The Effects of OMT on Cardiac Function in Patients with Hypertension Francesco Cerritelli MPH MS DO European Institute for Evidence Based Osteopathic Medicine (EBOM) AIOT Research Institute Pescara, Italy [email protected] 2011 AOA Research Conference October 30 – November 1, 2011 Orlando, Florida (USA) 1 Outline • Background on hypertension • Role of OMT in hypertension • Food for thought 2 Classification source: JNC 7 3 Burden of hypertension overall: 26.4% [95% CI 26.0, 26.8% man: 26.6% [26.0–27.2%] women: 26.1% [25.5, 26.6%] overall: 29.2% [28.8, 29.0%] man: 29.0% [28.6, 29.4%] women: 29.5% [29.1, 29.9%] 1.56 billion [1.54, 1.58] people Kearney, Whelton et al, Lancet 2005 4 Incidence Vasan, Beiser et al, JAMA 2002 5 Mortality • The mortality estimate for hypertension is 7.1 million premature deaths worldwide equal to 4.5% of the cardiovascular disease burden (64 million DALYs) Whitworth, J Hypert 2003 6 Morbidity stroke heart failure kidney chronic disease Redon J et al. Eur Heart J. 2011 Lawes CM et al. Stroke. 2004 7 Morbidity Association between hypertension and change in endothelial carotid wall • Safar ME, Levy BI, Struijker-Boudier H. Current perspectives on arterial stiffness and pulse pressure in hypertension and cardiovascular diseases. Circulation. 2003 Jun 10;107(22):2864-9 8 Diagnostic tools Intima-media thickness (IMT) measurement as a new tool for diagnosis and treatment of cardiovascular risk Simon A et al, J Hyper. 2002. 9 OMT and hypertension Effect of OMT on the cardiovascular system years 60’s Soft tissue manipulation of the upper thoracic and cervical vertebrae associated with a decrease in blood pressure and plasma fibrinogen and total fibrinolytic activity Celander E. J Am Osteopath Assoc. 1968 Fichera AP, J Am Osteopath Assoc. 1969 70’s Brown T, J Am Osteopath Assoc. 1970 Soft tissue manipulation (cervical/thorax) associated with a significant reductions in both systolic and diastolic pressures Mannino JR, J Am Osteopath Assoc. 1979 Chapman's techniques for adrenal glands Aldosterone levels declined within 36 hours No significant reduction of SBP Morgan JP, J Am Osteopath Assoc. 1985 RCT: No association between reduction of SBP and OMT 80’s 10 OMT and hypertension Somatic dysfunction findings Cervical-dorsal passage Upper thoracic vertebras • Johnston WL, et al. J Am Osteopath Assoc. 1995 • Johnston, W.L., et al J Am Osteopath Assoc. 1995 • Cox JM et al J Am Osteopath Assoc. 198311 Pescara’s CBA research • Is there a statistically significant association between OMT and change in Blood Pressure (BP) and intima media thickness (IMT) at 12 months? 12 Methods • Non randomized trial at cardiologic practice • Baseline measurements of clinical characteristics (BMI, BP, etc) • Visits at 0, 12 months • Outcomes: • change in systolic and diastolic BP • change in IMT 13 Methods 72 cardiologic patients EXCLUSION CRITERIA: •renal/retinal disease, •hypercholesterolemia (>250 mmol/l), •diabetes, •metabolic problems (as obesity or X syndrome) •smoking 9 out 63 included 31 OMT 32 control 14 Treatment Procedures OMT was performed on the part of the body presenting greater TART modifications using fascial, cranial and balanced ligamentous tension techniques. 15 Statistical Analysis • Arithmetic means and SD for the general characteristics of study population • Univariate statistical tests for all differences between study and control group • Multivariate linear regression for OMT on primary outcomes 16 Study Population 17 Univariate analysis (1) 18 Univariate analysis (2) Variable Baseline Category SBP (mmHg) t12- t0 IMT (mm) t12- t0 DBP (mmHg) t12- t0 mean Δ±s.d. p>t mean Δ±s.d. p>t mean Δ±s.d. p>t Gender Female Male -0.25 ± 0.33 -0.29 ± 0.37 0.65 -23.88 ± 3.33 -24.23 ± 4.60 0.73 -10.63 ± 2.93 -10.13 ± 3.88 0.57 Age <55 >55 -0.26 ± 0.34 -0.28 ± 0.39 0.89 -23.94 ± 4.01 -24.55 ± 3.98 0.66 -10.52 ± 3.55 -9.73 ± 2.69 0.41 BMI <25 >25 -0.26 ± 0.35 -0.27 ± 0.35 0.99 -23.17 ± 3.38 -25.81 ± 4.56 0.03 -9.90 ± 2.87 -11.33 ± 4.21 0.17 Heart Rate <72 >72 -0.29 ± 0.36 -0.17 ± 0.28 0.20 -23.61 ± 3.60 -25.57 ± 4.94 0.18 -9.80 ± 3.03 -12.43 ± 3.96 0.03 Tot Dose <75 >75 -0.24 ± 0.32 -0.32 ± 0.43 0.53 -23.56 ± 3.83 -25.79 ± 4.14 0.09 -10.35 ± 3.26 -10.50 ± 4.01 0.90 SBP <154 >154 -0.31 ± 0.36 -0.12 ± 0.26 0.04 -23.43 ± 3.42 -26.21 ± 5.09 0.07 -9.63 ± 3.14 -13.00 ± 3.09 0.002 DBP <96 >96 -0.30 ± 0.36 -0.13 ± 0.26 0.05 -23.37 ± 3.29 -26.43 ± 5.26 0.06 -9.43 ± 2.83 -13.71 ± 3.24 0.0003 IMT <4mm >4mm -0.30 ± 0.36 -0.15 ± 0.28 0.08 -23.47 ± 3.27 -25.75 ± 5.35 0.12 -9.38 ± 2.88 -13.31 ± 3.22 0.0002 OMT No Yes -0.00 ± 0.10 -0.53 ± 0.30 -9.16 ± 2.41 -11.65 ± 3.84 0.003 <.0001 -21.69 ± 2.57 -26.48 ± 19 3.71 <.0001 Multivariate analysis (1) IMT (mm) t12- t0 β 95%c.i. p>χ2 Male -0.078 -0.197 – 0.040 0.190 Age 0.009 -0.001 – 0.018 0.068 BMI 0.046 0.004 – 0.088 0.033 Heart Rate -0.001 -0.025 – 0.023 0.915 Tot Dose t0 Tot Dose t12- t0 0.0004 0.004 -0.001 – 0.001 0.001 – 0.006 0.414 0.007 IMT t0 -0.005 . -0.080 – 0.069 . 0.889 . -0.028 -0.009 -0.066 – 0.009 -0.035 – 0.016 0.138 0.437 DBP t12- t0 0.041 -0.006 -0.007 – 0.089 -0.035 – 0.022 0.070 0.661 OMT -0.613 -0.680 – -0.353 <.0001 IMT t12- t0 SBP t0 SBP t12- t0 DBP t0 20 Multivariate analysis (2) SBP (mmHg) t12- t0 β 95%c.i. p>χ2 Male -0.529 -1.856 – 0.799 0.428 Age 0.017 -0.089 – 0.125 0.742 BMI -0.045 -0.531 – 0.441 0.853 Heart Rate 0.064 -0.200 – 0.327 0.630 Tot Dose t0 Tot Dose t12- t0 -0.001 0.003 -0.013 – 0.012 -0.028 – 0.035 0.887 0.834 IMT t0 1.106 -1.126 0.341 – 1.871 -4.258 – 2.006 0.005 0.473 -0.894 . -1.239 – -0.550 . <.0001 . DBP t12- t0 0.654 0.499 0.173 – 1.135 0.212 – 0.785 0.009 <.0001 OMT -4,317 -6.421 – -2.214 <.0001 IMT t12- t0 SBP t0 SBP t12- t0 DBP t0 21 Multivariate analysis (3) DBP (mmHg) t12- t0 Β 95%c.i. p>χ2 Male 0.345 -0.839 – 1.530 0.560 Age -0.044 -0.138 – 0.051 0.359 BMI 0.151 -0.280 – 0.581 0.484 Heart Rate 0.073 -0.161 – 0.307 0.536 Tot Dose t0 Tot Dose t12- t0 0.005 0.005 -0.005 – 0.016 -0.023 – 0.032 0.336 0.737 IMT t0 -0.525 -0.615 -1.245 – 0.195 -3.409 – 2.180 0.149 0.661 0.591 0.394 0.249 – 0.933 0.168 – 0.621 0.001 <.0001 DBP t12- t0 -1.080 . -1.422 – -0.740 . <.0001 . OMT -0.348 -2.511 – 1.816 0.748 IMT t12- t0 SBP t0 SBP t12- t0 DBP t0 22 Multivariate analysis (4) 23 Discussion BP is influenced by several factors: • Neurological: • Grassi G, Am J Hypertens 2010 • Charkoudian N et al, Mayo Clin Proc 2009 • Neuro-humoral: • Schlaich MP et al, Hypertens 2004 Marvar et al, Curr Opin Pharmacol 2011 24 Discussion inflammatory process, endothelial dysfunction and HBP Bautista, J Hum Hypertens 2003 25 Discussion OMT effects on sympathetic activity Outcome: fibrinolytic enzyme system and fibrinogen levels Methods: soft tissue manipulation therapy Results: decrease in plasma fibrinogen and total fibrinolytic activity Conclusion: First scientific justification for the effects of OMT on hypertension and autonomic nervous function Celander E et al, J Am Osteopath Assoc. 1968 26 Discussion OMT effects on sympathetic activity Henley CE et al, Osteopath Med Prim Care. 2008 27 Discussion OMT and anti-inflammatory effect Meltzer KR, Standley PR. J Am Osteopath Assoc. 2007 28 Hypothetical mechanism of action Narkiewicz et al., 2005 Henley CE et al., 2008 Meltzer and Standley, 2007 Cerritelli F et al, J Bodyw Mov Ther. 2011 29 Discussion Diastolic blood pressure control • Hackam DG et al.Can J Cardiol. 2010 30 Limitations • No random allocation • No formal computation of power and sample size • No data on practice variation 31 Conclusions • The present study shows that after a one-year follow-up, osteopathic treatment is independently associated to a statistically significant improvement in systolic blood pressure and intima media thickness. 32 Food for thought • Where are we now? Possible role of OMT in hypertension • Where do we want to go? public health mechanisms of action 33 Acknowledgments Barlafante G. Carinci F. Pizzolorusso G. 34 Thank you for your attention Francesco Cerritelli MPH MS DO European Institute for Evidence Based Osteopathic Medicine (EBOM) AIOT Research Institute Pescara, Italy [email protected] 35
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