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hcspFACTsheet Hepatitis C Support Project • www.hcvadvocate.org
western medicine due to the lack of evidence-based research to support safety and efficacy. Couple this with the potential harm these substances can inflict and it is easy to see why physicians are reluctant to endorse herb use. Some patients are interestedin alternative methods to use with or instead of the treatmenttheir physicians have prescribed. This is particularly true forpatients living with chronic hepatitis C virus (HCV). Although hugeprogress has been made in the HCV treatment arena, current antiviral therapy has many side effects and is not always effective.
Hepatitis C Add these elements to the symptoms some people experience from HCV and it is no wonder that herbs seem attractive.
Although herbs and other supplements may seem appealing, a 2nd Edition number of herbs can cause harm. Some herbs are known to have potentially carcinogenic properties and to cause neurologicaldamage. There are herbs that can be particularly harmful to the liver and can cause damage and death. It is because of thepotential for hepatotoxicity (poisoning of the liver) that HCVpatients are advised to avoid herbs or to use them cautiously.
The Food and Drug Administration (FDA) is the federal agencyresponsible for drug and food safety. Drugs undergo years of Interest in herbs and supplements seems to be on rigorous testing on animals and humans before the FDA allowsthe rise. When I first wrote this article, it was them to be marketed. Herbs and supplements, on the other hand, difficult to find reliable sources of information are considered to be dietary supplements. This means that theyare regulated by different standards, called the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under available, it became clear it was time to update this act, it is the manufacturer that ensures the safety of the “Herbs and Hepatitis C.“ This article is not meant dietary supplement. In general, the supplement manufacturers do to be the final stop on the information highway. I not need FDA approval and do not need to register their product.
They are required, however, to label the supplement in a truthful hope the reader will use this as a tool towards gaining more insight and knowledge about theworld of herbs. Of course, this information is not The point at which the FDA may become involved with herbs is meant to be used for medical care. Always talk to after marketing. The FDA may monitor product labeling,information, and safety. Adverse event reporting is voluntary.
your primary healthcare provider before using Whether the FDA should regulate supplements is a hotly debated issue. The FDA has been criticized both for regulating and underregulating dietary supplements. For a variety of reasons, the The use of herbs for medicinal purposes has a long and FDA's involvement with herb use has been minimal. To date, the interesting history. The origins of some modern notable exception to this is the sale of dietary supplements medications are actually plants, such as aspirin from containing ephedrine alkaloids. Ephedra, also called Ma Huang, is white willow bark, digitalis from foxglove, morphine from one of the plants that are a source of ephedrine alkaloids. Its use poppies and warfarin (Coumadin) from sweet clover. Many has been associated with an increase in blood pressure, a cultures use indigenous plants for healing purposes. The condition which will increase the risk of heart attack, stroke, and use of herbs, however, is controversial in contemporary There is very little independent research involving the use of manufacturer complies with particular standards. A seal of herbs. The gold standard randomized, controlled, double approval from ConsumerLab.com (CL) also carries some blind placebo controlled studies are few in the area of distinction. Another standard is that of the world's leading botanical remedies, let alone the use of herbs and HCV. In authority on herbs, the German Commission E. This agency is 1991, the U.S. Congress established the Office of the German equivalent of the Food and Drug Administration Alternative Medicine (OAM) within the National Institutes of (FDA). The American Herbal Pharmacopoeia is also developing Health (NIH). In 1998 the National Center for standardization guidelines for the American marketplace.
Complementary and Alternative Medicine (NCCAM) became ConsumerLab.com has provided a much-needed service by a new center of the NIH. Responding to the need for more testing popular supplements. This company has discovered that research about the safety and efficacy of herbs and many products do not contain the levels of key ingredients that supplements, NCCAM and the NIH Office of Dietary are on the products' labels. A product that passes their Supplements established the first Dietary Supplements inspection may carry the triangular label with the Research Centers with an emphasis on botanicals. The ConsumerLab.com quality of approval. The use of this service specific subject of herbs and viral hepatitis was included in does have a fee associated with it. Companies that belong to the the Complementary and Alternative Medicine in Chronic American Herbal Products Association and submit to this Liver Disease conference in 1999 and a few clinical trials organization's code of ethics are another good choice.
are being conducted in this area. Unfortunately funding islimited and evidence-based data about herbs and HCV is Suggested Guidelines for Herbal Use • Assess your overall health. If you smoke, drink alcohol, and The insufficiency of independent research does not mean have other unhealthy habits, do not expect herbs to offset the that there is no value in herbs. Herbs have made a potential damage these habits can cause. Adopting healthy significant contribution to medicine. Herbal practice has habits will provide far more benefit than any herb can possibly been around for centuries and has produced some sound observations. Indigenous practitioners relied on botanicals • Discuss herb and supplement use with your healthcare for medicine. In these modern times it is common for provider. Identify all the herbs and supplements you take, even if people to self-treat mild sunburns with aloe vera, mild you think your doctor might disapprove. Drugs and supplements stomach aches with ginger, or mild colds with peppermint can interact with each other as well as with other health or chamomile tea. Generally these are assumed to be safe alternatives. However, the use of herbs for treatment of • Apply the same commonsense approach and standards to more serious conditions such as HCV is more complicated herbs as you would to any drug. If you are reluctant to take any and raises a number of questions. For example, when prescription or over-the counter drug, be equally as reluctant to choosing an herb, which part of plant is used, when is it harvested, and how is it processed? Botanicals are not • Be informed and be sure your information is current.
made in a lab setting. This means that the consistency of • Before you take an herb or supplement, find out if it is the product is at risk. Is the herbal product safe, which compatible with other drugs or supplements you are taking.
brands are the best, and what is the recommended dose? Verify that the supplement is not contraindicated for any othercondition you may have (see “A Warning about Milk Thistle and To answer these questions, start with the label. Herbs can vary in strength and purity, so it may be wise to take a • Take extra precautions if you have a history of allergies.
standardized and certified form. Certification and Botanical products can cause allergic reactions.
standardization is voluntary. The goal of the United States • Follow the label's dosage recommendations. More is not Pharmacopeia (USP) is to set industry standards for drugs and dietary supplements in the U.S. The label of a • Know your source. Herbs may be contaminated. Before supplement that displays the USP seal is worth considering.
ingesting anything, ask yourself what you know about what you A product that is certified by NSF International (formerly the National Sanitation Foundation) is another indicator that the • Choose herbs and supplements that are standardized.
• Comfrey (Symphytum officinale and S. uplandicum) • Buy products that submit to voluntary self-regulation.
• Natural does not equal healthy or safe. Snake venom is natural but not healthy.
• Do not be swayed by bargain prices. Herbs are not all equal.
• Check the expiration date on the container.
• Do not rely on the health food store staff for health care • Mistletoe (Phoradendron leucarpum and viscum album) information. Although they may be helpful, remember that salespeople are usually not licensed to practice medicine. Donot treat your condition on the advice of a salesperson.
• Be skeptical. Claims made by the product manufacturer or seller may vastly differ from independent evidence-based • Skullcap (Scutellaria lateriflora) Valerian research.
• Do not be swayed by personal testimonies. Although individuals may benefit from botanical use, the notion that "one Although not specifically associated with liver toxicity, size fits all" does not apply in medicine.
products containing ephedrine alkaloids (ephedra) should be • Do not be influenced by the latest supplement to make avoided. Reports of heart attacks, strokes, seizures, headlines. Dietary supplements can be compared to cars. When psychosis, and death have been linked to the use of new models are introduced, sometimes it takes time before ephedrine alkaloids. The FDA has banned the sale of dietary problems develop. A product that really has value will be around supplements containing ephedrine alkaloids, including • Herbs and supplements should not be given to children ortaken by pregnant or nursing women without a physician's approval. Older adults and those with various health conditions Milk thistle, Silybum marianum, is the most commonly used should also exercise extra caution before taking non-prescribed herb for liver problems. A frequently asked question supplements. Herbs should never be used with decompensated regarding chronic hepatitis C viral (HCV) infection concerns the use of this herb. If you are considering taking a milk • Some herbs prolong bleeding times or interfere with thistle product, talk to your doctor and find out if it is anesthetics. Stop all herb use at least a week prior to any compatible with other drugs or supplements you are taking.
surgery or procedure that uses anesthesia. Tell your attending Verify that the supplement is not contraindicated for any physician and anesthesiologist about any herbs you are using, other condition you may have (see “A Warning about Milk particularly if the procedure occurs before you have sufficient Thistle and Drug Interactions” below). Do not use milk time to observe this "wash-out" period.
thistle if you have decompensated cirrhosis.
• Report any suspected adverse reactions to an herb orsupplement to the FDA's monitoring program, Medwatch. Call Medical consultants for the Consumers Union 800-322-1088 or www.fda.gov/medwatch.
recommended the following in the April 2001 issue ofConsumer Reports On Health: Some Herbs Associated with Liver Toxicity • Patients should not use milk thistle to replace a This list is primarily liver specific and by no means exhaustive.
conventional treatment for viral hepatitis; The substances on this list are referred to in their oral form only.
• Patients should not take milk thistle while on aconventional treatment for viral hepatitis; • Milk thistle is probably safe and no one should bediscouraged from taking it if there are no other options; • Choose a brand that contains silibin and phosphotidyl choline, which may be better absorbed.
There is insufficient research to establish a suggested daily • transplant drugs - cyclosporine (Neoral, Sandimmune), dose of milk thistle. Typical dosages are in the range of 140-420 mg in divided doses, 2-3 times a day of 70-80%silymarin. See the section "Suggested Guidelines for Herbal Milk thistle also has the potential to lower levels of the Use" (above) for more information on choosing milk thistle • anti-parasite drugs - Mepron (atovaquone)• sedatives/sleeping pills - Ativan (lorazepam) A Warning About Milk Thistle and Drug Raman Venkataramanan and colleagues1 at the Universityof Pittsburg reported observations about silymarin, a There is virtually no research on the safety of herbs and compound found in milk thistle. In short, this report raised supplements co-administered with peginterferon/ribavirin concerns that silymarin may impair the metabolism of therapy. Because of this, it is common for patients to abstain certain drugs when taken together. Further, the potential from milk thistle and herb use while undergoing antiviral exists for increased toxicity of co-administered drugs in the therapy. Even commonly used botanicals need to be used with caution. Some herbs and supplements can hinder the ability ofthe blood to clot. For instance, ginger is widely used to relieve The medications levels of the following may nausea. However, patients with gallstones should talk to their taken by people who are also using milk thistle. The source health care provider prior to using ginger. Additionally, ginger for this list is the Community AIDS Treatment Information has an anticlotting action and should not be taken if you have Exchange (CATIE) and is not meant to be complete.
reduced blood clotting ability. Interferon therapy and/or cirrhosis can also interfere with blood clotting, so there may be an increased risk if some herbs are used simultaneously under these conditions. Other commonly used herbs, such as • heart drugs - Tambocor (flecainide), Rythmol chamomile and St. John's Wort carry a warning of potential drug interactions. The rule of thumb is to be informed and talk to your healthcare provider prior to using any botanical product.
• anti-seizure drugs - carbamazepine (Tegretol)• antidepressants - St. John's wort, Zyban/Wellbutrin Warning: Bupleurum is a popular herb used in a variety of (bupropion), Paxil (paroxetine), Prozac (fluoxetine), Luvox Traditional Chinese and Japanese Medicine Mixtures for liver (fluvoxetine) Serzone (nefazodone), Zoloft (sertraline), conditions. At least 16 deaths have been reported in Japan for HCV patients being treated simultaneously with alpha interferon • antihistamines - Hismanal (astemizole), Seldane and Xiao Chai Hu Tang (Minor Bupleurum).
(terfenadine)•antifungals - itraconazole (Sporanox), Ketoconazole (Nizoral)• gastrointestinal motility agents - Prepulsid (Cisapride) Herbs have been part of the healing arts for centuries. Clearly • ergot drugs - Ergonovine, Ergomar (ergotamine) more information and research needs to be conducted in this • anti-psychotics - Clozaril (clozapine), Orap (pimozide) area in order to better understand and incorporate the use of • sedatives/sleeping pills - Ambien (zolpidem), Halcion botanical products into current health practices. In the meantime, make informed decisions regarding your health. Your • lipid-lowering drugs (statins) - Lescol (fluvastatin), Mevacor (lovastatin), Pravachol (pravastatin) and Zocor(simvastatin), Baycol (cerivastatin) 1 Venkataramanan R, Ramachandran V, Komoroski BJ, et al. Milk thistle, aherbal supplement, decreases the activity of CYP3A4 and uridine diphosphoglucuronosyl transferase in human hepatocyte cultures. Drug Metabolism and Disposition 2000;28(11):1270-1273.
• The American Pharmaceutical Association Practical Guide toNatural Medicines by Andrea Peirce.
• The ABC Clinical Guide to Herbs edited by Mark Blumenthal,et al at the American Botanical Council.
• ConsumerLab.com's Guide to Buying Vitamins &Supplements: What's Really in the Bottle by Tod Cooperman,M.D., William Obermeyer, Ph.D., Denise Webb, R.D., Ph.D.
• The Green Pharmacy by James A. Duke.
• Herbs of Choice by James E. Robbers and Varro E. TylerPDR for Herbal Medicines published by the Medical EconomicsCompany.
• Tyler's Honest Herbal: A Sensible Guide to the Use of Herbsand Related Remedies by Stephen Foster and Varro E. Tyler,Ph.D.
• American Botanical Council - 512-926-4900www.herbalgram.org• American Herbal Products Association - www.ahpa.org• ConsumerLab.com - www.consumerlab.com• FDA Dietary Supplement website - vm.cfsan.fda.gov/~dms/supplmnt.html• HerbMed - www.herbmed.org• Memorial Sloan-Kettering Cancer Center - www.mskcc.org/aboutherbs• National Center for Complementary and Alternative Medicine -888-644-6226 http://nccam.nih.gov• National Institutes of Health Clincal Trial Information -www.clinicaltrials.gov •hcspFACTsheet
• National Sanitation Foundation - http://www.nsf.org A publication of the Hepatitis C Support Project
• NSF International - www.nsf.org• The United States Pharmacopeia - 800-822-8772 E x e c u t i v e D i r e c t o r
Editor-in-Chief, HCSP Publications
• UC Berkeley Wellness Letter - www.wellnessletter.com • United States Pharmacopeia - www.usp.org Design
Paula Fener
should consult a medical practitioner fordiagnosis and treatment of HCV.
Production
C.D. Mazoff, PhD
This information is provided by theHepatitis C Support Project • a nonprofit Contact information:
Support Project • Reprint permission is granted and encouraged with credit tothe Hepatitis C Support Project.

Source: http://www.hbvadvocate.org/FactSheets_old%20archive/Herbs2.pdf

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