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From the Townsend Letter
May 2015

Complete Diabetes Care Now that We Have TACT
by L. Terry Chappell, MD; T. Rae Neal, MSN, CNP; and Natallie Paphanchith, MSN, ACNP-BC
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Patient Decision-Making
In the meantime, TACT is clearly the best evidence available showing that chelation therapy might benefit vascular disease. The new guidelines for vascular problems call for the treating physician to have a conversation with his or her patients explaining the risks and potential benefits of all options of therapy. Then it is imperative that the patient decides what mode of therapy sounds best to him or her. This is the new "gold standard."35 The patient is the decision-maker, not the doctor. Chelation therapy should be discussed in light of the evidence of TACT. If TACT-2 replicates TACT-1, chelation might be suggested for all diabetic patients. With the current status of evidence, chelation therapy should be offered to patients as an option for treatment, especially if they have signs of vascular disease.
   
Physicians trained in providing intravenous chelation report better overall results than TACT.36 One reason that clinical practice might be better is that continued monthly maintenance is commonly offered after the basic course of treatment. TACT treated patients intravenously only for the first 20 months, but followed them for 5 years. Another reason could be that TACT did not follow patients with challenge tests for heavy metals or vascular testing to assess progressive improvement. A reaccumulation of toxic metals is not unlikely. Finally, other nutritional therapies are often added by integrative physicians. All of these measures contribute to the best care for each individual patient and would likely improve the overall results.

Table 5
   
Chelation therapy has been opposed by conventional doctors for many years. In 1980, the AMA effectively said to the chelation community, "Put up some evidence, or stop doing the therapy." With the help of NIH funding, and cooperation between doctors familiar with the therapy and a group of courageous cardiologists, the evidence has arrived. As clinical scientists who continually advocate evidence-based medicine, physicians are obligated to accept good evidence when it conflicts with their beliefs.37 The rest of this article puts forth a comprehensive approach to diabetic patients that includes chelation therapy and alternative medicine as therapeutic options for prevention, control of the disease, avoidance of complications, and a longer lifespan.

A Comprehensive Integrative Approach to Diabetes
First, patients must be diagnosed when they have either prediabetes or diabetes. This requires screening tests by their doctors' orders or at health fairs, especially for anyone who is overweight or has a family history of diabetes. Patients with hypoglycemia not infrequently convert to diabetes as they grow older. Fasting blood sugars are a reasonable start, but HbA1C tests are more accurate. Those who are overweight should be encouraged to eat less and better, and exercise more. Obesity is a major cause of gene expression into active diabetes.
   
As soon as prediabetes or diabetes is detected, a careful reassessment of lifestyle factors should be instituted. The patient and the family must embrace responsibility for controlling the disease. A healthful diet is crucial, with a special emphasis on low carbs, especially if high triglycerides or the metabolic syndrome is present. Regular exercise and an effective way to deal with stress are important. Smoking and excessive environmental pollution are to be avoided as much as possible. Regular monitoring of lipids, HbA1C, kidney function tests such as creatinine with GFR and microalbumen, vitamin D3 levels, annual eye exams, vascular screenings, and careful attention to the feet are all required. The sensitive CRP, homocysteine, and ferritin levels should be checked at least once. A challenge test is the best way to screen for toxic metals.

Nutritional supplements can help control the disease and avoid complications. Vitamin C, biotin, chromium, magnesium, zinc, selenium, B-complex, inositol, and alpha-lipoic acid should all be considered. Several herbal supplements could also be selected if further control of the blood sugar is needed. Good candidates include cinnamon, bitter melon, and berberine. Fenugreek, Gymnema sylvestre, Korean or American ginseng, KJM, and combinations of herbs from India or China also might have therapeutic benefit. Milk thistle might help by its detoxification of harmful chemicals. Psyllium is also good for detox, and aids constipation. Generally, herbals are safer and less likely to cause hypoglycemia than medications.
   
Medications are next on the list. Oral medicines are discussed above, and insulin is a reasonable choice if needed, whether or not the patient is insulin dependent. Doctors must be careful to avoid overmedication that can lead to HbA1C readings that are too low, hypoglycemic episodes, and severe injuries, especially in the frail elderly. Control of the disease is imperative. Therapeutic goals for the HbA1C should be 6.5 to 7.0 for most patients and 8.0 for unstable elderly patients. Of course, lower levels of HbA1C are desirable if they are achieved without the help of medications.
   
The most dramatic evidence of treatment success in the last few years came with TACT. Chelation therapy reduced future cardiac events and lowered the death rate for patients with diabetes who had a previous myocardial infarction. The magnitude of benefit was perhaps greater than any intervention other than considerable weight loss or insulin therapy. The probable mechanism has to do with free-radical activity and inflammation caused by toxic metals, which are removed with chelation. Confirmatory research is coming with TACT-2, but cardiologists and endocrinologists should at least describe the remarkable evidence generated by TACT-1 and let patients choose whether they want chelation, either before or after significant vascular disease has developed. After all, most of the complications from diabetes are vascular, which can lead to devastating disabilities and/or premature death.

Notes
1.   Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: US Department of Health and Human Services; 2014.
2.   Kahn SE, Hull RL, Utzschneider KM. Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature. 2006; 444:840–846. doi:10.1038/nature05482.
3.   Brand-Miller J, McMillan-Price J, Steinbeck K, Caterson I. Carbohydrates – the good, the bad and the whole grain. Asia Pac J Clin Nutr. 2008;171 (Supplemental):16–19.
4.   Gaby AR. Endocrine disorders: diabetes mellitus. In: Nutritional Medicine. Concord: Fritz Perlberg Publishing; 2011:1081–1105.
5.   American Diabetes Association. Standards of medical care in diabetes – 2014. Diabetes Care. 2014;37:S14–S80.
6.   Nelson JM, Dufraux K, Cook PF. the relationship between glycemic control and falls in the older adult. J Am Geriatr Soc. 2007.
7.   Lee SJ, Eng C. Goals of glycemic control in frail older patients with diabetes. JAMA. 2011;305(13):1350–1351. doi:10.1001/jama.2011.404
8.   DeMarco T. Bending towards integration: a mulltiple case studies assessing the progressive landscape of interprofessional collaborative care within U.S. integrative healthcare centers. Glob Adv Health Med. 2013;2(Supplemental):1–2.
9.   University of Wisconsin-Madison. Diabetes. UW Health Integrative Medicine Updates. 2005;1(1).
10. Wendling P. Remote weight loss program works long term. Fam Pract News. 2011;57.
11. Esposito K, Maiorino MI, Petrizzo M, Bellastella G, Guigliano D. The effects of a Mediterranean diet on the need for diabetes drugs and remission of newly diagnosed type 2 diabetes: follow up of a randomized trial. Diabetes Care. 2014;37:1824–1830.
12. Perez-Martinez P, Garcia-Rios A, Delgado-Lista J, Perez-Jimenez F, Lopez-Miranda J. Mediterranean diet rich in olive oil and obesity, metabolic syndrome and diaetes mellitus. Curr Pharm Des. 2011;17:769–777.
13. Birdee GS, Yeh G. Complementary and alternative medicine therapies for diabetes: a clinical review. Clin Diabetes. 2010;28:147–155.
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18. Fuangchan A, Sonthisombat P, Seubnukarn T, Chanouan R, Chotchaisuwat P, Siriguisatien V, et al. Hypoglycemic effect of bitter melon compared with metformin in newly diagnosed type 2 diabetes patients. J Ethnopharmacol. 2011; 134: 422–428.
19. Tan M J, Ye JM, Turner N, Hohnen-Behrens C, Ke CQ, Tang CP, et al. Antidiabetic activities of triterpenoids isolated from bitter melon assocciated with activitation of the AMPK pathway. Chem Biol. 2008;15: 263–273.
20. Vuksan V, Sung MK, Sievenpiper JL, et al. Korean red ginseng (Panax ginseng) improves glucose and insulin regulation in well-controlled type 2 diabetes: results of a randomized, double-blind, placebo-controlled study of efficacy and safety. Nutr Metab Cardiovasc Dis. 2008;18(1):46–56.
21. Vuksan V, Sievenpiper JL, Xu Z, et al. Konjac-Mannan and American Ginsing: emerging alternative therapies for type 2 diabetes. J Am Coll Nutr. 2001;10:370S–380S.
22. Copeland A. A study to determine the effectiveness of berberine Hcl on lowering HbA1c. Orig Internist. 2014;171–172.
23. DiNardo MM, Gibson JM, Siminerio L, Morell AR, Lee ES. Complementary and alternative medicine in diabetes care. Curr Diabetes Rep. 2012;12:749–761.
24. Hasani-Ranjbar S, Zahedi H S, Abdollahi M, Larjani B. Trends in publication of evidence based tradional Iranian medicine in endocrinology and metabolic disorders. J Diabetes Metab Disord. 2013;12:49.
25. Wang H, Mu W, Zhai J, et al. the key role of Shenyan Kangfu tablets, a Chinese patent medicine for diabetic nephropathy: study protocol for a randomized, double blind and placebo-controlled clinical trial. Trials. 2013;14:165.
26. National Center for Complementary and Alternative Medicine. Get the Facts: Diabetes and Dietary Supplements. Washington DC: National Institue of Health; 2013.
27. Lamas GA, Goertz C, Boineau R, et al. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013;309:1241–1250.
28. Lamas GA, Bouneau R, Goertz C, et al. EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: the factorial group results of the Trial to Assess Chelation Therapy. Am Heart J. Published by Mosby Inc. as an open access article under the CC BY-NC-ND license, July 2014. Reprint requests from (gervasio)lamas@msmc.com.
29. Peguero JG, Arenas I, Lamas GA. Chelation therapy and cardiovascular disease: connecting scientific silos to benefit cardiac patients. Trends Cardiovasc Med. 2014;24:232–240. Available at http://www.sciencedirect.com.
30. Lamar CP. Chelation therapy of occlusive arteriosclerosis in diabetic patients. Angiology 1964;15:379–394.
31. Cutler P. Deferoxamine therapy in high-ferritin diabetes. Diabetes. 1989;38:1207–1210.
32. Escolar E, Lamas GA, Mark DB, et al. the effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cariovasc Qual Outcomes. 2014;7:15–24.
33. Hancke C. The long-term effect of chelation therapy: a 6–12 year follow-up of a 1993 study. Clin Pract Alt Med. 2000;1:158–163.
34. Chen Kuan-Hsing and associates. Effect of chelation therapy on progressive diabetic nephropathy in patients with type 2 diabetes and high-normal body lead burdens. Am J Kidney Dis. 2012;60:530–538.
35. Chappell LT. The new cardiovascular risk factor guidelines require patient decisions – guest editorial. Townsend Lett. 2014;Aug–Sept:97–98.
36. Chappell LT, Shukla R, Yang J, et al. Subsequent cardiac and stroke events in patients with known vascular disease treated with EDTA chelation therapy: a retrospective study. Evid Based Integr Med. 2005;2:27–35.
37. Maron DJ, Hlatky MA. Trial to assess chelation therapy (TACT) and equipoise: when evidence conflicts with beliefs. Published by Mosby Inc. Department of Medicine, Stanford University. 2014. E-mail requests to david.moran@standford.edu.

Corresponding author:
Dr. Chappel
terrychappell@healthcelebration.com
419-358-4627; fax 419-358-1855

None of the authors have any conflicts of interest to report.

L. Terry Chappell, MD, is in private family practice in Bluffton, Ohio. He has served as president of ACAM and ICIM and was an investigator for TACT.

T. Rae Neal, MSN, CNP, is new to primary care. Her background is in cardiac admission and interventional care. She has served as adjunct faculty at Ohio Northern University.

Natallie Paphanchith, MSN, ACNP-BC, is currently working with St. Rita's Professional Services Endocrinology, specializing in diabetes, in Lima, Ohio.

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