EBM and CAM

[Guest guest]

Dr. Margaret Chesney, Deputy Director of the National Center for

Complementary and Alternative Medicine (NCCAM), takes on the issue of

the scientific evidence and CAM in her session, Complementary and

Alternative Medicine: An Evidence-Based Approach. Highlights of

Evidence Based Medicine From The American College of Physicians 2005

Annual Session

Introduction and Complementary and Alternative Medicine: An

Evidence-Based Approach  CME/CE

Introduction

The primary purpose of any respectable scientific assembly is to bring

updated and practical information to its participants so they may

improve the care of their patients. Although most of the information

exchanging hands at these conferences is certainly current and useful,

the extent to which it is also evidence-based varies considerably from

one session to the next. Advocates of evidence-based medicine are quick

to point out that expert opinion is the least reliable form of

evidence. The experts who are invited to present at these conferences

have a choice. They can select individual studies that support their

own preconceived clinical recommendations, or they can systematically

review the literature (where it exists) and formulate evidence-based

recommendations. Most presenters land somewhere in between.

While it is not possible to gauge the evidence-based nature of all 260

events at this year's ACP conference, the meeting did include a number

of sessions specifically addressing evidence in clinical practice.

Numerous workshops offered hands-on training in the retrieval of

Web-based information and the use of PDAs. There were 4 sessions in

particular that highlighted evidence-based medicine and its application

at the point of care.

Complementary and Alternative Medicine: An Evidence-Based Approach

(see link for other three sessions...)

Complementary and Alternative Medicine (CAM): An Evidence-Based Approach

A common, sweeping definition of CAM is that of a diverse collection of

presumably healthy lifestyles, therapies and systems of healing that

falls outside the mainstream of conventional medicine and has yet to be

validated by scientific methods. One way to interpret this definition

is that unlike conventional therapies, CAM therapies have yet to be

proven safe, effective, or both. But once they are, they will promptly

join the ranks of mainstream practice. This overly simplistic view

fails to account for a number of principles of evidence-based medicine.

First, supportive evidence is not synonymous with proof of

effectiveness. Although large randomized controlled trials (RCTs)

provide valuable information about the relationships between

interventions and outcomes, they do not prove cause and effect. The

boundary between what works and what doesn't is not a bright, narrow

line easily crossed with the publication of a single or even multiple

studies. It is a wide and shifting zone, continuously fed by

conventional and unconventional therapies moving in various directions

as the evidence for their effectiveness accumulates or diminishes with

time. CAM therapies, therefore, do not simply " cross over " when proven

effective, and neither should conventional ones.

Second, evidence-based medicine is not simply the direct application of

outcomes research to the care of patients. It involves the judicious

use of scientific evidence to support, not supplant, clinical judgment.

Even a preponderance of evidence supporting the effectiveness of an

unconventional therapy would not persuade many clinicians to adopt it.

Glucosamine and acupuncture, for example, both have evidence supporting

their effectiveness for osteoarthritis of the knee.[1,2] If this

evidence were to be equally consistent between the two, glucosamine

would stand a better chance of acceptance among conventional

physicians. Whereas the biological effects of a dietary supplement like

glucosamine are plausible, if not well understood, the theoretical

basis of acupuncture's effectiveness is akin to eastern mysticism, a

conceptual stretch beyond the reach of most western-trained clinicians.

The standard argument goes: when it comes to CAM, we should be patient

and wait for the research. In the meantime, it is best to err on the

side of skepticism and assume that an intervention is ineffective until

proven otherwise. This way of thinking certainly has merit,

particularly from the perspective of safety and cost. We should not

expose unwitting patients to potentially dangerous and expensive

treatments until we can reasonably weigh their risks against their

benefits.

However, not all clinical questions can, or should, be answered. The

standard position presupposes that patients can wait for evidence that,

in many cases, will never exist. Evidence is expensive, and no research

budget will ever be large enough to answer even the majority of

clinical questions. Certainly, if the risks and costs are high and the

benefits unknown, the intervention should be rejected until it can be

adequately studied. In the case of many " unproven " CAM therapies,

however, the risks are small and their modest costs are largely borne

by the patients themselves. Adopting an evidence-based approach means

recognizing and accepting its limitations. When it comes to treating

patients, balancing risks against benefits of any therapy –

conventional or unconventional – will always be necessary in the

absence of data.

Dr. Margaret Chesney, Deputy Director of the National Center for

Complementary and Alternative Medicine (NCCAM), took on the issue of

the scientific evidence and CAM in her session, Complementary and

Alternative Medicine: An Evidence-Based Approach.

To set the stage for her discussion of CAM research, Dr. Chesney

reviewed its popularity among American consumers and its penetration

into the healthcare system. In a 2002 national survey of 31,044

randomly sampled adults,[3] 36.5% said they used CAM within the past 12

months. This number jumped to 62% if prayer was included as a CAM

intervention. The most common therapies used were herbal therapies

(19%), deep breathing (12%), meditation (8%), chiropractic (8%), yoga

(5%), massage (5%) and diet-based therapies (4%). Hospitals offering

CAM service increased from 8% in 1998 to 17% in 2002.[4] Specific

services offered were massage (78%), pastoral counseling (62%), stress

management (61%), and yoga (58%). Patient demand, not clinical

effectiveness, was the key reason hospitals gave for offering these

services. It is this consumer interest that has been largely driving

the research agenda in CAM rather than the possibility of clinical

effectiveness.

Yet despite this popular interest, CAM remains conspicuously

understudied. Several factors have combined to dissuade world-class

scientists and well-funded research institutions from taking it on.

First, rigorous research requires strict adherence to consistent

standards across interventions. A hallmark of many CAM practitioners,

however, is their devotion to individualization and therapeutic

heterogeneity. Classifying subjects into uniform groups and treating

them all the same often contradicts their practice philosophy.

Moreover, in the case of herbal medicine where diagnostic uniformity

should be possible, it is still a challenge for researchers to

guarantee consistent quality, purity, and dose across batches of plant

extracts.

Second, the private sector is reluctant to invest in CAM research,

foreseeing no return on their investment. This drawback is again well

illustrated in the case of herbs. Since these products are rarely

patentable, pharmaceutical companies see no profit in investing large

sums of research dollars to determine their safety and effectiveness.

They will either ignore the products in favor of patentable drugs, or

market them without doing the research (which federal law permits).

And third, CAM research has been hampered by a lack of direction and

cooperation. Poorly funded researchers operating in isolated silos

succeed only in moving their agenda forward in fits and starts.

Notwithstanding her personal stake in the matter, Dr. Chesney believes

all this changed in 1999, when Congress required the National

Institutes of Health to create NCCAM with an initial annual budget of

$50 million (its FY 2005 budget is now $123.1 million). Unlike most NIH

entities, the majority of NCCAM's research budget supports clinical

studies rather than basic science research. NCCAM's 4 broad strategic

goals are to:

•

Invest in CAM research

•

Train CAM practitioners in research and conventional practitioners in

CAM

•

Disseminate evidence-based CAM information to healthcare professionals

and the public

•

Facilitate the integration of CAM into the practice of allopathic

medicine

Manipulative and body-based practices. These involve the manual

movement of body parts to produce a variety of health outcomes.

Chiropractic, osteopathic manipulation, and massage therapy are popular

examples. Dr. Chesney gave relatively little attention to these

services, focusing exclusively on the comparative safety and

effectiveness of chiropractic. The evidence to date indicates that

chiropractic and conventional regimens are comparable in relieving

symptoms and restoring function for acute, subacute, and chronic low

back pain.[5,6] In experienced hands, chiropractic is safe. Minor

adverse effects, such as short-term discomfort in the treated area, are

not uncommon. Although the risk of serious harm is low, stroke, for

example, has been reported following neck manipulation.[7] Since the

effectiveness of chiropractic for cervicogenic pain has yet to be

established, it remains a matter of debate whether this unknown benefit

is outweighed by this small risk.

Other practices also reviewed in this article, available at link,

include: biologically based medicine (phytonutrients), energy medicine,

traditional Chinese medicine, and Mind-Body medicine.

http://www.medscape.com/viewarticle/507242

Sears

PDX

[Guest guest]

As we say in golf ..."Dead solid perfect!" thanks for this timely post. As I have now said several times the CAO is putting a task force together to formulate a policy statement to further clarify the "Clinical Justification Rule's" rational. The nexus between our ratings of the evidence and the ESTDP existing rule, "clinical freedom," and what third party payers should be responsible for etc., etc. I like the name; "Evidence and Consensus Based Best Practices"

Just as we were with the Outcomes language in the CJ rule just prior to the start of the 2007 legislative session (which made all the difference and why the CAO's SB-585 & HB-2588 both made it to the Gov's desk) so to we need to be proactive as per "Best Practices" as there are forces outside the profession who are currently developing a "Best Practices Box" (my words) for us that could impede our "clinical freedoms," the very thing our good colleague Dr. Judith Boothby as expressed concerns for on so many occasions.

Thanks again for this timely article ....as always the Chiropractic Assoc. of Oregon is all over it!

Have a great Sunday,

Vern Saboe

EBM and CAM

Dr. Margaret Chesney, Deputy Director of the National Center for Complementary and Alternative Medicine (NCCAM), takes on the issue of the scientific evidence and CAM in her session, Complementary and Alternative Medicine: An Evidence-Based Approach. Highlights of Evidence Based Medicine From The American College of Physicians 2005 Annual SessionIntroduction and Complementary and Alternative Medicine: An Evidence-Based Approach CME/CEIntroductionThe primary purpose of any respectable scientific assembly is to bring updated and practical information to its participants so they may improve the care of their patients. Although most of the information exchanging hands at these conferences is certainly current and useful, the extent to which it is also evidence-based varies considerably from one session to the next. Advocates of evidence-based medicine are quick to point out that expert opinion is the least reliable form of evidence. The experts who are invited to present at these conferences have a choice. They can select individual studies that support their own preconceived clinical recommendations, or they can systematically review the literature (where it exists) and formulate evidence-based recommendations. Most presenters land somewhere in between.While it is not possible to gauge the evidence-based nature of all 260 events at this year's ACP conference, the meeting did include a number of sessions specifically addressing evidence in clinical practice. Numerous workshops offered hands-on training in the retrieval of Web-based information and the use of PDAs. There were 4 sessions in particular that highlighted evidence-based medicine and its application at the point of care.Complementary and Alternative Medicine: An Evidence-Based Approach(see link for other three sessions...)Complementary and Alternative Medicine (CAM): An Evidence-Based ApproachA common, sweeping definition of CAM is that of a diverse collection of presumably healthy lifestyles, therapies and systems of healing that falls outside the mainstream of conventional medicine and has yet to be validated by scientific methods. One way to interpret this definition is that unlike conventional therapies, CAM therapies have yet to be proven safe, effective, or both. But once they are, they will promptly join the ranks of mainstream practice. This overly simplistic view fails to account for a number of principles of evidence-based medicine.First, supportive evidence is not synonymous with proof of effectiveness. Although large randomized controlled trials (RCTs) provide valuable information about the relationships between interventions and outcomes, they do not prove cause and effect. The boundary between what works and what doesn't is not a bright, narrow line easily crossed with the publication of a single or even multiple studies. It is a wide and shifting zone, continuously fed by conventional and unconventional therapies moving in various directions as the evidence for their effectiveness accumulates or diminishes with time. CAM therapies, therefore, do not simply "cross over" when proven effective, and neither should conventional ones.Second, evidence-based medicine is not simply the direct application of outcomes research to the care of patients. It involves the judicious use of scientific evidence to support, not supplant, clinical judgment. Even a preponderance of evidence supporting the effectiveness of an unconventional therapy would not persuade many clinicians to adopt it. Glucosamine and acupuncture, for example, both have evidence supporting their effectiveness for osteoarthritis of the knee.[1,2] If this evidence were to be equally consistent between the two, glucosamine would stand a better chance of acceptance among conventional physicians. Whereas the biological effects of a dietary supplement like glucosamine are plausible, if not well understood, the theoretical basis of acupuncture's effectiveness is akin to eastern mysticism, a conceptual stretch beyond the reach of most western-trained clinicians.The standard argument goes: when it comes to CAM, we should be patient and wait for the research. In the meantime, it is best to err on the side of skepticism and assume that an intervention is ineffective until proven otherwise. This way of thinking certainly has merit, particularly from the perspective of safety and cost. We should not expose unwitting patients to potentially dangerous and expensive treatments until we can reasonably weigh their risks against their benefits.However, not all clinical questions can, or should, be answered. The standard position presupposes that patients can wait for evidence that, in many cases, will never exist. Evidence is expensive, and no research budget will ever be large enough to answer even the majority of clinical questions. Certainly, if the risks and costs are high and the benefits unknown, the intervention should be rejected until it can be adequately studied. In the case of many "unproven" CAM therapies, however, the risks are small and their modest costs are largely borne by the patients themselves. Adopting an evidence-based approach means recognizing and accepting its limitations. When it comes to treating patients, balancing risks against benefits of any therapy – conventional or unconventional – will always be necessary in the absence of data.Dr. Margaret Chesney, Deputy Director of the National Center for Complementary and Alternative Medicine (NCCAM), took on the issue of the scientific evidence and CAM in her session, Complementary and Alternative Medicine: An Evidence-Based Approach.To set the stage for her discussion of CAM research, Dr. Chesney reviewed its popularity among American consumers and its penetration into the healthcare system. In a 2002 national survey of 31,044 randomly sampled adults,[3] 36.5% said they used CAM within the past 12 months. This number jumped to 62% if prayer was included as a CAM intervention. The most common therapies used were herbal therapies (19%), deep breathing (12%), meditation (8%), chiropractic (8%), yoga (5%), massage (5%) and diet-based therapies (4%). Hospitals offering CAM service increased from 8% in 1998 to 17% in 2002.[4] Specific services offered were massage (78%), pastoral counseling (62%), stress management (61%), and yoga (58%). Patient demand, not clinical effectiveness, was the key reason hospitals gave for offering these services. It is this consumer interest that has been largely driving the research agenda in CAM rather than the possibility of clinical effectiveness.Yet despite this popular interest, CAM remains conspicuously understudied. Several factors have combined to dissuade world-class scientists and well-funded research institutions from taking it on. First, rigorous research requires strict adherence to consistent standards across interventions. A hallmark of many CAM practitioners, however, is their devotion to individualization and therapeutic heterogeneity. Classifying subjects into uniform groups and treating them all the same often contradicts their practice philosophy. Moreover, in the case of herbal medicine where diagnostic uniformity should be possible, it is still a challenge for researchers to guarantee consistent quality, purity, and dose across batches of plant extracts.Second, the private sector is reluctant to invest in CAM research, foreseeing no return on their investment. This drawback is again well illustrated in the case of herbs. Since these products are rarely patentable, pharmaceutical companies see no profit in investing large sums of research dollars to determine their safety and effectiveness. They will either ignore the products in favor of patentable drugs, or market them without doing the research (which federal law permits).And third, CAM research has been hampered by a lack of direction and cooperation. Poorly funded researchers operating in isolated silos succeed only in moving their agenda forward in fits and starts. Notwithstanding her personal stake in the matter, Dr. Chesney believes all this changed in 1999, when Congress required the National Institutes of Health to create NCCAM with an initial annual budget of $50 million (its FY 2005 budget is now $123.1 million). Unlike most NIH entities, the majority of NCCAM's research budget supports clinical studies rather than basic science research. NCCAM's 4 broad strategic goals are to:• Invest in CAM research• Train CAM practitioners in research and conventional practitioners in CAM• Disseminate evidence-based CAM information to healthcare professionals and the public• Facilitate the integration of CAM into the practice of allopathic medicineManipulative and body-based practices. These involve the manual movement of body parts to produce a variety of health outcomes. Chiropractic, osteopathic manipulation, and massage therapy are popular examples. Dr. Chesney gave relatively little attention to these services, focusing exclusively on the comparative safety and effectiveness of chiropractic. The evidence to date indicates that chiropractic and conventional regimens are comparable in relieving symptoms and restoring function for acute, subacute, and chronic low back pain.[5,6] In experienced hands, chiropractic is safe. Minor adverse effects, such as short-term discomfort in the treated area, are not uncommon. Although the risk of serious harm is low, stroke, for example, has been reported following neck manipulation.[7] Since the effectiveness of chiropractic for cervicogenic pain has yet to be established, it remains a matter of debate whether this unknown benefit is outweighed by this small risk.Other practices also reviewed in this article, available at link, include: biologically based medicine (phytonutrients), energy medicine, traditional Chinese medicine, and Mind-Body medicine.http://www.medscape.com/viewarticle/507242 SearsPDX