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FY 2002 Hearing on Chronic Diseases
Witnesses Appearing before the House Subcommittee on Labor, DHHS, Education Appropriations
Stephen E. Straus, M.D., Director
National Center for Complementary and Alternative Medicine
March 28, 2001
Mr. Chairman and Members of the Committee:
The past year, NCCAM's second, has been exciting and productive. With your generous support we continued to build a new research enterprise dedicated to defining the effectiveness and safety of diverse complementary and alternative medical practices. Many Americans turn to these practices to relieve or prevent the ravages of chronic illness. We have the scientific tools, the commitment, and resources to begin to guide their decisions to do so. Allow me to provide brief examples of our approach.
Decades of research established the benefit of many drugs for pain; however, there are acute and chronic conditions for which effective pain management remains elusive. A major focus of our research portfolio is the evaluation of complementary and alternative medicine (CAM) therapies for pain management, with the goal of expanding treatment options.
One prospect involves acupuncture, which emerges after millennia of empiric development and widespread use in Asia as an exciting but still poorly understood tool for pain management. The ancients saw pain as resulting from imbalances in energy flow through defined body channels, or meridians. Insertion of needles at precise points was deemed capable of correcting the pain-provoking energies. In contemporary neurobiological terms we envision chronic pain as resulting from abnormal actions within key nerve signaling pathways from the periphery to the central brain.
NCCAM grantees are testing the value and the mechanisms of acupuncture for pain relief. Studies using remarkably sensitive imaging techniques have pinpointed pain processing centers in the brain and showed that their activity is altered when needles are inserted at the body sites defined by the ancient Chinese practitioners as affording pain control. Acupuncture-mediated analgesia is not imagined—it is real. Our studies in the clinic are revealing the range of conditions for which acupuncture may provide effective pain relief. Our largest such study of acupuncture involves the pain of chronic arthritis.
Osteoarthritis, or degenerative joint disease, is caused by the deterioration of the cartilage that cushions the ends of bones and permits their surfaces to slide smoothly across one another within the joint. The pain and limitation of motion caused by osteoarthritis are significant contributors to disability and dependence to millions of older Americans.
In the largest and most rigorous trial to date, cosponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the short- and long-term safety and efficacy of acupuncture for the pain of osteoarthritis are being evaluated. In this study of osteoarthritis of the knee, 570 aging Americans are being randomly assigned to 1) true acupuncture; 2) sham acupuncture; or 3) standard education and attention for arthritis for six weeks. The goal is to determine whether patients receiving true acupuncture have significantly more improvement in pain and functional limitation than patients in the other groups. A separate follow-up of the patients in this study will evaluate the long-term outcomes and cost-effectiveness of the acupuncture intervention.
In another major collaboration with NIAMS, NCCAM is exploring the dietary supplements glucosamine and chondroitin sulfate for osteoarthritis of the knee. These are two natural substances found in and around the cells of cartilage. The study, involving nearly 1,600 osteoarthritis patients at study centers across the country, is expected to prove their clinical safety and effectiveness, alone or in combination, in reducing joint pain and improving mobility.
NCCAM is applying this same energy and commitment to studies of cancer and other chronic diseases. Surveys conducted by Richardson, et al., have shown that over 80 percent of cancer patients avail themselves of CAM to alleviate the discomfort or side effects of cancer and its treatment, or less frequently as a primary treatment of cancer itself; however, the subject goes largely unexplored in dialogues between oncologists and their patients. Among the most popular modalities are spirituality, vitamins and herbs, and movement/physical therapies. It is possible that some are beneficial, while others are ineffective or otherwise diminish the effectiveness of conventional treatments.
Our rapidly growing research portfolio encompasses both the study of CAM cancer interventions and palliative care. In FY 2000 NCCAM funded two new Specialty Research Centers dedicated to studying the safety and effectiveness of several popular CAM cancer therapies. In one center, the mechanisms of action, safety, and clinical efficacy of hyperbaric oxygen (oxygen at greater-than-atmospheric pressures) is under evaluation for the treatment of head and neck cancers. The other center conducts studies of breast cancer as well as the first randomized, placebo-controlled clinical trial of a popular mixture of eight Chinese herbs known as PC-SPES in men with hormone-refractory prostate cancer. This latter study will evaluate PC-SPES for disease progression, bone pain, and quality of life issues such as changes in sexual function that so often attend prostate cancers and their treatment. (The name PC-SPES means hope for prostate cancer.)
Some menopausal and postmenopausal women find symptom relief through conventional estrogen replacement therapy (ERT). Moreover, research has shown that ERT benefits cardiovascular, skeletal, genitourinary, and cognitive health. Despite these benefits, less than 20 percent of American women use ERT, in part because it seems to be associated with an increased risk of breast cancer, dissuading some women from using it and excluding its application for breast cancer survivors. Many women explore alternative approaches to estrogen replacement to eliminate the risks of conventional ERT, with the hope of reaping its benefits while avoiding its potential hazards. Soybeans are rich in naturally-occurring compounds with estrogen-like activity. Several preliminary studies of popular soy-derived phytoestrogens (PEs) yielded unclear and contradictory results, leaving open the question of whether soy may protect against breast cancer or, like conventional ERT, promote its emergence. NCCAM intends to study these issues and assess the impact in Phase II clinical trials of PE supplementation on the health of women after a breast cancer diagnosis.
Cancer patients for whom a cure is not an option face not only death but also face the diminution of quality of life and intractable pain. Perhaps as many as 70 percent of these cancer patients are seeking complementary and alternative therapies to expand their end-of-life care options, according to Eidinger, et al. NCCAM will solicit Phase I and II clinical trials of CAM modalities for the prevention and management of symptoms associated with the end of life, including secondary side effects of chemotherapy and radiotherapy; and the enhancement of the well-being of persons facing a life-limiting illness.
Coronary Artery Disease
Coronary artery disease (CAD) is the leading cause of mortality for both men and women in the United States. Despite increasingly effective conventional treatments many turn to alternative approaches including the use of ethylenediaminetetraacetate (EDTA) chelation therapy, a popular but controversial approach for treatment of CAD. To date, however, studies of chelation therapy for CAD have been few, very small in size, and poorly designed, affording few conclusions concerning its true safety and effectiveness. To address this important public health issue, NCCAM plans, in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), to solicit and fund the first major, multi-site clinical trial to investigate the efficacy and safety of EDTA chelation therapy in individuals suffering from CAD, using rigorous trial design and validated outcomes measures. A formal solicitation (RFA) is being finalized with NHLBI and is planned for release during FY 2001.
The above are but a few of the major chronic diseases targeted in our robust research portfolio. With NCCAM's continued and accelerated research into practices once considered unorthodox, I am confident through the use of exacting science that many new CAM interventions will be integrated into conventional medical education and practice. Even as we continue to witness the graying of America, more of our citizens are choosing alternative medicine approaches when conventional medicine fails to relieve pain or treat other chronic and degenerative diseases. It is therefore imperative that we continue to expand our research portfolio, train researchers, and fund research studies which will scientifically establish critical safety and efficacy information for dissemination to healthcare providers and consumers.
I am now happy to take your questions about these or any other of NCCAM's activities and plans.