**Transcript of Cyberseminar**

**Spotlight on Pain Management**

**Does CAM have a role in Chronic Pain?**

**Presenter: Steven Ezeji-Okoye, M.D.**

**February 5, 2013**

**Does CAM have a role in Chronic Pain?**

**February 5, 2013**

Heidi:  Our presenter today is Steven Ezeji-Okoye – I am sorry, I probably completely butchered that.  He is the deputy chief of staff at VA Palo Alto Healthcare System.  He is board certified in internal medicine and he has served as the chair of the VHACO, a complementary and alternative medicine field advisory committee and as a VHA subject matter expert on CAM since 2004.  And with that introduction, Steven I’m going to turn things over to you.

Steven Ezeji-Okoye:  Thank you very much Heidi.  One of the roles that the field advisory committee has is that we attempt to look for the evidence behind CAM modalities to see whether or not they can be integrated into VA care.  And certainly, there has been a lot of interest in CAM and with it, there’s been a lot of interest in the potential applicability in chronic disease.  And so, the question of what role CAM might have in the management of chronic disease such as chronic pain has been raised.  

So what I’d like to do in terms of a brief overview is talking about the use of CAM in both the United States and in VA, the relationship of CAM and pain, some of the evidence behind CAM and its use in pain, and then summations and just get some comments in terms of, you know, what does this mean for VA and perhaps where do we go from here.  So, CAM in the United States and in VA.  Just before I begin, I want to make sure that we’re all on the same page in terms of how we – you know, how we talk about CAM and what we mean by CAM.  So, the NCCAM definition of complementary and alternative medicine alternative medicine is a group of medical and healthcare systems’ practice and product which aren’t considered presently be part of conventional medicine.  When these modalities are used in conjunction with conventional medicine, it’s referred to as complementary medicine.  When it’s used in place of conventional medicine, it’s often referred to as alternative.  And the term integrative really refers to the combination of mainstream medical practices and CAM therapies which there’s some high quality scientific evidence.  And I think it’s safe to say that within VA, most CAM practices are really used in integrative or complementary fashion. 

So what is the state of CAM within the United States?  Well, the most recent national survey we have is in the 2007 National Health Interview Survey where they talk to almost 30,000 households and about 75,000 individuals, and what they found is that 38% of adults in the United States – some 83,000,000 of them are using some form of complementary alternative medicine.  And they’re certainly willing to pay for it, because almost $34 billion dollars in out of pocket expenditures are spent on CAM activity.  It’s almost $12 billion on practitioners, almost $15 billion on non-vitamin, non-mineral natural products.  And, over $7 billion on other CAM modalities, such as yoga, tai chi, you know, homeopathic medicine and relaxation techniques.  And this really represents quite a significant out of pocket expenditure that represents over 11% of the total out of pocket expenditures of US individuals on healthcare.  And of that expenditure, two-thirds of it’s really on self-care.  CAM practitioners still are barely significant, and the 25% of what is spent on mainstream physicians, 25% of that is also – is spent on CAM practitioners.  

Now, compared to the last time a national survey was done, about 10 years earlier, what you say is the largest increase in – this expenditure has really been on self-care modalities.  And it’s been about a 50% decline in visits to practitioners.  However, acupuncture is an exception; with acupuncture, there is a three-fold increase in visits over that time period.  So really, quite widespread and you know, really permeating all aspects of healthcare.  

So how does CAM fit into VA care?  Well, certainly, CAM’s focus on wellness and disease prevention and health promotion is certainly consistent with VA’s approach to care.  The move to providing more proactive, personalized healthcare certainly really – and personalized healthcare – really does speak to CAM having a potential role in that care.  And given that there are a number of chronic diseases that burden veterans, the potential promise that CAM has in not just promoting health and wellness but helping the management of chronic disease seems that there would be a good fit with CAM and its integration to VA care.  However, CAM is not explicitly part of the uniform benefits package or the medical benefits package.  The medical benefits package[s] just talk about the VA being able to provide those modalities which promote, preserve or restore health.  However, it’s promote or preserve or restore health, and are basically generally accepted as regular parts of medical care, or part of mainstream care.  And the main thing that would move something from being considered an alternative or complementary practice into mainstream medicine would be sufficient evidence to support its inclusion into more mainstream therapies or as a more mainstream therapy.

Now certainly, the definition of something of the CAM modality is a fluid one.  As evidence grows, practices that are once considered alternative or CAM certainly can become considered part of conventional medicine.  And practices such as biofeedback may already have made that move, and certainly chiropractic care, which was considered a CAM modality has been wildly adopted within VA, and for all intents and purposes of the VA, it’s considered part of conventional medicine.  

In addition, VA has –

Heidi:  Steven, I’m sorry, can I interrupt for just a second?  Could you pull your microphone just a little bit closer to your mouth?  We’ve gotten a couple people saying that they’re not quite able to hear everything you’re saying.

Steven Ezeji-Okoye:  OK, I will – is that any better?

Heidi:  That sounds a little bit better, yes.  Thank you.

Steven Ezeji-Okoye:  OK.  So, VA is also – has an increased focus on providing evidence based medicine.  And, one thing that is plaguing much of CAM practices is a lack of high quality research.  And with it, high quality evidence to support its use.  In addition, many CAM practices lack standardized educational accrediting bodies; they lack state regulation or state licenser and there’s no national certifying body which, even if the CAM practice was found to be helpful, it does pose additional burden of being able to ensure that the person who would deliver the practice is appropriately educated and trained.

Despite all that, CAM is really widely offered within VA.  The most recent HAIG survey – the Healthcare Analysis and Information Group survey – on CAM utilization in VA was completed in 2011 and it found that 89% of VA facilities or 125 of them provided some form of CAM.  And the most commonly offered modalities ranged from acupuncture to yoga, with the top five being meditation, stress management and relaxation therapy, guided imagery, progressive muscle relaxation and biofeedback.  So really there’s a wide array of CAM modalities already offered.  However, almost all of it is provided by conventionally trained practitioners and part of this is because VA lacks occupational classes that would allow the hiring of CAM practitioners.  These modalities are generally integrated into treatment plans as a form of integrative medicine.  However, there is wide variation in the process used to credential [and privilege] providers, as well as limited oversight in their training and experience in the certification process.  Despite some of the limitation in terms of the level of evidence that’s available, most facilities are attempting to use scientific evidence to support CAM’s use and the most common things for which CAM is being used for are for the treatment of mental health conditions as well as the treatment of pain conditions.  

When surveyed as to why they were offering CAM, most facilities listed the promotion of wellness, a feeling that was consistent with what patients would like as an adjunct to disease management, and is being proven clinically effective as the main reasons for why they were making these modalities available.  

Heidi:  Steven, I’m sorry to interrupt again.  The audience is finding a lot of value and they really don’t want to miss anything.  Is there any way you could talk a little bit louder?

Steven Ezeji-Okoye:  Sure.  Let me switch to a different headset, see if that will solve the problem.  Is this better?

Heidi:  That is significantly better, yes.  Thank you.

Steven Ezeji-Okoye:  Well, so much for the technology [laughs].

Heidi:  We tried but the audience is really – they’re finding a lot of value and they really want to hear it so –

Steven Ezeji-Okoye:  [Should I] go forward or just – or summarize what has just been – what [I just went over].

Heidi:  I have it recorded.  We will have a transcript.  So if you just want to move forward from here, that should be fine.

Steven Ezeji-Okoye:  Great.

Heidi:  Thank you.

Steven Ezeji-Okoye:  So, what is the relationship between CAM and pain?  Well, pain affects more than 100,000,000 Americans.  The burden of disease is greater than that of cancer, diabetes, coronary artery disease and stroke combined.  And you’re – and the US is spending anywhere from you know, $560 to $635 billion dollars annually.  And, in terms of chronic pain, the most common form of chronic pain is low back pain.  And worldwide, low back pain is the number one cause of disability.  And, in terms of how people are treating pain, people are seeking care from all sorts of different types of practitioners and up to 40% of the patients with chronic pain may use a CAM modality.  

So what is the evidence to support CAM’s use?  Well, the National Center for Complementary and Alternative Medicine lists some of the scientific evidence that supports CAM’s use for chronic pain as in low back pain promising evidence for massage and spinal manipulation, progressive relaxation and yoga; for arthritis, promising evidence for acupuncture; and for headache, again, promising evidence for acupuncture and spinal manipulation.  So there is some evidence that suggests that at least there are some reasons to look at CAM as a potential treatment modality for many of these chronic pain conditions.  So I’m going to review some evidence for some common modalities such as acupuncture, massage, mindfulness based stress relaxation music, tai chi and yoga.

So acupuncture.  VA TAP which is a VA technical advisory panel, unfortunately no longer in existence, but in 2007, they did a synthesis of the literature looking at randomized controlled trials and both qualitative and quantitative synthesis of randomized control trials.  And what they did, is they looked at acupuncture and its use including its use in pain modalities or pain conditions rather, and they rated it with a modified US preventive services task force rating system and what they found was that there’s really good evidence to support the use of acupuncture in post operative dental pain.  So, essentially, pain post-dental extraction.  They found promising evidence, you know – cannot say conclusively, but the evidence is trending towards positive for its use in migraine, low back pain, fibromyalgia, osteoarthritis of the knee, tennis elbow and labor pain.  Some inconclusive evidence for carpal tunnel, and that it was ineffective in postherpetic neuralgia.  

Since that time, there was actually a new study that came out that is of – I think of quite considerable interest – and that’s a review – I’m sorry, a study of acupuncture and low back pain by Daniel Cherkin.  And in this, they comment that you know, acupuncture is a leading cause for people to visit – back pain’s the leading cause for people to visit an acupuncturist.  And they randomized participants to individual acupuncturist so people [wondered whether] individual [sets] and find acupuncturists and the points and needles were determined by the acupuncturist versus standard acupuncture where standard acupuncture points – corresponding to low back pain were used, versus simulated or sham acupuncture, or usual care, or control.  There were 638 patients with chronic low back pain, between ages 18 and 70, with less than three months duration of low back pain.  And they were evaluated with a disability questionnaire is at eight weeks, 26 weeks and 52 weeks, all patients received 10 treatments over seven weeks two times a week for three weeks, and then weekly for four weeks.  And what they found was there was statistically significant improvement in dysfunction in all the acupuncture groups compared to usual care.  And that was seen at eight weeks and persisted through the 52-week period.  But there’s no difference between the acupuncture groups which included both the individual acupuncture, the standard acupuncture, and the sham acupuncture.  There were statistical improvements in symptoms in acupuncture group in week eight, but this did not persist through weeks 26-52.  However, the use of medication did decrease significantly in all the acupuncture groups, but not persistent through all 52 weeks.  So the conclusions they had were the acupuncture was effective in the treatment of chronic low back pain; however, the site of needling is unimportant.  And, you know, this does raise some questions as to what is going on in acupuncture and that the sham group was as effective as acupuncture.  And so, is it effective?  Needling, that has a positive effect, or is it that there’s something to do with the interactions with the provider that are having the positive effects – just questions that are raised about how exactly acupuncture may be providing its benefits.  

Now there is a more recent systematic review of acupuncture that came out in September of last year by Andrew Vickers titled Acupuncture for Chronic Pain, where they looked at high quality randomized clinical trials, comparing acupuncture to sham acupuncture to controls.  And what they found is there was statistical improvement or statistical significantly better result with the use of acupuncture versus control or no acupuncture.  As well as a statistical improvement between acupuncture and sham acupuncture.  However, the difference between the sham acupuncture and acupuncture in terms of clinical effect was really quite small, again raising the question about even though acupuncture may be beneficial, it’s not entirely clear how it’s producing those effects.

So let’s move on to massage, and massage can include soft tissue massage, using the hands, using a mechanical device, as well as massage that is concentrated over a specific acupuncture point for example, to produce beneficial effect.  The systematic review we’re looking at here is by Furlan.  And what they found is only eight studies made their inclusion criteria, and they’re really looking at the four outcome measures of pain, returning to work, symptom improvement, and improvements in functional status.  And they wanted to look at both short-term effects which were immediately post-intervention as well as long-term effects which they defined as greater than three months post-intervention.  Looking at adults and looking at non-specific with low back pain, so that’s low back pain that they would not attribute to a specific cause or other underlying disability.  They were looking at both the acute period, less than four weeks, sub-acute, four to twelve weeks as well, and chronic, eight to twelve weeks.  And their aim was to really see whether or not acupuncture was more effective than placebo or other medical treatments and as a secondary goal, whether or not there’s any difference between the different types of acupuncture if you combine – sorry, different types of massage – if you combine massage with other treatments.

So what they found was that massage showed itself to be better than other modalities such as cham laser as acupuncture self-care which is essentially education – I’ll give you an educational brochure for both symptom control and functions.  They found it was essentially equal to spine manipulation and that the effects were quite long lasting, lasting up to 52 weeks.  However, they did find that it was perhaps less effective than electrical stimulation such as that given by a TENS Unit.  When they combined massage and education and exercise, they found this combination was better than exercise alone, but only better than massage alone in terms of short-term relief, but not in terms of a long-term result.  And they also found that acupuncture massage was better than classic or Swedish massage when it was analyzed for improvements in both pain and function.  They concluded that given the relative paucity of the evidence that we couldn’t – basically couldn’t really make too firm of conclusions.  But they did find the evidence was too poor to make an assessment in acute low back pain, but that there appeared to be benefit when you are looking at both sub-acute and chronic low back pain in both the improvement and symptoms and function, and the effects were long-lasting, as I said lasting up to a year.  And that there’s a suggestion that specific types of massage may be better than others and that acupuncture massage appeared to have benefits over classic massage. 

So, next I want to talk a little bit about mindfulness based stress reduction.  And when we’re talking about MBSR, this is probably the most commonly used mindfulness based intervention.  And with mindfulness, what you’re really trying to achieve is a sort of dispassionate non-evauative, moment-to-moment awareness of your mental state, and that really includes awareness of both physical sensations, perceptions, and your effective state, with the thought being the development of more accurate perception of your being and of your response system – mental and physical stimuli – will allow you more control, and with that more control, the ability to affect how you react to such states such as chronic pain.  So in this meta-analysis by Grossman, they were looking at mindfulness based stress reduction and stress relaxation and its effects on general health.  And they’re looking at both published and unpublished studies where the intervention was taught, which is typical of most MBSR programs.  These programs are usually quite structured with an eight to ten week course, sessions lasting from 2 1⁄2 hours – up to 2 1⁄2 hours a week and usually, one all-day course on a weekend as well as daily homework.  They looked [for wins] that all have quantitative outcome measures and out of 64 studies, they only found 20 with acceptable quality.  This was looking at a wide array of diagnoses from fibromyalgia to cancer to just coping with stress.  And what they were hoping to see was, did MBSR improve health related dimensions in the chronically ill, and then how large were those benefits, and was further study warranted.  

In terms of the results where MBSR was done against a control group, they were able to find 10 studies which identified mental health, parameters such as anxiety and depression, and others that looked at physical health findings – just pain or disability and function.  And what they found in MBSR was superior – significantly so – in both mental health and in the physical health domains.  And when we looked at observational studies, where there is pre- and post-comparison physical and mental health variables, they again found that these results were statistically significant; although in the mental health category, they marked such heterogeneity in the subjects that the conclusions – you should be cautious about how firm a conclusion you were to draw.  So, in summary, they felt that there was – MBSR was proved to be useful in a broad array of chronic disorders.  It seemed that it helped with the coping with everyday distress and disability as well as the coping with more serious conditions such as cancer pain.  However, because the interventions really only evaluated immediate post intervention period, we can’t really draw any conclusions about long-term effects, and they really felt that further study was warranted.  

In looking at a systematic review looking at MBSR and low back pain by Kramer, what they looked at again was only randomized clinical trials and unfortunately three such trials met criteria.  And again, they were looking for the main outcomes of pain intensity and back related disability.  Again looking at adults, two were looking at – I’m sorry, they were looking at three randomized control trials, a total of 117 patients; two were looking at older adults, adults over the age of 65 with chronic low back pain of greater than three months, and they were looking at eight weeks of MBSR combined with education and in one trial, patients of any age with Failed Back Syndrome, so that’s people who have had back surgery and then had subsequent return of back disability.  And they’re looking at a combination of eight weeks of MBSR plus education, plus mindful meditation and yoga.

In terms of the results, MBSR versus the weight list control, what you saw was in the non-specific lower back pain, there was really no significant difference in pain intensity and disability.  There was some significant difference seen for physical functioning and for pain acceptance and in Failed Back Syndrome, there was significant improvement in pain intensity, disability, acceptance, medication intake, and sleep quality.  When compared, MBSR versus health education, there was really no significant difference.  Now, they conclude that really more research again was needed, and there’s limited evidence that MBSR could provide short-term relief of low back pain.  The one trial that did show improvement in symptoms was MBSR plus yoga in patients with Failed Back Syndrome.  And the concern here was it’s not clear if – how much of the benefit was due to the yoga component rather than the MBSR and that it may be that yoga was crucial to its success and without it, you would not have seen any significant difference.  And, again, they concluded that while there might be some evidence to support MBSR in short term, there really is no evidence for the long-term effects.  

Another modality often used in the management of pain is music.  In this, we’re looking at people listening to music as opposed to engaged in music therapy where they may be playing, singing, as well as listening to music.  The systematic review was done by Cepeda and looking at 51 randomized clinical trials and looking at the effect of music on a wide array of clinical conditions.  They attempted to combine trials that had clinical homogeneity and then to compare music to no music and then looking at pharmacological and non-pharmacological intervention, and hoping to see a decrease in both pain scores as well as opioid requirements.  Due to the heterogeneity of the studies, they’re really only able to evaluate the effects on acute pain, but they did see a decrease in opiate use amongst those exposed to music.  And, in the small number of trials that looked at this, it was rated roughly the equivalent of 1 milligram less of morphine over two hours, or 5.7 milligrams less over 24 hours.  And they did see a significant improvement in the decrease in pain in those exposed to music.  And there was a decrease of about half a point on a zero to ten point scale.  So, they were able to conclude that music did appear to improve both pain intensity scores and opiate use; however, in both these cases, the magnitude of the benefit was so small that it’s not clear just how clinically significant this is.  Typically, the degree of pain reduction was equivalent – was actually perhaps equivalent for [inaud] was less than what might have been expected if patients had taken Tylenol, and that the reduction in the pain intensity scores was usually less than what one would consider to be a meaningful clinical difference.  So the other thing that was of interest was that the effect was not seen if patients chose their own music, and I’m not sure what that says about the type of music we listen to but certainly patient preference in that case didn’t result in any improvement in symptoms.  

So tai chi – tai chi is often referred to as moving meditation; it’s both a form of physical exercise as well as a social activity with a meditative component.  In a systematic review of looking at tai chi, musculoskeletal pain conducted by Hall, they were looking again at randomized clinical trials, looking at its use in osteoarthritis and five studies for rheumatoid arthritis and one in tension headaches.  And, there are about five types of tai chi used and they were able to determine that the Yang style was used in 42% Sun in 42% in the Wu in 16.  And they’re looking at effectiveness in tai chi and decreasing pain, decreasing disability, improving physical function and improving quality of life.  In terms of self-reported pain, there was a statistically significant improvement as well as – when in terms of self-reported disability; however, in terms of physical performance, there were only three studies which evaluate this and two out of the three use the 50 foot walk test.  And here, even though there was a 0.4 second reduction in time, seen with tai chi, it was not statistically significant. And in quality of life, the results of the studies were too heterogenious to pool, and although there was a trend towards positive effect in terms of overall physical heath, tension levels and satisfactions in patients with osteoarthritis, it didn’t meet statistical significance.  

So their conclusions were that there was a small positive effect from the short-term on self-assessed pain and disability; however, again, the clinical significance and degree of improvement was unclear.  However, it did point out that because tai chi is often done in a social setting rather than a clinical setting – so, you know, done in community centers and parks and the like – and that it has, you know, benefits of socialization and it’s a form of group exercise as well as being very low cost that as an additive measure and adjunctive measure, it may be quite reasonable to consider and that the improvements although small, may be more significant given the relative ease for which it can be implemented and spread across a fairly large population.

So, yoga; again, many people are familiar with yoga – it’s a practice that originated in India approximately 4,000 years ago and it comes from the Sanskrit term yug which means to bind or to join.  And there are many different schools of yoga in the United States; Hatha Yoga is probably the most common, and within Hatha, there are multiple different styles.  People are probably familiar with Bikram Yoga or essentially hot yoga – yoga carried out at temperatures around 100 degrees; Iyengar Yoga yoga, which uses props in addition to the postures, Kundalini Yoga which emphasizes a lot of diaphragmatic breathing and Bindi Yoga which again is breath and postures and can also be adapted to patients’ physical conditions and states.  The key elements in Hatha Yoga really are – there’s three main elements – the breathing exercises, the pranayama, the postures, the saunas and then meditation, the Dhyana.

So, in the paper by Wren, looking at new finds and directions of an ancient practice, they looked at 13 randomized clinical trials again across a fairly wide array of different pain states and the one issue about this is that the subjects were primarily white, middle-aged women of higher socioeconomic class.  There were multiple different styles of Hatha Yoga, primarily Hatha Yoga that were tried.  And, what they found was general improvement in all of the different conditions; both improvement in pain and grip strength in carpal tunnel syndrome, improvement in pain in osteoarthritis, improvement in pain in medication use in chronic low back pain, improvement in pain and acceptance of their discomfort in fibromyalgia, and – as well as improvement in pain and fatigue and sleep disturbance in hemodialysis.  And so essentially, seeing that generally – that yoga in a significant way improved the pain, quality of life, and the use of medications – so really quite broad benefits seen across a wide array of conditions.  But the magnitude of these results were still, again, relatively small.  The conclusion was the suggestions – the conclusion was suggestion that yoga could have promise in persistent pain condition and that these benefits seem to occur despite the particular yoga intervention that was chosen.  One of the problems however is that the study populations were all pre-homogeneous.  And, there are people with limited to moderate disability and so it’s really unclear whether or not these same benefits would be seen if the populations were more heterogeneous and if the conditions – the extent of disability were more severe.  So really, further research will be needed. 

So, in summation, what does this mean?  What are the implications for VA?  Well, despite – there’s a growing body of evidence, and there’s higher quality studies coming along, the evidence is still insufficient to say that these modalities can be considered a mainstream or should be incorporated as a basic or first line option in the management of chronic pain.  And so, while they don’t rise to the level of being able to be said that they can be considered a standard of care, it may still show – there may still be benefit in using these modalities as an adjunctive measure.  So, you know, the use of pharmacological agents or other pain interventions may still be first line, but incorporating these things into VA care may not be unreasonable.  And the most promising interventions are acupuncture, yoga and massage.  So, acupuncture probably has the best evidence, although yoga and massage also have promising evidence to support their use.  And one of the things I think that is particularly exciting about this is that all three of these modalities could be provided by existing – could be provided by existing, conventional practitioners who can double as CAM providers within VA.  So, acupuncture can be delivered by both chiropractors and physicians and yoga and massage may be potentially adapted for treatment by patients of physical therapy.  And while there may not be a state licenser for yoga, there are really some quite rigorous certification standards for some of the yoga practices; Iyengar for example is a two to five year process to become certified.  So there will be ways to be able to verify the credentials and the training of these practitioners.  And both acupuncture and massage do have state license, although not in every state, and so it does lay the groundwork that would be needed to be able to one, show there’s sufficient evidence to incorporate these practices into VA care, and to be able to show that we have adequate – sort of like – adequate process to certify the education, training and credentials of these practitioners. 

In order to make this a reality, there does need to be more work done to create occupational classes for CAM providers.  And, acupuncture is potentially the best test case for this, although massage would be a reasonable second.  In terms of work that’s going on that may help further this, because of the growing interest in providing acupuncture services in VA, we do want to see that it can be provided by anybody who’s appropriately trained, so that would not just be chiropractors and physicians, but also licensed acupuncturists.  And so what we are pursuing is a memo for the under secretary which would go to the secretary to try to establish acupuncture – an occupational class for acupuncture within VA.  And, this would allow a charge to develop this occupational class and develop the qualification standards that would be needed and we’re providing some statutory justification to help support this.  This would help create an occupational class where a licensed acupuncturist would be hybrid title 38 providers.  Unfortunately, to become a pure title 38 would require legislation and you know, the ability to do it as a hybrid would represent the potentially quicker and easier route to expanding the occupational classes within VA.  This is, I think quite needed in that there are a number of places where there are conventionally trained practitioners who are also trained in acupuncture, but unfortunately don’t – the scope of practice of their occupational class does not allow them to do acupuncture, and that would include such occupations such as nursing.  The ability to have an occupational class for acupuncture would then open up them – open up the ability for them to practice underneath the acupuncture portion of their training and therefore allow those treatments be delivered to veterans.  

So, while there may not yet the evidence to say that CAM modality is standard of care, there certainly is growing evidence that CAM may have a role to play in some chronic diseases, and certainly, you know, the use of acupuncture, yoga, massage in chronic pain as an adjunct to other interventions seems reasonable.  At this point, I’m going to stop and we’ll open – turn it back to Heidi and I’m available to answer questions for the next 15-20 minutes.

Heidi:  OK, sounds great.  We do have some questions, some comments, all that sort of stuff out here.  So, let me just find the first one here.  All right.  As a board certified music therapist in a discipline that was recognized by a war department memo in 1948 or so in a professional GS0638 within VHA, how is it that music therapy is still considered as CAM?

Steven Ezeji-Okoye:  Well, I guess that has more to do with how it’s viewed in terms of – viewed in terms of conventional practice and that perhaps not as high profile or not as widely practiced.  So, and then, also the level of evidence supporting its use may be part of the reasons why.  Although, there may be ability for people to be appropriately trained and licensed that it hasn’t gained enough acceptance, so people view it as necessarily part of conventional medicine.  But again, as I said, a lot of these definitions are fluid, and it may depend upon the context and setting – what’s considered CAM in one area may not be considered CAM in another.

Heidi:  Great.  Thank you.  The next question I have here: could you clarify what exactly sham acupuncture is?

Steven Ezeji-Okoye:  So, Sham acupuncture can refer to either the use of needles that retract and don’t actually penetrate the skin so that you may stimulate the skin, but not actually puncture it.  It can also refer to stimulating what are felt to be non-active acupuncture points.  So the idea is that the patient is given the impression that they’re undergoing needling but it’s occurring in a fashion that’s not supposed to result in stimulation or rebalance of the chi or the body energy.

Heidi:  Great, thank you.  And also, I just wanted to let you know, we do have Matt on the line now, he – we were able to get him in, so he may be answering in on some of these questions also if he has anything to add; just wanted to let you know.

Steven Ezeji-Okoye:  Sure.

Heidi:  The next question I have here –

Matt Gallagher:  Can I just make a comment, Steve?  

Steven Ezeji-Okoye:  Certainly.

Matt Gallagher:  I just asked a question; you mentioned activating chi and yet there’s some pretty reasonable evidence now, I believe – this is Matt Gallagher by the way – that acupuncture also activates stimulation provoked analgesia, is that not correct?  Is that – would that be why the sham acupuncture is closer to the effect of acupuncture than the controls, in the studies you mentioned?

Steven Ezeji-Okoye:  So I don’t think –

Matt Gallagher:  Talk a little bit about that because I think there is a, you know, neurophysiologic explanation as well as the traditional chi explanation for the effects of acupuncture.  And I’d like you to mention a little bit about that.

Steven Ezeji-Okoye:  Sure.  So I think that the – you know, I think it’s not clear exactly what’s causing the benefit in the sham arm.  And so what I think what you can say is certainly there’s an effect being produced by acupuncture; whether or not it’s being produced by the modulation of other – the modulation of pain, or whether or not it’s being produced by that plus the practitioner benefits – I don’t think that’s clear.  And so, that is an area of potential further study, is whether or not you can tease out, whether or not the actual active needling itself does create a beneficial effect or whether or not it’s the practitioner; or what was suggested in the Vickers trial, perhaps it’s, you know, maybe a bit of both, and you are getting some practitioner benefits but the stimulation of the points in real acupuncture may produce a beneficial effect over and above that, albeit small, but still statistically significant.  So it may be that there is the modulation of pain that’s occurring just – that’s occurring from the needling that does result in a beneficial effect.  But I think the problem is that there’s not enough evidence to say one way or another exactly what’s happening.  I think what you can say is that clearly, there appears to be a benefit over placebo controls.  

Matt Gallagher:   Given that we do have some emerging evidence, and given the safety relative to other treatments such as long-term exposure to opioids or NSAIDs, in terms of organ systems, with – how does that elevate acupuncture, specifically I’ll just focus on that right now, given the fact we do have some growing evidence, probably it sounds like you have some level one studies, that – instead of – how does that elevate it to a mainstream, or does it elevate it to a mainstream treatment, given the balance of the risk/benefit ratio relative to exposure to other treatments that are more dangerous and risky. 

Steven Ezeji-Okoye:  Well, I think that in terms of, you know, US Preventative Services Task Force ranked or its prior rating, it would probably still be a C as opposed to a B in most areas; B being it should be – you know, it’s reasonable to offer it and certainly the evidence is trending towards positive.  So I think in terms of the overall, you know, it’s certainly – I think you could say that the evidence is certainly promising.  And, as you mentioned, it does have potential benefits over other therapy such as, you know, chronic opiate use or some other interventions which may be more invasive.  And given that even though the level of evidence may not rise to the sense where you would say it’s a first-line therapy or that it’s a – or it should be the preferred therapy – I think there’s enough evidence to suggest that it’s reasonable to consider its use, and that’s part of the reason why we’re pursuing things like trying to get the occupational class for acupuncture, in that it seems like that’s an area where there’s enough evidence to suggest we should be looking for more ways to incorporate it into care.

Matt Gallagher:  Let me just mention that, as you probably know, the VA has recently – patient care services – committed themselves to a large, primary care education and training project in pain management, as well as we were just funded by the DOD-VA [to an] investment fund program [for] a large grant on collaboration with the DOD in training providers in pain management at the PAC level, at the primary care level, and a whole system of care.  What we’re going to really need is to have your group very involved with us as we roll out this curriculum so that we can assure that the CAM therapies that are reasonable and show promise can be integrated into primary care.  I don’t know if you have any comments on that but we’ll be looking forward to working with you.

Steven Ezeji-Okoye:  No, so I – I’m aware of those and we are very interested in being involved in that.  I think, you know, part of the issue – we want to make sure is that – you know, we remain committed to providing evidence based care.  We also want to be sure that we’re offering things which allow patients choice and also things that perhaps take them away from the medical mall which I think is some of the advantages of some of the things such as yoga or you know tai chi, in that they, you know, do offer benefits that are really in the hands of the patient and that don’t require practitioners to deliver them.  What it may, you know, some of the best things that we may be able to do is be able to let people know about what is known about these interventions and then the settings where they may be helpful.  And help encourage the spread or also be able to help encourage at least the initiation of patients these practices through the VA sites.  And, you know I think – I’ve spoken before about the difference between treatment and wellness in that, you know, wellness activities – things that are largely patient driven and under the patients’ control, that there’s some of those activities; you can include tai chi potentially or something like that, [and potentially] yoga as things that we really want to try to make sure that patients are aware of what their health benefits are and expose them to those perhaps through VA, even though they wouldn’t necessarily be considered part of medical benefits package, or considered a treatment.  Whereas things like acupuncture – you know, in areas where they’re showing where it shows benefit as the evidence grows, being able to have a mechanism to have those practitioners more widely available and also to make it known, what are those conditions in which there’s the best evidence and where there should be consideration given to it being included as part of the medical benefits package and as a treatment. 

Matt Gallagher:  Well I interrupted a question of before, so let’s listen from the field and see what other questions we have.

Heidi:  Great.  Thank you.  We do have quite a few questions here, so we’ll try to get through as many as we can.  Steven, I know you have an appointment at the top of the hour, so we’ll try to get through as many as we can in just the nine minutes we have left here. 

The next question: as most CAM modalities suffer from small numbers of patients and lower quality studies, is VA investing in effectiveness research for mindfulness or other therapies?

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Steven Ezeji-Okoye:  So, VA is partnering with other groups, such as Samuel Elliot Institute, also within CAM, to do more studies to try and answer these questions more definitively.  I believe there’s a large trial looking at CAM – or there are trials being funded by VA looking at CAM modalities and the treatment of PTSD for example.  But there are – there is a fair bit of research being funded by VA to try to get at these questions.  The NCCAM or the National Center for Complementary and Alternative Medicine, one of the parts of NIH, is also doing a lot of studies, both at the – looking at mechanisms as well as the utility of CAM in real-world conditions.  So, you know, I think that is one of the key things, is that if we’re going to have growing acceptance or if there’s going to be greater usage of it, that being able to show for what conditions CAM is effective, what conditions CAM may not be effective, but also how it should be delivered, you know, including things such as frequency and duration, will be important.  Since we may only, you know, in these discussions that we had in terms of research we reviewed today really talked about whether or not there’s evidence of it being effective or not.  We didn’t really – we hadn’t really gotten to the next stage of saying well yes, it’s effective and that this is really the best way to deliver it.

Heidi:  Great, thank you.  The next question here: why do you think there’s a lack of research investigating yoga’s effects for persons with more pain or disability?  Do you think physicians are comfortable approving this type of intervention, in terms of safety?

Steven Ezeji-Okoye:  So, there’s two parts there.  One, I’m not sure why the yoga trials all seem to congregate around a certain, you know, a certain set of people.  It may just be that as an intervention, it’s something that is not – it’s not seen as something of – it may not be familiar to as broad a population as other potential interventions.  I think in terms of safety, I think there’s certain types of acupuncture which – sorry, yoga – which people may have more concerns about exposing their patients to.  You know, Bikram Yoga may not be for everybody, given that it’s practiced in high temperatures.  And then some of the other forms of yoga are much more physically strenuous, but there’s so many different schools and abilities to adapt yoga that I think it’s entirely reasonable that yoga would be safe if adapted for the age and the level of disability of the population.  Certainly people have done things such as chair yoga; I know that many people have talked about the use of Iyengar Yoga in people with amputations and other disabilities.  So, I think as a safety, it appears to be – I think it can be adapted to be really quite a safe practice.  And I think the bigger issue now may be more raising awareness about a potential applicability in chronic diseases and its ability to be used in a wide array of populations.

Heidi:  Great, thank you.  The next question here: please briefly describe acupuncture massage.

Steven Ezeji-Okoye:  So, acupuncture massage is essentially doing soft tissue massage but over – but combining that with the acupuncture pressure points, so acupressure essentially.  You’re creating essentially like an acupressure effect.

Heidi:  Thank you.  The next question: any evidence to support use of healing touch for chronic pain and improvement of quality of life or peaceful death?

Steven Ezeji-Okoye:  So, there are some – there’s a couple of systematic reviews looking at touch therapies from healing touch reiki, and they’re a bit mixed.  Effects appear – there may be some trend towards some positive effects, but not enough to be conclusive.  Again, I think an area where more study is needed and there probably also needs to be some separation between the various modalities because, you know, healing touch or therapeutic touch is, you know, can be a component of nursing practice and may be a little bit different than, I think another example of something like reiki, and I think issues regarding standardization of practice and standardization of training are issues with some of the touch therapies, particularly reiki. 

Heidi:  Thank you.  We have a couple questions here on references; the first one: can you give us the name of the author who did a recent systemic review of acupuncture treatments.

Steven Ezeji-Okoye:  So, that study was, I think they’re referring to what I mentioned, acupuncture for chronic pain, that’s Andrew Vickers, and it’s in Archives of Internal Medicine, volume 172, number 19, October 22, 2012.  And that’s the one that showed the difference between sham acupuncture, acupuncture, and then control.  Also, I believe that if you Google VA TAP and acupuncture, you will be able to see their final report on acupuncture which came out I believe in 2007, or VA technical advisory panel acupuncture.

Heidi:  And the other reference question: can you please share the Wren reference you mentioned relating to the yoga meta-analysis. 

Steven Ezeji-Okoye:  That’s on my slide, so that’s actually included in the slide set.

Heidi:  OK.  Perfect, so –

Steven Ezeji-Okoye:  So I tried – on each of these – so for each of the meta-analyses I went over today, I did include the reference underneath the slide.

Heidi:  OK.  And for our audience, if you still need a copy of the slides, the link was included in the reminder that was sent out to you this morning.  You can just click on that link and you’ll get these slides right there.  We’ve got about one minute left so let me try to get this in here.  I am trained in auricular acupuncture but cannot use it here at the VA as I am told I have no collaborating physician.  I am an advanced practice RN and would like to use it when I council my patients who are trying to quit using tobacco.  Would the changes in policy allow me to use my skills here at the VA?

Steven Ezeji-Okoye:  If you’re a licensed acupuncturist, they would.  If that becomes – if licensed acupuncture becomes an occupational class, and if you were trained as a licensed acupuncturist and you, you know, met those standards, then yes.

Heidi:  Great.  Thank you.  As we’re not quite at the top of the hour, I’m going to try to sneak one more question in here.

Steven Ezeji-Okoye:  Sure.

Heidi:  It seems that the placebo effect is an important aspect for CAM research; has the VA HSR&D supported research on placebo and CAM?

Steven Ezeji-Okoye:  That I don’t know.  I know that there’s a lot of – that they are supporting research on CAM; but I don’t know they’re specifically supporting research looking at placebo.  We’d have to [inaudible] –

Heidi:  OK.

Steven Ezeji-Okoye:  – the [ORO].

Heidi:  OK.

Steven Ezeji-Okoye:  Sorry, ORD.

Heidi:  Mac, have you heard anything about that?  No response; I’m going to guess no.  We are at the top of the hour; I am going to try to respect the time constraints here, and I am going to wrap things up.  I know we do still have a few pending questions out there.  I’m sorry, unfortunately, we did not have time to get to everything today.  Hopefully, we were able to hit a wide range – I know that we weren’t able to get to everyone’s questions.  Steven, I really want to thank you for the time that you put into preparing and presenting for today’s session.  We really appreciate all of the time you put into that.  Mac, thank you for being available for questions today; we appreciate that, and I wish you had been there for the introduction, but we were able to get through to our audience, thank you very much for joining us for today’s spotlight on pain management cyberseminar.  

After today’s session, you will be prompted with a feedback survey.  If you could take a few minutes to fill that out, we would very much appreciate it.  We really do read through all of that feedback and we use it for our current and upcoming sessions.  If that feedback form does not pop up for you, feel free to email us at cyberseminar@va.gov and we will get a copy of it sent out to you.

Thank you everyone for joining us for today’s spotlight on pain management cyber seminar and we hope to see you at a future session.  Thank you.

**[End of Recording]**

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