Called the "silent epidemic," hepatitis C can remain asymptomatic for decades before it progresses to chronic liver disease in infected individuals.  Surprisingly the medical community is not well educated about hepatitis C and many cases go undiagnosed and untreated.  This virus—discovered only in 1989—mutates frequently, creating many strains that can be virtually undetectable by current assays.  For this reason, experts believe that the prevalence of this disease may be much greater than statistics show.  More than 80 percent of those infected with hepatitis C will develop chronic liver disease.  The average estimated lifetime cost for one hepatitis C patient—in the absence of liver transplant—is approximately $100,000, and assuming 80 percent will develop the chronic forms of liver disease, the cost to society in both human and economic terms could be staggering in the coming years.  Worldwide, some two hundred million people are infected with hepatitis C.  Dr. Dan Wen, president of Honso, Inc., a daughter company of the Japanese firm Honso Pharmaceutical Corporation, Ltd., is actively advocating an alternative approach in the West to this global health issue.

Harmony:  You have said that roughly half of the individuals infected with hepatitis C in the United States—now estimated at five million—are not treatable with interferon therapy, the conventional medicine currently in use.

DW:  Interferon therapy does the job poorly . . . the majority of patients are either not responding to it very well or they are having severe side effects and complications.  Basically every person with liver disease is looking for some alternative medicine therapy, so I feel it's very important for us to introduce traditional Chinese medicine (TCM) treatment for chronic liver disease at this time. 

Harmony:  Has TCM treatment for liver disease been studied before?

DW:  I have been involved with a group in China that pioneered the treatment of hepatitis B with TCM in the early 80s.  At that time in China there were about three major research groups:  one in Shanghai, one in Beijing, and one in Wuhan, at Hubei Traditional Chinese Medicine University, where I was located.  My mentor, Professor Wang Bo-xiang, is a very famous integrative medicine doctor in the liver disease area.  At that time in the 80s, his group was already doing formal clinical studies using TCM formulas for hepatitis B patients. . . .  From my point of view, it's very important to know that in China, as early as the 70s and 80s, modern medical technology had been integrated together with TCM, particularly in the liver disease area.

Harmony:  Can you talk about alternative TCM treatment approaches to hepatitis C and chronic liver disease that you and your company are involved with?

DW:  I recently came back from a trip to Shanghai, where our company has established a cooperative relationship with Shanghai TCM University Liver Disease Institute.  They are very, very much further developed there—it's state of the art, basically.  They have a lot of research facilities.  In this collaboration, we will work with the Institute to bring one of their liver treatment formulas into the U.S. into a formal clinical study to treat hepatitis C patients, who tend to develop cirrhosis and fibrosis disease.  As you may know, when a patient is suffering from hepatitis C infection we first see inflammation, and when the disease goes on, fibrosis develops, and then it moves into the cirrhotic stage, and then finally the patient either progresses to liver cancer or dies from other complications.

This treatment that we are looking at seriously from Shanghai TCM University—the formula itself—specifically targets liver fibrosis, and that formula has been studied for twenty years.  Over the last two decades, generations and generations of this research group have accumulated from fifty to seventy research papers published in Chinese medical journals and some in English in the U.S.  Their data seems very strong.  The product is already approved in China as prescription Chinese herbal medicine.  So that's one thing we're very interested in. 

Harmony:  Are there any studies currently underway in the U.S.?

DW:  Our company has been involved with two clinical trials of the classical herbal formula xiao chai hu tang, or in Japanese, called sho-saiko-to.  One trial is in New York at Memorial Sloan-Kettering Cancer Center.  That trial is for treating hepatitis C patients who are not responding to interferon therapy.  Basically we are targeting a group of patients who are not treatable with conventional therapy.  This trial is a Phase II trial with an IND (investigative new drug) approved by the FDA.  IND-approved means this herbal formula went through the review process and is FDA approved for clinical human study using this herbal medicine.  This trial is halfway through and is already starting to report preliminary data . . . in the next year or two the trial will be finished.

Harmony:  And the other trial?

DW:  The second trial we are involved with is the treatment of liver cirrhosis caused by hepatitis C.  This is with the Liver Center at the University of California at San Diego (USCD).  In the liver disease path, during the fibrotic and cirrhotic stages, there are no conventional therapies available for patients.  So we would like to see if xiao chai hu tang has certain clinical effects for liver cirrhosis patients.  There have been several clinical studies in Japan demonstrating indeed that xiao chai hu tang is effective in treating hepatitis B and C patients who develop cirrhosis.  We would like to see if we can repeat that type of result in a more rigorous clinical design.  This UCSD trial was designed as a placebo-controlled, double-blind study, so that's a very rigorous study design.  That trial is just starting and we have already several patients enrolled.  This trial will also help us to further understand the efficacies of traditional Chinese medicine formulas. 

Harmony:  Do you have any information you can share about the economic burden of hepatitis C?

DW:  The number is tremendously high, including direct and indirect costs of health care on the society.  I will share those numbers when I present at the Building Bridges of Integration conference in October.  Just to give you an example, the treatment of interferon therapy for one year costs between $15,000 to $20,000 per patient.  You can easily imagine how affordable TCM treatment can be. 

Harmony:  How does the cost of TCM treatment actually compare to interferon therapy?

DW:  For example, the cost of xiao chai hu tang is only $60 per month.  That's what we're looking at.  So if a practitioner is integrating acupuncture together with herbal medicine treatment, you're looking at $150 or $200 maximum per month.

Harmony: In terms of acceptance of TCM treatment for chronic liver disease in the West, are you finding there's more of a tendency to listen now because of the cost benefit? 

DW:  I think the efficacy is the most important thing.  Some people are not insured, but the majority of patients that are seeking health care have a certain amount of insurance.  So while interferon therapy is costly, it's a cost covered by insurance.  On the other hand, acupuncture, particularly herbal treatment, is not covered by insurance, even though it is low in cost.  So I think acceptance by the society is mostly dependent on efficacy.  I think if we can provide more research data and provide efficacy support, then the acceptance of TCM treatment for chronic liver disease will be much more successful.

Dr. Dan (Jipu) Wen, M.D. (China), holds degrees in both Western and Chinese medicine and has an extensive background of more than twenty years in clinical and laboratory research in the area of integration of Chinese and Western medicines. 

Practitioners:  Dr. Wen will present basic and advanced treatment tools for hepatitis C and chronic liver disease at the 2006 Building Bridges Conference.  Learn the most recent results—and their treatment significance—from the clinical trials of TCM formulas for liver disease currently underway in the U.S. as well as advanced research developments in China and Japan.  Visit www.tcmconference.org for information and to register.