NationalCenter for Complementary and Alternative Medicine

2010-2015 Strategic Plan

Stakeholder Commentary

By the

American Association of Naturopathic Physicians

November 19, 2009

Introduction

While conventional medicine’s focus on treatment of disease has produced many benefits, especially in acute and life-threatening conditions, its effectiveness for the treatment of chronic disease or the promotion of health is limited. This limitation has been a major cause of the out-of-control healthcare costs plaguing the nation.

There is, at present, a severe shortage of primary care physicians. A number of proposals have been put forth as to how to fill that shortage and many of these are aimed at increasing the number of medical students going in to primary care. However, there are also a number of proposals to utilize the skills of other licensed healthcare practitioners to expand access to patient-centered primary care in both federally funded and private health care offerings—e.g., naturopathic physicians (NDs). What is now required is the development and funding of outcomes-based research initiatives that demonstrate how this care will enable the transformation of our disease-based system into one that is rooted in sustainable health and wellness.

Naturopathic medicine is a system and philosophy of medicine that has been in use for over 100 years. The American Association of Naturopathic Physicians (AANP) represents licensed naturopathic physicians who are trained at fully accredited four-year, residential medical programs. Graduates of our medical schools serve as primary care physicians and have the same training in the basic and clinical sciences as conventional medical doctors. In addition, NDs receive training in a variety of core treatment methods including nutrition, botanical medicine, homeopathy, pharmacology, physical therapy, and minor office surgical procedures. Some licensed naturopathic physicians are also trained in traditional Chinese medicine, acupuncture and Ayurvedic medicine as well as clinical specialties such as natural childbirth. Therefore, naturopathic medicine and NDs provide the ideal laboratory to test a complement to the present primary-care-deficient model of health care.

The Changing Role of Natural Medicine

As NCCAM evaluates its existing strategic direction for the next five years, it is essential to recognize the dramatically changing landscape of the “complementary and alternative” (CAM) world. Terminology and practices are shifting daily, opening new doors and breaking down barriers. Practitioners of natural medicine and alternative therapies continue to organize themselves professionally and academically. In addition, there is growing acknowledgement and acceptance of these practices in the more conventional environments, as is evidenced by the utilization of terminology that includes integrative medicine and integrative health – terminology that is utilized by conventional and non-conventional providers alike.

How the research community and NCCAM itself respond to integration of ‘alternative’ and ‘conventional’ medicines stands to dramatically impact the development of a sustainable health care system. Integration holds the potential for a newly defined worldview of wellness,increasing acceptance of treating the whole person and systemically valuing true prevention and the body’s ability to heal at a time when chronic disease promises to cripple our financial future. Yet it is essential to note, research initiatives that are successful in demonstrating effective integration of conventional and natural medicine will require continued commitment to educational and testing standards by the professions, and established research protocols that recognize the underlying principles associated with each profession. The Commonwealth Working Group on Traditional Complementary Health Systems at the University of Oxford, in a study of developing countries across Asia, India and Africa, found that successful integration of CAM and conventional medical systems requires the professions to first self-regulate standards of practice and training (Bodeker, 2001). AANP, along with many of the other CAM professional organizations, stand committed to establishing standards on par with that of their allopathic counterparts. In addition, the study concluded that the central regulation of natural products through good manufacturing practices and sound research is essential to effective integration efforts (Bodeker). Viable pathways towards effective integration of ‘alternative’ care into the conventional paradigm should be viewed with careful consideration. Why? In China, it was demonstrated that domination of conventional medicine can result in the dilution of traditional philosophies and practices, compromising the quality of education (Bodeker, 2001). Today, existing research initiatives fail to incorporate the relevance of philosophy to both the practitioner and the health care outcomes of the patient – ergo, the relationship of the naturopathic physician to his or her patient is undervalued in the current effectiveness evaluation scales.

We strongly encourage thoughtful development of research paradigms that are 1)outcomes-based, 2) incorporate the importance of philosophy and education, 3) evaluate the provider/patient relationship, and 4) serve to redefine and quantify the standard interpretation of health and wellness programs.

NCCAM Capacity to Conduct Effective and Representative Research

The Center has an enormous opportunity over the course of the next five years to meet its stated mission relating to 1) the composition of the Advisory Council, 2) availing itself of “appropriate expertise” from the CAM scientific realm, and 3) the call to include accredited and licensed professions in the evaluation of alternative and complementary treatment. In the naturopathic medical field alone, the number of qualified researchers, the research programs at accredited institutions and the number of naturopathic physicians practicing in integrative environments has grown dramatically. NCCAM, and the federal agencies that are best suited to partner in CAM research initiatives, should avail themselves of the numerous high-quality, cost-effective medical practice patterns of highly skilled physicians and practitioners for the purpose of conducting quality, outcomes-based research. Expanding NCCAM’s worldview of developing research initiatives and private sector offerings, could significantly impact the types of projects undertaken across federal agencies, and substantially add to the growing body of research on outcomes and effectiveness of naturopathic treatment.

In April 2009, the AANP submitted testimony to the Federal Coordinating Council for Comparative Effectiveness Research on its commitment to outcomes research, the determination of best practices and the need to fund evaluation of alternative systems of healthcare. We specifically proposed funding of health information technology and electronic medical records in a practice-based research network (PBRN) containing both conventional and naturopathic medical practices to compare “real world” effectiveness and cost-effectiveness for type 2 diabetes. Creation of this PBRN has been initiated, and will include collaboration with other private and public sector research and academic institutions. The proposal calls first for retrospective and pilot prospective studies to test the feasibility of protocols based on an informatics approach to naturopathic medicine outcomes research and to characterize the populations before going on to more definitive study. If there are positive results with comprehensive treatment, the treatment and the outcomes data can be examined for factors associated with improvement.

Comparative Effectiveness Research: A Case Study

The initial proposal is for a study on type 2 diabetes (T2D). T2D is epidemic and often inadequately controlled (only 37% in adequate glycemic control) by approved treatments. Nearly half (47.9%) of US diabetes patients also use complementary and alternative medicine (Garrow & Egede 2006; Yeh, Eisenberg, Davis & Phillips, 2002). The Diabetes Prevention Program (DPP) conclusively demonstrated that diet and lifestyle changes could prevent diabetes more effectively in a susceptible population than metformin (58% reduction in incidence versus 31%). The DPP lifestyle intervention used lifestyle coaches and a focus on weight loss and exercise, and although it proved less expensive per case of diabetes prevented than pharmacological management alone, it still presents a substantial cost to implement. ND practices will be used to test modifications to this model that include a primary care setting allowing diabetes prevention to be incorporated into patients’ overall focus on health. It may be even more effective, e.g., through the inclusion of nutritional supplementation (Bartlett & Eperjesi, 2008; Farvid, Jalali, Siassi & Hosseini, 2005; Bonnefont-Rousselot, 2004)), and potentially, more cost-effective.

Diabetes is paradigmatic of endemic chronic diseases for which NDs have specific well rationalized treatment protocols of which the elements, individually, show promise but have not been tested in combined practice. This PBRN proposal can be used to test components of primary care that can also be incorporated into conventional practice.

Diabetes is an important chronic condition but it is only one of many conditions toward which the informatics-based research infrastructure that we propose can be targeted. NCCAM funding of such systems could enable the determination of the best approaches to general primary care/family practice, pain, and other chronic disease conditions.

Opportunities and Obstacles for Outcomes-Based Research

NCCAM’s original mandate reads “the Director of the Centers shall identify and evaluate alternative and complementary medical treatment, diagnostic and prevention modalities in each of the disciplines and systems which the Center is concerned, including each discipline and system in which accreditation, national certification, or a State license is available.” The AANP would assert that NCCAM has not fully availed itself of the unique opportunities associated with cost-effectiveness research across the naturopathic profession. Federal funding for health research in many agencies remains restricted to those professions identified in the Social Security Act, overlooking the other primary care providers licensed in many states across the country. And, despite the fact that corporations are experiencing enormous success in the implementation of even the most basic wellness programs, Congress and many policy makers remain unconvinced and unable to attribute savings for these programs. Thus, federal law and the current health insurance reform efforts are not able to avail themselves of programs that stand at the forefront of reducing the prevalence of chronic disease, and transformation from a disease-based system.

Cost-effective, Quality Outcomes

One such example of how naturopathic medicine is transforming outcomes in the private sector exists in Vermontwith the “Jump Start To Better Health” program for employees of a statewide association. The program uses an approach to improving employee wellness that includes fitness and weight loss challenges, a monthly newsletter, on-site flu immunization clinics, on-site health awareness screenings, a smoking cessation program, online wellness center, the FirstLine Therapy Therapeutic Lifestyle Change program, and a comprehensive incentive program with $10,000.00 in cash prizes.

The “Jump Start To Better Health” program was designed by a naturopathic physician, Dr. Bernie Noe. It has dramatically improved the health of association members, and has helped cut healthcare costs. In the first two years of the program, the occurrence of high blood pressure decreased by 49 percent, while the occurrence of high cholesterol decreased by 26 percent. The occurrence of smoking, physical inactivity, and multiple risk factors for cardiovascular disease, all decreased by more than ten percent. The Association estimates that during the program’s first two years, it saved an average of $8.20 in health care costs for every $1.00 invested in the program. This translates into an overall savings of $1,421,000 in direct and indirect health costs during that time period.

Another powerful example of the direct correlation between patient access to a wide range of healthcare provider options and more efficient, cost-effective healthcare has been demonstrated in a study funded by NCCAM. In the study, Patricia Herman, ND, compared conventional and naturopathic lower back pain treatments. Dr. Herman found that the naturopathic model of care was less costly than conventional treatment, when accounting for absenteeism. The naturopathic model also had the added benefits of improving health outcomes and lowering other medical costs.

A second study by Dr. Herman, also funded by NCCAM, found that integrative care can reduce reliance on conventional drugs in a study of patients with eating disorders. A comparison of patients treated conventionally, and those treated with added integrative therapies including dietary supplements, acupuncture and massage showed that patients receiving integrated treatments generally had decreased symptoms and reliance on conventional medications. Two common conditions in eating disorder patients, constipation and sleep disorder, reduced significantly. In fact, reliance on sleep medications was reduced from 55 percent to 11 percent in the integrated patient group. Naturopathic therapies, in place of or in conjunction with conventional care, can provide increased health outcomes at reduced costs. NCCAM funding of studies such as these is evidence that utilization of naturopathic expertise can greatly ease the burden on our nation’s healthcare system.

Conclusion

In fall, 2009, the Department of Labor issued a custom report defining the role of a naturopathic physicianto read:

“Diagnose, treat, and help prevent diseases using a system of practice that is based on the natural healing capacity of individuals. May use physiological, psychological or mechanical methods. May also use natural medicines, prescription or legend drugs, foods, herbs, or other natural remedies. Sample job titles include Naturopathic Physician, Naturopathic Doctor, Physician, and Doctor of Naturopathic Medicine. (Occupational Information Network, 2009)”

The world of medicine is rapidly changing throughthe promulgation of regulation, the passage of legislation and in the daily practice of medicine itself. Naturopathic physicians, acupuncturists and yes, our conventionalpartners, the advanced practice nurses, are a growing force in the transformation of our healthcare system. It is a force that is driven by consumer experience and increased consumer demand. It is medicine that demands increased research. There is enormous opportunity in recognizing the redefinition of how primary care is provided in this country. Enhancing research efforts on the work of those previously designated as alternative, and now quickly becoming mainstream, is a precursor to true health care reform.

The AANP stands ready to support NCCAM’s efforts to enhance infrastructure, expand research opportunities in the naturopathic field, and advocate for funding of outcomes-based research initiatives that demonstrate the effectiveness and sustainability of natural medicine andpatient-centered care.

Bodeker, G. (2001). Lessons on Integration from the Developing World’s Experience.

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Bartlett H, Eperjesi F. Nutritional supplementation for type 2 diabetes: a systematic review. Ophthalmic & Physiological Optics [serial online]. November 2008;28(6):503-523.

Farvid MS, Jalali M, Siassi F & Hosseini M. Comparison of the effects of vitamins and/or mineral supplementation on glomerular and tubular dysfunction in type 2 diabetes. Diabetes Care. 2005 Oct;28(10):2458-64.

Garrow D, Egede LE. National patterns and correlates of complementary and alternative medicine use in adults with diabetes. J Altern Complement Med. 2006b Nov;12(9):895-902.

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