http://www.medpagetoday.com/Cardiology/InterventionalCardiology/tb/1362
DURHAM, N.C. July 14-Can prayers for divine intervention affect the outcomes of cardiac interventions? God only knows.
That's the dispassionate, science-based conclusion of investigators in the multicenter MANTRA II trial, a study looking at the effects of distant prayer and of combined music, imagery, and touch therapy on patients scheduled to undergo cardiac catheterization. It was published in the July 16 issue of The Lancet.
In a study involving 748 patients at eight centers slated for catheterizations, patients who, unbeknownst to them, were randomly assigned to be the subjects of multi-faith prayers before their procedures, fared no better than controls (un-prayed for) patients, reported Mitchell W. Krucoff, M.D. of the Duke Clinical Research Institute here and colleagues.
In addition to seeing no effect of prayer, they found that patients who were randomly assigned to receive music, imagery and touch therapy shortly before their scheduled procedures reported having lower stress going into the procedure. Yet they did no better than controls on measures of major cardiovascular events or hospital readmission, although treated patients have a lower risk of death at a six month follow-up.
The authors bent over backwards to be respectful of divergent beliefs and practices, and emphasized that the influence on health of so-called "noetic" interventions -- defined as therapies that don't involve the use of tangible drugs or devices -- deserves further scientific scrutiny.
"If we want to understand the role of human capacities and resources in the midst of our most advanced medical technologies, we have to do good science," Dr. Krucoff said. "With no notion of the actual mechanisms involved in ancient healing practices such as prayer or touch or music, structured outcomes research allows us to collect data that we can learn from in many ways."
The task that the MANTRA II investigators set for themselves was like trying to nail Jell-O to a wall -- an effort to apply solid scientific reasoning and unbiased measurement tools to intangible spiritual and metaphysical concepts.
They attempted it by randomly assigning 748 cardiac procedure candidates to either off-site prayer by established congregations of various religions or to no prayer; or to music, imagery, and touch (MIT) therapy conducted by a practitioner certified in Level 1 Healing Touch, or no MIT.
In all, 192 patients received only standard care, 182 received off-site prayer, 185 had MIT therapy only, and 189 had both prayer and MIT.
MIT consisted of a 40-minute open bedside session before the procedure, in which each patient was taught relaxed breathing techniques, and was asked to choose and focus mentally on an image of the most peaceful, beautiful place he/she could think of. Patients chose a preferred type of music from a standardized selection, and each practitioner applied 21 Healing Touch hand positions applied for 45 seconds each. Patients were also allowed to listen with headphones to their music of choice during the procedure.
For the prayed-for group, the name, age and illness of each patient was furnished to each of 12 Christian, Muslim, Jewish, and Buddhist prayer groups within 30 minutes of randomization. In the final year of enrollment, a second tier of 12 prayer groups was added.
"When a patient was assigned prayer therapy, the second-tier groups were not given information on the name, age or illness, but were simply notified that a patient had been enrolled and asked to pray for the prayers of the primary-tier congregations," the authors explained.
The primary study outcome was a composite endpoint of in-hospital major cardiac adverse events or death or readmission to hospital within six months of the procedure. Pre-specified secondary endpoints included major adverse cardiovascular events, death or readmission, and mortality, each within the following 6 months.
Major adverse events included death, new myocardial infarction on ECG or a rise in creatine phosphokinase more than twice the upper limit of normal, new congestive heart failure, repeat percutaneous coronary intervention, or coronary bypass surgery.
Among the 717 patients available for complete six-month follow-up, there were a total of 263 (37%) composite endpoints, 179 (24%) major cardiovascular events, 238 (33%) hospital readmissions, and 27 (4%) deaths.
Among the MIT patients, there were no differences between treated patients and controls in the composite primary or secondary endpoints. There was however a significant difference in the isolated endpoint of death within six months, with MIT-treated patients having a significantly lower risk of dying than controls (hazard ratio 0.35 [95% CI, 0.15-0.82, p=0.0156]).
Although treated patients in this group reported lower levels of distress prior to the procedure, "we cannot with certainty discern whether the mechanism of this effect relates to the presence of a compassionate human being at the bedside or to any individual component of the treatment strategy (the music, the imagery, or the touch)," Dr. Krucoff's group wrote.
In the prayed-for patient group there were no significant differences between prayer and no-prayer groups in any of the primary or secondary endpoints. In addition, there were no significant differences between the single-tier or two-tier prayer groups.
A comparison among all four combinations (prayer only, MIT only, prayer plus MIT or standard care alone) showed no significant differences in the primary or secondary composite endpoints. Six-month mortality was slightly lower in patients assigned to both prayer and MIT than in those assigned to standard care or to prayer only, with hazard ratios of 0.34 (95% CI 0.09-1.25; p=0.10) and 0.26 (95% CI 0.07-0.93; p=0.04).
"Active bedside compassion and prayers for the sick are widely practiced for healing throughout the world. Whether such bedside and remote practices have any effect on clinical outcomes remains controversial," the investigators commented.
"Do the results of the MANTRA II study rule out the use of noetic therapies in modern scientific medicine?" Lancet editors asked in an accompanying editorial. "Such a conclusion would be premature. The contribution that hope and belief make to a personal understanding of illness cannot be dismissed so lightly. They are proper subjects for science, even while transcending its known bounds."
