Hocus-Pocus As Applied To Arthritis by Annabel Hecht [Graphic Omitted] FDA CONSUMER A REPRINT FROM FDA CONSUMER MAGAZINE DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION OFFICE OF PUBLIC AFFAIRS. 5600 FISHERS LANE ROCKVILLE, MD 20857 You can sit in an abandoned radium mine, hang a Vryllium tube on your lapel, bury yourself up to the neck in horse manure, swill Dr. Fenby's Formula X, or take a dose of "Chuifong Touku-Wan," but you will not be able to cure your arthritis. It is a distressing fact of life that although there are drugs to relieve the pain and reduce the inflammation of arthritis, there are no cures for most of the more than 100 types of this painful and sometimes crippling disease. Yet many people with arthritis turn to unproven devices and "miracle" cures, such as those mentioned above. They do no good and in some cases can do considerable harm. However, the peddling of these unproven cures is a big business, with more than a billion dollars a year spent on them. It is not too surprising that this business flourishes. There are plenty of people to prey on-over 37 million Americans suffer from arthritis and related disorders. Arthritis is a chronic condition. Once you develop it, it often stays with you the rest of your life, bringing pain and sometimes disability. Not only are there few cures, but also scientists don't know for sure what causes most types of the disease. Arthritis apparently has been around as long as man. Bones of the Java Ape Man and Egyptian mummies show signs of arthritic damage. The word arthritis literally means inflammation of a joint. Like many medical words, it is taken from Greek, combining the Greek words arthron for joint and itis for inflammation. The various types of arthritis have different causes, symptoms, and types of treatment. Medication, rest, heat or cold, special exercise, and surgery are all used to relieve symptoms. What's best for a person with arthritis depends on an accurate diagnosis of the type of disease that person has. Treatment programs are tailored to fit the individual because the disease varies from person to person, and people themselves vary in the way they react to therapies. Promoters of unproven remedies don't take such factors into consideration when they peddle their wares. All forms of arthritis are the same to them: One drug or one device cures all. Unfortunately, quacks persist even in this age of enlightenment. In part, that's because arthritis has a way of coming and going unpredictably, an aspect of the disorder known as spontaneous remission. The pain and swelling can simply disappear for days, weeks, months, or even years. People who experience such a remission are easily convinced that whatever they were taking or doing brought relief. The Food and Drug Administration has long been concerned about fraudulent drugs and devices and has, over the years, taken legal action to get many of them off the market. One of the earliest gadgets to make its appearance in this country was "Perkins Tractors," two pointed rods about three inches long-one gold-colored, the other silver. A number of conditions-especially gout, pleurisy, rheumatism, violent insanity, "inflammatory tumors," and yellow fever-resulted from a surcharge of an electric fluid in the body, inventor Elisha Perkins claimed. This electricity could be released through drawing the tractors over the affected area. Perkins and his "tractors" were the biggest thing going-in 1796. In the 20th century, people with arthritis have been lured by an astounding variety of quack devices, ranging from simple copper or magnetic bracelets to complex "electronic" mechanisms, such as the Palorator device seized by FDA in 1954. It had two electro-magnetic coils that vibrated a couple of knobs on the front of a box. Another was the Gonsertron. Billed as "A New Concept in the Field of Electrotherapy," it was a cabinet filled with various electrical components connected to a chair and, not coincidentally, to the house current. Still another was the Magnetron, a 6,000-volt transformer hooked up to a homemade condenser; the claim was that it provided an adequate and effective treatment for diabetes, tumors, varicose veins, and rheumatoid arthritis. Other such devices are still turning up despite FDA efforts to get them out of circulation. Things that vibrate-chairs and mattresses for example-also have been "hot" items in the arthritis quack's bag of tricks. The vibrators may produce interesting sensations, but they certainly are not harmless since they can further aggravate already inflamed joints. So too could the Slim-Twist Exerciser, two pieces of wood connected by a ball-bearing swivel joint. Stand on the top piece, pretend to dance the "Twist," and you could lose weight, cure heart and vascular problems, or relieve arthritis, asthma and diabetes, the promoters claimed. Another popular unproven remedy is uranium. Not only have people sat in abandoned mines to soak up the "curative" powers of this dangerous ore, but they have been hoodwinked into buying mittens, gloves, mattresses, and pads of assorted sizes supposedly filled with radioactive material. What they receive is crushed rock with less radiation than a radium watch dial emits. According to the Arthritis Foundation, there are some scientific reasons to think that diet affects arthritis, but there is not enough evidence to tell how diet helps or hurts or to recommend any specific diet as a treatment. Everything from cod liver oil, alfalfa, pokeberries, and black-strap molasses to a mixture of honey, vinegar, iodine, and kelp have been sold for arthritis diets. At one time "immune milk" was a big item. This supposedly came from cows injected with streptococcus and staphylococcus vaccines. Seawater was highly promoted in the early 1960s by a physician who claimed to have rejuvenated his 97-year-old father with this treatment. Serious complications were reported in cardiac and rheumatic patients who were swept up by what then FDA Commissioner George Larrick called a "nation-wide seawater swindle." FDA went into action in Texas, California, Indiana, Ohio, Pennsylvania, and Michigan to seize about 2,000 bottles of seawater packaged by a Florida laboratory. Diet cookbooks for arthritics have appeared on the scene, as have special biological health regimens. One book, There Is a Cure for Arthritis, recommends a treatment that includes elimination of all drugs, therapeutic fasting, enemas two or three times a day, and a diet heavy in fresh fruits, raw vegetables, herb teas, and other so-called natural or whole-grain foods. Two professors at Rutgers University theorized that arthritis is caused by eating vegetables classed as "nightshades." This includes tomatoes, white potatoes, green peppers, and eggplant. Such treatments have not been studied scientifically. An offbeat diet might not do too much injury, but an unapproved drug could. Groff's Arthra Tone, Ar-Thry-Go Tablets, Ring's Golden Herb Tonic, Elmore's R'heumative Goutaline and Dr. Fenby's Formula X are the names of some drugs that FDA and the U.S. Postal Service authorities put a stop to. Many of these "cures" were combinations of herbs, aspirin, and alcohol. Not so innocuous was the Tri-Wonda Treatment, a three-part concoction consisting of one bottle of dilute hydrochloric acid and dilute nitric acid with traces of tartaric and acetic acids; a second bottle containing cream of tartar, senna, sulfur, and phenophthalein, a laxative; and a third bottle containing a 44 percent alcohol solution of fluid extract of Jamaica dogwood, thiamine hydrochloride, and wild cherry flavoring. It took seven years for FDA to get Tri-Wonda off the market, because of legal maneuvering by the manufacturer. Even more dangerous is Leifcort, a powerful drug and an unapproved arthritis treatment. Leifcort is a hormone compound developed and promoted some 30 years ago by a Dr. Robert Leifmann, who fled to Canada because he was wanted by U.S. marshals for selling a baldness cure. Leifmann prescribed his compound in Montreal until the Canadian Food and Drug Directorate raided his clinic. Charged with marketing an unapproved drug and other violations, Leifmann continued treating his own patients while various appeals were pending. FDA became concerned about Leifcort after the death of an American woman who went to Canada and came back with a year's supply of the drugs on the strength of a glowing report in a popular magazine. The agency issued press information alerting the public to the danger of this drug. Leifmann has since died, but his scheme made a comeback a number of years after his death, being sold as "Hormone Balance Treatment," "Holistic Balance Treatment," and "Rheumatril." Whatever the name, Leifcort was sold in clinics often set up in hotel rooms. There the victim got a cursory physical examination and a six-month supply of the drug for $640. A more recent case of arthritis hocus-pocus involved a "magic wand" type device imported and advertised by a Fort Worth, Texas, firm. Called an Energy Point Stimulator, the device purported to relieve arthritis by applying an electric energy charge to certain "energy points" in the ear. Literature accompanying the device implied that digestive problems could be treated by stimulating the leg, and that migraine headaches responded to stimulation of the lower leg and wrist. A bulk order of the devices seized from Kansas stores was destroyed by court order in June 1988. Still other recent examples involved unproven arthritis remedies containing drugs or for which drug claims were made. A Phoenix firm agreed to stop distributing two over-the-counter products that contained potent prescription drugs. One, imported from Hong Kong, in tea bag form, was called Chuifong Touku-Wan. In December 1988, the same firm was ordered to pay the government $68,000 in court costs for a newer product called "Earth's Magic" that contained the same two potent drugs. Drug claims, including arthritis cures, were made for 40 items sold over-the-counter in 1988 by a Utah firm. The items were for treatment of a variety of maladies. The arthritis treatment products were called AR-ALL and ARTHO-Pak. The firm, Nature-All Inc., has agreed to abide by a court injunction against the products. While no one would consider aspirin an unproven remedy, a number of medical writers have labeled the "glorification" of the more expensive forms of aspirin a kind of medical misrepresentation. Special arthritis-strength formulas are nothing more than plain aspirin with small amounts of caffeine or antacid added. The tablet may be bigger than an ordinary aspirin, but so is the price. A few years ago, a panel of nongovernment experts evaluating aspirin and other pain relievers for FDA said that terms such as "arthritis strength" or "arthritis pain formula" should not be included in the labels or advertising of aspirin products. Ads suggesting arthritis is a minor disease or that alleviation of pain with "extra strength aspirin" will control the disease could delay proper diagnosis and treatment, the group said. Arthritis is not a minor disease, but its pain can be relieved and its crippling effects can be prevented in many cases by prompt and proper treatment. People with the disease should be wary of products that offer "special" or "secret" formulas that promise quick or easy cures, and that are promoted by case histories and testimonials. Such products should be shunned or left capped-there are no genies in those bottles, and the products can do more harm than good. The Many Guises of Arthritis The most common forms of arthritis are osteoarthritis, rheumatoid arthritis, and gout. Osteoarthritis is the most prevalent, and its prevalence increases with age. It involves the breakdown of tissue that allows the joints to move smoothly. Some 16 million Americans are afflicted with it, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The common systems of osteoarthritis are pain and stiffness. Pain is usually felt when certain joints are used, especially finger joints and those that bear the body's weight-namely knees, hips and spine. Disability most often occurs in these weight- bearing joints. Rheumatoid arthritis generally starts between the ages of 20 and 45 and affects almost three times as many women as men. Rheumatoid arthritis involves many joints, but most commonly the small joints of the hand. Inflammation and thickening of tissue around the joints may cause destruction of the bones, deformity, and eventually disability. In some cases the disease may be mild; in others it can be crippling. While the cause is unknown, some scientists believe rheumatoid arthritis may be sparked by a virus and linked to a disruption of the body's defense, or immune, system. Gout is the easiest form of arthritis to diagnose and treat, and it is the best understood. It most commonly affects the joints of the feet, particularly the big toe, although other joints may be involved. Most cases of gout occur in men. Gout gets its start when too much of a certain body chemical, uric acid, is deposited in the tissues. Crystals of uric acid form in the joints, causing inflammation and severe pain. Attacks of gout may follow minor injury, excessive eating or drinking, overexercise, or surgery, or may occur for no apparent reason. Arthritis in children can take many forms. The most common is juvenile rheumatoid arthritis. It affects primarily those under 8, causes growth disturbances, and can produce high fever and skin rash. It can be controlled with proper treatment. Psoriatic arthritis affects about 10 percent of the people who have psoriasis, a common but sometimes severe skin disease. Systemic lupus erythematosus, an uncommon form of arthritis, affects the skin, joints, and internal organs. Like rheumatoid arthritis, women suffer more often than men from this variation of the disease, and it usually crops up between the ages of 20 and 40. Ankylosing spondylitis, also known as rheumatoid spondylitis or Marie-Strumpell disease, affects mostly males in late adolescence or young adulthood. Back pain, stiffness, and loss of spinal mobility are the main symptoms. Bursitis is inflammation of a bursa, a small sac containing fluid that lies between a tendon and the bone over which the tendon moves. Popular names for bursitis are "tennis elbow" and "housemaid's knee." Fibrositis involves pain, stiffness or soreness of the fibrous tissue, especially in the coverings of the muscles. It does not affect joints directly. A disease of the body's connective tissue with accompanying symptoms of arthritis in the joints is called scleroderma. This disease causes thickening and hardening of the skin and sometimes inflammatory and other changes in internal organs, including the esophagus, intestinal tract, heart, lungs, and kidneys. Scleroderma strikes more woman than men and can occur at any age, although it most often starts in the 40's and 50's. For more information about arthritis, write to: National Institute of Arthritis and Musculoskeletal and Skin Diseases Building 31, Room 4C05 Bethesda, Md. 20892 Therapies for People With Arthritis Therapy for arthritis depends on the type of disease being treated, its severity, and patient response. Here are some common forms of treatments being used to treat the major types of arthritis. Anti-Inflammatory Drugs These are widely used to treat the symptoms of many types of arthritis, as well as other conditions, including muscular pains and fever. Salicylates-The most widely prescribed medications to reduce swelling, fever and pain, they include: * Aspirin (acetylated salicylates). For arthritis, this most commonly used salicylate is prescribed in doses higher than those allowed for over-the-counter use. Because of potential side effects, their use should be monitored by a physician. * Non-acetylated salicylates (choline salicylate, magnesium salicylate, sodium salicylate). These drugs are similar in structure to aspirin and are an alternative. * Coated and time-release salicylates. Aspirin and the newer non- acetylated salicylates also are available in forms that may increase the body's tolerance to them or allow taking fewer doses. Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)- Structurally related compounds that have similar benefits and side effects. They work much as aspirin does to block a biochemical pathway that produces prostaglandins, which promote inflammation. NSAIDS include: Carprofen, diclofenac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, meclofenamate, naproxen, piroxicam, phenylbutazone, tolectin, and sulindac. Corticosteroids These potent drugs are similar to a naturally occuring hormone, cortisol. They can very quickly reduce inflammation. However, because of the possibility of significant side effects, corticosteroids are used only in carefully evaluated circumstances. They may be given orally or injected directly into muscles, veins or joints. Corticosteroids include: Hydrocortisone, prednisone, prednisolone, methylprednisolone, and triamcinolone. Slow-Acting and Disease-Modifying Agents Most commonly used to treat advanced forms of rheumatoid arthritis, these drugs normally take longer to act than corticosteroids and NSAIDS, but have been found to have a lasting benefit for some arthritis sufferers. They include: *Gold-used for at least 50 years, brings significant improvement to some people. Its use is limited due to potentially severe side effects. It is given orally or by injection. * Penicillamine-sometimes produces the same benefits as gold and is prescribed as an alternative to it. Significant side effects are possible. * Antimalarials-originally used to treat malaria, they have sometimes been found to be of benefit in early treatment of some forms of rheumatoid arthritis. Use is limited primarily because of side effects involving the eyes. Immunosuppressive Drugs These drugs control inflammation by suppressing the immune system. Because of their potency, they must be used under close supervision. * Methotrexate-effective in low doses to treat rheumatoid arthritis and psoriatic arthritis. * Azathioprine-used in treating severe rheumatoid arthritis. Gout Gout occurs when output of uric acid, a normal waste product in the body, becomes excessive. Uric acid can form crystals that collect in and around the joints, causing inflammation and pain. Drugs effective in treating gout include: * Allopurinol-blocks the formation of uric acid. * Colchicine-may relieve swelling and help prevent the frequency of attacks. * Indomethacin and other NSAIDS-relieve pain and swelling. * Probenecid-decreases the frequency of attacks of gout by increasing the kidney's excretion of uric acid. Treatment Without Drugs Medication at times is not the best or only choice of treatment for arthritis. Physical therapy or surgery may be indicated, or prescribed in combination with drugs. A decision should be made by the patient, physician, and any other members of the treatment team. * Physical therapy-can be performed at home or with professional supervision. * Rest-important in treatment of painful, inflamed and fatigued joints, but it can lead to temporary stiffening of diseased joints. * Moist heat or cold-often reduces pain and increases the range of motion. A shower, a bath, heat packs, hydrotherapy, and paraffin treatments are examples. Occasionally, for acutely inflamed joints, ice packs are an initial treatment. * Exercise-helps maintain range of motion in affected joints. Special daily exercises also can strengthen the muscles that surround an arthritic joint. * Devices-splints, braces and crutches may give relief by resting or supporting painful joints. Aids for daily activity can help by supporting a joint that is painful, weak or impaired. Surgery Sometimes orthopedic surgery is indicated. Surgeons can correct some deformities, remove inflamed tissue, repair ligament damage associated with arthritis, or replace a diseased joint. A REPRINT FROM FDA CONSUMER MAGAZINE Printed September 1993. This article originally appeared in the September 1980 FDA Consumer. Updated August 1989. PUBLICATION NO. (FDA) 90-1080 We hope you found this reprint from FDA Consumer magazine useful and informative. FDA Consumer, the magazine of the U.S. Food and Drug Administration, provides a wealth of information on FDA- related health issues: food safety, nutrition, drugs, medical devices, cosmetics, radiation protection, vaccines, blood products, and veterinary medicine. For a sample copy of FDA Consumer and a subscription order form, write to: Food and Drug Administration, HFI-40, Rockville, MD 20857. *U.S. Government Printing Office 1993-342-343/80040