Hepatitis C and the Hepatitis C Virus

Paul Reller, L.Ac.

Hepatitis C virus (HCV) has become a major worldwide health problem, causing both an acute and chronic liver inflammatory disease that varies widely in its severity and presentation. In 2005, the World Health Organization (WHO) estimated that 2% or more of the world population was infected with HCV, and determined that HCV was the most common chronic bloodborne infection in the United States. These disease prevalence statistics, though, are considered to potentially underestimating the number of persons infected with this virus by a large number. This is because the studies that we must rely on are conducted on select populations that are not representative of the whole population. For example, U.S. studies have relied upon blood testing of blood donors and patients with a diagnosed liver disease. In countries where larger and broader population studies have been conducted, for example in China, Egypt and Pakistan, the incidence rates have been reported as ranging from 3.2% to 6.5%. The fact that HCV is a consistent pathogenic virus across the entire world shows that it is not a viral illness that is spread in a simple manner. Hepatitis C virus, unlike the other prevalent causes of hepatitis, or liver inflammation, is both persistent and often asymptomatic and undiagnosed.

Currently, the CDC estimates that 3.2 million persons in the U.S. have the chronic form of Hepatitis C virus, with a vast majority unaware of their infection. The CDC estimates that each year, about 17,000 Americans become acutely infected. Acute infection usually does not produce significant symptoms, and when they occur, mild symptoms may appear anytime from 2 weeks to 6 months after exposure. Symptoms of the chronic HCV can take up to 30 years to develop, with slowly progressing liver disease resulting. Both acute and chronic HCV may produce symptoms of low-grade fever, fatique, loss of appetite, nausea, abdominal discomfort, joint pain, dark urine, grey-colored stools, and jaundice. Risks for chronic HCV include liver dysfunction, cirrhosis and cancer. There are many things that a person can do to decrease risks, improve immune function, improve liver health, and even inhibit the progression of HCV in the body. There is evidence that many herbal chemicals may help the body to clear viral infection as well, both acutely and with chronic infection. Complementary Medicine may be integrated with standard care intelligently to achieve these goals, and the Licensed Acupuncturist and herbalist is ideal to utilize in this regard. While acupuncture alone will not quickly cure the hepatitis, or remove HCV from the body, it will act as an important aid in achieving the goals of improving liver function, immune health, inflammatory modulation, and overall health within a comprehensive protocol that uses evidence-based herbal and nutrient medicine to achieve these various goals.

Hepatitis C viral infection is naturally cleared in approximately 40 percent of cases of acute infection. Complementary Medicine works by promoting the natural immune responses that achieve such clearance. In addition, acupuncture, herbal and nutrient medicine, and a healthier diet and lifestyle may alleviate the adverse health problems associated with Hepatitis C virus (HCV) and the resulting liver fibrosis and other health problems. Since most cases of Hepatitis C are slow to progress, the patient often has the time to gain an understanding of this disease process and how a conservative treatment protocol can help the body to clear the disease and repair the damage.

Understanding Hepatitis and Hepatitis C viral infection is the most important step in prevention and treatment of HCV

Hepatitis C virus was first discovered in 1989, and was termed a non A or B hepatitis for many years. The estimated incidence of HCV in the United States relies on a poor pool of data, but the Centers for Diseases Control and Prevention (CDC) has estimated that the incidence of this viral disease increased steadily from 1965 to 1989 from less than a half of one percent to nearly two percent of the population, may have dropped in incidence in the 1990s, but is expected to rise in incidence in the upcoming decades. Because the studies of prevalence have relied on hospital and clinic reporting that targets specific subsets of the population, the disease has been associated with blood transfusions from unscreened donors, injection drug use, unsafe therapeutic injections and blood sampling, and other health care procedures, but because the prevalence is similar in undeveloped countries where these means of transmission could not account for the prevalence of HCV, it is widely assumed that we still do not understand the actual possibilities of transmission. In China, it has been found that a substantial number of those affected acquired the infection at birth from a mother that often did not know that she was infected. As many patients diagnosed with HCV will testify, their disease was not acquired via injection drug use or blood transfusion. The array of causes of infection cannot be oversimplified. Of course, transmission of HCV via blood transfusion is a problem, with the WHO estimating in 2005 that 43% of donated blood in the developed world was not adequately screened for HCV. In the U.S. blood donor screening has improved remarkably, and is now purported to be very reliable. Sexual transmission was considered the potential cause of the many inexplicable cases, but numerous studies showed that sexual transmission of HCV is far less efficient than that of other sexually transmitted viruses, and no reliable study has proven that sexual habits or even sex with an infected person substantially increases the risk of HCV infection. The conclusions by experts in recent years has been that the epidemiology of HCV infection in the developing world has not been well-characterised (Colin W Shepard, CDC, Lancet Infectious Diseases 2005;5:558-67).

For persons infected with HCV, or for those who want to reduce risks of acquiring an HCV infection, the situation is not simply and clearly defined. Of course, preventing blood-borne infection is important, not sharing injection equipment if you are a drug user, informing the drug using population of risks and providing health services to reduce this population spread, such as needle exchange programs, which help the entire population by decreasing HCV incidence, and being cautious about tattoo and body piercing are recommended to decrease risk of infection. Other blood-borne risks may include questionable clinics that provide botox injections or other cosmetic surgerical procedures, and questionable clinics that take blood samples for testing. Sharing of personal items that may have come into contact with blood, such as razors, nail clippers, toothbrushes, or glucose monitors may also be avoided. But these precautions alone may not be sufficient to guarantee that you will never acquire HCV. We are still not certain that a number of routes of transmission are possible or even avoidable. Vaccination is not an option either, as the pharmaceutical research, despite much effort, has failed to find a vaccine. Supporting healthy immune and liver systems may be the most important way that an individual can prevent chronic hepatitis C infections and complications.

Diagnosis of Hepatitis C infection and Hepatitis disease

To diagnose, a request has to be made for specific blood tests. Typically, HCV antibodies are tested first, and then a viral load test can be obtained. Antibodies are either natural (innate) antibodies, or are acquired in response to specific infectious antigens, especially antigens on viruses. Antibodies are also known as protein immunoglobulins (Ig), and are produced by a type of white blood cell (WBC) called a plasma cell, either attached to a B cell, or secreted from inside the B cell. The B cell class of white blood cells are thought to be part of the innate, or memory, immune system, but do work closely with the more acquired T cell class of immune cells, which are part of the immune complement system. The T-helper cells are often needed to fully activate the B cell responses, and a person with an immunodeficiency syndrome may not have the T-helper cell response needed to stimulate a substantial B cell antibody response. When infected with the Hepatitis C virus (HCV), the individual would normally form antibodies specific to this viral antigen, allowing a complicated immune response to occur. Antibodies to HCV may exist in the body when no active disease is present, may indicate a threatening viral disease in the present, or past existence of HCV in the body that is not threatening.

Understanding the viral physiology helps the patient to understand the nuances of testing and diagnosis. The Hepatitis C virus (HCV) is a relatively small and simple virus, composed of a enveloped single-strand of RNA, and belongs to the Flaviviridae family of viruses, which includes West Nile, Dengue Fever, Yellow Fever, and other vector borne types that are often spread by mosquitoes and ticks. The envelope around the DNA consists of a glycoprotein and fatty component. The RNA consists of 9600 nucleotides that becomes part of the host cell genetics, producing a single protein that may be processed into multiple smaller proteins. The main cells of the liver (hepatocytes) are believed to be the main host of this HCV virus, but HCV may also become part of blood cells in circulation, called lymphocytes, monocytes and macrophages, so that other immune reactions in the body may contribute to expression of the HCV pathological protein. HCV has a wide variety of genotypes and mutates rapidly, producing so many variants that the HCV is considered a type of species of virus, or a quasispecies. Both the relative simplicity of the virus, the family of the virus, and the ability to mutate rapidly, make this particular type or viral quasispecies difficult for the immune system to identify and eradicate. As with all viruses, the clearing of the virus involves attacking the host cells. This involves a complicated array of complement immune cells and processes. The healthier and less stress the complement immune system is, the better chance that the body will be able to either control or eradicate the virus.

Finding antibodies to the HCV is important but does not reveal the extent of the virus in the body or the level of threat and disease. The antibodies could protect the individual from the virus, and experimental vaccines are being developed that may one day stimulate production of these antibodies. It is believed that up to 40% of patients with positive antibodies have naturally cleared the HCV from their bodies with the strength of the immune system alone. Making sure that the antibody testing is performed with the latest type of ELISA test is very important to insure accuracy. If the antibody test is positive, to better assess whether you actually have a Hepatitis C viral pathology, you need further testing for assessment of viral load, which is called RNA analysis, and usually involves polymerase chain reaction tests (PCR).

RNA analysis, usually achieved with polymerase chain reaction (PCR), is more expensive than simple antibody testing, and more complex, revealing a number of genetic differences between common HCV genotypes and subtypes. Different areas of the world are tested differently to find the most common subtypes of the HCV that are typical for that specific population. Different genotypes of HCV have been found to respond differently to various pharmaceuticals. Genotypes 1 and 4 are less responsive to interferon-based treatment. In North America, genotype 1a predominates, but 2a, 2b and 3a are also common. RNA testing would produce what is called the viral load, or an indicator of how many cells may be hosting HCV in the body. The viral load is the measure of the severity of infection, and is measured as an estimate of the number of virally infected host cells in a selected sample of body fluid. Typically, the viral load indicates the number of replicated DNA in a milliliter of blood plasma. The viral load is tested with various nucleic acid amplification processes (NATs), or a non-nucleic acid test. The NATs that is typically used is the polymerase chain reaction (PCR), where an enzyme is used to stimulate replication of the DNA in samples. Reverse PCR and Nucleic Acid Sequence Amplification (NASBA) are also used in some labs. A less expensive non-nucleic acid test called the EXAViRTM LOAD is a largely manual test now approved in Europe for clinical use in viral load monitoring, so that more frequent monitoring may be affordable. A viral load of greater than 100,000 within 6 months of developing antibodies (seroconversion) is considered a higher risk of developing liver disease or immune deficiency. For many patients with a chronic HCV infection that is asymptomatic, the viral load may be higher than this and still non-threatening.

A viral load in chronic Hepatitis C infection is considered high if it is over 800,000 IU/mL. Anything under 800,000 is considered low, which means that it would typically respond to therapy better. HCV viral load does not tell the patient how fast their hepatitis is progressing, though, and we are measuring the viral load in circulating blood, not the liver itself. The viral load does not necessarily predict the natural course of the disease, either. Viral load is just one piece of information by which the patient and their treating physicians base the individualized treatment strategy. If the viral load is under 800,000 and the there are no symptoms, or mild symptoms, a number of more benign strategies with Complementary Medicine may be tried before resorting to more harsh pharmaceutical protocol. Standard therapy still relies mainly on the use of synthetic interferon, which is a chemical produced naturally by the immune system, and which can be stimulated with herbal medicine. Viral load can be retested to judge the effectiveness of any treatment strategy. A drop in viral load is judged by its logarithmic change, meaning that if it drops to half with therapy, this is not very significant, but if it drops to a tenth, this is a very significant change. In other words, if the viral load is 500,000 and drops to 5000 with treatment, this is very significant. The sustained significant drop in viral load is the most important factor, though, and monitoring this level 6 months and a year after treatment is very important. Less expensive testing in the clinic has been developed and approved in Europe to make this more affordable.

The RNA testing can be quantitative or qualitative. In the U.S. the medical doctors usually obtain a quantitative analysis, since this is considered more useful to assess the degree of viral threat. The quantitative RNA analysis is not as sensitive as the qualitative analysis, though, and the qualitative test gives more distinct information by which to assess the individual. A negative sensitive qualitative RNA test in a person with a positive antibody result indicates to many experts that the HCV infection has resolved. Other experts may believe that this test, a negative qualitative RNA test after a positive HCV antibody test, would indicate that the antibody test was falsely positive, or that the RNA test was falsely negative, or that the individual has an intermittent viral activity or a low-level viral illness. These judgements are important, as they determine the need for the therapy. To be more cautious before starting therapy, some patients will get a second opinion from a medical doctor not affiliated with the first doctor. As we see, both the testing and assessment may be variable from one medical doctor to another. We also see that there is some possibility of false positive and false negative test results. The newer ELISA antibody tests have shown a sensitivity of 97%, though, meaning that only 3% of patients with antibodies will still show a negative result. The antibodies are often undetectable in patients in the first 15 weeks after infection, though, and the 97% detection reliability applies to patients with HCV infection for greater than 6 months. This is important to understand.

In some patients, a liver biopsy is recommended. This is a tissue sample from the liver useful to accurately assess the viral damage, and is a testing procedure that is being debated still. Initially, the biopsy was considered a sound way to guide therapy, but as the therapy has gained greater acceptance, many medical doctors now have the opinion that the biopsy is not important, has some risks, and should be skipped in assessment of treatment strategy in cases of chronic active HCV. Many other experts and clinical practitioners still think that the biopsy is essential in chronic HCV, considering that the treatment is unsuccessful about half the time, partially successful in a great percentage of patients, and the side effects of treatment are harsh. The liver biopsy gives the patient the objective information to assess the stage of liver fibrosis and degree of liver inflammatory damage. This data is helpful for the patient trying to make difficult decisions with the therapeutic protocol. While standard medicine still counsels that the only therapeutic protocol is the interferon and protease inhibition, the smart patient learns that a wide variety of treatment protocols may be integrated from Complementary Medicine, and the extent of liver damage is important when deciding whether to try more conservative treatment with less risk of side effects and adverse health effects.

Prognosis in HCV infection and Hepatitis

About 85% of patients diagnosed with acute HCV infection eventually progress to chronic infection, but the outcome, or prognosis, is highly variable in these chronic cases. Since the acute infection is usually not dramatic, it is believed that most acute cases are not diagnosed. About 15 to 20% of patients diagnosed with chronic HCV infection will eventually develop liver fibrosis and cirrhosis, and a small percentage will eventually develop liver cancer. The various causes of cancer make it impossible to attribute the liver cancer entirely to the HCV in each case, but it is a risk factor of importance. While liver, or hepatocellular, cancer is relatively rare in the United States, it is the fifth most common tumor type and the third most common cause of death from cancer worldwide. Besides cancer and cirrhosis, a variety of other disease associations with HCV are more difficult to assess. The National Institutes of Health Clinical Center states: “The diverse clinical syndromes associated with hepatitis C underscore the multifactorial and polygenic nature of HCV infection. Both viral and host factors likely contribute to variations in infection outcome, disease susceptibility and progression, and treatment response.” While genetic variations are more highly touted in standard medicine as probable explanations of why one person will progress to a serious negative outcome and another will easily clear the virus, we see that a variety of factors make this disease difficult to predict or treat allopathically. As always, multifactorial and complex diseases demand a holistic approach to treatment, addressing an array of factors, both in the host and with variations in the virus itself. One may not be able to change their genetic makeup, or even avoid the virus completely, but the other host factors can be affected. Diet, lifestyle and health maintenance with Complementary Medicine can alter these host factors and provide improved prevention and immune response.

While there are many studies of HCV and hepatitis, there are few actual long-term outcome studies to clearly define this highly variable disease. A large group of Irish women were infected with HCV genotype 1b via contaminated anti-D immunoglobulin in 1977, though, and have been studied for many years. These women were diagnosed in 1994 and it was found that 87 tested positive with RNA viral load, while 68 tested negative. The most common symptoms reported were fatigue and arthralgia, and 77% of the women with chronic Hepatitis C experienced psychological distress. Liver fibrosis was observed in a substantial percentage of these women, but cirrhosis and liver cancer were not observed five years after the 1994 diagnosis. Women tested positive with RNA/PCR testing showed a high rate of associated disorders, though, with 12.7% experiencing mixed cryoglobulinemia, 7.6% with sicca complex (Sjogren's syndrome), 13.9% with positive thyroid autoantibodies, 5.1% with antinuclear antibodies, 3.8% with rheumatoid factor, and 3.8% with antimitochondrial antibodies. Women with signs of jaundice in the acute infection, and with the genetic allele of HLA DRB1-01 had a much greater clearance of the virus and lack of a chronic disease. The most common outcomes 22 years after infection were not liver cirrhosis and cancer, but a more benign course of disease, with fatigue and joint pain, and a higher incidence of autoimmune disorders, were seen (S. Barrett et al; Center for Liver Diseases, Mater Miscricordiac Hosp. Dublin, Ireland; Gut 2001;49:423-430). This study implies that perhaps we are ignoring the incidence of HCV in the larger population as health authorities continue to focus on subsets of patients that are injection drug users, have a diagnosed liver disease, etc. Many patients complain of chronic fatigue, joint pain and psychological distress, and an increasing incidence of autoimmune disorders, especially among women after the age of 40, is seen today, and rarely will these patients be tested for HCV.

In this cohort Irish study, the incidence of liver fibrosis and high ALT was significantly lower in RNA/PCR negative women than in those that tested positive with a chronic infection. Liver biopsies showed that RNA/PCR negative women had no detectable HCV RNA in the liver cells, while all of the women with a positive test showed HCV RNA in liver cells detected via biopsy. This study is relied upon for many of the disease statistics we see today. The main features of the disease were a greater than 40 percent natural viral clearance, the benign manifestation of disease long-term in most patients, the relative high association with autoimmune disorders, and the positive outcomes when the viral load was reduced. While many patients that are asymptomatic with positive antibody and viral loads are reluctant to go through a harsh pharmaceutical treatment regimen, reduction of viral load and improvement in liver and immune health with Complementary Medicine provides another avenue for better long-term outcomes without harsh side effects and risks. Since the success rate of standard therapy is relatively low, integrating Complementary Medicine with standard protocol also provides the infected patient with a better chance of long-term successful outcome when integrated with standard therapy.

The Goals of Therapy in Hepatitis C infection and liver damage, and how Complementary Medicine may help achieve these goals

The treatment goals in standard medicine include prevention of complications of HCV infection and eradication of the HCV. This is assessed by the sustained virologic response (SVR), defined as the abscence of detectable HCV RNA in serum at the end of treatment and 6 months later. The success rate of the SVR, with standard pharmaceutical therapy alone, during or just at the end of treatment is much higher than the SVR at 6 months after treatment. This is considered a “relapse”, but may represent a near eradication of the HCV in circulating blood during treatment, but not in the liver cells. A large percentage of patients undergoing interferon plus protease inhibitor therapy are considered partial responders, meaning that the HCV RNA levels decline with therapy but never become undetectable in blood serum. The patients with liver damage, such as fibrosis or cirrhosis, or even cancer, may have the goal of also reversing liver damage. The pharmaceutical therapy would only indirectly achieve these goals. Other goals of therapy would pertain to those patients that had associated complications, such as other viral illnesses, immunodeficiency, or autoimmune disorders associated with the HCV. The goals of the patient in these cases would be to resolve these associated health problems. Once again, the standard therapy would only indirectly help in this regard. Obviously, the patient that wants to throughly treat both the viral load and the liver damage and associated health problems would utilize a more comprehensive protocol to achieve these goals.

This is where Complementary Medicine integrates well with standard therapy to achieve an array of treatment goals, not just the reduction, perhaps temporary or partial, of the viral load. In addition, the treatment goals may be to go through standard therapy with fewer side effects and adverse health effects. Here too, the smart patient can easily see that utilization of Complementary Medicine would be very helpful. While standard medicine would portray these treatment decisions as binary, meaning do they work or not, or do you choose standard pharmaceutical treatment of the “alternative medicine”, often portrayed as unsubstantiated, unproven, and even quackery, the smart patient is beginning to get the clear picture that the decision to utilize Complementary Medicine is not a binary decision, but just a decision to increase the chances of success, decrease the side effects, and achieve more goals in therapy.

Experts agree that activation of innate immunity has been proven to play an important role in antiviral and antitumor defenses, as well as antifibrogenesis, in chronic liver injury from hepatitis C. The role of natural killer cells (NK) and interferon-gamma in this innate immune response is shown to be very important for patients that naturally clear HCV. Research has shown that in advanced liver disease these innate immune defenses are suppressed, and that this may be due to increased production of TGF-beta (transforming growth factor) in liver stellate cells during this advanced stage of liver injury and functional illness. As research progresses in understanding of the physiological mechanisms of liver damage in HCV infection, more and more proof of the effectiveness of natural medicines to promote this innate immune responsiveness is uncovered. Along with, or instead of, synthesized interferon gamma, a number of novel herbal and nutrient chemicals are being found that will help activate the natural innate immune defenses of NK cells and interferon-gamma, without significant side effects. Nutrient and herbal chemicals that may help regulate TGF-beta are also being discovered. Formulas of these chemicals may be devised in Complementary Medicine and promote a better innate immune response to reverse liver damage and clear viral load.

The most common reason why Complementary Medicine is gaining popularity in the treatment of Hepatitis C, despite the negative propaganda disseminated in standard medicine for no apparent reason other than economic, since this treatment is well studied, relatively inexpensive, and without harm, is that many patients have now heard stories of the adverse effects of standard therapy. The main therapeutic tool, synthesized alpha interferon, has a well documented history of serious side effects and long-term adverse effects. To minimize these alarming side effects, standard medicine has combined this therapy with other drugs, mainly protease inhibitors, to reduce effective dosage. Still, a large majority of patients experience alarming side effects during the course of treatment (see a link to a UK review below). Interferon is a chemical immunomodulator in the complement system of our bodies, and various forms have been utilized in medicine for some time. Purified natural leukocyte, recombinant interferons, and lymphoblastoid interferons can be used. The systemic adverse effects of synthesized alpha interferon are still poorly understood, but do exert significant imbalance of a neurohormonal immune system. We now know that immune modulating chemicals, or cytokines, do trigger both neurochemical and hormonal receptors, and that a cross-effect occurs when the body experiences a loss of balance in this complex regulatory system. Complementary Medicine may work to enhance and stimulate the natural interferon response, maintaining a neuroimmunohormonal homeostasis during treatment.

The high rate of serious adverse effects of standard therapy, though, is another reason why standard medicine should integrate with Complementary Medicine, as medicine is increasingly doing with cancer therapies that produce harsh side effects and adverse outcomes. A 2007 study in Poland (cited below) found that with standard treatment of interferon alpha and ribavirin, that approximately 90% of patients suffer from at least one adverse effect, with 15% requiring reduction in dosage, and 5% being discontinued from treatment by their treating doctors. The most alarming of the adverse effects include neuropsychiatric, hemotological (anemias), and endocrinological (mainly thyroid diseases). Interferon-induced thyroid disease was divided into two groups, autoimmune (Hashimoto’s, Graves, subclinical), and non-autoimmune (hypothyroidism and toxic). The most common thyroid disorder induced was found to be the subclinical autoimmune thyroid dysfunction, which is often not diagnosed due to abscence of symptoms and normal levels of active thyroid hormones in circulation. These experts suggested that a new classification of interferon-induced thyroid disease be established with guidelines to evaluate patients more thoroughly. Complementary Medicine has made great strides in treating thyroid disorders with a holistic approach in recent years, and integration of Complementary Medicine could potentially reduce these adverse outcomes considerably.

In recent years, there has been some progress in predicting who will fail standard pharmaceutical therapy for HCV. In 2010, Dr. Zoltan Kutalik, from the University of Lausanne, Switzerland, reported that his research found that individuals with a variation in a gene encoding for interferon lambda react less well to treatment. The University conducted a large study to try to detect genetic variations that would predict the 50 percent failure rate for standard therapy. Individuals with a specific allele in the gene encoding interferon lambda were much more likely to either naturally clear HCV or respond to standard interferon alpha therapy. Dr. Kutalik stated that this finding could spare many patients from the unnecessary harsh side effects of standard therapy by predicting treatment failure in screening. Such patients could be more focused on treatments in Complementary Medicine to try to alleviate health problems and clear the virus.

Evidence-based Complementary Medicine in the treatment of HCV and liver inflammation, or Hepatitis

Many herbs have been shown to inhibit viral replication or to enhance the body's own antiviral immune mechanisms, and they have been effective for thousands of years. You don't have to wait for the industry to create expensive pharmaceuticals to achieve success against viral illnesses. The science is there for the modern herbalist to achieve success today with safe and effective herbal therapy, enhanced by the immunostimulating effects of acupuncture. This type of therapy needs to be comprehensive, holistic, and address the whole immune system as well as specific responses. The advantage in Complementary Medicine, especially TCM (Traditional Chinese Medicine), as practiced by a competent Licensed Acupuncturist, is that the treatment protocol can be diverse and comprehensive in strategy and effects. Of course, this diversity in the herbal formulas and treatments does not lend itself to standard scientific testing in clinical trials, where the protocol needs to be simple and specific to assess efficacy and safety. This is the main reason why we have so little evidence-based study with human randomized placebo-controlled (RCT) clincial trials of high quality. This type of scientific study does not represent the actual clinical treatment. It was designed to test simple pharmaceutical treatment, not a comprehensive treatment protocol like we see in TCM, or Complementary Medicine.

Besides these human randomized clinical trials of specific aspects of the TCM therapeutic clinical protocol, though, there are literally thousands of published studies of the effects of herbs, acupuncture and nutritional medicines in the laboratory. These studies show the actual effects of the herbal and nutrient chemicals, and the effects of acupuncture, both locally and centrally. Both the randomized clinical human trials and this vast array of in vivo and in vitro laboratory study are utilized today by TCM physicians, and combined with the centuries of clinical study and the current clinical experience of the TCM physician, to provide the proper treatment protocols for the individual. Is this treatment as simple as taking a couple of pills? No. But is it effective in many diverse ways? Yes.

So far, in the United States, only a couple of herbs, and one simple and common herbal formula have gone to human clinical trials. The formula, Xiao Chai hu Tang, showed promise in a study at the reknowned Memorial Sloan-Kettering Cancer Center in New York. Improvement in elevated liver enzymes AST and ALT were observed in 67 and 75% of the patients and viral load reductions reduced significantly in 7 of 24 patients. Among the patients that received liver biopsies, 21% showed significant improvement of 2 points or greater on the histology activity index (HAI), meeting the pre-defined criteria for response to the therapy. While Xiao Chai hu Tang is a formula often used for common liver dysfunction, it is not a primary cure for serious liver inflammatory disease, but was researched in China as an adjunct in treatment of hepatitis. In this regard it does prove effective in a high quality human clinical trial performed by one of the most respected medical institutions in the United States (Deng G et al; J Ethnopharmacol. 2011 Jun 14;136(1):83-7).

Another more appropriate classic Chinese herbal formula, San Huang Xie Xin Tang, composed of three herbs, Da huang, Huang qin and Huang lian, was studied at Kaohsiung Medical University in Taiwan in 2010 to assess the efficacy in treating Hepatitis C. These researchers found that a chemical extract of the formula, a catechin containing fraction, exhibited effective inhibition of HCV replication, and also displayed synergistic anti-HCV effects when combined with interferon alpha, protease inhibitor telaprevir, or polymerase inhibitor 2'-C-methlycytidine. The chemical fraction from the formula extract also caused a dose-dependent decrease in the induction of COX-2 and NF-kB expression, two inflammatory mediators expressed by HCV replication or HCV NS5A protein (J Viral Hepat. 2011 Jul:18(7):e315-24; PubMed: 21692943).

While these two simple formulas have proven efficacy in the overall treatment protocol for HCV, more well constructed and specific formulas are commonly used today, and based upon research of a number of specific herbs. A number of these studies are available with links at the end of this article in additional information. In the United States, another herb used more widely in liver dysfunction and disease to normalize liver enzymes, Milk Thistle, or Silymarin, has also gone through human clinical trials with the National Institutes of Health. This herb, studied by the National Cancer Institute and the Division of Cancer Epidemiology and Genetics; Freedman ND et al; Rockville MD, was used as an adjunct treatment for patients with advanced hepatitis C-related disease and was associated with reduced progression from fibrosis to cirrhosis. The overall impact on the clinical outcome of the advanced hepatitis C with liver damage was not significant, but the effectiveness as part of the treatment protocol was. Silymarin, or Milk thistle extract, is today used in numerous studies to compare the effects of other herbal extracts on liver function and liver protective effects. In this regard, Silymarin has gained quite the respect. In 2010, a study at the University of Washington, in Seattle, Washington, found that specific silymarin-derived compounds may influence HCV disease course significantly in some patients by suppressing TNF-alpha activation of NF-kappaB dependent transcription to inhibit certain genotypes of HCV (PMID:20231449). The researchers suggested that further studies “where standardized silymarin is dosed to identify specific clinical endpoints are urgently needed”, suggesting high expectations for Silymarin within the treatment protocol for HCV.

To date, it is widely acknowledged that Chinese herbal medicine has been broadly utilized for decades in China to treat hepatitis, including hepatitis C. The array of herbal chemicals studied and utilized is broad, and the use of herbal chemicals to achieve liver protection, improved liver function, alleviation of symptoms, and other goals of a holistic approach, as well as the immune enhancement that may help the body eradicate the virally infected cells, provides the Licensed Acupuncturist and herbalist with a comprehensive array of treatment tools. Evidence-based research improves each year in herbal medicine, and the combination of herbal chemistry with nutrient medicine and acupuncture provides for increased success as well. A conservative approach may be tried before standard therapy, which comes with harsh side effects and the threat of long-term adverse outcomes. TCM treatment may also be integrated with standard therapy to minimize both immediate side effects and long-term adverse outcomes. The choice is with the patient in a patient-centered approach to medicine, and a pro-active and informed patient may feel comfortable making these treatment decisions.

Acupuncture in the treatment of Hepatitis

Many human clinical trials and studies of acupuncture effects support the utilization of acupuncture in the treatment of hepatitis. The application of randomized double-blinded placebo-controlled human clinical trials, though, has been problematic. To utilize a so-called placebo acupuncture that both the patient and the treating physician are blinded to is of course logically almost impossible to achieve. Yet, this is the standard to which acupuncture has been held. Alternatives have been devised where the so-called placebo has utilized a so-called “sham” acupuncture. This design often uses actual acupuncture stimulation at points other than the ones designated in the design, with the treating physicians unaware that these so-called sham points are not the real acupuncture points in the study design. Of course, these so-called sham acupuncture points chosen have effects as well, and the study is designed to compare the positive effects of the studied points with the so-called sham points. Obviously, it would be easy to design studies that do not statistically result in a dramatically higher success rate with the chosen points over the so-called sham points. This is the state of manipulated research over the last decade or two, more of a political and economic manipulation of evidence-based medicine and public opinion than a real attempt to study the positive effects of acupuncture. Despite these hurdles, acupuncture has proved efficacy in the treatment protocol applied to hepatitis.

After numerous studies proved efficacy of acupuncture in the overall treatment protocol for hepatitis, these studies were evaluated and deemed of low quality. A 2010 evaluation of these studies at the Capital Medical University in Beijing, China, found that the reasons for classification of these numerous studies as low-quality was that methods of randomization were not adequately described, upcoming treatment assignments were not adequately concealed, blinding of the so-called placebo or sham acupuncture was not adequately reported, and none used a group of patients that were given intention to treat but received no treatment as comparison. 70 randomized clinical trials were reviewed, but only 2 met the criteria of a high-quality study with a JADAD score. While this seems complicated to the lay person, an objective look at the whole situation easily shows that acupuncture is being held to standards that are almost impossible to meet, and that manual medicine will never meet the same criteria as well-funded pharmaceutical human clinical trials. This does not mean that the acupuncture does not deliver positive benefits, and the public needs to gain an awareness of this big picture. Lack of ultimate success in this arena of human clinical trials with absurd standards that do not fit the study of manual therapies, such as acupuncture, do not indicate that acupuncture does not work.

More and more clincial human studies are being performed to evaluate the positive effects of acupuncture within the broad scope of treatment protocol in hepatitis treatment. For example, a 2010 study in Turkey (cited below) investigated the efficacy of acupuncture to treat depressive symptoms and muscle pain in patients undergoing interferon therapy. Treatment continued once per week for six weeks, with patients divided into subsets, and the research found that: “Significant improvements in end-treatment Beck’s Depression Inventory (BDI) and in myalgia scores compared to baseline levels were found.” (PMID: 20530097) (Acup Med. 2010 Sep.28(3):136-9) Numerous human clinical trials are also performed to evaluate the combination of acupuncture and Chinese herbal medicine with standard modern treatment with drugs. Consistently, the addition of this standard TCM protocol produced much higher rates of success, measured by viral load and liver enzyme assays. Some of these studies are cited below. Yet, these studies, which are logical and sensible in design, do not meet the unrealistic standards applied in the Western standard medical journals, and are not presented to the public, and do not influence standard treatment guidelines in the United States. This type of biased evaluation appears as if it will go on endlessly. The public is slowly gaining an understanding of this game, though, and increasingly, turning to Traditional Chinese Medicine, or Complementary Medicine, to enhance their chances of successful outcomes in treatment of Hepatitis C.

More promising research in the treatment of hepatitis C

Finding an effective array of herbal and nutrient chemicals that activates our innate immune responses of interferon-gamma (IFN-gamma) and natural killer cells (NK-beta), and decreases transforming growth factor (TGF-beta), may be the key to a successful core therapy in Complementary Medicine to treat chronic hepatitis C. Beta-carotene has been well studied and carotenoids have been found to modulate cytokine production of T cells, as well as to stimulate a significant antioxidant response. A study at Kanazawa University in Japan, in 2010 (PMID: 20681644) found that oral administration of beta-carotene and capsaicin increased interferon (IFN-gamma) and IL-2 production in animal studies, and did so safely, without changing the lymphoid cell population. A 2010 study at Tongji University in Shanghai, China (PMID: 20487553) found that three nutrient medicines, beta-catotene, Vitamin D2, and linoleic acid were found in cell culture to inhibit HCV RNA replication. DHA and EPA, commonly referred to as omega-3 fatty acids, and found in krill oil, were reported to also demonstrate inhibition of HCV RNA replication. An ongoing human clinical trial of 1084 chronic hepatitis C patients compared to 2326 healthy subjects produced findings that suggested that chronic HCV patients may benefit from adjunct nutritive therapy utilizing beta-carotene, Vitamin D3 cholecalciferol or foods with D2 ergocalciferol, linoleic acid, and EPA and DHA omega-3 fatty acids. Conjugated linoleic acid (CLA), derived from safflower oil, is now heavily researched at such prestigious schools as the University of Wisconsin. Another form of linoleic acid is found in the black currant seed oil extracts, with a good profile of CLA with GLA (gamma linolenic acid). Of course, such nutrient chemicals are found in a variety of healthy foods, oils and herbs. In addition, some quality nutritional formulas are available with beta-carotene combined with other potent antioxidants, such as Extension Antioxidant from Vitamin Research Products, which includes curcuma and carotenoids, which may help in the adjunct therapeutic protocol for HCV as well. In 2011, research at the University of Catania, in Italy, showed that supplementation with acetyl-L-carnitine reduced both mental and physical fatigue and improved quality of life in patients with hepatitis C undergoing interferon therapy plus ribavirin.

These studies in Asia, Europe and the United States would suggest that patients undergoing therapy for HCV, or patients wishing to prevent HCV infection or control asymptomatic or milder infections, may benefit from a nutritional medicine protocol. While the tendency of individual patients is often to try one or another of these products, or buy products that are heavily advertised, there is much buyer-beware warnings in the last decade concerning nutritional products. Utilizing a professional Complementary Medicine physician to help guide, prescribe, and acquire quality products may be essential to a successful outcome.

A number of scientific studies point to novel herbal activation of interferon gamma. A 2008 study at Chosun University College in Korea (PMID: 18929637) found that the Chinese herb cordyceps militaris extract induced IL-18 mRNA to result in increased activation of interferon-gamma production. A 2007 study at the Kaohsiung Medical University in Taiwan (PMID: 17052829) found that the Chinese herb Bupleurum kaoi possesses antiviral activity by induction of type 1 interferon expression. A study in 2007 by the East China University of Science and Technology in Shanghai, China (PMID: 17466920), found that the Chinese herb Ganoderma lucidum (Reishi or Ling zhi mushroom) was able to increase the expression of both interferon-gamma and interleukin-2. These are just some of the examples that add scientific weight to the prescription of immune stimulating herbal formulas in TCM. While a single herb may not be a cure for hepatitis C, an array of herbal and nutrient therapies, enhanced by acupuncture stimulation, provides a treatment protocol that achieves a number of therapeutic goals, which is vitally important in a complex and multifactorial disease.

History and science of the virus and viral illness

A century of modern pharmaceutical study still has not produced a significant drug to treat viral illness. To read more information on viral illnesses, go to the web article on this site devoted to this subject. The failure to produce synthetic drugs to clear vial illness is profound. The promise of biologics, drugs or natural chemicals that target homestatic mechanisms, is the new hope. Two relatively new drugs, Tamiflu and Prostatin, derived from herbal medicine and very effective, still produce too many side effects and present a greater risk than benefit ratio to be widely prescribed. Herbal extracts with an array of synergistic chemicals are found to be antiviral and safe, but even isolating and reproducing specific chemicals from herbs has been problematic. This is because science still lacks a fundamental understanding of the virus, which is not a living invading organism, but merely an incredibly small bit of a gene, encapsulated by a protein, and sometimes a phosolipid, or fatty membrane. This small genetic entity becomes part of our cells, and the ability to get rid of it is very complicated. The problem with modern medicine is that to patent the chemical and make profit, it has to be synthesized. Natural chemicals found medicinal planst cannot be patented, and will not generate huge profits. To bring a medicine to this market requires synthesis of a particular chemical, and it appears that a more complicated approach is necessary to treat viral illness.

The entities we call viruses appear in innumerable forms, are so small that they can exist within unseen particles of moisture or dust in the air, and not be captured by the most sophisticated screens known to man. One expert in viruses, Dr. Nathaniel Brown, senior VP at the drug company Idenix Pharmaceuticals of Cambridge, Massachusetts, explained modern approaches to antiviral agents in a NY Times interview: “You can't kill something that is not living. The only thing that you can inhibit for a virus is replication.” Inhibiting replication is more complicated than we orignially surmised, though. Modern science still does not understand the origin of viruses, or why most viruses are apparently harmless, yet some are the most dangerous threats to human life. The first virus discovered was in 1899, the tobacco mosaic virus, discovered by Martinus Beijerinck. Today, over 5000 types, or families, of viruses have been identified, with innumerable variations of the virus for each type. With potential variations of viruses that could cause infection or disease numbering in the tens if not hundreds of thousands, finding a cure-all drug is perhaps impossible. Sifting through the innumerable ways that viruses use to replicate and transcribe harmful proteins is a daunting task as well.

Complicating the subject of viral illness is the fact that viruses, which are just bits of genetic material, make up a large portion of our human genome. This viral DNA, previously called “junk DNA”, has been found to be active and important in our genetic makeup with the study of the human genome in the last decade. Viral genetic material appears to be a vital source of evolving human cell data. Medicines that inhibit viral replication or protein expression may have many negative effects on the beneficial viral DNA and RNA in our cells, creating a variety of side effects and adverse health outcomes. Treating the virus as a completely bad entity, instead of viewing it with a realistic nuance, often vital to our adaptation in nature, and providing our cells with necessary genetic information, is perpetuating a belief system that is not objective or scientific, and hinders our ability to work effectively with nature in managing the potential ill effects of viral replication in our bodies. Modern science is trying to develop chemicals to stop the viral replication, but we should be aware of the potential pitfalls in this simplified approach. Inhibiting pathways of viral replication could have negative implications for our natural evolution of adaptive genetic coding. On the other hand, understanding and aiding the complex natural system we have evolved to manage viral effects in our bodies, with the use of evolved herbal and nutrient chemicals, presents possibilities of aiding our complex complement immune responses in many beneficial ways.

A virus is not a live pathogen, but just a bit of genetic material, DNA or RNA, that may become part of the genetic material of your cells. How complicated could a virus be if it's just a bit of DNA or RNA? One type of virus, the Baculovirus HasNPV, studied in China, was found to have considerable genetic variation within this one type of virus. 131,403 nucleotides were found to make up the virus, and 100 places in this DNA sequence proved to be variable in study. This amount of genetic variance in one type of virus was first thought to be a mistake in analysis, but later proved to be true. Multiply this by the over 5000 types of viruses now known, and the possiblities are enormous. The Baculovirus HasNPV virus is published in GENBANK. With this type of potential genetic variation, there will probably be no creation of the 'magic bullet' type of antiviral drug. One answer to this dilemma is to utilize nature's own array of antiviral chemicals in herbs, and to increase the health of your own immune responses to attack the problem in a comprehensive manner. This latter strategy has also been a subject of pharmaceutical study, especially with interferon, a chemical that mimics a chemical found in our own bodies that is used to enhance the immune response to viral infections. The side effects and failures of interferon therapy in treatment of Hepatitis has prompted many European medical doctors to utilize the herb Viscum Alba, commonly called European Mistletoe, to stimulate the interferon system in a much safer and benign manner. Given the complexity of viral variations, utilizing a number of herbs in a comprehensive protocol based on available study evidence is a way to increase the chances of a successful outcome. Using a step-by-step approach, first treating the infection and then improving the immune function, is the most logical approach to prevent recurrence of viral illness.

Modern allopathic medicine is so frustrated with the complete lack of treatment for viral illnesses that a sort of neuroses has been developed. Medical doctors routinely prescribe bacterial antiobiotics for viral illnesses when patients ask them for treatment, fully aware that the antibiotic will have no effect on the viral infection. Often, the antibiotic is prescribed as the course of the viral illness is naturally being completed, giving the impression that the antibiotic had some effect on the recovery. We know for a fact that bacterial antibiotics have absolutely no effect on the viral illness, yet we pretend as a society, that they do. More proven treatments to enhance prevention or recovery from viral illnesses, utilizing herbal medicine, are still not widely utilized, and a general lack of belief in these proven scientific medicines, and sensible treatment protocols of immune enhancement and adaptability to stress, still persists despite a wealth of scientific study. This general neurosis extends even to the federal government's Center for Disease Control, which distributes public information on the flu vaccines that state that these vaccines are generally unable to infect the patient because the virus is “killed”, when the scientists at the CDC are well aware that a virus is not a living microorganism, and thus cannot be killed. The newer, and now most common type of vaccine is called a “live attenuated” virus, delivered in a nasal spray to achieve low dose effectiveness. Once again, this virus is not living, yet is referred to as a living organism, by the highest authorities. These strategies occur because of the desperate frustration and need to have some type of modern medicine to counter the viral illness.

In our own lives, we are constantly affected by viruses, with the coronaviruses, or common cold strains, and influenza viruses, affecting most of us each year. The flu vaccine, popular but proven ineffective, is poorly understood by the public, with almost no common knowledge that the vaccine is designed to protect us against only a few of the most dangerous strains of influenza known, and has virtually no effect on the common influenza strains that produce our mild cases of the flu. The Center for Disease Control released a long-term study in 2006 that showed virtually no success in its targeted reason for use of the vaccine, which was to decrease influenza deaths in the most immunodeficient population, the elderly. The rest of us take this vaccine not to decrease our own incidence of common flu, but to try to decrease the incidence in the general population of a few dangerous types that recur over time with no distinct pattern. The total number of types of influenza recorded in the United States by the Center for Disease Control in 2008 was 158, and the number of viral types in the vaccine was 5. Public health information concerning this fact is misleading at best. Our modern science has no other ideas of how to protect us from this yearly influenza health threat, and so still recommends the vaccine despite poor results. In the meantime, popular knowledge of the success of herbal medicine in preventing influenza grows despite lack of spending on research, but is still not widely accepted. This scenario creates a false security in the efficacy of viral vaccination, and may be creating a lack of interest in a more practical approach to prevention and treatment of serious viral illness, utilizing herbal medicine.

The sudden spread of viral illnesses across the world is still a mystery to us. The virus has been known to appear in a new form simultaneously around the world, as in the 1918 influenza pandemic that killed as many as fifty million people worldwide, and ended World War I. In 2003, the West Nile virus suddenly appeared in 45 states, seriously sickened 9,862 patients, and killed 264 Americans. In subsequent years, incidence has been much less, with 3630 cases reported across the country in 2007, and 2539 cases in 2004. Studies showed almost no evidence of antibodies in the population, and science has no substantial theory on how or why it suddenly appeared across the entire United States. The persistence of calling this virus a West Nile virus, implying that it should stay localized to northern Africa, and implying that there is no variation in this type of virus, is misleading, and contributes to the neurotic attitude toward viral illness. Scientists are still uncertain of how this particular type of virus has spread. The first evidence we have of this virus in the United States dates to 1999, with only 62 cases, and the pattern of incidence and spread of the disease does not follow logical patterns in epidemiology. The virus has no real lifespan, yet it can disappear in one form and appear in another, and modern science has found no way to accurately predict its future forms, or determine which form is going to be dangerous to public health. Until recently, our science could not even 'see' the virus, and even with electron microscopes we see only a 'shadow' of the virus. Only recently, with magnetic resonance microscopy, have we been able to capture an indistinct three dimensional image of a virus. Obviously, we are living in a false reality concerning viral threat, and the lack of study of how nature has evolved protections for us against viral illness, and persistence of belief that modern science alone should produce a remedy, is not benefitting public health.

Hepatitis, or Liver inflammation due to various viruses

Hepatitis C is a very prominent chronic viral illness that now affects a sizable portion of the population of the United States. Hepatitis B is a type of viral liver inflammation that was widespread over much of the world in the past, especially in Asia and Africa, and is now endemic in China (maintained as a chronic infection in the population, mainly via transmission during birth). Hepatitis B has infected more than 2 billion people worldwide, and it is thought that more than 350 million people around the world are chronic carriers of the virus. Hepatitis A is a type of viral disorder that is more rare, and largely confined to infection via intake orally, or water of food. These most common types of viral hepatitis do not represent the vast array of viruses that may cause liver inflammation, though, and only represent the common pathological presentations that modern medicine can efficiently diagnose. Many viruses may affect liver function, and often the patients affected do not receive a good explanation for their condition.

In order to downplay the subject of viral inflammatory disease of the liver in the past, health authorities have told us that this is a disease confined to drug addicts and sexually promiscuous individuals. This is the same public health tactic that was applied to the HIV retroviral infection, or AIDS, originally, where most of the public felt that they were free from risk if they were not gay. These viral illnesses, such as AIDS, were also characterized as dooming one to serious health consequences or death, initially, but today we see most patients with HIV-induced AIDS surviving well and leading healthy lives. The result of this massive misinformation concerning viral illness, such as Hepatitis C, is now finally emerging as a serious public health threat that must be dealt with finally in an open and honest manner. If hepatitis, or chronic liver inflammatory disease, is not treated in a sensible manner, it may lead to liver cancer, as well as other serious health problems related to poor liver function. Hepatitis is also associated with increased risk of autoimmune disorder, especially thyroid disorders, as well as psychological and neurological illness. The patient need not wait until they have received the diagnosis that their health is seriously threatened by Hepatitis C. Prevention and health maintenance are sensible approaches. TCM and Complementary Medicine may provide prevention and health maintenance even when this is not the primary focus, as many of the herbs and acupuncture therapies used for a large variety of conditions have antiviral effects, are liver protective, and immune enhancing. There is a variety of treatment approaches that the person with hepatitis can utilize to protect their health, as well as to diminish the effects of the viral infection. Doing nothing, ignoring the liver inflammatory disease until it finally stimulates untreatable liver cancer or other serious disease, or waiting until the one simple miracle drug appears, is not the way to deal with chronic viral liver disease.

The first thing a person needs to do when suspecting that they may have a form of hepatitis is to get tested. This testing has been severely discouraged in the United States, as the medical doctors and public health authorities promoted the idea that hepatitis was a disease limited to drug addicts and sexually promiscuous individuals. This is and was far from the truth. In fact, modern science still is not sure how so many cases of hepatitis are transmitted. The real fact is that there is not a sound treatment protocol for hepatitis, and so the standard medical establishment has not wanted to deal with this dilemma. The patient, and the general public, should take a proactive approach to this health threat and proceed in a positive manner to educate themselves, and to do all the right things to either prevent the disease, treat the disease, prevent the spread of the disease, and/or improve the health of the immune system and liver to prevent serious consequences of the disease, especially liver cancer, which is one of the most fatal of cancers, and autoimmune disease, which is associated with a percentage of patients prone to hepatitis. This is where the patient and the Complementary Medicine physician can work together to arrive at the best outcome. Herbal medicine research is finding more and more natural chemicals with potent antiviral effects, immune modulating effects, liver protecting effects, etc. Nutrient medicine is progressing by leaps and bounds to help the physician stimulate healthy physiology and restore homeostatic balance. Acupuncture research is uncovering the complex ways that specific needle stimulation exerts potent anti-inflammatory, neurohormonal, and immune modulating effects. The combination of these therapies offer the patient an array of therapies to address all the negative health aspects of hepatitis.

After testing and finding out that you are infected by one of the hepatitis viruses, the next thing that the sensible patient needs to do is to educate themselves. Hepatitis is a term that literally means liver inflammation, and is a nonspecific term. There are a family of viruses that we refer to when we use the term hepatitis, and in fact a family of viruses, or species genus, that we refer to when we use the terms Hepatitis B, C etc. This is one reason why the allopathic approach, which targets a specific virus, is a failure. Hepatitis B virus, or HBV, is a species of the genus type Orthohepadnavirus. Hepadnaviruses are a family of viruses that cause liver inflammation in humans and animals and have been around for millions of years. For all our scientific study, we still do not understand this family of viruses well enough to explain how many people with the viral infection do not show symptoms, while others have a severe acute illness, and many others eventually have severe diseases many years after the infection. The specific Hepatitis B that we study is similar to a retrovirus. The retrovirus is a type that replicates by becoming part of a cell's DNA and stimulating its genetic code via RNA replication. The Hepatitis B virus that we have created a vaccine for has a double encapsulation of lipid and protein around a bit of non-living genetic material, or DNA, that ends with a DNA polymerase enzyme. There are 8 known types of prevalent Hepatitis B in the world to deal with. These are labeled A through H, and the variations between these genotypes are in about 8% of the gene sequence. Various parts of the world are predominantly affected by the various types of Hepatitis B.

There are parts of the hepatitis B virus that are common to all types, and the vaccine created addresses these similarities, especially the surface antigens on the lipoprotein capsules. The vaccination against Hep B stimulates an antibody response to the surface antigens found on most hepatitis B viruses. While this vaccination has been shown to be highly successful in most cases, about 10%, or 1 in 10, individuals that are vaccinated do not respond with a sufficient antibody response to the surface antigens, and this leads to questions about the immune system and the response to vaccination. In addition, long term studies have shown that the vaccine stimulates a sufficient antibody response for about 15 years, although infants and children younger than 4 appear to lose this antibody response sooner than adults. Since many people have become infected at birth by exposure to the parent's virus in the birthing fluids and blood, immunization vaccine is always recommended at birth for babies born to a mother that has tested positive in the past for Hep B.

The immune system problems seen in Hepatitis patients

A percentage of people have been found to be nonresponsive to the hepatitis B vaccine, and the Mayo Clinic determined in 2003 that there is a strong association between a genetic inheritance of the DQ2 human leukocyte antigen (HLA) genotype, as well as celiac disease (hyperresponsive immune antibody reaction in the intestinal lining to glutens and gliadins) (PMID: 14572581). The Mayo Clinic concludes that a humoral immune deficiency is linked to both hepatitis vaccine nonresponsivenes and celiac disease. Researchers in Europe had previously concluded that the prescence of autoimmune antibodies to smooth muscle (organ tissue such as the liver) cells is common in Hepatitis B infection, and that most autoimmune diseases do not develop until later in life (PMID: 12093985). These clear links to immune dysfunction and deficiency point to the need to incorporate a more thorough treatment protocol with Integrative and Complementary Medicine, not only vaccinating against and treating the viral disease, but also stimulating increased immune function, resolving celiac disease and GI dysfunction, and also aiding the health and function of the liver.

Anti-viral medicines

While modern pharmaceutical science still has not produced a significant antiviral drug, our greatest laboratory, Mother Nature itself, has evolved myriad chemicals to protect the living organism from the ill effects of the virus. This has been a matter of survival for both animals and plants. Viruses do not specifically target only animal cells or only plant cells. Chemicals that evolved in plants to protect them from the viruses in their environments also appear to work very well in humans. Thus we have numerous recommendations from the medical industry to use such plant-based medicines as echinacea and goldenseal to help protect against the more virulent strains of viral disease, and of the few anti-viral medicines that are being researched, a number are based on herbal medicines and chemicals, such as Tamiflu, which is based on a specific chemical from a type of star anise used for centuries in Traditional Chinese Medicine, and Prostatin, an antiviral based on a Samoan herb. The professional herbalist has many herbs with antiviral chemicals in them to choose from, and a library of reference studies and empirical information on the proven effects of these herbal antiviral chemicals.

The subject of viral illness seems grossly misunderstood by the public despite being the most prevalent health problem in the world. A virus, unlike a bacteria or fungi, is not a living organism, yet we still see advertisements from such products as Lysol that claim to kill viruses. If the public actually believes that products like Lysol are their best bet to prevent viral illness, this could be perceived as a public health threat. Bacteria, on the other hand, are living organisms that reproduce independantly and cause infection when they get past our natural immune defenses, or when there is an imbalance of the natural symbiotic controls of bacterial colonies on our skin or membranes. Bacterial infections are treated with antibiotics, which are products of living organisms, usually other bacteria, which inhibit the growth of the infectious living bacteria, slowing the rate of reproduction so that our own immune systems have a chance to kill the bacteria before they kill us. Our own immune systems counter bacterial infections by producing a host of antibodies, or protein molecules that react specifically with invading bacteria, called antigens. When the antibody proteins react, immune cells are attracted that kill the invading bacteria. Since there are a limited number of bacteria in our world, our bodies retain a complex immune memory which helps it to act quickly. The immune responses that counter viral illness are much different, because the virus in not a living organism, and new strains of viruses pop up each year.

Antibiotics do not inhibit nonliving viruses, yet we still see routine prescription of bacterial antibiotics by medical doctors for viral illness. As stated, a virus is either a bit of DNA or RNA that is encapsulated by a protein shell to protect it, and reproduces only with the mechanisms in the cells that it invades. Our own immune systems fight viruses with a very complex assortment of immune cytokines that identify our own cells which have taken in the DNA or RNA of the virus, and then proceed to kill the infected cells. This mechanism is very complex and difficult. To illustrate, our own genetic material, or genome, found in every cell of our body, is filled with viral DNA or RNA. We have called this viral genome 'junk DNA' in the past, but recent research is finding that some viral DNA plays an active role in our genetic expression and evolution. Our immune systems must identify which of our own cells has bits of the viral genetic material that is active and generating harmful replicants of itself, or producing expression of harmful proteins.

Since we still don't have pharmaceuticals that are safe and effective in inhibiting viral replication, doctors still prescribe antibiotics rather than admit that they have nothing for you. If the antibiotics don't work against viruses, do they help us at all? In certain circumstances, viral infection inflames our membranes, exposing us to a greater chance of developing bacterial pneumonia. If this occurs, yes, the antibiotic is useful. Also, some viruses can invade bacteria as well as normal cells of our body, and in this case, the antibiotic would have some effect against the viral population, or at least that part associated with a concurrent bacterial infection. For the most part, though, the antibiotics will be ineffective, and the standard course of the viral illness involves waiting until our own immune systems react sufficiently to control the viral illness.

Viruses pose a threat to us because they appear in so many different forms that living organisms can't form a simple immune defense that is remembered. Viral vaccines are difficult to create, because, as one expert, Dr. Michael Decker, head of scientific affairs at Aventis, one of the three U.S. vaccine makers, states: “By the time you know what's the right strain, you can't do anything about it.” Viruses can't be killed and when they enter our bodies, our own immune systems try to break them down, digest them, or excrete them. Our bodies have a limited success with this set of tactics, as seen from the genome studies that show that a majority of our genome is now composed of nonworking bits of viral material. Certain viruses have increased potential to bind to and enter our cells. The most virulent viruses, the flu and common cold families, have proteins on the surface that attach more easily to surrounding cells in our membranes. Most of the cells that these viruses attach to are actually immune cells sent to counter the infection. Other types of viruses don't attach to membrane cells easily, but penetrate deeper into our bodies, often lying latent for years before expressing and causing symptoms, like Human Immunodeficiency viruses and Herpes viruses, or quietly infecting our own immune cells and causing the production of autoantibodies that create serious autoimmune disorders.

Information Resources

1. Current reports of the failure of pharmaceutical medicines that target viral illnesses can be seen in this NY Times article at: http://www.nytimes.com/2009/01/09/health/09flu.html?em If you have trouble accessing this website by clicking on this address, the story can be easily found by a search on Google, using the keywords Flu Drug New York Times Health January 8, 2009.
2. Current reports of the failure of interferon therapy with long term studies, the HALT-C Trial, published in the New England Journal of Medicine on Dec. 8, 2008, can be seen in this Science Daily article at: http://www.sciencedaily.com/releases/2008/12/081204133645.htm If you have trouble accessing this website by clicking on this address, the story can be easily found by a search on Google, using the keywords HALT-C interferon New England Journal of Medicine 2008.
3. The occurrence of serious side effects with interferon alpha treatment for chronic hepatitis C patients is well documented, and a principle reason why many patients without imminent threat are now utilizing Complementary Medicine to treat conservatively at first, which has almost no side effect. This review of adverse effects in 1997, at the Royal Free Hospital and School of Medicine in London, UK, reports that a majority of patients receiving alpha interferon therapy report adverse effects of muscle and joint pain, headache, fatique, and fever with the initial course, and up to 10% of patients discontinue therapy due to the severity of side effects. Adverse effects over time are also considerable, with depression and irritability most troublesome, anemia, and hormonal effects common, and a significant occurence of induction of an autoimmune disorder, the most frequent being autoimmune thyroiditis, but with other autoimmune disorders seen as well. These doctors also report that up to 1% of patients experience very serious side effects, including thyroid, kidney, heart, visual and auditory impairment, as well as pulmonary fibrosis, sometime irreversible: http://www.ncbi.nlm.nih.gov/pubmed/9305675
4. A 2007 review of the high prevalence of both acute side effects and long-term adverse outcomes with interferon alpha therapy is reviewed by experts at this Polish Academy of Medicine in Gdansk. These experts propose that a new disease classification of interferon-induced thyroid disease be adopted so that patients are more thoroughly evaluated for thyroid disease after treatment, especially for subclinical autoimmune thyroid disorders: http://www.ncbi.nlm.nih.gov/pubmed/18583950
5. A 2008 review of the prevalence of interferon-induced thyroid disorders at the Medical School of the Federal University of Bahia, in Brazil, found that thyroid disorders are more common in patients with chronic HCV, as well as after interferon alpha therapy, and therefore, screening for subclinical autoimmune thyroid disease should be performed before administering alpha interferon therapy, especially in older women. These experts recommend that this testing be performed before, during and after this treatment: http://www.ncbi.nlm.nih.gov/pubmed/18641852
6. Current reports of herbal colchicine versus standard interferon therapy in European clinical trials: http://www.natap.org/2008/EASL/EASL_09.htm Colchicine, from the Chinese herb Shan Ci Gu, or rhizome of the Iphigenia Indica, has been used for centuries in China and studied in relation to treatment of cancer. It has toxicity and is used with care professionally. Other herbal therapies for hepatitis C are clinically proven and also effective as a package of treatment.
7. Current phase three clinical trials of a common classic Chinese herbal formula, Xiao Chai Hu Tang, called Sho-Saiko-to in Japan, for treatment of hepatitis C, are being undertaken in 2008 by the Natianal Institute of Health and the University of Virginia. This formula of seven herbs has been proven effective in Japan, and does not even contain the most effective single herbs shown to inhibit hepatitis C: http://clinicaltrials.gov/ct2/show/NCT00633230 Success of this clinical trial will demonstrate that even the most classic and widely used formulas in TCM are proven effective for a wide variety of health problems.
8. Research in 2011 at the Dr. B.C. Roy College of Pharmacy and Allied Health Sciences in Durgapur, India, found that a review of current scientific studies found that significant liver protective efficacy has been seen with Silymarin (Milk thistle), glycyrrhizin (Gan cao) and Liv-52 formula, containing curcumin (Yu jin and E zhu), phyllanthin (Ye xia zhu), andrographolide (Chuan xin lian), and picroside (Hu huang lian): http://www.ncbi.nlm.nih.gov/pubmed/21595500
9. Research in 2011 at the University of the Punjab, Pakistan, found that Silymarin, or Milk thistle extract, and its chemical fractions S1 and S2 inhibit HCV core gen of 3a genotype and would improve the treatment effects when combined with interferon: http://www.ncbi.nlm.nih.gov/pubmed/21453551
10. Research in 2011 at the University of Malaya, Kuala Lumpur, Malaysia, found that the Malaysian herb Orthosiphon stamineus, exerted a significant dose-dependent liver protective effect, restoring elevated liver enzymes near to normal: http://www.ncbi.nlm.nih.gov/pubmed/21647311
11. A 2001 study of incidence of chronic subclinical hypthyroidism and autoimmune hypothyroidism as a result of interferon therapy: http://jcem.endojournals.org/cgi/content/abstract/86/5/1925 Support therapies with Complementary Medicine have proven effective in treating such long term side effects of therapy.
12. A 2002 study of randomized controlled trials of Chinese herbal medicine combined with interferon therapy by the University of California showed that the herbal therapy research was extremely encouraging: http://www.universityofcalifornia.edu/news/article/4785 Support therapies with Complementary Medicine have been proven effective in enhancing standard therapeutic protocol with viral illnesses as well as antibitic resistant bacterial infections, and the holistic approach helps reduce the horrible side effects from harsh synthetic drugs.
13. A 2001 study of antiviral and immunomodulatory effects of viscum album, or European Mistletoe, also called Iscador extract, and a review of subsequent clinical trials and research published on the NIH database PubMed: http://www.ncbi.nlm.nih.gov/pubmed/16927531 http://www.ncbi.nlm.nih.gov/pubmed/11317168
14. Research into the herb Homalanthus nutans by the University of California at Berkeley demonstrates the remarkable potential for herbal medicines in antiviral therapy: http://www.ethnomedicine.org/research/prostratin.asp As more research from China is opened to the universities in the United States, a flood of useful treatment data is expected for herbal physicians in the United States.
15. Research into the herb Lithospermum erythrorhizon (Zi cao) in 2003, revealed that a chemical in this herb effectively inhibits HIV replication, including drug-resistant and pediatric variations in the HIV family; Zi cao was shown to be an inhibitor for a variety of chemokine receptors, making it potentially effective in modulation of a variety of viral and inflammatory diseases: http://aac.asm.org/cgi/content/short/47/9/2810
16. Research in 2005 at the Walter Reed Army Medical Center in Washington D.C. found that 5-10% of individuals apparently do not adequately respond to Hepatitis B vaccine. The importance of a more thorough treatment protocol stimulating a better immune function with Complementar Medicine is highlighted by such research: http://www.ncbi.nlm.nih.gov/pubmed/16271539
17. Research in 2005 at the National Center for Infectious Diseases, Center for Disease Control, of the United States government, found that the duration of protection against infection from the Hepatitis B vaccine was strong for 15 years, but that children and infants immunized at birth to age 4 showed antibody levels decreasing the most within this window of immunity: http://www.ncbi.nlm.nih.gov/pubmed/15738452
18. Research in 2010 has discovered that a number of Chinese herbs are proven effective at inhibiting common viral pathogens. A study at confirmed that even Siberian Ginseng (Eleutherococcus senticosus) effectively inhibited the DNA viruses human rhinovirus (HRV) and respiratory syncytial virus (RSV), two common viruses that perpetuate sinusitis and rhinitis: http://www.ncbi.nlm.nih.gov/pubmed/11397509?dopt=Abstract
19. A clinical trial of acupuncture combined with Chinese herbal medicine added to the standard treatment protocol for Hepatitis C, performed a Henan College of TCM in China, found that the integration of this TCM therapy improved outcomes for various subsets of patients consistently, with about a 20% improved effective rate of success, measured by viral load and liver enzyme assay: http://www.ncbi.nlm.nih.gov/pubmed/20088415
20. A 2011 clinical trial of addition of acetyl-L-carnitine to a drug regimen to treat hepatitis C in Italy, at the University of Catania, found significant improvement in both mental and physical fatigue and improved quality of life with this common nutritional medicine: http://www.ncbi.nlm.nih.gov/pubmed/21923249

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