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Journal club: Cardiovascular Disease


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Naturopathic Treatment for the Prevention of Cardiovascular Disease: A Randomized Pragmatic Trial CCNM – Journal Club Sept 30th, 2010 Dugald Seely, ND, MSc Director; Research & Clinical Epidemiology The Canadian College of Naturopathic Medicine

Published in: Health & Medicine, Business

Journal club: Cardiovascular Disease

  1. 1. Naturopathic Treatment for the Prevention of Cardiovascular Disease: A Randomized Pragmatic Trial CCNM – Journal Club Sept 30th, 2010 Dugald Seely, ND, MSc Director; Research & Clinical Epidemiology The Canadian College of Naturopathic Medicine Authors/contributors : Dugald Seely, ND, MSc, Orest Szczurko, ND, MSc (cand), Kieran Cooley, ND, MSc (cand), Heidi Fritz, ND, MA (cand), Craig Herrington, ND, Serenity Aberdour, ND, Qi Zhou, PhD, Patricia Herman, ND, PhD, Ryan Bradley, ND, MPH, Philip Rouchotas, MSc, ND, David Lescheid, PhD, ND, Tara Gignac, ND, Bob Bernhardt, PhD, Gordon Guyatt, MD, MSc
  2. 2. Outline <ul><li>Background </li></ul><ul><li>Methodology </li></ul><ul><li>Results </li></ul><ul><li>Interpretation </li></ul>
  3. 3. Background – 4 th in Series of Pragmatic Naturopathic Clinical Trials With Canada Post and the Canadian Union of Postal Workers <ul><li>Chronic back pain </li></ul><ul><li>Anxiety </li></ul><ul><li>Rotator cuff tendonitis </li></ul><ul><li>Cardiovascular Disease Prevention </li></ul>
  4. 4. Canada Post <ul><li>Nation wide employer: 6 th largest in Canada (~72,000 employees) </li></ul><ul><li>High costs associated with worker disability, prescription drugs </li></ul><ul><li>2003 labour negotiations created a National Joints Benefit Committee </li></ul><ul><ul><li>Goal to improve employee health </li></ul></ul><ul><li>Approached CCNM (2005) for pilot project on LBP: research study was proposed </li></ul><ul><li>Working with Canada Post and the Union ever since </li></ul>
  5. 5. Hypotheses 1. Naturopathic medicine will reduce the risk of developing cardiovascular disease 2. Naturopathic care has the potential to reduce overall company and societal costs of medical care.
  6. 6. Three Phases to the Trial <ul><li>Phase 1 – Participant Screening and recruitment </li></ul><ul><li>Phase 2 – Pragmatic Trial </li></ul><ul><li>- Compare naturopathic care to standard care to reduce risk of cardiovascular disease </li></ul><ul><li>- CEA for societal and employer costs </li></ul><ul><li>Phase 3 – Knowledge Translation </li></ul><ul><li>- Dissemination and Education across Canada Post </li></ul>
  7. 7. Phase 1 – Pre-Screening <ul><li>1125 people prescreened over 15 days </li></ul><ul><ul><li>415 Toronto </li></ul></ul><ul><ul><li>302 Edmonton </li></ul></ul><ul><ul><li>408 Vancouver </li></ul></ul><ul><li>Equal distribution of gender </li></ul><ul><ul><li>Average age 49 yrs old </li></ul></ul><ul><li>Aim to recruit workers with highest relative risk of developing Cardiovascular Disease  TC/HDL </li></ul>
  8. 8. Prescreened Participants Highest risk of developing cardiovascular disease ~ 400 approached N = 246 consented
  9. 9. Phase 2 – Clinical Trial Flow of Participants through Trial 246 interested participants with highest relative risk of CVD consented 879 not enrolled due to lack of interest, low TC/HDL ratio AND/OR not meeting inclusion/exclusion criteria Randomization Naturopathic Treatment + Usual Care for 12 months N = 124 Usual Care for 12 months N = 122 <ul><ul><li>1125 CUPW members prescreened </li></ul></ul>106 (84.5%) evaluable using ITT 101 (82.3%) evaluable using ITT 18 (14.5%) Dropped out < 6 months 21 (17.2%) Dropped out < 6 months
  10. 10. Phase 2 – Clinical Trial Methodology <ul><li>Design: Open label randomized pragmatic clinical trial </li></ul><ul><li>Ethics approval provided by CCNM REB </li></ul><ul><li>Randomization: central randomization in blocks of 8 stratified to age (<50, >= 50) </li></ul><ul><ul><li>A) Naturopathic treatment plus conventional care </li></ul></ul><ul><ul><li>B) Conventional care only </li></ul></ul><ul><li>Allocation list provided to clinicians at each site </li></ul><ul><ul><li> impossible to shift grouping allocation </li></ul></ul><ul><li>Intervention and follow up: 1 year </li></ul>
  11. 11. - 7 Visits in 1 year - Real-life Practice 0 4 wks 8 wks 18 wks 26 wks 35 wks 52 wks Final Visit Initial visit Mid-way visit 1 2 3 4 5 6 7 Visit Schedule for Naturopathic Group 1 2 3 Visit Schedule for Usual Care Control Group
  12. 12. Naturopathic Interventions <ul><li>Informed by clinician experience, evidence based material, and a two day training workshop </li></ul><ul><li>Treatments individually tailored to each participant </li></ul><ul><li>Focus placed on a mix of treatments using evidence based nutritional, lifestyle, and natural health products </li></ul>
  13. 13. Treatment Pallet 10 min/day Diaphragmatic breathing 3 sets of 10; 2-3x/wk. Exercise- resistance 30 min/d 5x/wk Exercise – aerobic 1-2 lbs/wk Weight loss counseling: Lifestyle Interventions 2-3 serv/wk Fatty fish consumption 50 g/d (1.6 oz) Soy protein 1 sach./8 oz fl. 1-2x/d Fibre ½ cup/d Oatmeal/oatbran 300-600 mg/d ALA 4 serv. Ea./day Fruit and vegetable intake 100 mg/d CoQ10 2 tbsp/d Raw extra virgin olive oil 1000mg/d or ½ tsp Cinnamon ¼- ½ cup/d (14-28) Raw almonds and/or walnuts 500mg TID w meals Plant sterols n/a ↓ saturated & trans fat, cholesterol 2000mg EPA/DHA Fish oil n/a Portfolio Diet for Dyslipidemia; DASH Diet for HTN Supplement-based Interventions Dietary Interventions Optimal Dose Intervention Optimal Dose Intervention Naturopathic Interventions commonly recommended to treatment group
  14. 14. Naturopathic interventions for CVD prevention - made simple <ul><li>Key Interventions: </li></ul><ul><ul><li>exercise 30 minutes per day, 5 days/week </li></ul></ul><ul><ul><li>sleep at least 7 hours per day </li></ul></ul><ul><ul><li>practice deep breathing </li></ul></ul><ul><ul><ul><li>in for 3 s, hold for 7 s, out for 8 s </li></ul></ul></ul><ul><ul><li>5 breaths 3 times /day or 10 minutes / day </li></ul></ul>
  15. 15. Key interventions <ul><li>14 to 28 walnuts or almonds/d </li></ul><ul><li>raw extra virgin olive oil (not cooked) </li></ul><ul><li>4 servings of fruits/d </li></ul><ul><ul><li>1 serving = 1 medium fruit </li></ul></ul><ul><li>4 servings of vegetables/d </li></ul><ul><ul><li>1 serving = ½ cup </li></ul></ul>
  16. 16. Key interventions <ul><li>½ cup soy per day </li></ul><ul><ul><li>edamame </li></ul></ul><ul><li>1 cup pomegranate juice per day </li></ul><ul><li>fish 2-3 times per week </li></ul><ul><ul><li>pregnancy: 1 x per week </li></ul></ul><ul><ul><li>have lots of small fish: </li></ul></ul><ul><ul><li>salmon, herring, mackerel, sardines </li></ul></ul><ul><ul><li>avoid fish that eat other fish: </li></ul></ul><ul><ul><li>tuna, pike, swordfish </li></ul></ul>
  17. 17. Key Interventions <ul><li>lots of high fibre foods </li></ul><ul><ul><li>whole grains </li></ul></ul><ul><ul><li>legumes </li></ul></ul><ul><ul><li>seeds </li></ul></ul><ul><ul><li>nuts </li></ul></ul><ul><ul><li>leafy greens </li></ul></ul><ul><li>less than 66 grams (2oz) fat per day </li></ul><ul><ul><li>less than 30% of calories from fat </li></ul></ul>
  18. 18. Key Interventions <ul><li>bitters </li></ul><ul><ul><li>1 tsp of lemon juice or apple cider vinegar in ½ cup of water 10 minutes before eating </li></ul></ul><ul><li>this helps your liver process fat </li></ul><ul><li>which is crucial for cholesterol metabolism </li></ul><ul><li>bitter foods such as </li></ul><ul><ul><li>kale, broccoli, spinach, and green tea </li></ul></ul>
  19. 19. Key interventions <ul><li>less than 11 grams (1/2 oz) of animal fat per day </li></ul><ul><ul><li>less than 5% of calories from saturated fat </li></ul></ul><ul><ul><li>avoid </li></ul></ul><ul><ul><ul><li>fried foods </li></ul></ul></ul><ul><ul><ul><li>cheese </li></ul></ul></ul><ul><ul><ul><li>red meat (including pork) </li></ul></ul></ul><ul><ul><ul><li>salty foods </li></ul></ul></ul><ul><ul><ul><li>processed foods </li></ul></ul></ul><ul><ul><ul><li>artificially sweetened foods </li></ul></ul></ul>
  20. 20. Omega 3 fatty acid fish oil <ul><li>2000 mg of EPA and DHA fish oils </li></ul><ul><ul><li>attention – most fish oil pills contain 1000 mg of oil, but only contain 300 mg of the EPA + DHA per pill </li></ul></ul><ul><li>300 mg per pill = 6 to 7 pills per day to reach 2000mg </li></ul><ul><li>can also take 1 Tbsp of liquid fish oil </li></ul><ul><li>check label, take fish oils with foods </li></ul>
  21. 21. Omega 3 fatty acid fish oil <ul><li>Cautions </li></ul><ul><li>fish oil can reduce clot formation </li></ul><ul><ul><li>a good thing for most but can be a problem for hemophiliacs or if you are on clot reducing medications such as warfarin </li></ul></ul><ul><li>allergies to fish oil </li></ul><ul><ul><li>rare, but can occur. Be watchful for </li></ul></ul><ul><ul><li>any signs of allergy including shortness </li></ul></ul><ul><ul><li>of breath or tightness in chest </li></ul></ul>
  22. 22. CoQ10 <ul><li>can be beneficial to those who have high blood pressure or those taking statin drugs like Lipitor or Crestor </li></ul><ul><li>Up to 100mg per day (cost dependent issue) </li></ul><ul><li>The heart is a muscle </li></ul><ul><li>CoQ10 is an enzyme that helps provide the energy needed to keep it pumping </li></ul>
  23. 23. Fibre <ul><li>very important to help the body remove the cholesterol </li></ul><ul><li>the liver removes the cholesterol from the blood, processes it, and secretes it into the intestines </li></ul><ul><li>if there is plenty of “roughage”, the cholesterol mixes with fibre and gets removed </li></ul><ul><li>1-2 Tbsp of psyllium or ground flax seeds daily in a big glass of water </li></ul>
  24. 24. Final Tips <ul><li>habits of healthy living will see you through the years better than any medication could </li></ul><ul><li>build a routine for exercise that gives you 30 minutes per day, 5 days per week and stick to it! </li></ul><ul><li>drink water, stop drinking pop </li></ul><ul><li>never go food shopping when hungry </li></ul><ul><li>ask family and friends to help you with your goals </li></ul>
  25. 25. Final Tips <ul><li>90% rule: eat good and real foods 90% of the time, can allow 2 “free” meals per week </li></ul><ul><li>eat in a relaxed state, while seated, off a plate </li></ul><ul><li>chew food well, wait 20 min before taking seconds </li></ul><ul><li>pack lunch if you know you’ll be tempted by unwise restaurant/cafeteria options </li></ul><ul><li>focus on what you can eat to push out the worst offenders (sugar, white bread, fatty foods, salt) </li></ul><ul><li>make yourself a priority, you deserve it! </li></ul>
  26. 26. Primary Outcomes of Analysis <ul><li>Two compound outcomes to predict risk of developing cardiovascular disease </li></ul><ul><ul><ul><li>coronary, cerebrovascular, peripheral </li></ul></ul></ul><ul><ul><li>Framingham Cardiovascular Risk Profile </li></ul></ul><ul><ul><li>Incidence of Metabolic Syndrome </li></ul></ul>
  27. 27. Statistical Analysis <ul><li>For continuous data, mean and standard deviation were used to summarize baseline and week 52 results and to report the mean and 95% confidence interval for the change at week 52 compared to baseline. We also assessed the difference of changes between the groups in mean and 95% confidence intervals. </li></ul><ul><li>For the binary data, event count and proportions were reported for both visits and the change of week 52 comparing to the baseline was measured by the proportional difference and its confidence interval. </li></ul><ul><li>To test for significant difference from baseline, the paired t-test was applied to continuous data and McNemar’s test for the binary data. To compare the difference of change between the groups, the Z-test was performed. </li></ul>
  28. 28. General Cardiovascular Risk Profile for use in Primary Care: The Framingham Heart Study D’Agostino et al. Circulation 2008 Developed from 8491 participants from the Framingham Heart Study Cohort
  29. 29. Framingham CVD risk Profile point scores for women 36 yr old female; Score = 2 + 0 + 1 + 4 + 3 + 0 = 10
  30. 30. Framingham CVD risk Profile score conversion  10 yr risk 6.3% risk of having a CVD related event within ten years
  31. 31. CVD risk Profile score conversion  vascular age 36 yr old women has the heart or vascular age of a 59 year old
  32. 32. Diagnosis and Management of the Metabolic Syndrome: An American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement Grundy et al. Circulation 2005 Adapted from the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) diagnostic criteria for Metabolic Syndrome
  33. 33. Diagnostic Criteria for Metabolic Syndrome
  34. 34. ‘ Secondary’ Outcomes <ul><ul><li>1. Objective cholesterol/glucose/BP measures </li></ul></ul><ul><ul><ul><ul><li>LDL,TC, HDL, triglycerides, TC/HDL, BP, FG, HbA1C </li></ul></ul></ul></ul><ul><ul><li>3. Weight and fat distribution </li></ul></ul><ul><ul><ul><ul><li>BMI, Waist/hip ratio </li></ul></ul></ul></ul><ul><ul><li>4. Other chief complaints and QoL </li></ul></ul><ul><ul><ul><ul><li>MYMOP, SF36 </li></ul></ul></ul></ul><ul><ul><li>5. Adverse effects </li></ul></ul>
  35. 35. Baseline Comparison
  36. 36. Results – Metabolic Syndrome P = 0.21 Δ = - 27.4%; 95% CI (-41.74%, -13.07%) p = 0.0002
  37. 37. Cardiovascular Age P = 0.31 Δ = -5.4; 95% CI -7.7 , -3.1) p < 0.0001 Actual age Actual age
  38. 38. Results – 10-year CVD Risk P = 0.49 Δ = - 3.6%; 95% CI (-5.1%, -2.3%) p < 0.0001
  39. 39. 10-Yr Risk of CVD <ul><li>Calculated from Framingham Data </li></ul><ul><li>(D’Agostino et al., Circulation, 2008;117:743-753 ) </li></ul><ul><li>10-yr CVD risk </li></ul><ul><ul><li>Naturopathic care: -2.9% </li></ul></ul><ul><ul><li>Usual care: 0.7% </li></ul></ul><ul><li>Net reduction: 3.6% (95%CI: 2.3 to 5.1) </li></ul><ul><ul><li>Equivalent to 3.6 fewer workers (out of 100) experiencing a CVD event in the next 10 years; NNT=28 </li></ul></ul><ul><ul><li>Roughly 20.5 additional HYLS over next 10 years for every 100 treated </li></ul></ul>
  40. 40. Secondary Outcomes with Significant Difference (p < 0.05)
  41. 41. Chief complaints experienced by all participants x 2
  42. 42. Cost Effectiveness of Naturopathic Treatment for the Prevention of Cardiovascular Disease Patricia M Herman, ND, PhD University of Arizona AANP – Portland, OR August 2010
  43. 43. 1,125 Workers gave informed consent to screening and were screened 246 participants with highest risk of CVD – informed consent & initial visit Low risk of CVD AND/OR not meeting inclusion/exclusion criteria Randomization Naturopathic Treatment + Usual Care N = 124 Usual Care N = 122 After 12months eligible for free initial naturopathic visit. Follow up covered on insurance plans Subset with consent to claims and sick leave data N = 79 Cost effectiveness analysis performed on these subgroups Subset with consent to claims and sick leave data N = 77 Number who attended 6-month data collection visit n=68 Number who attended 12-month data collection visit n=59 Number who attended 6-month data collection visit n=66 Number who attended 12-month data collection visit n=62 Participant Flow
  44. 44. Baseline Data * p value = .050; All other comparisons: p value >.05 Characteristic Treatment Control Female 36.7% 29.9% Average age (years) 49.9 48.4 Smokers 15.2% 13.0% Hypertensive meds* 27.8% 14.3% Hyperlipidemia meds 15.2% 11.7% CVD: 10-yr Risk <10% 61.0% 62.3% 10-yr Risk 10-20% 23.4% 26.0% 10-yr Risk >20% 15.6% 11.7%
  45. 45. Cost Effectiveness Analysis <ul><li>Captures both costs and effectiveness </li></ul><ul><li>Societal perspective </li></ul><ul><li>Intent to treat analysis </li></ul><ul><li>Multiple imputation used to address missing data </li></ul><ul><li>Bootstrapping for confidence intervals </li></ul><ul><li>Focus here on results during study year (vs projected costs) </li></ul>
  46. 46. Costs <ul><li>Direct medical costs </li></ul><ul><ul><li>Cost of the intervention (ND visits plus supplements) </li></ul></ul><ul><ul><li>Cost of visits (MDs, DCs, PTs, MTs, LAc) </li></ul></ul><ul><ul><li>Cost of medications </li></ul></ul><ul><ul><li>Cost of supplements patients use on their own </li></ul></ul><ul><li>Indirect costs (Productivity) </li></ul><ul><ul><li>Absenteeism </li></ul></ul><ul><ul><li>Presenteeism (productivity while at work) </li></ul></ul>
  47. 47. Resource Use (Net of baseline; Average by group over 12 months) * p value <.05; All other comparisons: p value >.05 Resource Treatment Control MD visits* -1.2 2.9 Chiropractic visits -0.04 -0.9 Physical therapy visits -0.3 1.4 Massage visits -0.1 0.2 Acupuncture visits -0.4 0.2 Absentee hours lost 10.5 4.3 Presentee hours lost -57.3 -2.3
  48. 48. Unit Costs (all in 2008 CAD) <ul><li>Multiplied by resource use </li></ul>* Average cost per insurance claim Resource Unit Cost ND visit (per hour) $152.50 MD visit $56.10 Chiropractic visit* $43.31 Physical therapy visit* $65.77 Massage visit* $59.82 Acupuncture visit* $57.03 Wage rate per hour $27.40
  49. 49. Cost of the Intervention (per participant) <ul><li>Cost of naturopathic care: </li></ul><ul><ul><li>$152.50 per hour (average of $125-$180) </li></ul></ul><ul><ul><li>1 hour initial visit + 3 * 30 minute visits + 1 hour 6 month visit + 1*30 minute visit + 1 hour 12 month visit – 1.97 protocol hrs = 3.03 hours of naturopathic care </li></ul></ul><ul><ul><li>$152.50 * 3.03 hours = $462 </li></ul></ul>
  50. 50. Total Societal Costs (Net of baseline; Average per patient over 12 months) Resource Treatment Control Net Cost ND visit cost $462 $462 MD visits ($67) $164 ($231) (-$391 to -$71) Other visits ($46) $76 ($122) (-$347 to $51) Medications $148 $100 $48 (-$94 to $180) Supplements $228 $71 $157 ($15 to $295) Productivity ($1283) $56 ($1339) (-$3374to $997) TOTAL ($558) $467 ($1025) (-$3168 to $1443)
  51. 51. Effectiveness <ul><li>Several measures available: </li></ul><ul><li>Reduction in risk of CV event </li></ul><ul><li>Reduction in risk of CV death </li></ul><ul><li>Increase in quality-adjusted life years (QALYs) </li></ul>
  52. 52. QALY Gain Over 12 Months <ul><li>Calculated from SF-36 (Brazier, J Health Econ, 2002) </li></ul><ul><li>Gain in quality-adjusted life-years (QALYs): </li></ul><ul><ul><li>Naturopathic care: 0.019 </li></ul></ul><ul><ul><li>Usual care: 0.014 </li></ul></ul><ul><li>Small net gain: 0.005 (95%CI: -0.016 to 0.026) </li></ul><ul><ul><li>Instead of 12 months of baseline health quality (73.6% of ‘perfect’), an average of 7.2 ‘perfect’ health days during the year </li></ul></ul>
  53. 53. 10-Year Risk of CVD <ul><li>Calculated from Framingham Data (D’Agostino et al., Circulation, 2008;117:743-753 ) </li></ul><ul><li>10-yr CVD event risk </li></ul><ul><ul><li>Naturopathic care: -2.5% </li></ul></ul><ul><ul><li>Usual care: 0.8% </li></ul></ul><ul><li>Net reduction: 3 .3% (95%CI: 1.7 to 4.8) </li></ul><ul><ul><li>Equivalent to 3.3 fewer workers (out of 100) experiencing a CVD event in the next 10 years; NNT=30 </li></ul></ul><ul><ul><li>Roughly 18.2 additional HYLS over next 10 years for every 100 treated </li></ul></ul>
  54. 54. Cost-Effectiveness <ul><li>Societal cost savings: $1025 in first year </li></ul><ul><li>Effectiveness: </li></ul><ul><ul><li>Gain in QALYs = 0.005 in first year </li></ul></ul><ul><ul><li>Reduction in 10-year CVD risk of 3.3% </li></ul></ul><ul><ul><li>Reduction in 10-year CVD mortality risk of 0.9% (95%CI: 0.2 to 1.6) </li></ul></ul>
  55. 55. Cost-Effectiveness Plane 82% cost saving
  56. 56. Sensitivity Analysis QALYs CVD Risk Reduction Events Mortality Base Case (n=79, 77) 0.005 3.3% 0.9% At least 2 visits (n=72, 68) 0.007 3.3% 1.1% Full data (n=41, 42) 0.008 3.9% 1.0% Mod/High Risk (n=32, 29) 0.011 5.6% 1.9%
  57. 57. Comparison to Other Primary Prevention Interventions (2008 CAD) Source: Franco et al. Int J Technol Assess Health Care . 2007;23(1):71-79. HYLS/100 Cost/Yr Annual $ /HLYS ND care 31.3 $305 + $157 $1477 Smoking cessation 0.9 – 3.4 $38-$269 $4239-$7825 Aspirin 12.3 $77 $626 Anti-HTNs 5.2 $343 $6631 Statins 14.0 $860 $6134
  58. 58. Trial in Context Naturopathic Care vs Statins 2 fold improvement in benefit + 2 fold reduction in cost = 4 x more Cost Effective
  59. 59. Cost Analysis Summary <ul><li>Cost savings (Societal perspective) </li></ul><ul><li>Reduction in 10-yr risk of CVD event </li></ul><ul><li>Reduction in 10-yr risk of CVD death </li></ul><ul><li>Small reduction in QALYs over 12 months </li></ul><ul><li>ND care costs in the “ball park” of smoking cessation, aspirin, anti-HTNs, and statins </li></ul>
  60. 60. Patient Safety <ul><li>One case of acute diverticulitis (Tx group) resolved and not believed related to Tx </li></ul><ul><li>One case of melanoma (Control group) </li></ul><ul><li>Two cases of negative reactions to fish oils (Tx group) - resolved by avoidance </li></ul><ul><li>Once MI (Control group) </li></ul><ul><li>No adverse events necessitating withdrawal </li></ul>
  61. 61. Trial Strengths <ul><li>Generalizability </li></ul><ul><li>Pragmatic trial mirrors real life conditions and clinical practice </li></ul><ul><li>Standard control comparator reflection of real care people receive </li></ul><ul><li>Individualized, whole system of care </li></ul><ul><li>Possibly augment overall compliance (>80%) </li></ul><ul><li>Multi-modality approach might augment effect </li></ul>
  62. 62. Limitations <ul><li>Open label trial </li></ul><ul><ul><li>Impossible to control for possible contamination and discussion between groups </li></ul></ul><ul><ul><li>Possible negative expectation effect in control group </li></ul></ul><ul><li>Estimating risk not hard outcomes </li></ul><ul><ul><li>Would have been optimal to have included HsCRP </li></ul></ul><ul><li>Multi modality treatment approach </li></ul><ul><ul><li>No way of differentiating between therapeutic effect </li></ul></ul><ul><ul><li>Impossible to identify specific causal associations </li></ul></ul><ul><ul><ul><li>Or Synergists/ detractors </li></ul></ul></ul>
  63. 63. Summary <ul><li>Treatment designed to provide individualized holistic/naturopathic care </li></ul><ul><ul><li>Effectively combining multiple therapies for treatment, prevention, and overall health </li></ul></ul><ul><li>No safety concerns uncovered </li></ul><ul><li>Benefits demonstrated in most of the objective risk factors measured and most importantly in the compound outcomes that best reflect real risk. </li></ul><ul><li>The addition of naturopathic medicine is significantly more effective than only community care with a medical doctor for the prevention of cardiovascular disease </li></ul>
  64. 64. Acknowledgments <ul><li>ND Clinicians </li></ul><ul><li>Orest Szczurko ND, MSc (cand) – Toronto </li></ul><ul><li>Craig Herrington ND – Edmonton </li></ul><ul><li>Serenity Aberdour ND – Vancouver </li></ul><ul><li>Trial Coordinators </li></ul><ul><li>Orest Szczurko, ND, MSc (cand) </li></ul><ul><li>Heidi Fritz, MA, ND </li></ul><ul><li>Kieran Cooley ND, MSc (cand) </li></ul><ul><li>Statistics and Epidemiology </li></ul><ul><li>Qi Zhou, PhD </li></ul><ul><li>Gordon Guyatt, MD, MsC </li></ul><ul><li>Economist </li></ul><ul><li>Patricia M Herman, ND, PhD </li></ul><ul><li>Expert Panel Members </li></ul><ul><li>Ryan Bradley, Philip Rouchotas </li></ul><ul><li>Tara Gignac, David Lescheid </li></ul><ul><li>Funding and Support: </li></ul><ul><li>Trial funded by Canada Post and the Canadian Union of Postal Workers </li></ul><ul><li>CCNM; Bob Bernhardt, PhD </li></ul><ul><li>Seroyal; supplements at a discount to patients </li></ul>