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