A confluence of factors in developed countries will propel a change in medicine, creating a need that coincides with this mission. These factors include a growing international interest in integrative medicine, aging populations, increasing availability of health information, and the expanding diversity of practitioners.
At the same time the field of integrative medicine should be bold in its mission, it may be wise to be cautious in what is claimed. Claims do not constitute evidence of efficacy. Research is needed to provide the evidence base for integrative medicine.
Integrative medicine is pressured from many sides. There are those in conventional medicine who cast doubt on complementary and integrative medicine. While many proponents of integrative medicine are eager to find evidence that an intervention is effective, research documenting efficacy can fall prey to "error". Medical research is designed to lean to the side of avoiding the false positive. By trying to reduce the likelihood of false positive, one can increase the likelihood of the false negative.
The cost of a false negative is that a potential treatment that could have major public health benefit is lost. In integrative medicine, false negatives can be "headline news" because in many cases they convey to the public that something it is already doing may not be effective.
Examples of recent large clinical trials of popular dietary supplements that failed to demonstrate efficacy include studies of popular dietary supplements, including saw palmetto, Glucosamine/Chondroitin, and Echinacea. Each of these trials pointed to questions that could have been addressed in preliminary studies, including questions about optimal species of botanicals or dosing. This raises a question about the potential need for pre-clinical research on mechanism, as well as case-control, cohort and observational studies prior to committing to a specific design, dose, sample size and protocol of a Phase III efficacy trial.
This more systematic approach is relevant to all areas of integrative medicine, including mind-body interventions, manual therapies, and acupuncture. For example, what is the optimal dose of meditation or yoga needed to achieve reduction of pain in different populations? Have the doses that are used in typical clinical practice optimal ? Should research investigate these questions prior to committing to a Phase III efficacy study? The cost of failing to include an adequate dose, or to underestimate the placebo effect can be a false negative and claims that a mind-body intervention is "ineffective". While it would be tempting to launch large Phase III trials in the hope of finding positive results, the experience to date suggests that conducting preliminary studies to optimize trial designs would be a more prudent approach. While this systematic approach may take more time, it is more likely to yield positive results and avoid false negative outcomes.
Integrative medicine is rich with challenges to its practitioners and scientists. Just a few include gaining an understanding of the optimal approaches to integrative medicine across the life span, studying "whole system" interventions, investigating how to individualize or personalize approaches, optimizing adherence to interventions, and maintaining clinical progress achieved by integrative medicine over time.
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Margaret A. Chesney Ph.D., is NCCAM’s first Deputy Director and leads the Center’s Division of Extramural Research and Training. Dr. Chesney partners with NCCAM’s Director in planning, directing, and managing the programs and resources of the Center. She helps formulate, guide, and oversee the management of all NCCAM-funded extramural centers, investigator-initiated research, research contracts, fellowships, and training and career awards.
Dr. Chesney received her undergraduate degree, summa cum laude, from Whitman College, Walla Walla, WA. She received her master’s and doctoral degrees in clinical psychology and counseling from Colorado State University, Fort Collins, CO. Dr. Chesney completed postdoctoral fellowship training in the Department of Psychiatry at Temple University’s School of Medicine, Philadelphia, PA.
Prior to joining NCCAM, Dr. Chesney was professor of medicine and epidemiology at the School of Medicine, University of California, San Francisco (UCSF), where she was co-director of the Center for AIDS Prevention Studies and director of the behavioral medicine and epidemiology core of the UCSF Center for AIDS Research. Most recently, she was also a senior visiting scientist in the NIH Office of Women’s Health, in the Office of the Director.
Throughout her career, Dr. Chesney has designed and conducted original research on the relationship between behavior and chronic illness, and on behavioral factors in clinical trials, including issues of recruitment, adherence, and retention. She also worked on the development and evaluation of psychosocial and behavioral interventions for health promotion, illness prevention, and treatment.
Dr. Chesney is a past president of the Academy of Behavioral Medicine Research, and a former president of the American Psychosomatic Society. She is also a past president of the Division of Health Psychology of the American Psychological Association (APA). A recipient of many awards and honors, she received the annual award for Outstanding Contributions to the APA’s Division of Health Psychology in 1982 and in 1986; the President’s Award from the Academy of Behavioral Medicine Research in 1987; and the Charles C. Shepard Science Award from the Centers for Disease Control and Prevention in 1999. In 2000, she was a senior fellow at the Center for the Advancement of Health in Washington, DC, and in 2001 she was elected to the Institute of Medicine of the National Academies.
An author and coauthor of over 240 scholarly research papers and publications, Dr. Chesney is Associate Editor of Psychology, Health and Medicine and serves on a on a number of editorial boards, including those for Psychosomatic Medicine and the British Journal of Health Psychology.
www.nccam.nih.gov
Dr. Chesney received her undergraduate degree, summa cum laude, from Whitman College, Walla Walla, WA. She received her master’s and doctoral degrees in clinical psychology and counseling from Colorado State University, Fort Collins, CO. Dr. Chesney completed postdoctoral fellowship training in the Department of Psychiatry at Temple University’s School of Medicine, Philadelphia, PA.
Prior to joining NCCAM, Dr. Chesney was professor of medicine and epidemiology at the School of Medicine, University of California, San Francisco (UCSF), where she was co-director of the Center for AIDS Prevention Studies and director of the behavioral medicine and epidemiology core of the UCSF Center for AIDS Research. Most recently, she was also a senior visiting scientist in the NIH Office of Women’s Health, in the Office of the Director.
Throughout her career, Dr. Chesney has designed and conducted original research on the relationship between behavior and chronic illness, and on behavioral factors in clinical trials, including issues of recruitment, adherence, and retention. She also worked on the development and evaluation of psychosocial and behavioral interventions for health promotion, illness prevention, and treatment.
Dr. Chesney is a past president of the Academy of Behavioral Medicine Research, and a former president of the American Psychosomatic Society. She is also a past president of the Division of Health Psychology of the American Psychological Association (APA). A recipient of many awards and honors, she received the annual award for Outstanding Contributions to the APA’s Division of Health Psychology in 1982 and in 1986; the President’s Award from the Academy of Behavioral Medicine Research in 1987; and the Charles C. Shepard Science Award from the Centers for Disease Control and Prevention in 1999. In 2000, she was a senior fellow at the Center for the Advancement of Health in Washington, DC, and in 2001 she was elected to the Institute of Medicine of the National Academies.
An author and coauthor of over 240 scholarly research papers and publications, Dr. Chesney is Associate Editor of Psychology, Health and Medicine and serves on a on a number of editorial boards, including those for Psychosomatic Medicine and the British Journal of Health Psychology.
www.nccam.nih.gov