6. Self-Care: Over-the-Counter Products, Herbal Therapies, and Drugs for Health Promotion

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Self-Care

Over-the-Counter Products, Herbal Therapies, and Drugs for Health Promotion

Objectives

Key Terms

alternative medicine (ăl-TĔR-nă-tĭv, p. 60)

complementary medicine (kŏm-plě-MĔN-tă-rē, p. 60)

health promotion (HĔLTH pră-MŌ-shun, p. 67)

herbal (ĔR-băl, p. 61)

integrative practices (ĬN-tě-grā-tĭv, p. 60)

imagehttp://evolve.elsevier.com/Edmunds/LPN/

Overview

When we think of patient drugs, we often forget that many of the drugs patients use are those they buy in drugstores because they learned about them from their friends, read about them in magazines or saw a television ad. More than ever before, people are learning about how to care for themselves and are more likely to purchase over-the-counter (OTC) products. Health care remedies not prescribed by health care providers also did a booming business in the United States in 2007; Americans spent $18 billion on nonprescription remedies. The majority of drugs that patients buy and use are OTC. What is safe for patients to take? What do they need to know about OTC products? What products should they take to keep them well? Can they believe the articles and stories about “wonder” drugs they can get without a prescription that promise such good results for chronic problems? How can you answer their questions?

Documenting Patient Health Care Practices

It is important for you to be familiar with the many nonprescription products now available to patients. Many of these products contain chemicals that are useful in treating common health problems. Nurses should be familiar with these products, so that they can help patients choose the safest product for their current health concerns, problem, or illness. Some of the active chemicals in these products may make existing medical problems worse or interact with a patient’s prescribed medications.

Always ask about OTC medications that patients may be taking when you ask about their drug history. Patients often neglect to tell their providers about these products because they may regard them as harmless and not a “real drug.” Many Americans consider herbal or OTC products to be safe because they are so easily available. But they may not be safe for all patients. Ask patients to bring questionable products to the attention of the patient’s physician or health care provider.

It is also important to have patients bring in all herbs or drug remedies they are using so that what they are taking may be accurately recorded as patients often do not know the active ingredients or effects of natural medications they are taking. Seeing products in their original bottles or boxes gives more information that might be needed to tell if the products are safe. This action may be very helpful in preventing drug interactions or complications.

Patients who rely on complementary and alternative medicine (CAM) may be taking alternative products (herbs, supplements, or other drugs) instead of prescription drugs because of the cost, or they may use such products in addition to prescription drugs in a complementary way. When asking a patient about the use of CAM, do not make judgments about these treatments. This approach is important if you wish to have patients trust you enough to tell you the truth about what health regimens they are following or what herbal and OTC products they are taking. Understand that patients who use these different treatments do so for many reasons:

Over-the-Counter Medications

The role of OTC agents in health care today is growing, because there are now more people who are better educated and believe they should take an active role in their own health care. The Nonprescription Drug Manufacturers Association estimates that more than 100,000 products are now available over the counter. These products contain one or more of approximately 700 active chemicals and come in a variety of dosage forms, sizes, and strengths. The sales of OTC products total more than $20 billion a year.

Nonprescription medications, or OTC products, are defined as drugs that are thought to be safe and effective for people to use without instructions from a health care provider about how to use them. OTC products differ from prescription medications in five ways:

The most common categories of OTCs are similar to those available by prescription. These include laxatives, peptic acid disorder products (antacids, H2 receptor antagonists), analgesics, cough and cold products (antihistamines, decongestants, expectorants, antitussives), vaginal antifungals, stop-smoking pro­ducts, and topical steroids. Also, many drugs that were once available only by prescription have now been given OTC status although frequently in lower dosages.

OTCs are sold in pharmacies, grocery stores, gas stations, and many other places. Less than one half of all OTC products are sold in pharmacies. Because there are so many different names and versions of these products, it is important to learn the generic drug name instead of just the product (trade) name. Many of these products have multiple ingredients. The cost of these combination products can be more than buying all of the ingredients singly, so it is important to check out commonly used products for price comparisons.

Product Labeling

The U.S. Food and Drug Administration (FDA) requires that OTC product labels contain important information in a manner that a typical person can read and understand. Drug companies are required to use a standard labeling format for all OTCs sold in the United States. Key information, beginning with active ingredients, followed by purposes, uses, warnings, and directions, is placed in the same order on all OTC packages in an easy-to-read format. Surveys show that women are the family members most likely to buy OTC products, and they are also more likely than men to read labels before taking medications.

One of the most important things to look for on the OTC label is the presence of other chemicals in a product that might pose a risk. These “hidden” chemicals are used for different purposes: to help make the drug taste better, to help preserve the drug, to give color, and to help deliver the product or make it more stable. Consumers who have an allergy or intolerance to even small doses of any of these products may not be aware of the risk unless they read the label. Table 6-1 lists a number of common hidden chemicals in OTC products.

Table 6-1

Common “Hidden” Ingredients in Over-the-Counter Products

HIDDEN DRUG OVER-THE-COUNTER CLASS THAT MAY CONTAIN THE DRUG
Alcohol (ethanol) Cough syrups and cold preparations, mouthwashes
Antihistamines Analgesics, antiemetics, asthma products, cold and allergy products, dermatologic preparations, menstrual products, motion sickness products, sleep aids, topical decongestants
Antimuscarinic agents Antidiarrheals; cold, cough, allergy preparations; hemorrhoidal products
Aspirin and other salicylates Analgesics, antidiarrheals, cold and allergy preparations, menstrual products, sleep aids
Caffeine Analgesics, cold and allergy products, diuretic and menstrual products, stimulants, weight control products
Estrogens Hair creams
Local anesthetics (usually benzocaine) Antitussives, cold sore products, dermatologic preparations, hemorrhoidal products, lozenges, teething and toothache products, weight-loss products
Sodium Analgesics, antacids, cough syrups, laxatives
Sympathomimetics Analgesics, asthma products, cold and allergy preparations, cough syrups, hemorrhoidal products, lozenges, menstrual products, topical decongestants, weight control products

Modified from Katzung BG: Basic and clinical pharmacology, ed 10, New York, 2006, McGraw Medical.

Patient Teaching

There are some basic facts health care providers should tell patients about OTC products. Sometimes this information is printed and given out to the patient, because it is so important for patients to know about it. Whether they are given verbally or in writing, these are some of the key facts patients should learn:

• Always read the instructions on the label.

• Do not take OTC medicines in higher dosages or for a longer time than the label states.

• If you do not get well, stop treating yourself and talk with a health care professional.

• Side effects from OTCs are relatively uncommon, but it is your job to know what side effects might result from the medicines you are taking.

• Because every person is different, your response to the medicine may be different than someone else’s.

• OTC medicines often interact with other medicines, and with food or alcohol, or they might have an effect on other health problems you may have.

• If you do not understand the label, check with the pharmacist.

• Do not take medicine if the package doesn’t have a label on it.

• Throw away medicines that have expired (are older than the date on the package).

• Do not use medicine that belongs to a friend.

• Buy products that treat only the symptoms you have.

• If cost is an issue, generic OTC products may be cheaper than brand name items.

Parents should know the following special information about using OTCs for children:

• Parents should never guess about the amount of medicine to give a child. Half an adult dose may be too much or not enough to be effective. This is very true of medicines such as acetaminophen (Tylenol) or ibuprofen (Advil), in which repeated overdoses may lead to poisoning of the child, liver destruction, or coma.

• If the label says to take 2 teaspoons and the dosing cup is marked with ounces only, get another measuring device. Don’t try to guess how much should be given.

• Always follow the age limits listed. If the label says the product should not be given to a child younger than 2 years, DO NOT give it.

• Always use the child-resistant cap, and relock the cap after use.

• Throw away old, discolored, or expired medicine or medicine that has lost its label instructions.

• Do not give medicine containing alcohol to children.

Complementary and Alternative Medicine, Including Herbal Therapies

Patients often believe they know more than their health care providers do about their health problems, and that their providers do not listen to them or respect their choices. These individuals often turn away from traditional Western medicine and seek other forms of alternative health care.

The practices that are known as alternative medicine have often been somewhat of a mystery, and the scientific basis for the action of alternative therapies has been uncertain. Because of the lack of research to explain therapeutic action, most medical and nursing schools do not teach their students about alternative medicine. Alternative therapies include herbal therapies, aromatherapy, chiropractic care, acupuncture, massage, and homeotherapy. A similar type of treatment known as complementary medicine includes these same basic alternative therapies and is preferred by many because it uses these therapies together with standard medical care and not as an alternative. Another term to describe this type of treatment is integrative practices.

Recent studies have found that 40% to 50% of Americans are using some type of alternative therapy, and even more are taking herbs and supplements. A survey estimated that in 2008 more than 48 million adults in the United States used herbal products and dietary supplements. Another survey estimated that approximately 18% of the U.S. population uses herbal therapy on a regular basis. More than half of those users said the products were important to their health and well being, and 70% may not tell their regular health care provider about what products they are taking.

The estimated number of visits to providers of alternative medicine (425 million) exceeded those to all primary care physicians (325 million). There is increasing patient interest in herbs, supplements, and homeopathic remedies, but there is little scientific information in texts and reference books about these products. Most of the books and articles about herbal therapies are written to sell products. You will want reliable information about the medicines patients are taking. Because of the widespread use of herbal products, it is crucial that you have up-to-date, balanced, and scientific material to help you understand herbal therapies and learn about strengths, weaknesses, clinical indications, proper dosages, toxicities, and interactions of different alternative drug therapies so you are able to answer patient questions accurately.

Herbal Therapies and Supplements

Use of herbal medicine (drugs made from plant sources) has long been an accepted part of health care in many cultures. China and other Asian cultures have used herbal products for centuries as an important part of medical practice. People in the United States are now using these same herbal remedies in growing numbers, because they wish to prevent disease, treat illness, and improve health. Because herbal therapies have such a long history in different cultures, this may have created the impression in the minds of some consumers that they are safe, natural, and effective. The fact that something is “natural” does not mean it is safe or effective. With the growing scientific research into use of many herbal products, there is growing belief in the health care community that if herbs are effective, then they should be used under the direction of a health care professional.

Product Labeling

Herbal preparations are not regulated anywhere in the world. Germany has done the most in terms of scientific research into the safety and efficacy of some of these herbs, but these studies have been small and do not begin to meet the scientific standard demanded by the FDA for prescription drugs. Unlike prescription and OTC drugs, the FDA does not require manufacturers to determine purity or potency of herbal products. In fact, some products have been found to contain contaminants, including prescription drugs or heavy metals, and their potency depends on many factors, such as what part of the plant is used and the climate and soil conditions where they are grown, harvested, and stored. Some herbal preparations have even resulted in toxicities.

The FDA has taken action as a result the Dietary Supplement Health and Education Act passed by Congress in 1994, which said health and disease claims are different than structure and function claims. The act says that labels cannot make claims that a product cures a disease or has a special benefit or health effect without special FDA approval. The act allows general statements about the product’s function in the body. The new rules bar makers of supplements and herbal remedies from claiming to cure, prevent, or alleviate cancer, acquired immune deficiency syndrome, and other specific diseases. Companies are limited to making general claims about the product’s ability to make the immune system stronger. Critics claim that most disease treatments can be described in terms of their effects on a structure or function of the body, so it will be difficult to tell the difference between structure and function claims, which are allowed, and disease claims, which are not. The herbal drug manufacturer must now use the following statement in their labeling: “This product is not intended to diagnose, treat, cure, or prevent any disease.”

It might be noted that the labels on herbal products are designed to promote sales and product use and not necessarily to educate the consumer, so health professionals with a general understanding of popular herbs and supplements can talk to patients about efficacy, common side effects, risks, and interactions. When talking to the patient on admission, the nurse may ask about his or her patients’ use of unconventional medicines. This might alert the physician or nurse practitioner that they need to explore these products more to avoid drug interactions with medications ordered in the hospital or clinic.

The FDA does have the authority to remove a product from the market, but this happens only after the agency can prove that the product is unsafe or ineffective. This was the case when the FDA banned products containing ephedra because of adverse cardiovascular effects and prohibited sales of kava because of concerns about liver toxicity.

Patients with medical problems should not use herbs and dietary supplements without medical supervision. When patients rely on themselves for diagnosis and treatment, they may delay the essential diagnosis of serious medical problems, and this delay may worsen their condition. Additionally, some herbal products have adverse effects and may interact with prescribed medications.

Concerns about Herbal Products and Dietary Supplements

Herbal products and dietary supplements are widely available in supermarkets and other retail outlets, as well as by mail order. Because of the wide use of alternative therapies, there has been growing interest in research on the action of various products. The scientific community has expressed concern about drugs that are not tested or regulated. Because some of these medications have “folk” acceptance, they may be cheaper than regular drugs, and there may be fewer barriers to purchasing them, so their use has increased. As more of these products are being used over longer periods, researchers are now starting to pay attention to them. Until there are more scientific studies, health care providers should urge caution in the use of herbal products.

Pros and Cons

Safety, purity, and effectiveness are the major issues in evaluating herbal products. Important questions to consider in looking at herbal products include:

Herbal products are made by grinding up parts of the plant and making them into pills, capsules, or liquids. One of the major criticisms of herbal products is that the plants vary so much in concentration or dosage because plants make different amounts of chemicals, depending on the soil, water, and sun where they were grown. That is, the weight of one leaf may be the same as that of another, but the amount of biologically active chemical in each leaf may vary according to the amount of sunlight, the nutrition in the soil, and the extent of watering.

Hormone replacement therapy has become a hot market for the use of “natural” products. Natural estrogens are really estrogen-like chemicals called phytoestrogens. Examples of plants containing natural estrogens or phytoestrogens are flaxseed, red clover sprouts, and soy flour. Herbs thought to contain chemicals that act as stimulants for hormones are licorice, ginseng, Vitex, and black cohosh. It generally takes 6 to 8 weeks to see an improvement in symptoms of menopause when taking these products. Again, these herbal preparations do not deliver the same amount of chemicals with each dose, and there is no way to know the purity of the product. There is also no way to know if the product will do what it claims it will do. For example, many women in China have long used an herb called dong kwai, claiming it reduces or eliminates hot flashes. However, research thus far has failed to find estrogen or estrogen-like chemicals in dong kwai, and its efficacy in menopause is not documented. More research is needed to determine if these are really effective.

Many nonprescription products are advertised to have the same function as prescription drugs. For example, there are herbal preparations that are supposed to act like sildenafil (Viagra). Herbal antiobesity products were sold as alternatives to fenfluramine and dexfenfluramine when these products were taken off the market. Herbal products for depression, high cholesterol, and asthma are also for sale. However, products containing St. John’s wort have not been completely tested for their effectiveness as antide­pressants in the United States. They may also include 6-hydroxytryptophan (closely related to another chemical linked to a rare and potentially fatal blood disorder) and ephedra, an amphetamine-like compound that may cause high blood pressure, heart irregularities, strokes, and death. The claim that garlic reduces cholesterol to an acceptable level also has not been confirmed by scientific research. Patients who take these products in place of prescription drugs should consider that they are taking an experimental drug. Because of dangers such as these, the FDA took action to remove some of these products from the market and posts information about these products on their MedWatch home page (http://www.fda.gov/medwatch/).

There is a group of industry members led by the Council for Responsible Nutrition that has developed voluntary guidelines some herbal drug makers are now using. Patients need to look for products that have been standardized by the manufacturer by measuring the amount of the key ingredient. However, the purity and potency of many products sold in the United States are unknown.

Some European countries have more extensive experience with selected herbal products than the United States. Many of the products now gaining attention in the United States have been used for years in other countries—either as OTC products or by prescription. A lot of information has been learned not only about the effects of these products, but also about how they interact with other foods and medications. For example, natural products that reduce blood glucose or blood pressure or have a sedating effect may be dangerous when taken along with prescription drugs with the same actions. Table 6-2 shows the herbs considered by non-U.S. regulatory authorities to be relatively safe and effective if used in recommended dosages and made by companies that standardize their drug making process. Table 6-3 lists herbs that are considered unsafe for use, based on reports or observations.

Table 6-2

Herbs Considered Safe and Effective

COMMON NAME USE FOR WHICH PROMOTED SAFETY, EFFICACY, DOSAGE
Arnica External remedy for healing bruises, muscle strains, and sprains; reduces inflammation Toxic when taken orally
Black cohosh Reduces menopausal symptoms Clinical trials using black cohosh to relieve menopausal symptoms have yielded conflicting results. Some women experience benefits with the herb with few side effects. Appears safe, but limit use to 6 months and avoid use in those with a history of estrogen-dependent tumors.
Chamomile Antiinflammatory, antispasmodic, antiinfective In capsule form, FDA considers chamomile safe. Use with caution in individuals allergic to ragweed, as cross-allergenicity may occur. Allergic symptoms may include tongue thickness, tight sensation in throat, angioedema of lips and eyes, diffuse pruritus, urticaria, and pharyngeal edema. May produce sedation, so use with caution with medications that also have sedative side effects or with alcohol. Oral doses vary from 400 to 1600 mg per day (standardized to 1.2% apigenin per dose). Chamomile is often brewed as a tea; 1 heaping teaspoon of dried flowers steeped in hot water for 10 minutes may be drunk up to 3 times a day.
Chaste tree Female hormone regulation Safe and effective; rare indigestion
Cholesten Serum cholesterol reduction Safe
Echinacea Stimulates the immune system; used in treatment or prevention of colds and flu or urinary tract infections A wide variety of echinacea preparations and doses have been studied; results are inconsistent. E. purpurea seems to be modestly effective for preventing the common cold in those at risk (e.g., sick contacts). Evidence that the herb may reduce the duration of cold symptoms is mixed. Patients allergic to ragweed, with progressive autoimmune disorders, and on hepatotoxic drugs should avoid echinacea. May take 6-9 doses (1 g dried root) of echinacea juice per day for 2 weeks; very safe, no side effects.
Fennel Internal: increases milk flow in lactating women; External: oil eases muscle and joint pain Safe and effective
Feverfew (Tanacetum parthenium) Migraine headache prevention or reduces severity and frequency; inhibits platelet aggregation Safe and effective; take 125 mg twice daily; do not use concurrently with aspirin or warfarin (Coumadin).
Garlic (Allium sativum) May lower some blood lipids; inhibits platelet aggregation; lowers blood pressure Safe and effective; destroyed by heat; take 2.5 g/day raw or 0.4-1.2 g/day dried; do not use concurrently with aspirin, ibuprofen, or warfarin. Those taking antihypertensive medications should exercise caution and monitor BP for rare cases of orthostatic hypotension. Should be avoided by those with history of orthostasis or unexplained dizziness. A lack of standardization of garlic products and formulations makes it difficult to recommend a dose or specific product. For dyslipidemia, patients may benefit from taking 600 to 1200 mg of garlic powder daily in divided doses, or up to 4 g of raw garlic daily.
Ginger (Zingiber officinale) Antiemetic, good for motion sickness; inhibits platelet aggregation Safe and effective; take 1-2 g/day; do not use concurrently with aspirin or warfarin. Can be safely recommended in the majority of patients.
Ginkgo (Ginkgo biloba) Improves blood flow to brain and extremities; improves brain tissue tolerance to hypoxia; reduces capillary fragility; alleviates vertigo and ringing in the ears; may slow dementia Ginkgo is an option in patients with Alzheimer’s disease who are also receiving medical care, but the herb has antiplatelet activity and thus may not be appropriate for patients with bleeding disorder or on antiplatelet or anticoagulation agents. Safe and effective; take 60 mg twice daily of standard extract. Only useful to elderly or debilitated persons; of no use in persons with normal brain function.
Ginseng Taken for hot flashes but may make them worse Safe but questionable efficacy; not an aphrodisiac; no effect on fatigue or stress. No robust clinical trials. Do not exceed labeled dosage, since adverse effects may occur. Discourage use in those anticoagulated or with cardiovascular or metabolic disease, such as hypertension and diabetes.
Goldenseal Prevention or resolution of upper respiratory infections Safe and effective mullein expectorant, decreases bronchial spasms; reduces colds, bronchitis
Mullein Expectorant, decreases bronchial spasms; reduces colds, bronchitis Safe and effective
Rose hips Fights infections by reducing capillary fragility; contains high concentration of vitamin C Safe and effective
St. John’s wort Antidepressant The most commonly studied dose for depression is 300 mg taken 3 times a day, standardized to 0.3% to 0.5% hypericin per dose. Do not use in addition to other antidepressants. Depressed patients should not take without medical supervision; should be used only in the mildly depressed patient with an aversion to prescription medication. Has numerous potential drug interactions with P450 enzyme system.
Saw palmetto Reduces benign prostatic hypertrophy Safe and effective; take 0.5-1 g/day. Men with obstructive urinary symptoms should not self-medicate with saw palmetto. Such patients should be under medical supervision, because the symptoms of BPH can mimic other more serious disorders, such as prostate cancer and prostatitis. This herb should be reserved for men with mild BPH symptoms who have an aversion to prescription drugs and are also under medical care.
Valerian (Valeriana officinalis) Mild tranquilizer and sleeping aid Safe and effective; take 1-3 g/day; enhances the effects of other drugs that calm, sedate, or tranquilize. Chemicals may help insomnia. Mild side effects have included paradoxic stimulation (restlessness and palpitations), especially with long-term use. Valerian should not be used during pregnancy. This herb may have an additive effect with other central nervous system depressants. Patients should be cautioned regarding the operation of machinery when initiating therapy until they are accustomed to the effects. Other potential side effects include headaches, excitability, and uneasiness. Typical dosages for insomnia are 200-400 mg (standardized to 0.8%-1% valeric acids per dose) at bedtime.

BP, Blood pressure; BPH, benign prostatic hyperplasia; FDA, Food and Drug Administration.

Data from Edmunds MW, Mayhew MS: Pharmacology for the primary care provider, ed 2, St Louis, 2004, Mosby; Krinsky DL, LaValle JB, Hawkins EB, et al: Natural therapeutics pocket guide, ed 2, Hudson, Ohio, 2003, Lexicomp; and Hulisz DT: Top herbal products: efficacy and safety concerns (online): Available at http://www.medscape.com/viewprogram/8494. Accessed January 4, 2008.

Table 6-3

Herbs Considered Unsafe

COMMON NAME USE FOR WHICH PROMOTED SAFETY, EFFICACY, DOSAGE
Blue cohosh Labor induction; reduction of menopause symptoms Causes birth defects in animals
Borage Antidiarrheal, diuretic Contains pyrrolidine alkaloids that are potentially carcinogenic and toxic to the liver
Broom (broom tops) Miscellaneous Toxic
Calamus Antipyretic, digestive aid Has produced malignancy in rats
Chaparral Natural antioxidant, blood purity, anticancer, acne treatment Causes severe liver damage; two cases known in which liver transplants were required
Coltsfoot Antitussive, demulcent Contains carcinogenic alkaloids
Comfrey Wound healing Obstruction of blood flow from liver; has caused cirrhosis and death
Ephedra Anorectic, bronchodilator Ineffective as an anorectic; effective for bronchodilation; unsafe for those with hypertension, diabetes, or thyroid disease; unsafe with caffeine; may cause serious toxic reactions when taken concurrently with MAO inhibitors
Germander Anorectic Causes hepatotoxicity
Jin Bu Huan Stomachache, insomnia, antitussive Causes hepatitis, respiratory depression with bradycardia
Licorice Expectorant, antiulcer Effective, but safe only in small doses for short periods; may cause sodium retention and potassium loss
Lobelia Bronchodilator High doses can decrease respiration, raise heart rate, and lower blood pressure
Pennyroyal Abortion agent Causes severe hepatotoxicity, interference with clotting
Royal jelly Insomnia, liver ailments Causes serious to fatal allergic reactions
Sassafras General tonic Contains safrole, a carcinogen
Senna (Senna alexandrina) Laxative Causes electrolyte imbalance, particularly potassium loss
Stephania magnolia Weight loss Causes renal toxicity
Willow bark Antipyretic Causes gastritis, bleeding, and Reye syndrome
Yohimbé Aphrodisiac Causes psychosis, loss of consciousness

MAO, Monoamine oxidase.

Modified from Edmunds MW, Mayhew MS: Pharmacology for the primary care provider, ed 3, St Louis, 2009, Mosby.

Table 6-4 lists a few nonherbal natural remedies that are in common use and considered both safe and effective. Sometimes the products themselves, such as calcium, may be of proven use. However, if the calcium comes from oyster shells taken from polluted waters, the shells may be filled with lead, zinc, or arsenic. A similar problem occurs with melatonin, a hormone extracted from the pineal gland of the cow. If the drug maker does not make sure that the cow is disease free, the consumer may be at risk for diseases from the cow (e.g., “mad cow” disease).

Table 6-4

Natural Remedies Other than Herbs or Vitamins

NAME SOURCE USES SAFETY AND EFFICACY
Chondroitin Cow cartilage Eases aches and pains; protects and rebuilds cartilage Safe and effective; 400 mg/day
Dehydroepiandrosterone (DHEA) Androgen hormone synthesized from wild yams Alleviates cancer, heart disease, and autoimmune disease; antiaging remedy Believed to be safe, but all side effects are not known; toxic to liver in sufficient quantities; efficacy not proven
Glucosamine Oyster shells Eases aches and pains; protects and rebuilds cartilage Safe and effective if shells are not from polluted water; 500 mg/day
Melatonin If produced from natural sources, it comes from the pineal glands of cows Cure for jet lag; helps regulate the body’s clock; sleep aid; antiaging remedy May inhibit sex drive in men; 1-3 mg at bedtime

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Modified from Edmunds MW, Mayhew MS: Pharmacology for the primary care provider, ed 3, St Louis, 2009, Mosby.

Aromatherapy

Essential oils extracted from the petals, leaves, bark, resins, rinds, roots, stalks, seeds, and stems of aromatic plants are used to promote health and well being. It is also believed by some that these oils have medical properties that fight bacteria, viruses, bacterial toxins, and fungi. The scents are thought to work by triggering hormones that govern bodily functions. Massage with oils or inhaling their vapors is effective, but these oils should never be swallowed or applied near the eyes. It is believed that when these oils are applied to the skin or the vapors are inhaled, their molecules attach to oxygen molecules in the lungs and circulate through the body, helping the body to heal itself. Although the practice of aromatherapy has many followers, there is very little research presently available to support its use. If nothing else, aromatherapy may give the patient a sense of well being and that in itself can be therapeutic.

Drugs for Health Promotion: Vitamins and Minerals

Another major category of drugs used for self-care is vitamins and minerals. People in the United States are using vitamins and minerals to prevent cancer, boost immunity, cope with stress, strengthen bones, and increase their overall sense of well being. Sales of these products are now at record highs. Patients often decide on their own that they need such products. They may or may not seek advice from a health care provider or pharmacist about what to take. Many different products are for sale, and the price varies a lot for the same product. Costs for some products are high because of the claims made about their effectiveness, but not all such claims for vitamins and minerals have been proved. Does more expensive mean better? What is fact and what is fiction about the use of vitamins and minerals?

Pros and Cons

What is known is that vitamin and mineral supplements are useful when the patient has a deficiency, as may be the case in women in their childbearing years and in the elderly population. The American Heart Association has suggested that people should eat more fruits, vegetables, and whole grains; implement an exercise program; replace saturated fats with oils from fish and nuts; and limit salt and alcohol intake. Most official sources suggest that if a variety of healthy foods are eaten, the necessary vitamins can likely be obtained from diet alone. However, supplements may be required for some patients, mostly those who may be deficient. For supplementation, vitamins should have 50% to 150% of the recommended dietary allowance (RDA), and daily treatment should not provide more than 2 to 10 times the RDA for a specific vitamin.

There are known dangers to vitamin use, especially high-dose use. When megadoses of most vitamins are taken, the excess amount is quickly excreted in the urine with no additional benefit to the patient. Occasionally, when large doses of vitamin A are taken, the amount not used rapidly by the body may be stored in the tissues, causing the skin to turn yellow. Most vitamin products can be toxic to children, and iron can be deadly to small children. Folic acid can react with anticancer treatment medications and mask signs of vitamin B12 deficiency. Sometimes the body starts to rely on large doses of vitamin C when taken over a prolonged period, and the body may believe there is a deficiency when the patient returns to a normal dose. Patients with diarrhea may lose vitamin and mineral products unchanged in the stool. There is also some evidence that vitamin use may weaken the efficacy of immunizations for flu in the older adult population.

Overuse of minerals can also be dangerous. Large amounts of calcium can limit the absorption of iron and other trace elements. They can also cause constipation and reduce kidney function. Calcium is needed primarily in menopausal women and older men, particularly those who are at risk for bone loss.

Antioxidant vitamins have a prominent place in the current literature on nutritional supplements. The major antioxidant vitamins are vitamin E, or alpha-tocopherol; beta-carotene or provitamin A, which is a precursor to vitamin A; vitamin C, or ascorbic acid; and selenium. All of these vitamins are found in fruits and vegetables. Many research studies are being done to determine the mechanism of action of antioxidants. Current research suggests that when low-density lipoprotein (LDL) cholesterol is oxidized, the oxidation is often incomplete. (The analogy has been made to wood that burns incompletely in a fireplace and “pops,” sending sparks against the screen.) This incomplete oxidation produces free radicals that often lead to atherosclerotic plaques. It is believed that antioxidants slow or prevent LDL cholesterol oxidation because they are oxidized better than LDL cholesterol. This slows or eliminates atherosclerosis. It is also believed that antioxidants slow the process that may cause cells to become cancerous. This has caused a large increase in the sales of antioxidants in an attempt to decrease cardiovascular disease and cancer.

Although many major research studies have looked at antioxidants and found they may have some benefits, no major clinical studies have concluded that antioxidants prevent cancer. There is evidence that those who eat fruits and vegetables regularly have less risk of cancer. However, there is no evidence that this is the result of antioxidants. Therefore, taking antioxidant vitamins may be helpful to some extent. Research has also found that vitamins C, B6, B12, and E may be helpful in preventing coronary artery disease.

Advertisers suggest that natural products are better than synthetic vitamins. However, current research concludes that vitamins are probably the same whether they are natural or synthetic, costly or cheap. In fact, natural vitamins may contain other chemicals or impurities that may make them less effective than standardized synthetic products. The most important differences are that some preparations may dissolve better than others or contain the active product in amounts that increase the absorption of other vitamins and minerals taken at the same time.

National surveys have shown that those who least need extra vitamins and minerals are the most likely to take them, including people who eat well, exercise, and do not smoke. There is no evidence that people who take vitamins live longer or suffer less illness or disease. A benefit of vitamins and minerals to the average healthy individual who consumes a variety of foods has never been proved. The United States Department of Agriculture’s new MyPlate tool reminds people to balance what they are eating so they get their essential nutrition every day.

Supplements cannot make up for a poor diet or unhealthy lifestyle practices such as smoking or lack of exercise. Patients who do not eat a well-balanced diet and do eat lots of high-fat or “empty-calorie” foods may want to consider taking a multivitamin and mineral supplement. Most women in the United States 20 years of age or older eat approximately 1673 calories a day. Women who diet may eat fewer calories and may need to work harder to get the RDAs for essential vitamins and minerals. If patients cannot eat certain foods such as dairy foods, they may need to supplement their diet to make sure they are getting the nutrients they need.

An increasing amount of research suggests that taking specific nutrients may offer protection against problems such as osteoporosis, birth defects, heart disease, stroke, infectious diseases, macular degeneration, and cataracts. These products are taken to maintain or improve a person’s health and well being, or for health promotion. Some of these products are discussed in the following sections. Chapter 24 provides a complete discussion of the types of vitamins and minerals, their actions, uses, adverse reactions, and drug interactions.

Calcium

In 1993, the FDA approved the use of a health claim on food and supplement labels about the role of calcium in reducing the risk of osteoporosis and the need for calcium supplements by people who do not get enough calcium from their diets. The current advice is for people older than the age of 50 to consume at least 1200 mg of calcium daily. More than three glasses of low-fat milk per day would be required to provide this much calcium. Calcium-fortified (or enriched) products such as orange juice, sardines, salmon, tofu, and other dairy products help meet the daily requirements. The calcium citrate malate found in fortified orange juice is one of the best forms of calcium because it tends to be absorbed better than other types. The calcium carbonate found in Tums and other antacids is also acceptable. Vitamin D is important for calcium absorption. It is available as a supplement in multivitamins and fortified milk and naturally from exposure of the skin to the sun. Some calcium products also come with a small amount of magnesium, which also helps calcium absorption. Calcium supplements are best absorbed when taken with food because food slows down their passage through the large intestine.

Folic Acid, Vitamin B6, and Vitamin B12

There is now a significant amount of scientific data showing that eating foods containing folate (citrus fruits, cereals, leafy greens, and whole grains) or taking a multivitamin containing folic acid protects against fetal neural tube birth defects such as spina bifida and anencephaly and may also reduce the risk of heart disease and stroke. The neural tube of the fetus is formed within the first 28 days of pregnancy, before many women know they are pregnant. However, the evidence for folic acid in preventing neural tube defects is so strong that the U.S. Public Health Service issued an official recommendation that “all women of childbearing age in the United States who are capable of becoming pregnant should consume 0.4 mg of folic acid per day for the purpose of reducing their risk of having baby with spina bifida or other neural tube defects.” This warning applies to women throughout their childbearing years. The dose of folic acid should be increased to 4 mg/day for at least 3 months before a woman plans to get pregnant.

Research has also established that modestly elevated homocysteine levels in the blood are a risk factor for heart disease. Folic acid and vitamins B6 and B12 have been shown to reduce homocysteine levels. The intake of these three B complex vitamins, found primarily in vegetables and legumes, has been shown to be low in the United States, particularly in the older adult population. Vitamin B12 is also found in meat and fish but is not absorbed as easily by people as they age. Some experts say that those at risk for heart disease should take a supplement that contains folic acid and vitamins B6 and B12. Folic acid may be more readily absorbed from supplements and enriched foods than from other sources.

Iron

Iron has long been known to be necessary for people who suffer from anemia caused by blood loss. Thus young women of childbearing age are often given iron supplements. Most menopausal women would probably benefit from a multivitamin containing 10 milligrams of iron or less. Iron supplements for people who do not have blood loss have not been shown to be needed or desirable. High levels of iron in the blood can result in heart disease, cancer, and serious infection. However, it is hard to find a multivitamin without iron. People should take iron and calcium supplements at different times because these two minerals compete for absorption and taken together, neither one will have sufficient therapeutic action. Iron may also be very constipating, especially in some elderly patients.

Summary

The scientific information about herbal products and alternative health care is still sparse. These herbal products are not benign and should be respected as important chemicals. Consumers with serious or chronic health complaints will often self-diagnose and self-treat with OTC drugs, herbs, and supplements. This is not ideal, because many of these patients need supervised medical care.

It is good practice for health professionals to advise anyone pregnant or breastfeeding to avoid use of herbal products because the effects on fetal development and breast milk excretion are unknown. Similarly, use in infants and younger children should be strongly discouraged.

If patients are taking herbal products or supplements, advise them to take the dosages that have been studied in clinical trials and not to exceed labeled amounts. Patients should avoid products with labels that fail to specify the exact amount of the herb contained per dosage unit. Generally, herbs should be taken only for a short time.

If patients tell you they are taking herbal products, take a careful history regarding any plant allergies, especially to ragweed and daisies, as many patients with allergic rhinitis (runny nose) may not know what allergens trigger their attacks. Patients who are allergic to ragweed and flowers in the daisy family (asters, chrysanthemums) may have allergic reactions to products containing echinacea and chamomile. Some herbs are photosensitizing (e.g., St. John’s wort), and patients should be cautioned appropriately (especially fair-skinned individuals).

Herbal products should be discontinued at least 2 weeks prior to planned surgery, and patients should notify the anesthesiologist of herbs they have used routinely. Some herbals (e.g., garlic, ginkgo, ginseng, and ginger) may interfere with normal blood coagulation, predisposing patients to prolonged bleeding and interactions with warfarin. See other related chapters for more details on these products.