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Chapter 7: Nonprescription Options

GOVERNMENT REGULATIONS FOR DIETARY SUPPLEMENTS

Key Points

  1. Regulation of prescription drugs as well as over-the-counter (OTC) drugs by FDA is explicit and defined by federal statutes contained in the 1938 Federal Food, Drug, and Cosmetic Act (FDCA). This Act is continually being amended and updated. New prescription drug marketing approval and postmarketing safety monitoring are the core responsibilities of the Center for Drug Evaluation and Research (CDER) at FDA.
  2. As a result of the passage of the Dietary Supplement Health and Education Act of 1994, the regulation of dietary supplements by FDA is extremely limited, except in cases of clear danger to public health. This amendment to the 1938 FDCA defined dietary supplements as food rather than drug, allowing dietary supplement manufacturers to claim health benefits that would otherwise have been illegal under the FDCA.
  3. The authority and ability of FDA to regulate prescription drugs custom compounded by pharmacies for individual patients (as opposed to manufacturing of prescription drugs by commercial drug manufacturers) has been disputed for decades. Recent concerns about drug purity and safety claims for some compounded drugs have resulted in new enforcement authority for FDA to inspect pharmacies and remove products from the market. In general, it is the responsibility of individual state medical and pharmacy boards to regulate the compounded drug industry.
  4. The practice of medicine, including the ability of healthcare providers to prescribe drugs and advertise their products and services is not regulated by FDA but rather by individual state medical boards.

VITAMINS AND MINERALS—CALCIUM

Key Points

  1. Calcium is the most abundant mineral in the human body, occurring predominantly in bones and teeth.
  2. The importance of adequate calcium intake for skeletal health is well established; randomized clinical trials of calcium in combination with vitamin D demonstrate a role in fracture prevention.
  3. The main dietary sources of calcium are dairy products (including milk, cheese, and yogurt), which provide an average of 70% of the total calcium intake in midlife and older women.
  4. Calcium requirements for skeletal maintenance in women fluctuate throughout life but increase after menopause due to increased bone resorption and decreased intestinal calcium absorption, both of which are associated with decreased ovarian estrogen production.
  5. Supplemental calcium but not dietary calcium has been linked to an increased risk of kidney stones. Recent studies also have raised the possibility that calcium supplements may increase the risks of cardiovascular disease, but the research to date is inconsistent and inconclusive.

Recommendations for Clinical Care

  1. The Institute of Medicine (IOM) 2011 report set the Recommended Dietary Allowances (RDA) for calcium at 1,000 mg per day for women aged 50 years and younger and 1,200 mg per day for those aged older than 50 years. (Level I)
  2. The IOM also set the tolerable upper intake level (intakes above which adverse events may occur) at 2,500 mg per day for women aged 50 years and younger and 2,000 mg per day for those aged older than 50 years. (Level II)
  3. Many women can meet the RDA for calcium by eating calcium-rich foods. For those who cannot eat (or do not enjoy) dairy products, other dietary sources of calcium include bone-containing fish such as sardines or salmon, calcium-fortified juices and cereals, tofu, and broccoli, collard greens, and kale. (Level I)
  4. Calcium supplements should be considered if diet does not provide the recommended amount of calcium. Many women, however, are taking excessive doses of supplemental calcium and may need only about 500 mg per day in supplements to reach the RDA. (Level II)

VITAMINS AND MINERALS—VITAMIN D

Key Points

  1. Vitamin D is a sterol-like compound that increases the intestinal absorption of calcium and is essential for bone health.
  2. The main sources of vitamin D are cutaneous synthesis following ultraviolet-B exposure; foods such as fortified dairy products, fatty fish, and some mushrooms; and supplements.
  3. Risk factors for vitamin D deficiency/insufficiency include limited sun exposure, older age, dark skin pigmentation, obesity, low dietary intake of vitamin D, malabsorption syndromes, selected medications (anticonvulsants, antituberculous therapy), and renal or hepatic disease.
  4. Observational studies suggest an association between low vitamin D levels and nonskeletal health outcomes, including heart disease, cancer, and diabetes, but evidence from randomized trials is sparse, inconsistent, and does not prove a cause-and-effect relationship.

Recommendations for Clinical Care

  1. The Recommended Dietary Allowances (RDA) for vitamin D were set by the Institute of Medicine (IOM) in 2011 at 600 IU per day for adult women aged 70 years and younger and 800 IU per day for women aged older than 70 years. The IOM also set the tolerable upper intake level (intakes above which adverse events may occur) at 4,000 IU per day. (Level I)
  2. Other guidelines for vitamin D intake in women have been proposed by other professional organizations and have generally ranged from 800 IU to 2,000 IU per day. (Level II)
  3. The blood concentration of 25-hydroxyvitamin D (25OHD) is a marker of vitamin D exposure. The IOM recommends achieving a 25OHD level of 20 ng/mL (50 nmol/L) or higher, but several other professional organizations recommend levels of 30 ng/mL (75 nmol/L) or higher. (Level II)
  4. The IOM has specified that 25OHD levels above 50 ng/mL (125 nmol/L) may be associated with adverse health effects. (Level II)
  5. Although universal screening of the population for vitamin D deficiency is not recommended, vulnerable populations at increased risk (the elderly or institutionalized, patients with medical conditions such as malabsorption or osteoporosis, patients taking anticonvulsants or other selected medications) may benefit from screening as well as from vitamin D supplementation. (Level II)

VITAMINS AND MINERALS—MAGNESIUM

Key Points

  1. Magnesium has an important role in bone health and is a necessary cofactor for numerous enzymes involved in energy metabolism.
  2. Manifestations of severe magnesium deficiency include impaired calcium homeostasis, a higher risk of hypertensive vascular disease, excessive platelet aggregation/thrombosis, and osteoporosis.
  3. Magnesium is present in a wide variety of foods. The richest dietary sources are nuts, legumes, certain seeds, various marine fish, and dairy products.Magnesium salts taken orally tend to have a cathartic effect.
  4. Magnesium salts taken orally tend to have a cathartic effect.

Recommendations for Clinical Care

  1. The Institute of Medicine’s daily recommended intake of magnesium for women is 320 mg per day. The evidence supporting recommended intakes of magnesium is considered weak because there are no well-accepted indicators of optimal magnesium status. (Level III)
  2. Although the clinical significance of low intake is less clear than for many other nutrients, it would be desirable to improve magnesium intake status for most adults. The median magnesium intake in US adult women is approximately 230 mg per day. It has been estimated that about 60% to 70% of the US population has an intake below the recommended level. (Level II)
  3. Magnesium supplementation may be indicated for patients with malabsorption conditions, including celiac disease, and in patients with excessive magnesium loss caused by gastrointestinal disease (eg, diarrhea, vomiting). (Level II)

OTHER VITAMINS AND MINERALS

Key Points

  1. A healthy diet that includes vegetables, fruits, low-fat dairy products, whole grains, chicken, fish, and nuts is associated with reduced rates of diabetes, hypertension, cardiovascular disease, colorectal adenoma, and colorectal cancer.
  2. Vitamin and antioxidant supplements do not appear to prevent cardiovascular disease, breast cancer, cataracts, or mortality, and there is a potential for harm with high intake of certain vitamins and supplements.
  3. Several meta-analyses have indicated that various B-vitamin supplements are not protective against cardiovascular events or cognitive decline, whereas there is conflicting evidence concerning B-vitamins and cancer.

Recommendations for Clinical Care

  1. The importance of a healthy, nutrient-rich diet that includes increased consumption of vegetables, fruits, low-fat dairy products, whole grains, chicken, fish, and nuts should be promoted at every comprehensive visit. (Level II)
  2. Recent evidence suggests that the use of multivitamins or individual vitamins may not reduce the risk of various chronic diseases in most healthy individuals, so midlife women should be advised to limit the use of supplements and instead try to improve their diets. (Level II)

OTHER SUPPLEMENTS

Key Points

  1. Coenzyme Q10 has been used for heart failure, hypertension, and statin-induced myopathies; however, study results are inconsistent. Coenzyme Q10 is superior to placebo for migraine prophylaxis.
  2. Most of the cardiovascular and triglyceride lowering benefits of omega-3 fatty acids are seen with fish oils (composed of DHA and EPA).
  3. Clinical trial evidence supports the use of glucosamine sulfate in improving pain and function in patients with osteoarthritis (OA). The benefit of chondroitin in improving OA symptoms is unclear.
  4. Studies with S-Adenosyl Methionine (SAMe) have shown benefit in mild to moderate depression.

Recommendations for Clinical Care

  1. Coenzyme Q10 may be considered for migraine prophylaxis. (Level II)
  2. Omega-3 fatty acids from fish oils may be used to lower triglyceride levels, with the greatest benefit seen in patients with very high triglyceride levels. (Level II)
  3. Glucosamine sulphate may be used to improve symptoms and function in patients with OA. The need to use chondroitin in combination with glucosamine is unclear. (Level II)
  4. SAMe may be of benefit in the treatment of mild to moderate depression, although studies in severe depression are lacking. (Level II)

OVER-THE-COUNTER HORMONES

Key Points

  1. Over-the-counter (OTC) hormone preparations containing dehydroepiandrosterone (DHEA), melatonin, and topical progesterone are regulated as dietary supplements in the United States, whereas in Canada, all but melatonin are sold as prescription drugs.
  2. The evidence of efficacy of OTC topical progesterone cream for menopause symptoms is limited, and because dose and absorption vary among formulations, OTC topical progesterone typically does not provide adequate levels for endometrial protection with systemic estrogen use.
  3. Dehydroepiandrosterone has been studied for a variety of conditions, including sexual function, depression, aging, and well-being, with inconclusive results.
  4. The effects of melatonin on sleep and behavioral sedation are inconsistent; however, evidence supports favorable effects for circadian-rhythm sleep disorders.

Recommendations for Clinical Care

  1. Over-the-counter topical progesterone cream should not be used to provide endometrial protection with estrogen use, and any benefit for menopause symptoms is unproven. (Level III)
  2. The role of oral DHEA in improving mood, sexual function, and general well-being remains unproven. (Level III)
  3. Melatonin supplementation may have a role for circadian-rhythm sleep disorders, including shift work and jet lag. (Level II)

 

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