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
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Journal club: Cardiovascular Disease
- 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
- 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.
- 8. Prescreened Participants Highest risk of developing cardiovascular disease ~ 400 approached N = 246 consented
- 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
- 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
- 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
- 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
- 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%
- 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
- 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)
- 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
Editor's Notes
- 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.