Continuing Education

Published through an educational grant from WYETH-AYERST LABORATORIES
TRENDS IN PHARMACY AND PHARMACEUTICAL CARE

An ongoing CE program of The University of Mississippi School of Pharmacy and DRUG TOPICS

The University of Mississippi School of Pharmacy is approved by the American Council on Pharmaceutical Education as a provider of continuing pharmaceutical education. Accredited in every state requiring CE. ® ACPE # 032-999-00-024-H04

This lesson is no longer valid for CE credit after 12/31/03.

CREDIT:

This lesson provides two hours of CE credit and requires a passing grade of 70%.

OBJECTIVES:

Upon completion of this article, the pharmacist should be able to:

• Describe the meaning of complementary and alternative medical procedures

• List the potential risks and benefits associated with complementary and alternative medical procedures

• List complementary and alternative medical procedures that are undergoing scientific evaluation

• Identify potentially fraudulent complementary and alternative medical schemes

GOAL:

• To educate the pharmacist about commonly used alternative or nontraditional therapies

New perspectives on alternative medicines

By John S. Williamson, Ph.D.,

Associate Professor of Medicinal Chemistry and Research Associate Professor, National Center for Natural Products Research, Research Institute of Pharmaceutical Sciences, School of Pharmacy, University of Mississippi and

Christy M. Wyandt, Ph.D.,

Associate Professor of Pharmaceutics and Research Associate Professor, National Center for Natural Products Research, Research Institute of Pharmaceutical Sciences, School of Pharmacy, University of Mississippi

As the twentieth century drew to a close, the past one hundred years could be easily defined as the renaissance century for modern science, technology, and medicine. This was also the century that closed on the genesis of a new generation devoted to environmental awareness, a society intent on getting back to nature, and one that many times perceives simple and natural as better, regardless of logical scientific parameters.

In the field of medicine, nature has always served as a vast reservoir for countless structurally unique biomolecules, precursors of hundreds of synthetic derivatives that are developed into clinically useful medicines. In fact, the expanse of this reservoir is only now becoming fully realized, with recent technology that allows for the examination of organisms inhabiting extreme environments and of extremely large numbers of bacteria that up until now have been unculturable and unclassified.

No doubt that nature has provided a framework for many successful pharmaceu-ticals. Nevertheless, even with the great advances in the pharmaceutical and medical fields, science has yet to provide all of the answers and cures. Where science has failed, millions have turned to alternatives, including herbals and mysticism, in what is popularly referred to as complementary and alternative medicines and medicinal techniques (CAMs).

According to a 1998 article published in JAMA, 42% of the U.S. population used at least one alternative therapy in 1997. Use was more frequent among women than men (49% vs. 38%) and was most frequent (50%) in the 36- to 49-year age bracket. Use was higher in those with a college education (51%) and with an income over $50,000 (48%).

Of the 16 alternative therapies surveyed, the most commonly used in 1997 were:

• Relaxation techniques (primarily meditation), used by 16.3% of the population (up from 13.1% in 1990). Of those who used these techniques, 15.3% consulted a practitioner in 1997.

• Herbal medicine, used by 12.1% (compared with only 2.5% in 1990). Of users in 1997, 15.1% consulted a practitioner.

• Massage, used by 11.1% (compared with 6.9% in 1990). Of 1997 users, 61.6% consulted a practitioner.

• Chiropractic, used by 11% (10.1% in 1990). Of users, 89.9% consulted a practitioner in 1997.

• Spiritual healing by others (7.0%).

• Megavitamins (5.5%).

• Self-help groups (4.8%).

• Imagery (4.5%).

• Commercial diet (4.4%).

• Folk remedies (4.2%).

• Lifestyle diet (4.0%).

• Energy healing (3.8%).

• Homeopathy (3.4%).

• Hypnosis (1.2%).

• Biofeedback (1.0%).

• Acupuncture (1.0%).

Overall, 42.1% of the population used one or more of these techniques in 1997, compared with 33.8% in 1990. The reason for the trend toward the use of CAM is largely unknown; however, one explanation has been offered in a recent issue of the journal The Scientific Review of Alternative Medicine. In the article, the author suggests that "there are a number of predisposing psychological and political influences. In North America, such influences include a mistrust of government, politicians, highbrows, elitists, professionals, and other authorities. Other factors are deregulation, loss of power of governmental agencies, increasing court awards for perceived injuries, and Internet do-it-yourself medicine. In Germany, perhaps a key factor is the feeling of unity with Nature (Naturphilosophie) required for action to be complete and satisfying. Add a tint of Hahnemann's homeopathy, Steiner's anthroposophical medicine, and a few mystical legends.

In Britain, perhaps it is the tolerance of the unique, eccentric, and bizarre. In Asia, it is the sense of tradition and partnering of spirituality and cosmology with all phases of life. North Americans are enamored of a melange of folkways from European countries, mixed through the eighteenth and nineteenth centuries into a new brand of alternative lifestyles. Regardless of the source, the trend involving the use of CAM is increasing, and it is once again the responsibility of the traditional health-care providers to ensure the well-being of their patients, whether they incorporate the use of CAM or not.

What exactly is CAM?

The Office of Alternative Medicine (OAM) was established by congressional mandate in 1992 as a part of the National Institutes of Health (NIH). The NIH is one of eight operating divisions of the U.S. Public Health Service, which is part of the Department of Health & Human Services (DHHS). The NIH is made up of 25 separate institutes and centers, including the National Center for Complementary and Alternative Medicine (NCCAM). NCCAM's purpose is to facilitate the evaluation of alternative medical treatment modalities to determine their effectiveness.

NCCAM defines CAM as:

... covering a broad range of healing philosophies, approaches, and therapies. Generally, it is defined as those treatments and health-care practices not taught widely in medical schools, not generally used in hospitals, and not usually reimbursed by medical insurance companies.

The National Council Against Health Fraud (NCAHF), which describes the OAM as "a public relations boon for quackery ... yet to yield a single benefit to health care," includes in its definition of CAM everything from herbal medicines, homeopathy, and aromatherapy to the use of acupuncture, therapeutic touch, prayer at a distance, faith healing, chelation therapy, and miraculous cancer cures. NCAHF membership includes Nobel Laureates and a virtual Who's Who from the established scientific and medical community. It believes that the need for objective, scientific critiques of the claims of alternative or nonconventional medicine has never been greater, due in part to: a lack of readily available, reliable information about the efficacy of such treatments; media that all too often dote on controversial and false claims without providing careful examination; a variety of new pseudoscience/medicine journals devoted exclusively to the advocacy of alternative medicine; the public and some medical professionals who seem unaware that credible, scientific assessments of many alternative medicine claims already exist and that new evaluations based on available information are possible; and a critical need to test new claims before they are marketed to the public.

For the purposes of this article, CAMs (referred to as alternative when used alone, and complementary when used in combination with conventional therapies) are referred to as those nontraditional therapies not generally taught in traditional schools of medicine or pharmacy, not generally used in traditional medical settings, not generally dispensed or recommended as established medicine by pharmacists, and not usually reimbursed by medical insurance companies. While some CAMs maybe somewhat familiar within the Western medical philosophy, others are very far outside any realm of any accepted Western medical theory and practice.

Laws, greed, and money, money, money

There has always been a small group of individuals who make and sell products with questionable effects that compete with proven pharmaceuticals. Although some of the products last longer in the marketplace than others, most are relatively short-lived. Throughout the nineteenth and early twentieth centuries, CAMs were widespread in this country. The proverbial snake oil salesman hawked his wares of powdered rhinoceros horn, liver tonics, and virtually a cure-all for every disease. Healers preyed on the faith of the chronically ill and openly competed with competent physicians in disease diagnosis and treatment. This was a time when it was difficult to distinguish between health-care providers with respectable diplomas and those with a certificate from a fly-by-night or mail-order college.

Much of this hodgepodge of medical quackery fell victim to the laws and regulations established by a Congress and public fed up with the rampant medical fraud and deceit. After more than 50 years, the American marketplace—including pharmacies, supermarkets, department stores, malls, specialty shops, and others—is once again filled to the brim with hundreds of CAM products and promotions. Instead of the traveling snake oil salesmen, today's manufacturers and promoters use the mass media to market their products, using books, magazines, and infomercials to prey upon the public's desire for longevity and wellness. Actors are used to promote the power of the latest techniques, theories, supplements, antioxidants, athletic fuels, exercises, brain foods, and special diets. Books and articles, supposedly written by nonbiased scientists and physicians, promote unproven CAMs in little more than blatant advertisements for the CAM manufacturer.

Today there exists a growing reversal of trust for established medical practices, attributable in part to the replacement of the trusted family physician and local hospital with what appears to many to be an insurance-manipulated health-care system based on greed rather than care. This modicum of distrust for the established medical community is likely inflamed by the recently well-publicized Food & Drug Administration recalls of drugs supposedly proven safe and effective, as well as by popular television documentaries exposing incompetent physicians and fraud in third-party payment systems.

Over the past few years, enterprising entrepreneurs using lax federal laws and regulations have capitalized on an audience seeking simple answers to what are often complex medical problems. Today, the CAM business is big business, with annual revenues estimated in the multibillions of dollars. The size and power of this industry became apparent to many in the medical field with the tactics and lobbying that preceded Congress' passing of the Dietary Supplements Health & Education Act of 1994 (DSHEA). This legislation has been considered by some to be a near knockout blow to the scientific integrity of the established pharmaceutical and medical fields. It has opened the door for unscrupulous manufacturers, distributors, and proponents of many CAMs to sidestep the rigors of the FDA's drug and medical appliance safety and efficacy testing. As a result, many CAMs are no longer subject to the premarket safety and efficacy evaluations. Armed with a modicum of scientific and clinical data, an enormous number of half-truths, and the mantra that nature is the best provider of medical preventatives and cures, many CAM manufacturers and proponents have begun a merciless war against the basic scientific values of traditional medicine. Today it is clear that many CAM manufacturers have perfected techniques of sales propaganda, legal maneuvering, and political contributing and have reached a significant level of influence that has allowed for marketing products without proof of effectiveness and flooding the marketplace with nonstandardized, sometimes unsafe or even toxic, CAMs.

Many CAM proponents promote their products by suggesting that there exists a conspiracy within the realm of modern science and medicine to withhold information from the public, thereby "proving" the efficacy of their CAM claims. Unable to withstand the rigors of scientific peer review, many practitioners and manufacturers of CAMs have created journals for the sole purpose of advocating their own "science" and products. The marketing of fraudulent CAMs has become so out of hand in the European community (the community that many in the CAM movement claim leads the way in utilizing CAMs) that it is now considering the removal of many CAMs from lists for medical reimbursement.

Pharmacists: Caught in the middle

When it comes to CAMs, the retail pharmacist can be placed in an awkward position. On one hand, the education of pharmacists in the methods of modern science (observe, measure, record, analyze, and reason) generally prevents them from being taken in by many CAMs. On the other hand, numerous patients who swear to the success of CAMs confront the pharmacist on a daily basis.

In some cases, pharmacists have refused to market, sell, or recommend virtually any CAM, while others have capitalized on the CAM movement, advertising themselves to be CAM experts and their establishments to be CAM headquarters. Of course, the majority of retail pharmacists fall somewhere between these two extremes. That is, advertisements of CAMs, along with traditional over-the-counter medications and the latest diet fads, are generally promoted "out front," and the pharmacist's typical recommendation of a CAM product goes no further than "it seems to work for some people."

Although patients and medical cases will vary greatly, one general rule of thumb should be that, as an ethical health-care provider, the pharmacist should never recommend any CAM over a proven and established medicine or procedure to a patient. The retail pharmacist can ethically play two roles, that of a traditional health-care provider and that of a CAM advisor and information source. Pharmacists should take the time to warn their patients—in particular their older clientele, who are major targets of extensive CAM schemes. It is important for pharmacists to remember that they can offer ethical CAM advice and information and still continue their role as the frontline health-care information providers.

Pharmacy isn't the only profession that has been hit hard by the CAM revolution. Many traditional physicians have succumbed to the profitable CAM business by offering a variety of CAMs along with traditional medicines. This practice is becoming more common, even though virtually all of the professional organizations representing physicians have denounced CAMs in general. Many pharmaceutical giants have also capitalized on the boom in CAMs. For example, American Home Products Corp. has added herbals to its Centrum line, Bayer Corp. has added herbal supplements to its One-A-Day product line, and Warner-Lambert Co. has recently introduced the new Quanterra herbal product line.

CAMs under investigation via NCCAM

In recent years, a wide range of unconventional therapies has appeared on the public scene. Few would argue that the need for objective, scientific critiques of the claims of CAMs have never been greater and that these claims should be based on scientific evidence that proves the effectiveness of these treatments. In the modern scientific process, claims for valid medicine and medical techniques are considered on their merits, including double-blind, full-scale controlled clinical trials. Some of the alternative therapies currently under study with grant support from NIH include:

• Acupuncture to treat depression, attention deficit hyperactivity disorder, osteoarthritis, and postoperative dental pain. Acupuncture is a procedure involving the stimulation of specific areas on or near the skin by the insertion of needles or by other methods. In Asian societies, the procedure has been used for several thousand years. The procedure was banned in China in 1929 but underwent resurgence in the 1960s as part of the Cultural Revolution. In the United States, acupuncture is used mainly for pain relief. Some states permit only licensed physicians to perform acupuncture; others license laypersons as well. While acupuncture organizations are trying to standardize training, researchers are still attempting to determine whether acupuncture offers any significant medical uses.

The NCAHF contends that an array of modern research and clinical trials performed during the past 20 years has failed to demonstrate acupuncture as effective against any disease and that perceived effects of acupuncture are probably due to a combination of expectation, suggestion, counterirritation, operant conditioning, and other psychological mechanisms.

• Hypnosis for chronic low back pain and accelerated fracture healing. Hypnosis can generally be characterized by intense concentration, extreme relaxation, and high suggestibility. It is commonly used in behavior-modification therapy to assist suggestive individuals in overcoming phobias or bad habits. It also has other uses that are more controversial. Although much is known about hypnosis, there is much still unknown. It is acknowledged that:

• there is a significant correlation between being imaginative and being responsive to hypnosis

• the best candidates for hypnosis are fantasy-prone individuals

• vivid imagery enhances suggestibility

• while under hypnosis, one may become very suggestible

• memory is easily "filled in" by the imagination and by suggestions (confabulation is quite common under hypnosis)

• the greatest predictor of hypnotic responsiveness is what a person believes about hypnosis

Most medical experts agree that hypnosis may be worthwhile in helping people quit smoking, stick to a diet, or recall license plate numbers of cars used in crimes. Using hypnosis to help victims or witnesses of crimes remember what happened may be useful, but it can also be dangerous because of the ease with which the subject can be manipulated by suggestions from the hypnotist. Using hypnosis to help people recover memories of sexual abuse by close relatives or abduction by aliens can be immoral, degrading, and dangerous. Memories are lost because neural connections are lost, not waiting somewhere to be retrieved under hypnosis. Although studies are not yet complete, the usefulness of hypnosis in medical procedures seems obvious, and for suggestive individuals there is likely to be some degree of benefit. Unfortunately, for nonsuggestive individuals there is likely to be little benefit.

• Ayurvedic herbals for Parkinson's disease. Ayurvedic medicine proponents suggest that the techniques originated in ancient time, but much of it was lost until reconstituted in the early 1980s by the Maharishi Mahesh Yogi. Its origin is traced to four Sanskrit books called the Vedas—the oldest and most important scriptures of India, which attribute most disease and bad luck to demons, devils, and the influence of stars and planets.

Ayurveda's basic theory is that the body's functions are regulated by three irreducible physiological principles called doshas, whose Sanskrit names are vata, pitta, and kapha, designating types and the traits that typify them. Ayurvedic writings include long lists of supposed physical and mental characteristics of each constitutional type; for example, vata is said to govern all body functions concerning movement and to accumulate during cold, dry, windy weather. Ayurvedic proponents claim that the symptoms of disease are always related to the balance of the doshas. This balance can be determined by feeling a patient's forearm to find a mystical pulse that is used to detect diabetes, cancer, musculoskeletal disease, asthma, and imbalances at early stages when there may be no other clinical signs. Balance of the doshas is achieved through diets, procedures, and products. Through various combinations of vata, pitta, and kapha, 10 body types are possible.

• Biofeedback for diabetes, low back pain, and face and mouth pain caused by jaw disorders. Biofeedback became popular in the 1960s, when electronic devices commonly used to measure involuntary function were utilized in psychological research subjects to teach control over involuntary processes. Biofeedback is said to alter brain activity, blood pressure, heart rate, and other body functions normally not controlled voluntarily. Today, most scientists agree that biofeedback may provide, at best, a "placebo-type" help in the treatment of some diseases and painful conditions. Nevertheless, many CAM proponents promote biofeedback for the treatment of migraine and tension headaches, disorders of the digestive system, high and low blood pressure, cardiac arrhythmias, Raynaud's disease, epilepsy, and paralysis.

• Electric currents to treat tumors. Since man began to control electrical current, there have been attempts to utilize electricity in the treatment of disease. Some researchers have observed that direct electrical current of sufficient magnitude and duration can destroy tissue and that this capability may be useful for inoperable metastatic lesions, as shown in some animal model studies. Preliminary results suggest that the electrical technique is potentially useful for treating some tumors. Electrical current in the human has many consequences, and researchers emphasize that much more experimental data are needed before clinical conclusions can be drawn.

Electroconvulsive therapy for treatment of depression, primarily in elderly female patients, is making a clinical comeback. However, studies show that the death rate associated with electroconvulsive therapy for elderly patients is as high as 1 in 200, not 1 in 10,000, as the American Psychiatric Association states. In addition, the FDA has issued a warning about a pain-control device that, when pressed against the skin, sparks and causes a small electrical shock. Manufacturers of the device claim it can relieve headaches, back pain, arthritis, stress, menstrual cramps, earaches, sinusitis, nosebleeds, flu, and other ailments. Although the device is touted by many CAM proponents, there is no evidence that the device is safe or effective.

• Imagery for asthma and breast cancer. With imagery, patients are guided to see themselves in a different physical, emotional, or spiritual state. For example, patients might be guided to perceive themselves in a state of vibrant health and the disease sources as weak and destructible. Mental imagery is a method expounded in popular books published in the 1980s. For example, Imagineering for Health: Self-Healing Through the Use of the Mind promotes imagery as a means of accomplishing practically any healthful state through cooperative healing, emotional, and motivational therapy, idea therapy, verbal therapy, and visual therapy. While these alternative therapies are considered the subject of scientifically valid investigations, it is important to remember that their safety and efficacy are still unproven.

Other popular CAMs

• Chiropractic therapy. Chiropractic therapy continues to be a controversial health-care delivery system, despite an estimated 24,000 practitioners licensed in every state. Many chiropractors do not share a common view with traditional health-care professionals, particularly in the use of drug therapy and surgery. Chiropractic therapy has a long and controversial history extending back to folk healers who employed the techniques as cure-alls. Today there is substantial evidence that chiropractic therapy has significant value in treating back pain, and several studies have found that about one-third of patients will experience a more rapid relief from such manipulation than with other modalities. In fact, chiropractic therapy is probably not utilized as fully as it might be—for example, in relieving the symptoms of migraine pain.

Chiropractic therapy has risks, and many cases of serious complications following such therapy have been reported in the medical literature. Overuse of X-rays by the chiropractor poses serious potential harm, especially the use of full spine X-rays. As with other professions, there do exist unscrupulous practitioners in chiropractic who prey upon a patient's fear of surgery and drug abuse associated with drug therapy. For those patients interested in seeking chiropractic therapy, the pharmacist might suggest that they first obtain a referral from their primary health-care provider.

• Aromatherapy. No credible studies have been published in reputable scientific or medical journals validating fragrant substances, particularly essential oils from flowers or herbs, as having beneficial health effects beyond the enjoyment of their pleasurable aroma. Claims of mental and physical health effects likely derive from a placebo effect.

• Homeopathy. According to the NCAHF, these are the basic principles of homeopathy:

• Most diseases are caused by an infectious disorder called the psora.

• Life is a spiritual force that directs the body's healing.

• Remedies can be discerned by noting the symptoms that substances produce in overdose and applying them to conditions with similar symptoms but in highly diluted doses (Law of Similia).

• Remedies become more effective with greater dilution (Law of Infinitesimals).

Homeopathy's principles have been constantly refuted by the basic sciences of chemistry, physics, pharmacology, and pathology; thus, the value of homeopathic products can be no more than a placebo effect. Homeopathic products are not required to meet the standards of effectiveness of drugs, and homeopathic services are poorly regulated. There are examples of homeopaths having used products adulterated with therapeutic levels of FDA-approved drugs for the purpose of deceiving customers into acceptance of their scheme.

• Magnetic therapy. Magnets have been promoted as therapeutic devices for hundreds of years, but their efficacy still remains controversial. The FDA has approved the use of time-varying electromagnetic machines that generate a pulsating electromagnetic field for the treatment of delayed and non-union fractures. Although not approved for such use, these machines are also employed for pain relief and soft-tissue injury. Research into the efficacy of touted applications for static magnetic devices is unconvincing—or, at best, conflicting. In a 1994 survey of 200 physical therapists and rheumatologists, only about 5% found that magnets produced any pain relief for seven different conditions. Ongoing investigations into magnetic therapy by legitimate practitioners may conclusively answer efficacy claims; however, the laws of physics predict that the magnetic effects will be inconsequential.

Unfortunately, many CAM proponents and manufacturers do not limit themselves to claims based on the current state of knowledge.

• Colonic irrigation. Colonic irrigation (CI) is a procedure in which large quantities of liquids are infused into the colon via the rectum through a tube, in an effort to remove its contents. CI differs from an ordinary enema, which infuses less volume into the rectum only. Also referred to as a high colonic, CI may involve the use of gallons of liquids using gravity or force. Liquids used in CI are often specified for particular disease or physical states and commonly include coffee, herbs, enzymes, and wheat grass extracts. Proponents of the procedure advertise that CI detoxifies the body and that regular CI therapy is necessary to maintain good health.

Studies performed in the 1920s found that CI was without therapeutic value. In the 1930s, CI was contraindicated for treating ulcerative colitis; in the 1980s, further studies prompted the California Health Department to mandate that neither physicians nor chiropractors should perform CI. CI can be hazardous, causing illness and death by contamination of equipment; death by electrolyte depletion; general physiologic upset; and perforation of the intestinal wall. Currently, CI is popular as a health fetish, with a substantial amount of marketing aimed at the male homosexual community. Patients should be cautioned not to use colonics and to avoid practitioners employing this procedure.

• Glucosamine and chondroitin. Glucosamine sulfate and chondroitin sulfate are marketed as a cure for degenerative joint disease. Unfortunately, there is no evidence that this is the case, or even that long-term therapy has any beneficial effects on pain and/or disease progression.

Animal studies have shown that these substances, which are among the natural constituents of healthy joint cartilage, have some stimulatory effects on chondrocytic production of cartilage and possibly some inhibitory effects on proteolytic enzymes that may be involved in degenerative joint disease. However, the likelihood that supplemental intake of these substances can drive biochemical processes in the human body is not very great. Instead, pharmacists should advise arthritis sufferers to focus on weight management, appropriate exercise, physical aids, and nonsteroidal anti-inflammatory agents as the primary treatment strategies.

• DHEA. DHEA (dehydroepiandrosterone) is a hormonal substance found in the adrenal glands as well as in the gonads of primates and a few nonprimate species. (It is also produced via synthesis.) From this substance other important hormones are derived (i.e., estrogen, progesterone, testosterone, and cortisone), thus providing many CAM proponents with a variety of health-promoting claims for DHEA—among them, that it is a preventive against breast, prostate, and bladder cancers and that it offers decreased risk of cardiovascular disease, treatment of adult onset diabetes, treatment of nerve degeneration, life extension, fat melting, sexual stimulation, prevention of osteoporosis, boosting of the immune system, improvement of mood, treatment for Alzheimer's disease, and relief from lupus. Although there is potential for DHEA in a few cases, these claims are not yet proven. Unfortunately, DHEA can affect the human physiology, and medical experts and the FDA warn against self-dosing. In addition, at least one animal study has found liver cancer to be greatly increased by DHEA.

• BD, GHB, and GBL. Prompted by reports of at least three deaths and several severe adverse reactions, the FDA has declared 1,4-butanediol (BD) a class I health hazard, meaning its use could pose a potentially life-threatening risk. The agency has also warned the public about gamma-hydroxybutyric acid (GHB) and gamma butyrolactone (GBL), compounds sold on the Internet, in health-food stores, and through ads in muscle-building magazines. Health officials believe that manufacturers of these products, which are marketed as sleep aids, party drugs, date-rape drugs, and dietary supplements for insomnia, are renaming them and substituting BD for GBL. BD, GBL, and GHB can cause dangerously low respiratory rates, unconsciousness, vomiting, seizures, and death. BD has an additive depressant effect when combined with alcohol and other depressant drugs. Recently the team physician for the Phoenix Suns blamed a near-fatal seizure suffered by National Basketball Association star Tom Gugliotta on a GBL-containing product commonly marketed as a sports-recovery supplement. The FDA has issued two voluntary recalls on products containing GBL, declaring such products "potentially life-threatening," and has linked GBL to nearly 150 cases of serious illness, at least three of which have resulted in death.

• Melatonin. Melatonin is secreted at night by the pineal gland. Some researchers have suggested that hormones secreted by this gland transmit information concerning the light-dark cycle, which in turn helps to regulate an individual's biological clock. This information has resulted in marketing strategies, with claims of potentially legitimate uses for such maladies as jet lag, shift work, and seasonal affective disorder (SAD), being extended to ludicrous claims of reversing the aging process and offering a curative for cancer, AIDS, and blindness. While there is evidence that the medication is effective in jet lag therapy, researchers contend that it will take years of additional studies to determine the long-term side effects of this drug. It is interesting to note that the Canadian government has banned the sale of melatonin because it has not been proven safe.

• Coenzyme Q-10. Coenzyme Q-10 is a synthetic version of the naturally occurring enzyme coenzyme Q, or ubiquinone. It is promoted to slow aging and enhance the immune system. Ubiquinone is a lipid-soluble universal electron carrier that functions in the nonaqueous environment of membranes, accepting electrons and conserving free energy. While ubiquinone can accept one or two electrons, there is no evidence for the claims associated with coenzyme Q-10, although it may be dangerous for patients with poor circulation.

• Dimethyl sulfoxide. DMSO is a degreasing solvent similar to turpentine, but it has been promoted for arthritis relief. There are no controlled studies demonstrating its safety and/or effectiveness in relieving inflamed arthritic joints. Impure forms of DMSO can contain a variety of toxins, the delivery of which to the circulatory system is enhanced with topical use of the solvent. DMSO can be potentially fatal if it is used as a liquid for CI.

• Germanium. Germanium is an inorganic, nonessential element promoted for its ability to prevent and treat Alzheimer's disease, arthritis, and headaches. There is no scientific evidence to suggest that germanium is effective for any of these maladies. Unfortunately, use of this substance has been indicated in cases of serious irreversible kidney damage and death, according to FDA.

• Gerovital-H3. Gerovital-H3 is touted as a cure for arthritis, atherosclerosis, angina pectoris, hypertension, deafness, Parkinson's disease, depression, diabetes, and impotence. One of its ingredients is the local anesthetic procaine hydrochloride. None of the health claims for gerovital have yet to be substantiated, and the FDA considers it an unapproved new drug. Use of the concoction has caused incidents of low blood pressure, respiratory difficulties, and convulsions.

• Phosphatidylcholine. Phosphatidylcholine (lecithin), a component of lipid biosynthesis, is touted for lowering cholesterol and treating Alzheimer's disease. Although from a purely biochemical standpoint there exists some rationale for the cholesterol-lowering claim, there is no proof of its effectiveness for either lowering cholesterol or treating Alzheimer's disease.

• Low-intensity lasers. Low-intensity lasers have been promoted to relieve arthritis pain. However, there exists no proof for this claim, and the FDA has not approved low-intensity lasers for this or any other use.

• Superoxide dismutase. SOD is an enzyme produced by the body to scavenge and neutralize a destructive oxidizing radical species produced through normal oxidative processes. The enzyme is promoted as a mechanism for slowing the aging process and treating Alzheimer's disease. Some studies have shown higher tissue levels of SOD in longer-living species. A survey of a large number of different animal species revealed, in fact, that the longest-lived species in the survey, human beings, had the highest tissue levels of superoxide dismutase. Nevertheless, there is no evidence to suggest that SOD supplements increase blood or tissue levels of SOD or act to prolong life.

FDA's top frauds list

The FDA has compiled a list of its top fraudulent medical schemes, several of which are popular CAMs.

• Fraudulent arthritis products. Ineffective scams include, but are not limited to: copper bracelets, Chinese herbal remedies, large doses of vitamins, and snake and bee venoms. These scams are successful many times, since the symptoms of arthritis go into remission periodically, and individuals who try these unproven remedies tend to associate the remedy with the remission.

• Spurious cancer clinics. There are clinics offering miracle cures via unproven and ineffective treatments and medicines. Many cases have been particularly tragic, especially with young children, because common childhood cancers such as leukemia or Hodgkin's disease are highly curable through legitimate treatment.

• Bogus AIDS cures. Victims of incurable diseases are especially vulnerable to the promises of charlatans. "Underground" clinics offering homemade treatments have sprung up in the United States, the Caribbean, and Europe. There is no cure for AIDS yet, and proposed treatments, including massive doses of antibiotics, typhus vaccine, or herbal teas, are all unproven.

• Instant weight-loss schemes. It has been estimated that 25% of the American population is overweight. This has generated numerous weight-loss gimmicks that include special diets, hypnosis, skin patches, herbal capsules, grapefruit diet pills, and Chinese magic weight-loss earrings. Unfortunately, there is no quick way to lose weight.

• Fraudulent sexual aids. Many products and services are promoted to enhance libido and sexual pleasure. The FDA, however, says no nonprescription drug ingredients have been proven safe or effective as aphrodisiacs, and it has acted to ban these products.

• Quack baldness remedies, appearance modifiers. Fraudulent entrepreneurs make huge profits by convincing consumers to buy their versions of the Fountain of Youth, be it a remedy to grow hair or prevent its loss, a cream to removes wrinkles, or a device to develop the bust. No nonprescription products have been shown to stimulate the growth of hair on balding men, to be effective in reducing wrinkles, or to act as enhancers of breast development.

Advice for the patient

The community pharmacist can be an excellent advisor and information source for patient information related to CAM. Following are a few tips that may be passed along to patients for evaluating CAMs:

• Consult your family physician or pharmacist before employing any type of CAM therapy.

• The golden rule for evaluating health claims is: If it seems too good to be true, it probably is.

• Avoid products or services that claim the medical establishment or government will not accept this wonderful discovery.

• Avoid products or services that use testimonials and anecdotes to support their claims.

• Avoid products or services that use questionnaires as a means of diagnosis.

• Avoid products or services that claim to make weight loss easy.

• Avoid products or services that make claims of quick and dramatic results or of secret formulas.

• Avoid products and services that are promoted over the telephone, in the back pages of magazines and newspapers, by mail order, through infomercials, and via radio and TV talk shows.

References are available upon request.

TEST QUESTIONS

Write your answers on the answer form appearing below (photocopies of the answer form are acceptable) or on a separate sheet of paper. Mark only one correct answer.

1. According to the authors, advances in modern science, technology, and medicine help define the 20th century as:

a. The Dark Ages
b. Medieval times
c. A renaissance
d. The age of pharmacy

2. Before a hypothesis can be established as fact, today's scientific community demands that it be justified with:

a. Sound scientific validation
b. Numerous testimonials
c. Actor endorsements
d. Common sense

3. According to a 1998 article published in JAMA, what percentage of the population used at least one alternative therapy?

a. 14%
b. 27%
c. 42%
d. 63%

4. According to the above-mentioned JAMA article, which category exhibited the most frequent use of alternative therapies?

a. Women with no college education
b. Women with some level of college education
c. Men with no college education
d. Men with some level of college education

5. The same article showed that of the 16 alternative therapies included in the survey, the one most commonly employed was:

a. Herbals
b. Relaxation techniques
c. Massage
d. Acupuncture

6. According to the JAMA article, what two alternative medical procedures did a majority of patients consult a practitioner about?

a. Relaxation techniques and massage
b. Aromatherapy and herbal therapy
c. Vitamins and hypnosis
d. Chiropractic and massage

7. Which of the following was not given as a suggested reason for the increased interest in alternative and complementary medicines?

a. A mistrust of government, politicians, highbrows, elitists, professionals, and other authorities
b. Deregulation, loss of power of governmental agencies, increasing court awards for perceived injuries
c. Internet do-it-yourself medicine
d. Endorsement of such therapies by the FDA

8. The Office of Alternative Medicine was established by congressional mandate in 1992 as a part of the National Institutes of Health, an operating division and part of the Department of:

a. Agriculture
b. Commerce
c. Health & Human Services
d. Housing & Urban Development

9. The mission of The National Center for Complementary & Alternative Medicine includes all of the following except:

a. Facilitating the evaluation of alternative medical treatment modalities
b. Determining the effectiveness of alternative medical treatment modalities
c. Providing resources for the evaluation of alternative medical treatment modalities
d. Marketing effective alternative medical treatment modalities

10. The NCCAM defines complementary and alternative medical treatment modalities to include those treatment and health-care practices:

a. Not taught widely in medical schools
b. Generally used in hospitals
c. Usually reimbursed by medical insurance companies
d. Taught widely in medical schools

11. The National Council Against Health Fraud suggests that a modern array of research and clinical trials shows acupuncture to be:

a. Effective as supportive care against the pain associated wiith migraine headaches
b. Effective against the tremors associated with Parkinson's disease
c. Effective in helping patients overcome nicotine addiction
d. Not effective against any disease

12. Which of the following alternative therapies do the authors indicate are currently under study with grants from NIH?

a. Acupuncture for treating depression
b. Electrical stimulation for postoperative dental procedures
c. Hypnosis for curing AIDS and AIDS-related infections
d. Magnets for breast cancer

13. Which of the following alternative therapies do the authors indicate are currently under study with grants from NIH?

a. Acupuncture for osteoarthritis
b. Ayurvedic herbals for postoperative dental procedures
c. Hypnosis for diabetes
d. Magnets for alcoholism

14. As stated in this article, chiropractic therapy can have risks and serious complications following:

a. Overuse of full spine X-rays
b. Intense spiritual meditation
c. Foot massage
d. Magnetic therapy

15. According to the authors, studies have been published in reputable scientific and medical journals validating the medical potential of:

a. Aromatherapy
b. Homeopathy
c. Bee venom for arthritis
d. None of the above

16. Of the following alternative medicines, which one has examples of practitioners using the product adulterated with therapeutic levels of FDA-approved drugs for the purpose of deceiving customers?

a. Aromatherapy
b. Colonic irrigation
c. Homeopathy
d. None of the above

17. The FDA has approved the use of time-varying electromagnetic machines that generate a pulsating electromagnetic therapy for the treatment of:

a. Prostate cancer
b. Bladder infections
c. Delayed and non-union fractures
d. Sore feet

18. Colonic irrigation can be hazardous, causing:

a. Illness and death by contamination of equipment
b. Death by electrolyte depletion
c. Perforation of the intestinal wall
d. All of the above

19. Instead of recommending glucosamine sulfate and chondroitin sulfate as a cure for degenerative joint disease, pharmacists should advise arthritis sufferers to focus on:

a. Weight management
b. Appropriate exercise
c. Nonsteroidal anti-inflammatory agents as the primary treatment strategy
d. All of the above

20. Which of the following should never be recommended for any medical malady?

a. 1,4 butanediol
b. Gamma hydroxybutyric acid
c. Gamma butyrolactone
d. All of the above

 

John Williamson. New perspectives on alternative medicines. Drug Topics 2001;1:57.