Complementary Alternative Cardiovascular Medicine

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142 Alternative Cardiovascular Medicine accompanied by insightful discussion. Byrd acknowledged that a limitation of the study design was that it did not control for other prayer not associated with the study. In other words, patients in both groups, their friends, and family likely prayed for them during the course of the study, and there was no attempt to prevent such activity or even account for it. As such, the study was essentially examining only the role of “supplementary” intercessory prayer. With this important observation, Byrd defined the landscape of clinical trials of prayer where scientific study could never expect to absolutely test the healing power of prayer. With so much “ambient” and unaccounted-for prayer in cultures in the world, the only appropriate query for a scientifically based hypothesis would be as an assessment of incremental benefit from systematically added spiritual interventions, with uncontrolled prayer activity adjusted for by the use of prospectively designed, randomized treatment assignments. The next trial that sought to define the effect of prayer on CCU patients was published in 1999 (11). One thousand thirteen patients were randomized to receive standard CCU care, with or without teams of intercessors praying for them. Extending Byrd’s observations about the landscape of clinical trials of healing prayer, Harris and colleagues were concerned that the spiritual terrain of an intensive care unit would change if staff and patients even knew a study was ongoing. That consideration was taken to the institutional ethics board/review board at the Mid-America Heart Institute, which granted permission for the study to go forward without getting informed consent from patients and without the awareness of staff. In this study by Harris et al., teams of intercessors were given the first name of the patient only, without knowledge of the type of illness or severity of disease. They were instructed to pray for 28 d for “a speedy recovery with no complications” and “anything else that seemed appropriate to them” (11). The primary end point in this study was a predefined CCU score that sought to quantify the severity of the illness, the hospital course, and the procedures used. The authors found an 11% reduction in the weighted CCU score (indicating better outcome) in the 484 patients in the prayer treatment group, as compared to the 529 in the control group. In an unweighted score, which merely totaled the number of events, procedures, and prescriptions, the prayer treatment group had 10% fewer elements. For both of these comparisons the p value was 0.04, indicating a statistically significant intervention benefit. Length of stay between the two groups was not statistically different. Attempts to replicate the Byrd study’s findings in CCU patients by using the “good” vs “bad” hospital score showed no difference between the treatment and the control group. Like the Byrd
Chapter 9 /Prayer and CVD 143 scale, the differences seen with the Mid-America CCU severity score were of unclear clinical importance, which currently remains unreplicated and unvalidated. Although this study further advanced the possibility that distant healing prayer might play a beneficial role in a CCU population, the cumulative weight of evidence from the two studies remained marginal. Far more significant was the approval by the institutional review board (IRB) of the protocol design to allow the study to go forward without obtaining patients’ informed consent. As presented in the discussion of the final manuscript, this decision was based on the assumption that there was no known risk to receiving intercessory prayer and, similarly, no known risk for the patients not receiving the intervention. As opposed to the Byrd study in which the patients knew that a study was being conducted and gave informed consent, the investigators also mention that they did not want to create extra anxiety in patients who might worry that they were placed in the control group and therefore not receiving extra prayer. With this study, Harris and colleagues uniquely opened the dialogue on the balance of optimal trial design for demonstration of prayer efficacy vs the protection of human subjects, which is essentially a safety concern. On the one hand, study designers were concerned that awareness that a prayer study was ongoing might itself stimulate an increase in prayer by both patients and staff in the CCU, lessening the uniqueness measurable in the prayer therapy arm. They were also concerned that awareness of the study and the randomized design might stimulate anxiety or enhance suffering. However, in the balance, the decision that the study could be ethically conducted without the informed consent of participating subjects centered on the assumption that healing prayers could not possibly do harm. In the absence of mechanistic knowledge, it is this assumption that prayer with healing intention is intrinsically safe that remains most controversial. A third study was published in 2001 from the Mayo Clinic, which sought to determine the effects of remote, intercessory prayer on longterm cardiovascular outcomes of CCU patients (12). In this double-blind study, informed consent was obtained and patients who gave consent were randomized at hospital discharge to receive 28 d of intercessory prayer in addition to standard medical therapy or standard therapy alone. Four hundred patients were randomized to intercessory prayer, and 399 were assigned to the control group. Patients were stratified according to risk of disease progression. The primary end point was a composite of death, cardiac arrest, coronary revascularization, rehospitalization for CVD, or an emergency department visit for cardiac disease at 26 wk. No
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Complementary and Alternative Cardi
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CONTEMPORARY CARDIOLOGY CHRISTOPHER
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© 2004 Humana Press Inc. 999 River
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vi Preface physician or other healt
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viii Contents 10 Massage Therapy an
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x Contributors ERIN L. OLIVO, PhD
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Chapter 1 / CAM and CVD 1 1 Complem
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Chapter 1 / CAM and CVD 3 patients
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Chapter 1 / CAM and CVD 5 The crite
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Chapter 1 / CAM and CVD 7 disease c
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Chapter 1 / CAM and CVD 9 analyses,
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12 Alternative Cardiovascular Medic
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Chapter 3 / Botanical Medicine and
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Chapter 4 / Herb and Dietary Supple
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Chapter 5 / Vitamin Therapy and CVD
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Table 2 Type and Quantity of Dietar
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Table 2 (Continued) Type and Quanti
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Chapter 16 / A Guide for Physicians
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Index 279 INDEX A N-Acetylcysteine
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Index 281 taurine studies, 106 Conj
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Index 283 Homeopathic medicine, see
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Index 285 funding of studies, 148 g
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Contemporary Cardiology COMPLEMENTA
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