April 15, 2016
Josephine P. Briggs, M.D.
National Center for Complementary and Integrative Health
9000 Rockville Pike
Bethesda, MD 20892
Re: Comments on the NCCIH's Draft Strategic Plan
Dear Dr. Briggs,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the National Center for Complementary and Integrative Health (the NCCIH or the "Center") on its Draft Strategic Plan issued March 30, 2016. Representing over 90,000 registered dietitian nutritionists (RDNs),1 nutrition dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation's health through food and nutrition across the lifecycle. Members include more than 3,600 professionals in our Dietitians in Integrative and Functional Medicine (DIFM) Dietetic Practice Group who practice in, or have specific interest in, an integrated and personalized approach to nutrition, health, and healing. The Academy supports the NCCIH's efforts to focus, support, and conduct scientific research on complementary and integrative health approaches, particularly strategies for promoting health and preventing disease through food and nutrition.
The Academy enthusiastically supports the Draft Strategic Plan and offers the below comments on current and future needs and directions for complementary and integrative health research and research training, particularly emerging research needs and opportunities related to integrative diet therapies that "are amenable to rigorous scientific inquiry."
Much of complementary and integrative health involves nutrition therapies, making integrative RDNs the experts in the delivery and research of these modalities. Providing evidence for the benefits, safety, and efficacy, of nutrition approaches administered by integrative RDNs is necessary to accomplish the stated objectives of the Draft Strategic Plan.
Objective One: Advance Fundamental Science and Methods Development
RDNs — and specifically integrative RDNs — know the power that diet has to transform individuals' health and lives, but are challenged by a frustrating lack of research and clinical trials to assess and confirm the benefit of a variety of therapeutic diets, nutritional therapies and dietary approaches for patients living with a host of chronic illnesses. The work of the NCCIH to identify research gaps related to integrative health approaches is critical to future practice, and RDNs look forward to partnering with the NCCIH in researching and implementing these approaches. Integrative RDNs understand the mechanisms of action of these modalities from evidence-based research and evidence formed in clinical practice and seek continued and enhanced collaboration with those identifying advanced findings in these areas nationally and internationally.
The Academy strongly supports the creation of a more comprehensive database of natural products, their active constituents, and their mechanisms of action, as such a database is likely to support the NCCIH's objectives. If a database were to be developed, it is important to acknowledge that in plant-based medicine, the beneficial therapeutic activity often comes from the synergy of plant constituents working in tandem. Utilizing herbalists in the research and development of this database would support the creation of a robust tool for use by integrative health practitioners. We support the NCCIH's recognition that "it is necessary to identify the individual components responsible for a specific activity and determine how those components interact with other components."
The NCCIH's use of the term "natural products" is potentially problematic, however, given the lack of either a legal definition or a uniform understanding of the term. The Food and Drug Administration (FDA) is presently receiving comment on the definition of the term "natural" in the labeling of human food products (including dietary supplements)2 and we encourage the NCCIH to be cognizant of the implications of any particular definition in addition to developments resulting from the FDA's request for comments.
Similarly, we assert that the term "probiotics" itself is too limited and is potentially misunderstood. It may be useful for the NCCIH to specifically identify and distinguish research on different forms of probiotics as necessary to provide clarity (e.g., fermented vegetables, digestive supplements, kombucha). To that end, we understand that organizations such as the International Scientific Association for Probiotics and Prebiotics have formally defined these terms and may be useful resources for clarification.
Research on diet therapies can be challenging in that compliance with diet may be difficult, and, as noted above with complementary therapies generally, it may be hard to isolate which aspects of the dietary approach are having the therapeutic effect. Barriers to progress in research include the lack of standard methods for determining supplement quality and standards for disease specific supplement protocols and the need to establish biological signatures of dietary supplements. There are also some appropriate benchmarks for gauging progress, including blood markers/labs (e.g., lipid panels, inflammatory markers, blood sugars, HgAIC, and auto-antibodies); McGill Pain Questionnaire; patient subjective questionnaire; blood pressure and weight loss evaluation; stool analysis; endoscopies; and colonoscopies.
Many integrative and functional health care practitioners use functional lab tests to identify metabolic, inflammatory, psychiatric, toxic, and allergic imbalances in their patients. Many of these tests are not yet accepted in the mainstream, owing to a lack of rigorous validation and concerns about their reliability and reproducibility. These limitations present an area that would warrant investigation and could also help NCCIH guide future research efforts.
Objective Two: Improve Care for Hard-to-Manage Symptoms
Americans continue to be aware of and are increasing their use of mind-body medicine and practices related to holistic health. The effectiveness, validity, and specificity of best practices for mind-body medicine has been challenging to isolate, but emerging research is mounting, particularly with yoga, Qi Gong, Tai Chi, and meditation complementing nutrition therapy and nutrition counseling from an integrative RDN. Variables in how one handles stress is pivotal in determining how effectively one focuses on daily living habits.3 These complementary therapies may ameliorate a lack of coping skills and other tools related to stress management that negatively influence dietary choices and lifestyle behaviors and are thus worthy of further investigation. We continue to have significant concerns with polypharmacy in this country; implementation of these integrative modalities have significant potential to help manage multiple conditions, reduce opiate addiction, and enhance traditional allopathic treatment.
The Academy agrees that pain, anxiety, and depression are important areas for the NCCIH's continued research, but emphasize the importance of also including the need for enhanced research into complementary and integrative modalities for diabetes, cancer, and cardiovascular disease. Clients and patients with autoimmune diseases and digestive dysfunction frequently seek complementary and integrative health providers and these conditions are also worthy of the NCCIH's further research.
We also strongly support the development of "well-characterized and meaningful clinical and laboratory outcome measures . . . to fully determine safety and to definitively measure benefit or the lack thereof." There remains a continual need for outcomes research in quality of life, performance measures, and lab diagnostics for dietary nutrition counseling, especially related to cardiovascular disease, diabetes, oncology, and obesity. In addition, the role of neuroplasticity research and training needs to be better defined and woven into the alternative healthcare models. We also strongly encourage the NCCIH's proposal to conduct studies in "real world" clinical settings, given the continuing and distinct need for knowledge on supplements' and other complementary health approaches' efficacy, safety, and risk-benefit ratio.
Objective Three: Foster Health Promotion and Disease Prevention
The number of people living with chronic diseases has increased exponentially over the past several decades. Many of these diseases, which are often treated with medication, are directly related to diet and lifestyle and could be prevented, addressed, and in some cases reversed by focusing on nutritional therapies and strategies that are less costly to the individual and our health care system and provide additional health benefits. Most health practitioners are beginning to understand the fundamental impact that diet has on prevention of the chronic diseases now plaguing this country, but many are hesitant to recommend dietary protocols that could be highly effective without ample research to back them up. Existing clinical trials on many nutritional therapies are scarce or have small sample sizes.
We support the Center's interest "in exploring the potential of 'omics' technologies" and consideration of the bio-individuality of research subjects when conducting future research on complementary and alternative medicine (e.g., MTHFR gene mutations). The Academy also encourages the validation of recommendations for the most commonly used supplements and coordination with the Office of Dietary Supplements (ODS) to develop and cultivate disease-specific evidence for supplement uses, indications, dosing, and contraindication. It is an appropriate use of resources for NCCIH and ODS to identify whether and to what extent various dietary supplements might effectively prevent or treat diseases or other chronic conditions.
The Academy strongly supports the NCCIH's objective in this regard, as our members have seen diverse populations benefit form these modalities, including yoga. Integrative RDNs are the diverse health coaches with substantive, evidenced-based competencies who can deliver these interventions in a safe and effective manner. We suggest potentially including in this objective potential ways in which complementary health approaches can help our military and frontline healthcare teams. These men and women are exposed to extreme amounts of stress, anxiety and pressure, and they deserve our focus in arming them with the self-care and stress management skills necessary.
To clarify the subsections of Objective Three, we recommend minor changes. Specifically, we suggest revising subsection 1 to, "Investigate mechanisms of action of complementary and integrative health approaches in health resilience and practices that improve health and prevent, address, reverse, or slow the progression of disease." (Emphasis added.) We also suggest revising subsection 2 to, "Study complementary health approaches to promote health and wellness across the lifespan in diverse populations, including lower socioeconomic backgrounds." (Emphasis added.)
Finally, we agree that including diversity in this Draft Strategic Plan is highly important, as is emphasizing the importance of commitment to developing strategies that can be used to effectively study natural therapies. Many of the most common, beneficial interventions are based on an individual assessment and involve multiple recommendations, necessitating a very different strategy than studying a single intervention and single outcome.
Objective Four: Enhance the Complementary and Integrative Health Research Workforce
The interdisciplinary collaborations and partnerships supported here are exactly the type of research and partnerships health care practitioners and researchers need and that our integrative RDNs are longingly searching for. Integrative RDNs need help measuring the outcomes of proactive based evidence and we need partners like the NIH to make our case and highlight the positive and outcomes based work we are doing. It is critical that we offer our support and assistance in this objective, and hope to work with the Center in coordinating its work with that of the Academy of Nutrition and Dietetics Health Informatics Infrastructure (ANDHII), a tool that collects nutrition care impact data for use in public policy and quality improvement research.4 The time for action and collaboration is now, and our members are ready to work with our healthcare colleagues, government and non-government organizations on these initiatives.
Objective Five: Disseminate Objective Evidence-based Information on Complementary and Integrative Health Interventions
Objective Five is critical in translating the evidence into efficacious and safe interventions for the public. As the NCCIH moves forward, we encourage it to work with professional associations to highlight how RDNs and other trusted practitioners can help strategically accomplish this objective.
As noted in the Draft Strategic Plan, much of the landscape is "either not based on evidence or [is] of questionable quality and reliability." Thus, it is critical to not only educate the public on what information is accurate, but also which sources of information can be trusted to deliver information and conduct interventions. Integrative RDNs are effectively promoting and practicing evidence-based interventions and are getting positive outcomes. As the Draft Strategic plan indicates, consumers not only use the vast majority of dietary supplements without a recommendation from qualified experts, but "most botanical supplement users do not report [their use of supplements] to their health care providers."5 The Academy shares your desire to improve clinicians' understandings and perceptions of dietary supplements and their patients' usage. Finally, we earnestly look forward to working with the Center and seek guidance on how we can be of greater use to you in achieving the objectives laid out in the Draft Strategic Plan.
ConclusionThe Academy appreciates the opportunity to comment on the Draft Strategic Plan and to serve as a resource to the NCCIH as you finalize the plan, develop and conduct research, and as RDNs and other practitioners implement and integrate the findings nationwide. We are happy to discuss these recommendations in greater detail in the near future. Please contact either Jeanne Blankenship at 202/775-8277, ext. 6004 or by email at firstname.lastname@example.org or Pepin Tuma at 202/775-8277, ext. 6001 or by email at email@example.com with any questions or requests for additional information.
Jeanne Blankenship, MS RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government and Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 Use of the Term "Natural" in the Labeling of Human Food Products; Request for Information and Comments, 80 Fed. Reg. 69905 (Nov. 12, 2015).
3 Mellin L (2010) Wired for Joy: A Revolutionary Method for Creating Happiness from Within, Carlsbad, CA, Hay House. See also, Kabat-Zinn J. Full Catastrophe Living (Revised Edition), Using the Wisdom of Your Body and Mind to Face Stress, Pain, and Illness. Bantam; 2013.
4 Academy of Nutrition and Dietetics Health Informatics Infrastructure website. Accessed April 12, 2016. Available at https://www.andhii.org/info/.
5 Mellin L (2010) Wired for Joy: A Revolutionary Method for Creating Happiness from Within, Carlsbad, CA, Hay House. See also, Kabat-Zinn J. Full Catastrophe Living (Revised Edition), Using the Wisdom of Your Body and Mind to Face Stress, Pain, and Illness. Bantam; 2013.