Academy Comments to NCCIH

May 18, 2015

Josephine P. Briggs, M.D.
Director
National Center for Complementary and Integrative Health
9000 Rockville Pike
Bethesda, MD 20892

Re: Request for Information: Soliciting Input for the National Center for Complementary and Integrative Health's New Strategic Plan (NOT-AT-15-006)

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 (NCCIH) on its Request for Information related to the development of a new strategic plan issued April 14, 2015. 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 Dietetic Practice Group who practice in, or have specific interest in, an integrated and personalized approach to nutrition, health, and healing. The Academy supports NCCIH's efforts to focus, support, and conduct scientific research on complementary and integrative health approaches.

The Academy 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. At the outset, we generally recommend carrying over the excellent needs and directions from the 2011 Strategic Plan to the 2016 Strategic Plan.

Nutrition and Mind-Body Medicine

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, 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.2 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. 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.

As noted above, the focus on "integrative care" complicates the ability to isolate variables in replicating research. Nonetheless, research continues to accumulate on the benefits of complementing dietary modifications with mind-body medicine in a variety of areas, including:

  • Increased respiratory efficiency;3
  • Enhancement in genes associated with energy metabolism, mitochondrial function, insulin secretion, telomere maintenance and reduction in inflammatory response;4
  • Mood, anxiety and Thalamic GABA levels in the brain;5
  • Alteration in brain structure and pain tolerance;6
  • Attention, stress management and mood;7, 8, 9
  • Enhancement of insulin sensitivity and on insulin receptors;10, 11
  • Reduction in obesity, reversal of beneficial contributing factors in reversing the effects of heart disease, and decreased weight gain;12, 13
  • Reduction in medication usage;14 and
  • Improvement in mental health status.15

Herbal, Botanical, and Natural Product Supplements

Americans have increased their use of herbal, botanical, and natural product supplements over the past thirty years, with half of American adults using one or more within thirty days of responding to the National Health and Nutrition Examination Survey (NHANES).16 The Dietary Supplement Health and Education Act of 1994 defines a dietary supplement, in part, as a product intended to supplement the diet that contains any of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by humans to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, a constituent, extract, or combination of any ingredient mentioned above.17

The Academy believes that Americans who purchase dietary supplements to address a nutritional deficiency or for other purposes should be able to have confidence in the safety, quality, and verifiability of the supplements they consume. Americans purchased a staggering $30 billion worth of dietary supplements in 2011,18 and we encourage NCCIH to continue and strengthen its partnership with the National Institutes of Health's Office of Dietary Supplements (ODS) to coordinate areas of research and opportunities for synergies with NCCIH's 2016 Strategic Plan. Future research needs for NCCIH include further research on the relationship of genetics and the impact of natural products as the field of genomics continues to expand. We also encourage NCCIH's development of plans for the provision of clinical decision making tools on supplement use and education competencies and methods to validate practice-based clinical outcomes.

The 2011 Strategic Plan articulated several research needs related to dietary supplements, including the need to consider the bio-individuality of research subjects when conducting future research on complementary and alternative medicine (CAM) (e.g., MTHFR gene mutations). The Academy also encourages the validation of recommendations for the most commonly used supplements and coordination with 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.

Barriers to progress in research include the lack of standard methods for determining supplement quality and standards for disease specific supplement protocols. There is also a distinct need for knowledge on supplement efficacy, safety, and risk-benefit ratio. Safety concerns regarding the use of dietary supplements arise in part from the possibility that the dietary supplements, when combined with prescription drugs, will interact to either cause harm or reduce the pharmaceuticals' efficacy.19 A study published in the Journal of the Academy of Nutrition and Dietetics found that adults were two and a half times more likely to use dietary supplements while taking prescription medication compared to adults without a diagnosed medical condition.20 Consumers are often motivated to initiate a dietary supplement regimen after a cancer diagnosis, with cancer survivors frequently continuing to use dietary supplements for myriad reasons.21 Interestingly, herbal supplement users are more likely to be uninsured, use more prescription and over-the-counter medications, and are less likely to disclose their use to healthcare providers.22 We encourage NCCIH to work to improve clinicians' understandings and perceptions of dietary supplements and their usage.

Consumers using dietary supplements are not waiting for confirmed science to catch up to claims made by purveyors of pseudoscience and ineffective quick fixes, whether they are physicians on syndicated daytime talk shows or politicians selling diabetes "cures" on the internet. Notably, only 23 percent of dietary supplements were reported to have been used upon the recommendation of a physician or other health care provider.23 In fact, 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."24 Particularly given this lack of communication about supplement use with health care providers, we note that there is a distinct need for guidelines, criteria, utilization data, and best practices for hospital policies for dietary supplement use (i.e., peri-operative/anesthesia use, anticoagulant use, vulnerable populations' use, pediatric use, maternity/lactation use, drug-nutrient interactions, informed consent and shared decision-making, documentation in EMR, adverse event reporting policy, and formulary policy). To address the issues identified above there is also a need to conduct research into supplement/pharmaceutical interaction and the cost effectiveness of supplement use compared to pharmaceuticals for particular disease states or conditions.

Functional Laboratory Tests

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 help NCCIH guide future research efforts.

The Academy notes below some of the most common nutrition-related functional lab tests, a description of need related to them, a scientific rationale for further research, and detail on the public health impact of the tests as currently used.

  • Testing for Adverse Food Reactions. This is one of the most common lab tests done for food allergies and intolerances by integrative and functional health care practitioners.
    • Description of Needs: (1) Standardization of antigens and assessment methods used as this is considered proprietary between labs and makes the tests variable. (2) Identification of appropriate antibody or other biomarker that correlates with adverse food reactions (e.g., IgE, IgG, IgG4, IgA, (Cyrex Labs, ImmunoLabs, US Biotek) mediator release testing (LEAP MRT) and antigen leukocyte antibody test (ALCAT) are commonly used. (3) Comparison testing between labs for reliability of data and correlation of results to an elimination diet. (4) Identification of protocols for dietary elimination after a positive result, as providers have highly variable recommendations for how long foods should be eliminated.
    • Scientific Rationale: There are very few studies that validate the use of these tests even though they are in widespread use.
    • Public Health Impact: Many tests appear to have false positive and false negative results that leave patients confused. Our members report that patients become anxious about eating the foods that show up as positive on the test for fear that they will cause harm in the body. Many patients also develop restrictive eating habits that can cause disordered eating patterns and potential nutritional deficiencies, especially if their tests had many positive results. These tests are widely used in both adults and children, and if reliable markers for food sensitivities were identified, it could positively affect health and ability to heal from chronic inflammatory conditions.
    • Benchmarks for Success: Identification of reliable markers for adverse food reactions, standardization of testing methods, and evidence-based protocols for implementing therapeutic diets based on test results.
  • Markers of Dysbiosis and Digestive Imbalance
    • Description of Need: (1) Holistic practitioners who work with digestive and inflammatory conditions often use some form of stool testing to identify imbalances in the pH, bacteria and yeasts, inflammatory markers, short chain fatty acid, and enzyme production in an effort to diagnose the underlying cause of disease. Most of the research on the validity of this testing has been done by the labs that produce the tests and independent verification would be beneficial. The Academy encourages research on the correlation of the analytes measured to a variety of inflammatory and digestive conditions to validate the specificity of the analytes to those conditions and to come up with validated therapeutic protocols to treat the imbalances. (2) Another area of controversy is breath testing for small intestine bacterial overgrowth (SIBO) using lactulose, hydrogen or glucose and intestinal permeability testing.
    • Scientific Rationale: These tests are in widespread use yet have limited research to support their usefulness.
    • Public Health Impact: Validation could lead to the tests being covered by insurance, reducing out of pocket expenses for patients. In addition, these tests could help identify less costly treatments for inflammatory and digestive conditions with fewer negative long term side effects.
    • Benchmarks for Success: Validation of analytes and biomarkers in relation to various digestive and inflammatory conditions and evidenced-based treatment protocols.
  • Markers of Nutrient and Neurotransmitter Status (White Blood Cell Micronutrients, Red Blood Cell Fatty Acids, Urine Organic Acids and Neurotransmitter Testing)
    • Description of Need: Validation of testing methods and significance in relation to various diseases (inflammatory, psychiatric, metabolic) to ascertain if these are reliable diagnostic methods for identifying underlying causes of a variety of health conditions.
    • Scientific Rationale: These are widely used tests and lack validation.
    • Public Health Impact: If validated, these tests could help healthcare practitioners identify nutrient deficiencies that could help support treatment for many chronic inflammatory, psychiatric, and metabolic diseases.
    • Benchmarks for Success: Validation of the above biomarkers in relation to various diseases (inflammatory, psychiatric, metabolic), and established protocols for repletion if deficiencies exist.
  • Genetic Testing for Nutrition SNPs (Single Nucleotide Polymorphisms)
    • Description of Need: Healthcare practitioners are increasingly using genetic testing for nutrition, metabolism, detoxification, methylation, and hormones to personalize dietary and supplement recommendations. Research is necessary to ascertain which SNPs are useful and how best to interpret the data to make appropriate recommendations based off of the results. Notably, some testing is offered direct to consumer, which can cause confusion.
    • Scientific Rationale: These are widely used tests and lack validation
    • Public Health Impact: If validated, these tests could help healthcare practitioners provide more personalized recommendations to their patients and could potentially help prevent some associated chronic diseases.
    • Benchmarks for Success: Validation of genetic nutrition SNPs relationship to health and disease and established intervention protocols.

Diet Therapies

RDNs know the power that diet has to transform individuals' health and lives. Unfortunately, there is presently 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 NCCIH to identify research gaps related to integrative health approaches is critical to future practice.

The number of people living with chronic diseases has increased exponentially over the past several decades. Many of these diseases, 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.

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. There are 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.

With regard to the existing strategic plan, the Academy encourages NCCIH to more clearly define "diet-related therapies," using specific, consistent terminology. We note that food and nutrition are necessary and confusion arises associated with the fact that nutrition therapy is thus complementary within itself. Challenges and barriers arise from the confounding variables present with several recommended modalities and within dietary modifications, resulting in a challenging research model. A more magnified view of needs and investigation into integrative and functional medicine and nutrition as a whole are critical opportunities for future research.

The below are dietary approaches that many integrative practitioners have found to be effective or believe may be beneficial but which lack sufficient evidence for many mainstream practitioners to believe are sufficiently efficacious to prescribe them as an intervention protocol. Included are references to studies that mention the merit of further research/randomized clinical trials on these diet therapies.

  • The Specific Carbohydrate Diet25 as a therapeutic dietary approach to Inflammatory Bowel Disease.
  • The Anti-inflammatory Diet26 as a way to address cardiovascular disease, diabetes and other inflammatory conditions like arthritis, and autoimmune issues like rheumatoid arthritis and inflammatory bowel disease.
  • A Detoxification Diet Protocol27 that eliminates potential food allergens and focuses on whole and minimally processed foods and potentially supplementation that up-regulate enzymes known to be supporting to liver, kidney and gastro-intestinal function, and also avoids exposure to highly processed, highly refined foods containing additives, preservatives or other chemicals including pesticides. Relevant considerations include
    • What are the effects of this diet/protocol (long term and short term) on what are often deemed to be idiopathic issues like fibromyalgia, chronic fatigue syndrome, autism, Parkinson's, and autoimmune issues like multiple sclerosis, rheumatoid arthritis, Hashimoto's Disease.
    • Effects of switching to an all organic diet on a variety of health issues, such as asthma, irritable bowel syndrome (IBS), in addition as the aforementioned illnesses above.
  • Effects of Paleo diet28 on cardiovascular markers, cholesterol, diabetes,
  • Effects of reducing sources of Omega 6 rich foods in the diet and increasing Omega 3 rich foods in order to provide the body with a more balanced ratio to reduce inflammation and inflammatory markers.29
  • Effects of the LOW FODMAPS diet30 as a way of addressing IBS.

Conclusion

The Academy appreciates the opportunity to comment on the Scientific Report and serve as a resource to HHS and USDA as you finalize the 2015 Dietary Guidelines for Americans and develop resources to implement and encourage them 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 jblankenship@eatright.org or Pepin Tuma at 202-775-8277 ext. 6001 or by email at ptuma@eatright.org with any questions or requests for additional information.

Sincerely,

Jeanne Blankenship, MS, RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics

Pepin Andrew Tuma, Esq.
Director, 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 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.

3 Bernardi L, Passino C, Spadacini G, BonWchi M, Arcaini L, Malcovati L, Bandinelli G, Schneider A, Keyl C, Feil P, Greene RE, Bernasconi C. Reduced hypoxic ventilatory response with preserved blood oxygenation in yoga trainees and Himalayan Buddhist monks at altitude: Evidence of a different adaptive strategy? European Journal of Applied Physiology 99:511–518, 2007.

4 Bhasin MK, Dusek JA, Chang B, Joseph MG, Denninger JW, Fricchione GL, Benson H, Libermann TA. Relaxation Response Induces Temporal Transcriptome Changes in Energy Metabolism, Insulin Secretion and Inflammatory Pathways. PLOS ONE Vol 8, Issue 5, May 2013.

5 Streeter CC, Whitfield TH, Owen L, Rein T, Karri SK, Yakhkind A, Perlmutter R, Prescot A, Renshaw PF, Ciraulo DA, Jensen JE. Effects of yoga versus walking on mood, anxiety, and brain GABA levels: a randomized controlled MRS study, Journal of Alternative and Complementary Medicine, 16:1145-52, 2010.

6 Villemure C, Ceko M, Cotton VA, Bushnell MC, Insular Cortex Mediates Increased Pain Tolerance in Yoga Practitioners, Cerebral Cortex (in press), 2013.

7 Tang Y, Ma Y, Wang J, Fan Y, Feng S, Lu Q, Yu Q, Sui D, Rothbart MK, Fan M, Posner MI. Short-term meditation training improves attention and self-regulation. Proceedings of the National Academy of Sciences, 104:17152–17156, 2007.

8 Hartfiel N, Havenhand J, Khalsa SB, Clarke G, Krayer A. The effectiveness of yoga for the improvement of well-being and resilience to stress in the workplace. Scandinavian Journal of Work, Environment and Health, 37:70-6, 2011.

9 Hartfiel N, Burton C, Rycroft-Malone J, Clarke G, Havenhand J, Khalsa SB, Edwards RT, Yoga for reducing perceived stress and back pain at work. Occupational Medicine 62:606–612, 2012.

10 Mukherjee A, Banerjee S, Bandyopadhyay SK, Mukherjee PK, Studies on the interrelationship between insulin tolerance and yoga, Indian Journal of Physiology and Allied Sciences 46:110-115, 1992.

11 Sahay BK. Role of yoga in diabetes. Journal of the Association of Physicians of India, 55:121-6, 2007.

12 Bera TK, Gore MM, Kulkarni DD, Bhogal RS, Oak JP. Residential and non-residential Yoga training on health related physical fitness of obese patients. Yoga Mimamsa 34:166-187, 2003.

13 Gould KL, Ornish D, Scherwitz L, Brown S, Edens RP, Hess MJ, Mullani N, Bolomey L, Dobbs F, Armstrong WT, et al. Changes in myocardial perfusion abnormalities by positron emission tomography after long-term, intense risk factor modification, Journal of the American Medical Association, 274:894-901, 1995.

14 Moliver N, Mika E, Chartrand M, Burrus S, Haussmann R, Khalsa S. Increased Hatha yoga experience predicts lower body mass index and reduced medication use in women over 45 Years. International Journal of Yoga, 4:77-86, 2011.

15 Copeland W, Shanahan L, Costello EJ, Angold A. Cumulative prevalence of psychiatric disorders by young adulthood: a prospective cohort analysis from the Great Smoky Mountains Study. Journal of the American Academy of Child and Adolescent Psychiatry, 50:252-61, 2011.

16 Bailey RL, Gahche JJ, Miller PE, Thomas PR, Dwyer JT. Why US adults use dietary supplements. JAMA Intern Med. 2013;173(5):355-61. (Internal citations omitted.)

17 Dietary Supplement Health and Education Act of 1994. Public L No. 103-417 (codified at 42 USC 287C-11).

18 Considering a post-DSHEA world. Nutrition Business Journal. 2012;17:1-9. Accessed May 17, 2015.

19 Sood A, Sood R, Brinker FJ, Mann R, Loehrer LL, Wahner-roedler DL. Potential for interactions between dietary supplements and prescription medications. Am J Med. 2008;121(3):207-11.

20 Farina EK, Austin KG, Lieberman HR. Concomitant dietary supplement and prescription medication use is prevalent among US adults with doctor-informed medical conditions. J Acad Nutr Diet. 2014;114(11):1784-90.e2.

21 Bailey RL, Gahche JJ, Miller PE, Thomas PR, Dwyer JT. Why US adults use dietary supplements. JAMA Intern Med. 2013;173(5):355-61. (Internal citations omitted.)

22 Ibid

23 Ibid

24 Ibid

25 Pilot Testing a Novel Treatment for Irritable Bowel Syndrom. SCD website. Accessed May 18, 2015

26 Olendzki BC, Silverstein TD, Persuitte GM, Ma Y, Baldwin KR, Cave D. An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. Nutr J. 2014;13:5.

27 Lamb JJ, Konda VR, Quig DW, et al. A program consisting of a phytonutrient-rich medical food and an elimination diet ameliorated fibromyalgia symptoms and promoted toxic-element detoxification in a pilot trial. Altern Ther Health Med. 2011;17(2):36-44.

28 Lindeberg S, Jönsson T, Granfeldt Y, et al. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007;50(9):1795-807.

29 Noori N, Dukkipati R, Kovesdy CP, et al. Dietary omega-3 fatty acid, ratio of omega-6 to omega-3 intake, inflammation, and survival in long-term hemodialysis patients. Am J Kidney Dis. 2011;58(2):248-56.

30 Magge S, Lembo A. Low-FODMAP Diet for Treatment of Irritable Bowel Syndrome. Gastroenterol Hepatol (N Y). 2012;8(11):739-45.