Complementary Alternative Cardiovascular Medicine

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