Answers to Self-Assessment Questions - ACCP

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or cardiovascular disease, drinking green tea or taking a reliable, standardized green tea extract may be worth a try. Therefore, Answer B (taking an extract may be worth a try) is correct. Answer A (risks of adverse events with green tea outweigh the benefits) is incorrect because it indicates there are substantial adverse events with this approach, which is not the case. It appears that both the catechin and caffeine components of green tea may be important for any weight loss or maintenance benefit. Green tea generally contains an amount of caffeine considered sufficient for the beneficial effect on weight, making Answer C (she will need to both drink green tea and take an extract) incorrect. Although patients with hypertension or cardiovascular disease may be at increased risk of adverse events with green tea because of its sympathetic activity, there is no reason to believe that green tea extract would exacerbate osteoarthritis, making Answer D incorrect. 1. Westerterp-Plantenga MS, Lejeune MP, Kovacs EM. Body weight loss and weight maintenance in relation to habitual caffeine intake and green tea supplementation. Obes Res 2005;17:1195–204. 2. Diepvens K, Westerterp KR, Westerterp-Plantenga MS. Obesity and thermogenesis related to the consumption of caffeine, ephedrine, capsaicin, and green tea. Am J Physiol Regul Integr Comp Physiol 2007;292:R77–85. 3. Seeram NP, Henning SM, Niu Y, Lee R, Scheuller HS, Heber D. Catechin and caffeine content of green tea dietary supplements and correlation with antioxidant capacity. J Agric Food Chem 2006;54:1599–603. 66. Answer: D According to DSHEA, a dietary supplement manufacturer may make a structure or function claim on the label as long as “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease” also appears on the label. The claim that cranberry helps promote urinary tract health is clearly a function claim and is thus allowed as long as the disclaimer is present (Answer D is correct). Sometimes the distinction between structure or function claims and disease prevention or treatment claims is very difficult to determine. However, in this case, the claim would not be construed as a disease prevention claim (e.g., “helps prevent urinary tract infections”); therefore, Answer A (prevents bacteria from invading and proliferating in the urinary tract) is incorrect. If a claim is deemed to be a disease prevention or treatment claim, the product would be considered a drug and thus misbranded as a dietary supplement. Again, because this is a function claim, the cranberry would not in this case be considered a drug, making Answer B (decreases the duration of urinary tract infections) incorrect. According to the FDA, such a claim can only be made for drugs, not dietary supplements. Structure or function claims can be made based on a single ingredient within a multi-ingredient product; therefore, Answer C (decreases the severity of urinary tract infection symptoms) is incorrect. This claim can be made if the product contains only cranberry or other substances promoting urinary health; if it contains other ingredients, it would be considered misbranded. 1. Overview of dietary supplements. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition. January 3, 2001. Available at www.cfsan.fda.gov/~dms/dsoview.html#regulate. Accessed April 10, 2009. 2. U.S. Food and Drug Administration. Structure/function claims. Available at www.cfsan.fda.gov/~dms/labstruc.html. Accessed April 10, 2009. 67. Answer: C U.W., a 45-year-old woman who takes Saint John’s wort for depression, has been admitted to the hospital for complications related to her diabetes. In its Statement on the Use of Dietary Supplements, the American Society of Health-System Pharmacists (ASHP) discourages selfadministration of the patient’s own supply of dietary supplements during hospitalization because of lack of information regarding safety and efficacy, as well as inadequate standards for product quality. Therefore, Answer A (she may be allowed to self-administer her own supply if ordered by her physician) and Answer B (she may be allowed to self-administer her own supply after the pharmacist has verified the identity and checked for drug interactions), both of which concern self-administration of the patient’s own supply of drug, are not consistent with the ASHP recommendations and are incorrect. It is recommended that hospitals have a general policy in place regarding inpatient use of dietary supplements, but Answer D is not the best response because Saint John’s wort is not actually on the formulary but rather must be obtained for use in this patient. Answer C best follows recommendations; the pharmacy could supply the dietary supplement if Saint John’s wort is on the formulary, the physician specifically prescribes it, and the pharmacist checks the patient profile for drug interactions; thus Answer C is correct. 1. American Society of Health-System Pharmacists Council on Professional Affairs. ASHP statement on the use of dietary supplements. Am J Health Syst Pharm 2004;61:1707–11. 2. Bizzie KL, Witmer DR, Pinto B, Bush C, Clark J, Deffenbaugh J Jr. National survey of dietary supplement policies in acute care facilities. Am J Health Syst Pharm 2006;63:65–70. 3. Cohen MH, Hrbek A, Davis RB, Schachter SC, Kemper KJ, Boyer EW, et al. Emerging credentialing practices, malpractice liability policies, and guidelines governing complementary and alternative medical practices and dietary supplement recommendations: a descriptive study of 19 integrative health care centers in the United States. Arch Intern Med 2005;165:289–95. 68. Answer: B The question relates to the design of a demographic survey of dietary supplement use and what aspects of the design could lead to overstating the prevalence of use. Recent surveys of the use of dietary supplements in the United States have reported a broad array of percentages of the population using these supplements, largely because of the population studied, the definition of dietary supplement, and the definition of recent use. Dietary supplements are used more commonly among women than men. Older people use them more commonly than younger people, making Answer C (excluding people older than 65 from the survey) incorrect. Answer D (oversampling of minorities with lower socioeconomic status) is also incorrect because dietary supplement use in the United States is more common in those of higher socioeconomic status and education Gastroenterology and Nutrition Answers 50 Pharmacotherapy Self-Assessment Program, 6th Edition
level. Exclusion of conventional vitamins and minerals from the definition of dietary supplements (Answer A) would make supplement use appear to be less common than more common, making Answer A incorrect. Because more people will have used dietary supplements within the past month than within the past week, querying about use of supplements within the past month rather than the past week (Answer B) would appear to make supplement use more common; therefore, Answer B is correct. 1. Kelly JP, Kaufman DW, Kelley K, Rosenberg L, Anderson TE, Mitchell AA. Recent trends in use of herbal and other natural products. Arch Intern Med 2005;165:281–6. 2. Kennedy J. Herb and supplement use in the U.S. adult population. Clin Ther 2005;27:1847–58. 69. Answer: A D.L. has heard that black cohosh may alleviate some of her menopause-related symptoms but is concerned about the risk of developing breast cancer. Although the evidence demonstrating efficacy of black cohosh in relieving vasomotor symptoms associated with menopause is inconsistent, it appears to be safe and may be of benefit for some women experiencing mild symptoms. The dosages most commonly used in clinical trials were black cohosh extract standardized to the 1-mg equivalent of 27-deoxyacetein twice daily (Remifemin 20–40 mg or equivalent product twice daily). Most studies were of short duration, typically lasting a maximum of 6 months. Based on this evidence, Answer A (a cautious trial using 20–40 mg of Remifemin or equivalent twice daily for up to 6 months is unlikely to do harm) is the best response and the correct answer. A few cases have been published reporting hepatotoxicity associated with the consumption of black cohosh; however, more than 2000 subjects have been enrolled in clinical trials with black cohosh extract, and no reports of hepatotoxicity have been published. In addition, there is currently no known plausible biologic mechanism for hepatotoxic activity of black cohosh. The recommendation of the National Center for Complementary and Alternative Medicine and the National Institutes of Health Office of Dietary Supplements is on the side of caution, recommending monitoring liver function in patients consuming black cohosh. Based on this information, Answer B (the risk of hepatotoxicity with black cohosh is well established and its use should be avoided) is incorrect. Current evidence does not support the mechanistic view of black cohosh possessing estrogenic effects. Instead, research suggests that black cohosh inhibits binding of serotonin 5-hydroxytryptamine- 1A and 5-hydroxytryptamine 7 , both of which are associated with the hypothalamus. Current information is inconclusive regarding black cohosh and the risk of breast cancer. It appears to be safe in women with no increased risk of breast cancer; however, current evidence is insufficient to recommend its use in women with increased risk. Therefore, Answer C (recent trials have demonstrated an estrogenic effect of black cohosh on breast tissue) is incorrect. Insufficient evidence exists to support an effect of black cohosh on cardiovascular health; therefore, Answer D (black cohosh can be recommended for primary prevention of cardiovascular disease) is also incorrect. 1. National Center for Complementary and Alternative Medicine, National Institutes of Health Office of Dietary Supplements. Workshop on the safety of black cohosh in clinical studies. National Institutes of Health, Bethesda, MD. November 11, 2004. Available at nccam.nih.gov/news/pastmeetings/ blackcohosh_mtngsumm.htm. Accessed October 31, 2008. 2. Huntley A, Ernst E. A systematic review of the safety of black cohosh. Menopause 2003;10:58–64. 3. Osmers R, Friede M, Liske E, Schnitker J, Freudenstein J, Henneicke-von Zepelin HH. Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms. Obstet Gynecol 2005;105:1074–83. 70. Answer: A D.L. decides to try black cohosh. She wants your recommendation for the most efficacious product. Remifemin black cohosh extract is the most widely studied product showing possible efficacy among products available in the United States (Answer A); therefore, Answer A is correct. Answer C (studies reporting efficacy and safety of Remifemin black cohosh extract support use of the extract for periods extending up to 1 year) is incorrect because most studies have only lasted 6 months or less. The manufacturer of Remifemin has switched between isopropanolic and ethanolic preparations and between fluid extracts and dried fluid extracts, and the package labeling has changed at least twice. These changes make it difficult to compare the results of the various trials using Remifemin; therefore, Answer B (Remifemin black cohosh extracts used in clinical studies has been consistently manufactured) is incorrect. No black cohosh product has been consistently demonstrated to increase bone density; therefore, Answer D (because Remifemin has been demonstrated to increase bone density, it should be the black cohosh product of choice) is incorrect. 1. Newton KM, Reed SD, LaCroix AZ, Grothaus LC, Ehrlich K, Guiltinan J. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial. Ann Intern Med 2006;145:869–79. 2. Jellin JM, Gregory PJ, Batz F, eds. Pharmacist’s Letter/ Prescriber’s Letter Natural Medicines Comprehensive Database, 9th ed. Stockton, CA: Therapeutic Research Faculty, 2007. 3. DerMarderrosian A, ed. The Review of Natural Products. St. Louis, MO: Elsevier Inc., 2005. 71. Answer: C L.B., a 62-year-old man with hypertension, hyperlipidemia, and coronary artery disease, wants to take ginkgo to prevent Alzheimer’s disease. Although some studies have shown ginkgo extract to be efficacious in slowing progression and ameliorating symptoms of Alzheimer’s dementia, the overall combined evidence of benefit in patients with cognitive impairment or dementia fails to demonstrate consistent efficacy for these disorders. Therefore, Answer B (ginkgo extract appears to be efficacious, but adverse effects and drug interactions preclude its use) and Answer D (terpene ginkgolide B is a potent inducer of cytochrome [CYP] P450 3A4 and has the potential to interact with drugs metabolized by this isozyme) are both incorrect. Ginkgo is relatively safe, and adverse effects are usually mild. Ginkgolide B is a potent inhibitor of platelet-activating factor, and there is an increased risk of bleeding if the extract is taken concomitantly with antiplatelet agents, such as aspirin. Therefore, Answer C (ginkgo is generally well tolerated, but Pharmacotherapy Self-Assessment Program, 6th Edition 51 Gastroenterology and Nutrition Answers
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