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Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
Journal club: Cardiovascular Disease
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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 …

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

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  • lots of high fibre foods whole grains, legumes pumpkin and sunflower seeds, ground flax seeds, walnuts, almonds kale, Romaine lettuce, spinach less than 66 grams (2oz) fat per day less than 30% of calories from fat
  • 1 tsp of lemon juice or apple cider vinegar in ½ cup of water 10 minutes before eating help to “prime” your digestion
  • Main points: This was the primary outcome of the study We saw a statistically significant 3.6% reduction in the average risk of a cardiovascular event (heart attack, stroke, CHF, etc) over the next 10 years. This translates into 3.6 fewer workers (out of 100) having a heart attack, stroke, etc over the next 10 years. The number needed to treat is notably low at 28 over 10 years. We would only have to treat 28 patients with naturopathic care to have one avoid a CVD event. For comparison the 10 year NNT for statins ranges from 35-125. [statins have a NNT of at least 70-250 over 5 years; roughly 35-125 over ten years] This 3.6% reduction generates over 20 additional healthy years of life saved (years without CVD) per 100 workers treated over the next 10 years
  • Other includes the following symptoms (n): dizziness (5), chronic sinusitis, tight scalp, homework, acne, upper bronchial infxn, phlegm, anger, hand numbness (2), hand tingling, hot flashes, cough, frequent urination, snoring, feet tingling, libido, itchiness
  • Main points: Over 1000 screened across 3 worksites Primary prevention, so no existing CVD Only those with higher risk of CVD invited to the trial Of those, 246 gave consent and were randomized Of those, the cost-effectiveness analysis will focus on the subset who consented to have their insurance claim and sick leave data pulled. At this point note that the randomization was done after both informed consents, so individuals who gave consent for claims and sick leave data had an equal chance of being allocated to either group. This subset was analyzed and found to be no different than those who did not consent to these data according to any of the variables measured, including outcomes. [I wouldn’t get into the fact that they were less likely to provide cost diary data because it would take too long to explain and it is a ‘duh’ result anyway.]
  • Groups pretty well matched at baseline; across the 40+ variables tested, only the prevelance of hypertensive meds was marginally significant under an alpha<.05 assumption.
  • Main points: What cost-effectiveness analysis does is add information on costs to what is known about effectiveness. The cost-effectiveness analysis presented here utilizes the societal perspective which captures all costs and benefits no matter who incurs them. We did an intent-to-treat analysis and used multiple imputation to fill in missing values And for the most part the costs presented here are those incurred during the study year; Only the last slide makes some attempt to estimate maintenance costs.
  • Main points: Costs are generally calculated by measuring changes in resource use and multiplying these times the unit cost of each resource. As you can see, naturopathic treatment generally reduced resource use. Note that absenteeism in terms of paid and unpaid leave increased in both groups, but only by a few hours over the year. More important are these larger changes in presenteeism hours. Presenteeism is productivity while at work. Productivity improved in the treatment group by a total of between 7 and 8 days over the year, while it declined for the control group by an average of about 4 days.
  • These are the unit costs that we used to value the resource use changes shown on the last screen.
  • Main points: As an example of using unit costs and resource use to calculate costs… Naturopathic care was valued at $152.50 per hour There were 7 visits over the study year: 3 full-hour visits at baseline, 6 months and 12 months, and 4 - 30 minute visits (3 in the first 6 months and 1 in the second). From this total of 5 hours we subtracted the time taken by the study protocol and for data collection. The three main data collection points were the baseline, 6 month and 12 month visits. About 30 minutes of each of those visits were taken up with research protocol business, and about 7 minutes of each of the 30 minute visits. So this works out to $462 for naturopathic care over the study year.
  • Main points: So here are what the study year costs look like across the cost categories As you can see, on average naturopathic treatment offers substantial cost savings per participant to society as a whole. As you can also see, the bulk of those savings accrue to the employer in terms of productivity savings – and most of those from increased productivity while at work.
  • Main points: We were surprised and pleased to see a small (not statistically significant) increase in QALYs from naturopathic care during the study year. This small gain translates into on average participants getting 7 of the days in the year at ‘perfect’ health rather than all days at average quality.
  • Main points: This was the primary outcome of the study We saw a statistically significant 3.6% reduction in the average risk of a cardiovascular event (heart attack, stroke, CHF, etc) over the next 10 years. This translates into 3.3 fewer workers (out of 100) having a heart attack, stroke, etc over the next 10 years. The number needed to treat is notably low at 30 over 10 years. We would only have to treat 30 patients with naturopathic care to have one avoid a CVD event. For comparison the 10 year NNT for statins ranges from 35-125. [statins have a NNT of at least 70-250 over 5 years; roughly 35-125 over ten years] This 3.3% reduction generates over 18 additional healthy years of life saved (years without CVD) per 100 workers treated over the next 10 years
  • Main points: So here are our main outcomes A cost savings to society of $2470 A slight gain in QALYs during the study year A significant reduction in 10-year CVD event risk And this reduction in event risk embodies a 1% reduction in CVD mortality risk - this means one less CVD death over the next 10 years per 100 workers treated, and this also translates into an average of 5.0 YLS per 100 over the next 10 years.
  • Main points: So here are the cost-effectiveness results for the study year across 1000 bootstrapped samples. As you can see almost all of the samples show average cost savings and all show a significant reduction in CVD risk. Harking back to the matrix I showed you earlier, almost all the data points are in the purple section of that graph.
  • Main points: The rest of the presentation up to this point focused on the study year results. Here is an attempt to look at maintenance costs and compare naturopathic medicine to other interventions for the primary prevention of CVD. As you can see (last column) naturopathic treatment compares very favorably to other more conventional interventions. Note that our results are not completely comparable to these others because (as you remember from an earlier slide) some of our participants were already on statins (about 25%) and some were already on hypertensive medications (between 12 and 15%). But this difference only serves to favor naturopathic care because it is showing these types of impacts in addition to what statins and blood pressure medications can do.
  • Transcript

    • 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. Outline <ul><li>Background </li></ul><ul><li>Methodology </li></ul><ul><li>Results </li></ul><ul><li>Interpretation </li></ul>
    • 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. 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. 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. 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. 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. Prescreened Participants Highest risk of developing cardiovascular disease ~ 400 approached N = 246 consented
    • 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. 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. - 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Framingham CVD risk Profile point scores for women 36 yr old female; Score = 2 + 0 + 1 + 4 + 3 + 0 = 10
    • 30. Framingham CVD risk Profile score conversion  10 yr risk 6.3% risk of having a CVD related event within ten years
    • 31. CVD risk Profile score conversion  vascular age 36 yr old women has the heart or vascular age of a 59 year old
    • 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. Diagnostic Criteria for Metabolic Syndrome
    • 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. Baseline Comparison
    • 36. Results – Metabolic Syndrome P = 0.21 Δ = - 27.4%; 95% CI (-41.74%, -13.07%) p = 0.0002
    • 37. Cardiovascular Age P = 0.31 Δ = -5.4; 95% CI -7.7 , -3.1) p < 0.0001 Actual age Actual age
    • 38. Results – 10-year CVD Risk P = 0.49 Δ = - 3.6%; 95% CI (-5.1%, -2.3%) p < 0.0001
    • 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. Secondary Outcomes with Significant Difference (p < 0.05)
    • 41. Chief complaints experienced by all participants x 2
    • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Cost-Effectiveness Plane 82% cost saving
    • 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. 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. Trial in Context Naturopathic Care vs Statins 2 fold improvement in benefit + 2 fold reduction in cost = 4 x more Cost Effective
    • 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. 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. 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. 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. 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. 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>

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