Complementary Alternative Cardiovascular Medicine
Complementary Alternative Cardiovascular Medicine
Complementary Alternative Cardiovascular Medicine
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144 <strong>Alternative</strong> <strong>Cardiovascular</strong> <strong>Medicine</strong><br />
differences were seen between the two groups. Also, there were no differences<br />
between the groups in a quality-of-life score.<br />
As the most recent of the published trials of prayer in CCU patients,<br />
the Aviles Mayo Clinic study brought clearer focus to several new areas<br />
of study design. Rather than a single all-comer’s CCU population, the<br />
Aviles study risk stratified the patient cohort into high-risk and low-risk<br />
groups. Instead of derived indices, the Mayo Clinic study used wellaccepted<br />
clinical outcome measures as end points and powered the study<br />
to observe a therapeutic benefit based on expected outcomes rates in the<br />
control population. In fact, the morbidity and mortality rates in the control<br />
population were lower than those used for the power calculations,<br />
reducing the power of the study to detect a treatment benefit in the<br />
population size studied.<br />
Another issue crystalized by the Mayo Clinic report is the timing of<br />
therapy. Although the patients studied were CCU patients, therapy with<br />
prayer was begun only after discharge, whereas in both the Byrd and<br />
Harris studies, prayer therapy was initiated shortly after enrollment,<br />
when patients were still in the acute phase of CCU care. Also, whereas<br />
Byrd and Harris had set out specific content for the prayer, this was not<br />
the case with Aviles. Intercessors were allowed to pray however they<br />
wanted. They were asked to pray at least once a week, and it is certainly<br />
possible that some prayed more. Therefore, the authors comment that a<br />
potential limitation of their study is that the “dose” of prayer was not<br />
regulated.<br />
The fourth prospective randomized controlled clinical trial in cardiology<br />
patients was the Monitoring & Actualization of Noetic TRAinings<br />
(MANTRA) Pilot study, also published in 2001 (13). This study was<br />
conducted in an all-male population in the CCU at the Durham Veterans<br />
Affairs Medical Center. All patients in this study had unstable coronary<br />
syndromes and were scheduled for acute cardiac catheterization and<br />
angioplasty or coronary stenting. Outcomes measured were short-term<br />
(procedural and in-hospital) and long-term (6-mo postdischarge) standard<br />
cardiovascular complications, compiled as major adverse cardiovascular<br />
end-points. The study was a feasibility pilot to evaluate standard<br />
therapy vs four noetic therapies: stress relaxation, imagery, touch<br />
therapy, and double-blind off-site intercessory prayer. A total of 150<br />
patients were enrolled, with 30 patients randomized to each treatment<br />
group. There were no safety or feasibility concerns. Absolute reductions<br />
in the number of patients suffering major adverse cardiac events<br />
(MACE), as well as a reduction in postangioplasty evidence of ischemia<br />
on continuous electrocardiogram monitoring, were observed in patients