Acknowledgment
The editors and author would like to acknowledge Emily WhiteHorse, the author of this chapter in the previous editions.
Complementary and integrative health refers to the incorporation of practices and techniques to gain or maintain better health but fall outside of the realm of traditional Western medicine. Patients and practitioners use complementary practices to supplement conventional medicine. Integrative medicine refers to the conscious and coordinated combination of conventional and complementary practices. Another commonly used designation is alternative medicine , which refers to practices and systems of care used in place of conventional medicine. According to the National Center for Complementary and Integrative Health (NCCIH, formerly the National Center for Complementary and Alternative Medicine), a center within the National Institutes of Health (NIH), about 34% of Americans use some form of complementary health approach, and more than 50% of Americans use a dietary supplement based on the National Health Statistics Report. The NCCIH dropped the term alternative from its name to reflect the facts that much of what was once considered alternative is joining the mainstream in a variety of health care settings and that most of its use in this country is in conjunction with medical care.
The mission of the NCCIH, established in 1998 within the NIH, is to “define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions and their roles in improving health care.” It provides a coherent approach to researching various complementary products and techniques as well as providing a clearinghouse for evidence-based information on both the efficacy and potential dangers of complementary products and techniques. The NCCIH considers complementary health approaches in two major categories, natural products and mind–body practices. The former includes herbs, vitamins, minerals, and special diets, and the latter refers to a broad range of therapies such as yoga, chiropractic manipulation, acupuncture, and guided imagery.
In addition to these broad categories, there are whole systems of care such as traditional Chinese medicine, Ayurvedic medicine, naturopathy, and homeopathy that hold an approach to healing that is very different from that of conventional Western medicine. Patients and practitioners may subscribe entirely to one of these traditions or may use practices from another system of care as a complementary technique. For example, traditional Chinese medicine conceives illness as a disharmony within the body and between the body and the world around it. Balance between the opposing and complementary forces, yin and yang, promotes the free flow of energy (qi) through the body, promoting good health. There is not the same distinction between mind and body as there is in the Western conception of health, and a particular type of imbalance will lead to both physical and mental or psychological consequences. Acupuncture, tai chi and qi gong (both exercise and movement practices), and various herbal formulations are all used to gain and maintain this balance. Of course, this system, which dates back thousands of years, is far richer and more complex than can be described here. Another ancient system is Ayurvedic medicine (Sanskrit for “science of life”) developed in India that uses a variety of techniques and remedies. As with traditional Chinese medicine, Ayurvedic medicine is based on an Eastern worldview that is very different from that of empiric Western science. Other examples include homeopathy in which very small doses of a particular toxin or irritant are used to prevent or heal the ailment it causes.
Given the common and increasing use of many practices outside the realm of traditional Western medicine, clinicians must have a basic understanding of some of the more commonly used therapies and techniques and be able to access the relevant scientific evidence in regard to their safety and efficacy. As with other therapeutic realms such as physical therapy, occupational therapy, and dentistry, the physician assistant (PA) must be acquainted with commonly used complementary modalities and prepared to advise patients. Having open conversations with patients on their use of complementary therapies can serve to improve the patient–provider relationship. Discussion of patient’s use or potential use of complementary and integrative medicine also creates the basis for relaying information on current research.
Research on the expansive array of complementary and integrative practices and products has been difficult for a number of reasons. For natural products, there are two major problems, both related to funding. Because most of these products are widely available and account for approximately two thirds of the $33.9 billion of out-of-pocket expenditures for complementary health in the United States, there is little incentive for manufacturers and marketers to engage in robust research. In addition, because there is no available patent for most plant-based and herbal remedies, there are not the same economic forces as exist in the far more tightly controlled pharmaceutical market. In addition to the fiscal difficulties, there is little standardization in terms of formulation and potency of most products both in research and in the public marketplace.
The Dietary Supplement and Health Education Act of 1994 classifies vitamins, minerals, botanicals and amino acids as nutritional supplements that can be marketed without proof of safety or efficacy. Marketers may not claim an undocumented (and Food and Drug Administration [FDA]-approved) clinical indication but may make claims that the product supports or enhances normal function. For example, a particular supplement may be said to “support bone health” but not to “treat osteoporosis.”
For mind–body practices, there is the additional difficulty in conducting good research trials: Accounting for the placebo effect is complicated. Although it is simple to use an inert substance in place of an herb, it is more difficult to design an effective sham procedure for something such as acupuncture and to ensure blinding throughout a study. That said, the data on complementary and integrative practices are increasing. In the following pages, we will review some of the most commonly used products and practices and the available research.
Your patient is a 23-year-old woman who is pregnant for the first time. She has been experiencing a lot of morning nausea and was told by her grandmother that she should try chopping fresh ginger and boiling it for 15 minutes to make a tea. She asks if this is safe during early pregnancy. Her only current medication is a prenatal vitamin.
You quickly check on the NIH’s website (see “Resources” ) and find that not only is ginger safe in pregnancy but also is likely effective. You let her know that she might try the ginger tea but to call if she continues to have difficulty. At your next visit, she states that she is no longer experiencing nausea, and the ginger tea was very helpful.
Your patient is a 48-year-old man with HIV infection previously well controlled on a single tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil. His most recent laboratory test results showed an increase in viral RNA. You question him on adherence and he states he has not missed any doses and takes the medication with food as directed. His only other medication is bupropion 150 mg twice daily for depression, a dose that has been unchanged for several years. You ask about over-the-counter medications or other supplements. He reluctantly admits that, on the advice of a friend, he had started taking St. John’s wort to see if this natural remedy might allow him to discontinue his antidepressant. His intent was to start reducing his dose of bupropion after taking the herb for a month or two.
You check on the NIH’s website and find that hypericin, the active ingredient in St. John’s wort, has many drug–drug interactions, including a likely reduction in the activity of cobicistat used in his HIV medication to boost the activity of elvitegravir to levels sufficient to control his HIV with a once-daily dose. You explain this to your patient, and he agrees to discontinue the herb and to review his psychiatric medication with his psychiatrist.
Natural Products
The use of special diets for health maintenance or to manage disease is common and in constant flux. There is ongoing controversy regarding the efficacy of various approaches, but the overall recommendation for most Americans is to maintain a healthy weight; consume more fruits, vegetables, and whole grains; and reduce sugar and salt. The Healthy People 2020 goals include increasing the total intake of vegetables (from a 0.77-cup equivalent for the years 2001 to 2004 to a 1.14-cup equivalent per 1000 calories) and reducing the percent of total daily calories from added sugars (from 15.7% for the years 2001 to 2004 to 10.8%). The DASH (Dietary Approaches to Stop Hypertension) diet, which includes a combined total of 8 to 10 servings of fruit and vegetables daily, has been shown to reduce hypertension and improve lipid levels. The need for vitamin and mineral supplementation depends on the overall quality of the diet and the presence of specific health conditions.
The use of natural products other than vitamin or minerals is widespread; 17.7% of adults use them, according to the 2012 survey. Plant-based products are generally considered to be safe in small quantities, but concentrated forms and large doses may have adverse effects. Some of these products may interact with prescribed medications or otherwise cause harm, so it is critical for PAs to find out what products a patient uses and be able to offer guidance. The NCCIH offers online reference materials, and we will cover several of the more commonly used products here. Review the NCCIH website or one of the other resources listed for products not listed or for further information.
Aloe vera is a succulent plant that contains a viscous gel often used for a variety of skin conditions and found in a multitude of products. It is sometimes used orally for constipation and a variety of other conditions. Although the plant does contain a laxative, it is hard on the kidneys, and the FDA required aloe to be removed from laxative products in 2002 because of safety concerns. Aloe vera can reduce blood sugar when used orally, but the same safety concerns must be considered. Rodent studies of oral aloe vera have shown clear evidence of carcinogenesis. In humans, this risk is unknown, but it can cause diarrhea and abdominal cramping and can reduce the absorption of medications.
As a topical therapy, aloe vera can increase circulation and control bacteria and thus may promote healing. Studies of this effect have, however, been mixed, and it may actually reduce healing in some situations, particularly deeper wounds. It is likely safe and effective for minor burns and abrasions.
Black cohosh or snakeroot is a plant whose root is formulated into teas or tinctures. Research on its most common use of relieving the symptoms of menopause, particularly hot flashes, has been mixed and is ongoing. There do not appear to be any significant interactions with medications. People with any form of liver dysfunction or who take other medications that may harm the liver should avoid black cohosh. There have been several cases of hepatitis in women taking black cohosh, though the relationship is unclear.
Chamomile is a flowering plant used for anxiety, sleeplessness, and upset stomach. The flowering tops are made into a tea or tincture. It is also a common ingredient in topical therapies for ulcers and abrasions. Early studies on the topical use of chamomile indicate that it may be effective for minor skin irritations and for mouth ulcers. There are not yet any conclusive data regarding its efficacy as an oral agent. It does not appear to have any major interaction with medications, and its only known harmful effect is allergic reaction in some individuals.
Cinnamon is widely used in the United States as a flavoring agent in sweets and curries and is certainly safe when taken in small doses. There is some research on its potential beneficial effects on diabetes and heart disease, but there is not yet any clear evidence of its utility for these conditions. Cinnamon contains coumarin, also found in warfarin, but there are no data on its effect on clotting. However, because of its potential effects on clotting those with clotting disorders or on warfarin, patients should be advised against consuming large quantities of cinnamon. Similarly, the potential effect of lowering blood glucose should be considered for those on medication for diabetes.
Cranberry is widely used in food and beverages. Its most common use is in preventing urinary tract infections. Current research demonstrates that it may be effective in preventing bacteria from adhering to the epithelium off the urinary tract, but cranberry has not been shown to have any role in the treatment of an established UTI. A more recent potential use for cranberry is in reducing the ability of Helicobacter pylori to survive in the stomach. Some preliminary research supports the possibility of this effect. It may also serve to reduce dental plaque. There are no documented adverse effects of cranberry, but it should be used with caution in those taking warfarin or aspirin.
Echinacea is widely used to stimulate immune function and to treat or prevent colds and influenza. To date, research has not clearly supported this indication, although studies continue. There is some indication that people with asthma and atopy are more likely to have allergic reactions to echinacea, but it seems to have no other significant adverse effects. Echinacea may interact with caffeine and with medications metabolized by cytochrome P450, CYP 3A4 such as some statin medications, estrogen, some antiretroviral drugs, and macrolide antibiotics.
Ephedra (ma huang) is used in the East to treat colds and congestion. In the West, it was previously used in products for weight loss and for athletic performance. In 2004, the FDA banned the use of ephedra in dietary supplements because of the very high rate of adverse events. Ephedra can cause seizures, gastrointestinal distress, high blood pressure, stroke, arrhythmia, and heart attack. Herbal teas and traditional Chinese remedies may still contain ephedra. It has some efficacy for short-term weight loss, but this effect cannot be balanced against its many adverse effects. One should never combine ephedra with other stimulants, including caffeine.
Garlic is, of course, an everyday ingredient for cooking. As a supplement, it may be effective for cardiovascular disease and in the prevention of certain cancers. Current research indicates some effect in lowering blood pressure and a possible effect on cholesterol levels. Studies on cancer prevention are ongoing, but no current data confirm its utility for this indication. Garlic may also be an effective topical antifungal agent (0.6% ajoene gel).
Oral garlic interacts with antiplatelet medications, increasing the risk of bleeding, and with most protease inhibitors, reducing their activity. Garlic decreases levels of isoniazid, used in treating or preventing tuberculosis, as well as some antiretroviral medications (nonnucleoside reverse transcriptase inhibitors and some protease inhibitors). Garlic is otherwise safe for most people.
Ginger , commonly used in cooking, is helpful to treat nausea. It can be used fresh, generally coarsely chopped and boiled to make a tea, or in powdered form. Placebo-controlled trials of ginger for nausea in early pregnancy have shown a positive effect. The results of studies using ginger for nausea related to surgery are mixed. Ginger may also be efficacious in treating menstrual pain and for osteoarthritis, although results for this use are also unclear. The data on drug interactions are unclear, but ginger is likely safe at lower doses for most patients. It may reduce clotting and blood sugar, so use caution recommending ginger to those on diabetes medication or anticoagulants.
Ginkgo biloba is an ancient tree found originally in China whose leaves and seeds have been long used there for a variety of conditions, mostly those involving mental function. It seems to have some effect in improving circulation and reducing clotting. Smaller studies showed some beneficial effect in Alzheimer disease and dementia, but a large study (>3000 participants) conducted by the NIH showed no difference in cognitive function between those on ginkgo and placebo after 6 years. Research on ginkgo for anxiety disorders and depression as well as for premenstrual syndrome and hypertension has not yet demonstrated a consistent effect.
Those with seizure disorder should not take ginkgo because it may induce seizures. It may also increase the risk of serotonin syndrome for those taking serotonin reuptake inhibitors (SSRIs). It may also increase the risk of bleeding in those taking Coumadin or other blood thinners. Be cautious in using ginkgo along with any medication metabolized through the liver. The nuts of the ginkgo tree have shown some toxicity and carcinogenesis in animal studies.
Ginseng is a root made into capsules, tablets, or teas used to treat or prevent colds and flu. Smaller studies have shown a substantial effect for respiratory infections, but the data remain inconclusive in larger trials. It may also have the effect of reducing blood sugar in those with diabetes. Ginseng is the subject of many current research studies for these uses as well as for improving cognitive function in those with Alzheimer disease. Some have attributed the mixed research results on ginseng to variable dosing in different preparations.
Side effects include gastrointestinal, sleep disturbances, headaches, and allergic reactions. It has potential drug interactions with angiotensin-converting enzyme inhibitors, calcium channel blockers, and anticoagulants.
Goldenseal is widely used in the United States as an immune booster and for respiratory infections. Although there is some evidence that one of its components, berberine, may have some beneficial effect, there is no evidence that the currently available preparations are effective. It has many potential interactions with a wide variety of medications including antibiotics and antivirals. Breastfeeding women should avoid goldenseal because it may cause or exacerbate jaundice in infants.
Kava root is formulated into teas or tinctures to improve mood and well-being. There are no data regarding its effectiveness, yet there are numerous reports of significant adverse effects, including liver damage and central nervous system (CNS) effects. Kava interacts with most medications that affect the CNS.
Milk thistle is an herb used for its effect on protecting the liver from damage by toxins or infection. Studies by the NIH have not shown any significant effect on the disease process of patients with chronic hepatitis C, although it did show some effect in reducing the symptoms of the disease. Milk thistle may also be helpful in managing diabetes and hyperlipidemia. Some patients may have an allergic response to milk thistle, particularly those with ragweed allergies.
Saw palmetto is a small palm used to relieve symptoms of prostatic hypertrophy and for prostate cancer. To date, placebo-controlled studies have not confirmed this effect, but studies are ongoing. It is generally safe but may interact with anticoagulant medications, increasing their effect.
St. John’s wort is widely used for depression, obsessive-compulsive disorder, and premenstrual syndrome. Research on its use has had mixed results, but larger studies have shown no significant effect. It has significant interactions with many medications, including many used to treat HIV and antidepressants.
Tea tree oil comes from an Australian tree long used by the aboriginal people. Topical tea tree oil is likely effective to fight bacterial and fungal infections. In vitro studies have given preliminary data confirming its antibacterial properties, and smaller studies have supported its activity as an antifungal and antiacne agent. It can cause irritation when used in higher strengths. It should not be taken internally, but the topical use of diluted forms is considered safe.
Turmeric is a widely used herb that also has a history of use in Ayurvedic and Chinese medicine for a variety of ailments. Turmeric is taken medicinally for intestinal ailments and for its potential antioxidant and immune-boosting properties. There are also some data indicating that turmeric may be helpful in treating osteoarthritis. Data on these effects are mixed, but turmeric is certainly safe in its normal culinary use and in usual doses as a supplement.
Valerian is a bitter root used for insomnia as a tea, capsule, or tincture. There are several studies indicating it may be helpful and others showing no effect. Valerian should not be combined with sedative medications but is otherwise considered safe.
Yohimbe is used to improve sexual function in men and for anxiety and depression. It has many potential side effects, including tachycardia, tremor, hypertension, hyperglycemia, anxiety, and agitation. It has drug interactions with some antidepressants and antihypertensives. It is available in prescription form as yohimbine, and clinicians should review the prescribing information of this product before recommending for or against its use.
