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DURHAM, N.C. -- Distant prayer and the bedside use of music, imagery and touch (MIT therapy) did not have a significant effect upon the primary clinical outcome observed in patients undergoing certain heart procedures, researchers at Duke Clinical Research Institute (DCRI), Duke University Medical Center, the Durham Veterans Affairs Medical Center (VAMC) and seven other leading academic medical institutions across the U.S. have found. Therapeutic effects were noted, however, among secondary measures such as emotional distress of patients, re-hospitalization and death rates.

The study marks the first time rigorous scientific protocols have been applied on a large scale to some of the world's most ancient healing traditions, the authors said, and the trends they observed may yield important clues to understanding the role of the human spirit in modern, technology-laden cardiovascular health care.

"Prayers for the sick and healing-touch are among the most widely practiced healing traditions around the world," said Mitchell Krucoff, MD, interventional cardiologist at Duke and lead author of the study. "As widespread as these practices are, few rigorous studies exist to explain any mechanism of action or reliable measures of safety or effectiveness. While many of us are fascinated culturally or philosophically with the mystery of healing and prayer, for the practice of medicine we need to understand these phenomena with data-driven insight."

The report from Duke, which appears in the July 16, 2005, issue of The Lancet, is based upon data from the Monitoring and Actualization of Noetic TRAinings (MANTRA) II study – the first multicenter, prospective, randomized trial of distant intercessory prayer and bedside music, imagery and touch therapy (MIT). "Noetic" interventions like prayer and MIT therapies are defined as "an intangible healing influence brought about without the use of a drug, device or surgical procedure," according to the researchers.

A total of 748 patients with coronary artery disease who were to undergo percutaneous coronary intervention (a type of stenting procedure) or elective cardiac catheterization with possible percutaneous coronary intervention were enrolled at one of nine study sites between May 1999 and Dec. 2002. Patients were randomized equally to each of the two noetic therapies or standard care, creating four treatment groups. One group (189 patients) received both off-site intercessory prayer and MIT therapy; a second group (182 patients) received off-site intercessory prayer only; a third group (185 patients) received MIT therapy only, while the fourth group (192 patients) received neither the intercessory prayer nor the MIT therapy. The interventional heart procedures were all conducted according to each institution's standard practice, and the study called for a six-month period of follow-up.

The prayer portion of the randomization was double-blinded, meaning that patients and their care team did not know which patients were receiving intercessory prayer. Per Institutional Review Board policies governing clinical research, all patients were aware that they might be prayed for by people they did not know, from a variety of faiths. The MIT portion of the study was not blinded, so patients and their care team knew if they were randomized to those groups.

The prayer groups for the study were located throughout the world and included Buddhist, Muslim, Jewish and multiple Christianity-based denominations. The researchers noted 89 percent of the patients in this study also knew of someone praying for them outside of the study protocol altogether.

Examining the effects of prayer upon health outcomes has been controversial, the authors acknowledge. However, "carefully examining the role of the human spirit in health care does not diminish its mystery, but it separates the mystery from the question of utility in health care practice," Krucoff said.

MIT therapy was performed by a certified practitioner for 40 minutes at the patient's bedside after enrollment but before the coronary procedure. The patient was taught relaxed abdominal breathing, chose a preferred place image (defined as the most beautiful,peaceful place he or she had ever been)and selected a musical preference (easy listening, classical, or country music). Identical cassette-tape music-imagery scripts were used for all patients in all enrollment sites. After the imagery script, the practitioner applied 21 healing touch hand positions, each for a period of 45 seconds. The patient then had the option to wear the headphones with musical background during the coronary procedure.

The primary clinical outcome included a combination of in-hospital major adverse cardiovascular events such as death; new signs of heart attack or a rise in the damage-indicating enzyme creatine phosphokinase to more than twice the upper limit of normal; new congestive heart failure; the need for additional coronary stenting; or the need for heart bypass surgery, and/or re-hospitalization or death within the six-month post-discharge follow up. Pre-specified secondary study endpoints included subsets of the primary endpoint combination, such as six-month death or re-hospitalization, as well as measures of emotional distress prior to a patient's procedure.

The researchers found no significant differences among the treatment groups in the primary composite endpoint. However, six-month mortality was lower in patients assigned bedside MIT, with the lowest absolute death rates observed in patients treated with both prayer and bedside MIT. Patients treated with bedside MIT also showed changes in self-rated emotional distress prior to catheterization and stenting.

"The most statistically significant finding of our analyses so far is the relief of pre-procedural distress with the use of music, imagery and touch administered by a trained practitioner at the patient's bedside," said Suzanne Crater, ANP-C, cardiology nurse practitioner at DUMC and Durham VAMC and co-director of the MANTRA study project at the DCRI. "Whether this relief of distress translates into better outcomes will require further analysis but the implications for every bedside practitioner are of great interest."

The researchers say their study design sets a foundation for further research in this area.

"While it's clear there was no measurable impact on the primary composite endpoints of this study, the trends and behavior of pre-specified secondary outcome measures suggest treatment effects that can be taken pretty seriously when considering future study directions," Krucoff added.

Following the terror attacks of Sept. 11, 2001, enrollment rates in the study fell sharply for approximately three months. During that time, the research team chose to amend the study by adding a two-tiered prayer strategy. Twelve additional "second-tier" prayer groups were added. When new patients were added to groups receiving intercessory prayers as part of the study, the second-tier prayer groups were asked to pray for the primary prayer groups that had been praying for the patients all along. The researchers created this design to simulate a higher dose of prayer for the remaining patients enrolled in the study. Patients treated with "two-tiered" prayer had absolute six-month death and re-hospitalization rates that were about 30 percent lower than control patients, statistically characterized as a suggestive trend.

"While these are ancient healing modalities in all of the world's cultures, the scientific literature and understanding of the role of intangible human capacities in our world of high tech medical care is very, very young" said Krucoff. "The MANTRA II study shows that we can do good science in this arena, and that we can disseminate what we learn in high-level peer-reviewed publications. This is an early step, not a final one, in advancing our paradigms of optimal cardiovascular care."

The enrollment sites included: Durham VAMC, Duke University Hospital, Washington Hospital Center, Scripps Center for Integrative Medicine, Scripps Mercy Hospital, Florida Cardiovascular Research Group, Abbott Northwestern Hospital, Geisinger Medical Center and Columbia University – New York Presbyterian Hospital.

Funding for the study was provided by grants from the RAMA Foundation, Bakken Family Foundation, George Family Foundation, FACT Foundation, Duke University Heart Center, Duke Clinical Research Institute, Columbia University Medical Center, Geisinger Medical Center, Scripps Clinic, and the Institute of Noetic Sciences.

Other authors on the study include Dianne Gallup, Daniel Mark, MD and Kerry Lee, of the Duke Clinical Research Institute; Michael Cuffe, MD and Michael H. Sketch, Jr. MD, of Duke University Medical Center; Harold G. Koenig, MD, of the Geriatric Research, Education and Clinical Center, Durham VAMC; Kenneth Morris, MD, of Durham VAMC; James C. Blankenship, MD, of Geisinger Medical Center; Mimi Guarneri, MD, of Scripps Center for Integrative Medicine; Richard A. Krieger, MD, of Florida Cardiovascular Group; Vib R. Kshettry, MD, of Minneapolis Heart Institute; Mehmet Oz, MD, of Columbia University College of Physicians and Surgeons; and Augusto Pichard, MD, of Washington Hospital Center, Washington, DC.