Bimal H. Ashar
Over the past decade, the use of alternative medicine in the United States has skyrocketed. In 2002, an estimated 62% of patients reported using at least one type of alternative medicine therapy during the previous year (1). Yearly, out-of-pocket expenditures relating to alternative medicine by individuals in the United States are estimated at approximately $27.0 billion, roughly equivalent to the out-of-pocket expenditures for all U.S. allopathic physician services (2). Alternative medicine is broadly defined as approaches not routinely used by conventional practitioners. The term complementary medicine evolved in an effort to foster a positive relationship between allopathic and nonallopathic medicine. The idea that nonconventional therapies can serve as an adjunct to established Western medical practices has received increasing attention from patients, physicians, and governmental agencies. The National Center for Complementary and Alternative Medicine (NCCAM) was established by the National Institutes of Health (NIH) in 1999 to foster research, education, and the dissemination of evidence-based knowledge regarding alternative medicine. In an attempt to simplify these tasks, NCCAM has classified complementary and alternative medicine (CAM) practices into five major categories that encompass hundreds of individual modalities (Table 5.1). This chapter provides the clinician with an overview of some of the more popular CAM modalities currently used by patients. It will serve as a guide to enhance discussion between physicians and their patients.
Understanding the use of Complementary and Alternative Medicine
The Patient's Perspective
Before a discussion of specific CAM modalities is undertaken, a general understanding of some of the factors
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that may be responsible for the patient-driven alternative medicine movement is necessary (Table 5.2). A general theme underlying a majority of CAM therapies is their emphasis on “natural” modes of healing. Acupuncture, chiropractic, massage therapy, and homeopathy are purported to stimulate and invigorate the body's natural potential for preventing and treating disease. Similarly, herbs serve as natural supplements that many patients assume are milder and safer than human-derived medications. This desire of the public to return to nature has been bolstered by media hype, product advertising, and the widespread availability of information (and misinformation) over the Internet.
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TABLE 5.1 National Institutes of Health Classification of Complementary and Alternative Therapies |
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TABLE 5.2 Reasons for Use of Complementary and Alternative Therapies |
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Additionally, the status of the conventional physician has changed over the past 25 years. Distrust in the medical profession has developed, in part because of conventional medicine's failure to provide effective and safe therapies for a number of common ailments. Diseases such as chronic fatigue syndrome, fibromyalgia, and other pain syndromes have been defined with little understanding of their pathophysiology and without any specific therapy for their treatment. Patients with these conditions represent a large subset of seekers of alternative modalities of care.
The Physician's Role
Despite the widespread prevalence of CAM use among the general population, most patients do not inform their physicians of such use (2). It is imperative that clinicians incorporate an “alternative medicine” history into their routine patient evaluations. Information regarding the types of therapies the patient is using, as well as the reasons for choosing such therapies, should be sought. Further discussions should center on the patient's experiences (positive or negative), and on efficacy data (if available), cost, and potential toxicity of the patient-chosen therapies. Physicians should encourage correspondence with CAM providers in an attempt to develop referral networks. These steps should serve to strengthen the patient–physician relationship and ensure monitoring of potential untoward effects. Specific approaches to obtaining a CAM history are described elsewhere (3).
Acupuncture
Technique
Acupuncture is a system of medicine derived primarily from ancient Asian practices. It involves the insertion of fine needles into the skin in order to restore the balance of energy, or qi (pronounced “chee”), in the body. Qi flows through channels called meridians that are distinct from neurologic dermatomal patterns.
Patient Experience
An initial acupuncture evaluation begins with the history and physical examination. Conventional allopathic techniques are combined with an in-depth musculoskeletal examination designed to identify potential sensitive areas (trigger points). Additional parts of the examination may include detailed inspections of the tongue, radial pulse, and ear. Once a treatment plan is developed, the patient is placed in the supine or prone position on a flat table. Thin needles ranging from 0.1 to 3.5 mm in diameter (Fig. 5.1) are then inserted into defined points to affect the flow of qi. The needles traverse to a depth of 0.5 to 8 cm, depending
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on their location. Additional modalities, such as manual manipulation of the needles, heating of the needles with mugwort (moxibustion), or electrical stimulation, may be employed to assist in the movement of energy (4). The pain experienced by the patient depends on the skill of the practitioner, the thickness of the needle, the depth of insertion, the needle location, and patient sensitivity. Determination of a patient's response usually requires 8 to 12 weeks of therapy. The need for maintenance therapy usually is determined by the chronicity and severity of the underlying condition.
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FIGURE 5.1. A 20-gauge needle (center) compared with two typical acupuncture needles (left and right). |
History of Acupuncture in the United States
Although the acupuncture movement seems to have only recently gained popularity, its origins in the United States date back to the 19th century. In the first edition of Principles and Practice of Medicine, Sir William Osler described acupuncture as the “most efficient treatment” for acute lumbago (5). In more modern editions of that text, however, references to acupuncture do not appear, reflecting a subsequent lack of confidence in acupuncture as a treatment modality. In 1971, reporter James Reston described how the use of acupuncture successfully relieved his postoperative pain after an appendectomy (6). His article served to stimulate interest among physicians, the public, and the government. More recently, the NIH released a consensus statement that validated the use of acupuncture for certain conditions and strongly encouraged further research (7).
Mechanism of Action
The reluctance of Western medicine to accept acupuncture as a therapeutic tool stems from a lack of knowledge regarding the pathophysiology of the acupuncture response. Studies show alterations in a number of biologic mediators, including endorphins, neurotransmitters, and neurohormones (7). Functional magnetic resonance imaging studies suggest a correlation between specific acupuncture points and regionally specific brain cortical activation (8). Blood flow is also affected by acupuncture needling (9,10). Despite these studies, no unifying mechanism has arisen to completely explain the purported benefits of acupuncture.
Efficacy and Safety
More than 9,000 articles are indexed in Medline under the search term “acupuncture.” Yet, only a few of these papers describe clinical trials on the efficacy of acupuncture therapy. Most of the trials that have been done suffer from small sample sizes and methodologic flaws. Many challenges exist to the performance of meaningful acupuncture research. One major study barrier is the lack of standardization of the acupuncture field. There are many different types of acupuncture practiced today. Traditional Chinese acupuncture, auricular acupuncture, five-elements acupuncture, and hand acupuncture are just a few examples that would use unique points for similar conditions. Even among individuals who practice the same type of acupuncture, great variation may exist in actual point selection based on the practitioner's history, physical examination, and personal style. In the United States, many physician-acupuncturists have been instructed in a more disease-oriented approach that attempts to standardize treatments. Acupuncturists trained in the Chinese tradition typically spend 3 years learning to individualize treatments. In addition, they frequently use Chinese herbs in combination with acupuncture techniques to obtain a response. A major criticism of negative acupuncture studies by traditionalists is the abandonment of holism and individualization of care. Another major obstacle to acupuncture research is the difficulty in blinding practitioners and subjects. The use of “sham” acupuncture (needling inactive points) has been used in many trials, but has also been criticized because the flow of qi is still theoretically affected.
Despite their limitations, randomized controlled trials have been performed for a number of clinical conditions. The NIH consensus report stated that there is strong evidence to support the use of acupuncture for postoperative and chemotherapy-induced nausea and vomiting (7). Additional evidence exists for its efficacy for the treatment of chronic low back pain, although it has not been shown to be superior to other therapies (11,12) and its usefulness for acute low back pain has not yet been proven (11). Systematic reviews of the literature suggest the potential for positive effects on lateral epicondylitis and osteoarthritis of the knee (13,14). Equivocal evidence exists for the use of acupuncture for chronic pain depression and asthma (15, 16, 17). There is also strong evidence against the use of acupuncture for conditions such as smoking cessation and tinnitus (18,19).
The use of acupuncture is associated with very few serious adverse effects. There are case reports linking acupuncture therapy with pneumothorax, organ puncture, hepatitis, and skin infections; however, these events were usually attributable to improper sterilization of needles or practitioner negligence. Side effects, such as needle pain, tiredness, localized bleeding, and vasovagal syncope, are more commonly seen, but without serious sequelae (20).
Chiropractic
Chiropractic is a branch of Western medicine that has fought for professional respect since its inception in the late 1890s. Today, it is probably incorrect to classify
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chiropractic as a form of “alternative” medicine. Just under 10% of the population are estimated to have sought out chiropractic care for an underlying ailment, usually musculoskeletal in origin (1,21). Chiropractors are licensed in all 50 states. Most third-party payers, including Medicare, cover many of the services chiropractors provide.
Chiropractic Principles
Chiropractic philosophy places the nervous system at the center of health and well-being. Disease is considered to be fostered by imbalances in the neurophysiology of the body. This imbalance can be corrected by diagnosing and correcting mechanical abnormalities or subluxations in the spine. Although much variation exists in technique and adjunctive treatments, spinal manipulation remains at the core of the chiropractic approach to disease. It is a holistic form of health care in that it relies on the body's ability to ultimately restore physiologic balance after manipulation.
Patient Experience
A careful history and physical examination is performed by the chiropractor. Specific emphasis is placed on diagnosing spinal dysfunction. Areas along the spine are inspected and palpated for abnormalities in symmetry, tenderness, tone, and temperature. Passive and active range of motion are assessed carefully. Radiographs, ultrasonography, heat-sensing devices, and other tests may be employed to aid in diagnosis. After the diagnosis of a spinal abnormality, the patient may be placed with the side of the spinal restriction upward. The doctor's hands are then placed on certain points of the body so as to deliver a high-velocity, short-amplitude thrust to that spinal joint. This is typical of manipulation by direct contact (short-lever technique). In the long-lever technique, the spine is manipulated by thrusts to areas linked to the spine (e.g., a thrust to the thigh moves the vertebrae in the lower spine). Frequently, the patient experiences a cracking or popping noise. Possible adjuncts to therapy include massage, heat application, and trigger-point deactivation (22,23).
Efficacy and Safety
The most common condition treated by chiropractors is low back pain. Similar to the trials on acupuncture, chiropractic research generally suffers from methodologic flaws and difficulties in design. A recent meta-analysis of randomized controlled trials suggested that spinal manipulation appears to be more effective than sham therapy for acute or chronic low back pain, but not superior to other standard treatments such as analgesics, physical therapy, and back exercises (24). Although chiropractic for low back pain may not be the most cost-effective strategy (25), patient satisfaction seems to be higher than for nonmanual treatments (26).
Chiropractic has been used for a number of other conditions, including neck pain and headache syndromes. The data on efficacy are contradictory based on a few well-designed clinical trials (27,28). Some patients also turn to their chiropractor for the treatment of other disorders, such as menstrual pain, hypertension, asthma, and fibromyalgia. Again, no definitive conclusions regarding efficacy can be drawn because of the lack of research.
A number of serious adverse effects of chiropractic have been reported. Vertebrobasilar vascular accidents with subsequent infarction, vertebral fracture, diaphragmatic paralysis, internal carotid artery dissection, and tracheal rupture have been described and attributed primarily to cervical manipulation (23). The incidence of such severe complications is unknown but is thought to be rare. Serious complications of lumbar spine manipulation are also thought to be quite uncommon, and consist primarily of cauda equina syndrome (23). Minor complications, such as localized pain, are common but transient.
It is important for the primary physician to recognize contraindications to spinal manipulation. Patients with a coagulopathy, whether from illness or from medication, should be advised to refrain from chiropractic treatments. Additionally, patients with osteoporosis, rheumatoid arthritis, spinal infections, spinal neoplasms, spinal instability, or an absent odontoid process should avoid such therapy. Open communication between the patient, chiropractor, and the primary physician is vital to avoid serious complications.
Herbal and Nonherbal Supplements: Overview
Extent of Use
Of all the fields encompassed by the category of CAM, none has grown more rapidly in recent years than the use of over-the-counter supplements. An estimated 19% of the population used over-the-counter natural products in 2002 (1). Billions of dollars are spent each year by consumers searching for natural substances to foster and maintain their health. The reasons for the popularity of supplements are easy to understand. These are easily accessible, relatively inexpensive, “natural” substances that are purported to improve a number of conditions. Many patients use them to fill the void created by the dearth of available preventive medications. Others see them as a quick, hassle-free cure to an underlying problem. There is potential for gain without the need for practitioner visits, lifestyle changes, or unpleasant procedures. To many physicians, however, supplements are unproven, unregulated, potentially dangerous “drugs” that offer limited benefits to their patients. The roles of various supplements in allopathic medicine will most likely change rapidly as issues of safety, efficacy, and regulation are settled.
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Regulation in the United States
The U.S. Food and Drug Administration (FDA) historically regulated dietary supplements as foods, to ensure premarket safety and truthful labeling. In 1994, Congress passed the Dietary Supplements Health and Education Act (DSHEA), which served to expand the definition of “dietary supplements” and to deregulate the industry to meet the concerns of consumers and manufacturers. Vitamins, minerals, amino acids, herbs, and other botanicals are now all considered dietary supplements. Premarket testing for safety or efficacy is no longer required. Supplements are assumed to be safe unless proven otherwise by the FDA. The DSHEA attempted to place restrictions on labeling, however. Manufacturers can make claims only regarding the supplement's effects on a “structure or function” of the body (e.g., “for prostate health”). They cannot claim that their product is “intended to diagnose, treat, cure, or prevent any disease” (e.g., “for the treatment of benign prostatic hyperplasia”). Claims regarding structure and function are not required to be approved by the FDA before marketing. Despite the media attention given to the DSHEA, approximately one-third of Americans who use dietary supplements regularly believe that supplements are currently regulated by the government (29).
The lack of regulation of herbal and nonherbal supplements poses a number of problems. There are presently no standards in place to guarantee homogeneity among different products. For example, a patient may wish to take ginkgo biloba to potentially improve his memory. At the store he may choose from a number of different ginkgo products that vary tremendously in their composition. There is no assurance that the active ingredient or ingredients from the plant are even present in a given preparation. Variation also exists among batches from the same manufacturer owing to differences in plant composition, handling, and preparation. In many instances, the active ingredients are unknown, making standardization impossible.
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TABLE 5.3 Common Herbal Medications |
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The sale and distribution of herbs depends on proper identification of plants. A number of case reports have described breakdowns in this process. More than 40 cases of Chinese herb nephropathy were caused in Belgium by the inadvertent substitution of the nephrotoxic herbAristolochia fangchi for Stephania tetrandra, an herb used in weight-reduction pills. Many of the affected patients went on to develop urothelial carcinoma (30). Cases of adulteration of Chinese herbal products with steroids, benzodiazepines, nonsteroidal anti-inflammatory drugs, and diuretics have also been described. Reports of contamination of herbal products with heavy metals also exist (31).
Herbal Medicines
In general, adequate evidence is lacking to support many of the herbs marketed today. A number of herbal products rely on anecdotal evidence to support their use. Many of the clinical trials in the literature are small-scale, nonrandomized, and/or nonblinded. Large-scale randomized controlled trials are not cost-efficient for manufacturers because herbs are not patentable. Organizations like the Cochrane Collaboration have attempted to pool study data to draw conclusions from meta-analyses. Many of the analyses have been equivocal. The herbs listed in this section and in Table 5.3 represent a few of the more popular herbs
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used by Americans today. The suggested dosage usually is based on historical usage rather than specific safety or toxicity testing and may be quite variable.
Cranberry
Folklore has for years perpetuated the use of cranberry for the treatment of urinary tract infections (UTIs). Basic science research has suggested that the proanthocyanidins present in cranberries may inhibit the adherence of Escherichia coli to urinary tract epithelial cells. To date, no clinical trials have been done to suggest efficacy of cranberry juice or cranberry extract for the treatment of urinary tract infections. However, a recent systematic review of the use of cranberry for the prevention of UTI suggested efficacy, although the number of trials available for review were limited (32). Although cranberry supplementation is generally accepted to be quite safe, the possibility of inducing nephrolithiasis exists (33).
Ephedra and Bitter Orange
Traditional Chinese medicine has for centuries touted the use of ephedra for the treatment of asthma, congestion, and bronchitis. Also known as ma huang, it consists predominantly of two alkaloids, ephedrine and pseudoephedrine. In the United States, ephedra had become a popular ingredient in over-the-counter weight-loss preparations. When combined with caffeine, ephedrine caused significant weight loss over a 6-month period (34). However, as use of the dietary supplement increased, so did the number of adverse event reports. Hypertension, arrhythmias, myocardial infarction, stroke, and death have all been attributed to the use of ephedra products. This led to its eventual ban by the FDA in April 2004.
The prohibition of the sale of ephedra products, has led to the development and sale of a number of “ephedra-free” supplements for weight loss. Many of these supplements are marketed as safer alternatives, despite little evidence of safety or efficacy. One herb that has now become commonly used in such products is Citrus aurantium. Also known as bitter orange or zhi shi, this herb contains synephrine, a sympathomimetic amine that can theoretically raise pulse and blood pressure. To date, there is little efficacy data supporting its use for weight loss (35). Case reports have begun to emerge linking its use to myocardial infarction (36), QT prolongation and syncope (37), and ischemic stroke (38).
Echinacea
Echinacea is one of the most popular herbs in use. It is used primarily to prevent and treat upper respiratory tract infections. Although the plant genus Echinacea consists of a number of different species, medicinal use has centered predominantly on three of them (Echinacea purpurea, Echinacea angustifolia, and Echinacea pallida). These herbs have been thought to boost the immune system by stimulating cytokine activity. A number of clinical trials have demonstrated a positive effect on prevention and treatment of upper respiratory tract infections. Yet, definitive conclusions regarding efficacy have been difficult to make owing to study limitations (39). More rigorously designed trials seem to have negative results (40). There also exists great variation in species of plant studied, parts of the plant used (root, leaf, flower, seed), and extraction methods, further complicating interpretation of trials. Echinacea is thought to be quite safe for short-term use. No serious side effects have been reported, although hypersensitivity reactions can occur. Because of its ability to stimulate the immune system, echinacea is not recommended for patients with autoimmune disease or human immunodeficiency virus infection for fear of worsening disease. This concern remains a theoretical risk rather than an established fact. No long-term data on the safety of chronic use are presently available.
Feverfew (Tanacetum parthenium)
Feverfew has been used for centuries for a variety of conditions. It is commonly used for the prevention of migraine headaches. It is thought to inhibit prostaglandin synthesis, histamine release from mast cells, and degranulation of platelets. Additionally, it may have direct vasodilatory effects. There is currently very little evidence to support the use of feverfew migraine headache prophylaxis (41). If the leaves of the plant are chewed directly, mouth ulceration may occur. Otherwise, it is considered safe. Because of its effects on platelets, a theoretical concern about bleeding exists, although no cases have been reported to date.
Garlic (Allium sativum)
Garlic is one of the most highly studied herbal medications available. It has been thought to possess antimicrobial, anti-inflammatory, antifungal, antiprotozoal, antioxidant, and antineoplastic properties that make its use as a general tonic attractive. More recently, focus has shifted to garlic's effects on cardiovascular diseases and risk factors. A meta-analysis suggested that garlic supplementation may decrease levels of total cholesterol and low-density lipoproteins modestly, but only in the short-term. Platelet aggregation is significantly reduced, but the clinical importance of this finding remains elusive. No significant effects on blood pressure or glucose levels have been
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noted (42). Additionally, garlic has not been shown to improve symptomatic peripheral vascular disease (43). Garlic toxicity is usually mild and consists of gastrointestinal upset and body odor. Case reports of spontaneous bleeding and interactions with anticoagulants have been described (31).
Ginkgo biloba
Ginkgo biloba use has skyrocketed over the last few years based on reports and claims of its use for improving memory and treating dementia, peripheral vascular disease, and tinnitus. It is thought to have a number of biologic effects, including increasing blood flow, inhibiting platelet-activating factor, altering neuronal metabolism, and working as an antioxidant. Although overall data is limited, modest improvements in cognitive performance and social functioning in patients with Alzheimer disease or multi-infarct dementia have been seen with the use of ginkgo extract Egb 761 (44). However, there is currently no evidence that Ginkgo biloba is effective for the prevention of memory loss or dementia. Ginkgo has a modest effect on symptoms of intermittent claudication (45) but little effect on tinnitus (46). Side effects are rare and usually consist of gastrointestinal complaints or headaches. Cases of spontaneous bleeding (47) and seizures (48) have been reported. Because of the possible potentiation of anticoagulant effects, Ginkgo biloba use should probably be avoided in patients who are taking warfarin.
Ginseng (Panax species)
Ginseng is thought of by many as a virtual panacea. Asian ginseng (Panax ginseng) has been used for centuries as a general tonic, stimulant, and stress reliever. In Chinese medicine, American ginseng (Panax quinquefolius) has been used, but it is thought to possess less stimulant activity. Siberian ginseng (Eleutherococcus senticosus) has also gained popularity but belongs to a different plant species. The mechanism of action for ginseng is unknown but is thought to involve the concentration of ginsenosides, which are believed to act as an antioxidant and on a number of tissue receptors. Although small studies have suggested some improvement in mental performance and diabetic control, a systematic review of clinical trials failed to provide compelling evidence for advocating ginseng for improving physical performance, psychomotor performance, cognitive function, or for treating diabetes (49). In general, ginseng is considered safe. Reports of hypertension, insomnia, vomiting, headache, vaginal bleeding, Stevens–Johnson syndrome, and mastalgia have been cited (50). The possibility of an interaction with warfarin (reduced international normalized ratio [INR]) has also been raised (51). Care should be taken in patients who are taking anticoagulants.
Kava-kava (Piper methysticum)
Kava has been used for thousands of years by inhabitants of South Pacific islands. It is usually ingested as a mildly intoxicating beverage distinct from alcohol. Current interest in kava has centered on its use as an anxiolytic agent. Its mechanism of action on the central nervous system is unknown. Its effects seem to be independent of benzodiazepine-binding sites. A review of randomized, double-blind, clinical trials suggested that kava extract is superior to placebo for short-term treatment of anxiety (52). Undesired effects usually consist of mild gastrointestinal upset and allergic skin reactions. Eye irritation and a yellow, scaly, dry rash (kavaism) has been described with heavy, chronic use (50). Although rare and idiosyncratic, case reports of hepatitis, fulminant hepatic failure, and death have also been reported (53). These reports have prompted many European countries and Canada to ban its sale. Concomitant use with other anxiolytics or alcohol should be avoided to protect against excess sedation. Patients using kava should also have their liver function tests monitored periodically.
Saw Palmetto (Serenoa repens)
Benign prostatic hyperplasia is a common clinical condition among elderly men. Despite numerous conventional treatment options, many men choose against therapy because of the potential for adverse effects. This has led to the popularity of saw palmetto as an agent to treat symptoms associated with an enlarged prostate. A number of short-term studies show it to be effective in improving urologic symptoms and flow measures (54). Its exact mechanism of action is unknown, but may be related in part to inhibition of 5α-reductase. In a head-to-head trial, saw palmetto was shown to be equivalent to finasteride and tamsulosin in improving symptoms associated with benign prostatic hyperplasia. Fewer sexual side effects and no change in levels of prostate-specific antigen were seen in the group receiving the herbal treatment (55,56). However, saw palmetto has not yet been shown to prevent the complications of benign prostatic hyperplasia (e.g., acute urinary retention). Side effects reported with the use of saw palmetto have been mild and rare, although adequate data on long-term use are lacking. It should be noted that there is no known clinical evidence to support its use for the prevention of benign prostatic hyperplasia or prostate cancer.
St. John's Wort (Hypericum perforatum)
St. John's wort has been used extensively by Americans for self-diagnosed depression and dysphoria. It is the most widely prescribedantidepressant medication in Germany. Its mechanism of action and active ingredients have yet to be conclusively defined. However, data suggest that preparations of Hypericum extract may inhibit monoamine
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oxidase activity as well as synaptic neurotransmitter reuptake (57). The results of trials on St. John's wort for major depression are quite heterogeneous. A number of studies show minimal beneficial effects compared to placebo, whereas others suggest efficacy equivalent to a number of currently prescribed antidepressants (58). Clearly, lack of product standardization is an issue. In general, side effects of St. John's wort are mild and infrequent. The most commonly reported reactions include gastrointestinal irritations, allergic reactions, fatigue, dizziness, dry mouth, and headache. There are reports of photosensitization (57). Rare cases of serotonin syndrome have been reported with the combined use of St. John's wort and selective serotonin reuptake inhibitors (31). Therefore, caution must be exercised by patients taking prescription antidepressants. Most of the safety concerns regarding St. John's wort have revolved around potential drug–herb interactions, primarily as a consequence of its effect on the cytochrome P450 system (see below, Supplement-Drug Interactions and Table 5.4).
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TABLE 5.4 Supplement–Drug Cautions |
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Nonherbal Supplements
A number of nonherbal supplements have gained popularity over the past decade. These products consist predominantly of molecules normally found in the body. Vitamins, minerals, amino acids, and metabolic intermediates are just a few of the substances encompassed within this category. A manipulation of the concentrations of these molecules is thought to produce beneficial effects toward the prevention and treatment of disease. The efficacy, safety, and regulatory issues that surround herbal medications similarly apply to these supplements. The following paragraphs describe a few of the more popular products in this category.
Coenzyme Q10 (Ubiquinone)
Coenzyme Q10 is a substance produced by the body (and found in some foods) that is structurally similar to vitamins E and K. It is considered to be an antioxidant and also plays a major role in mitochondrial oxidative phosphorylation. It has gained popularity for the prevention and treatment for various cardiac disorders. To date, most of the trials on coenzyme Q10 have focused on its use in the treatment of congestive heart failure. A multicenter Italian study showed a reduction in hospitalizations and serious complications in patients with New York Heart Association class III and class IV heart failure treated with coenzyme Q10 (59). Other studies, however, have failed to show positive results (60,61). A recent review of the data concluded that there was no convincing evidence for or against the use of coenzyme Q10 for cardiac conditions (62). There is presently no evidence to either suggest that it reduces cardiac mortality or to support its use for the primary prevention of cardiac disease.
Supplementation with coenzyme Q10 has also been suggested to prevent beta-hydroxy-beta-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin)-induced myotoxicity. This assertion is based upon the demonstration of reduced levels of circulating coenzyme Q10 levels in patients taking statins. However, it is unclear whether this documented decrease is a true marker of tissue levels of coenzyme Q10. Additionally, if tissue levels are truly decreased, it is not known whether supplementation would restore these levels or result in clinical benefit (63). Coenzyme Q10 is also being used for a variety of other conditions, including hypertension, human immunodeficiency virus (HIV), and migraine headaches. There is very limited evidence to support its use for these conditions. There has been some promising data on the use of high-dose (>1000 mg/day) coenzyme Q10 in Parkinson disease (64), although it is premature to make definitive recommendations. The most commonly reported side effects with coenzyme Q10 administration are nausea, heartburn, and diarrhea. Its structural similarity to vitamin K has been suggested as the cause of a decrease in responsiveness to warfarin when administered concurrently (65,66). Typical doses for the treatment of cardiac disease are 50 to 200 mg/day.
Glucosamine Sulfate and Chondroitin Sulfate
Glucosamine and chondroitin are two of the most widely accepted supplements currently available. Even though they have not lived up to their initial claims as a “cure” for arthritis, they have provided many patients with some degree of relief from chronic joint pain. Glucosamine is an amino sugar that is a substrate for the production of glycosaminoglycans and proteoglycans, which are essential building blocks of connective tissue. Chondroitin is a glycosaminoglycan that may inhibit enzymatic destruction of synovial tissue and serve as an anti-inflammatory agent in addition to its role in structural cartilage formation. Meta-analyses of clinical trials have concluded that glucosamine–chondroitin preparations result in symptomatic and functional benefits for patients with osteoarthritis of the knees or hips and may slow the progression of joint space narrowing (67,68). Such effects may not be as pronounced with glucosamine alone (69,70). Both glucosamine and chondroitin are generally well tolerated. Mild gastrointestinal side effects are rarely seen. The recommended doses of glucosamine sulfate and chondroitin sulfate are, respectively, 500 mg three times daily and 400 mg three times daily. Treatment effect may not be seen for up to 8 weeks after beginning therapy. No significant drug interactions have been noted, although a theoretical risk of bleeding with concurrent administration of chondroitin sulfate and anticoagulants exists owing to chondroitin's structural homology with a small component of certain heparinoids (71). There is also theoretical concern about
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glucosamine inducing hyperglycemia. However, studies in type II diabetics have failed to demonstrate clinically significant rises in blood glucose or glycosylated hemoglobin (72).
SAMe (S-Adenosylmethionine)
S-adenosylmethionine (SAMe) is a common metabolic intermediary produced in the body through the interaction of methionine and adenosine triphosphate (ATP). It is considered to be vital to appropriate cellular functioning and survival. Because of its role in numerous metabolic pathways, it is suggested to be beneficial for a wide array of diseases, the best studied of which is osteoarthritis. A number of small clinical trials have suggested that its ability to improve the symptoms of osteoarthritis is equivalent to that of nonsteroidal anti-inflammatory drugs but with fewer side effects (73,74). A number of small studies on the use of SAMe for the treatment of depression show positive results (73,75). Many of these studies were conducted using a parenteral rather than oral form of medication because of the poor oral bioavailability of the medication. Studies on oral SAMe have typically used doses between 1200 and 1600 mg/day. Nausea and abdominal discomfort have been described rarely with the use of SAMe. In a number of depression trials, subsets of patients experienced hypomania (76). Additionally, there is concern for interactions with tricyclic antidepressants (77,78); consequently, concomitant use should be avoided. A major limitation to the use of SAMe is its cost. At its suggested dose of 400 to 1,600 mg/day, a 1-month supply can amount to well over $200 in out-of-pocket expense.
Supplement–Drug Interactions
It is estimated that one of every five adults taking prescription medications is also using over-the-counter supplements (2). Given that many of the supplements in use today have not been rigorously studied, little is known about their potential interactions with prescription medications. A number of case reports suggest that some herbal and nonherbal products may directly interact with certain drugs to inhibit or enhance their effects. Additionally, supplements may indirectly potentiate or oppose medication effects through independent mechanisms.Table 5.4 lists some potential problems when mixing prescription medications and supplements. Most of the cited cautions are based on case reports and theoretical concerns. It is
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imperative that physicians discuss the possibility of interactions with their patients and report any suspected cases to the FDA. The MedWatch program has been set up to monitor the safety of drugs, devices, biologics, and dietary supplements. Physicians should report any significant adverse reactions or supplement–drug interactions to this program. Reporting can be done over the Internet (at the MedWatch website, http://www.fda.gov/medwatch) or by telephone (1-800-FDA-1088).
Homeopathy
The principles of homeopathy were first publicized by Samuel Hahnemann in the late 1700s. Since then, it has generated much controversy and experienced waxing and waning popularity. Common diagnoses currently treated by homeopaths include otitis media, depression, allergy, hypertension, arthritis, and headache. In the United States, an estimated 3.6% of the population uses homeopathic remedies (1). This has occurred despite criticism from many scientists who believe that the homeopathic effect is nothing more than a placebo response. Much of the opposition stems from the inability to scientifically validate the basic tenets of this unique medical treatment system.
Homeopathic Principles and Medicines
The basis of homeopathy relies on two concepts: the law of similars and the use of dilutions. The law of similars suggests that patients with certain sets of symptoms can be cured of their ailments by administration of a drug that induces those symptoms in a healthy individual. An example of this principle in conventional medicine is the use of digoxin to treat arrhythmias, which it is capable of causing. The principle of dilutions suggests that substances retain their biologic activity even when they are diluted to levels at which no molecules of the original substance remain.
Homeopaths tend to focus on subjective symptoms and sensations rather than objective medical diagnoses. Thus a wide variety of medications can be used for the same diagnosis, depending on the clinical presentation. Various encyclopedias of homeopathic remedies exist (called materia medica) that describe symptoms produced by various diluted medications when administered to healthy individuals (provings). The patient's symptom complex is matched with the drug provings to determine the optimal therapeutic regimen. Treatment frequency can range from one or two doses to chronic daily dosing. Typically, patients are observed weeks later to determine progress and the need for alterations in the treatment plan.
Homeopathic medicines are usually derived from plant, mineral, or animal sources. They are regulated by the FDA under the Food, Drug, and Cosmetic Act of 1938. Most remedies are sold over the counter and require labeling information that includes ingredients, recommended dose, indications for use, and dilution. Homeopathic medications are typically exempt from requirements related to expiration dating and finished product testing because they contain little or no active ingredients. Additionally, these remedies are not restricted to the 10% alcohol limit of conventional drugs (97).
Efficacy and Safety
A number of clinical trials have been done on a variety of homeopathic remedies. Many of them, however, are of low methodologic quality. Three systematic reviews of placebo-controlled trials suggest that the effects of homeopathy are superior to those of placebo, whereas one review failed to support such a positive finding (98). Yet, analysis of individual conditions and treatments are less supportive. Reviews of homeopathic remedies for the treatment of osteoarthritis (99), asthma (100), dementia (101), and the prevention and treatment of influenza (102) are inconclusive. An examination of eight trials done on a specific homeopathic medication (Arnica montana) used for postoperative recovery failed to show efficacy beyond that of placebo (103). As with most other CAM therapies, systematic and rigorous research is needed to definitively prove effect.
Although serious toxicity from the use of homeopathic medicines is rare, unpleasant effects are quite common. “Aggravation reactions” occur when a patient's symptoms worsen acutely after starting a remedy. Homeopathic physicians view these reactions as desirable and as prognostic of a favorable outcome. Patients, however, may equate aggravations with side effects. As with herbal products, the potential for contamination and adulteration of homeopathic medications exists because these preparations are exempt from standard finished product testing.
A more serious problem exists when patients choose to defer effective conventional therapy for an unproven homeopathic remedy. Such cases have occurred with a number of CAM therapies. Additionally, some homeopaths discourage the use of conventional drugs because they are thought to hinder the effectiveness of homeopathic remedies. Many homeopathic physicians are also opposed to immunization and may influence patients against proven preventive health measures (104).
Miscellaneous Complementary and Alternative Therapies
Massage Therapy
Therapeutic massage is defined as the manipulation of soft tissues so as to improve the overall health of the body.
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It is commonly used to relieve stress and anxiety, to promote relaxation, and to treat certain pain disorders. There are a number of different types of massage (e.g., Swedish, deep-tissue, neuromuscular, shiatsu). Massage therapists commonly combine various methods during a typical session. Swedish massage is the most common form currently practiced. It consists of a number of different techniques (Table 5.5) designed to relieve muscle tension and improve circulation. Aromatic oils are frequently employed as lubricants during treatments. Acupressure or shiatsu massage consists of the application of heavy pressure for extended periods at particular pressure points on the body. It is designed to affect the flow of energy and consequently to restore balance to the body. In deep-tissue massage, increasing amounts of pressure are applied to structurally align the body. Rolfing (structural integration) is a form of deep-tissue massage designed to improve muscular function through manipulation of fascial planes.
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TABLE 5.5 Techniques Used in Swedish Massage |
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Efficacy and Safety
Massage therapy is used primarily as a relaxation technique. It has been shown subjectively and objectively to assist in stress reduction, although the intensity and duration of the response can be quite variable. Small studies support the use of massage for a number of conditions, including fibromyalgia, chronic fatigue, anxiety, and depression, but there is insufficient evidence to make definitive recommendations for its routine use for the treatment of these conditions. However, a review of three clinical trials of massage therapy for chronic low back pain suggested that it is useful for this condition and more cost-effective than other CAM therapies, such as acupuncture or spinal manipulation (105). Massage is generally considered to be safe. Care needs to be taken in patients with coagulation disorders, especially with the use of deep-tissue techniques.
Aromatherapy
Most people experience pleasant and unpleasant smells on a daily basis. Some odors may make us happy, while others may be irritating. The impact that these odors have on our bodies as a whole forms the basis for aromatherapy. In this CAM therapy, plant-derived essential oils are used to induce changes in emotion and health. Jasmine, chamomile, and lavender are just a few of the oils used to induce a positive relaxation response. Aromatherapy has been used alone or in combination with massage therapy for stress reduction. Evidence for its use for specific medical conditions, including anxiety, is presently inconclusive (106). No serious adverse effects are attributed to this therapy, although allergic responses may occur.
Specific References*
For annotated General References and resources related to this chapter, visit http://www.hopkinsbayview.org/PAMreferences.
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