Complementary and Alternative Medicine
Mauro Moscucci
Sara L. Warber
Keith D. Aaronson
Complementary and alternative medical (CAM) therapies can be defined as medical interventions that are currently not an integral part of conventional medicine and that, as such, are not taught widely in United States medical schools and are generally unavailable at U.S. hospitals (1). Since 1990, documentation by several surveys of the widespread and increasing use by consumers of CAM therapies has brought the attention of the health care community, employers, and insurers to the importance of this form of therapy. In 1998 Eisenberg et al. (2) reported that 43% of Americans used at least one form of CAM therapy in 1997 and that a 25% increase in the number of users and a 43% increase in visits to CAM practitioners had occurred since 1990 (1). Eighteen percent of patients taking prescription drugs were also using herbal remedies, and the estimated market for CAM therapy was $21 billion annually. More recently, a survey from the Josiah Macy, Jr., Foundation (3) showed that in the year 2001, more than 50% of Americans were using CAM therapies. An estimated 600 million visits per year were made to CAM practitioners, with an estimated market of $30 billion annually. In that survey, the estimated market for herbal remedies was $10 billion, with a growing market share estimated at 20% to 30% per year. In addition, as shown by another survey of 376 consecutive patients undergoing preoperative or postoperative cardiac surgery evaluation at Columbia Presbyterian Medical Center in New York, many patients use some form of alternative medicine but do not or do not want to discuss its use with their physicians (4). Among patients surveyed, 75% admitted the use of alternative medical therapy (44% without prayers and vitamins), but only 17% had discussed this use with their physicians, and 48% did not want to discuss it with their physicians. Thus it is increasingly important for practitioners to gain familiarity with various forms of CAM and specifically to elicit and document a history of use of CAM from patients.
CLASSIFICATION OF COMPLEMENTARY AND ALTERNATIVE MEDICAL THERAPIES
CAM therapies can be categorized in five major groups [National Institutes of Health classification (5)]: (a) alternative medical systems, (b) mind-body interventions, (c) manipulative and body-based methods, (d) energy therapies, and (e) biologically based treatments.
Alternative Medical Systems
Alternative medical systems can be defined as complete systems of theory and practice of medicine that have evolved independently and often before the conventional medical system (5). Examples of alternative medical systems include Asian medical practices, homeopathic and naturopathic medicine, Ayurveda medicine, and other traditional medical systems developed by
Native American, Aboriginal, African, Middle-Eastern, Tibetan, and Central and South American cultures. The characteristics and principles of several systems are summarized in Table 40.1.
Native American, Aboriginal, African, Middle-Eastern, Tibetan, and Central and South American cultures. The characteristics and principles of several systems are summarized in Table 40.1.
In contraposition to conventional allopathic medicine, alternative medical systems are generally characterized by the recognition that mind, body, and spirit are integrated and interconnected and that treatment of illnesses should be aimed toward reestablishment of lost balances and promotion of self-healing processes. As outlined in Table 40.1, many alternative medical systems include the use of herbal therapies. Herbal therapies commonly used in cardiovascular care are discussed later in this chapter, in the section on herbal remedies.
Mind-Body Interventions
Mind-body interventions can be defined as interventions aimed toward promoting the ability of the mind to affect body functions and symptoms (5). Examples of mind-body interventions include art therapy, biofeedback, dance and movements, hypnotherapy, interactive guided therapy, meditation, music therapy, neurolinguistic therapy, poetry therapy, relaxation therapies, spiritual healing and prayer, yoga, and cognitive-behavioral approaches.
Now extensive evidence supports the importance of mind-body interactions in the development of cardiovascular disease. In particular, type A behavior, hostility, stress, and low physical activity have been identified as important correlates of the development of cardiovascular disease (6,7). On the basis of these premises, it is conceivable that mind-body interventions could have an important impact on the natural history of cardiovascular disease. This hypothesis has been confirmed by the results of a meta-analysis of 23 randomized clinical trials evaluating the addition to conventional therapy of interventions addressing emotional and psychosocial issues (8). In that analysis, the addition of mind-body interventions was found significantly to reduce morbidity and mortality rates. More recently, an extensive review of various mind-body interventions, including social supports, yoga, religious attendance, imagery, and meditation in the treatment of cardiovascular diseases, revealed that many interventions used as complementary or stand-alone therapy might have beneficial effects on disease progression and on long-term outcomes (9). Scientific evidence of efficacy based on randomized clinical trials is still limited. However, the lack of significant adverse effects and the anecdotal and, in some instances, scientific evidence of effectiveness supports a potential role of mind-body interventions as complementary therapy for cardiovascular disease.
Manipulative and Body-Based Methods
These therapies are based on manipulation of the body and movements and include chiropractic, massage therapy, and osteopathic medicine.
Chiropractic is based on the relation between body and function and on the foundation of facilitating the body’s own healing power. The aims of this therapy are to alter local tissue stresses, to reduce mechanical stimulation, and to allow the organism to recover. The most common and best-known chiropractic treatment is spinal manipulation. However, chiropractic also includes lifestyle counseling, nutrition management, rehabilitation, and other physiotherapeutic modalities. The beneficial effects of chiropractic have been documented in several clinical trials, and it is now considered an effective treatment modality for spine and related disorders (10). It is important to note that spinal manipulation is not completely risk free and that several reports of stroke and of vertebral and carotid artery dissection during manipulation of the cervical spine have been made. Thus extreme caution is advisable, particularly for patients with cerebrovascular disease. Hypertension is the only cardiovascular disease listed among conditions treated relatively often by chiropractors (11).
TABLE 40.1. Alternative medical systems | ||||||||||||||||||||||||||||||||||||||||
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Massage therapy is one of the oldest health care practices; its origin can be traced back to China in 2,000 B.C. It can be divided in five major categories: traditional European; contemporary Western; Asian (acupressure, shiatsu, tuina, AMMA therapy, jin shin do); energetic; and structural, functional, and movement integration. Each of these categories is based on different principles, but the common denominator is promotion of the body’s ability to heal itself.
Energy Therapies
Energy therapies are based on the concept of healing through manipulation of energy fields originating within the body (biofields) or through application of energy fields from other sources (electromagnetic fields) (5).
Examples of biofields therapies include polarity therapy, Qi gong, reiki, and therapeutic touch. Polarity therapy was developed by Randolph Stone, and it incorporates in its philosophy healing based on the flow or disruption of electromagnetic fields in the human body. Qi gong is based on the integration of mind, body, and breathing through meditation, movements, self-massage, and special healing techniques. It is one of the major branches of traditional Chinese medicine, and it relies on the same principles of Qi, the vital force that connects body, mind and spirit, and on the principle of yin/yang and meridians in the pathogenesis of disease. Reiki can be traced back to Tibet (3,000 B.C.). It was later developed and practiced in Japan in the mid-1800s. Reiki is a touch healing system (“laying on of hands”) that promotes healing on the physical, mental, emotional, and spiritual levels. The practitioner, by laying his or her hands on the patient’s body, channels the healing energy of the “universal life-force energy.” The skills of the practitioner are acquired through training from a reiki master or teacher who has the ability to connect the student to the reiki energy. At this time, no objective evidence supports the medical use of any of these modalities.
Biologically Based Treatments
Biologically based treatments are practices, interventions, and products aimed toward modification of biologic functions and processes (5). They include herbal, dietary, enzyme, and orthomolecular therapies. Chelation therapy and special diet therapies such as those proposed by Drs. Robert C. Atkins, Dean Ornish, Nathan Pritikin, and Andrew Weil are also part of this group.
ACUPUNCTURE
Acupuncture has been extensively used in Western countries for the treatment of numerous conditions, including chronic
pain, postoperative pain, asthma, drug addiction, headache, nausea, osteoarthritis, fibromyalgia, allergies, and gastrointestinal motility disorders. An extensive review of available evidence by a National Institutes of Health (NIH) panel of the effectiveness of acupuncture brought consensus that acupuncture is effective for pain control and for the treatment of nausea. It might also be promising in other conditions, including asthma, myocardial infarction, bronchitis, and rehabilitation from stroke (12).
pain, postoperative pain, asthma, drug addiction, headache, nausea, osteoarthritis, fibromyalgia, allergies, and gastrointestinal motility disorders. An extensive review of available evidence by a National Institutes of Health (NIH) panel of the effectiveness of acupuncture brought consensus that acupuncture is effective for pain control and for the treatment of nausea. It might also be promising in other conditions, including asthma, myocardial infarction, bronchitis, and rehabilitation from stroke (12).
However, data on the use of acupuncture for the treatment of cardiovascular disease are currently limited. In Russia and in China, acupuncture has been used for the treatment of hypertension, congestive heart failure, and myocardial ischemia. However, these uses have not yet been tested in randomized clinical trials. In spontaneously hypertensive rats, acupuncture-like electrical stimulation activates central opioid pathways, which leads to a decrease in sympathetic activity and in blood pressure. Thus a pharmacologic basis appears to exist for the use of acupuncture in essential hypertension and in other conditions such as congestive heart failure, in which sympathetic activation plays an important role. An NIH-sponsored randomized clinical trial is currently recruiting patients with hypertension to determine the effectiveness of acupuncture in essential hypertension (13).
HERBAL REMEDIES
An herb is a plant or part of a plant that produces and contains chemical substances that can exert a biologic or pharmacologic effect. According to the Dietary Supplement Health and Education Act of 1994, herbal remedies or botanicals are currently not regulated by the U.S. Food and Drug Administration if sold as dietary supplements. Therefore they are not regulated for purity, potency, standardization, and formulation. The lack of regulation for potency and composition implies that significant batch-to-batch variability might exist and often many active ingredients are found in the same preparation. The current regulations allow marketing with statements explaining their reported effect on the structure or function of the human body or the role in promoting general well-being, but not for diagnosis, treatment, cure, or prevention of diseases. Table 40.2 lists the most common herbal remedies used for cardiovascular care.
Garlic
The medicinal use of garlic (Allium sativum) dates back to early Egyptian times, and it has been advocated for the treatment and prevention of several diseases. The active ingredient is allicin, an odorous sulfurous compound that has been shown to exert several pharmacologic effects, including inhibitions of platelet aggregation (possibly irreversible), reduction of cholesterol and triglyceride levels, and reduction of blood pressure. In animal models, garlic has an antiatherosclerotic effect, as evidenced by a reduction of the development of new atheromatous lesions and a slowing in the progression of existing lesions. Garlic is currently available as fresh cloves, extracts, powders, and tablets. Several studies have suggested that at least one-half garlic clove per day (14,15) is required for a pharmacologic effect. Dried powders and tablets appear to be more practical formulations, but doses of the active ingredient are often inadequate. Several studies have assessed the effect of garlic on serum lipids and blood pressure control. Two recent meta-analyses showed that garlic administration resulted in a 9% to 12% reduction in total cholesterol, a modest reduction in triglyceride levels, and no significant changes in high-density lipoprotein levels (14,15). A meta-analysis of eight antihypertensive trials showed on average an 11-mm Hg reduction in systolic blood pressure and a 6.5-mm Hg reduction in diastolic blood pressure (15). Another well-designed randomized clinical trial evaluating the effect of garlic on claudication secondary to peripheral vascular disease showed no significant effect on pain-free walking distance or on ankle/brachial index. In yet another double-blind, randomized, placebo-controlled clinical trial evaluating the effect of garlic oil
on serum lipoprotein levels and potential mechanisms of action, no significant effects on serum lipoproteins, cholesterol absorption, or cholesterol synthesis were identified (16). Variation in the concentration of the active compound in formulations may explain some of the differences between the results of clinical trials. The most common adverse effects of garlic are on the gastrointestinal system and include flatulence, esophageal pain, and abdominal pain. A significant interaction between garlic and an antiretroviral agent has been reported. This interaction results in marked reduction of blood levels of the anti-human immunodeficiency virus drug saquinavir in patients taking garlic supplements (17).
on serum lipoprotein levels and potential mechanisms of action, no significant effects on serum lipoproteins, cholesterol absorption, or cholesterol synthesis were identified (16). Variation in the concentration of the active compound in formulations may explain some of the differences between the results of clinical trials. The most common adverse effects of garlic are on the gastrointestinal system and include flatulence, esophageal pain, and abdominal pain. A significant interaction between garlic and an antiretroviral agent has been reported. This interaction results in marked reduction of blood levels of the anti-human immunodeficiency virus drug saquinavir in patients taking garlic supplements (17).
TABLE 40.2. Herbal products and orthomolecular therapies commonly used in cardiovascular care | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Soy Protein
Soy protein has been shown to be effective in reducing cholesterol through a decrease of cholesterol absorption, a decrease in bile reabsorption in the gut, and a phytoestrogenic effect. A meta-analysis of 22 trials showed a 9% decrease in total cholesterol levels, a 13% decrease in low-density lipoprotein (LDL) levels, and a 10% decrease in triglyceride levels (18). A more recent study showed that the lipid-lowering effect is present both in normocholesterolemic and in hypercholesterolemic men. The health claim for soy protein at a dose of 25 g per day has been approved by the Food and Drug Administration.
Cholestin (Red Rice Yeast)
Cholestin is a fermented product of rice on which red yeast is grown, and it has been used for centuries in China. It contains starch, proteins, fiber, and at least eight statin compounds that function as 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors. Chinese studies have shown that total cholesterol reduction after cholestin administration varies from 11% to 32%. A more recent randomized clinical trial showed a 15% reduction in total cholesterol and a 22% reduction in LDL cholesterol (19). Because cholestin contains several statin-like compounds, its use requires the same precautions as with prescription statins.
Guggulipid (Guggul Gum)
Gugulipid is an extract from the natural resin (gum guggula) of the mukul myrrh tree. It has been used in India to reduce cholesterol levels, and it has been evaluated in well-designed clinical trials performed in India (20,21,22,22a). These studies showed that gugulipid administration results in a reduction of total cholesterol levels ranging from 11% to 22% and a reduction of triglyceride levels ranging from 12% to 25%. One study showed a 12% reduction of LDL. More recently, oral 3-times-daily doses of guggulipid (1,000 mg) were compared with high-dose guggulipid (2,000 mg) and with matching placebo in a randomized clinical trial including 103 adults with hypercholesterolemia. Contrary to the expectation, administration of standard-dose and high-dose guggulipid was associated with a 4% to 5% increase in LDL-cholesterol. In that study, in six patients treated with guggulipid, a hypersensitivity rash developed (22b).
Ginkgo biloba
Ginkgo biloba has been used for memory loss and to improve circulation. The EGB 761 extract of Ginkgo biloba is highly standardized, and it is currently widely used in Europe. At least three active compounds are found in Ginkgo biloba: ginkgo flavone, glycosides, and terpenoids. Ginkgo biloba has an antiplatelet and antioxidant effect, it reduces platelet-activating factors, and it reduces production of thromboxane A2 (23). It has also been shown to enhance endothelial cell-derived nitric oxide through either an increase in nitric oxide synthase activity or a decreased breakdown of nitric oxide mediated by its antioxidant effect. Ginkgo biloba has been approved in Europe for treatment of dementia. In a study involving 202 patients, Ginkgo biloba was found to decrease the Alzheimer’s Disease Assessment Scale-Cognitive subscale score better than did placebo (24). No significant differences
in the incidence of adverse reactions were found.
in the incidence of adverse reactions were found.
Overall, Ginkgo biloba is considered a safe supplement; the most common adverse effects are headache and gastrointestinal. However, cases of subdural hematomas and bleeding have been described (25,26,27). It is currently believed that the increase in bleeding risk is due to ginkgolide B, an important inhibitor of platelet-activating factor. Thus the use of Ginkgo biloba is currently not recommended for patients receiving anticoagulants, aspirin, or nonsteroidal antiinflammatory agents or for patients undergoing surgical procedures.
Hawthorn (Crataegus)
The use of hawthorn as a cardiac medication can be traced back to Roman physicians in the first century A.D. Since then, it has been used for the treatment of congestive heart failure. Hawthorn is derived from a small, fruit-bearing tree that grows throughout the world in woodlands. It has been used in Japanese, Chinese, European, and Native American traditional medicine and by American herbalists. The active components include two groups of polyphenolic derivatives that are present in the leaf and the flower, and, at a lower concentration, in the berries. The polyphenolic compounds include flavonoids and their glycoside and oligomeric proanthocyanidins. Triterpene acids are additional active components (28a). The pharmacologic effects of hawthorn include a positive inotropic effect, coronary and peripheral vasodilation, and antioxidant and antiinflammatory effects, resulting in an overall cardioprotective activity. Hawthorn has been evaluated in several clinical trials enrolling a total of 1,500 patients. In these studies, administration of hawthorn was found to improve exercise efficiency, to increase duration of exercise to anaerobic threshold, to increase left ventricular function, and to result in beneficial hemodynamic changes, which include a decrease of systemic blood pressure, a decrease in heart rate, an increase in cardiac output, a decrease in pulmonary artery pressure and pulmonary wedge pressure, and an overall decrease in systemic vascular resistance. These studies are limited in that some were unblinded and uncontrolled, they were largely limited to New York Heart Association class II patients, and background therapy usually included only diuretics and possibly digoxin. The place of hawthorn in the contemporary management of chronic congestive heart failure has been investigated in two randomized, placebo-controlled clinical trials, both using Crataegus special extract WS1442 (Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany). The Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) study enrolled 120 patients to evaluate changes in exercise capacity, left ventricular function, quality of life, neurohormonal profile, and oxidative stress (28b). The results showed that the use of hawthorn extract in patients with mild-to-moderate chronic heart failure (HF) is not associated with any additional beneficial effect in patients already receiving standard concomitant medical therapy (28b). The Study of Prognosis in Congestive Heart Failure (SPICE) randomized 2,681 patients with NYHA class 2 to 3 heart failure and an LVEF of 35% or less to receive either WS-1442 (900 mg daily) or placebo for 2 years. All participants received standard drug therapy, which included diuretics in 85%, ACE inhibitors in 83%, β-blockers in 64%, glycosides in 57%, and aldosterone blockers in 39% of patients.
The primary end point was a 24-month composite of sudden cardiac death, death due to progressive heart failure, fatal or nonfatal myocardial infarction, or hospitalization due to progression of heart failure, measured at 24 months. Also in this study, no significant difference in the incidence of the primary end point was found between the group of patients treated with WS-1442 and the group of patients treated with placebo (28% vs. 29%) (28c).
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