The Naturopathic Medical Research Agenda: The Future And Foundation Of .
The Naturopathic Medical Research Agenda:The Future and Foundationof Naturopathic Medical ScienceA report produced through a grant fromthe National Institutes of Health – National Center forComplementary and Alternative MedicineLeanna J. Standish, ND, PhD, LAc (Principal Investigator)Carlo Calabrese, ND, MPH (Co-Principal Investigator)Pamela Snider, ND (Co-Investigator)
Library of Congress Number 2004114971ISBN 0-9722715-0-3Copyright 2005 byBastyr University Press14500 Juanita Drive NEKenmore, WA 98028(425) 602-3027www.bastyr.eduDisclaimerThe Publisher, the Editors, and the Contributors do not assumeany responsibility for any injury and/or damage to persons orproperty arising out of or related to any use of the materialscontained in this textbook. The reader is advised to check theappropriate literature and the product information currentlyprovided by the manufacturer of each therapeutic substance toverify dosages, the method and duration of administration, orcontraindications. It is the responsibility of the treating practitioner, relying on experience and knowledge of the patient, todetermine dosages and the best treatment for the patient.
The Naturopathic Medical Research AgendaReport written byLeanna J. Standish, ND, PhD, LAc (Principal Investigator) Bastyr UniversityCarlo Calabrese, ND, MPH (Co-Principal Investigator) National College of Naturopathic MedicinePamela Snider, ND (Co-Investigator) Bastyr UniversityNMRA Core Research Team ContributorsKonrad Kail, PA, ND, Director of Research, Southwest College of Naturopathic MedicineLinda Kim, ND, Associate Medical Director, Southwest College of Naturopathic MedicinePeter Martin, ND, DC, Former Dean, University of BridgeportMark Mattie, MD, PhD, Director of Research, College of Naturopathic Medicine, University of BridgeportEdward Mills, DPh, Director of Research, Canadian College of Naturopathic MedicineStephen Myers, PhD, BMed, ND, Professor & Director,Australian Centre for Complementary Medicine Education and Research,A joint venture of the University of Queensland and Southern Cross University,Michael Traub, ND, DHANP, CCH, Chair of Scientific Affairs,American Association of Naturopathic PhysiciansHeather Zwickey, PhD, Director of Research, National College of Naturopathic Medicinewith the assistance ofNMRA Workgroup MembersPauline Baumann, NDBabette Brumback, PhDDan Cherkin, PhDRonald A. Chez, MDAnnette Fitzpatrick, PhDClark Johnson, PhDWayne Jonas, MDDavid Kroll, PhDWilliam Lafferty, MDRichard Lyons, MD, MPHDiana Miglioretti, PhDPatrick O’Carroll, MD, MPH, FACPMJune Riedlinger, R.Ph, PharmDCheryl Ritenbaugh, PhD, MPHJanet StecherAlan Trachtenberg MD, MPHHenry Ziegler, MD, MPHandNMRA Research Associate Workgroup MembersHeather Greenlee, ND, MPH, Research Fellow, Mailman School of Public Health, Columbia UniversityLynne Shinto, ND, MPH, Assistant Professor, OHSUWendy Weber, ND, MPH, Research Assistant Professor, Bastyr UniversitySenior Editor, Sheila QuinnNote: A complete list of key participants and their affiliations can be found in Appendix A.Funded by grant R21 AT833 from the National Institutes of Health—National Center for Complementary and Alternative Medicine
Forewordby Dan Cherkin, PhD, NMRA Workgroup memberAssociate Director & Senior Scientific InvestgiatorGroup Health Center for Health StudiesSeattle, WashingtonThe completion of the Naturopathic Medical Research Agenda is an historic occasion. I very much enjoyed participating as oneof the “conventional” scientists on the Naturopathic Medical Research Agenda (NMRA) Workgroup. It was a great pleasure tomeet and work with the intellectually stimulating, intelligent, and socially committed individuals who were assembled for theNMRA Workgroup. I enjoyed speaking with naturopathic medical students, naturopathic clinicians and researchers, with theimpressive group of outside advisers that were assembled, and with the naturopathic medical college faculty and leadership. Icommend the NMRA Core Team for their wisdom and courage in including researchers from other disciplines, many of whomgave feedback that challenged some long-held assumptions and provided the NMRA Workgroup with valuable insights into theways of thinking that are more conducive to successful scientific research in naturopathic medicine. Though honest and direct,NMRA Workgroup discussions were always respectful and collaborative. I learned a great deal during this two-year process andI am grateful and honored to have been included.Despite being what might be considered a “conventional” scientist working within a conventional medical research setting I sharemany important values with the naturopathic profession. I believe that the current medical approach to illness and disease in ourcountry is irrational, inequitable, often ineffective and wasteful, and definitely unsustainable. I also believe that there is more tohealing than medications and invasive procedures and that the art of healing in this country has often been supplanted by thetechnology and business of medicine. While naturopathic medicine may not have all the answers, I do believe that there is muchto learn from its emphasis on the whole person and on its use of less toxic and less invasive approaches to healing.Research is always a challenging and demanding endeavor. The exciting research sound bites on the 11 o’clock news tell nothingof the enormous amount of sustained effort that teams of researchers expend over several years to successfully complete a project,much less the years of frustration often required to obtain grant funds to begin the project in the first place. Obtaining researchfunding is particularly difficult for new researchers entering new areas of research, including complementary and alternativemedicine. However, with the completion of the NMRA report, the naturopathic profession has taken a large step forward. Youare wisely focusing your enthusiastic but limited energies and resources on collaborations with colleagues both within and outsidethe naturopathic medical profession. You are also painstakingly and methodically laying the groundwork that will be necessaryto prepare you to conduct the large scientifically rigorous randomized controlled trials that will ultimately be required in order tohave a major impact on clinical care in the United States.Research is a difficult business, demanding patience, passion, and perseverance. But like all well-prepared pioneers you now knowwhere you are headed, you have a map, you have your teams assembled, and you will follow the stars to your dreams. Congratulations on your pioneering efforts in establishing a research agenda for naturopathic medicine. Your agenda is truly a milestone inthe development of the profession and will shape the future of research in naturopathic medicine for years to come.
The Naturopathic Medical Research AgendavTABLE OF CONTENTSEXECUTIVE SUMMARY . 1Figure 1. The Naturopathic Medical Research Agenda.4THE GRANT. 5Workgroup Photo, Session II .6Kona Retreat Photo .6THE PEOPLE . 7Acknowledgments .7Scientific and Clinical Consultation .7NMRA AANP Special Topics Thought Leaders .7NMRA AANP Special Topics Notetakers .7Technical Assistance .8Institutions and Organizations .8Administrative Assistance .8NMRA Workgroup Members.8NMRA Research Associate Workgroup Members .8Investigators .8THE BACKGROUND. 9Narrative Description .9The Naturopathic Profession .10Naturopathic Practice .11Naturopathic medicine and chronic disease .12Brief History of Naturopathic Medicine .12Naturopathic Principles and Clinical Theory .13Table 1. The therapeutic order.14Table 2. Determinants of health .15THE PROCESS OF DEVELOPING THE NMRA . 16Consensus building for the NMRA .16Figure 2. The NMRA iterative feedback process .16The NMRA Workgroup .17Developing the Research Agenda – the Broad Outline.17The Process in Detail .17Results from Stakeholder Prioritization Filters .18Naturopathic Medical College Forums, Special Topics Sessions .19Table 3. Special topics presentations from the AANP 2003 .20Summary of Themes and Trends .20THE GUIDING PRINCIPLES . 22What is Naturopathic Medical Research? .22Three Hypotheses .22Criteria for Prioritization .23Table 4. Six criteria developed by the NMRA Workgroup to filter research ideas .23Vision and Values .25Goal Statement.25NATUROPATHIC MEDICAL RESEARCH – THE AGENDA . 26The Methodological Environment for the Agenda .26Clinical Trials .261. Standardization .26Table 5. Types of naturopathic medical research: A proposed taxonomy .272. Individualization of treatment .293. Combination therapeutics—effect size and safety .304. Non-specific healing effects .305. Outcomes and measures .316. Controls and blinding .327. Whole-practice models.32
viThe Naturopathic Medical Research AgendaObservational Studies .33Basic Science Studies .34NMRA and Public Health .35Medicine and Public Health .35Prevention and Public Health .35Naturopathic Medicine and Public Health .35Future Directions for Naturopathic Medicine and Public Health .36NMRA Clinical Research in Diabetic Patients and the Elderly .37NMRA Diabetes Research .37NMRA Gerontology Research.38The NMRA and Scientific Discovery .38NMRA Research Methods and Strategies .39Table 6. Scientific research directions called for by naturopathic medicine principles and theory .40Research Readiness .41Table 7. Scientific research infrastructure and track record for the six accredited naturopathic medical schoolsin North American and Australia.42Implementation of the NMRA .43Overview .43NMRA Implementation Core Team .43Participants .43Purpose .43Table 8. NMRA Implementation Core Team .44Web-based Network .44NMRA Mentorship Program .45Structure of the NMRA: The Tracks .45Publications and Information Dissemination Track .45Diabetes Track .47Gerontology Track .48Whole Practice and Methods Track .49Goals and Activities of the NMRA .51NMRA Deliverables 2004-2010.51Conclusion .52REFERENCES . 53APPENDICES . 56Appendix A: Affiliations of Key NMRA Participants .57Appendix B: History, Theory and Practice of Naturopathic Medicine .59Appendix C: Input from NMRA Workgroup and the naturopathic medical profession .74Appendix D: AANP Special Topics: Presentations, Thought Leaders, Teams, and Contact Information .83Appendix E: AANP Special Topics Reports by Thought Leaders .85Report on Women’s Health and Hormone Replacement for the Naturopathic Medical Research Agenda .85Report on Environmental Medicine for the Naturopathic Medical Research Agenda .89Special Topics Report on Diabetes for the Naturopathic Medical Research Agenda .92Special Topics Report on Asthma for the Naturopathic Medical Research Agenda .109Report on Health Services and Workforce Issues for the Naturopathic Medical Research Agenda:Integrating Naturopathic Physicians into Mainstream Delivery Systems .115Appendix F: Naturopathic Medical Science: Examples of Clinical Protocols and Algorithms .120Appendix G: Presentations and publications arising from the NMRA process .138Appendix H: Letters of Support for the NMRA .141Appendix I: Glossary (including acronyms for organizations and agencies) .149INDEX . 154
Executive SummaryEXECUTIVE SUMMARYThis report documents the process and findings of the Naturopathic Medical Research Agenda, aproject funded by NIH-NCCAM through a grant that ran from August 1, 2002 through August31, 2004. The goals of this project were: Goal 1: To bring together naturopathic physicians and conventional research scientists inorder to establish the Naturopathic Medical Research Agenda Workgroup; Goal 2: From this process, to produce a document entitled “The Naturopathic MedicalResearch Agenda” that includes a prioritized list of research questions and areas, coupledwith appropriate research design methods for each.Participants in the project included over 1200 individuals, representing a broad range of scientificand clinical backgrounds. Input from the naturopathic profession itself was substantial, involvingparticipants from the naturopathic medical colleges and the national professional association, andencompassing many of the profession’s leading faculty, researchers, clinicians, and writers. Conventional physicians and scientists also participated broadly and made significant contributionsthrough the NMRA Workgroup.A series of meetings was held during the project period to elicit, discuss, analyze and prioritizefeedback on the direction of the Agenda, and on the criteria by which decisions would ultimatelybe made. Articulation of the following guiding principles emerged:The Agenda should be designed to test three fundamental hypotheses: Naturopathic medicine is safe and effective for health promotion and for the preventionand management of a broad range of common conditions. Increased availability of the services of naturopathic physicians will improve patient healthin a cost-effective manner. The scientific exploration of naturopathic medical practices and principles will yield important, perhaps even revolutionary, insights into the nature of health and the biology ofhealing.The Agenda should use the following prioritization criteria in determining the specific focus offuture research efforts: Study conditions with the highest burden of illness Study problems of existing and emerging public health significance Study those naturopathic treatments thought to be most effective Study naturopathic approaches with real potential to make significant advances in patientcare Foster the development of needed methods and infrastructure For initial studies, focus on near-term feasibilityThe Agenda should reflect the following goals: first, to improve the health of patients; second,to improve naturopathic medical practice; third, to focus primarily on populations, not diseases;fourth, to conduct research on the whole practice of naturopathic medicine rather than on singleagents.1
2The Naturopathic Medical Research AgendaResearch RecommendationsConsistent with the emphasis on studying people and populations, and with the prioritization criteria statedabove, two populations were identified for the initial focus of naturopathic medicine research: the first is definedby a diagnosis (type 2 diabetes) and the second by a stage of life (elderly).The significance of diabetes can scarcely be overstated; the Centers for Disease Control recently estimated thatone in three children born in the year 2000 will eventually become diabetic. Demographics make studying theelderly an extremely high priority – as the baby boomers age, a major impact on costs and suffering can beachieved by reducing the incidence of serious chronic disease, of secondary complications from chronic disease,and of debility associated with aging.Healthy aging, of course, must begin with infants and children, and the development of habits and physiological predispositions from childhood on will be important future priorities. Rising rates of conditions such asasthma, allergies, attention disorders, obesity, and type 2 diabetes in children do not bode well for a healthyolder population in those who are at the beginning of their lives. Therefore, research on a pediatric populationwas identified as an important future priority.The NMRA calls for systematic reviews and the collection of preliminary clinical data in preparation for a largerandomized controlled trial assessing the effect of individualized naturopathic medical care in comparison toconventional care in a population of individuals with type 2 diabetes. Outcomes of whole-practice researchon a diabetic population will include biomedical disease markers, including assessment of co-morbidities, andhealth and health services indicators.Controlled studies of naturopathic medical care for the preservation and the promotion of optimal healthin geriatric populations are specified in the Agenda. The NMRA also recommends the collection of data fromdemonstration projects with health plans that include naturopathic physicians, as these are clinical sites whereoutcomes and cost of service can be studied. Neurogerontology and diabetes prevention and treatment in theelderly have been identified as an initial focus of NMRA gerontology/geriatrics research.The NMRA can help naturopathic medicine be part of the healthcare solutions our nation clearly needs bydoing excellent research in critically important areas. Through the NMRA process, the following recommendations were made regarding the priorities for how to approach naturopathic medical research in the twopopulations: Design and execute whole-practice research protocols, with a focus on naturopathic medicine as aprimary care practice for the two populations (diabetics and the elderly); Continue research on the components of naturopathic medicine (e.g., single agents for a particulardiagnosis, mechanism of action studies); and Perform contextual research, examining important aspects of the practice of naturopathic medicine(e.g., the patient-practitioner interaction) or its relationships with the larger health system (integration)through observational studies.Most research to date on naturopathic medicine has been component research. As yet, little work has been donein the areas of whole-practice and context research.Finally, there was strong support for women’s health research among naturopathic physicians in the field, especiallycomponent research on natural hormone replacement therapy for women in their peri- and postmenopausal years.At the 2004 annual national meeting of the Association of Naturopathic Physicians held in Portland, Oregonthere was widespread agreement that the evaluation of the safety and efficacy of bio-identical steroid hormonesfor the treatment of menopausal women was of high priority. A group of naturopathic physicians specializingin women’s health met with NMRA leadership at this national meeting. Fro
Seattle, Washington The completion of the Naturopathic Medical Research Agenda is an historic occasion. I very much enjoyed participating as one of the "conventional" scientists on the Naturopathic Medical Research Agenda (NMRA) Workgroup. It was a great pleasure to
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