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

-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

-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

-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

-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

-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

-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

-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