ArticlesMusic, imagery, touch, and prayer as adjuncts to interventional cardiac care: the Monitoring and Actualisation of Noetic Trainings (MANTRA) II randomised study
Introduction
In 2001, the US National Center for Complementary and Alternative Medicine defined “frontier medicine” as those therapies “for which there is no plausible biomedical explanation”.1 Examples cited included bioelectromagnetic therapy, biofield and energy healing, homoeopathy, and therapeutic prayer or spiritual healing. Although these therapies are used extensively by the general population, few high-quality data are available to elucidate the mechanisms underlying these approaches or to prove their safety or effectiveness. Epidemiological findings clearly suggest that mood, hostility, depression, and spiritual affiliation are all associated with cardiovascular outcomes,2, 3, 4, 5 but the effect of frontier therapies on disease natural histories remains undefined.
We examined the effect of these therapies on patients with coronary-artery disease. Patients undergoing cardiac catheterisation with a view to percutaneous coronary intervention are informed about risks, including death, and are awake during the procedure. With predictable periods of distress, noetic therapies might be useful to induce vasodilation, to slow the heart rate, to calm the mind,6 or to promote healing through undefined mechanisms. Noetic interventions, defined as therapies for which the method of administration does not use a tangible drug or medical device were explored in the MANTRA I pilot study,7 in which there was a measurable reduction in preprocedure distress8 that might affect clinical outcomes.9 Limitations of the pilot study included limited power, enrolment of exclusively male patients at a single centre, and the inability to assess combinations of several noetic modalities. The MANTRA II study was designed to address these limitations.
Section snippets
Design
Nine US centres participated (webappendix 1). In all centres, approval by the institutional review board was obtained. Informed consent, listing participating prayer groups, was obtained from all patients.7 The study design was a 2×2 factorial randomisation scheme (figure 1). Patients were randomly assigned bedside noetic intervention (music, imagery, and touch [MIT] therapy) or no intervention, and sites were informed of the assignment. Patients were simultaneously randomly assigned off-site
Results
748 patients were enrolled between May, 1999, and December, 2002. 737 (99%) underwent cardiac catheterisation and 563 (75%) percutaneous coronary intervention. Inhibitors of glycoprotein IIb/IIIa were used in 341 (61%) of the 563 patients undergoing percutaneous coronary intervention. Baseline demographic characteristics and clinical features, interventional procedures, and baseline measures of mood, anxiety, spirituality, and quality of life were well balanced across the treatments (table 1).
Discussion
Active bedside compassion and prayers for the sick are widely practised for healing throughout the world. Whether such bedside and remote practices have any effect on clinical outcomes remains controversial.15 Although these approaches are among the most ancient of healing practices, scientific quantification of the methods, mechanisms, safety, and effectiveness of “frontier medicine” is at a very early stage.
In MANTRA II, we studied two noetic strategies in patients undergoing coronary
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2017, Clinical TherapeuticsCitation Excerpt :However, this concept that our social environment (families, relatives, friends, peers) contributes to treatment outcomes is not new but is almost completely ignored when it comes to PRs. It is, for instance, assumed that the claimed “healing power” of religious prayers28,29 when reported in well-designed trials30,31 may not be due to the prayer but to a stronger social network in religious families; however, a specific brain-effective analgesia of religious symbols and prayers cannot be ruled out.32 Although we agree that it may be complicated if at all possible to assess the influence of the “social environment” of a patient during evaluation of PRs, efforts can and should be made toward a standardized assessment of features of this network.
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