Integrative noetic therapies as adjuncts to percutaneous intervention during unstable coronary syndromes: Monitoring and Actualization of Noetic Training (MANTRA) feasibility pilot

Background Patients undergoing percutaneous coronary intervention (PCI) for unstable coronary syndromes have substantial emotional and spiritual distr ess that may promote procedural complications. Noetic (nonpharmacologic) th erapies may reduce anxiety, pain and distress, enhance the efficacy of phar macologic agents, or affect short- and long-term procedural outcomes. Methods The Monitoring and Actualization of Noetic Training (MANTRA) pilot study examined the feasibility of applying 4 noetic therapies-stress relaxa tion, imagery, touch therapy, and prayer-to patients in the setting of acut e coronary interventions: Eligible patients had acute coronary syndromes an d invasive angiography or PCI. Patients were randomized across 5 treatment groups: the 4 noetic and standard therapies. Questionnaires completed befor e PCI reflected patients' religious beliefs and anxiety. Index hospitalizat ion end points included post-PCI ischemia, death, myocardial infarction, he art failure, and urgent revascularization. Mortality was followed up for 6 months after hospitalization. Results Of eligible patients, 88% gave informed consent. Of 150 patients en rolled, 120 were assigned to noetic therapy; 118 (98%) completed their ther apeutic assignments. All clinical end points were available for 100% of pat ients. Results were not statistically significant for any outcomes comparis ons. There was a 25% to 30% absolute reduction in adverse periprocedural ou tcomes in patients treated with any noetic therapy compared with standard t herapy. The lowest absolute complication rates were observed in patients as signed to off-site prayer. All mortality by 6-month follow-up was in the no etic therapies group. In patients with questionnaire scores indicating a hi gh level of spiritual belief, a high level of personal spiritual activity, a low level of community-based religious involvement, or a high level of an xiety, noetic therapies appeared to show greater reduction in absolute in-h ospital complication rates compared with standard therapy. Conclusions Acceptance of noetic adjuncts to invasive therapy for acute cor onary syndromes was excellent, and logistics were feasible. No outcomes dif ferences were significant; however, index hospitalization data consistently suggested a therapeutic benefit with noetic therapy. Of all noetic therapi es, off-site intercessory prayer had the lowest short- and longterm absolut e complication rates. Definitive demonstration of treatment effects of this magnitude would be feasible in a patient population about 4 times that of this pilot study. Absolute mortality differences make safety considerations a mandatory feature of future clinical trials in this area.