Combining Therapies For Optimal Results

1. Combining Therapies For Optimal Results Complementary and Integrative Care for Inflammatory Bowel Disease Gary Weiner, N.D., L.Ac. Pearl Natural Health www.pearlnaturalhealth.com

2. Why Am I Here? Because there are two sides to every coin…

3. Goals of Presentation • Describe the rationale for integrative care • Help you understand what we are doing with your patients when they visit our clinics • Show examples of the care provided • Convey what we are telling your patients when they seek our help

4. Definitions • Alternative Medicine: • ”Healing arts not taught in traditional western medical schools that promote options to conventional medicine that are not taught in these schools…” (medterms.com,2013) • “Alternative” refers to using a non-mainstream approach in place of conventional medicine (nih.gov 2013).

5. Definitions • Complementary Medicine: • “A group of diagnostic and therapeutic disciplines that are used together with conventional medicine. (medterms.com 2013) • “Complementary” generally refers to using a non-mainstream approach together with conventional medicine (nih.com 2013)

6. Definitions • “Integrative Medicine” • The integration into care of an array of “non-mainstream” approaches (nih.gov).

7. CAM and IBD “The use of complementary and alternative medicine is widely prevalent among IBD patients, and is more frequent among those with experience of adverse effects of conventional medications…”

8. CAM and IBD “Patients using CAM report benefits that extend beyond simply improved disease control. Using CAM allows patients to exert a greater degree of control over their disease and its management than they are afforded by conventional medicine. There is limited evidence of the efficacy of CAM therapies in IBD. It is important for physicians caring for those with IBD to be familiar with common forms of CAM and to be able to provide general counseling to their patients about CAM use...”

9. Treatment Decisions Conventional Medical Plan Alternative Medical Plan OR

10. Integration “Combining parts so that they work together, or form a whole…” Conventional Medical Plan ComplementaryMedical Plan “Combining parts so that they work together, or form a whole…” Signs Symptoms

11. Integration “Combining parts so that they work together, or form a whole…” Conventional Medical Plan ComplementaryMedical Plan Integrative Plan Signs Symptoms

12. The Integrative Approach • The disease is treated in the context of the patient’s total health

13. Patients at CAM Clinics • Refractory cases • Often feel they are not presented with any options • Desire control, want to play a role in their care • Fearful of the next step being presented • Often presenting as a medication fails, wanting to avoid the immunosuppressants or biologics. • Dissatisfied with side effects or level of wellness on their plan

14. Principles of Integration • Integrate therapies that create the conditions for healing • Identify and treat the cause • First, do no harm • Provide education • Engage in prevention • Treat the “whole” person

15. PROMOTE HEALTHY LIFESTYLE TREAT THE WHOLE PERSON REMOVE OBSTACLE: DYSBIOSIS REMOVE OBSTACLE: INTESTINAL PERMEABILITY REMOVE OBSTACLE: SUB-OPTIMAL DIGESTION ` IMPLEMENT MOST EFFECTIVE DIETARY STRATEGY REMOVE OBSTACLE: ADRENAL HYPOFUNCTION Integrative Treatment Paradigm REMOVE OBSTACLE: NUTRITIONAL INSUFFICIENCIES REMOVE OBSTACLE: PSYCHO-EMOTIONAL REMOVE OBSTACLE: STRESSORS REMOVE OBSTACLE: IMMUNE DYSREGULATION PROVIDE NECESSARY SUPPORT MONITOR RESPONSES CAREFULLY

16. “Since the gut microbiota is plastic and responds to dietary modulations, the use of probiotics, prebiotics, and/or dietary alterations are all intriguing complementary therapeutic approaches to alleviate IBD symptoms…” “However, the interactions are complex and it is unlikely that a one-size-fits all approach can be utilized across all population…as we move towards an era of personalized medicine to treat IBD…” “Recent evidence suggests that specific changes in dietary have led to a shift in the composite human gut microbiota resulting in the emergence of pathobionts that can thrive under specific conditions, in the genetically susceptible host…”

17. Implement Dietary Strategy w Standard American Diet (SAD) Specific Carbohydrate Diet (SCD) Anti-Inflammatory Diet Hypoallergenic Diet “Paleolithic” Diet Individualized Diet Formal support to make the transition Food as medicine: which strategy promotes symptom reduction and mucosal healing?

18. This case series indicates the potential for the IBD-AID to be used as an adjunctive or alternative therapy for the treatment of IBD. Notably 9 our of 11 patients were able to be managed without anti-TNF therapy and 100% of the patients had their symptoms reduced. To make clear recommendations for its use in clinical practice, randomized trials are needed alongside strategies to improve acceptability and compliance with the IBD-AID.

19. Dietary Strategy Implementation • Start simple • Calm down disease expression  • Build diet in complexity  • Sensitize patient to learn what serves him/her best • Provide clinical support as a program

20. PROMOTE HEALTHY LIFESTYLE TREATMENTS: Dietary strategy Treatment of deficiencies Nutritional IV Supplements REMOVE OBSTACLE: DYSBIOSIS TREAT THE WHOLE PERSON TREATMENTS: Dietary strategy Anti-microbial therapy Fecal transplant Proiotics Pre-biotics REMOVE OBSTACLE: SUB-OPTIMAL DIGESTION REMOVE OBSTACLE: INTESTINAL PERMEABILITY TREATMENTS: Anti-Inflammatory therapies ` TREATMENTS: Acupuncture Chinese herbal therapies Ayurvedic medicine Homeopathy IMPLEMENT MOST EFFECTIVE DIETARY STRATEGY REMOVE OBSTACLE: ADRENAL DYSFUNCTION REMOVE OBSTACLE: NUTRITIONAL INSUFFICIENCIES TREATMENTS: Conventional drug therapies Herbal Meidicines Low Dose Naltrexone Down-regulatory strategies REMOVE OBSTACLE: PSYCHO-EMOTIONAL TREATMENTS: Herbs Enzymes Betaine Hydrochloride Dietary strategy REMOVE OBSTACLE: STRESSORS REMOVE OBSTACLE: IMMUNE DYSREGULATION TREATMENTS: Hormone augmentation Adrenal treatments Stress reduction Counseling PROVIDE NECESSARY SUPPORT MONITOR RESPONSES CAREFULLY

21. Remove Obstacle: Dysbiosis • Make attempts to Identify disruption of microbiota: bacteria, fungi, parasites • Use stool, saliva, breath; antigen, antibody, other markers • Treat any findings; use both pharmaceuticals and botanicals (fecal transplants, “worm” therapy) • Nourish healthy flora • VSL#3 • Other probiotics • Prebiotics

22. Remove Obstacle: Immune Dysregulation • Downregulate an upregulated immune system • Treat the dysbiosis • Treat any toxicity that can be quantified; do general detoxification protocols • Decrease intestinal permeability with optimal diet • Use supportive supplements • Consider Low Dose Naltexone (LDN)

23. Remove Obstacle: Adrenal “Dysfunction” • Assess adrenal function • Salivary test: 4-point cortisol, dhea-s, pregnenalone • 24 hour urine • ACTH stimulation • Blood tests • Treat any adrenal imbalance • Consider restoration of cortisol adequacy as treatment strategy (i.e., low dose cortef or compounded hydrocortisone

24. Remove Obstacle: Intestinal Permeability • Quantify degree of permeability • Remove allergens from diet • Remove pathogens that can be isolated • Build mucosal integrity

25. Remove Obstacle: Sub-optimal digestion • Support all phases of digestion • Use laboratory to assess absorption & malabsorption, digestion of carbohydrates, lipids, proteins • Address constipation • Use supports such as betaine hydrochloride, amylases, lipases and proteases, herbs, supplemental oils, acupuncture, and other therapies as necessary

26. Remove Obstacle: Nutritional Deficiencies &Insufficiencies • Perform complete nutritional assessment • Treat all demonstrated or suspected deficiencies and insufficiencies. • Through diet, if possible (often problematic) • Through oral supplementation, if possible (often problematic) • Through nutritional IV therapy

27. Remove Obstacle: Stressors/Psycho-Emotional Issues • Perform stress survey • Counsel toward removal of environmental, physical, psychological, and social stressors • Evaluate adrenal health • Provide or refer to supportive therapies or programs • Consider Mindfulness-Based Stress Reduction (MBSR)

28. “We believe that providing these services in a GI practice could be cost effective in the long run by potentially decreasing use of our resources and time, such as fewer office visits, emergency room visits, and telephone calls…”

29. TREATMENTS: Dietary strategy Treatment of deficiencies Nutritional IV Supplements PROMOTE HEALTHY LIFESTYLE TREAT THE WHOLE PERSON REMOVE OBSTACLE: DYSBIOSIS TREATMENTS: Dietary strategy Anti-microbial therapy Fecal transplant Proiotics Pre-biotics REMOVE OBSTACLE: SUB-OPTIMAL DIGESTION REMOVE OBSTACLE: INTESTINAL PERMEABILITY TREATMENTS: Anti-Inflammatory therapies ` TREATMENTS: Acupuncture Chinese herbal therapies Ayurvedic medicine Homeopathy IMPLEMENT MOST EFFECTIVE DIETARY STRATEGY REMOVE OBSTACLE: ADRENAL HYPOFUNCTION REMOVE OBSTACLE: NUTRITIONAL INSUFFICIENCIES TREATMENTS: Conventional drug therapies Herbal Meidicines Low Dose Naltrexone Down-regulatory strategies REMOVE OBSTACLE: PSYCHO-EMOTIONAL TREATMENTS: Herbs Enzymes Betaine Hydrochloride Dietary strategy REMOVE OBSTACLE: STRESSORS REMOVE OBSTACLE: IMMUNE DYSREGULATION TREATMENTS: Hormone augmentation Adrenal treatments Stress reduction Counseling PROVIDE NECESSARY SUPPORT MONITOR RESPONSES CAREFULLY

30. Evaluation in Integrative Setting • Medical History: establish the role of IBD in the context of total health with special attention to diet, nutritional status, life-style considerations, stressors, adrenal health, evidence of dysbiosis, and general wellness • Determine extent of success /failure of medical plan; examine prior medical records; coordinate with gastroenterologist as necessary • Discuss patient goals • Assess possibility of CAM making an impact on prognosis • Use variety of diagnostic methods to determine possible therapies

31. Evaluation • Patient goals outlined: • patient leads the agenda • better control of symptoms? • reduced corticosteroids? • decrease reliance on medication? • improved quality of life? • dietary refinement? • treatment of side effects of other medication? • more energy?

32. Lab Testing Helpful in CAM • Dysbiosis testing: stool, saliva, breath, antigen, antibody - l • Adrenal tests: saliva, urine, serum • Food allergy and intolerance testing • GI function and pathogen panels • Nutritional panels • Inflammation markers: ESR, SRP, Fecal Calprotectin, Intestinal Lysozyme, Anti- alpha chymotrypsin, Stool Leukocytes

33. Integrative Treatment Plan More Responsive to Meds Or Fewer Meds Better Health More Control Implement dietary strategy Meds Symptoms Treat Dysbiosis/microbiota Symptoms Symptoms Improve digestion Successful Integrative Plan No Treatment or Unsuccessful Treatment Improve nutritional status Symptoms Symptoms Work further on lifestyle Symptoms Symptoms Improve adrenal function Address psycho-emotional factors

34. What We Tell Patients • We are “exploring” the role complementary therapies can play in your care. This is a process. • We recommend commencement of the complementary plan without changing the medical plan to best assess how baselines change, with continual re-evaluation. • We explain that a dietary strategy will be implemented while simultaneously investigating the role of dysbiosis (disruption of microbiota), adrenal fatigue (suboptimal adrenal function), food allergies and intolerances, functional digestive issues, immune dysregulation, and nutritional insufficiencies may be playing. We will implement treatments as patterns that can be perceived emerge.

35. What We Tell Patients • We describe how as baseline symptoms or markers improve as treatments are implemented, then there is a basis for discussion of possible changes in the medical plan in an environment of proper monitoring (e.g., follow-up endoscopies to assure mucosal healing and cessation of progressive disease). • We recommend continued and ongoing relationship with conventional gastroenterology to stage progress/regress and utilize medical treatment as required.

36. Integrative Case Snapshots

37. 43 year old nurse, 2011 • Diagnosed 2008 with CD after the stress of nursing school. Under care of gastroenterologist confirming disease well under control on Asacol, Cimzia, Hyoscyamine sulfate, Methotrexate, Vicodin bid. However baseline abdominal cramping constant 2-3/1-10, worse waking. No D, but chronic fatigue, headaches, and depression. Patient miserable and frustrated.. Was seeing an ND (Naturopath) who dispensed many supplements and various diets. SCD had been tried, improperly ,and assumed a failure • Blood work revealed nutritional insufficiencies. SCD was re-commenced with support, along with weekly nutritional IV therapy x 2 months +weekly acupuncture. • Response was excellent, with improvements in baseline symptoms within weeks. • In coordination with gastroenterologist, all meds tapered over 6 months. Anti-depressant tapered. • There have been no relapses. Patient continues timely follow-up with gastroenterologist.

38. 13 year old boy, 2008 • CD unresponsive to Asacol, Entocort, Azathioprine, Anucort, Remicade and others. Only responsiveness was high dose prednisone, which when tapered led to relapse: vomiting, acute diarrhea, abdominal pain. Psychological depression and osteopenia at age 13, no growth for 1 year. • Immediate response to Specific Carbohydrate Diet. Still my patient 8 years later, maintained only on SCD + LDN + adrenal extract + vitamins and minerals. At time of presentation, tests indicated adrenal fatigue, dysbiotic organisims, intestinal permeability, allergy. Return to standard diet led to relapse. When Humira was considered, dietary strategy was chosen. • He experiences rare minor flares, addressed with return to stricter version of diet and rare use of “physiological dosing “ of bio-identical compounded hydrocortisone, nutritional IV therapy.

39. 13year old boy 2008 L W

40. 2011 2011 “W” “L”

41. 38 year old P.T. student, 2013 • UC since age 11 well managed by Mesalamine enemas until high school when she required prednisone frequently until college when Asacol was added. Managed well with Asacol ununtil pregnancy and childbirth in 2013. Flared with birth of daughter , and Asacol no longer held remission. At presentation, just finished 40mg Prednisone taper with flare of constant abdominal pain, 8-10 urgent liquid stools/day, still on Asacol and being offered Humira next. Breastfeeding newborn and refusing to go on immunosuppresants. • Treatment work up commenced while implementing SCD trial with full clinical support. One month on diet led to reduction of numbers of stools to 5 per day, and with persisting but decreased urgency, and less pain. Stool and Saliva testing testing yielded Candida Albicans overgrowth and suboptimal adrenal cortisol production. Nystatin prescribed alternatiing with anti-fugal supplements, as well as low dose “physiological dosing” of compounded hydrocortisone, 5mg am, 2.5mg late am, and 2.5 mg late afternoon. • After 2 weeks, patient reports normal stools 1-2 day, good formation, and no abdominal pain. She is asymptomatic and happily breastfeeding. Will have follow-up colonoscopy in 1 month.

45. 10 year old boy, 2013 • Referred by pediatric gastroenterologist for complementary care because family is interested in a dietary strategy for child’s UC after 2012 conventional care failed to hold with Pentasa. Steroids were re-commenced and a variety of dietary options discussed. In counseling patient, a simple “paleolilthic” type diet was started as SCD appeared too limiting and overwhelming. • Diet alone appeared to allow successful taper of prednisone without flaring and very low level of abdominal pain. Remicade infusions q 8 weeks added to plan, but baseline, minor abdominal pain persists. Allergy testing informed further modifications to diet, and along with digestive support from supplementation (enzymes, HCL), pain appears to be decreasing.

47. 27 year old female • Found clinic through clinic’s monthly IBD support. CD since age 6, now under fairly good control with Remicade every 8 weeks. However frustrated because she starts to flare at 6 weeks of each cycle with frequency, urgency, and abdominal pain . Mildly elevated CRP. GI doc suggests next step in meds which patient wishes to avoid. • SCD is properly implemented with support and brings improvement to the last two weeks of the cycle, but not enough for patient satisfaction. • Allergy test reveals that she is eating many foods to which she has apparent intolerance and substantial IgG reactions. • Removal of those foods ameliorates symptoms further to patient satisfaction, with Remicade infusions holding for entire cycle. CRP and other inflammation markers will be followed prior to next colonoscopy. • Instruction in mindfulness based stress reduction helps patient further.

49. 63 year old Fistualizing CD • Referred by gastroenterologist for complementary care post total proctocolectomy (1970’s) with stoma inflammation, reoccurrence of fistula, recent MRI showing new areas inflammation in ileum and jejunum, fatigue, elevated CRP. Patient has history of intolerance to Remicade and Humira. • Work-up yields lack of evidence of dysbiosis, lack of evidence of adrenal fatigue, allergies to only cane sugar, no gross nutritional deficiencies save vitamin D, but elevated fasting blood sugar. • SCD attempted, but too much weight loss and strategy abandoned. Patient agrees to decreased refined carbohydrates and commences Low Dose Naltrexone (LDN), weekly methlycobalamin injections at home, and periodic nutrtional IV support, as well as supplemental Curcumin. • 3 months later: improved energy, closed fistula, normalized CRP, stoma uninflamed. Excellent example of good, coordinated complementary care.

50. What’s Working? Combining therapies, observing outcomes • Overall integration • Implementing a dietary strategy • Microbial balancing • Treating the “whole” of digestion • “Energetic” medicine component • Low Dose Naltrexone Therapy • Treating nutritional deficiencies & insufficiencies SCD, GAPS, AID, Hypoallergenic Anti-microbial meds, herbs, SCD, probiotics, fecal transplant? hypochlorhydria, pancreatic insufficiency, probiotics E.G., Acupuncture 1.5mg – 4mg at bedtime Oral supplementation, intravenous nutrition, anti-oxidants, amino acids, trace minerals