Chapter 17  Lyn Patrick, ND |
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Introduction Several over-the-counter products are marketed to people living with hepatitis C for which many claims have been made. It can be very hard at times to determine if the claims are true and what to believe. Furthermore, your Western medical provider may not be able to provide you with guidance because he or she may not be familiar or experienced with these products. Making a decision about whether or not to use one or more of these products can be difficult at best. In addition, there is no way to be sure how any one individual will react to any one product. One of the most common complaints from Western health care providers about alternative products is there is little or no data on their effectiveness. The data that does exist is often from studies that were not well designed and therefore not acceptable to most Western-trained physicians. While for the most part this is true, it is also changing. Many manufacturers of alternative products are realizing that, in order to gain credibility within the Western medical community, they need hard evidence that proves their case. Products Marketed To People with Hepatitis C Some of the products marketed to people with hepatitis C
are reviewed in this section. Many more are available that do not appear
here. The inclusion or exclusion of any product should not be considered
to deny or affirm its existence or effectiveness. The products we have
selected are those people with hepatitis C seem to be most aware of and
therefore ask about most frequently. Bee Propolis Propolis is a resinous material produced by bees from plant parts. It is used as sealing material for the hive. Because it has significant antibacterial and antifungal activity, it has been used as a topical medicine for skin, ear, nose, and throat problems.1 Propolis also has antiviral activity, specifically to influenza and herpes viruses.2 This antiviral activity is thought to be due to the flavinoids in propolis. These vitamin-like substances come from the plant materials picked up by the bees. Flavinoids also appear to be the active ingredients in the plant-based folk remedies used by traditional African medicine practitioners for the treatment of hepatitis.3 No animal or human studies have been conducted on propolis as a treatment for hepatitis. Eurocel Eurocel™ is a proprietary herbal formula specifically marketed for the treatment of chronic hepatitis C by Allergy Research Group®, a company that markets supplements to doctors and the public. Eurocel™ contains the herbs Patrina villosa, Artemesia capillaris, and Schizandra fructus; the exact amounts of each ingredient are not disclosed. These are common Chinese and Korean herbs that have been used historically for the treatment of liver disease. The company cites unpublished data that the formula has been tested for toxicity in mice and found to be essentially nontoxic and non-mutagenic (it did not cause genetic mutations in the animals tested). The company Internet site (www.allergyresearchgroup.com) also reports data from a small, unpublished pilot study involving ten people with hepatitis C. The participants were recruited from a clinic in South Korea. The patients were in different stages of the disease (between 3 and 20 years after diagnosis), but all had elevated ALT levels and HCV viral loads. Participants were given two capsules (500 mg each) of Eurocel™ twice daily for a period of 6-24 months. Patients were treated for anywhere from 6 to 25 months. Apparently, the herbal combination was stopped after the viral load dropped to 1000 copies/mL in five patients who were followed with viral load testing for a period of six months, although the follow-up data was not included in the report this author received. No specific data was provided about ALT levels or other markers that were said to have improved. The report did not contain information about how many patients had low viral loads six months after stopping the herbal combination, or whether their ALT levels remained stable after stopping the product. If that data exist, it was not supplied by the company. However, they do state that the response to Eurocel™ is "an individual response." This author was referred to a Korean physician, Dr. Ba, when Allergy Research Group was contacted. In speaking with Dr. Ba, he said he knew nothing about the study, nor that it was conducted in Korea. He did not have contact information for the providers who conducted the study. Without the missing information, it is difficult to assess the effect of this herbal combination. Research data exists on the use of specific extracts of schizandra for hepatitis C (see Chapter 14, Modern and Traditional Chinese Medicine), but there is no way of knowing whether Eurocel™ capsules contain significant quantities of schizandrin B and C since the ingredients are not listed by quantity. Although this appears to be a nontoxic therapy, it is expensive (between $90 and $126 for a 45-day supply) and incomplete data on ten patients is not enough to back the company's claim that, "Hepatitis C viral titers plummet with Eurocel™." God's Remedy The milk thistle product is also a liquid extract. Information about the silymarin or silybin content of the product is not provided, so it is difficult to know the potency of this extract. Silymarin is the active ingredient in milk thistle, and all the clinical trials involving milk thistle specify of the dose of silymarin. See Chapter 15, Naturopathic Medicine for additional information on silymarin. Hepacure™ is another product sold by this manufacturer. It is claimed to be similar to Hepatico™. (See Hepatico™ listing in this chapter for information about this product.) The advertising text for this product refers to clinical trials with Hepatico™ in the Republic of Georgia and Russia quoting, "a 91% success rate" in hepatitis and some degree of reversal of cirrhosis in 1-7 months. The text goes on to say the product has been researched and is safe for treatment of acute and chronic forms of hepatitis A, B, and C, and cirrhosis. However, there is no reference to the source of this information. It is also unclear where this product was researched and how it was determined to be safe. As mentioned in the section under Hepatico™, none of the references mentioned were published studies. The only published study we found was an animal study looking at the toxicity of the plants in Hepatico™. The ingredients listed for Hepacure™ are very different from the original Hepatico™ formula. Hepacure™ is said to contain nettle, plantain, horsetail, yarrow, golden rod, chamomile, feikhoa batsu, fern, ekala, pau d'arco, cleaver, black Indian hemp, and mayapple in a base of milk thistle, dandelion, and turmeric root. The Immune Booster™ formula contains goldenseal root, red clover blooms, yellow dock root, burdock root, witch hazel, wild American ginseng, capsicum, pau d'arco, and echinacea. The Immune Booster™ formula text states, "Numerous studies have shown that these remarkable natural substances stimulate our immune system's ability to recognize and surround foreign matter and eliminate it at a cellular level." The only actual published data looking at the immune stimulating effects of these plants have been with echinacea, berberine (the active ingredient in goldenseal), burdock root, and pau d'arco (Tecoma curialis). The relative amounts of each botanical in the formula are not given, so it is difficult to know how strong the immune stimulating activity of the formula really is. The Energy Formula™ is advertised to diminish fatigue and contains American, Korean, Siberian, and Tienchi ginsengs, kola nut, guarana, damiana, and wild ginger root. Both guarana and kola nut contain caffeine, and various over-the-counter products that contain these herbs have been found to contain very high amounts of caffeine. Because this is a liquid formula, the amount of caffeine in the product would be hard to regulate and difficult to label. If high amounts of caffeine are the ingredient producing the "needed boost throughout the day," green tea or another inexpensive source of caffeine may provide an economical alternative. Hepatico™ Hepatico™ is a botanical compound producers claim has been used in Russia "for more than 150 years." It is currently a patented product owned by Alta Natural Herbs & Supplements, Ltd. It is a combination of three common plants, plantain, nettle, and immortelle in a base of three other plants, turmeric, milk thistle, and dandelion root. Each capsule contains 250 mg of a combination of the first three plants in 250 mg of a combination of the base herbs. The manufacturer does not provide information about the individual action of the first three plants. However, none is commonly known to have any action on the liver or gall bladder. The base botanicals are known to have effects on the liver and bile ducts, but the doses are low. The exact amounts are unknown, but are less than 250 mg total of base botanicals in each capsule. The amount of Hepatico™ used in an unpublished study (discussed below) was one to two capsules three times daily. This means the amounts of the botanicals involved in the study were below the amounts commonly used in published research that has examined the individual action of turmeric, milk thistle, and dandelion root. The information available from the manufacturer includes a study done in Canada with 23 patients who had either hepatitis B or C, or both. The majority had chronic hepatitis C. Study participants were given one or two capsules of Hepatico™ three times daily (depending on the patient's weight) for a period of 20-40 days. At the end of the study period, four of 23 participants had normalization of their ALT levels, and three of 23 participants had normalization of their AST levels. Participants who experienced normalization of their liver enzymes had varying histories of hepatitis C infection from 2-24 years duration. There is no information about their individual disease progression. A second group of ten hepatitis C patients took Hepaticov™ for the first month of a 7-month trial. Two had normalization of their blood ALT levels. The investigators reported the participants in this study had relief from digestive symptoms and insomnia, but they did not document when or for how long this occurred. The study gave incomplete information about the patients' medical conditions. The only other liver test conducted on participants was GGT levels, which did not change significantly during treatment. Liver biopsy results were not available. It is unknown whether the claims for this product could be reproduced in clinical trials conducted in the United States. According to a study done in Canada (unpublished), improvement (normalization of ALT levels) occurred in only a small minority of patients. Hepato-C® IP-6™ AbulKalam M. Shamsuddin MD, PhD holds the US patent for IP-6™ (inositol and myoinositol hexaphosphate). His research has demonstrated immune enhancing and anticancer actions of IP-6™, a combination formula found to be effective against cancer cells in the test tube. Myoinositol hexaphosphate is a B vitamin combined with phytic acid, a naturally occurring substance found in certain plant fibers (grains such as rice are particularly high in phytic acid). IP-6™ is the subject of many published studies on cancer in animals and cultured cell lines, but this author found only one study on the use of IP-6™ in liver disease.5 A study in rats that included IP-6™ in their diet appeared to prevent the accumulation of fat in the liver that would otherwise have occurred because of a high-sugar diet. Whether this finding has any relationship to hepatitis is questionable because different factors are responsible for liver damage in chronic hepatitis C. There is no evidence to date that IP-6™ has any direct effect on chronic viral hepatitis. LIV.52® LiverCare® LiverCare® is one of the currently marketed
brands of LIV.52®. Although the LiverCare®
manufacturer's Internet site states there are over 168 clinical papers
published on the use of LIV.52®, only 50 clinical and
experimental (animal) studies were found by this author in a search of the
medical literature. One clinical study evaluated 24 people with chronic active hepatitis B who were taking LIV.52®.8 A significant number of patients in this study had jaundice, ascites, and cirrhosis, all of which are signs of liver damage resulting from long-term infection. After treatment with LIV.52®, 58% of the study participants had significant decreases in their liver enzymes. The researchers considered this an improvement in symptoms. However, we cannot assume that LIV.52® would have the same effect in people with chronic hepatitis C. First, HCV is a very different virus from the hepatitis B virus. Western medications that are effective in treating chronic hepatitis B do not work with chronic hepatitis C. Second, lower viral loads and/or improved biopsy results need to be seen to prove improvement with chronic hepatitis C. Decreases in liver enzymes alone are not enough to prove efficacy. The authors cite an older published study that showed long-term improvement in people with chronic hepatitis who took LIV.52® for nine months. However, this study was unavailable for review. A separate study examined the effects of LIV.52® on 188 patients with alcoholic cirrhosis. Study participants took LIV.52® for two years. Among patients with the worst cirrhosis, those taking LIV.52® had a higher death rate than those not taking the supplement (23 deaths versus 11 deaths). It is unclear if LIV.52® was related to this observed increase in death rate. An increased death rate was not seen in study participants with less severe cirrhosis.9 There is no mention of a recommended dosage on the LiverCare® Internet site. The standard dosage suggested by Ayurvedic practitioners is two tablets twice daily with meals. However, each individual's dosage should be adjusted by a qualified Ayurvedic practitioner. Liverite® Liverite® is a nutritional supplement containing B complex vitamins, phospholipids, cysteine, and bovine liver hydrolysate (cow liver that has been broken down by enzymes). Many studies examining the effects of these preparations on liver cells have been published in the European and Japanese medical literature. However, human studies have failed to show any clear benefit in hepatitis.10, 11 Liverite® contains an unlisted amount of phosphatidylcholine, a type of fat found naturally in food. Approximately 20 years of medical research exists on the effects of phosphatidylcholine on the liver. Phosphatidylcholine has been shown to have a protective effect on liver tissue in alcoholics and people who are exposed to toxins, large doses of liver-damaging pharmaceuticals, and viruses.12 Most studies used a combination of intravenous preparations of phosphatidylcholine and oral doses of 450-700 mg. Other studies used only oral doses of 1,350-2,350 mg per day for alcoholic liver damage or hepatitis. Studies of chronic hepatitis B patients taking phosphatidylcholine and steroid therapy showed improved liver biopsy results. Acute hepatitis B resolved more quickly in those taking 1,350 mg phosphatidylcholine daily compared to those not taking the supplement. Phosphatidylcholine has also been studied in people with severe liver disease. In these studies, phosphatidylcholine used both intravenously and orally produced a reversal of fibrosis or scarring of the liver and a return to normal liver function tests.13 Whether Liverite® is the best dose or source (practically or economically) of phosphatidylcholine is unclear. Microhydrin® Mannatech™ Mannatech™ is a proprietary (secret) formula discovered by Terry Pulse, MD and Reg McDaniel, MD while they were working with AIDS patients. Mannatech™ is distributed by a multilevel marketing firm. It is based on a group of complex sugars called acemannan derived from the aloe vera plant that are known to have immune stimulating and antiviral properties.14,15 The manufacturers also use a product called arabinogalactan, a type of fiber that has been demonstrated to have an immune stimulating effect in humans.16 In a study published in the "Proceedings of the Fisher Institute for Medical Research" (a publication that lists research using the Mannatech™ products), a group of eight chronic hepatitis C patients received "glyconutritional powder and an antioxidant supplement."17 The patients in the study had declined interferon therapy or had experienced interferon treatment failure before entering the study. Participants were given the "glyconutritional powder and an antioxidant supplement" twice a day for six months. After six months on this protocol, ALT levels normalized in three out of eight patients, and four reported improvements in energy level. Liver biopsy was done on all eight patients at the beginning of the study, but no information is given about follow-up biopsy results. Viral loads were not available. Although this small pilot study is interesting because there is reason to think that the ingredients in this proprietary formula may be useful, a much larger and more detailed study would need to be done to determine if these plant nutrients have any antiviral or immune stimulating effect in hepatitis C. MGN-3™ MGN3™ is a molecule called an arabinoxylane that is extracted from rice bran. It has been tested in cancer studies and in small trials. The studies showed MGN3™ has the ability to enhance the immune response of cancer patients and to decrease the side effects of chemotherapy in studies with rats.18,19 There is clear evidence from papers published by Mamdooh Ghoenum, PhD and others that this compound increases blood levels of natural killer cells (a special type of immune cell). It also increases levels of gamma-interferon and another substance called tumor necrosis factor. Although the boost in immunity may be useful in cancer therapies, hepatitis C is a different condition. In chronic viral infection, the immune system already makes too much tumor necrosis factor, which may be a large part of the problem in hepatitis C. To date, any direct effects of MGN3™ on hepatitis C are unproven. MTH-68/B Vaccine Phlogenzyme® Phlogenzyme™ is an oral enzyme therapy manufactured in Germany. It contains proteolytic (protein digesting) enzymes and a vitamin from the flavinoid family called rutosid. A trial with hepatitis C patients in Egypt compared Phlogenzyme™ to alpha-interferon and ribavirin.23 Patients in the study were divided into four groups: 20 took ribavirin, 20 took interferon, 20 took Phlogenzyme™, and 20 took a liver support protocol that consisted of vitamins and antioxidants. After four months, the researchers compared the results of the four groups. Phlogenzyme™ was more effective than interferon or ribavirin at lowering liver enzymes (ALT, AST, and GGT). It was also associated with a 50% reduction in symptoms including appetite loss, weight loss, fever, itching, fatigue, jaundice, and spider nevi (small broken blood vessels in the skin). Interferon and ribavirin were associated with smaller reductions in symptoms. The liver support protocol was considered ineffective for both symptom reduction and liver enzyme reduction. Tolerance of Phlogenzyme™ was rated as "good" in 14 patients, whereas tolerance of interferon and ribavirin were rated as "good" by only one and four patients, respectively. This study clearly demonstrates Phlogenzyme™ has an anti-inflammatory effect on the liver. However, with no information about viral loads, the antiviral activity of this product is unknown. It is also unclear how long patients were followed after the four-month treatment period. We do not know how many (if any) of those in the Phlogenzyme™ group relapsed after 6-12 months. Mucos Pharma is the German pharmaceutical company that produces this product. They are reportedly planning larger clinical trials that will follow patients for longer periods. These studies will give us more information about how to most effectively use this natural compound in the treatment of hepatitis C. Thymic Protein A Thymic protein A was formulated by immunologist and research scientist Terry Beardsley, PhD. He currently holds the U.S. patent on this protein and is involved in research evaluating its use in immune disorders. Thymic protein A is chemically identical to a protein produced by the human thymus gland. It was originally derived from the thymus tissue of calves, but is now produced with the technology of cell cloning (reproducing cells in the laboratory). It has been shown to be absorbed orally, a problem with other thymus proteins. It increase the body's production of CD4 cells (T-helper cells) and natural killer cells, the immune system's virus killing cells.24 One study evaluated the effect of thymic protein A on people with chronic fatigue syndrome (Epstein-Barr disease). Participants were treated with 12 mcg (micrograms) of thymic protein A daily for 60 days. Treatment resulted in significant Epstein-Barr viral load reductions of 50% or greater in 67% of patients.25 Thymic protein A has not been studied in hepatitis C. However, the use of another thymic protein, thymosin alpha-1, has been the subject of hepatitis C studies. In one study, people with HCV were treated with a combination of thymosin alpha-1 plus interferon or interferon alone for 26 weeks. A higher proportion of patients treated with the combined therapy cleared virus and had a normalization of ALT compared to patients treated with interferon alone.26 Post-treatment liver biopsy results were better in the combined therapy group than in the interferon group. In the follow-up period, the biochemical response rate dropped to 14% and 8% in the combined therapy and interferon groups, respectively. Thymosin alpha-1 is a 28 amino acid
protein fragment and is much smaller than the 500 amino acid thymic
protein A. Therefore, thymic protein A may work differently than the
thymosin alpha-1. In general, a larger protein fragment (thymic protein A)
would be expected to have a greater effect than a smaller protein fragment
(thymosin alpha-1). Thymic protein A has been tested in mice, cats, and
humans and has been found to enhance immune response to viral infections.
To date, there are no published studies evaluating the effects of thymic
protein A on hepatitis C infection. Thymic protein A is sold
over-the-counter under the brand name of ProBoost®. Ultraviolet Blood Irradiation Ultraviolet blood irradiation (UBI) is not a product, but rather a technique that was popular in the early 1930s in the United States as a treatment for poliovirus. It involves removing blood from the body and exposing it to ultraviolet light. After the discovery of the Salk vaccine for the prevention of polio, and the advent of antibiotics in the 1950s, the use of UBI declined and basically disappeared until recently when it became reapproved by the FDA for the treatment of a specific type of cancer (cutaneous T-cell lymphoma).27 This particular type of UBI called "photophoresis" is currently being used in clinical trials for the treatment of autoimmune diseases like arthritis. This process is time-consuming and expensive (each treatment takes about five hours), and although a study has been published on the process being used to treat acute hepatitis A and B in 1959, there have been no published studies on the use of this technique to treat hepatitis C.28 Because this process can destroy white blood cells if it is not done properly, it should only be administered in a medical setting by a licensed physician who specializes in this procedure. It is available outside of the United States for the treatment of chronic hepatitis. Reasons for Using Over-The-Counter Products and Who May Benefit People decide to pursue complementary and alternative medicine (CAM) treatments for a variety of reasons. You may have decided to decline western therapy at this time. On the other hand, you may have experienced a treatment failure. Or perhaps your doctor has advised you to follow a "watchful waiting" course (you are monitored for disease progression but are not being treated). The reason for your interest in CAM therapy is not nearly as important as making sure whatever you decide to do is safe. It is extremely important to seek safe, clinically tested CAM treatments. As you look into your options, realize that any treatment should have proof that it is effective at improving liver function and/or quality of life in people with hepatitis C. A product that has not undergone safety studies in animals or humans may not be a wise choice. Many botanicals (both western and traditional Chinese) have been shown to be harmful to the liver. Your first concern should always be to do no additional harm to your liver. If you are on treatment and are having side effects from
your medications, there are ways to reduce these symptoms. A licensed CAM
provider can help you use botanical medicines, acupuncture, and
supplements that are specific for the side effects you are experiencing.
Their guidance can also help insure that whatever CAM therapies you use do
not interfere with your treatment's antiviral, and/or immune-enhancing
activities. Unfortunately, none of the products mentioned in this chapter
have been shown to reduce side effects from interferon-based therapy.
Reasons for Not Using Over-The-Counter Products Essentially, it is not your personal situation but the product that is in question here. If the manufacturer or provider cannot provide a reference to a published study documenting a positive effect in hepatitis C, you are taking a chance that it may not be safe and/or may have no beneficial effects. Before you take anything, we urge you to consider checking with a licensed CAM provider who treats people with chronic hepatitis C. Many botanicals (both western and traditional Chinese) have been shown to be harmful to the liver. It is best to have someone trained in complementary and alternative medicine oversee your alternative treatments. He or she can work with your primary care doctor or gastroenterologist/hepatologist. Check with the American Association of Naturopathic Physicians (AANP), the American College for Advancement in Medicine (ACAM), or the American Holistic Medical Association (AHMA) for help in finding a qualified CAM practitioner. (See the Resource Directory for contact information.) Over-the-counter products marketed to people with hepatitis C can be very expensive, especially when taken for months or years. Very few (if any) of these products are covered by health insurance policies. You also need to be aware that there are no regulations governing the manufacture of these products. Therefore, it is often difficult to know if you are actually getting what is listed on the product label. Further, there is no assurance that you will get the same product from one bottle to the next. It is sometimes challenging to find reputable distributors for these products.
Summary Many over-the-counter products are marketed to people
with hepatitis C. While some of these products may benefit the user, there
are very few documented studies on the effectiveness of these products. It
may be difficult to find reliable advice on which products are or are not
appropriate for you. Many western health care professionals are unfamiliar
with these products, and are generally skeptical about their possible
benefits.
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