Articles

Integrative Medicine Invades the U.S. Military: Part One

Integrative medicine proponents claim superiority over physicians practicing “conventional” medicine. (Which I will refer to as “medicine” so as not to buy into integrative medicine’s implied claim that medicine can be practiced with two separate standards.) While conceding that medicine is good for treating conditions like broken arms and heart attacks, physicians who purport to practice integrative medicine argue it ignores “the whole person, including all aspects of lifestyle.” Their vision of a new, improved practice of medicine “emphasizes the therapeutic relationship between practitioner and patient, is informed by evidence, and makes use of all appropriate therapies.””

But, as we know, the practice of medicine already takes into account “the whole person, including all aspects of lifestyle,” is “informed by evidence” and uses “all appropriate therapies.” This includes recommendations regarding diet, exercise, relaxation and vitamin and dietary supplement use, which are often erroneously labeled “CAM.” Medicine appears to be well aware of problems in the current model of health care delivery and is actively seeking ways to improve it. If integrative medical practitioners and their proponents were simply directing their time, energy and resources toward facilitating a better model for delivering health care I suppose no one would have any problem.

But they aren’t. They are claiming rights to an entirely new specialty in medicine. Proponents do this by advancing two dubious arguments. First, integrative medicine alone can deliver on this “whole person” model of care. Second, inclusion of alternative medicine is essential to good patient care.

From a consumer protection standpoint, I find integrative medicine troubling. Proponents are unfairly misrepresenting medical practice as inferior and offering themselves as the solution when there is no evidence that they can deliver on these claims. Unfortunately, despite this lack of evidence, integrative medicine has seized the imagination of public policy makers and legislative bodies. It is included in the Affordable Care Act and continues to metastasize throughout the military health care system, which together will soon control delivery of the vast majority of health care in this country.

In the next two weeks we will examine one unfortunate example of this process in the making. This week, we look at recent testimony of Wayne Jonas, M.D., before a Senate Committee and how it exemplifies the unconvincing arguments in favor of integrative medicine. Next week we will consider the proposed legislation Dr. Jonas supports.

Senate hearing

In May, the Senate Committee on Veterans’ Affairs, chaired by that champion of alternative medicine, Sen. Bernie Sanders (I-VT), heard testimony on Senate Bill 422 and 852, which would, respectively, increase veterans’ access to chiropractors in particular and to complementary and alternative medicine in general.

Apparently, no proponents of science-based medicine were invited to testify. Only an emissary from integrative medicine, Wayne Jonas, M.D., made an appearance. (His testimony begins at about 1:09 on the video. He also submitted written testimony.) Dr. Jonas is currently the President of the Samueli Institute. The Institute’s revenues for 2012 were about $13 million, approximately half of which (about $6,750,000) came from the federal government. In his testimony, he described Samueli as a nonprofit research institute “that examines the inherent healing capacity of individuals with a scientific lens in order to determine how they can be implemented into whole systems.” Dr. Jonas is past Director of the U.S. Office of Alternative Medicine, the predecessor of NCCAM. (You can read more on Dr. Jonas here.)

Dr. Jonas’s short testimony was interesting indeed. As is typical of integrative medicine proponents, he began with criticism of medicine as currently practiced. The solution?

We need a whole system, whole person approach to dealing with these things the way people experience them, not a divided disintegrated system. Thus, we need practices that can help them reset, re-heal, tap into their inherent healing processes, and more importantly teach them the skills that they need in order to build resilience for the long run . . . We want . . . a life time of optimal healing and functioning. These practices have the potential, if they’re properly evaluated and integrated, not just simply to treat a disease, but in fact to provide that resetting.

I am sure you noted that his testimony starts off with two of the signature, but wholly unproven (in fact, wholly implausible), claims of alternative medicine: it taps into the body’s inherent healing capacity and it doesn’t just treat the disease, but the whole person.

Dr. Jonas then referred to three studies which I presume he feels support his notion that the practice of integrative medicine is superior and that this superiority stems, in part, from the inclusion of alternative treatments. We will first look at what Dr. Jonas said about each study and then take a look at the actual studies.

Study 1: chiropractic

Jonas’ testimony:

We just published actually – one of our funders that we publish – the first randomized control trial published in Spine of low back pain with chiropractic, demonstrating that chiropractic added on to usual care significantly improved chiropractic in active duty populations who have carried big loads for many years.

(As an attorney, I’ve winced many times at transcriptions of depositions I took or hearings in which I participated. Verbal stumbles are easy to make when you are speaking, even from prepared notes, so I am not going to be snarky about the occasional stumbles here. I think it is clear what he meant.)

The study: Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study.

This study was headed by Christine Goertz, D.C., Ph.D., of the Palmer Center for Chiropractic Research. According to the journal article in Spine announcing its results, “Samueli Institute grant funds were received to support this work.” No other funding source is listed, but according to the Palmer chiropractic school website, Samueli funded the study out of a grant from the Uniformed Services University of the Health Sciences. The Palmer research facility has received $30 million in grants and other funds since 2000, a lot of it from the federal government. One of the research center’s three areas of study is:

mechanisms of care, which encompass normative data, spine lesions (e.g. vertebral subluxation complex) and spinal manipulation/adjustment.

Putting 2 and 2 together, it appears U.S. taxpayers are funding research into the “vertebral subluxation complex” and the “adjustment” of subluxations. As a taxpayer, I would be interested in knowing how they conduct research on something that doesn’t exist.

This was a prospective, 2-arm randomized controlled trial pilot study comparing Standard Medical Care (SMC) plus Chiropractic Manipulative Therapy (CMT). Participants were U.S. Active Duty Military Personnel. Median duration of participant current low back pain was 9 days and 43% had radicular signs. The primary outcome measures were changes in back-rated pain on a numerical rating scale and physical functioning at 4 weeks on a disability rating scale. There was no blinding of participants or practitioners. At the end, results from 32 SMC only and 41 SMC plus CMT patients were analyzed. According to the article, “participants had a higher expectation of helpfulness for SMC plus CMT compared to SMC.”

Now, to the interventions. The study didn’t restrict access to SMC or prescribe a SMC delivery protocol. Here is what actually occurred:

Standard care included any or all of the following: a focused history, diagnostic imaging as indicated, education about self-management including maintaining activity levels as tolerated, pharmacological management with the use of analgesics and anti-inflammatory agents, and physical therapy and modalities such as heat/ice and referral to a pain clinic.

In both groups, SMC was delivered by physician assistants, family practice physicians, physical therapists or aides, nurse practitioners, physical medicine practice physicians, athletic trainers and chiropractors. Yes, according to the study, chiropractors constituted 3% of the providers in the SMC group. Go figure. The mean number of visits for SMC was 1.4, although the majority had only 1 visit (range 0-8), in the SMC group and 1(range 0-4) in the SMC plus CMT group.

In the SMC plus CMT group, CMT included high velocity low amplitude spinal manipulation delivered to the lumbar spine or sacroiliac joint for all participants. In addition,

patients may have received 1 or more of the following services provided by the DC: mobilization, brief massage, use of ice in the lumbar area, stretching exercises, McKenzie exercise, advice for activities of daily living, postural/ergonomic advice. The median number of visits to the DC was 7 visits for CMT (range 2-8).

I e-mailed Cristine Goertz, D.C., the lead author, asking her to explain why the manipulation is described as “chiropractic,” and whether there was some way this manipulation was different than that performed by other providers. I also asked how the determination was made to manipulate at a particular location and whether that it involved the detection of a “subluxation.” Finally, I asked why visits for SMC were reported as a mean and visits for CMT were reported as a median number. I received an auto-reply that she is out of the office until early August so I will have to update this when and if she replies.

The authors’ conclusion:

The results of this trial suggest that CMT in conjunction with SMC offers a significant advantage for decreasing pain and improving physical function when compared with only standard care, for men and women between 18 and 35 years of age with acute LBP.

Well of course it did! If you want to do a study guaranteeing your results will show an added intervention will work better than standard care, make sure the group getting the additional intervention already expects it will work, give them eight times more treatments for back pain than the other group, give both groups a non-standardized mixture of (by my count) 18 different treatments so you don’t know what really worked and what didn’t, further confuse the issue by giving a few of the same treatments to both standardized care and the additional intervention groups, and don’t blind the participants or the providers.

But that is just a layperson’s view.

Here’s something I’ll bet you’ve already predicted. The last sentence of the article:

It is clear that additional high quality randomized controlled trials are required to establish the appropriate role definitively for CMT in diverse populations within pragmatic health care settings.

Fortunately for the Palmer Research Center and the Samueli Institute, such a study is already underway. They and the RAND Corporation received a $7.4 million, four-year grant from the Department of Defense last year to conduct a similar multi-site clinical trial, this time with a sample size of 750 active-duty military personnel.

Study 2: acupuncture

Jonas’ testimony:

We just completed a study at Walter Reed [National Military Medical Center], with – in partnership with Walter Reed – looking at the use of acupuncture for post-traumatic stress syndrome. One month of eight treatments of acupuncture reduced post-traumatic stress syndrome by 56 percent, and improved all the other symptoms of the trauma spectrum, including pain, improved sleep, reduced medication, and even, to my surprise, improved cognitive function.

Dr. Jonas also claimed that “they continued to maintain improvement” in follow-up.

The study: Acupuncture for Treatment of Post-Traumatic Stress among Military Personnel.

A 56% reduction in the syndrome itself plus improved cognitive function goes far beyond what the current research would have predicted. As Carl Sagan wisely advised, the prudent person would require extraordinary evidence for this extraordinary claim.

From his description, I had trouble finding the study at clinicaltrials.gov or published results so I sent an e-mail to the Samueli communications department asking them to “please identify the study . . . and tell me where I could find more information about the study, including the clinical trial number, methodology and results.” I got a very cordial and quick response telling me that it is NCT00320138. According to clinicaltrails.gov, the treatment is “Acupuncture, using Chinese Medicine methodology,” consisting of 4 weeks of 2 treatments per week, 4 being “standardized” and 4 being “individualized.” These terms are not further defined. There are 55 participants, one group randomized to acupuncture and the other to “no intervention/ wait list /usual care.”

If you were hoping I would describe the results, you’ll have to wait. According to the e-mail from Samueli,

The study in question is under review and has not yet been published. Dr. Jonas is not the lead author.

The study’s completion date is listed on clinicaltrials.gov as 2007, so I am not sure why there are no results available in 2013. Nor do I know why, if the study is still “under review,” Dr. Jonas was able to announce the apparently unqualified results in his testimony. Again, stay tuned. I’ll be checking back on this one.

Study 3: guided imagery and healing touch

Jonas’ testimony:

And the study published about four or five months ago that we did in conjunction with Scripps at – and the Camp Pendleton Marines and post-traumatic stress syndrome, took a very simple relaxation self-care practice taught by nurses to induce a relaxation skills training program in individuals with post-traumatic stress syndrome, added on to usual behavioral care, significantly reduced posttraumatic stress syndrome.

When that was then followed up, as was the acupuncture, when after those were finished, three months later they continued to maintain improvement. In other words, it wasn’t a one-off treatment, it was actually a reset, a rehealing of those practices.

The study: Healing Touch with Guided Imagery for PTSD in Returning Active Duty Military: A Randomized Controlled Trial.

This study offers another excellent example of what Harriet Hall has aptly named “tooth-fairy science.” The researchers go through all kinds of standard research mechanisms and statistical analyses: excluding pregnant women and nursing mothers, using a CONSORT flow diagram, determining sample size using a power analysis, measuring results with reliable scales, calculating p-values, and so forth.

The alternative practices this time consist of listening to guided imagery tapes plus healing touch, two sessions per week for 3 weeks, with 102 participants, who were experiencing “one or more” post-traumatic stress disorder symptoms. The healing touch was delivered by nurses, who played the guided imagery tapes during the sessions, a decision “based on consultations with expert practitioners.” Participants were encouraged to listen to the tapes at home, although the researchers don’t know if they did. Obviously, there was no blinding of participants or practitioners. It was done under the auspices of the Scripps Center for Integrative Medicine with Erminia M. Guarneri, M.D. taking the lead there. The Samueli Institute participated as well. Study results were published in Military Medicine.

According to the article, the group receiving treatment as usual with these two CAM interventions had “substantial reductions in PTSD symptoms.” We won’t spend much time on “guided imagery,” a definition of which is provided on the website of Belleruth Naparstak, a psychotherapist and proponent of guided imagery who has apparently managed to convince a lot of folks to buy into her enthusiasm for guided imagery and to buy her guided imagery tapes.

Guided Imagery is a kind of deliberate, directed daydreaming that uses soothing music and narrative to evoke multisensory memory, symbol and fantasy. This combination gently guides the overactive mind into a relaxed, immersive state of healing reverie.

A small number of studies have looked at guided imagery for various health conditions but they were generally of poor quality and there isn’t any good evidence of its effectiveness.

For “healing touch,” which is apparently the same thing as therapeutic touch, the evidence is clear cut: it shouldn’t work and it doesn’t. Which leads me to wonder how researchers continue to slip this one by the IRBs. Here’s how the article defined healing touch:

a type of biofield therapy that involves gentle, non-invasive touch by trained practitioners, who utilize specific techniques with the intention of working with the body’s vital energy system to stimulate a healing response.

Never mind that the body doesn’t have a “vital energy system.” But wait, it gets worse. There are specific types of healing touch. In this study three were used:

Chakra Connection . . . involving techniques used along the body, intended to stimulate movement of vital energy though the body.

Mind clearing . . . techniques performed on the head, intended to stimulate mental relaxation.

Chakra Spread . . . an advanced technique . . . generally reserved for patients with more severe symptoms, intended to promote deep healing for emotional and/or physical pain.

Chakras are, for the uninitiated, “energy centers” in the body that, when blocked, cause illness. Unblocking whatever is blocking the free flow of energy restores balance and health. Just like acupuncture, subluxation-based chiropractic, reflexology, cranial sacral therapy, reiki and Ayurveda. (It is odd that so much of alternative medicine, which can be so . . . um . . . creative in its approaches, still manages to end up at the same place.)

And despite Dr. Jonas’s claim that results were maintained at follow up, the journal article states that, while follow-up assessment was originally planned, it was not possible due to unavailability of participants because of their deployment.

In addition to Dr. Jonas’s testimony, hype also flowed from Scripps. From the Scripps website, which describes healing touch as “an energy-based, non-invasive treatment that restores and balances the human biofield to help decrease pain and promote healing”:

Healing touch combined with guided imagery (HT+GI) provides significant clinical reductions in post-traumatic stress disorder (PTSD) symptoms for combat-exposed active duty military, according to a study released in the September issue of Military Medicine. . . . “Scores for PTSD symptoms decreased substantially, about 14 points and below the clinical cutoffs for PTSD,” said Dr. Guarneri. “This indicates that the intervention was not just statistically significant, but actually decreased symptoms below the threshold for PTSD diagnosis. It made a large difference in reducing PTSD symptoms.”

I’ll leave it to the experts to evaluate the results from a statistical standpoint. Here’s the layperson’s view of this study: Relaxation tapes may have some as-yet-undetermined value in treating PTSD. Healing touch does not, and this study doesn’t prove that it does. There is no “energy system” to “stimulate” or “human biofield” to “restore and balance.” You can’t measure something that doesn’t exist.

And, yes, you guessed it:

Future studies examining the impact of this intervention as a complementary treatment to help eliminate PTSD and depression in our military are warranted.

Maybe it’s just me, but are you starting to notice that research outfits which get a lot of money for studying alternative medicine keep pushing for more studies of alternative medicine? And, as a taxpayer, are you concerned, like I am, that you are paying for these studies?

Given the opportunity to present, without any opposition, the most recent, most compelling evidence in support of integrating alternative medicine into the Veterans’ Administration health care system, this is the best integrative medicine can do? I’m underwhelmed. I hope the Senate is too.

Next week: Two bad bills.

Posted in: Acupuncture, Chiropractic, Clinical Trials, Energy Medicine, Legal, Politics and Regulation

Leave a Comment (27) ↓