Study of the Therapeutic Effects of Intercessory Prayer (STEP) in Cardiac Bypass Patients: A Multicenter Randomized Trial of Uncertainty and Certainty of Receiving Intercessory Prayer

Herbert Benson, MD; Jeffery A. Dusek, PhD; Jane B. Sherwood, RN; Peter Lam, PhD; Charles F. Bethea, MD; William Carpenter, MDiv; Sidney Levitsky, MD; Peter C. Hill, MD; Donald W. Clem, Jr, MA; Manoj K. Jain, MD, MPH; David Drumel, MDiv; Stephen L. Kopecky, MD; Paul S. Mueller, MD; Dean Marek; Sue Rollins, RN, MPH; Patricia L. Hibberd, MD, PhD

Disclosures

Am Heart J. 2006;151(4):934-942. 

In This Article

Results

Patients were enrolled between January 1998 and November 2000. Of 3295 eligible patients, 1493 did not wish to participate, and 1802 patients enrolled (Oklahoma, 548; Massachusetts, 492; Washington, DC, 284; Tennessee, 256; Minnesota, 200; Florida, 22) (Figure 1). Intercessory prayer was provided according to the protocol to 99% (1192/1205) of patients randomized to groups 1 and 3, over the course of the study period (1046 days). The overall daily mean of intercessors was 33 (range 10-58). Intercessors reported praying from 30 seconds to several hours, from 1 to 4 times per day.

STEP flow chart.

There were no important differences in baseline or operative characteristics ( Table I ) across the 3 groups. These characteristics are similar to those reported by the Society of Thoracic Surgeons Adult Cardiac Surgery Database,[24] the New York State Cardiac Surgery Reporting System,[25] and both characteristics, and our 45% refusal rate are comparable to the Bypass Angioplasty Revascularization Investigation.[26]

Similar proportions in group 1 (68.2% [412/604]), group 2 (63.0% [376/597]), and group 3 (64.4% [387/601]) strongly agreed with the statement, “I believe in spiritual healing.” Almost all subjects believed that friends, relatives, and/or members of their religious institution would be praying for them—group 1 (95.0% [574/604]), group 2 (96.8% [579/597]), and group 3 (96.0% [577/601]).

The independent DSMB reviewed the interim data. An independent statistician provided blinded, then unblinded, interim results to the DSMB members. Similar proportions of patients in group 1 (51% [151/299]) and group 2 (51% [155/304]) had at least 1 complication (P = .905). Sixty three percent (186/297) patients in group 3 had a complication compared with 51% patients in group 1 (P = .003), which did not reach the interim boundary. Without evidence of early efficacy and in the absence of concerns about safety, the DSMB advised that the trial be completed as planned.

Effect of Intercessory Prayer on Outcomes (Group 1 vs Group 2). Any Complication. Fifty-two percent (315/604) in group 1 and 51% (304/597) in group 2 had at least one complication (relative risk 1.03, 95% CI 0.92-1.15, P = .67) (Figure 2). These proportions include 25 patients who had missing data—21 did not have CABG (group 1, 11; group 2, 10) and 4 had no complication before being lost to follow-up before day 30 (group 1, 2; group 2, 2); all 25 assumed a priori to have had a complication. In a “modified intent-to-treat” analysis (excluding these 25 patients), the results were similar: 51% (302/591) in group 1 and 50% (292/585) in group 2 had at least one complication (relative risk 1.02, 95% CI 0.91-1.15, P = .68). The proportion of patients with at least one complication varied from 40% to 65% across the 6 hospitals. Details of the complications are shown in Table II (see AHJ website for individual complications doi:10.1016/j.ahj.2005.05.028). There were no differences between groups 1 and 2 in planned subgroup analyses Figure 3, A).

Presence of any complication (Society of Thoracic Surgeons Adult Cardiac Surgery Database Definitions). IP, Intercessory prayer; ITT, intent-to-treat; RR, relative risk.

A, Complications (Society of Thoracic Surgeons Adult Cardiac Surgery Database Definitions) in subgroup analyses group 1 vs group 2. B, Complications (Society of Thoracic Surgeons Adult Cardiac Surgery Database Definitions) in subgroup analyses group 3 vs group 1. Relative risk estimates appearing to the right of the vertical line at 1.0 indicate a higher estimate for the specific group on that side of 1.0 compared with the specific group on the left side. Confidence intervals overlapping the vertical 1.0 line indicate that the observed relative risks are similar. IP, Intercessory prayer; MI, myocardial infraction; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; PVD, peripheral vascular disease; CVA, cerebrovascular accident; UCS, untreated carotid stenosis; Immuno Therapy, immunosuppressive therapy; EF, ejection fraction; BSA, body surface area.

A, Complications (Society of Thoracic Surgeons Adult Cardiac Surgery Database Definitions) in subgroup analyses group 1 vs group 2. B, Complications (Society of Thoracic Surgeons Adult Cardiac Surgery Database Definitions) in subgroup analyses group 3 vs group 1. Relative risk estimates appearing to the right of the vertical line at 1.0 indicate a higher estimate for the specific group on that side of 1.0 compared with the specific group on the left side. Confidence intervals overlapping the vertical 1.0 line indicate that the observed relative risks are similar. IP, Intercessory prayer; MI, myocardial infraction; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; PVD, peripheral vascular disease; CVA, cerebrovascular accident; UCS, untreated carotid stenosis; Immuno Therapy, immunosuppressive therapy; EF, ejection fraction; BSA, body surface area.

Any Major Event. Eighteen percent (109/604) in group 1 versus 13% (80/597) in group 2 (relative risk 1.18, 95% CI 1.03-1.35, P = .027) had at least one major event within 30 days of CABG. These proportions include 36 patients who had missing data—21 did not have CABG (group 1: 11, group 2: 10) and 15 had no complication before being lost to follow-up (group 1: 8 and group 2: 7); all 36 patients were assumed to have had a major event for the intent-to-treat analysis. After excluding these 36 patients in the modified intent-to-treat analysis, 15% (90/585) in group 1 and 11% (63/580) in group 2 had a major event (relative risk 1.20, 95% CI 1.04-1.39, P = .022).

Mortality. Three percent (16/604) of patients in group 1 and 2% (14/597) of patients in group 2 died within 30 days of CABG. The relative risk was 1.06 (95% CI 0.76-1.49, P = .74).

Effect of Certainty of Receiving Intercessory Prayer on Outcomes (Group 3 vs Group 1). Any Complication. In group 3, 59% (352/601) had at least one complication compared with 52% (315/604) in group 1 (relative risk 1.14, 95% CI 1.02-1.28, P = .025). These proportions included 25 patients who did not have CABG (group 3, 6; group 1, 11) or who had no complication before being lost to follow-up before day 30 (group 3, 6; group 1, 2). The results of the modified intent-to-treat analysis excluding the 25 patients were almost identical: in group 3, 58% (340/589) had at least one complication versus 51% (302/591) in group 1 (relative risk 1.14, 95% CI 1.02-1.29, P = .022). Although not a preplanned analysis, significantly, more patients had new onset atrial fibrillation/flutter in group 3 (32%, 192/601) than in group 1 (24%, 145/604) (relative risk 1.21, 95% CI 1.08-1.36, P = .0022). Patients in group 3 were consistently more likely to have a complication than those in group 1 across the planned subgroup analyses (Figure 3, B).

Any Major Event. Fourteen percent (85/601) in group 3 had a major event versus 18% (109/604) in group 1 (relative risk 0.86, 95% CI 0.72-1.02, P = .065). These proportions include 33 patients who had missing data—17 did not have CABG (group 3, 6; group 1, 11) and 16 patients had no complication before being lost to follow-up before day 30 (group 3, 8; group 1, 8). The modified intent-to-treat analysis (excluding these 33 patients) yielded similar results: 12% (71/587) in group 3 and 15% (90/585) in group 1 had a major event (relative risk 0.86, 95% CI 0.72-1.04, P = .10).

Mortality. Two percent (13/601) in group 3 and 3% (16/604) in group 1 died within 30 days of CABG. The relative risk was 0.90 (95% CI 0.60-1.35, P = .58).

Predictors of Occurrence of Any Complication. The independent predictors of occurrence of any complication within 30 days of CABG are listed in Table III . Neither social nor religious variables were associated with occurrence of any complication.

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