DURHAM, N.C. - - Cardiac patients who received intercessory prayer in addition to coronary stenting appeared to have better clinical outcomes than those treated with standard stenting therapy alone, according to researchers at Duke University Medical Center.
Their results further suggest that using rigorous scientific methods to study the therapeutic value of prayer and other noetic interventions appears feasible and warrants larger-scale, more definitive investigations. Noetic interventions are defined as "a healing influence performed without the use of a drug, device or surgical procedure," said the researchers.
Results of the phase I feasibility-pilot, known as the MANTRA (Monitoring and Actualization of Noetic TRAinings) Project, appear in the Nov. 1 issue of the American Heart Journal.
"We now know that clinically meaningful, high-quality research can be done in this area," said Duke cardiologist Dr. Mitch Krucoff, who co-directs the study with Suzanne Crater, a Duke nurse practitioner. "The data are suggestive that there may be a measurable therapeutic benefit related to noetic therapies in patients undergoing angioplasty."
Patients who received noetic therapies showed a 25 to 30 percent reduction in adverse outcomes (such as death, heart failure, post-procedural ischemia, repeat angioplasty or heart attack) than those without such therapies, according to the researchers. While increasingly popular outside of mainstream medicine, noetic therapies have not been widely studied with rigorous, scientific research methods. This study represents one of the first such efforts.
"We know patients are very interested in these types of treatments, particularly in the role spirituality and prayer play in their health and health care," added Krucoff. "To best understand how to respond to such widespread interest, we examined whether good, mainstream, fundamental research science could be applied to these areas."
One hundred and fifty patients with acute coronary insufficiency at the Durham Veterans Affairs Medical Center were enrolled in the prospective, randomized study from April 1997 to April 1998. All were scheduled for invasive cardiac procedures based on their clinical needs. In a five-way randomization, all patients were assigned (in equal distribution) to coronary stenting with standard care or to coronary stenting plus one of the following therapies: guided imagery, stress relaxation, healing touch or intercessory prayer. Of the 120 patients assigned noetic interventions, 118 (98 percent) completed the therapeutic assignment.
Differences in clinical outcomes between treatment groups were not statistically significant. However, those receiving noetic treatments "had lower absolute complication rates and a lower absolute incidence of post-procedural ischemia during hospitalization," said Crater.
"These noetic interventions help a patient achieve a state of calm equilibrium, or homeostasis, which puts them in a better state to help in their own recovery process," said Jon Seskevich, a Duke nurse clinician, who along with Crater, designed the non-prayer interventional therapies. He further noted that those assigned to receive prayer appeared to fare even better than those receiving the other types of noetic treatments and the control group.
To be eligible for enrollment, patients had to be experiencing chest pain at rest (with or without acute electrocardiographic changes) and be scheduled for invasive diagnostic angiography. All patients were managed in the coronary care unit of the hospital before and after angioplasty.
Off-site, intercessory prayer was provided by seven prayer groups of varying denominations around the world. The groups included Buddhists, Catholics, Moravians, Jews, Fundamentalist Christians, Baptists and the Unity School of Christianity.
"The name, age and illness of each patient assigned to prayer therapy was sent to each prayer group," Crater said. "These patients had prayers from all over the world said on their behalf for healing and recovery."
Denomination did not play a factor in the design of the study. Prayer and standard therapy assignments remained double-blinded to patients, family and staff. A trained volunteer performed the other noetic therapies at bedside within one hour of the cardiac procedure. Although small, the researchers believe the study is an important advance in this area of medical research.
"This is an important study because it provides preliminary information suggestive of a positive effect that needs further study in a larger study sample," said Dr. Harold G. Koenig, associate professor of psychiatry at Duke University Medical Center, and one of the study authors. "Some of the greatest scientific achievements have come from those who step outside of the box, and I believe that is what this study does. The results tend to lean toward prayer helping people, but more study is needed."
Research is continuing. Phase II of the MANTRA project has already enrolled nearly 500 patients out of an enrollment target of 1,500 patients.
The larger study is underway at nine sites throughout the U.S., including Duke University Medical Center, Columbia-Presbyterian Hospital in New York City, Washington Heart Center in Washington, Abbott Northwestern Hospital in Minneapolis, Scripps Clinic/Scripps Mercy Hospitals in San Diego, Geisinger Clinic in Danville, Pa., Florida Cardiovascular Center in Atlantis, Fla., and the Durham VAMC.
Preliminary data from this pilot study were previously reported at the 71st meeting of the American Heart Association in 1998. The American Heart Journal article represents the complete, tabulated, peer-reviewed results of the phase I study.
Funding was provided in part by grants from G.E.-Marquette Electronics, Milwaukee; the Institute of Noetic Sciences, Sausalito, Calif.; the Bakken Family Foundation (Hawaii); the Heart Center, Duke University Medical Center; and the Duke Clinical Research Institute.
Other authors of the study include: Cindy L. Green, Ph.D., Arthur C. Maas, MD, James D. Lane, Ph.D., Karen A. Loeffler, Kenneth Morris, MD, and Thomas M. Bashore, MD.
Journal
American Heart Journal