Evidence-based Synthesis Program- 15 -Department of Veteran Affairs

02-29-12 

**Evidence-based Synthesis Program**

**Department of Veterans Affairs**

**Efficacy of Complementary and Alternative Medicine Therapies for Posttraumatic Stress Disorder**

Jennifer L. Strauss, PhD

John W. Williams, Jr., MD

02-29-12 

Moderator:  So we are at the top of the hour.   I’d like to introduce our presenters for today.  We have Dr. Jennifer Strauss and she is a previous HSR&D Research Career Development awardee.  And currently she is the women’s mental health program manager in the Office of Mental Health Services at VA’s central office. 

Presenting with her is Dr. John William.  He is the director of the Durham Evidence Synthesis Program and his research focuses on systematic reviews and intervention to improve the care of patients with mental illness.

Also joining us later on as a panelist will be Dr. Paula Schnurr, Deputy Executive Director of the VA National Center for PTSD.  So we are very grateful to all of our presenters for joining us today.  And Jennifer, if you’re ready, I’d like to turn the screen over to you?

So, ladies and gentlemen, we are going to begin with a poll question and that is, “What is your primary role?”  Your options are:  mental health clinician, non-mental health clinician, researcher, trainee or other.  And you can go ahead and click on the circle that best describes your primary role.

We do have about half of our attendees have answered thus far.  And we’ll give everybody just a few more seconds and then I will close the poll and share the results with everybody and Jennifer you’ll be able to talk through the results.

Okay it looks like we have about three-fourths of everyone has voted.  So I’m going to go ahead and close the poll.  And I will share my screen now so everybody can see it.  And those are the results.  Jennifer, if you’d like to talk through them?

Dr. Strauss:  Yeah, okay.  So it looks as if we have kind of a—almost an even split between researchers and clinicians.  And then a strong group of others.  Yeah.  Let’s go to the next question please?

Moderator:  The next question should be showing up on your screen now, Attendees.  And that is, “Do you use complementary and alternative medicine CAM therapies?”  Yes in clinical practice; yes personally; yes both in clinical practice and personally; or, no not at all.

And about two thirds of our attendees have voted so we’ll leave it over for just a few more seconds.  Okay it looks like almost everybody has voted. I’m going to go ahead and close that and share the results.

Dr. Strauss:  Okay.  And this is Jennifer.  So interesting.  So about two-thirds use these approaches either personally or clinically or both.  And then another third not at all.  So great.  That will just help me to understand kind of where people are at and to try to gear the talk accordingly.

My Name is Jennifer.  My co-presenter is Dr. John Williams. We’re both out of Durham’s Evidence Based Synthesis Program.  And as mentioned, we are talking about a review that we completed last year looking at efficacy of complementary and alternative medicine therapies for post-traumatic stress disorder.  Next slide, please?

And also of course need to acknowledge co-presenters or co-investigators, Remy Coeytaux, Jen McDuffie, and research assistant extraordinaire, Avi Nagi, and medical editor extraordinaire, Liz Wing.  I think it’s important to note at the bottom of this slide for each of these evidence syntheses they were nominated.  And in our case, ours was nominated by the Office of Research and Development.  And our charge was to complete this evidence review so that we might help to inform VA’s research agenda in this area.  

I like to refer to this as the “I love my federal job” disclosure slide.  The fine points here are to note that we have funding from the Department of Veteran Affairs, both for the evidence synthesis program and also my career development award that was in place at the time. And always important to note that the findings in our report are those of us and our co-authors and do not necessarily represent the views of our esteemed employer, the Department of Veteran Affairs.

Just a little bit of information about the ESP programs.  They—these are sponsored by VA, Offices of R&D and Health Services Research.  The goal is to provide timely and accurate reports on topics that have been identified as important to VA, to staff, to leadership.  And there are actually four centers:  at Durham, at Los Angeles, at Portland, and at Minneapolis.  

And these centers are actually designed to kind of complement some existing parallel centers that are funded by AHRQ.  Next slide  

The important take-home here is that there is a nomination process for topics and there is a hyper-link actually at the bottom of this screen.  So for those in the audience, who—if there is something that seems pertinent to your clinical practice, research, and important to VA policy, please look into nominating a topic because that’s actually how these things get fed forward.  And so again, there’s a hyper-link at the bottom of that slide that will give you some guidance on how to do that.  Next slide.

And then a final note just to give you a little bit of information about how these programs work, for each topic that gets nominated we establish a technical advisory panel to provide content expertise relevant to that specific area.  And then we work in collaboration with external peer reviewers and policy partners all of which gets put into a draft report and that’s actually peer reviewed.  It’s a pretty—it’s a collaborative process and a pretty rigorous and thoughtful process.  Next slide.

And again these are reporting—we’re going to be reporting results here of a report that was published in August of 2011.  Again, there’s a link on your screen, so those who want the—to read the full 85-page version, uh, that’s readily available on the web.  Next slide?

Okay.  So background.  So I guess, starting at the beginning, why this topic?  Why PTSD?  Why complementary alternative treatment?  So knowing that we have those researchers and clinicians in the audience, let me just give you kind of a refresher course on post-traumatic stress disorder.  This is an anxiety disorder.  It is one of the most common mental disorders, often chronic, and associated with pretty significant adverse consequences.  So you often see high rates of psychiatric co morbidities, particularly depression, substance abuse, increased rates of suicidality, functional impairment, decreased quality of life, and even medical morbidities and high rates of health risk behavior and health service use.

In the general US population, the lifetime estimated prevalence of PTSD is about 7%.  Next slide, please?

But in VA, we actually see higher rates of PTSD among Veterans.  We know that PTSD is a mental disorder that is most commonly associated with combat and other potentially traumatic experiences that one can experience or might be exposed to during military service.  So for example, motor vehicle accidents during deployment or sexual assault.  And then of course we, you know, we think a lot these days about how to serve our newest generation of Veterans—those who have served in OEF, OIF, or OND.  And when we look at those who have accessed VA services, we’re seeing diagnosed rates of PTSD at about 22%.  And of course that estimate changes depending on what month, what quarter we’re looking at it.  But those are from published data from 2009. 

What’s interesting though is we’re also seeing a sharp increase in mental health service use access among Vietnam-era Veterans.  So it’s not just these newer Veterans.  But we actually are just seeing—VA I think has seen influx in service in medical service use among Veterans more broadly, including the newer OEF, OIF and OND, and also Vietnam.

So all of that kind of leads to, you know, the kind of take-home which is that last bullet on the slide that the VA strives to anticipate and serve the treatment needs of growing Veteran populations.  Certainly identifying and implementing effective PTSD treatments is a critical priority.  Next slide, please.

So the good news is we know a lot right now about how to treat PTSD.  There is a real solid, well-established literature base on first-line evidence based treatments.  And the data on this slide were drawn from the VA DOD clinical practice guidelines which were published in 2010.  And so when we look at first line evidence-based treatments, there are kind of three major categories.  And these are already out there in the field and again recommended.  

So you have a category—that first bullet—called trauma-focused cognitive behavior psychotherapies.   These are grounded in cognitive behavioral theory and they tend to be multi-component, so there will be some aspect of this PTSD specific, for example, exposure to trauma related stimuli, and that’s coupled with skills training, anxiety management, psycho education, etcetera.  

And there is three kinds of flavors right now of those out there; prolonged exposure, cognitive processing therapy, and EMDR or eye movement de-sensitization and reprocessing.  And it’s also worth noting that there is a little overlap with CAM; the complementary alternative medicine.  But some of the skills training involved in those treatments might include things like relaxation strategies that in another—that are consistent with CAM techniques.  But we fold them into cognitive behavioral therapies because really the theoretical rationale is grounded there.  So that’s one.  

We also have a sort of a category of treatments called stress innoculation training.  This is also a cognitive behavioral approach.  It’s kind of a toolkit approach, which is designed to teach skills to quote unquote “innoculate” folks against stress responses.  Here again just for the sake of noting it, some of the skills overlap with CAM.  So breathing relaxation, muscle relaxation, some of the skills that are being taught in these therapies are also consistent with complementary alternative techniques.  The difference is they’re really—in these cases they are considered, you know, cognitive behavioral theoretically grounded treatments versus an alternative medicine approach.

And then the third category of evidence-based first line treatments are pharmacotherapies.  The most common of these are SSRI’s and SNRI’s.  So this is all to say there is actually a really good treatment foundation right now out there that we have kind of in our armature to treat PTSD.  We know a lot about this.  Next slide please?

So the summary there—there are current evidence based treatments and there continue to be very strong efforts within the clinical research community to refine and optimize these approaches, which is great news.  And there are also, you know, as with probably, you know, any treatment modality, in each case each of our first line treatments can be associated with limitations and potential barriers to broader dissemination and uptake.  So for example, primary limitations that we see with these approaches; issues related to access.  These treatments typically, particularly some of the psychotherapies, provide some pretty rigorous provider training and frequent contact.  You know, once a week, twice a week, which is great for some and for those who maybe live in rural areas, who have jobs or childcare issues, that just many not be feasible or the patient’s preference.  So there’s that issue.

Not all patients are suitable for these medications.  There are some contra indications.  So again, maybe not always the best match for a patient; maybe not always aligned with the patient’s preferences or their own kind of—their own philosophy of how they would like to engage in care.  With medications in particular we see side effects which, you know, have different effects with different people.  And stigma, um, you know—for better or for—well not for better.  I would say, you know, unfortunately stigma is an issue with mental health care.  And mental health diagnoses.  And sometimes that is more pronounced when someone is asked to seek special mental health care in the mental health setting.  Which also raises the idea that maybe there are opportunities to meet patients, provide care in other settings that feel less stigmatizing to the patient.  Next slide, please?

So given that background and that foundation of where we are right now, that raises a reasonable question is gosh is there anything in the realm of complementary alternative treatment that would be—is worth exploring really as a potential first line or adjunctive treatment for PTSD that would just broaden the services that we have available to—and the options that we have available to treat these patients.  

There are different definitions of CAM. Broadly speaking you’re talking about a range of therapies that would be not considered standard practice of medicine in the United States or I guess in western medicine.  But that’s not to say there are other areas of medicine, other cultures, where these are part of—considered part of the traditional therapy. So this is really—we’re talking about complementary alternative medicine in the context of western medicine.  There are different definitions and ways of categorizing these.  We adapted the NIH’s National Center for Complementary and Alternative Medicine system or NCCAM which lists five broad categories of CAM treatment. 

So the first are mind-body medicine.  These are things like meditation, acupuncture, relaxation, yoga.  The second are manipulative and body-based practices; massage, chiropractic.  There’s kind of another category, things like energy therapies that don’t fit into those first two.  There’s also a whole category of natural products such as supplements and we do not include those in our review because the request was that we focus on non-product, non-natural product related options.  And then finally there are whole medicine approaches.  Things like Aruyvedic medicine, Chinese medicine; also not included in our review.  

We were really looking at ways of integrating potentially CAM treatments with more traditional westernized medicine versus exploring completely different medical systems.  So these are—it’s all worth noting that these are slightly imperfect categories.  There are some treatments I mentioned; you know, with our first-line psychotherapies, there are certain techniques and skills that would also be consistent with CAM such as relaxation, that kind of thing.  And then, you know, for example something like biofeedback, depending on—in some cases that gets sold as western medicine and in some cases it’s considered CAM.  So these are not black and white categories but this is I think the best categorization we have to work with right now.  Next slide, please?  

So the rationale for exploring this—we know that patients use them and ask for them.  So we know that these types of treatments are widely used by mental health consumers including Veterans.  And as we noted earlier in the talk, you know, a number of us providers, you know, we incorporate them into treatment, we incorporate them into our own personal practices.  So there is something to be said for patients under care and being open to what patients are asking for and exploring that as viable options. Also these treatments are considered minimally invasive and have a low anticipated risk of adverse effects although of course that’s a question for science.  So you would anticipate that these are relatively, you know, low risk interventions.  It would be—but we need data to support that.

So again if efficacious there’s a potential that these treatments could be considered as either first line or adjunctive treatments.  The bottom line, a number of stakeholders have expressed interest in this and this is I think why VA’s R&D Service asked us to delve into the literature and see what we know or don’t know and help them sort of guide their research on a timeline moving forward.  Next slide?

This is my attempt at humor.  The only cartoon I could find that was CAM related, but this is my meditation.  Next, okay, so the question is:  What is so systematic about a systematic evidence review?  So some in the audience might be real familiar with this, some might not.  The important things to know is that pretty much everything about this process is systematic.  So we won’t go through the methods in fine grained detail, but suffice it to say that this is a highly structured and objective and thoughtful process at every step of the way.  Next slide?

The first step is to figure out what your key questions are.  So we had four.  So, you know, what are we asking?  What do we want to know?  And I’ll just read through these.  So the first key question was:  In adults with PTSD are mind-body CAM therapies more efficacious than control for PTSD symptoms and health-related quality of life?

Second question, same as the first except instead of mind-body we ask the same question about manipulative and body-based CAM therapies.  

Question three, same question looking at movement based and energy therapies.

And then finally, in key question 4, what we really were looking for were randomized controlled trials.  That level of data in support of these treatments.  But for types of CAM treatments for which there were no randomized control trials, was there any evidence from any other study designs such as the prospective cohort design that would at least suggest some potential for treatment efficacy.  So that’s how we designed our inquiries.  Next slide.

And for those of you who brought your reading glasses today, this is an analytic framework.  The things that I’ll just point out here are that our primary outcomes were as I mentioned PTSD symptoms and health related quality of life.  We also were looking to see what we could find out about adverse events.  And then in the bottom right-hand part of the slide, secondary outcomes; patient satisfaction, treatment adherence, functional status.  That’s—those are the types of outcomes we were looking for and we limited our sample, bottom left, to adults with PTSD.  Next slide.

I will not go through all of this.  But the take-home as we worked closely with the medical librarian and what we—because we anticipated that there was not a large literature out there, we purposely designed a search strategy that would be as inclusive as possible.  So although limited to the peer reviewed literature, we really tried to cast a wide net and capture all that we could that would be related to application of CAM treatments with PTSD.  Next slide?

Nope.  I think we need to go back to slide twenty.  Again I won’t go through this level of detail, but the important things are we limited our search to the literature on adults with PTSD and they needed to have been diagnosed with PTSD in some way.  So we were looking at clinically elevated PTSD symptoms, diagnosed symptoms in adults.  And we were looking at outpatient settings versus inpatient settings.  I think those are the two important things to highlight there.  In terms of comparators, any other condition; PTSD, you know, the CAM treatment versus [weightless], versus a control, versus active treatment.  So all comers were welcome.  Next slide.

There are only three include—exclusion criteria that I want to highlight here.  And there’s an arrow next to each of those.  One, actually two in particular I think.  The first one is that we limited our search to studies that were conducted in western countries because again we were looking at the integration of these types of treatments into western medicine.  There’s a whole—there’s another literature for example out there looking at some of these treatments in Asian cultures where they’re considered more traditional to that culture, but we really were looking at how things play out in our system of medicine.

Okay and I think at this point I’m going to turn it over to John to do the next several slides.

Dr. Williams:  Sure, this is John Williams in Durham.  I’m going to quickly go through the next three method slides, the first one being on quality assessment.  So you should know that when we abstract the data from these published studies, we have two people abstract it separately, compare notes, and make sure that they’re getting the same information before we proceed to analysis.  A second step is to assess the risk of bias or the quality for each study.  So we look at some standard elements like the quality of randomization, were outcomes blinded, and that type of thing for randomizing controlled trials.  

For observational studies we look at some of the same things but we’re more attuned to issues such as selection bias; whether the analytic approach adjusts for differences in baseline characteristics across those exposed to the treatment and those who aren’t exposed. 

At the end of that process we assign each study a summary rating as being good quality, fair, or poor quality.  Most studies end up in the fair quality, that’s a broad category with a broad range of strengths and weaknesses and relatively few end up in the good quality or poor quality.  Next slide?

In terms of synthesis we start by describing the studies in summary tables looking at things like the patient population studied, the particular intervention, and the outcome effects.  We like to do a quantitative synthesis of meta analysis where possible because that gives us a nice summary estimate of the effect of the intervention.  But in this particular instance, there were not enough studies to conduct meta analyses.  We also found that studies use different measures.  So you could measure the symptom severity of PTSD using different scales and in order to facilitate comparison across studies, we computed a standardized mean difference which simply takes scores on different scales and communizes them to a common metric.

Some have suggested that a way to consider those results is that if you see an effect size in the range of point two to point four, that’s a small positive effect.  Around point five, a moderate effect. And when you get up to effect sizes of point eight and higher, that’s a very robust or strong effect.

In this particular instance we—our synthesis was limited to beyond the effect size is our standardized mean different?  That was one of the qualitative syntheses.  Next slide?

Finally we rate the body of evidence, considering all of the individual studies.  So all the particular studies for a mind-body therapy for instance, we would look at those, we would consider characteristics such as, are these randomized controlled trials versus observational studies, what is the individual quality of those studies, how precise are the estimates or are the confidence integrals very broad or narrow.  Is there any evidence of publication bias?  So did we find evidence that, for example, negative studies that have been conducted simply never saw the light of day and therefore we might be giving you a biased estimate of a fact.

We looked to see if the results are replicable.  So that, you know, in study 1 and study 2 and study 3 they get a consistent effect.  And if we find that that increases the level of evidence.

So we rate, using those factors, the body of evidence as being high when we have high confidence in the estimate of a fact and we think that future studies are unlikely to change that estimate. We rated as moderate when future studies may have an important impact on the confidence interval, and low when future research is very likely to have an important impact on the confidence and the estimate of a fact.

In some instances we rated it insufficient and that’s when we simply can’t calculate an estimate of an effect or just have such low confidence in the estimate that we calculate that we don’t even—we don’t feel we can even assign it a low grade—meaning that future research is almost certainly likely to change our estimate of effect.  Next slide?

And then the report was sent out for peer review and it’s reviewed by technical experts, clinical leadership, and experts in systematic review and meta analysis.  We incorporate their comments and address them in a tables comment which is also available in the report.  And I’ll turn it back over to Jennifer.

Dr. Strauss:  This is Jennifer.  And I’m getting some feedback if I’m difficult to hear.  Can somebody tell me if I’m coming through a little clearer now?

FEMALE1:  Yeah.  Just try and remain facing your speaker phone and maybe not turn the head and...  Yeah.  Just project your voice, but you’re doing great.  Thanks.

Dr. Strauss:  Okay.  Good.  If I start shouting, let me know that too.  So next slide, please?

Okay.  So here is the take-home here.  This is our literature flow diagram.  And what you’ll see in this top left is we initially identified over 1700 references that we thought might be relevant.  So our initial sweep of the literature, our database search, yielded over 1700 potentials.  

And then parallel to that, the right hand, almost all of those over 1700—1738 references—we at the title or abstract level we were able to decide were not relevant.  So we might have for example figured out it was an animal study or it wasn’t in PTSD or there was something that was just very clear just looking at the title of the study or the abstract that said it wasn’t relevant.

So going back to the left hand side, of those 1776 references we ended up pulling 36 that we said, “Okay we need to read through these.”  And there were two of us that read through in each case and came to a consensus agreement to see if they were relevant or not.  Of those 38, we excluded 29.  The most common reasons to exclude something were that either it wasn’t a PTSD population or when we read things more carefully we realized it wasn’t a CAM intervention. 

So out of that initial over 1700 references we ended up with 9 trials that were relevant.  And then some side companion studies that might have discussed methods or something in more detail.  

So going on the bottom from left to right, for our key question 1 where we were looking at randomized controlled trials of mind-body therapies, we had six trials.  For key question two looking at manipulative and body based CAM therapies, one trial.  For movement and energy based therapies—that’s key question 3—zero.  And then when we went beyond the randomized controlled trial literature to see if there were other approaches that yielded only two additional trials. So take-home there is the entire literature that we found that was relative was nine; nine studies.

Okay, now you can go to the “Drum roll please...” slide.  So drum roll please...?  What are the results?  Next slide.

So for that key question 1, looking at mind-body therapies, in all we found six randomized controlled trials, two in meditation, one in acupuncture, and one—or excuse me—three in relaxation.  And of those we found one good quality study that was acupuncture.  The remainder were fair or poor.  

We also then went a step further and looked at ClinicalTrials.gov to get a sense of looking at recently completed or ongoing trials is there some evidence looking at ClinicalTrials.gov of what sort of literature we think would be coming down the pike soon.  So things that are maybe wrapping up soon that we would anticipate would be part of the peer reviewed literature in the coming year.  Next slide, please?

And this simply summarizes the six studies that we found that were relevant.  Here’s what I think is interesting to look at here.  This slide presents on the left hand side the authors, the year of publication, the sample size.  And then on the right hand side what the intervention was.  So interesting to note that first of all one study in 1985 and then really just a handful in the nineties and more recently; 2007 and 2008.  

And small sample sizes, I mean not really really small but the two larger sample sizes, which would be Hollifield and Watson—so that’s the last study listed and the third from the bottom—which were a sample of 84 and 90, those were three arm trials.  So what these studies show were you’ve got basically per arm you have sample sizes of 12 to 20 per arm; relatively small trials.  Next slide, please?

      And this is the results of ClinicalTrials.gov and this just gives you an idea of what we think might be coming down in the literature.  So we see studies mostly looking at acupuncture coming up, you know, the top line.  And some meditation related studies; not a ton though.  I mean, so we did find 16 trials, but we didn’t find 116 trials coming up.  So still, although we think this is going to be a growing literature, not necessarily growing by leaps and bounds at least based on this indicator.  Next slide.

Okay our key question 2.  So what’s the evidence in randomized trials for manipulative and body based CAM therapies.  And here we found only one trial.  It was of poor quality meaning it was a sample size of eight.  And it was a massage intervention and basically in that trial everybody was in therapy and they either also got massage or didn’t.  But it’s very hard to draw a lot of conclusions based on a sample size of eight and a poorly designed trial.  So that’s just very very limited right now.  And nothing in ClinicalTrials.gov that sounds like we have anything in the works in this area.  Next slide?

Okay key question 3.  What do we know from the literature about movement-based and energy therapies?  And the answer is we didn’t find a single published randomized controlled trial and nor did we see anything in ClinicalTrials that would suggest that there are current studies that have not yet been published.  Next slide.

Our key question 4 we just wanted to go beyond the randomized controlled trial literature and look at other study designs.  And we found two trials they were both kind of multimodal therapies that incorporated CAM techniques with psycho education and to be honest it didn’t add that much to what we had already seen, but at least there are two—two more studies out there.

And then going to ClinicalTrials.gov there are two non-randomized trials going on right now: yoga and that was I guess, you know, at the time that we pulled those data.  And that’s it.  All right, next slide?

And this is simply a table that looks like what we showed you before showing on the left hand side the citations and the sample sizes of what we found for key question 2 and key question 4 and then a brief description of those interventions.  But, you know, here again, small sample sizes and poorly designed or fairly designed studies.  So...Okay, next slide?

So these are other complementary alternative techniques for which we found no evidence either in the published literature for PTSD or in clinical trials.  So in terms of untapped areas these are types of complementary alternative treatments for which we just could not say anything.  We did not find any evidence in the published literature for PTSD.  Next slide?

And this is kind of a scary looking slide, so let me highlight a few things that I would want to highlight here.  So what this slide is looking at is, you know, we mentioned that we rated the strength of the evidence for each type of study.  And then on the right hand side we ended up with—oh I like the highlights—on the right hand side we ended up with an estimate of the overall strength of evidence.  And overall we found either low or insufficient evidence to really draw conclusions. The only exception to that was acupuncture where we found that there was at least one good randomized controlled trial, one good quality trial.  And the—there were three instances in which we felt that we had enough information to begin to at least calculate an estimate of what the effect size was, or what we call standardized mean difference.

So for mediation on the right hand side you will see something that says, “SMD”, standardized mean difference.  But basically what we see are a range of estimates.  In general I would say meditation seems to fare better as opposed to usual control.  And we had a wide range of estimates if you look at the—in the parentheses that give you a confidence interval meaning that this is not a reliable estimate, there just wasn’t a lot of information.  But broadly speaking, based on our preliminary take it looks as if meditation seems to have a small to moderate effect as compared to usual care.  

Moving down to acupuncture, that’s where we had better evidence.  It was from a single study.  And it looks like actually a large effect relative to a controlled treatment.  

The bottom bottom part where it says standardized mean difference negative 35—that’s acupuncture versus an active control.  And I should say that the study that we based that on really wasn’t powered to even draw comparisons between two active treatments so less evidence there.  Next slide, please?

And the only thing I’d want to point out here—the yellow highlight—when we looked at relaxation.  In general relaxation was better than—seems—looks as if—and this is gosh really preliminary—had some effect.  But when you compared relaxation to other active treatments it actually appears to be less potent than other active treatments.  So I just think that’s notable that we actually saw the reverse where if you’re comparing relaxation to an active therapy, the active therapy tends to perform better.

Next slide?  Let’s put this in English.  Okay so in plain English what does all that mean?  Next slide.

So basically, highest quality of evidence seems to be for acupuncture.  And looks like we have a decent estimate that acupuncture does better than a weightless control.  Less evidence when you look at acupuncture versus an active treatment.  I mentioned that the study that that was based on really wasn’t powered to compare to active therapies.  Also the active comparator was group cognitive behavioral therapy, which really isn’t considered to be as potent as individual cognitive behavioral therapy for PTSD.  So maybe not the strongest comparator.  And again single randomized controlled trial—further studies needed.

Greatest breadth of  evidence for relaxation and by “breadth” I mean three randomized controlled trials of fair to poor quality, so I wouldn’t call that an enormous evidence base.  Generally sounds like there’s good—it looks like there’s moderate improvement.  But in all studies there were design flaws and actually it looked as if an active comparator did better than straight relaxation.  Next slide, please?

Evidence from meditation generally positive.  But these are two—we looked at two preliminary studies and they only focused on one sub-type of meditation; concentrative.  There are other styles of meditation that have not yet even been looked at.  But in general meditation relative to a control, a usual care, seems to do okay.  We really don’t know anything about how it performs about—next to an active treatment.  There wasn’t good evidence there.  

Ditto with massage.  I just don’t think there’s much you can say from one poorly designed randomized trial in 8 people.  That’s—I mean that’s—the study wasn’t meant to be the be all.  It was meant to be a small feasibility study and that’s what it was.  So it’s really hard to draw a conclusion from that.  

And again we just didn’t see any evidence for other types of CAM treatments.  Nor did we see a lot of information about adverse effects.  When retention rates were reported, which was not always, they did seem to be about consistent with what we see for evidence based approaches, which is interesting.  Okay next slide?

Main limitations I’ll point out are that we limited our review to randomized trials that were in PTSD samples.  So certainly there are other literatures out there looking at CAM therapies for other disorders that should—other anxiety disorders, depression—so that there are other disorders that are out there.  There’s a wider literature on CAM therapies, but we were asked just to limit our studies to PTSD.

And the other thing which is the second to last bullet that I think is worth noting, is there are what are known as third wave psychotherapies which are a form of complementary—excuse me—a form of cognitive behavioral therapy that incorporate many aspect that are—many sort of ideas that are theoretically consistent with CAM.  So they might incorporate aspects of mindfulness, meditation.  So it’s worth noting that there are also standard cognitive behavioral therapies right now that already are sort of integrating some of these ideas.  Okay, next slide?

Overall strength:  I think we went for quality over quantity here.  This is a really highly structured systematic review.  We applied really rigorous methods and we had just a great multidisciplinary team.   Next slide?

We—but in terms of conclusions, wow.   I mean we found seven randomized controlled trials that were relevant.  That is just such a small literature.  If you remember our initial charge, we were asked by—our topic was nominated by the Office of Research and Development to kind of help to provide a road map or just to inform their agenda as they explore maybe setting a research path in this area.  And, you know, we didn’t have a strong signal for any particular CAM therapy.  So, you know, the glass half empty?  The statement here would be that this is such a limited evidence base right now that you really can’t draw strong conclusions one way or the other right now.  The glass half full for the researchers in the audience:  wow, there is uncharted a lot of work to be done here.  And, so lots of work for everybody.  Okay, next slide?

Again other things to note, complementary alternative therapies encompass a broad range of treatments.  And it may also simply mean that not all hold the same promise for PTSD.  As I mentioned, we didn’t get a strong signal pointing to any one therapy over others.  And so if we were asked to sort of provide some recommendations then we really are limited in our ability to do that.  But it sounds as if, you know, there is some good quality early evidence for acupuncture.  

So if—in terms of bang for buck—if one were going to see just looking at what would the next steps be?  Where would you want to put some dollars for a randomized controlled trial?  That’s one possibility.  There are also, in the absence of really good quality evidence there are some treatments such as meditation for which there seems to be a real strong and well-established theoretical rationale and maybe that’s an area of interest.  

With regards to the areas—the types of treatments where there is really less science and less theory, for example energy therapies, it seems like the initial next step would be—for those interested—to start looking at smaller exploratory pilot studies.  That it’s just not at the stage of going further than that.  Okay next slide?

And this is really my final thoughts slide. Just to say dynamic and growing field and hopefully I think we can look forward to a more comprehensive evidence base in the future.  And I know we’re running short on time so, Molly, I want to give a chance for our panelists and for people to ask questions, so I think I’ll stop there.

Moderator:  Thank you very much.  And again I want to send my appreciation to everybody for staying tight through those technical difficulties.  And, yes, we do have some questions that have come in, but before—but first I’d like to turn it over to Dr. Schnurr and see if she has any comments she would like to make.

Dr. Schnurr:  Well in the interest of time, I’m going to defer because we really are short, but I would like the opportunity perhaps to respond to some of the questions if I feel I can contribute.  Okay, Molly?

Moderator:  That sounds great, thank you.

Dr. Schnurr:  Okay.

Moderator:  So we’re going to go ahead and with no further ado get to the questions.  So the first one that came in—hold on a second here.  The first question is:  I hope I didn’t miss this being defined earlier, but could you briefly explain what Trager therapy is?  I’m not familiar with that. 

Dr. Strauss:  You know, I don’t think I’m the best person to provide a definition of that.  I believe it has to do with—I can Google it—but honestly, I don’t consider myself an expert on all of the different treatments, so I can’t answer that question.

Moderator:  Not a problem.  We can move on to the next one.  How do animal therapies fit into CAM?

Dr. Strauss:  Interesting question.  So animal—you’re talking about like, for example, therapy animals.  And they’re not considered according to NCCAM at least, to be a complementary alternative treatment.  Just like I think, you know, music therapy would be something else that doesn’t fit under this umbrella.  But I would call it something—I think it’s its own category.  And it’s not something that we looked into.

Dr. Schnurr:  Jennifer, this is Paula, may I comment that in other schemes, for example, the VA’s Haig survey we did consider animal assisted therapy a form of CAM.  I actually thought that NCCAM did.  Maybe they used a different label.  And I can just comment that the evidence base is similarly poor for animal assisted therapy for PTSD or many other mental disorders and there really aren’t good randomized trials in this area for any problems in adults that I’m aware of—any mental health problems in adults.

Moderator:  Thank you for that response.  I do want to pause for just a second and let any attendees who know—that joined us after the top of the hour, if you are looking for how to submit a question or comment, just go to your Goto webinar panel on the right and hit the “questions” portion and you should be able to submit those.  

And the next question we have is:  How about hypnotherapy?

Dr. Strauss:  I think hypnotherapy is one that would be considered CAM by some and we actually did not find any randomized controlled trials on hypnotherapy.  There was one when we looked at the prospective designs there was one non-randomized controlled trial that included an aspect of hypnotherapy, but we did not find in our CP.

Moderator:  Thank you for that response.  When evaluating the quality of the study, did you consider the population characteristics?  For example, homogenous samples versus more diverse samples?

Dr. Williams:  Hi, this is John.  That certainly comes up in our evaluation of whether or not the results would be applicable in the VA population, but it does not go into the quality rating.

Moderator:  Thank you for that response.  Paula or Jennifer, did you want to add to that at all? 

Dr. Schnurr:  On that, no.

Moderator:  Okay.  The next question:  Are there opportunities in the VA for “traditionally” quote unquote trained psychologists to get training in CAM therapies?

Dr. Strauss:  This is Jennifer.  Paula might know more about this although I don’t want to put her on the spot.  I don’t think so.  But, you know, one thing I did not mention is there are some examples—the VA in Salt Lake has a very nice complementary alternative treatment program up and running.  So I would say that there is some evidence—not evidence—I would say that we have an example of these treatments being feasible to incorporate them into care in a VA setting.  I don’t know within Salt Lake if there are—I don’t know the clinical background of the providers.

Dr. Schnurr:  This is Paula.  And if I could comment that there—besides the Haig survey that was done this year, we had a—in addition to Jennifer and John’s evidence based synthesis analysis, there was also a survey of the specialized PTSD programs which revealed an even deeper use of CAM for PTSD.  But to my knowledge, VA has not yet invested in training practitioners.  So typically what we see is that people who are interested in delivering CAM either come to VA with that skill set or they go outside to get it.  We also see that in terms of care provision, many programs use external providers when it’s possible.  And they do that because they don’t have the internal providers.  For example there aren’t many acupuncturists around who worked in VA.  So a lot of that care is delivered by external people.

Moderator:  Thank you for that response.  We do only have two questions left, so we should be ending pretty closely to the top of the hour in just a few moments.  For our attendees who need to exit. Please feel free—no, please do fill out the survey that you will be prompted to at the end.

And the next question:  Mention was made of EMDR.  Were those studies dismissed because it is not considered a CAM therapy?  I would have thought this would have fit the category.

Dr. Strauss:  Oh, interesting.  So EMDR is actually considered a first-line evidenced base treatment according to the VA DOD guidelines.  So for our purposes, we would actually have categorized that, I mean I know there is a little—the theory behind that is not always considered to be CBT, but we considered it CBT and actually and active comparator.  So we don’t consider it CAM because it’s already considered—it’s actually something that’s in our clinical practice guidelines as a first-line treatment.  Paula, anything to add?

Dr. Schnurr:  EMDR isn’t considered in any framework to be a CAM treatment.  I realize that it is unusual—the rapid psychotic movements and the hand movements on the part of the therapist make it seem somewhat unusual.  But it really is a standard type of therapy and it happens to be effective one as well.  So it’s not included here or in any other categorization of treatment as a CAM.  

Moderator:  Thank you, both, for those responses.  The next question:  Did you consider that RTC’s may not be the most appropriate vehicle for studying CAM effects?  For example, possibly a comparative effectiveness study.

Dr. Williams:  This is John again.  And we certainly did consider that and certainly some of the best comparative effectiveness studies are randomized trials because they are just head-to-head comparisons between the novel intervention and an established one.  And these results were presented at a meeting in Washington and there was a vigorous debate about this very issue.  About whether there were alternative designs to standard randomized controlled trials.  We believe that RCT’s provide the best evidence so when we get to do our grading of the results, RCTs start as high quality evidence that typically lead to high strength of evidence with high confidence in the estimate of effect. 

Observational studies in the grade approach—so the strength of evidence—start out as low quality evidence.  But with certain characteristics like strong effect sizes, there’s response relationship, can be upgraded to moderate or in rare cases high strength of evidence.

So, yes, there are other ways to study these interventions.  But to give you the strongest conclusions, we thing randomized controlled trials give you that evidence.

Dr. Schnurr:  And this is Paula, if I could comment.  I think that the evidence based—if those trials had been included, there really isn’t enough there to draw any firm conclusions.  If you’re a researcher and many of you are, the field is very open.  Jennifer wasn’t kidding when she talked about that earlier.  It’s not as if there’s a lot of great potentially conclusive non-randomized studies out there.  There’s just very little research.  And what exists is often small or poorly described.  It doesn’t have adequate information about the intervention or [fair lead] to a protocol.  And so it’s very difficult to draw any conclusions.  I think that in my view—and I’m here as a critic because I was one of the reviewers for this study and I pushed Jennifer and John quite hard and they were very kind about that.  I think they have milked every bit of useable date from the existing evidence that we have right now and are giving us the best summary of what we know and where we might be able to go forward.  Could I say one more thing?  Now I’m taking my panelists floor option.

Moderator:  Absolutely.

Dr. Schnurr:  I think that much of this research may be not answering the right question.  Seeing how difficult it is to treat PTSD, especially in people who have chronic PTSD, I think many studies targeted at looking at the effects of a CAM intervention alone, on PTSD symptoms are really missing the boat.  In looking at what we know about CAM more generally, it’s very good for promoting wellness and it can actually help with problems.  So it can promote people moving from poor health to good health too.  But with the kind of Veterans that we’re seeing in VA, to me an equally and actually more important question is not whether CAM would be an appropriate treatment for PTSD, but how and for what CAM could be used to enhance the recovery.  And we are really trying to convert VA to using a recovering model for all the [quarters] and not just serious mental illness.   And so I think that the research that needs to be done, wouldn’t just be looking at a PTSD scale, but rather would be looking much more broadly at quality of life and functioning and well-being, because I think that’s where CAM has the greatest untapped and really unstudied potential.

Moderator:  Thank you for those comments, Paula.  As we have no more questions coming in, I’d also like to open up the floor to Jennifer and John for any concluding comments.

Dr. Strauss: This is Jennifer.  I mean, I know we’re running over.  I think, I just want to actually second what Paula just said.  What she said just resonated in terms of not just looking at CAM as a treatment for PTSD but really to understand how it might fit into a broader recover and kind of a health promotion—health and mental health promotion.  That makes a lot of intuitive sense.

Moderator:  John, would you like to say anything?

Dr. Williams:  Nothing to add.

Moderator:  Great.  Well we did get one more question; it was about the archive for this very informative presentation.  And all of our attendees will receive an email tomorrow with a direct link to the archive and you can also access handouts and audio there.  And feel free to forward it along to any colleagues who you think may be interested.  Also, once again, I’m going to plug our next ESP cyber seminar which is on April 16th.  So look for announcements for that.  And I would like to extend our gratitude to our presenters and to our audience.  And for everybody’s patience.  And once again, please do fill out that survey that you’ll be prompted to in just a moment.

So thank you very much, Paula, John, and Jennifer.  

And this does formally conclude today’s HSR&D’s cyber seminar. 

**[End of Recording]**