Why the study?
Elevated periosteal pressure sensitivity at the sternum reflects autonomic dysfunction in ischemic heart disease, and whether a non-pharmacological reduction program reduces all-cause mortality had not been tested in a randomized trial.
Does a non-pharmacological cutaneous sensory nerve stimulation and stress management program reduce all-cause mortality in patients with stable ischemic heart disease and elevated autonomic stress?
Does a non-pharmacological cutaneous sensory nerve stimulation and stress management program reduce all-cause mortality in patients with stable ischemic heart disease and elevated autonomic stress?
A specific non-pharmacological educational program focusing on cutaneous sensory nerve stimulation to reduce autonomic nervous system dysfunction significantly lowered 5-year all-cause mortality in patients with stable ischemic heart disease compared to standard cardiac rehabilitation.
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Adjunct PPS reduction may lower 5-year IHD mortality; extends prior observational findings with RCT evidence.
Background: Autonomic nervous system dysfunction (ANSD) is associated with negative prognosis of ischemic heart disease (IHD). Elevated periosteal pressure sensitivity (PPS) at the sternum relates to ANSD and sympathetic hyperactivity. Two previous observational case–control studies of the effect of reduction of PPS suggested lower all-cause mortality from IHD and stroke. We now used a specific daily, adjunct, non-pharmacological program of reduction of elevated PPS to test the hypothetical association between the intervention and reduced all-cause mortality in patients with stable IHD in a randomized controlled trial (RCT). Methods: We completed active (n = 106) and passive interventions (n = 107) and compared the five-year mortalities. We also compared the five-year individual all-cause mortality of each participant to approximately 35.000 members of the general population of Denmark. Pooling the mortality data from the active group of the RCT with the two preliminary studies, we registered the mortality following active intervention of 1.168 person-years, compared to 40 million person-years of the pooled general population. Results: We recorded fewer deaths of the active RCT intervention group than of the corresponding control group from the general population (p = 0.01), as well as of the passive RCT intervention group (p = 0.035). The meta-analysis of the three studies together demonstrated reduced 4.2-year all-cause mortality of 60% (p = 0.007). Conclusions: The test of the hypothetical effect of an intervention aimed at the attenuation of ANSD accompanied by a lowered PPS revealed reduced all-cause mortality in patients with stable IHD.
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Ballegaard et al. (2023) studied this question.
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