Most patients with chronic rheumatic diseases seek adjunctive care outside the medical mainstream. Although patients usually maintain relationships with medical physicians and take prescription medications, most will add some form of complementary and alternative therapy at some point during the course of their illness. Patient choices reflect their cultural and ethnic background, their financial resources, the availability of alternative providers, and their perception and satisfaction with conventional medicine. Not all interventions have been studied in a scientifically rigorous manner, but well-designed clinical trials continue to be published in a wide range of areas relevant to patients with rheumatic diseases.

Definition

Complementary and alternative medicine (CAM) has been defined as a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine. With the recognition of its widespread use and the provision of services like acupuncture within academic medical centers, however, defining the limits of alternative medicine has become more difficult. The National Center for Complementary and Alternative Medicine (NCCAM), established by Congress in 1998 as one of the centers within the National Institutes of Health (NIH), has revised its categorization of CAM therapies into (1) natural products (herbal medicines, vitamins, minerals, dietary supplements, probiotics); (2) mind-body medicine (meditation, yoga, acupuncture, deep-breathing exercises, guided imagery, hypnotherapy, progressive relaxation, qi gong, tai chi); (3) manipulative and body-based practices (spinal manipulation, massage therapy); (4) movement therapies (Feldenkrais method, Alexander technique, Pilates, Rolfing Structural Integration, Trager psychophysical integration); (5) practices of traditional healers (Native American practices); (6) energy medicine (magnet therapy, light therapy, Reiki, healing touch); and (7) whole medical systems (Ayurvedic medicine, traditional Chinese medicine). Furthermore, with the increasing number of randomized controlled trials examining these therapies, practitioners have a growing body of resources with which to evaluate the usefulness of CAM therapies, provide advice to patients, and consider incorporating CAM into standard treatment plans.

Epidemiology

Epidemiologic evidence from the 2007 National Health Interview Survey suggests that about 38% of the general public seek alternative care in a given year. Demographic data show that patients who use CAM are more likely to be older than age 65, have some college education, be in higher income brackets, and are less likely to be a member of a racial or ethnic minority. Patients with rheumatic disease who seek alternative care, however, use CAM more frequently and are more demographically diverse. Use correlates with pain and, for instance, over 90% of patients with diagnoses such as fibromyalgia may seek alternative care. Similarly, a variety of ethnic and racial groups and the elderly with musculoskeletal complaints have higher rates of CAM use than average American populations. Furthermore, recent data show that patients are considerably more likely to discuss their CAM use with their physician than they were in the past.

Quality & Safety Issues

Practitioners have a responsibility to help inform patients regarding their choices of alternative therapies, particularly where medical data exist. One of the most important sources of information is the NCCAM website (), particularly since it maintains an updated summary of references to studies supported by NCCAM funding. However, in this diverse and wide-ranging field, data may be lacking on a specific product or practice and patients often hold strong beliefs that alternative products are effective and safe.

Efforts to study aspects of traditional Chinese and Ayurvedic medicine and many herbal therapies have been hampered by the passage of the Dietary Supplement and Health Education Act by the US Congress in 1994. This legislation permitted the classification of numerous over-the-counter products with pharmacologic activity as dietary supplements. Dietary supplements are regulated like food. As such, they are exempted from the safety and efficacy requirements that must be met by prescription drugs. In fact, this legislation mandated that the US Food and Drug Administration (USFDA) assume the burden of proof when a product is considered for removal from the market as unsafe. Furthermore, consumers may make certain assumptions about testing, quality, and efficacy since the Dietary Supplement and Health Education Act permits labeling claims regarding “structure and function” that may suggest to the consumer that the products being sold have been proven to have health benefits. However, a manufacturer does not have to prove the safety and effectiveness of a dietary supplement before it is marketed. Dietary supplements do not need approval from USFDA before they are marketed. A manufacturer is permitted to say that a dietary supplement addresses a nutrient deficiency, supports health, or is linked to a particular body function (eg, immunity), if there is research to support the claim. Such a claim must be followed by the words “This statement has not been evaluated by the U.S. Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.” Manufacturers are expected to follow certain “good manufacturing practices” to ensure that dietary supplements are processed consistently and meet quality standards. Requirements for Good Manufacturing Practices went into effect in 2008 for large manufacturers and have been phased in for small manufacturers through 2010.

Recently, a number of safety considerations concerning herbal remedies were reviewed. A variety of herbs may themselves have toxic side effects (Table 74–1). They may also have important interactions with prescription medications. Garlic and gingko may increase bleeding risk in patients taking warfarin, whereas ginseng may reduce the ability of warfarin to lead to appropriate anticoagulation. St. John’s wort may reduce the plasma levels of numerous medications, including antidepressants, antiretroviral agents, oral contraceptives, and immunosuppressive drugs. Thus, even if a patient is not taking an herbal product to address arthritis symptoms, he or she should be questioned about all over-the-counter product use since medication interactions may be significant.

Adulterants and contaminants in herbal preparations have been reported, including heavy metals, microorganisms and their toxins, and pesticides. Unsuspected botanicals other than those identified on the label may be present. One such case involved contamination of a weight loss preparation with the root of Aristolochia fangchi, resulting in interstitial renal fibrosis, renal failure, and in some persons, urothelial carcinoma. Pharmaceuticals may be present as well. A number of reports have detailed the presence of glucocorticoids and nonsteroidal anti-inflammatory drugs (NSAIDs) in herbal arthritis preparations, with resultant side effects including gastrointestinal bleeding and hepatotoxicity. Contamination of other herbal products with warfarin, estrogen, fenfluramine, and glyburide has been reported.

To date, the USFDA has issued specific warnings about a number of alternative products (Table 74–2) but has only banned those containing ephedrine alkaloids.

Ephedrine alkaloids were found to present an unreasonable risk under ordinary conditions of use, including myocardial infarction, cerebrovascular accident, seizure and death, after numerous reports of toxicity and an extensive review of the literature, as well as congressional hearings on these agents. For a complete list of all FDA announcements regarding dietary supplements, go to .

In November 2004, the USFDA announced three initiatives to further implement the Dietary Supplement and Health Education Act: formulating a regulatory strategy that will improve the evidenciary basis for USFDA actions with regard to dietary supplements by working collaboratively with the NIH and federal regulatory bodies; holding a public meeting for discussion of issues arising from the regulation of dietary supplements; and formulating a draft document detailing the amount and type of evidence that should be used to substantiate “structure function claims.” On December 15, 2010, the USFDA took new steps aimed at protecting consumers from harmful products that are marketed as dietary supplements and that contain undeclared or deceptively labeled ingredients. USFDA found that these products are often promoted for weight loss, sexual enhancement, and bodybuilding. The new steps include (1) sending a letter from Commissioner of Food and Drugs Margaret A. Hamburg to the dietary supplement industry emphasizing its legal obligation and responsibilities to prevent tainted products from reaching the US market; (2) implementing a new rapid public notification system (RSS Feed) on its website to more quickly warn consumers about these products; and (3) implementing a mechanism for industry to alert USFDA about potentially tainted products and about the firms that make them. The USFDA encourages the reporting of adverse events by consumers, physicians, and manufacturers via their web site (www.fda.gov/medwatch) or telephone (consumers: 1-800-MEDWATCH; physicians: 1-800-FDA-1088).

The American College of Rheumatology revised its position statement on the use of CAM therapies in August 2008. The American College of Rheumatology acknowledges that CAM use is widespread among patients with rheumatic diseases. It notes that all therapies must meet the same rigorous standards of scientific scrutiny using scientific methods and that those proven safe and effective can be integrated into the therapeutic armamentarium. It further suggests that rheumatologists should be informed about CAM therapies and be able to knowledgeably discuss them with their patients. Many studies show that little discussion about CAM occurs in the office visit setting, however. Several authors have offered advice to physicians on what information should be discussed in order to facilitate the dialogue, particularly when patients are using herbal products (Table 74–3). Additional suggestions for both patients and practitioners to address this subject are given on the NCCAM website.

Avocado/Soybean Unsaponifiables

A popular treatment for osteoarthritis (OA) in Europe, avocado/soybean unsaponifiables is an extract of oils in a one third avocado to two thirds soybean mixture. A large body of in vitro and animal data suggest that this mixture possesses anti-inflammatory actions. A prospective, randomized, double-blind, placebo-controlled multicenter clinical trial of patients with knee and hip OA showed promising results. After 6 months of treatment with 300 mg of the extract, patients experienced significant reductions in pain and functional disability. Many required less NSAIDs. No significant side effects were reported. Patients with hip OA seemed to benefit more than those with knee OA. Avocado/soybean unsaponifiables may achieve these benefits through structural effects on cartilage, as suggested by a subsequent study. This 2-year trial showed that avocado/soybean unsaponifiables may reduce cartilage loss in patients with hip OA and advanced joint-space narrowing at baseline. A more recent, 6-month head-to-head comparison with chondroitin showed avocado/soybean unsaponifiables to be as effective in reducing pain and the need for rescue medication; however, the trial design without a placebo arm fails to address the potential that the results could be explained by simple regression to the mean. This product has become available in the United States but the utility of the product to alter the course of OA has yet to be confirmed.

Capsaicin

The American College of Rheumatology Subcommittee on Osteoarthritis 2000 and the European League Against Rheumatism 2009 Guidelines identify topical capsaicin cream as an option for treatment of OA symptoms. It may be used as an adjunct to systemic therapy or as monotherapy in those who wish to avoid oral medications. The cream should be applied four times daily. It initially results in a burning sensation but judicious and repeated use lessens the severity of the burning, which rarely results in discontinuation of therapy.

Capsaicin is one of a number of pharmacologically active substances found in the Capsicum red pepper. It is known to initially induce the release of the neurotransmitter substance P from skin sensory C fibers when applied topically. Repeated application leads to specific blockade of transport and de novo synthesis of substance P, resulting in desensitization to pain by raising the pain threshold. A number of randomized trials have suggested that capsaicin is useful in the treatment of neurogenic pain, including the pain of diabetic neuropathy, as well as low back pain and pain due to OA. A randomized, double-blind, parallel-group, placebo-controlled trial used instillation of capsaicin 15 mg or placebo vehicle into the surgical site following total knee arthroplasty prior to wound closure and results from the first 14 patients were recently reported. Pain scores did not differ between the groups tested but opioid use was reduced during the first 72 hours postoperatively and range of motion was increased at 14 days postoperatively in those who had received capsaicin.

Ginger

Extracts of members of the Zingiberaceae family have been used in Chinese traditional medicine and Ayurvedic tradition for millennia. Over 100 species have been tested and a number have been found to have anti-inflammatory effects, including inhibition of the actions of cyclooxygenase and lipoxygenase, synthesis of leukotrienes, and rat paw edema in an animal model of inflammation. Like other herbal products, what is labeled ginger is pharmacologically complex and may contain salicylate (though in amounts that are not thought to account for all of its anti-inflammatory effect), gingeroles, β-carotene, capsaicin, caffeic acid, and curcumin.

Fifty-six patients in Copenhagen with radiographically verified OA of the knee participated in a study in which they received either a ginger extract (Eurovita Extract 33, 170 mg orally three times a day), ibuprofen 400 mg orally three times a day, or placebo in each of three treatment periods of 3 weeks each. Overall, the investigators could demonstrate no differences between ginger and placebo. A larger multicenter study included 247 patients with radiographically confirmed knee OA. Participants were required to have visual analogue scores between 40 mm and 70 mm on a 100-mm scale for pain on standing during the 24 hours preceding the baseline visit. They received either placebo or ginger extract (Eurovita Extract 77, 255 mg orally twice daily) for 6 weeks in this double-blind, randomized trial. Patients in both placebo- and ginger-treated groups had improvement in pain on standing, but the ginger group had a higher percentage of responders (63% vs 50%), a greater degree of response on average (8.1 mm more in the ginger group), and a greater percentage of participants with large responses. Pain after walking and overall functioning measured by the Western Ontario and McMaster Universities OA composite index (WOMAC) were also significantly improved in the ginger group. Gastrointestinal side effects (eructation, dyspepsia, and nausea) were more common in the ginger group (45% vs 16%), but none were serious. The investigators concluded that ginger has efficacy for pain management in knee OA, but that a future dose-finding study would be of benefit as would long-term investigation of side effects. However, subsequent systematic reviews of the use of ginger for pain relief have concluded that evidence remains weak for its efficacy. Furthermore, a study of a ginger-based Ayurvedic preparation found no efficacy in the treatment of OA.

Thundergod Vine

Extracts of Tripterygium wilfordii

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