According to a large-scale, ongoing study published in the Aug. 18, 1999, issue of The Journal of the American Medical Association, women with osteoporosis who took either 60 milligrams (mg) or 120 mg of raloxifene daily had a 35-50 percent reduction in the risk of developing vertebral fractures, compared to women who took a placebo. The three-year study of 7,705 women aged 31 to 80 also showed that raloxifene helped build bone mineral density in the neck and spine.

The effects were more pronounced among women taking 120 mg of raloxifene, the study showed.

Raloxifene is a member of a class of drugs called “selective estrogen receptor modulators” (SERMs), which work by mimicking the effects of the hormone estrogen in some parts of the body while countering the effects of estrogen on other bodily tissues and organs. Raloxifene is currently approved by the Food and Drug Administration (FDA) only for the prevention of osteoporosis, but some studies suggest that it may help prevent breast cancer.

Osteoporosis afflicts 28 million Americans, 80 percent of whom are women.

Gilbert Ross, M.D., medical director of the American Council on Science and Health (ACSH), in New York, gives accolades to the new study and raloxifene. “Raloxifene will be an important new drug in the therapeutic arsenal. The new study took the osteoporosis issue one step further, saying that raloxifene not only increases bone mineral density but also lowers risk of fractures,” he says. “I predict that as the study continues, there will be reductions in fracture rates in other parts of the body.”

The risk of fractures in other parts of the body was not reduced in this three-year study.

Some women take estrogen supplements to stave off osteoporosis. Estrogen protects the bones and the heart but may slightly increase the risk of breast cancer. “Estrogen therapy preserves bone mineral density, but to date there have been no large clinical trials proving a benefit regarding fractures,” Dr. Ross points out.

In an accompanying editorial, Michael R. McClung, M.D., of the Providence Health System and Oregon Osteoporosis Center, in Portland, writes that “osteoporosis is no longer a disorder about which nothing can be done. Considering the current options for the prevention of bone loss and the reduction of fracture risk now available, the clinical challenge is to translate these new advances into the mainstream of routine medical practice in an appropriate manner by focusing on fracture reduction in high-risk patients.”

Although the study was not designed to look at breast cancer risk, women who took raloxifene did, in fact, have a lower risk for breast cancer, study authors note. The study also showed that women who took raloxifene had an increased risk of a blood clots in the veins, a condition called “venous thromboembolism.”

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Ease stiffness, keeping joints well lubricated.

Combat fatigue and increase energy.

Help relieve anxiety and depression.

Improve balance and function.

Increase flexibility and mobility.

Help prevent shortening of muscle fibers and expand range of motion without stressing or straining joints.

Improve posture, which protects joints in the neck, back, hips and knees.

Build muscle strength gradually.

Improve breathing.

Yoga and tai chi are also excellent for arthritis patients because they encourage a safe, gradual, individualized approach. “With tai chi you can go as slowly as you need to and do what’s comfortable for you,” said Kade Gray, chief instructor at the School of Tai Chi Ch’uan in Austin. “You can stay balanced, controlled and relax into it, without worrying about anybody else’s standards. You move slowly and don’t stress the joints at all. As you practice more, your body becomes more limber and you can perform bigger movements if you want.”

Some yoga is better than others. The Arthritis Foundation warns against “power yoga,” for instance. According to health educator Marian Garfinkel, of the Division of Rheumatology at the University of Pennsylvania School of Medicine, it can be harmful for people with arthritis and trigger flares. It’s very different from traditional yoga, which is gentle and moves slowly from one pose to another.

MacInerney agrees. “Ideally arthritis patients, even young ones, should find a yoga class for older people. If they go to the wrong class, it’s not going to be a pleasant experience. Anyone who offers yoga to seniors is used to working with people with limitations.”

There are also different tai chi styles. Most consist of slow, synchronized movements that are easy to learn. However, the quick, active Chen style is not recommended for most people with arthritis, according to the Arthritis Foundation.

Of course, beginning any exercise, especially with arthritis, can be challenging at first. “It may hurt a bit in the beginning,” MacInerney said. “It can be difficult to distinguish between the normal pain of arthritis and pushing a posture too far. I often talk to my students with arthritis about good pain vs. bad pain.”

The bottom line is not to push too hard. “I advise arthritis patients to notice how flexible they are at night and then to see how much ground they’ve lost the next morning. They want to recapture that ground. Beyond that, they need to be more careful, taking it slowly,” said MacInerney, who adds that he has seen good progress with arthritis patients. “I have a student who thought he had to give up driving because of arthritis in his neck. He couldn’t turn his head. He gained much more range of motion in his neck from yoga and was able to keep driving.”

Tai chi practitioners also see its impact on arthritis. “I suffered from arthritis before starting tai chi,” said Gordon Baker of Austin. “After two months, some time between learning the move ‘single whip’ and the ‘second brush knee push movement,’ I realized I was no longer having any pain in my hand or arm.”

Gray had a similar experience: “I used to suffer from arthritis. Since I’ve been practicing tai chi, I don’t have arthritis pain anymore, and my joints are much stronger. I’ve also seen tai chi help many of my students who have arthritis. They tell me their joints feel much better now.”

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An increasing number of arthritis patients are finding the ancient practices of yoga and tai chi to be fun and gentle ways to relieve pain and gain flexibility and strength. “Tai chi is a great way to ease yourself back into an exercise routine,” said Tom Gohring, director of the School of Tai Chi Ch’uan in Austin, Texas. “The nature of tai chi’s movement is especially good for arthritis. It works the joints, giving them a full rotation.”

Tai chi’s alignment also gives students an awareness of how to hold their bodies, according to Gohring. “Often the way people stand strains their knees and joints. With tai chi, they learn a more centered position, which places their weight correctly. This puts less stress on the joints and helps strengthen them.”

In many ways, yoga and tai chi are tailor made for arthritis according to yoga and tai chi instructors and the Arthritis Foundation. According to these experts, they
Are gentle, fluid and adaptable.

Are non-competitive.

Can be modified to suit individual restrictions and needs.

Go at a slow, flowing, relaxed pace.

Are low or non-impact.

Are relaxing and ease stress.

Are available and affordable.

As arthritis patients practice tai chi and yoga they gain more than physical progress. “One of the primary benefits comes from the mental aspects of yoga,” said Charles MacInerney, yoga instructor and owner of Expanding Paradigms in Austin. “With arthritis the immune system is out of balance and overactive. Researchers have found that the meditative components of yoga — relaxation, meditation, visualization, emphasis on thoughts, diaphragmatic breathing — help balance the immune system.”

MacInerney explains that yoga works on multiple levels: “On the mechanical level it moves the joints through their range of motion. It also stimulates the nervous system. You also get increased activity of the endocrine system through the massaging action of the postures. And then you impact the psychological through emphasis on attention: not thinking about your income taxes.”

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Conventional Therapies: Many of the therapies for OA and RA have the inflammatory component as their target. Glucocorticoids (steroids) have long been employed to control inflammation. Their use over the long-term is discouraged because of potential severe toxicities to muscle and other organs. However, over the past 20 years, treatment regimens have indicated that the commonly employed steroid prednisone in low doses of 7.5 mg or less may be employed over long periods and are usually well tolerated and safe. Non-steroidal anti-inflammatory drugs (NSAIDs) are also commonly used in initial treatment of RA and OA.

NSAIDs (i.e., diclofenac, tenoxicam, indomethacin, tenidap, ibuprofen, to name just a few) are powerful anti-inflammatory drugs that act by inhibiting several components of the inflammatory pathways, including macrophage function and by the pharmacological inhibition of prostaglandin synthesis, in general. Long-term use of NSAIDs can produce gastrointestinal side effects, and the gastrointestinal mucosa can be injured so that bleeding occurs without warning. However, NSAIDs may be the most common drug therapy in the treatment of OA. The so-called Disease Modifying Anti-Rheumatic Drugs (DMARDs) are usually not the first line of treatment in RA because of associated toxicity with long-term use. However, x-rays and clinical evidence of aggressive joint damage with progression in patients treated only with steroids or NSAIDs usually requires DMARDs to be employed in RA therapy. DMARDs are less commonly used in OA treatment. The DMARDs commonly employed in RA include, sulfasalazine (Azulfidine), hydroxychloroquine (Plaquenil) and methotrexate (Rheumatrex). These DMARDs appear to be less toxic than previously commonly employed DMARDs such as gold, penicillamine and azathioprine (Imuran). Methotrexate appears to be particularly effective in RA and combination therapy where multiple DMARDs may be required to fully regulate clinical symptoms of RA at different disease stages. Thus, DMARDs appear to alter the activity of inflammatory and immune cells active in the progression of RA.

Status of Novel Therapies:

Cox-2 inhibitors. NSAIDs inhibit the activity of enzymes, termed cyclooxygenase, required for the synthesis of prostaglandins and other eicosanoids. Prostaglandins synthesized by macrophages and other inflammatory cells are, in part, responsible for significant inflammation in arthritis. The finding in 1991 that a least two forms of cyclooxygenases exist, called Cox-1 and Cox-2, resulted in numerous experimental and clinical studies that showed that Cox-1 was a normal enzyme involved in tissue homeostasis, whereas Cox-2 was induced in that it was synthesized only at sites of inflammation. Thus, according to Dr. David Gotlieb, a South African rheumatologist, “Inhibition of Cox-1 is therefore undesirable… while the inhibition of Cox-2 is desirable.” Cox-2 inhibitors, such as celecoxib (Celebrex) are about 375-fold more selective for Cox-2 than Cox-1. Celebrex is effective in controlling the inflammation of arthritis with no significant complications when compared to placebo.

Inhibitors of tumor necrosis factor-alpha. Inflammatory arthritis is characterized, in part, by an increase in the amount of soluble mediators of inflammation called cytokines. One of these cytokines is tumor necrosis factor-alpha (TNF-alpha). Some RA patients resistant to conventional therapies with steroids, NSAIDs and even DMARDs have been treated with an anti-TNF-alpha antibody called infliximab (Remicade), which is a genetically engineered hybrid molecule made by combining human and mouse cell proteins or with another genetically engineered, human-derived molecule, etanercept (Enbrel). According to Drs. Maini and Taylor (Kennedy Institute of Rheumatology, London, UK) randomized phase II and III clinical trials of anti-TNF reagents have shown an acceptable safety profile and significant clinical efficacy in cases of RA that have not responded to conventional therapy. Anti-TNF combined with methotrexate appears to be particularly effective in RA patients whose disease persists even after therapy with DMARDs. However, RA patients with co-morbid conditions, including serious infection or cancer, are not advised to use anti-TNF therapies.

Oral Collagen. “Ingesting low doses of Type II collagen (the collagen type found in articular cartilage of synovial joints) may help relieve the severe joint pain, swelling and stiffness of the disease. In a clinical trial to determine the efficacy of oral collagen, RA patients continued on NSAIDs or oral steroids, but prednisone use did not exceed 10 mg. daily. The mechanism of the action of oral collagen presumably involves a reduction in the severity of the immune response associated with RA. According to Dr. John Stuart, a rheumatologist at the University of Tennessee in Memphis, oral collagen, “has the tremendous advantage in that it has no side effects.” The use of oral collagen therapy as an adjunctive treatment in RA continues to be studied.

Prosorba column. At 1999, the first non-drug therapy to treat RA was approved by the FDA. While the mechanism of action is incompletely understood, the Prosorba column improves RA symptoms with moderate to severe disease. The column is manufactured of purified bacterial protein A covalently bonded to silica. In a trial to study the effectiveness of this treatment, RA patients for two hours weekly for 12 weeks had their blood passed through the Prosorba column. The protein A is thought to collect the circulating immune complexes and antibodies, which significantly contribute to RA pathology.

According to an article published on The Lancet Interactive, the device worked so well that a phase III trial was halted early. Almost 50 percent of the 109 RA patients on the study, who had RA for a mean of 15.5 years, have significant improvement in symptoms. Additional studies are needed to further ascertain the mechanism of action of the Prosorba column and whether or not it will be useful in treating other autoimmune disorders in addition to RA.

B Cell Depletion. RA is perpetuated by a chronic cycle in which “autoreactive B lymphocytes generate their own antigen, called IgG rheumatoid factor,” according to Dr. Jonathan C. Edwards (University College, London, UK). Studies were designed by his group to determine whether or not B lymphocyte depletion would lead to clinical remission in RA patients. A monoclonal antibody, called anti-CD20 was employed in combination with prednisolone and cyclophosphamide (Cytoxan) to treat 20 patients who had RA refractory to other therapies for about 20 years. The results of these studies were reported this month at the American College of Rheumatology annual meeting in Philadelphia. The majority of RA patients responded to B-lymphocyte depletion brought about by anti-CD20 and were able to discontinue DMARDs. Reappearance of RA symptoms in some patients correlated with increased levels of B lymphocytes. Side effects of this novel therapy were reported to be minimal. A formal controlled clinical trial is planned.

Both conventional and novel therapies for the medical treatment of OA and RA provide an increased armamentarium for use by physicians in the care of patients with these diseases. More recently, novel therapies are directed at altering specific pathways implicated in both the pathogenesis and progression of OA and RA. The discovery of new pathways in these diseases will offer additional targets for drug intervention and perhaps even gene therapy. A better understanding of the relevance of these pathways integral to the inhibition of immune system dysfunction and inflammation should provide us with important new treatments for OA and RA in the next few years.

Recently, my colleagues and I were examining x-rays from patients with osteoarthritis (OA) of the femoral joint. These patients were quite young when their OA was first diagnosed. In these OA patients, the disease was clinically significant when they were in their 20s or 30s whereas in the general population OA does not usually present clinically until individuals are in their 40s or 50s. Genetic testing of these individuals indicated that several family members had a similar age onset of OA. The genetic defect is a mutation in the predominating collagen type that makes up the matrix of articular cartilage of synovial joints. In the many cases of inherited OA that we have examined, this precocious form of OA began when patients were in their teens, which often resulted in a bilateral total joint replacement sometime thereafter. Looking at the post-operative x-rays, I remarked to one of my colleagues, tongue-in-cheek, “Well there’s the cure for OA.”

Naturally when we discuss “arthritis cures” we can always include surgical intervention, which removes the dysfunctional joint.

Extraordinary advances in the technological development of joint prostheses and their application leading to joint replacement surgery have improved the quality of life for individuals with advanced arthritis of the peripheral joints.

Generally speaking, another interpretation of the term “arthritis cure” could occur when a medical intervention consisting of drug therapy and/or rehabilitation or fitness strategies delays or otherwise makes unnecessary the need for joint replacement surgery.

In this case, the patient’s clinical symptoms improve or are totally alleviated, a so-called “clinical remission” ensues and the patient’s clinical status is sustained over long periods of time. Does such a scenario exist in the therapy of arthritis now, and if not, what novel therapies are being developed to produce such an outcome?

Arthritis is often thought of as one disease, but in reality, while the final common pathway resulting in loss of joint function may be similar for all the arthritides, the pathogenesis or origin of the disease differs depending on which form of arthritis we are considering.

The most common form of arthritis is OA, affecting almost 80 percent of the population over the age of 50. OA has specific risk factors, namely, aging, obesity and repeated mechanical stress or trauma to joints, and so may be considered, in part, a “wear-and-tear” disorder of joints. Rheumatoid arthritis (RA), unlike OA, is an autoimmune disease because the immune system appears to react with self-antigens or self-proteins so that the immune system is activated to react with the body’s own tissue components. Thus, the body treats this response as if the tissue components were foreign proteins such as might occur when the normal immune response reacts to invading bacteria or viruses. There are contributing risk factors in RA as well. These include, allergy to foods, gut substances that might be exposed to peripheral blood, hereditary factors and exposure to certain microbes, which are in part an element of the hyperimmune response in the RA patient.

The final common pathway regardless of pathogenesis for both OA and RA involves inflammation. While OA is slowly progressive, activation of inflammatory cells appears to speed up the rate of progression to joint failure. Chronic inflammation is a hallmark of late-stage OA. Mild to chronic inflammation is a signature of RA at its inception. The proliferation of synovium in RA resulting in pannus causes significant aggressive destruction of cartilage and subchondral bone that is often irreversible. While the joints are mostly affected in RA and OA, in severe RA other organs may also be affected. These include the skin and lungs. The eyes also appear to be particular targets of the immune pathogenesis of RA. Muscle atrophy as a result of disuse is common, but the heart and blood vessels are less likely to be directly affected in RA.

to be continued…