of elastography in the measurement of liver fibrosis as compared to Liver biopsy.

In the study demonstrating LSM/LB equivalency, 327 patients with chronic hepatitis C underwent LB and LSM. METAVIR liver fibrosis stages were assessed on biopsy specimens by 2 pathologists, then these patients were evaluated with transient elastography. The assessments of fibrosis staging by LSM and LB were well correlated with a Kendall correlation coefficient: 0.55; P<.0001. Thus, for future testing, noninvasive assessment of liver stiffness with transient elastography appears to be a reliable tool to detect significant fibrosis or cirrhosis in patients with chronic hepatitis.