Advising Patients on Dietary Supplements, Herbs, and Other Complementary Substances
Advising Patients on Dietary Supplements, Herbs, and Other Complementary Substances
Author: Cynthia Sheppard Solomon, BPharm, RPh, FASCP, President, Sheppard-Solomon Biomedical Consulting, Dayton, OH.
Peer Reviewer: Jane L. Murray, MD, Medical Director, Sastun Center for Integrative Health Care, Overland Park, KS.
In the past half century, technology, environmental awareness, and modern science have surged. Yet, as in all generations, a significant number of consumers, perhaps intent upon getting back to simpler times, are choosing "healthful" therapies not fully accepted by the mainstream. In the past several decades, the use of complementary-alternative medicine (CAM), specifically dietary supplements, has grown dramatically. By 1998, Eisenberg reported in the Journal of the American Medical Association that 42% of the U.S. population was using at least one alternative treatment.1 Survey rates continue to substantiate that at least 35-50% of consumers are using dietary supplements or herbs regularly.2 Because it is difficult for health care professionals to know everything about the thousands of ingredients in dietary supplements, reviewing a few key concepts can be helpful. Dietary supplements may include vitamins, minerals, herbals, botanicals, amino acids and enzymes, microbial pro-biotics, and metabolites.3
Claims from both manufacturers and individual testimonials regarding CAM have never been greater. Those made about dietary supplements and herbs need thorough evaluation. Rules and regulations differ dramatically from those of prescription and over-the-counter medicines. Gone are the days when a physician could assume there would be no impact on the patient's current or long-term health with the use of a dietary supplement or herb. Health care professionals must not assume these products have only nominal effects. All biologically active substances have benefits and risks associated with use. To best identify the level of risk versus benefit for individual patients, physicians must be able to recognize the main ingredients in the most popular remedies. By discussing the issues in a balanced way, physicians will reinforce the patient-physician partnership.
Label requirements for dietary supplements and herbs differ from prescription and OTC drugs, and labels for dietary supplements may not always be accurate. To advise patients appropriately, it helps to know how to find accurate information. Physicians must verify the facts and clearly communicate the evidence in easy-to-understand terms.
Perceptions Versus Reality
For patients, dietary supplements generally are regarded as safe. Herbs and vitamins often are assumed to be milder and safer than prescription drugs.4 Consumers believe products chosen for health and well-being usually are derived from safe, natural ingredients, unlike prescription drugs, which may be manufactured synthetically.2 These commonly held perceptions, while not always accurate, can become the consumer's reality. Dietary supplements do not require a doctor visit or a prescription for use, making them easy, accessible, and convenient. Conventional care often can be fragmented and impersonal. When patients see a CAM practitioner, they often view him or her as optimistic and able to spend time talking with and touching them.5
While the public may believe that "natural" equates with "safe," it is clear that natural products can, at times, be toxic.5 A dangerous and mistaken belief held by much of the public is that natural products have no risks and will have the "advertised" or promoted benefit. Yet, misidentification of medicinal mushrooms has led to liver failure, and contamination of tryptophan supplements caused eosinophilia-myalgia syndrome.5 In general, consumers may not be aware that overdoses and drug interactions also can occur with dietary supplements.2 Constituents of natural products, such as St. John's wort,6 also may interfere with the metabolism of life-saving drugs.5 Patients may not realize that substances still may be unsafe in spite of being natural.
Contaminants, too, regularly turn up in supplements. In 1998 Richard Ko, PhD, of the California Department of Health Services reported that 32% of the Asian patent medicines he tested contained pharmaceuticals or heavy metals that were not listed on the label. The FDA has seized supplements adulterated with prescription drugs, including, in 2002, an herbal "prostate health" supplement called PC SPES that turned out to contain warfarin, indomethacin, and diethylstilbesterol.7,8
The American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Prevention (released in 2006) state that food still is the best source of vitamins and minerals. Because high doses of some nutrients have adverse effects, the best choice when supplementing is to take a balanced multi-vitamin with minerals containing no more than 100% of the daily value, formerly the RDA.9,10
On the other hand, some vitamins and minerals have been shown to require moderate supplementation. As viable protectors of good bone health, vitamin D and calcium are recommended for moderate supplementation.10 A randomized controlled trial of 3000 high-risk women given 1000 mg of calcium and 800 IU of vitamin D per day showed no overall reduced risk of clinical fracture rate.11 Some believe there may be a dose-related benefit for vitamin D (800 IU vs 400 IU, in certain fracture types).11
Fortified foods, such as calcium-containing orange juice, may not provide all the nutrition advertised. Due to problems of bio-availability, only a small percentage of the added calcium may be available for absorption. Research has shown decreased bioequivalence of some antibiotics, including ciprofloxacin and levofloxacin, when co-administered with calcium-fortified orange juice.12 The interaction does not appear to be related to chelation. Health News reported in 2006 on the lack of investigation in studying food fortified with amounts of multiple vitamins that equal or exceed many supplement products.13 These and many similar products are being promoted as convenient and healthful to millions of Americans. Consumers must be made aware that things are not always as they seem.
Surveys have shown that consumers believe mega-doses are often better than modest doses. There is a mentality among consumers that if a little is good, a lot must be better. An example of this is the popularity of mega-dose multi-vitamins. More is not necessarily better, especially with fat-soluble vitamins. Side effects of vitamin A (retinol, retinoic acid, retinal) include nausea, vomiting, headache, dizziness, blurred vision, clumsiness, birth defects, and liver problems. Some products may be harmful when consumed in high amounts, for a long period of time, or in combination with certain other substances.3 In general, supplementation with vitamin C, vitamin E, or beta-carotene offers no overall benefit in primary prevention of total cancer incidence or cancer mortality.14 Today, beta-carotene is not recommended for high-dose supplementation.10 Its theoretical benefits have been disproved, having been shown to be associated with ischemic heart disease, increased lung cancer,15,16,17 and an 8% increase risk of all-cause mortality.18 Multi-vitamin preparations usually contain 1000–10,000 IU of beta-carotene, equivalent to 0.6-6 mg, while individual beta-carotene supplements may contain 12-15 mg.10
While vitamin C can be effective in protecting the immune system in quantities not exceeding maximum body pools of 300-400 mg per day,10 higher amounts provide no greater protection to the immune system. Taking vitamin C does not prevent upper respiratory infections.19 There is no convincing evidence that taking vitaming C prevents any disease except scurvy.10 In amounts greater than 1000 mg, doses are poorly absorbed, cause diarrhea and other gastric irritation, and could increase urinary oxalate excretion to a level that can cause kidney stones.19 The topical use of vitamin C is found in cosmetics to exfoliate the top layer of skin. Tooth enamel may be damaged when vitamin C tablets are chewed without rinsing out the mouth.
A major factor that influences the purchase and use of certain products is the testimonial effect of a friend's recommendation. Consumers often feel they can trust a friend to be honest and helpful in directing them to new remedies. They may not believe their friend would mislead them. For many patients, their use of supplements represents an effort to take charge of and be instrumental in their own health care.4 Easy access to products without seeing a physician can be a big positive for consumers. It is the essence of wellness versus illness. Alternatively, they may not feel comfortable disclosing their CAM use to their physician for a variety of reasons, including anticipating their physician's disinterest, anticipating a negative response, or assuming their physician lacks sufficient knowledge to contribute useful information.20 When patients do not share complete information, it is difficult for physicians to identify4 adverse effects, as many patients use some form of alternative therapies.2 For both consumers and physicians, it can be a challenge to move toward honest, open communication regarding this subject.
Dietary supplement availability has resulted in a communication gap between physicians and patients.4 Physicians, concerned they might not be knowledgeable enough to advise patients on supplement ingredients, may steer clear of asking pertinent questions regarding regular or intermittent supplement use. If one assumes a patient does not take supplements just because she will not share information about them, a large piece of the medical history may never be uncovered. Physicians also may believe that a patient is complying with advice and fully understands what is expected if he or she has no questions for the doctor. Perhaps most troubling, physicians may not view dietary supplements and herbs as serious entities, which are not always risk free, especially when combined with other products. Some physicians believe patients do not need to tell all. Then, the physicians won't have to know all the answers.
To communicate clearly with patients, it is helpful to have credible, accurate efficacy and safety information on products. However, showing honest interest in assisting patients, even without the specific product-related evidence, can strengthen the patient-physician partnership. Registered pharmacists and medical librarians can provide useful information to support physicians' needs. Helpful sources for accurate information on supplements/herbs are found in Table 1. Using evidence-based data, health care professionals can lessen the power of subjective testimonials that are not usually based in fact.
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Rules and Regulations
The Office of Alternative Medicine at the National Institutes of Health was established in 1991 to consolidate all areas of CAM. Fraught with controversy about how and why it was established, it was renamed The National Center for Complimentary Medicine (NCCAM) in 1998. Its charge is to explore complimentary and alternative medicine healing practices in the context of rigorous science and to train CAM researchers and disseminate authoritative information to the public.21 Even in 2009, controversy still surrounds both the strategy for and the $122 million budget21 associated with its work. The National Cancer Institute also has an Office of Cancer Complimentary and Alternative Medicine (OCCAM) with a similar budget this year.
The regulation of dietary supplements, vitamins, and herbs changed dramatically in 1994 with the passage of the Dietary Supplement Health and Education Act (DSHEA). A dietary supplement is defined as a product other than tobacco that is intended for use by humans to supplement the diet by increasing total dietary intake and that contains one or more of the following ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, or a dietary substance. For the entire DSHEA, see reference.22
The use of supplements has increased significantly over the years, with more than 29,000 products exploding onto the market by the early years of the new millennium.23 More than an additional 1000 products are added every year. The passage of DSHEA has given the public access to a huge number of items marketed to promote or maintain health. Under DSHEA, the Food and Drug Administration (FDA) has little oversight. Efficacy and safety studies are unnecessary, as the supplement manufacturer is responsible for ensuring the product is safe before it is marketed. Manufacturers are responsible for making sure the product label is truthful and not misleading.2,24 Supplements are assumed to be safe unless proven otherwise by the FDA through post-marketing surveillance.4 The Federal Trade Commission (FTC)25 evaluates whether the manufacturer makes a "medical" claim, falsely advertising "a cure or preventive solution" for a medical illness. Advertising a dietary supplement as a cure or as a medical treatment is a crime. Unfortunately, the FTC operates under the same basic guidelines for all advertised products. It does not approve individual ads before their use.26 It relies on advertisement surveillance for enforcement of its guidelines.27 Although labels are required to be factual and helpful in content, often, they are not. They may not include a complete list of actual ingredients, their amounts, or safety information.25,28,29 And ingredients, as listed on the label, may not actually be present in the bottle. This increases the difficulty of identifying and handling adverse effects in a timely and efficient manner. Often the manufacturer withholds the proprietary information, touting the benefits of its particular recipe. Even when contacted, the manufacturer may withhold the facts. The FDA Med Watch program should always be alerted when any adverse effect is suspected with any supplement. The web site is www.fda.gov/MedWatch/report.htm.
DSHEA was designed to protect consumers' right of access to dietary supplements, so as to promote wellness. Dietary supplements are not meant to be used as medical treatments.2 For credible medical treatments, the FDA would demand the manufacturer file a new drug application (NDA) and require clinical studies for a potential prescription drug product.
For example, glucosamine/chondroitin is currently under evaluation by the government for its medical benefits. Although numerous studies have disproved its use as a preventive, the final word on its use as an osteoarthritis treatment remains out. Results may depend on which proprietary preparation is being studied. The supplement needs to be given around the clock and in appropriate doses. The preparation studied in the NIH project was a controlled-release product not currently available for sale in the United States.30 This has not stopped some glucosamine manufacturers from promoting their specific product as the one studied by the NIH, or from adding a number of other questionable ingredients, such as methylsulfonylmethane (MSM), into their formulations. Promoted as a natural source of sulfur, MSM as an ingredient had U.S. retail sales of $115 million in 2003.30 Protein in the diet is an abundant source of sulfur, found in the amino acids cysteine and methionine. No peer reviewed data exist on long-term safety and efficacy for MSM.31,32
Resources for Verifying Quality
The United States Pharmacopeia (USP) now offers the manufacturers of dietary supplements the opportunity to voluntarily submit their product for quality testing. Through the Dietary Supplement Verification Program (DSVP) (http://www.usp.org), products may carry a USP seal of approval on their label to assure quality standards are as stated on that label. When choosing between brands, it helps to have a manufacturer that has voluntarily submitted for this approval. At least the consumer will know that the ingredient being advertised is present and in the specified amount.
Internet purchases of drugs and related products are up dramatically. A safety feature for Internet drug sites allows consumers the opportunity to verify sites through the use of a VIPPS seal. This seal showcases specific sites as those fulfilling their obligation to use and employ registered pharmacists in the provision of drug therapy. Without the seal visibly displayed on the homepage, it is difficult to confirm whether applicable laws and regulations are being followed relative to procurement and dispensing of medications.
Specific Products
Many patients taking oral anticoagulants may be placing themselves at risk when they also use popular supplements, including those known to increase the risk of bleeding. These include ginger, ginkgo biloba, ginseng, cayenne, willow bark, St. John's wort, vitamin E, and coenzyme Q-10. These ingredients, when taken regularly, should be discontinued two weeks prior to surgical or dental procedures. In addition, cranberry juice recently was shown to increase INR values (International normalized ratio).33,34
Zinc has been studied to assess its value in treating the common cold. After a recent review of more than a dozen studies,35 there is still no therapeutic consensus. Half of the studies showed an effect, and half did not. The route of administration and timing are both important. The mineral has greater effectiveness in treating a cold when applied to the nasal mucosa in the nasal spray formulation or as a lozenge, which dissolves into the mucus membranes. The product needs to be used at the first sign of symptoms and must be used multiple times throughout the day. There is evidence of adverse effects, including altered taste, dry mouth, and gastrointestinal upset.
When eaten in sufficient quantities, allicin and alliium compounds found in garlic and onions help boost immune function. Garlic supplementation in powder form has never been proven to reduce cancer risk. It continues to be studied.9 Also, soy supplementation does not appear to reduce cancer risk, although soy eaten as whole food is an excellent source of protein.9 Women with a history of estrogen receptor-positive breast cancer are not good candidates for taking excess soy, a phytoestrogen, in either form. Recognizing when benefits are viable, disproved, and unproven can help patients make better choices. When product expense is high and safety and viability are low, patients may wish to reconsider use. Table 2 provides a quick look at some formulations with references.
Patients taking supplements may show an increased susceptibility to interactions with drugs, foods, or other dietary supplements. Patients with cardiac problems who take herbs are especially vulnerable to medicines such as cardiac glycosides and warfarin with narrow therapeutic windows. Patients with diabetes may be vulnerable to supplements affecting glucose control. And patients with depression using St. John's wort may not realize its interactions with protease inhibitors, cyclosporine, and other antidepressant medications. St. John's wort often is considered harmless, but it may cause hypersensitivity to the sun. It also will affect plasma concentrations of drugs that are metabolized by the cytochrome P-450 (3A4) system, lowering serum concentrations of certain drugs.
Many current supplements have multiple ingredients, making it very challenging to know the facts about each. If the label does not include complete information, one must seek out the specifics. The manufacturer may not provide it and may make it difficult to retrieve it. It is imperative to clarify each ingredient and its amount prior to use.
Six caffeine-containing plants, primarily consumed as beverages, are more widely consumed than all other herbal materials put together.36 These include ingredients such as guarana, cocoa, cola or kolanuts, coffee, and tea. Caffeine is an effective CNS stimulant that produces undesirable side effects at higher dosesfrom nervousness and insomnia to rapid or irregular heartbeats, elevated blood sugar and cholesterol levels, excess stomach acid, and heartburn. Recommendations have been made for non-pregnant adults to limit total caffeine to no more than 250 mg per day.36 Caffeine and water drinks and caffeine in tablet form also can add to the overall amount of caffeine taken in, placing users at increased risk.
In early May, the FDA issued a warning to consumers about one weight-loss, energy-enhancement supplement, Hydroxycut. The FDA has received multiple reports of serious side effects, including death due to liver failure, liver damage requiring transplant, elevated liver enzymes, and jaundice. Although the FDA says it cannot determine exactly which ingredient or ingredients in Hydroxycut may be associated with liver injury, hydroxycitric acid from the tropical Garcinia cambogia plant has been shown to cause atrophy in rat testes.37,38 In 1998, researchers determined that Garcinia cambogia was not associated with weight loss in humans.39 Garcinia still is found combined in many energy and weight-loss formulations.
An increasing number of multiple-ingredient combinations are being offered as caffeine-containing energy drinks for health and well being. Ginseng, taurine, guarana, and caffeine, all with CNS stimulatory effects, may be found in the products' energy mix, providing a powerful additive stimulatory effect. For reference, one cup of coffee contains 100-150 mg caffeine.40 If the entire 16-ounce can is consumed, additive and unpredictable stimulant effects can create potential for harm to an unknowing consumer. Emergency departments are seeing an influx of young people overdosing on these products. Parents may think it is harmless for a teen to drink a 100% juice drink. Seizures, tachycardia, coma, and death are all possibilities when these potions are consumed in large amounts.
Another example of a multi-ingredient product is a breast-enhancement formulation that contains a hormonal mix of estrogenic compounds (phytoestrogens-herbs, soy, etc.). Its advertisement claims include: increase breast size naturally; all natural, non-surgical, breast enhancement tablet; clinically proven formula; delivered discreetly; guaranteed increased cleavage; stimulate your breast glands just like when you were a teen. The ingredient list includes saw palmetto, black cohosh, fennel seed, damiana tumera, blessed thistle, dandelion, watercress, dong quai, and wild yam, a DHEA alternative. The mix of estrogenic substances may show a small effect in the breast tissue. Patients with a history of estrogen receptor-positive breast cancer should be wary of the increased risks this type of product might provide. These ingredients have significant risks associated with their use, including thromboembolic activity.
Warnings
The FDA has banned the use of ephedra, or ma huang, a stimulant with cardiac and respiratory properties historically found in weight loss dietary supplements. Although it does not have oversight into DSHEA products, the FDA can intercede if harm has been shown. Although the FDA long ago banned ephedra as a drug, dietary supplements commonly contained this ingredient after the DSHEA was passed. A prolonged battle was waged by the FDA to prove ephedra-containing products unsafe.1 The NCAA, the NFL, and the International Olympic Committee (IOC) also have banned this ingredient. Although now prohibited from use in this country both as a drug and as a dietary supplement, ephedra continues to find its way into products still on shelves. Also, some currently available weight loss remedies use herbs like bitter orange (Citrus aurantium), which create similar effects. Myocardial infarction, stroke, and syncope have been reported with their use.40,41,42
The FDA recently has notified consumers regarding tainted weight-loss preparations. The FDA web site (http://www.fda.gov/bbs/topics/NEWS/2009/NEW01977.html) lists more than 70 products, including some dietary supplements, involved in an agency recall of tainted weight-loss pills. An FDA analysis found undeclared active pharmaceutical ingredients, including prescription products such as sibutramine and phenytoin and other drugs not currently approved in the United States, as well as a suspected cancer-causing agent. These weight-loss products are promoted and sold on web sites and in retail outlets. Some claim to be natural or to contain only herbal ingredients, but they actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements.44
Another common ingredient in liquid weight loss supplements is aloe vera. When used topically, aloe is an efficacious and safe burn treatment. When ingested, however, it is a dramatic stimulant laxative that causes severe diarrhea and dehydration. Sadly, while patients may lose some water weight, calories still are ingested.45 In addition, dieter's teas continue to be promoted for their colon-cleansing effects, despite no evidence of efficacy. These concoctions contain large quantities of senna, aloe, buckthorn, and other plant-derived laxatives that, when consumed, can cause diarrhea, vomiting, nausea, stomach cramps, chronic constipation, fainting, and perhaps death.46
The "stress reducer" potion kava kava (from the pepper Piper methysticum) is a liver toxic47,48 herbal alternative to benzodiazepines. Found indigenously in Tahiti, its common name is "tribal tonic." Fulminant hepatic failure has been reported as a consequence of use.49 It should not be used. When ingested with alcohol or anti-anxiety agents such as benzodiazepines, additive sedation should be expected.
Since the publication of a 2003 study in Diabetes Care, cinnamon has garnered interest for more than just its flavoring appeal. Sixty South Asian adults with poorly controlled type 2 diabetes participated in a random controlled trial. Although changes in A1c were not measured, patients receiving various doses of cinnamon per day showed reduced blood concentrations of glucose, triglycerides, and LDL cholesterol. A 2008 meta-analysis of five randomized controlled trials involving 282 patients did not show significant improvement in fasting blood glucose, A1c, and lipid concentrations.50 Evidence remains contradictory, and as such, concentrated cinnamon oils as a dietary supplement should not be used.
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Inset A. Educating Consumers on Health-related Information Sources During the past decade, direct-to-consumer drug advertisement, the availability of dietary supplements, and increased media coverage about new health care technologies have created new demands for educational resources for consumers. Being able to depend on these resources is imperative. Is the information evidence-based or is it driven by personal experience (i.e., a testimonial)? With increased consumption of herbs/dietary supplements, there comes an abundance of direct-to-consumer ads and product promotion. This promotional agenda often has created an unprecedented manipulation of medical dataoften focused on innuendo and extrapolation instead of sound research for a particular medical claim. As the promotion of these unregulated products continues unabated, one must be aware that fact and fiction may be intertwined. Educating consumers to interpret and discriminate between sources of medical and health-related information becomes a major priority. Having the skill set to assess the relative importance of a breaking health-related story can be very important. Learning from each news report, consumers can get better at evaluating how a particular story or new study will affect them personally. Consumers need to be more savvy. They must consider that supplements and medications can and do interact in negative ways. Knowing the issues, sharing concerns and questions with a physician or pharmacist, and learning about each ingredient before it is consumed reduces risks. It often is impossible to obtain accurate information on dietary supplements just by reading the bottle labelit may not contain accurate information. It may require a phone call to the manufacturer to ascertain the actual composition of ingredientsboth the chemical name and dosage. The FDA does not regulate dietary supplements (1994 DSHEA act). Drug Information Services found in pharmacy departments of local hospitals or registered pharmacists can assist people in trying to compile more information on these types of products. Health-related web sites and other printed materials can be helpful in providing accurate, unbiased information on this subject. Use USP and VIPPS seals to identify credible products. The FDA has a consumer friendly web site at www.fda.gov, where one can find sources such as Medline Plus specifically for consumer use. |
Old-time remedies such as "grandma's hot toddy," with ingredients such as, sassafras, licorice, or sarsaparilla, are all liver toxic. Natural licorice, containing the ingredient glycyrrhizin, which is related to aldosterone and desoxycorticosterone, can cause pseudoaldosteronism. Decades ago, this was banned in medications by the FDA. It keeps popping up in teas and dietary supplements today.36 Sassafras, used as a root beer flavoring, was touted as a syphilis cure in the late 1800s. It is promoted as a liver-cleansing tonic today. Found in supplement combinations, it has been shown to be associated with various cancers.
Chamomile, often found in stress-reliever teas, is part of the ragweed family.36 It can be highly allergenic and should not be given to people with asthma or to patients with co-morbidities. It also should be avoided in infants and children.
Other herbs to avoid due to high probability of toxicity are comfrey, chaparral, coltsfoot, pennyroyal, germander, jin bu huan, mistletoe, ragwort, and tansy.
Counterfeit drugs, defined as those with no active ingredient, an incorrect amount of active ingredients, an incorrect ingredient, and/or unapproved labeling and packaging, represent an unquantified problem of international proportion. The problem of counterfeiting can involve natural products and ingredients found in dietary supplements and herbs.51 The most counterfeited drug product to date is sildenafil (Viagra). Between 2003 and 2005 in the United States and China, major problems with illegal manufacturing identified more than a million counterfeit tablets in various incidents.52,53 In addition, "herbal Viagra" often contains yohimbine bark, which increases peripheral blood flow to the penis. Also called yohimbe (Pausinystalia yohimbe),36 this herb manipulates blood pressure and has been associated with myocardial infarct, arrhythmias, respiratory depression, and death.8,36
Notions on Potions
For timely information on supplements, patients and physicians should utilize the expertise of registered pharmacists at pharmacies, medical centers, or mail-order prescription centers. Physicians also can consult with medical librarians to procure viable and pertinent information. Health care professionals can seek out credible references from the NIH, the NCCAM, and the FDA web sites for support. Having reference materials available, using the poison control centers, and understanding how to report possible adverse effects can help both physicians and their patients. Physicians must help their patients become more knowledgeable consumers. Patients who feel their product choices are free of risk will have difficulty connecting possible adverse effects with their use of those products. Educating consumers to be discriminatory about reliable references can be instrumental in developing more effective communication with them. (See Inset A.) Health care professionals must continue to use open-ended questions and nonjudgmental statements to provide a positive environment for developing this relationship further. Patients' responses to the use of supplements and herbs should be monitored and recorded. Adverse effects associated with all medications, herbs, and nutritional products can be reported to the FDA through the MED WATCH program at 1-800-FDA-1088 or on the Internet at www.FDA.gov.
As for the currently available products, buyer beware. Adulteration and counterfeiting are real-life occurrences that are happening with significant frequency. Making educated choices based on factual data will provide the path to the best health-related choices.
Converse with each patient. Share your concerns and ask their opinions. There is no excuse for not inquiring about what products patients use regularly or once in a while. Patients may not realize you care about their use of these types of substances. Demonstrating interest will go a long way toward reinforcing the patient-physician partnership. The road to success is paved with good intentions. Ask, and they might tell. It can make a difference to your patients and to you.
References
1. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997. Results of a follow-up national survey. JAMA 1998;280:1569.
2. Morrow JD, Edeki TI, El Mouelhi M, et al. American Society of Clinical Pharmacology and Therapeutics Position Statement on Dietary Supplement Safety and Regulation. Clin Pharmacol Ther 2005;77: 113-122.
3. FDA-Consumer Health Information. 2/21/09. Fortify your knowledge about vitamins. http://www.fda.gov/CONSUMER/updates/vitamins111907.html.
` 4. Ashar BH, Rowland-Seymour A. Advising patients who use dietary supplements. Am J Med 2008;121:91-97.
5. Straus S. Complimentary and alternative medicine. In: Kasper, et al, eds. Harrison's Principles of Internal Medicine, 16th edition. RR Donnelly and Sons; 2005: 66-70.
6. Hypericum Depression Trial Group. Effect of Hypericum perforatum (St. John's wort) in major depressive disorder. JAMA 2002;287:1807.
7. U.S. National Institiutes of Health. National Cancer Institute: Questions and answers about PC-SPES. http://www.cancer.gov/cancertopics/pdq/cam/pc-spes/Patient/Page2#Section_5.
8. CR Investigates: Dangerous supplements still at large. Consumer Reports. May 2004: 12-17.
9. Kushi LH, Byers T, Doyle C, et al. American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Prevention: Reducing the risk of cancer with healthy food choices and physical activity. CA Cancer J Clin 2006;56:254-281.
10. [No authors listed.] Vitamin supplements. Med Lett Drugs Ther 2005;47:57-58.
11. Porthouse J, Cockayne S, King C, et al. Randomized controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care. BMJ 2005;330:1003.
12. Wallace AW, Victory JM, Amsden GW. Lack of bioequivalence when levofloxacin and calcium-fortified orange juice are co-administered to healthy volunteers. J Clin Pharmacol 2003;43:539-544.
13. Orange juice with vitamin D. Health News 2006;12:16.
14. Lin J, Cook NR, Albert C, et al. Vitamins C and E and beta carotene supplements and cancer risk: A randomized controlled trial. J Natl Cancer Inst 2009;101:14-23. epub2008 Dec30.
15. Klein E. Supplements and the prostate: Widespread use, little evidence. Cleve Clin J Med 2003;70:169-176.
16. Omenn GS. Chemoprevention of lung cancers: Lessons from CARET, the beta-carotene and retinol efficacy trial, and prospects for the future. Eur J Cancer Prev 2007;16:184-191.
17. Satia JA, Littman A, Slatore CG, et al. Long term use of beta-carotene, retinol, lycopene, and lutein supplements and lung cancer risks: Results from the VITamins And Lifestyle (VITAL) study. Am J Epidemiol 2009;169:815-828. Epub2009Feb10.
18. Tanvetyanon T, Bepier G. Beta-carotene in multivitamins and the possible risk of lung cancer among smokers versus former smokers: a meta-analysis and evaluation of national brands. Cancer 2008;113:150-157.
19. Douglas RM, Hemila H, Chalker E, et al. Vitamin C for preventing and treating the common cold. Cochrane Database Syst Rev 2004;18;CD000980.
20. Adler SR, Fosket JR. Disclosing complimentary and alternative medicine use in the medical encounter: A qualitative study in women with breast cancer. J Fam Practice 1999;48:453-458.
21. Brown D. Critics object to "Pseudoscience" Center. Washington Post 3/17/09, page HE01. Accessed http://www.washingtonpost.com/wp-dyn/content/article/2009/03/16/AR2009031602139.html
22. Dietary Supplement Health and Education Act (DSHEA), Public law 103-417, 1994.
23. Blendon RJ, DesRoches CM, Benson JM, et al. Americans' views on the use and regulation of dietary supplements. Arch Int Med 2001;161:805-810.
24. FDA Consumer Health Information. U.S. Food and Drug Administration. http://www.fda.gov/consumer/updates/erectiledysfunction010408.html. Accessed 2/21/2009.
25. National Research Council. 2005. Dietary Supplements: A framework for evaluating safety.
26. The Federal Trade Commission. Dietary supplements: An advertising guide for industry. http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm.
27. The Federal Trade Commission. FTC testifies on the marketing of dietary supplements. http://www.ftc.gov/opa/2003/10/dietarysupptest.htm.
28. Gilroy CM, Steiner JF, Byers T, et al. Echinacea and truth in labeling. Arch Intern Med 2003;163:699-704.
29. Office of Inspector General. Dietary Supplement Labels: An assessment. OE1-01-01-00121. Boston: Office of Inspector General, DHHS; 2003.
30. Towheed TE, Maxwell L, Anastassiades TP, et al. Glucosamine therapy for treating osteoarthritis. Cochrane Database Syst Rev 2005;(2):CD002946.
31. Gregory PJ, et al. Dietary supplements in osteoarthritis. Am Fam Physician 2008;15;177-184.
32. Kim LS, Axelrod LJ, Howard P, et al. Efficacy of methylsulfonylmethane in osteoarthritic pain of the knee: A pilot clinical trial. Osteoarthritis Cartilage 2006;14:286-294.
33. Shalansky S, Lynd L, Richardson K, et al. Risk of warfarin-related bleeding events and supratherapeutic international normalized ratios associated with complementary and alternative medicines: A longitudinal analysis. Pharmacotherapy 2007;1237-1247.
34. Mohammed Abdul MI, Jiang X, Williams KM, et al. Pharmacodynamic interaction of warfarin with cranberry but not with garlic in healthy subjects. Br J Pharmacol 2008;154:1691-1700.
35. Caruso TJ, Prober CG, Gwaltney JM Jr, et al. Treatment of naturally acquired common colds with zinc: A structured review. Clin Infect Dis 2007;45:569-574.
36. Foster S, Tyler VE. Tyler's The Honest Herbal: A Sensible Guide To the Use of Herbs and Related Remedies. Binghamton, NY. The Haworth Press, 1999.
37. Food and Drug Administration web site. Press release 5/1/2009. Available at www.fda.gov/bbs/topics/NEWS/2009/NEW2006.html. FDA document from Iovate, INc. for Hydroxycut. Available at www.fda.gov/oc/po/firmrecalls/iovate205_09.html. Accessed May 2009.
38. Saito M, Ueno M, Ogino S, et al. High dose Garcinia cambogia is effective in suppressing fat accumulation in developing male Zucker obese rats, but highly toxic to rat testes. Food Chem Toxicol 2005:43:411-419.
39. Heymsfield SB, Allison DB, Vasselli JR, et al. Garcinia cambogia (hydroxycitric acid) as a potential anti-obesity agent: A randomized, controlled trial. JAMA 1998;280:1590-1600.
40. McCarthy M. The caffeine content in your morning fix. Wall Street Journal 4/13/04; D1.
41. Nykamp DL, Fackih MN, Compton AL. Possible association of acute lateral-wall myocardial infarction and bitter orange supplement. Ann Pharmacother 2004;38:812-816.
42. Bouchard NC, Howland MA, Greller HA, et al. Ischemic stroke associated with use of an ephedra-free dietary supplement containing synephrine. Mayo Clin Proc 2005;80:541-545.
43. Nasir JM, Durning SJ, Ferguson M, et al. Exercise-induced syncope associated with QT prolongation and ephedra-free Xenadrine. Mayo Clin Proc 2004;79:1059-1062.
44. US Food and Drug Administration. FDA Expands Warning to Consumers About Tainted Weight Loss Pills. Revised 1/08/09. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html. Accessed 1/13/09
45. Foster S. Aloe vera. Herbs at a Glance. National Center for Complementary and Alternative Medicine. http://nccam.nih.gov/health/aloevera. Accessed 1/11/09.
46. US Food and Drug Administration. Kurtzweil P. Dieter's Brews Make Tea Time A Dangerous Affair. www.fda.gov/fdac/features/1997/597_tea.html. Accessed 1/11/09 and 5/20/2009. FDA Consumer July-Aug 1997. Revisions 12/1997.
47. Wooltorton E. Herbal kava: Reports of liver toxicity. CMAJ 2002;166:777.
48. Russmann S, Lauterburg BH, Helbling A. Kava hepatotoxicity. Ann Intern Med 2001;135:68-69.
49. Clouatre DL. Kava kava: Examining new reports of toxicity. Toxicol Lett 2004;150:85-96.
50. Hume A. Potential role for cinnamon in type 2 diabetes treatment. Pharmacy Today/APhA 2008;14:20.
51. Ziance RJ. Role for pharmacy in combating counterfeit drugs. Pharmacy Today/APhA 2008;14:55-72.
52. U.S. Food and Drug Administration. FDA is alerting the public to counterfeit Viagra found in two California pharmacies. June 30, 2004. http://www.fda.gov/bbs/topics/news/2004/NEW01083.html. Accessed 4/17/07.
53. Lutter RW. Statement before the Subcommittee on Criminal Justice, Drug Policy and Human resources; Comm. On Government Reform; House of Representatives. http://www.fda.gov/ola/2005/counterfiet2202.html. Assessed 4/17/07.
54. Mitka M. FDA issues warning on all natural herbal product found to contain Viagra. JAMA 2003;289:2786.
55. Robbers JE, Tyler VE. Tyler's Herbs of Choice: The Use of Phytomedicinals. Binghamton, NY: The Haworth Press, Inc., 1999.
56. The Drug and Natural Medicine Advisor. Time Life, Inc. 1997.
57. Pharmacist's Letter. Stockton, CA. 1995-2004.
58. Sikon A, Thacker HL. Treatment options for menopausal hot flashes. Cleve Clin J Med 2004;71:578-584.
59. ACS Guidelines on Nutrition and Physical Activity for Cancer Prevention, 2002. CA Cancer J Clin 2002;52;92-119.
60. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. (English Translation)
61. Kronenberg F, Fugh-Berman A. Complementary and alternative medicines for menopausal symptoms: A review of randomized, controlled trials . Ann Intern Med 2002;137:805-813.
62. Bender DA. Daily doses of multivitamin tablets. BMJ 2002;325: 173-174.
63. Adams KE, Cohen MH, Eisenberg D, et al. Ethical considerations of complementary and alternative medical therapies in conventional medical settings. Ann Intern Med 2002;137:660-664.
64. Marcus DM, Grollman AP. Botanical medicinesThe need for new regulations. N Engl J Med 2002;347:25:2073-2076.
65. Ashar BH, Rowland-Seymour A. Advising patients who use dietary supplements. Am J Med 2008;121:91-97.
66. Institute of Medicine and National Research Council. Prototype monograph on chromium picolinate. http://www.iom.edu/Object.File/Master/19/558/Introduction%20and%20Chromium%20Picolinate%20Prototype%20Monograph.v.2.pdf. The National Academies Press: Washington, DC; 2004.
67. [No authors listed.] Vitamin supplements. Med Lett Drugs Ther 2005;47:57-58.
68. [No authors listed.] Lowering plasma homocysteine. Med Lett Drugs Ther 2003;45:85-86.
69. Medline Plus 2009 Consumer Info www.fda.gov. DHEA, Wild Yam (Dioscorea villosa and other Dioscora spp.) Dehydroepiandrosterone. Med Lett 2005:47:1208.
70. Complementary and alternative medicine at the NIH: What's in the bottle. Fall 2002;volume 9, no. 3.
71. [No authors listed.] DHEA: The last elixir. Prescrire Int 2002;11: 118-123.
72. Larsen MW, Moser C, Høiby N, et al. Ginseng modulates the immune response by induction of interleukin-12 production. APMIS 2004;112 369-373.
In the past half century, technology, environmental awareness, and modern science have surged. Yet, as in all generations, a significant number of consumers, perhaps intent upon getting back to simpler times, are choosing "healthful" therapies not fully accepted by the mainstream.Subscribe Now for Access
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