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"Frontiers of the Heart" with Mitchell Krucoff

"Frontiers of the Heart" with Mitchell Krucoff

Visionary: Mitchell W. Krucoff, MD

Dr. Mitchell Krucoff and host Marilyn Schlitz engage a thought-provoking discussion of noetic health care. After Dr. Krucoff's visit to a hospital in India, he was inspired to research the intangible. Why were the pediatric cardiology patients in India smiling? When children with severe heart problems didn't cry, he and his team wanted to know why. They created a year long feasibility study with cardiology patients in which they explored whether researching prayer, healing touch, spiritual therapy and other intangibles would interfere with patient treatments and eventually expanded their study to 700 patients to explore the Noetic side of healing. Some of their findings were expected ... and some were surprising!

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Institute of Noetic Sciences: I want to welcome everyone to the Shift in Action Program. We're excited to go back to ‘Consciousness and Healing’ tonight with Marilyn Schlitz and she'll be -- her guest will be Dr. Mitch Krucoff and she'll do the introductions. We'll have about forty minutes of dialog between the two of them and then open it up for discussion, Q and A and other exchanges. Take it away, Marilyn.

Marilyn Schlitz: Great. Well, thank you and hi, Mitch, how are you doing?

Mitchell Krucoff: I'm doing just fine. How are you?

MS: Good. Very well. So excited to finally have you on the call. You know we've been trying for about a year and with your busy schedule and mine and, we finally make it work. So, let me just introduce you to everybody. Dr. Krucoff is the Professor of Medical Cardiology at Duke Medical Center. He's a member of the Executive Faculty of the Duke Clinical Research Institute. He's a prolific author and data collector, clinical researcher and he's probably best known in our world for a recent study he did published in The Lancet looking at what he calls 'noetic intervention'. So, welcome and --

MK: Where do you think I got that from?

MS: I think it's a discerning filter you have, sir. So, maybe we could start just by you telling us a little bit about your work and what it's like to be a cardiologist in a leading medical center and the kind of stresses that come when you try to integrate, you know, noetic principles into that kind of high tech environment.

MK: Well, you know, Marilyn, as you do know, we anticipated a lot more stresses than we have actually encountered in terms of our colleagues. I think by and large, all the allopathic medical practitioners these day are so code and length of space focused, that they miss things, like concern and compassion. And to actually have focused research on the question of what happens to health when you don't have those elements, no matter how much technology you have, is a question that a lot of health care practitioners mainstream, allopathic health care practitioners, actually care about very deeply. But I think, you know, what I do and what our team does is, done in what's called an invasive cardiology procedure, the patients who we treat are either having heart attacks or on the edge of heart attacks from blockages in the arteries in their hearts and we put catheters through a needle puncture in the leg up to the heart and manipulate these arteries physically. And, as you also know well, the majority of the research that we've done is focused on the technology: On the devices that you use to unblock these arteries, the catheters, coronary stints, and the medicines that are used to accompany and promote safety in these procedures. And I think the whole mantra study project which led to the study that was just published in The Lancet, is no more or less a question of what if in addition to the technology research and the adjunctive medicine research, you actually put some research out pertaining to the rest of the human being.

And the term “noetic,” for us, was so precious because what that gets us into is a whole realm of intangible entities that by and large are the most ancient healing remedies on the face of the earth: love, compassion, prayer, touch. You know, gee, you can kind of go on and on. And noetic was such a wonderful term because it's a great umbrella, at least in our little corner of the healthcare world. To sort of corral that notion of, what is this stuff? Is love different from prayer when it comes to healing? Or is it the same but a different intensity or is it different because it's between people where prayer may be between an individual and God or whoever they happen to be praying to. So, we're basically cardiologists we work with a great deal of data generation, largely to evaluate the effectiveness of new therapeutic direction in patients who are very vulnerable. Heart disease kills people and if you do something inadvertently to someone with a procedure that has heart disease, you can kill a person with your own hand. So, safety in our universe is a very critical concept.

MS: But the huge concern, generally, in medicine now with iatrogenic illnesses getting such strong publicity and attention and, you know, hundreds of thousands of people dying from secondary illnesses related to actually seeking treatment from a conventional practitioner. So I imagine there is more attention paid now, for example, the time outs that you take prior to a surgery to make sure that everything's lined up the right way and the right organ is being worked on and so on. How is that, those kind of added pressures on the practice?

MK: Well, I only wish it was anywhere near as enlightened as you make it sound. But it took medicine about 40 years of training young doctors to realize that you actually make better decisions if you sleep.

MS: Uh-huh.

MK: So, that's more the level medicine, medical training, but all of these things are very double edged. And what we emphasize in our medical health care system, I mean, I am very much - make no mistake - a great advocate of our Western Hi-Tech Medical Health Care System. There are unequivocally, in my opinion, miracles, that you can describe. My dad was a, you know, was a good surgeon in medical school before penicillin existed. So, you know, with the advent of penicillin, you talk to him, you will hear somebody talk about a miracle.

MS: Mm-hmm.

MK: So, I think, to me, the exciting part of this is that we're not talking about antithetical issues here. In fact, it irks me that we were just at a sort of alternative therapy integrative medicine focused symposium and there was almost a tendency in the complementary community to posture antagonistically toward the allopathic community.

MS: Uh-huh.

MK: And that's so unnecessary. It's just the opposite. It's as much as we can come together is what will elevate medicine and --

MS: Yeah, this whole integral idea is really key. Just in terms of the shift that you're seeing I gave a grand rounds about two weeks ago at Kaiser Permanente and they were introducing a new technology where they were able to survey the doctors, there were about a hundred physicians in the room and they -- we were able to ask them a set of questions before the talk started and for example, how many of you feel that spirituality and understanding something about your patient's spirituality is important for your practice and it was the vast majority of people in the room who, you know, checked yes. Strongly support that and I was really kind of stunned by the wide receptivity that I found amongst that population and sort of what you're suggesting maybe people don't have the awareness but there's a lot of openness at this point. Would you agree with that?

MK: Yes an awareness and just appropriate degree of articulation, you know, we have a lot of metaphors in the intangible aspect of human experience and certainly the intentional aspects of healing practices, we have a lot of metaphors that are, honestly spoken, nothing more than and I think the way we develop our approach to intangible practices, it's really important to think clearly.

MS: Mm-hmm.

MK: So, for instance, in the American College of Cardiology Consensus Document on complementary therapies that was published last year, we wrote a section on spirituality that, the thing which is between spiritual support and spiritual therapy.

MS: Uh-huh.

MK: Spiritual support from a health care perspective is: How do you respond to needs that patients or families perceive as needs? Do you have a chapel on site? Do you have a chaplain who could be with me? Those kinds of questions really come from a patient and support implies: Is the health care system ready to meet those needs? In fact, the joint commission of hospital accreditation, just three years ago, began requiring nursing intake to have at least some spiritually oriented needs assessment, which is novel to our organized health care system. And the way you improve that kind of responsiveness is not really research, it's what's called quality improvement. You can follow it with measures like customer satisfaction, which hospital administrators love.

MS: In compliance, I suppose.

MK: Yep. Yep. So, support is something that I think follows a very different path and we need to clearly separate that path from what we call spiritual therapy. And spiritual therapy is really what we have done in Mantra, what Professor Benson and the Harvard Group did with a bypass patient and step study where we're not really talking about research, we're talking about deliberately applying an intangible therapeutic. So we've included music, imagery, touch therapy, stress relaxation and distant, double blinded off site, intercessory prayer in a few different forms.

MS: And these are what you're calling the noetic intervention?

MK: Exactly. And, again, this is why we love the term, in addition to loving you, we love the term because in our little corner of the world, it really is a great step. And, frankly, the areas that we're testing with music, imagery, touch, et cetera, is just scraping the surface because under the same umbrella, you could easily see Chi, Chi Gong practices, Reiki, you know, many things. We have limited resources, so we actually, just took advantage of expertise that happened to be in our immediate vicinity and that's the elegant scientific way we came to music, imagery, touch and we just had people around who were skilled enough to help us. But it's just scratching the surface of what's potentially applicable under the noetic grouping. But this is research and this where aspects of safety and things like getting informed consent and having and ethics committee review of protocol, it's a whole different process and I think we very nearly, very clearly need to separate the notion of support form the notion of research.

MS: Right. And intervention, as you talk about therapy.

MK: Right.

MS: So, I remember you talking about, how if you want to, you know, embark on a curing experience and you want to see your physician, if you really want healing or caring, in the context of a hospitalized visit, then you need to bring your family in. Can you say something about that? Like, what are the differences between what's being offered in conventional medicine and where we need adjunctive support to help, you know, round it out.

MK: Well, again, this is an arena in modern Western Medicine that largely has been mediated by nurses at the bedside, who intuitively will have supportive families more around the care arena and destructive families elsewhere, a very informal kind of general professional judgment. It's, in other words, not very sophisticated or articulated in how we practice. In fact, the whole range and I guess, our mental exercise usually, Marilyn, is to start by thinking about what are the range of patient perspectives that emerge. So, one is the patient who is surrounded by loving family. And aren't we silly if we don't let the family in the room and all those sorts of questions come up. Another is an individual who's actually quite ill but who has no family at all, who’s totally alone. So, again, the health care system configuration in that type of human need might be different than if you have 20 family members around, who are actually, better use of the oxygen in the room. A third is a patient who's totally unconscious and has no family. I mean, who, literally, you can't communicate in the routine verbal, visual terms that we usually think of human communication. If a patient's unconscious, again, then what? How does the health care system potentially bring intangible therapeutics to bear? So, family presence, you know very well, to me the ultimate example of welcoming the family in a structured health care environment is in Waimea, Hawaii and I'm very glad to say that as of the earthquake two days ago on the big island, it's still standing.

MS: Yeah.

MK: But there's a hospital, you know well there, that is built so that it will physically - the architectural design of the building is meant to facilitate family visiting with respect to the fact that in Hawaiian spiritual traditions, family includes your pet. So, every room in the hospital has a door to the outside because when your family comes to visit, that's gonna include your dog and your horse and whoever and that family is actually the direct mediator of God. It is the most eminent presence of God. So, here's a modern, high-tech hospital building that has built every single room to have an outside door to accommodate family visitations in local, spiritual terms.

MS: So, you're really talking not only about a curing environment, but a healing environment.

MK: Well, as you know, we would much rather focus on a healing environment and then whatever can be cured is more likely to be cured and whatever cannot be cured is more likely to be healed.

MS: Mm-hmm. So, even in the case of, you know, again we think about the high-tech aspect of cardiology today and yet here you are as somebody representing that profession who's also emphasizing how important the subtleties of a door opening out to the outside or I know we had Bridget Duffy on the call a couple times ago and, you know, talking to her about Earl Bakken’s program there on the Big Island and thinking about things like, for example, patients coming in and choosing artwork so that if they have a particular feeling that they're looking to have stimulated, they can actually select something and if they want to change the artwork the next day, they have the capacity to do that. These are subtle things that one wouldn't expect to make a difference and, yet, the data speak to the contrary. These things are very important. Why would they be so important?

MK: Well, first of all, I think we all have to honestly admit, we have no idea how much of a difference these things make. Even building a hospital, like the North Light Community Hospital, just building on a sacred tract of land, what is the energy of the meridian on which you build the building, have to do with healing? I mean, these are questions that are way beyond anything we could claim to have any knowledge about.

MS: But we do have data now, for example, about patients doing better if they have a window that looks out over nature as compared to a brick wall. You know, those kinds of subtleties that do seem to affect peoples disposition and, therefore, their healing capacity.

MK: Oh and I not only hope this is clear, I not only totally agree, I think we even maybe underestimate it.

MS: Uh-huh.

MK: How much of a degree. How much of a difference it makes to be near water, to have access to outdoor light. To be surrounded by compassion in a high-tech world, in fact, a lot of these things may be more important than in older medical styles where they were more uniformly distributed. So all I'm saying is that we're enormously ignorant in terms of any real measures at this stage. My sort of running comparison is to think about oxygen, on the one hand and devices on the other. So, oxygen, if you went back in human history a thousand years, every single person on the face of the earth was absolutely clear that they feel better when their head is in the air than under water. Nobody would argue about that.

MS: Mm-hmm.

MK: On the other hand, at that time, a thousand years ago, if you tried to explain to the intellectual leadership of the day that that was because there was this microscopic molecule that you breathe in to your lungs and it goes through the membranes of the tissue and adheres to a hemoglobin molecule in a blood cell that carries it around to an organ and delivers it where it needs it, they would have locked you up or burned you at the stake, as a nut. And largely that was because oxygen could surround you, completely invisible, completely odorless and, yet, without some sort of ability to recognize it, it was just that: invisible, odorless. How would you even know it was there? And all electromagnetic waves fit the same paradigm and I think it would be naïve to say we know about every kind of energy or energy construct or whatever that affects us, that we have tools that show us everything. I think would be incredibly naïve. So, what is spirituality? What is chi? What is energy healing? What is love? What is - what are all these Noetic entities? These intangible human capacities and then how do they relate to healing, depending on how you build a building, will let the sun shine in. These to me are some of the most exciting questions about the future of how we promote and provide health care.

MS: Hear, hear. So, on that line, then I suppose that that leads us directly into why do research. And part of why we do research is to answer question of, you know, what is it that promotes healing and are there ways in which something that intuitively might be helpful is actually harmful. How do we make sure that we have quality control even over these intangibles? But I think it's really to try and understand more fully, what is the scope of healing? And what is the scope of a healing response? So, maybe we could move into talking a little bit more specifically about your research and how it is that, you know, first of all you were stimulated to think about studying something like noetic principles in the context of cardiology and then how you designed a study and what you found.

MK: So, again, you are articulate and elegant beyond where I think we really are. I think at a much more mundane level, the starting point is still, how can we do better than we do and where do you look for the most likely direction to address? We were, through a whatever you want, series of coincidences or non-coincidental events, bumped into or were guided to a brick and mortar operating high-tech hospital: 320 beds, two digital cath labs, 5 operating theatres, in southern India that does a lot of exactly what we do, treating heart disease with the most advanced technology available. But this was part of an ashram in southern India and architecturally the structure was built with, and as sacred space, of a really phenomenal kind of combination of practical and sacred motifs. And the operation of the hospital since about 1991 has been our main inspiration and guiding light in terms of what we are not doing at Duke University or, frankly, anywhere in the western world. And the combination of this, sort of intangible human capacities, this noetic dimension, with our best technology, where, the intangible can reach into the fear, the existential fear. When you go to a procedure where your doctor is telling you that the complications of this procedure include death, having a heart attack, having a stroke, bleeding so much you're gonna need a transfusion. When, there's not too many pills unless you really knock a person out that reach that place with “I could die?” type of question. Where noetic therapy is - may do just that. That may be --

MS: When you went to India, you felt you found that in that environment?

MK: So, we rounded, Marilyn, in a hospital that, does about 3,000 caths and about a thousand open hearts for free in an indigent population in rural India. The almost half of what they do are birth defects or congenital anomalies of the heart in infants. When infants have congenital anomaly of the heart, they don't get enough oxygen into their blood. They don't get enough oxygen into their brain and anywhere you go in any hospital in the Western World, they cry. In this hospital, infants with hypoxic congenital heart disease, don't cry. The love is so concentrated and, again, from the architectural construct to just be personal interaction with the staff. In this place, the building is constructed so in the cardiology ward at five o'clock every day, as the sun sets, all of the patients who are not in intensive care and all of the staff, together, gather in one resonant spot and light incense and sing Bhajan, sing prayers, and the whole building vibrates, as the sun sets. So, you know, there are aspects – Now, if you were to do a thousand open heart procedures in that environment and a thousand open heart procedures at the Cleveland Clinic, would you have a measurable difference in death rates? Nobody knows. We really don't know. But wouldn't you want to ask that question?

MS: Mm-hmm.

MK: I mean, why would we not want to - I joke very seriously that all we're engaged in is doing our best to try and prove the obvious and the most mundane reason that we have approached this whole field is that the reason to generate data is that is the only currency of communication that will change Western Medicine. Data is it. We are locked into the religion of data driven medical practice, guidelines, etc., for a very good reason.

MS: Right.

MK: So, the other issue here is, that sometimes seems a little queer to talk about it, but to us is absolutely critical, is safety. And a brief observation from our pilot study of - We take visual analog scales, which are very quick and easy for patients to fill and use them twice before procedure to kind of define mood trajectories. So, it just logs happy, hopeful, worried, whatever and the patient can mark on a ten centimeter line where ever they feel they are, very much to not at all and we just measure the numbers of meters on the line. When you take patients along these lines and look at their own self assessment, there's a question of what are they telling us as they head into the stress of an invasive heart procedure? It turns out that, at least statistically, there's a suggestion that certain mood changes, like rising levels of hope, are statistically linked to patients who have fewer complication rates. And, patients who have higher levels of happiness and higher over all levels of hope on these very simple scales, have fewer complications in hospital. That's about a 36 hour time window with these procedures. And patients who are most likely to live for the next six months after a heart procedure, are patients who have the highest levels of worry before the procedure.

Now, when we started this work and started collecting these data, my intuitive hypothesis was that worry, any sort of mood distress and a body physiologically stirs up adrenalin and adrenalin makes the heart beat faster and makes blood vessels contract, makes the blood thicken. You know, all of the things you would want if you were running for your life from a mountain lion. But all of these things, if you're having a heart attack, are bad for you. The heart's beating too hard, blood vessels are constricted, and blood's clotting where it shouldn't. So, the relief of the stress and within that, the lessening of worry before a procedure, would have intuitively been what I would consider a successful therapy. That if we can make somebody less worried before a procedure, we're doing them a favor. We're making them feel like they feel better. And yet here are data that suggest that actually, you significantly increase their death rate over the next six months if you relieve them of worry before a heart procedure. And how do you make sense of that?

Well, fortunately, the very brilliant young man who was working with us at that time, as a medical student, had spent 6 months in China as a barefoot doctor apprentice and was able to wake us up a little bit that while you may, in Western terms, of adrenaline pumping, blah, blah, blah, but in Chinese medicine worry is a vital energy that emerges from the spleen in times of stress. And if you relieve a person or hemorrhage worry at the wrong time, you could kill somebody. So, even in the world of intangibles where energy healing and prayer and again, not black magic voodoo but loving, well intentioned prayer, the question of if you use this stuff with no mechanistic understanding in the wrong person at the wrong time, could you inadvertently harm someone? And that is not the realm of effectiveness, that is the realm of safety and, again, heart patients are vulnerable human beings and we take safety issues very seriously. So, it's interesting to be in a bunch of theologians, you know, we've, honestly, we've been doing this now about fourteen years and we have encountered very little in the way of antagonistic response from our mainstream Western allopathic professional colleagues. But you want to see antagonism, get into the middle of a bunch of theologians, just that with a loving, well intentioned prayer, we’re worried that you might inadvertently kill somebody. They - it's not an easy discussion.

MS: Yeah. Well, let's take a step back and say, so, you were in India and you had this feeling that things were more integral. That there was support for the many dimensions of the person and, so, this was enough to capture your imagination and then propel you to want to do a formal study? Is that how it transpired? Or how would you say you went from --

MK: Yes. Yeah, almost literally, it was an overwhelming - Rounding, one day of rounding in that place was literally overwhelming and I --

MS: Rounding meaning you go around and actually see patients.

MK: See patients.

MS: Uh-huh.

MK: Yes. You know, to round in a ward of hundreds of people with children who have very life threatening heart disease, who are smiling, who are beaming. These folks are in God's hospital. They have absolute faith that, you know, these are folks who have never seen a plumbing fixture, much less a digital biplane Phillip's cath line and they're totally without fear. They're totally without anxiety. They are in God's hands. And, all of the local constructs around that are - become secondary to the overwhelming sense that we - On the flight back, which is, you get a lot of time to talk - it's about 18 hours. But on the flight back it was simply inconceivable to us that when you change the atmosphere surrounding high tech interventions, to that degree, it's got to have a measurable somatic, bodily effect. And yet, no one has ever measured that effect. So, that launched us, very literally. It was not subtle and it was not small. It launched it.

MS: And, so, then what - how did you - You did a pilot study and that was looking at these noetic interventions including distant prayer and you might just tell us a little bit about how that was designed and how that led, you know, what you found in the pilot and how that led you to a larger study.

MK: So, we have a think tank here of people who do clinical care and clinical research, which is our Research Institute and we came back from India and actually on the flight back, wrote a protocol that was one we never actually executed but that's part of the discussion just here, amongst pretty experienced clinical investigators, nurses, statisticians. What do we do with this? Where do we go? And what emerged was what we call a feasibility pilot. It was conducted in patients who are pretty sick, who's care path is very time dependent. So things move along quickly, and the feasibility questions ranged from, you know, would patients who are sick even sign up for some, you know, voodoo intangible protocol? Would staff, taking care of people who are sick, resent this as an intrusion of some sort of folly rather than real science? Would - ultimately, we see the opportunity in time. Again, you can't interrupt the flow of care in these folks, but could you find a fifteen or twenty minute period of time consistently where the patient was basically waiting to go from one step to another and you could get in there with some sort of meaningful, intangible intervention? And, lastly, as you look at actual clinical outcomes for any sign that anything was actually happening, there was anything measurable going on, either good or bad, effectiveness or safety. So, in the pilot, we did this for a year. We took all patients in our most advanced, our most acute sort of care, our range, and found that it was clearly feasible and that was really what the first pilot and then, of course, the study we did showed. So we used healing touch. Again, feasibility questions include whether somebody who is really sick, short of breath, is having a heart attack, do they want to be touched? You know, there is, for instance, a phase of pregnancy that just before delivery, that traditionally is referred as to something that whatever you do, don't touch her.

MS: Mm-hmm.

MK: And I'm not sure that's the right answer but, again, care for the patients who are suffering these problems. When you're having a heart attack, do you want to be touched is an important question in the care universe. So, feasibility involved kind of testing the water of the patient's wants, do they feel anything different and do they create any measurable difference? And the bottom line was the staff was incredibly supportive, we enrolled a higher rate of patient - the patient receptivity was much higher than any sort of standard cardiology trial that we do in other circumstances. The ability to deliver the therapy without interrupting care, so to find that 15 or 20 minute window was over 90% and very clearly, you could impact on patients on feelings of distress, so that the trajectories of these zero visual and lock scores were very significantly affected by these interventions at the bedside before the procedure. Included in this whole thing was one arm that was double blind, which means nobody knows what they got, off site intercessory prayer and standard care. So, two-tenths of these patients have some kind, trained healing practitioner come into their room and then do some stretch relaxation or touch or an imagery thing with them. Two-tenths of these patients, nobody walked in the room and by the process of informed consent, all they really knew was, if nobody walked in the room, I have a fifty-fifty chance that there are a bunch of congregations around the world praying for my recovery or not.

MS: So, this is what we would call a three arm clinical trial?

MK: It was actually a five arm trial.

MS: Five arm, mm-hmm.

MK: There were four noetic therapies, stress relaxation, imagery, healing touch and double blind off site intercessory prayer.

MS: Uh-huh, right, 'cause you didn't combine them in the pilot?

MK: Right. Which was a clear - And, again, feasibility pilots are most useful, not for what they find, but what you realize after they’re over, you screwed up. So, feasibility trials are most useful for their deficiencies. And while on the one hand, I and members of, again, patient tolerance, etcetera, keeping these arms separate was important. At the end of the study there was absolutely no way to even ask the question whether a distant intervention and a bedside intervention together might be any different from one or the other, because there was no crossover. They were purely parallel randomization. So, this was also done on a single center, it was done at the Durham VA Medical Center, so it was almost exclusively male, although one patient of a hundred and fifty patients, all were male. We're - you know, down in North Carolina, we're in the middle of the Bible Belt, so how generalized was this to San Francisco or New York or Boston? But what the pilot did show us was that this was feasible, staff supported it, patients welcomed it. And there was in the pilot outcomes data certainly no suggestion of safety related issues but there was a modest suggestion of a possible treatment affect and, again, feasibility also means logistics, so if a treatment affect, in a pilot study shows you that you could really prove this for certain by doing a seventy-thousand patient trial, that's just not logistically feasible. On the other hand, if it suggests that you can actually get some degree of statistical certainty that the treatment was driving the effect you are measuring in a 700 patient trial, that is feasible and that's really what drove the design of the second study, the study that was published more recently in The Lancet.

MS: Right.

MK: Was the power calculations based upon the pilot data. So, we learned a lot.

MS: Yes - this may be quickly, because I know we want to open the line to callers, but - So, what did you then learn in the confirmation study and where does that lead you?

MK: I think we're only beginning to appreciate, actually, all the things that we have learned from the Phase Two study. The Phase Two study was a much stronger number of patients, a much stronger study design and to the point that not just the primary endpoints but, actually, in many ways I think we will learn more about where to go along this very ill defined path from secondary endpoints in the Phase Two study that give us real quality level signal because we had a bunch of sites who did very high quality work. So, the quality of the data itself, the structure of the data from Phase Two will give us, probably, much more accurate clues than the pilot feasibility study. And, again, this is the nature of almost any novel therapeutic area of research. I don't mean, this to sound cold, again, this is what I do for a living. This is what excites me. But when you really have no clue about mechanism, outcomes, clinical trials become a way of learning and actually imputing mechanisms backwards. So, again, one of the quickest ways to study oxygen is to concentrate it more or less even if you can't tell quite exactly what you're doing and then detect that it actually makes a difference when you concentrate it more than when you concentrate it less. And gradually that moves you towards much, much clearer understanding of both [?] and effectiveness and thus how to use these therapies and, you know, even whose roles it is to deliver these therapies.

MS: So, what you did fine, if I remember correctly, was really no overall significant outcome on what your primary measures were and, so, not really supporting the idea of any of these noetic interventions, including the distant healing, but that you found a very interesting sort of secondary result which had to do with this kind of multiplication of your source of oxygen, as it were. So, maybe you could say a little something about that and then we should probably switch over to callers.

MK: Sure. So, again, a big difference in any clinical investigation between what is proven and what is learned. Okay. So, basically, in the Phase Two study we have proved very little. On the other hand, we have learned a lot exactly as you say, from some of the secondary findings. And the two - I mean, secondary findings that we intend to follow up on are - we shifted at two-thirds of the way through the study from a single dozen congregations of prayers all around the world, who prayed for patients specifically by name, age and illness, to what [not known] and colleagues have published out of Columbia in a different setting but as a unique prayer structure method. Where in addition to someone praying for the patient specifically, there was a second tier of prayer that was recited on behalf of the prayers, of the prayer praying specifically for the patient.

MS: So, you have somebody praying for the patient or a congregation praying for the patient and then a group praying for the prayers of the patient. That's right, huh?

MK: No, the prayers of the pray-ers for the patient.

MS: Right.

MK: So, we would --

MS: Okay.

MK: For instance, the Carmelite Sisters in Towson, Maryland was one of what we call our Tier One Prayer Groups. So, when we enroll a patient, the Tier One Prayer Groups, like the Carmelites, would get a note that Mr. John Smith, age 56, having a heart attack, undergoing catheterization and they
would at Vespers, mention Mr. Smith by name, meditate on Mr. Smith through the day and they would pray for Mr. Smith's specific behalf. At the very same time, a monastery in Northern India would be notified just generally that a patient had been enrolled. But the monastery in India would know who our - would know for instance, that the Carmelite Sisters in Towson, Maryland were saying prayers on behalf of that patient.

MS: Mm-hmm.

MK: So, without knowing the patient's name or age or illness, the Milanda Monastery would pray for the prayers of the Carmelite Sisters who were praying for Mr. John Smith. And that was done in two tiers of a dozen congregations each. In the overall prayer treatment assignment versus no prayer treatment assignment, there was absolutely no measurable difference in outcomes in our study. Interestingly, in fact, 89% of the patients in both arms assigned prayer or not, already had somebody praying for them outside of the protocol to begin with.

MS: Uh-huh.

MK: And we followed that carefully, but, between the two groups, no measurable difference. On the other hand, when you looked exclusively in the last year of enrollment at the patients who had what we called two tiered prayer, there was about a 30% reduction in the primary endpoint. Now, again, this is not statistical proof, but this is a pretty interesting signal.

MS: Very interesting.

MK: The other strong signal that we got, again, not as proof but as something that I feel we have learned and learned to the point that I would certainly pursue it in future work is that bedside intervention in which the patient participates, at least by our kind of measures, appears to have a more obvious blip, a more obvious affect over our best standard care than distant interventions do. And in the second Mantra Study and the Lancet Study, the bedside intervention was a combination of music, imagery and touch. Where the patient was taught a relaxed abdominal breath and the music and imagery are a cassette on a Sony walkman, so every center in this multi-center trial delivers the same music, imagery script. But there are dual headphones, so the healing touch practitioner, who is with the patient, and the patient, literally, listens to the same music at the same time and, as you know, vibrationally, that may harmonize whatever touch therapy energy intervention may constitute when you unify the vibration, if you will, of the healer and the patient. So, that construct, we saw about a 6% reduction in death rates over the next six months. Now, you have to be again, very careful, these are rare events and this is definitely the kind of signal. So at the bedside, I think we would want to move forward with great interest and at the distant, which is nice scientific intervention 'cause you can double blind it, I think the two tier prayer construct, to us, are the two things that we really have learned so far from Mantra. And then you know we have a third one coming that I'd rather not detail right now, but it has to do with the intuition of healing practitioners, what they see and what you do. That's another very powerful feature in what actually helps people recover faster.

MS: Well, it's all fantastic and extremely interesting and I know that I have lots more questions but I think, Stephen, we probably ought to open it up.

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2006 IONS Teleseminars

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