Francesca Galiano
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08/08/2022 - Last update 30/12/2022

Francesco Cerritelli, Fabrizio Carinci, Gianfranco Pizzolorusso, Patrizia Turi, Cinzia Renzetti, Felice Pizzolorusso, Francesco Orlando, Vincenzo Cozzolino, Gina Barlafante | Year 2011

Osteopathic manipulation as a complementary treatment for the prevention of cardiac complications

Pathology:

Hypertension

Type of study:

Non-randomized controlled trial (as an explorative study)

Date of publication of the study’:

2011/Jan/15

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Purpose of the study

  • Objective: to evaluate the effects of OMT on hypertension using routine parameters used to prevent long-term cardiovascular risks
  • Measured outcomes:
    • Primary: changes in the intima media thickness and in systolic and diastolic blood pressure

Participants

  • Number: 63 people (32 female and 31 male)
  • Criteria of inclusion: patients who had presented themselves consecutively to a private cardiologist, hypertension classified grade 1 or + according to the WHO specifications, b-mode ultrasonography of the intima-media classified as II, III or IV
  • Criteria of exclusion: presence of multiple risk factors and with relevant complications in the previous 10 years (kidney disease, hypercholesterolemia, diabetes, metabolic problems such as obesity or X syndrome and smoking)
  • Groups of study: two non randomized groups
    • Group 1: standard care with the addition of OMT, 31 people (15 female and 16 male, average age 50 years)
    • Group 2: standard care, 32 persone (17 female and 15 male, average age 49.6 years)

Interventions and evaluations

 

  • Evaluation, with use of Holter for 24 hours, of blood pressure, thickness of the intima-media through b-mode ultrasonography, body mass index, height, weight, resting heart rate, both at baseline and after 12 months.
  • Fortnightly sessions of OMT for a year
  • Standard care: pharmacological therapy (calcium channel blockers, ACE-inhibitors, beta-blockers and diuretics, alone or in combination)
    OMT:
    • initial assessment: mobility test on different parts of the body, in particular, spring test for dorsal and lumbar spine, F.AB.ER. test for the hips, internal and external rotation test for the arms, and six movements test for the neck
    • treatment: organized based on the assessment’s results, use of fascial, cranial and balanced ligamentous tension techniques
  • All patients have been followed by the same cardiologist, who took care of the evaluations and of the standard care
  • OMT administered by one osteopath

Results

  • Primary outcomes: considering only the correlation between OMT and primary outcomes, the OMT has helped to statistically significantly reduce thickness of the intima-media, diastolic pressure and systolic pressure.

From the statistical analyses that considered also the importance of other factors – body mass index, blood pressure at baseline, dosage of the drugs taken, sex – it emerged that OMT favored the reduction of the intima-media thickness (-0.517mm, with a confidence interval, or CI, between -0.680 and -0.353) and systolic pressure (-4.317mmHg, with a CI between -6.421 and -2.214) in a statistically significant manner.

Discussion

OMT has been shown to contribute significantly to the reduction of cardiovascular risk by statistically significantly reducing the intima-media thickness and systolic blood pressure. The result is of particular importance as the effects occurred in people who simultaneously followed a standard drug therapy.

The rationale of this effect can be found in the capability of the OMT: to reduce the production of inflammatory cytokines through the manipulation of tissues; to promote a rebalancing of the autonomic nervous system.

The authors hope for more rigorous studies (e.g. calculation of sample size, randomization) to understand the scope of the OMT and its usefulness, also in terms of cost-benefit analysis, in the daily clinic as an added value to standard therapy.
Given the incidence of cardiovascular events, even fatal, that occur every year, having a non-invasive and potentially safe tool that can reduce the risk of them can be very important for the health system.

The review of Osteopedia

By Marco Chiera

Strengths: articulated statistical analyses that have considered the weight of other variables in order to evaluate the specific effect of the OMT; evaluation of the long-term effects; OMT evaluated in addition, and therefore in reference, to the standard drug treatment based on efficacy tests; use of routine clinical outcomes easily measurable in the daily practice.

Limits: it is not described how people were allocated between the two groups; the non-randomization may have led to including in the OMT group the people most inclined to receive it and therefore to improve; possible adverse effects have not been assessed (although it looks like there were none as they were not mentioned and no patient left the study); fortnightly treatment for a year is not something that everyone can afford, especially if offered by a private service.

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