Untapped Potential of “Medical Foods” in Developed & Developing Nations: A Mixed Method Study by a Systematic Review with Scientometric Analysis
Background: Currently medical foods for sick and healthy persons are gaining momentum globally from its nascent stage; so it is useful to study this area, not only for patients and clinicians, but also for public health experts across the globe. Methods: Systematic review as per PRISMA (2009) guidelines on key search word: “Medical Foods” was done from all major search engines; where any kind of full text article and abstract was available till 30th September 2014 from last 40 years, later on Scientometric analysis till this search date, across developed and developing world was done. Only published data on medical foods role in any kind of disease and health physiology and health pathology available globally from both developed and developing countries was included and analyzed in our study. All sort of unpublished data as well as medical foods biochemical studies were excluded from our study. Results: Analysis of 50 articles out of 150 articles searched revealed that; Medical foods research is concentrated mainly in developed countries (e.g. USA), with very few research in context of developing countries such as India (86% Vs 04%).The highest number of publications were from year 2012(26%) and belonged to English language(98%). The Scientific research publication papers (60%) with maximum citations between (5-10/reference) were found to be 54%. Conclusions: Medical foods strict regulations and monitoring processes need to remain active globally, otherwise its real potential can be lost in future. Medical foods research area needs promotion in developing countries, as there is a lot of scope of its development in these nations.
Jai Vir Singh,
Untapped Potential of “Medical Foods” in Developed & Developing Nations: A Mixed Method Study by a Systematic Review with Scientometric Analysis, International Journal of Nutrition and Food Sciences.
Vol. 4, No. 4,
2015, pp. 420-430.
Gauhier B & Yeow A. Medical Foods in the Middle. Available from: http://www.skimgroup.com/publication-medical-foods-nbj. [Last updated 2014, Jan 1; Last cited 2014 April 14]
New Business Opportunities Identified in Rapidly Growing $38 Billion Medical and Functional Foods Markets. Available from:http://www.prnewswire.com/news-releases/new-business-opportunities-identified-in-rapidly-growing-38-billion-medical-and-functional-foods-markets-216440021.html. [Last updated 2014, March 31; Last cited 2014 March 31].
Medical Foods Guidance Documents & Regulatory Information. [Internetc2013] Available from:http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/default.html. [Last updated 2013, Aug 21; Last cited 2014 March 26].
Thomas SM, F. CAPORASO,G.A. MILLER and R.M. KIRAL. Importance of sensory evaluation in the stability testing of a medical food. J Food Sci 1981;46(2):435-439.
Singh RH. The enigma medical foods. Molecular Genetics & Metabolism 2007;92(1-2):3-5.
Mueller C. The regulatory status of medical foods and dietary supplements in the United Sates. Nutrition 1999;15(3):249-251.
Task Force of the ILSI International Food Biotechnology Committee. Comp Rev Food Sci & Food Safety 2004;3:38-104.
Katz F. Active cultures add function to yogurt and other foods. Food Tech 2001;55(3).
Clemens R & Pressman P. Medical foods and irritable bowel syndrome. Food Tech 2006;60(8).
Shah RC. Medical foods for Alzheimer’s Disease. Drugs Aging 2011;28(6);421-428.
Kamphuis PJ, Verhey FR, Olde Rikkert MG, Twisk JW, Swinkels SH, Scheltens P. Efficacy of a medical food on cognition in Alzheimer’s disease: Results from secondary analyses of a randomized, controlled trial. J Nutr Health Aging 2011;15(8):720-724.
Kamphuis PJ, Verhey FR, Olde Rikkert MG, Twisk JW, Swinkels SH, Scheltens P. Effect of a medical food on body mass index and activities of daily living in patients with Alzheimer’s disease: Secondary analyses from a randomized, controlled trial. J Nutr & Aging 2011;15(8):672-676.
Vadillo-Ortega F, Perichart-Perera O, Espino S, Avila-Vergara MA, Ibarra I, Ahued R, Godines M, Parry S, Macones G,Strauss JF. Effect of supplementation during pregnancy with L-arginine and antioxidant vitamins in medical food on pre-eclampsia in high risk population: Randomized controlled trial. BMJ 2011;342:d2901.
Jones JL,Fernandez ML, McIntosh MS, Najm W, Calle MC, Kalynych C, Vukich C, Barona J, Ackermann D, Kim JE,Kumar V, Lott M, Volek JS, Lerman RH. A Mediterranean-style low-glycemic-load diet improves variables of metabolic syndrome in women, and addition of a phytochemical-rich medical food enhances benefits on lipoprotein metabolism. J Clin Lipidol 2011;5(3):188-196.
Bentley S, Hermes A, Phillips D, Daoud YA, Hanna S. Comparative effectiveness of a prenatal medical food to prenatal vitamins on hemoglobin levels and adverse outcomes: A retrospective analysis. Clin Ther 2011;33(2):204-210.
Faber J, Berkhout M, Vos AP, Sijben JW, Calder PC, Garssen J, van Helvoort A. Supplementation with a fish oil-enriched, high-protein medical food leads to rapid incorporation of EPA into white blood cells and modulates immune responses within one week in healthy men and women. J Nutr 2011;141(5):Epub 2011.
Deutz Nicolass EP, Safar A, Schutzler S, Memelink R, Ferrando A, Spencer H, van Helvoort A, Wolfe RR. Muscle protein synthesis in cancer patients can be submitted with a specially formulated medical food. Clin Nutr 2011;30(6):759-768
Weaver MA, Johnson A, Singh RH, Wilcox WR, Lloyd-Puryear MA, Watson MS. Medical foods: Inborn errors of metabolism and the reimbursement dilemma. Genet Med 2010;12(6):364-369.
Berry SA ,Kenney KM , Harris kB, Singh RH , Cynthia A. Cameron , Jennifer N. Kraszewski et al. Insurance coverage of medical foods for treatment of inherited metabolic disorders. Genetics in Medicine 2013;15,978–982.
Lindemann J, David Pampe E, Peterkin JJ, Orozco-Cronin P, Belofsky G, Stull D. Clinical study of the effects on asthma-related QOL and asthma management of a medical food in adult asthma patients. Curr Med Res Opin 2009;25(12):2865-2875.
Surette ME, Stull D, Lindemann J. The impact of a medical food containing gammalinolenic and eicosapentaenoic acids on asthma management and the quality of life of adult asthma patients. Curr Med Res Opin 2008;24(2):559-567.
Morgan SL, Baggott JE, Moreland L, Desmond R, Kendrach AC. The safety of flavocoxid, a medical food, in the dietary management of knee osteoarthritis. J Med Food 2009;12(5):1143-1148.
Zaman S, Mannan J, Lange S, Lönnroth I, Hanson LA. B 221, a medical food containing antisecretory factor reduces child diarrhoea: A placebo, controlled trial. Acta Paediatr 2007;96(11):1655-1659.
Morgan SL & Baggott JE. Medical foods: Products for management of chronic diseases. Nutr Rev 2006;64(11):495-501.
Yannicelli S, Acosta PB, Velazquez A, Bock HG, Marriage B, Kurczynski TW, Miller M, Korson M, Steiner RD, Rutledge L, Bernstein L, Chinsky J, Galvin-Parton P, Arnold GL. Improved growth and nutrition status in children with methylmalonic or propionic academia fed an elemental medical food. Molecular Genetics & Metabolism 2003; 80(1-2):181-188.
Heacock PM, Hertzler SR, Williams JA, Wolf BW. Effects of a medical food containing an herbal alpha-glucosidase inhibitor on postprandial glycemia and insulinemia in healthy adults. J Am Diet Assoc 2005; 105(1):65-71.
Maxwell AJ, Zapien MP, Pearce GL, MacCallum G, Stone PH. Randomized trial of a medical food for the dietary management of chronic, stable angina. J Am Coll Cardiology 2002;39(1):37-45.
Shell WE, Charuvastra EH, DeWood MA, May LA, Bullias DH, Silver DS. A double-blind controlled trial of a single dose naproxen and an amino acid medical food theramine for the treatment of low back pain. Am J Ther 2012 Mar;19(2):108-14.
Faber J, Berkhout M, Fiedler U, Avlar M, Witteman BJ, Vos AP, Henke M, Garssen J, van Helvoort A, Otten MH, Arends J.Rapid EPA and DHA incorporation and reduced PGE2 levels after one week intervention with a medical food in cancer patients receiving radiotherapy, a randomized trial. Clin Nutr 2013 Jun;32(3):338-45. doi: 10.1016/j.clnu.2012.09.009. Epub 2012 Sep 28.
Shell WE, May LA, Bullias DH, Pavlik SL, Silver DS.Sentra PM (a Medical Food) and Trazodone in the Management of Sleep Disorders. J Cent Nerv Syst Dis 2012 Apr 23;4:65-72.
Ochoa JB, McClave SA, Saavedra J.Issues involved in the process of developing a medical food. JPEN J Parenter Enteral Nutr 2011 Sep;35(5 Suppl):73S-9S.
Chalasani N, Vuppalanchi R, Navarro V, Fontana R, Bonkovsky H, Barnhart H, Kleiner DE, Hoofnagle JH.Acute liver injury due to flavocoxid (Limbrel), a medical food for osteoarthritis: a case series. Ann Intern Med 2012 Jun 19;156(12):857-60, W297-300.
Lamb JJ, Konda VR, Quig DW, Desai A, Minich DM, Bouillon L, Chang JL, Hsi A, Lerman RH, Kornberg J, Bland JS,Tripp ML. 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 Mar-Apr;17(2):36-44.
Ren A, Zhang W, Thomas HG, Barish A, Berry S, Kiel JS, Naren AP.A tannic acid-based medical food, Cesinex(®), exhibits broad-spectrum antidiarrheal properties: a mechanistic and clinical study. Dig Dis Sci 2012 Jan;57(1):99-108. Epub 2011 Jul 12.
Jackson MA, Burrell K, Gaddie IB, Richardson SD. Efficacy of a new prescription-only medical food supplement in alleviating signs and symptoms of dry eye, with or without concomitant cyclosporine A. Clin Ophthalmol 2011;5:1201-6. Epub 2011 Aug 25.
Scheltens P, Kamphuis PJ, Verhey FR, Olde Rikkert MG, Wurtman RJ, Wilkinson D, Twisk JW, Kurz A. Efficacy of a medical food in mild Alzheimer's disease: A randomized, controlled trial. Alzheimers Dement 2010 Jan;6(1):1-10.e1.
Bland JS, Barrager E, Reedy RG, Bland K.A Medical Food-Supplemented Detoxification Program in the Management of Chronic Health Problems. Altern Ther Health Med 1995 Nov 1;1(5):62-71.
Morgan SL. Dietary supplements and medical foods for osteopenia and osteoporosis. J Clin Densitom 2013 Oct-Dec;16(4):394-401.Epub 2013 Oct 4.
Schmitz SM, Lopez HL, MacKay D. Nutravigilance: principles and practices to enhance adverse event reporting in the dietary supplement and natural products industry. Int J Food Sci Nutr 2014 Mar;65(2):129-34.Epub 2013 Oct 11.
Katan MB.[Health claims for medical foods.[Article in Dutch]. Ned Tijdschr Geneeskd 2013;157(24):A6471.
US food and drug administration compliance program guidance manual. chapter 21 – food composition, standards, labeling and economics.2008;sep 30:1-30
The Medical Nutrition Market in India is Expected to Grow Tremendously in the Next Five Years. Available from: http://www.prnewswire.co.in/news-releases/the-medical-nutrition-market-in-india-is-expected-to-grow-tremendously-in-the-next-five-years-226692811.html.[Last updated 2013, Oct 7; Last cited 2014 March 25].
Dalmia,VP. India: Law Of Nutritional & Supplemental Food Products In India - The Conflict: Food Or Drug?[Internetc2014] Available from: http://www.mondaq.com/india/x/221116/food+drugs+law/Law+Of+Nutritional+Supplemental+Food+Products+In+India. [Last updated 2013, Feb 12; Last cited 2014 April 2].
About-axona.com. Available from: http://www.about-axona.com/ [Last updated 2013, May 02; Last cited 2014 April 30].
"Banatrol Plus". Available from: http://www.medtrition.com/banatrol-diarrhea-relief/. [Last updated 2013, Aug 30; Last cited 2014 April 30].
"Deplin® (L-methylfolate) | Official Site". Available from: http://www.deplin.com/ [Last updated 2013, June 3; Last cited 2014 April 30].
"Fosteum PLUS - The Purity of Genistein with the Strength of Calcium". Available from: http://www.fosteumplus.com/ [Last updated 2013, May 31; Last cited 2014 April 30].
"Osteoarthritis Information - Knee Osteoarthritis Symptoms". Limbrel. Available from: http://www.limbrel.com/osteoarthritis-symptoms.php Retrieved 2013-08-30. [Last updated 2013, Aug 30; Last cited 2014 April 30].
"Home"- Metanx.com. Available from: http://www.metanx.com/ 2013-01-24. [Last updated 2013, Aug 30; Last cited 2014 April 30].
American-therapeutics(theramine).Available From : http://journals.lww.com/americantherapeutics/pages/results.aspx?txtKeywords=theramine. [Last updated 2013, Aug 30; Last cited 2014 April 30].
David Boansi, Yield Response of Rice in Nigeria: A Co-Integration Analysis, American Journal of Agriculture and Forestry 2014; 2( 2): 15-24.
Roland Nuhu Issaka, Moro Mohammed Buri, Satoshi Nakamura, Satoshi Tobita, Comparison of Different Fertilizer Management Practices on Rice Growth and Yield in the Ashanti Region of Ghana. Agriculture, Forestry and Fisheries. 2014; 3(5):374-379.