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For thousands of years, plants have been used worldwide for medicinal purposes, dispensed by traditional herbalists who have been involved with their cultivation and preparation as well as assessment of their potency At present, most herbal products are commercially cultivated, processed in unregulated environments, and purchased over-the-counter without the counseling of a qualified health practitioner The use of herbs in the United States has increased dramatically over the past decade, although sales have leveled off over the past several years Herbal products are used by one of three Americans at an annual total cost of more than $4 billion, but fewer than half of those individuals discuss the matter with a conventional health care provider Consumers hold strong views about the efficacy of the supplements they take Seventy percent state that they would continue to take their favorite supplement even if a government study claimed it was not effective
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Herbal formulations include liquids (extracts, tinctures, infusions, and decoctions) and fresh, dried, and powdered preparations The potency of herbs varies widely depending on which part of the plant is used, where it is cultivated, and what variations there may be in growing conditions and methods of preparation To ensure a consistent percentage of the primary active ingredients across batches and brand names, standardized extracts have been developed Since multiple constituents may have pharmacologic activity, determining the active ingredients for standardization purposes can be a difficult task The European scientific community has played a significant role in producing and investigating high-quality standardized extracts that contain consistent quantities of marker compounds (ideally, the active ingredients) This work has laid the foundation for conducting phase 2 and phase 3 clinical trials The quality of research in the field is improving, but most herbal remedies have not been evaluated in controlled clinical trials
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In 1994, the United States Congress passed the Dietary Supplement and Health Education Act This legislative act classifies vitamins, minerals, herbs, and amino acids as nutritional or dietary supplements Under this law, supplements can be marketed without proof of safety or efficacy as long as no claim is made for their use in the diagnosis, treatment or cure, or prevention of disease Manufacturers can, however, make structure and function claims that a product enhances a normal body function or state such as thinking, mood, or immune function For example, saw palmetto can be marketed to support urinary tract health but not to treat benign
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Although many medicinal herbs are relatively safe, some have significant toxicity Herbs themselves can have unanticipated effects such as hepatotoxicity as seen with chaparral and germander Ten of twenty patients with fulminant hepatic failure referred to a liver transplant service over a 21-month period were recent or active users of potentially hepatotoxic supplements Ma-huang contains ephedrine and was sold as a component of many weight loss products and in a banned euphoriant called herbal ecstasy Over 800 adverse events
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Table 41 1 Advice to patients using herbal medicines
Communication Discuss use of all therapies with your health care provider Product Quality Manufacturers are not required to submit evidence to the FDA or any regulatory body to demonstrate product safety, effectiveness, or product quality Ask your primary care provider, a pharmacist, or a trained herbalist regarding the specific herbs you are using Use herbs that are standardized to contain a specific quantity of the active ingredients Select formulations that have been studied in clinical trials Select formulations that have been independently tested for quality Labeling Look for a seal of approval from an independent testing agency such as National Products Association (formerly National Nutritional Food Association), NSF International (formerly National Sanitation Foundation),or ConsumerLab It should state the common and scientific names of herb(s) It should state the concentration or dose of the herb(s) and provide instructions on dose and frequency It should state that the product is standardized to contain a certain amount of the active ingredient(s) It should state the methods used to ensure product quality It should state the name and address of the manufacturer It should state the batch or lot number and the expiration date It should list potential side effects and interactions Pregnancy Few herbs have been studied for safety during pregnancy Seek advice from your primary care provider before using herbs during pregnancy Interactions Discuss with your health care provider the safety profile and interactions that may occur when combining herbs and when taking herbs plus drugs Reporting Report any adverse reactions to your state poison control program or the FDA FDA, Food and Drug Administration
50% of all prescription medicines that are processed by this system such as warfarin, theophylline, and birth control pills Proving that a side effect experienced by a patient taking a dietary supplement is caused by that supplement is often difficult Practitioners should take a detailed history from the patient and, if possible, obtain a sample of the product to facilitate further analysis, if needed All suspected adverse events should be reported to the FDA s Medwatch Program (http://wwwfdagov/medwatch), although it is estimated that less than 1% are actually reported
Basch EM et al Natural Standard Herb and Supplement Handbook: The Clinical Bottom Line Elsevier Mosby, 2005 Bruno JJ et al Herbal use among US elderly: 2002 National Health Interview Study Ann Pharmacother 2005 Apr;39(4): 643 8 [PMID: 15741417] Gagnier JJ et al Quality of reporting randomized controlled trials of herbal medicine interventions Am J Med 2006 Sep; 119(9):800e1 11 [PMID: 16945616] Hu Z et al Herb-drug interactions: a literature review Drugs 2005;65(9):1239 82 [PMID: 15916450] Kelly JP et al Recent trends in use of herbal and other natural products Arch Intern Med 2005 Feb 14;165(3):281 6 [PMID: 15710790] Kennedy J Herb and supplement use in the US population Clin Ther 2005 Nov;27(11):1847 58 [PMID: 16368456] Nguyen MH et al Amphetamine lacing of an Internet-marketed nutraceutical Mayo Clin Proc 2006 Dec;81(12):1627 9 [PMID: 17165642] Wolsko PM et al Lack of herbal supplement characterization in published randomized controlled trials Am J Med 2005 Oct; 118(10):1087 93 [PMID: 16194636]
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