PROBLEMS WITH PLACEBOS/SHAMS
 
   

The Problem with Placebos/Shams

This section was compiled by Frank M. Painter, D.C.
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Alternative Medicine Approaches Forward Head Posture

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   An Amusing Quote:   

"A patient finally went to a chiropractor for her back pain after finding no relief with the orthopedist. After three adjustments and a week of no symptoms, she had a follow-up visit with her M.D.

Upon learning about the success of the D.C., the orthopedist stated, "That was just the placebo effect."

The patient responded, "If it works so well, why didn't you use it?"

–– Attributed to Robert Mootz, D.C.

 
   

Articles About Placebo Failures
 
   

The Power of the Placebo
BrainFacts.org ~ May 31, 2012

As many as one in three patients report feeling better after receiving a drug that has no active ingredients. For decades, these findings — called the placebo effect — were dismissed as purely psychological. Now new research indicates that placebos can cause real biological changes, a finding that is transforming how medicine is practiced.


Grasping The Placebo Effect:
Different Strokes For Different Folks

ChiroACCESS ~ 1-03-2012

The popular American idiom, “Different strokes for different folks” is believed to have emerged from the American south in the 1950s [1] before it was practically immortalized as Sly & the Family Stone’s top-selling single recording about a decade later. [2] What is becoming more and more apparent, however, is that a new lease on life for that slogan has emerged--as evidence-based medicine becomes more and more cognizant of patient expectations and values as part of the evidence base.


A Randomized Trial Investigating a Chiropractic Manual Placebo:
A Novel Design Using Standardized Forces in the Delivery
of Active and Control Treatments

J Altern Complement Med 2005 (Feb);   11 (1):   109–117

Patients in the control group were not successfully blinded; however, patients' perceptions of treatment group assignment did not significantly affect outcomes. The clinically significant improvement in both groups, independent of patient or clinician expectations, suggests the presence of therapeutic factors common to both groups, other than biomechanical force. Further studies examining other aspects of the clinical encounter, considered separately from biomechanical force, are warranted before arbitrarily designating any intervention as a “placebo.”


The Placebo, the Sensory Trick and Chiropractic
Chiropractic Journal of Australia 2004 (Jun);   34 (2):   58–62 ~ FULL TEXT

Stimuli used as placebo procedures in recent chiropractic clinical trials are quite similar, in terms of site and modality, to the "sensory tricks" that either cause substantial temporary relief, or, alternatively, provocation of symptoms in dystonic patients. Caution should be used in assuming that control (placebo) procedures used in chiropractic clinical trials lack specific effects on neuromusculoskeletal symptomatology.


Fables or Foibles: Inherent Problems with RCTs
J Manipulative Physiol Ther 2003 (Sept);   26 (7):   460 ~ FULL TEXT

The 7 case studies reviewed in this report combined with an emerging concept in the medical literature both suggest that reviews of clinical research should accommodate our increased recognition of the values of cohort studies and case series. The alternative would have been to assume categorically that observational studies rather than RCTs provide inferior guidance to clinical decision-making. From this discussion, it is apparent that a well-crafted cohort study or case series may be of greater informative value than a flawed or corrupted RCT. To assume that the entire range of clinical treatment for any modality has been successfully captured by the precision of analytical methods in the scientific literature, indicates Horwitz, would be tantamount to claiming that a medical librarian who has access to systematic reviews, meta-analyses, Medline, and practice guidelines provides the same quality of health care as an experienced physician.


Osteopathic Manipulation No Better Than Sham Therapy
for Chronic Back Pain ?

Spine (Phila Pa 1976) 2003 (Jul);   28 (13):   1355–1362

Here's another study with the unusual finding that the sham and the active treatment groups both fared similarly...that is, both groups improved, compared to the control group. It would be interesting to know the exact nature of the sham they were using. The Placebo/Sham Page is devoted to this issue...the difficulty in designing a truly inert sham or placebo for a manipulative trial.


Issues in Planning a Placebo-controlled Trial of Manual Methods:
Results of a Pilot Study

J Altern Complement Med 2002 (Feb);   8 (1):   21–32

The technical and personnel resources required to achieve adequate standardization of procedures at multiple sites may make a placebo-controlled trial unfeasible, given our current lack of knowledge about the active agent in manual chiropractic procedures.

Please note that the following 4 articles require the free Adobe Acrobat Reader to download these FULL TEXT articles.   Thanks to J Alternative and Complementary Medicine for providing access to them!


Methodological Changes in the Evaluation of Complementary and Alternative
Medicine:   Issues Raised by Sherman et al. and Hawk et al.

J Altern Complement Med 2002 (Feb);   8 (1):   11–19

The quest for methodologies appropriate for evaluating complementary and alternative medicine (CAM) continues to challenge the research community. Two papers in this issue (See below) demonstrate efforts by thoughtful investigators to develop legitimate placebo interventions and to address standardization of delivery.


Description and Validation of a Noninvasive Placebo
Acupuncture Procedure

J Altern Complement Med 2002 (Feb);   8 (1):   11–19

In the first experiment, the toothpick insertions were perceived as slightly more like real needling than the real needling (mean ratings of 2.8 and 2.1, respectively; p = 0.08). In the second experiment, 52% percent of those receiving the simulated needling versus 63% of those receiving real acupuncture believed they were "definitely" or "probably" receiving real acupuncture (p = 0.33).


Issues in Planning a Placebo-Controlled Trial of Manual Methods:
Results of a Pilot Study

J Altern Complement Med 2002 (Feb);   8 (1):   21–32

The technical and personnel resources required to achieve adequate standardization of procedures at multiple sites may make a placebo-controlled trial unfeasible, given our current lack of knowledge about the active agent in manual chiropractic procedures.


The Efficacy Paradox in Randomized Controlled Trials of CAM
and Elsewhere:   Beware of the Placebo Trap

J Altern Complement Med 2001 (Jun);   7 (3):   213–218 ~ Adobe Acrobat (100 KB)

Ever since it's formal inauguration in 1945, the double-blind, randomized controlled trial (RTC) has become the "Holy Grail" of medical methodology. This is understandable because the RTC has an advantage that the other methods are lacking: it – ideally – precludes bias.

End of Adobe Acrobat articles

COMMENTS ON: Chronic Pediatric Asthma and Chiropractic Spinal Manipulation: A Prospective Clinical Series and Randomized Clinical Pilot Study
J Manipulative Physiol Ther 2002 (Oct);   25 (8):   540–541 ~ FULL TEXT

One obvious problem in this study that is common to studies of physical-type treatments in general is an inadequate placebo treatment in the control or sham group. It is not inadequate in the classical sense of lacking a control group but inadequate in the sense that the sham control may be introducing a second active treatment in the supposed inert placebo intervention. The sham procedure used in this study requires some questionable assumptions.


Placebo Surgery
Chiropractic Journal 2002 (Sep)

Many scientists and clinicians consider the placebo-controlled trial the "gold standard" for evidence-based practice. Interestingly, surgical procedures are often exempt from such scrutiny. Ethical considerations are considered barriers to the use of placebo-controlled investigations for surgical procedures. [3,4] Interestingly, there have been five studies where placebo surgery was used as a control. The placebo group generally did as well or better than the group receiving the real operation.


Placebo Surgery Gains Wider Acceptance
New York (MedscapeWire) Mar 23, 2002

The ethical dilemma surrounding placebo surgery has been eclipsed by the controversial use — and failure — of stem cell therapy in 2 Parkinson's disease (PD) studies. News of the most recent setback in PD research was released on March 16 when the Genzyme Corporation and Diacrin Inc. reported that in preliminary results from phase 2 clinical trials, no significant improvement resulted from implanting the fetal cells of pigs into patient brains when compared with subjects who received placebo surgery.


Placebo and Placebo Effects - A Review
Psychother Psychosom Med Psychol 2002 (Aug);   52 (8):   332–342

Placebo controls in clinical trials are usually employed to filter out undesired, psychological or non-specific effects from "true" therapeutic effects. Although this is useful in the context of clinical trials for the purpose of proving pharmacological efficacy, it is misleading to generalize this strategy to therapy as a whole. This would imply that placebo effects are irrelevant.


A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee
New England Journal of Medicine 2002 (Jul 11);   347 (2):   81–88

In this controlled trial of arthroscopic surgery for osteoarthritis of the knee, a total of 180 patients with osteoarthritis of the knee were randomly assigned to receive arthroscopic debridement, arthroscopic lavage, or placebo surgery. Pain and function were assessed over a 24-month period. The result? "At no point did either of the intervention groups report less pain or better function than the placebo group." This investigation followed a smaller pilot study with similar results [10]. You may also enjoy this byline: Does Knee Surgery Actually Help?.


The Nocebo Effect: Placebo's Evil Twin
The Washington Post   Tuesday, April 30, 2002;   Page HE01

Fifteen years ago, researchers at three medical centers undertook a study of aspirin and another blood thinner in heart patients and came up with an unexpected result that said little about the heart and much about the brain. At two locations, patients were warned of possible gastrointestinal problems, one of the most common side effects of repeated use of aspirin. At the other location, patients received no such caution. When researchers reviewed the data, they found a striking result: Those warned about the gastrointestinal problems were almost three times as likely to have the side effect. Though the evidence of actual stomach damage such as ulcers was the same for all three groups, those with the most information about the prospect of minor problems were the most likely to experience the pain.


Manual Medicine Diversity:
Research Pitfalls and the Emerging Medical Paradigm

J Am Osteopath Assoc 2001 (Aug);   101 (8):   441–444 ~ FULL TEXT

Recent studies published in leading medical journals have concluded that chiropractic treatment is not particularly helpful for relieving asthma and migraine symptoms because even though study participants showed notable improvement in symptoms, those subjects who received sham manual medicine treatments also showed improvement. Yet the sham treatment received by control groups in these studies is reminiscent in many ways of traditional osteopathic manipulation. This seems to represent not only a failure to recognize the value of many manual medicine techniques but also an ignorance of the broad spectrum of manual medicine techniques used by various practitioners, from osteopathic physicians to chiropractors to physical therapists.


Use of a Pilot to Refine the Design of a Study to Develop
a Manual Placebo Treatment

J Neuromusculoskeletal System 2000 (Summer);   8 (2):   39–48

Development of an appropriate placebo treatment is one of the major challenges in designing chiropractic clinical trials. To date, such trials have not provided convincing eveidence that both 1) the manual placebo did in fact act as a placebo, and 2) patients were successfully blinded to treatment group assignment. In order to develop a manual placebo treatment that will satisfy these criteria, the authors first conducted a pilot study with a 2x2 factorial design to assess recruitment and study protocols and refine the study design.


A Randomized, Placebo-controlled Clinical Trial on the Efficacy
of Chiropractic Therapy on Premenstrual Syndrome

J Manipulative Physiol Ther 1999 (Nov);   22 (9):   582–585

Within the limitations of the study, the results support the hypothesis that the symptoms associated with PMS can generally be reduced by chiropractic treatment consisting of adjustments and soft-tissue therapy. However, the role of a placebo effect needs further elucidation, given that the group receiving the placebo first, although improving over the baseline, showed no further improvement when they had actual treatment.


Preliminary Study of the Effects of a Placebo Chiropractic Treatment
with Sham Adjustments

J Manipulative Physiol Ther 1999 (Sep);   22 (7):   436–443

Although VAS and GWBS scores improved with both treatments, a somewhat greater improvement occurred in most cases with the active treatment. Eight of 14 patients interviewed believed that the placebo had a treatment effect.


The Powerful Placebo: From Ancient Priest to Modern Physician
British Medical Journal 1998 (May 2);   316 :   1396 ~ FULL TEXT

"Placebo" formerly encompassed both drug and non-drug treatments of disease, but with the proliferation of controlled treatment trials since the 1950s the term has come to mean an "inert" substance or procedure used as a control in bioscience experiments, in particular clinical drug trials. The psychiatrist authors plead for a re-widening of the concept to cover all treatments, including psychotherapy. They define placebo as "any treatment, or component thereof, which is knowingly used for its non-specific physiological or psychophysiological therapeutic effect, but is without specific activity."


Debunking the Placebo Effect
Any beneficial effect derived from natural remedies such as vitamins, minerals and herbs is often discounted as being nothing more than the consumer's belief that they will work. With an air of authority, skeptics claim that natural medicine is quackery, effective only because of the placebo effect.

In 1955, Henry K. Beecher, M.D., was the first to report on the so-called placebo effect. Beecher claimed that about 35 percent of the time, patients who took a pill containing no active ingredients experienced an improvement in their condition.

In 1997, researchers at the Institute for Applied Theory and Methodologies in Health Care, in Frieburg, Germany, decided to look into Beecher's theory. Reporting in the Journal of Clinical Epidemiology, they scrutinized the 15 different clinical studies cited by Beecher. Here is what they found.


The Placebo Prescription
New York Times Magazine   Jan 9, 2000

An interesting article posits the question: "How did (the arthroscopic surgeon) know that whatever benefit came from this surgery wasn't a product of the placebo effect -- that is, that those who improved did so, not because the operation actually healed the knee joint, but because (the patient) expected it would?"   Fascinating reading, and may be applied to the chiropractic intervention as well.

 
   

Possible Solutions ???
 
   

A True Blind for Subjects Who Receive Spinal Manipulation Therapy
Arch Phys Med Rehabil 2009 (Feb);   90 (2):   366–368

In each subject, propofol and remifentanil were administered intravenously. Once unconsciousness was achieved (3-5min), subjects were placed in a lateral recumbent position and then randomized to either a control group (n=3) or an experimental group (with SMT, n=3); subjects received a single SMT to the lumbar spine. Subjects were given a standardized auditory and visual cue and then allowed to recover from anesthesia in a supine position (3-5min). In either the experimental or control group, subjects could not recall any event while under anesthesia. Some SMT subjects reported pain reduction greater than the minimally important clinical difference and greater than control subjects. No adverse events were reported.


Validation of a Sham Manipulative Procedure for the Cervical Spine
for Use in Clinical Trials

J Manipulative Physiol Ther 2005 (Nov);   28 (9):   662–666

The sham cervical manipulation studied here appears to approximate the necessary features of a placebo maneuver in that it is perceived by a majority of nonstudent neck pain subjects to be a real manipulation, although it does not produce any important change in cervical status. The small sample size of nonstudent participants precludes a strong recommendation for this procedure at this time.


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