1、Module 12: SupplementsThe Ob/Gyn Alliance Ask the Experts series is supported by an unrestricted educational grant from Xanodyne Pharmaceuticals. WHAT PHYSICIANS NEED TO KNOWBackgroundApproximately one-half of all Americans take some type of dietary supplement with the belief that they will feel bet
2、ter, have more energy, improve their health or prevent/manage a disease. The use of supplements has increased steadily over the past 20 years with total sales of supplements estimated to be in excess of $22 billion, $7.2 billion of which accounts for vitamins. The increase in use of supplements has
3、led to concerns about the safety, side effects and potential health risks.1 The Food and Drug Administration (FDA) sponsored a Health and Diet Survey which was conducted in 2002 via telephone interviews of English speaking US adults aged 18 years and older within the 50 states and District of Columb
4、ia.2 Findings indicated that 73% of adults had used a dietary supplement in the previous 12 months and 4% of them experienced what they believe to be an adverse event related to the dietary supplement. Among the participants, multivitamin/multiminerals were the most often consumed supplement (85%),
5、followed by single ingredients vitamins/minerals/ (77%), and then herbs, botanical, or “other” supplements (42%).2 Providers must recognize that underreporting of supplement use is common, as most patients are reluctant to share this information with their physicians for fear they will be advised no
6、t to take them.3 This lack of disclosure not only has the potential to undermine the doctor-patient relationship, it can also be detrimental to the overall health of the patient, making the identification of potential adverse events difficult. At the same time, there are many supplements which provi
7、de safe and effective alternatives to drug therapies. One such supplement, omega -3, can improve hypertriglyceridemia and hypertension. Various supplements are also recommended for certain population groups that are at-risk for deficiencies (i.e. the elderly, vegans/vegetarians, underprivileged popu
8、lations and pregnant women).Supplement OverviewThe definition of dietary supplements was expanded with the passage of the 1994 Congressional Dietary Supplement Health and Education Act (DSHEA).4 Based on the DSHEA (http:/nccam.nih.gov/health/supplements/wiseuse.htm), a supplement is a product that:
9、Is intended to supplement the diet Contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and certain other substances) or their constituents Is intended to be taken by mouth, in forms such as tablet, capsule, powder, softgel, gelcap, or liqui
10、d Is labeled as being a dietary supplement Supplements are regulated by the FDA differently than drugs. A manufacturer does not have to prove the safety and effectiveness of a dietary supplement before it is marketed. In addition, the manufacturers of supplements are not required to report adverse e
11、vents to the federal or public health agencies (though they may be captured via voluntary reporting by consumers). Supplement manufacturers are also not allowed to put health claims on their labels. For example, the supplement cannot claim to treat or diagnosis a disease. Supplement manufacturers ca
12、n make structure function claims describing the role or function of a nutrient in the body. These tend to be very general and not specific to the supplement for sale. For example, the calcium supplement product can state that “calcium builds strong bones,” but this structure function claim must be f
13、ollowed by a disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”Guidelines for Adequate Intakes of VitaminsVitamins are organic nutrients that are necessary in small amounts for normal
14、body functioning and good health. The body is able to manufacture only three vitamins from dietary sources: vitamin D, vitamin K and the B vitamin biotin. Acting as chemical partners for enzymes, vitamins and minerals are involved in the bodys metabolism, cell production, tissue repair and many othe
15、r vital processes. Healthcare providers should understand the Dietary Reference Intakes (DRI) estimates which are the amount of a nutrient that is needed to prevent a deficiency and to reduce the risk for chronic diseases. The DRI estimates expand upon and replaces what were the Recommended Dietary
16、Allowances (RDA). This represents a shift in nutritional emphasis from preventing deficiencies (the aim of the RDAs) to lowering risks of chronic illnesses, such as heart disease, some kinds of cancer, or osteoporosis. They are not meant to be prescriptive but do provide reasonable guidelines toward
17、s preventing deficiency and reducing the risk of chronic disease. Dietary reference intakes (DRIs) have been established for 14 vitamins and 12 minerals and are specific to both age and gender. These recommendations can be accessed through the USDA website noted below:http:/fnic.nal.usda.gov/nal_dis
18、play/index.php?info_center=423:1-302. Babgaleh T, Ross M, McCarthy P, Chung-Tung J.L, Dietary Supplements in a National Survey: Prevalence of Use and Reports of Adverse Events.3. Robinson A, McGrail MR. Disclosure of CAM use to medial practitioner: a review of qualitative and quantitative studies. C
19、omplement Ther Med. 2004; 12:90-98.4. Dietary Supplement Health and Education Act of 1994. Pub L No. 103 417, 21 USC 3419 (1994).5. Willett WC, Stampfer MJ. Clinical practice. What vitamins should I be taking doctor? N Engl J Med 2001;345: 1819-24.6. Godfrey KM, Barker DJ. Fetal nutrition and adult
20、disease. Am J Clin Nutr 2000;71: 1344-52.7. Wu G, Bazer FW, Cudd TA, Meininger CJ, Spencer TE. Maternal nutrition and fetal development. J Nutr 2004; 134:2169-728. Simopoulos, A.P. “N-3 Fatty Acids and Human Health: Defining Strategies for Public Policy” Lipids 36 (2001):S83-S89.9. Heaney RP, Smith
21、KT, Recker RR, et al. Meal effect on calcium absorption. Am J Clin Nutr 1989;49(2): 372-73.10. Schneyer CR. Calcium carbonate and reduction of levothyroxine efficiency. JAMA 1998;279(10):75011. Holick MF, High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc 2006;81:353
22、-7312. Holic MF, Siris ES, Binkley n, et al. Prevalence of vitamin D inadequacy among postmenopausal North American women receiving osteoporosis therapy. J Clin Endocrinol Metab 2005;90:3215-24.13. Lee JM, Smith JR, Phillipp BL, Chen TC, Mathieu J, Holick MF. Vitamin D deficiency in a healthy group of mothers and newborn infants. Clin Pediatr (Phila) 2007;46:2-4.14. Nagpal S, Na S, Rathnachalam T. Noncalcemic actions of vitamin D receptor ligands. Endocr Rev 2005; 26: 662-87.15. JAMA 287:47 2002.
