College of Physicians and APS Issue "Integrative" Back Pain Guideline; Sportelli & Choate Respond
Written by John Weeks
American College of Physicians & American Pain Society Issue "Integrative" Back Pain Guideline: Sportelli, Choate Respond
Summary: The American College of Physicians (ACP) and the American Pain Society (APS) recently issued a comprehensive joint clinical practice guideline for the diagnosis
and treatment of low back pain. Published in the October 2, 2007 issue of
the Annals of Internal Medicine, the guidelines may be considered "integrative" as they include self-care and "non-pharmacologic" approaches. Chiropractic and integrative care veteran Lou Sportelli, DC, who brought the guidelines to my attention, shares views on the pros and cons of this guideline, as does former NIH NCCAM health services researcher Christine Goertz Choate, DC, PhD.
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Lead role in the pain guideline
The October 2, 2007 issue of the Annals of Internal Medicine(2007;147:478-491)published a
"comprehensive joint clinical practice guideline for the diagnosis
and treatment of low back pain." The guideline was developed and endorsed by theAmerican College of
Physicians(ACP) and the American Pain Society(APS). Theguideline (see below) "offers recommendations
concerning how to categorize patients, when to perform imaging studies,
educational information for patients, self-care, when to prescribe medications
and what types, and non-pharmacologic therapy."
The "non-pharmacologic" components show up as the last bullet of the guideline:
"When
self-care options do not result in improvement, clinicians should consider
adding non-pharmacologic modalities shown to be of benefit. For acute low
back pain, the only modality in this category is spinal manipulation. For
chronic or subacute low back pain, modalities shown to be of benefit are
intensive interdisciplinary rehabilitation, exercise therapy, acupuncture,
massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy,
or progressive relaxation."
Notably, the previous six recommendations, regarding diagnostics, self-care and pharmacological approaches, are all characterized thusly: "strong recommendation; moderate-quality
evidence." The description of the non-pharmacological approaches has in common with the other recommendations that it is based on only "moderate-quality evidence." However, the conclusion stuck on these options by the ACP and APS guideline writers for the non-pharmacologic approach was: "weak recommendation; moderate-quality
evidence."
Roger Chou, MD, lead author of the Annals article
I called Roger Chou, MD, head of the APS' clinical practice guidelines effort to gain an understanding of what appears to potentially be a double standard. He explained that a "strong recommendation" meant that the team did not feel that future evidence would change their perspective. The "weak recommendation" for non-pharmacological approaches was due to concern that "a good strong trial of massage or acupuncture could come out that could shift" what was often "pretty weak evidence."
Chou underscored that the guideline is meant to reflect patient preference: "Some patients who prefer not to take medication can benefit from
non-drug
treatments, such as acupuncture, spinal manipulations or massage
therapy." The panel did not believe that any of the non-pharmacological approaches are proven to be more effective than others "to warrant
recommendation
as first-line therapy." The Integrator will separately run a more thorough interview with Chou. Perspective of Chiropractic Leader Sportelli: "A Step Backward"
The development of back-pain guidelines has been extremely controversial in the course of US medical history. In fact, a May 2006 issue of Business Weekacknowledged that an entire federal agency was gutted due to such a guideline. In 1994, the then Agency for Health Care Policy and Researchissued a guideline had been developed over a number of years by an MD-dominated, multi-disciplinary, government-appointed panel. They published a document that held that manipulation and watchful waiting were top of the heap for acute low-back pain. The agency's funding was removed the next year following a campaign led by a back surgeon. I asked Lou Sportelli, DC, who had brought the ACP/APS guideline to my attention, what he thought of this work. I emailed him the following:
"So,
what did you think on reading this? Is it a positive that the natural
therapies are even there? Or do you view it as a step backwards, more of the
same, what? Funny
that the 'least invasive' is the LAST thing they talk about."
Here is Sportelli's response:
"I view the guideline as a step backwards in the global sense of
(not) understanding that the focus should be on the least invasive. The guideline is a step
backwards in the lack of recognition that chiropractic care is more than spinal
manipulation. Relegating that therapeutic intervention to one issue is
reducing the complexity of the care process. Interventions are complex
encounters they involve the human communication, trust, understanding,
confidence, belief and culture surrounding the experience. Note that I said 'experience.'
"(The authors) remain caught up in a reductionist and mechanistic model of
care which as we are understanding more with each passing day, is less
and less the model of tomorrow."
- Lou Sportelli, DC
"These studies are funded by groups that
are still, intentionally or unintentionally, jaundiced and biased by the
medical model. They remain caught up in a reductionist and mechanistic model of
care which as we are understanding more with each passing day is less
and less the model of tomorrow. So it is good that an intervention which
a decade or more ago was deemed quackery is now included but not good
in the lack of understanding of the human health encounter."
Christine Goertz Choate, DC, PhD, a former health services research program officer at the NIH National Center for Complementary and Alternative Medicine agrees with Sportelli that it is good to see non-pharmacological approaches included. Said Choate, an Integrator advisor: "I commend the panel for a thorough job and for their inclusion of non-pharmacological approaches in a comprehensive way. Clinicians, including doctors of chiropractic, might view the guideline and terms like 'moderate quality evidence' as dry, but I think it's as enthusiastic as guidelines experts get."
Choate indicated concern with the panel's decision to place only a "weak recommendation" on non-pharmacological approaches. I shared Chou's explanation. Choate responded: "The problem might be with lumping them all together. Manipulation by itself should have met the 'strong recommendation' bar given the plethora of research."
Chou, the guideline co-author noted above, disclosed having received an honorarium
from Bayer. Another author disclosed relationships with Novo Nordisk,
Pfizer, Merck, Bristol-Myers Squibb, Atlantic Philanthropics, and
Sanofi-Pasteur.
Comment: The concept of the "therapeutic order" formed a central part of my education into the use-value of natural therapeutics, and my subsequent involvement in "integrative medicine." It's a major concept in naturopathic medical thinking and is also supported by many integrative medical doctors.
In the guideline, with all having only "moderate-quality evidence," that which is the least
invasive only gets a "weak recommendation."
The "therapeutic order"
in the guideline appears to be precisely
upside down.
The concept has been a grounding influence and a guiding light. It seemed common sense to use the least invasive (fewest adverse effects) therapies first, all else being equal. Growing awareness of the awful and not infrequent killing effects of pharmaceuticals over the past 2 decades reinforced the value of this grandmotherly wisdom. One might even say that an approach with somewhat less evidence, but with little or no side-effects, might reasonably be considered first as a matter of course, as long as no harm would come from waiting.
Now, in 2007, we are facing growing evidence of the human cost associated with our culture's rapidly escalating use of pain medications - following the pain guidelines of Joint Commission on Health Care Organizations in 2001. These merging data may in fact dwarf any previous findings on adverse effects.
Lou Sportelli, DC
One might have hoped in this context that we would see a guideline which would affirmatively embrace trying approaches without adverse efforts first. For various reasons reported in the interview with Chou, the therapeutic order appears to have bobbed toward a balance but ultimately failed to right itself. The failure may rest, as Sportelli asserts, in the group remaining firmly ensconced in a reductive view of the healthcare encounter.
Meantime, more practically, as Choate points out, the guideline writers may be doing an injustice to spinal manipulation by lumping it with less researched non-pharmacological approaches. The guideline may need to have more than one recommendation in this category.
_________________________________________
From the Annals of Internal Medicine Article
Specific
recommendations in the guideline are as follows:
Focused
history and physical examination should help categorize patients into 1 of
3 broad groups: nonspecific low back pain, back pain potentially
associated with radiculopathy or spinal stenosis, or back pain potentially
associated with another specific spinal cause. Evaluation of psychosocial
risk factors is essential during history taking because these predict the
risk for chronic disabling low back pain (strong recommendation;
moderate-quality evidence).
For
patients with nonspecific low back pain, clinicians should not routinely
perform imaging studies, including radiographs, CT scans, and MRI, or
other diagnostic tests (strong recommendation; moderate-quality evidence).
Patients
with severe or progressive neurologic deficits, or in whom history and
physical examination suggest cancer, infection, or other underlying
condition as the cause of their low back pain, should undergo imaging
studies and other appropriate diagnostic tests (strong recommendation;
moderate-quality evidence).
Patients
with persistent low back pain and signs or symptoms of radiculopathy or
spinal stenosis should undergo MRI or CT only if positive results would
potentially lead to surgery or epidural steroid injection for suspected
radiculopathy. In choosing an imaging procedure, MRI is preferred to CT (strong
recommendation; moderate-quality evidence).
Chrstine Choate, DC, PhD
Patient
education by clinicians should include provision of evidence-based
information on low back pain. Topics that should be covered include
expected course and effective self-care options. Clinicians should also
counsel their patients to stay physically active (strong recommendation;
moderate-quality evidence).
When
pharmacotherapy is considered, drugs of choice should be those with proven
benefits, and they should be used together with self-care and back care
education. Before starting a patient on pharmacotherapy, clinicians should
evaluate pain and functional deficits at baseline. They should also review
the risk-benefit ratio of specific medications before prescribing them and
should consider the relative lack of long-term efficacy and safety data
(strong recommendation; moderate-quality evidence). Acetaminophen or
NSAIDs are preferred first-line drugs for most patients.
When
self-care options do not result in improvement, clinicians should consider
adding non-pharmacologic modalities shown to be of benefit. For acute low
back pain, the only modality in this category is spinal manipulation. For
chronic or subacute low back pain, modalities shown to be of benefit are
intensive interdisciplinary rehabilitation, exercise therapy, acupuncture,
massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy,
or progressive relaxation (weak recommendation; moderate-quality
evidence).
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