Osteoarthritis

Recently, a landmark study demonstrated that acupuncture not only provides pain relief, but also improves function for people suffering with osteoarthritis of the knee, the most common form of the disease.

The largest-ever clinical trial of acupuncture for knee osteoarthritis was funded by the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health. The trial results, published in the Annals of Internal Medicine, support the healing art as a beneficial component in the standard of care for people suffering from the painful condition. The multisite study team, including rheumatologists and licensed acupuncturists, enrolled 570 patients aged 50 or older with osteoarthritis of the knee. Participants experienced significant knee pain before joining the study but had never experienced acupuncture. The results were clear.

"For the first time, a clinical trial with sufficient rigor, size, and duration has shown that acupuncture reduces the pain and functional impairment of osteoarthritis of the knee," said Stephen E. Straus, M.D., NCCAM director. "These results also indicate that acupuncture can serve as an effective addition to a standard regimen of care and improve quality of life for knee osteoarthritis sufferers. NCCAM has been building a portfolio of basic and clinical research that is now revealing the power and promise of applying stringent research methods to ancient practices like acupuncture."

The Post spoke with Brian M. Berman, M.D., director of the Center for Integrative Medicine and professor at the University of Maryland School of Medicine, as well as principal investigator of the national acupuncture study.

Post: Could you share findings from your recent four-year study on acupuncture?

Dr. Berman: We studied osteoarthritis, the most common form of arthritis that affects about 21 million people a year in the United States alone. Our study focused on the most common form of the disease, osteoarthritis of the knee. Using conventional medical approaches, we know we don't have all the answers for this chronic health disorder and often don't give adequate pain relief for our patients. Because there is no cure to date for osteoarthritis, treatment focuses on improving pain and physical function. We use nonpharmacologic approaches, such as weight loss, education, exercise, and physical therapy, and also offer different medications, if the nonpharmacologics aren't effective. These don't always work and pose potential side effects, especially for the elderly.

We have recently learned about the side effects of COX-2 inhibitors and other NSAIDs, so people are looking for safe, effective, alternative treatments, not forgoing conventional medical care but rather adding complementary therapies, including acupuncture.

Acupuncture has been around for more than 2,000 years. In the United States, there are about 5 million visits per year for acupuncture treatments, very often for pain-related problems such as osteoarthritis.

Reviewing the scientific literature, we noted that the results of trials of acupuncture for osteoarthritis were mixed. Some small studies demonstrated a beneficial effect in reducing pain, while others didn't.

Twelve years ago, we launched a small pilot study of 12 patients and followed this up with a study of 73 patients, both showing acupuncture to be safe and effective as an adjunctive therapy for osteoarthritis of the knee. Finally, we conducted the present study of 570 patients with osteoarthritis who had failed on their standard care and still experienced moderate to severe pain of the knee.

Participants in the trial were randomized into one of three groups--one group received true acupuncture, a second group received a sham acupuncture procedure, and a third group received an education program that the Arthritis Foundation promotes as a part of standard care. The group receiving true and sham acupuncture received 23 acupuncture treatments over a 26-week period, while remaining on background medical therapy. In the study, we used reliable, tested, true and sensitive standard outcome measures of pain and physical functioning specifically that are employed in osteoarthritis for clinical trials.

The results showed that people receiving true acupuncture experienced a significant reduction in physical pain by week 14, which was maintained throughout the rest of the 26 weeks. They had a significant improvement in physical function by week 8 that was maintained throughout the 26 weeks. The true acupuncture group improved significantly more than either the sham or education control group. They experienced about a 40 percent reduction in pain overall and about a 30 percent improvement in their physical functioning.

Post: Is this the largest scientifically randomized, controlled trial that has been conducted on acupuncture?

Dr. Berman: Yes it is. Most studies of acupuncture have 50 to 70 patients with perhaps a couple of studies including 200-plus patients. Rheumatologists and primary-care physicians want to see definitive studies that will help make clinical decisions in practice. Generally with osteoarthritis, we have a number of therapies with a small but significant effect. Today, the thinking is that a number of treatments with small effects can add up to a big effect. Acupuncture offers another option, another choice.

Post: Do we know what physiologic changes are at work with acupuncture?

Dr. Berman: We have some idea. Many studies under way around the country suggest that when placed in the acupuncture point, an acupuncture needle stimulates the release of neurotransmitters, or neurochemicals, from the brain and spinal cord--natural occurring painkillers such as endorphins and serotonin, among others--that help reduce pain and inflammation.

Post: Does the therapy inhibit release of inflammatory prostaglandins?

Dr. Berman: Absolutely. Our own group is investigating the idea that acupuncture has an effect on the hypothalamus-pituitary-adrenal access. Some studies show that cortisol and ACTH (adrenocorticotropic hormone) levels change. Other studies of acupuncture suggest that when you put a needle in the body, certain parts of the brain actually change. While we don't know how acupuncture completely works--as is true with many drugs, even aspirin until recently--a lot of research is under way to better understand the pain pathways, etc.

Post: Did the medication regimen of people in the trial change?

Dr. Berman: We have heard from patients in the study that they were able to reduce medications. We will be looking at that data later and publishing what we find.

Post: What was initial patient reaction to the therapy?

Dr. Berrnan: None of the people in the study had previously undergone acupuncture. They often thought it would hurt and were surprised that it did not. But it did take a number of treatments because acupuncture has a cumulative effect, especially for a chronic problem like osteoarthritis of the knee, so it took a while before patients began to notice a difference.

Post: In light of the current warnings about the cardiovascular side effects of some pain medications and publication of the article, have you received many inquiries?

Dr. Berman: I couldn't believe it. The NIH tracks the impact of a published study, and they told me that this study had 235 million media impressions, which includes Internet, print, radio, and television. I was flabbergasted. There is a lot of interest in these therapies.

Post: If consumers are interested in acupuncture, should they exercise caution?

Dr. Berman: Definitely. You want to go to someone who is a certified, licensed acupuncturist, whether a physician-licensed or nonphysician acupuncturist. Each state has licensing requirements. There is a national certification exam, and many practitioners have taken it. Word of mouth is also important, because people discover who is effective or not.

Post: The Post has been writing about emerging complementary therapies, including acupuncture and supplementation, for many years. Do glucosamine sulfate and chondroitin continue to demonstrate benefits in people with OA?

Dr. Berman: There have been around 14 randomized controlled trials of glucosamine and chondroitin sulfate. Overall, they have demonstrated a positive effect. Some studies have had problems with methodology, which is why the NIH funded a large multicenter trial that is nearing completion. It will be interesting to see the results of this large study.

One problem that I see with the potential effectiveness of glucosamine and chondroitin sulfate has to do with a specific product, because quality varies.

Post: In your own clinical practice, do you suggest other adjunctive therapies in addition to acupuncture?

Dr. Berman: We do. We have a clinic at the University of Maryland integrating conventional medicine with complementary therapies. Depending on the person and the clinical problem, we may suggest dietary changes such as adding omega-3, omega-6 or flaxseed oil, as well as glucosamine and chondroitin sulfate. We also try to teach people ways that they can help themselves. We use a technique called mindfulness meditation, including breathing exercises, to give people some tools that they can use to alter their perceptions and their reactions to the pain.

Post: You were recently a panel member of the Institute of Medicine report on complementary and alternative therapies. Is there anything new that you can share with us?

Dr. Berman: The Institute of Medicine and the NCCAM reports have a new strategic plan. Both reports say that we need to study these systems of care as a whole, and as they are practiced. The ultimate goal is a comprehensive system that is patient centered and evidence based. The NIH will also study mind-body approaches, as well as herbal medicines commonly used. With herbs, there is a whole strategy to better characterize products that consumers take.

Post: How many people are using complementary therapies?

Dr. Berman: A recent study conducted by the CDC showed that 60 percent of the American public is using some form of complementary therapy. Often, they are not using it instead of, but in addition to, conventional care. It is important for patients to communicate with their physicians what they are doing, so patients don't experience potential interactions between herbs and medications. It also keeps open the channels of communication.

Post: Are you finding that more physicians and medical schools are open to the potential of complementary therapies?

Dr. Berman: There has been a tremendous change over the past 15 years in this country. For example, until just recently I chaired the Consortium of Academic Health Centers for Integrative Medicine, which now is comprised of 27 universities--some of the most prestigious universities in the country--that have programs in integrative medicine. That has grown over the past three years from six to 27. In medical schools and universities, about two-thirds have some sort of course on complementary or alternative medicine. It is often not part of the required curriculum, but it is getting more hours in the required curriculum. So there is a big change going on. It is patient led. People are voting with their feet.

Post: What is the main message that you wish to share with people suffering from osteoarthritis?

Dr. Berman: Acupuncture is a safe and effective treatment in combination with standard care for osteoarthritis of the knee. It should be part of a multidisciplinary, integrative approach for osteoarthritis.

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