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What Techniques Might Be Used to Harness Placebo Effects in Non-malignant pain?

By |September 30, 2017|Placebo|

What Techniques Might Be Used to Harness Placebo Effects in Non-malignant pain? A Literature Review and Survey to Develop a Taxonomy

The Chiro.Org Blog


SOURCE:  

Felicity L Bishop, Beverly Coghlan, Adam WA Geraghty,
Hazel Everitt, Paul Little, Michelle M Holmes,
Dionysis Seretis, George Lewith

Department of Psychology,
Faculty of Social Human and Mathematical Sciences,
University of Southampton,
Southampton, UK.


OBJECTIVES:   Placebo effects can be clinically meaningful but are seldom fully exploited in clinical practice. This review aimed to facilitate translational research by producing a taxonomy of techniques that could augment placebo analgesia in clinical practice.

DESIGN:   Literature review and survey.

METHODS:   We systematically analysed methods which could plausibly be used to elicit placebo effects in 169 clinical and laboratory-based studies involving non-malignant pain, drawn from seven systematic reviews. In a validation exercise, we surveyed 33 leading placebo researchers (mean 12 years’ research experience, SD 9.8), who were asked to comment on and add to the draft taxonomy derived from the literature.

RESULTS:   The final taxonomy defines 30 procedures that may contribute to placebo effects in clinical and experimental research, proposes 60 possible clinical applications and classifies procedures into five domains: the patient’s characteristics and belief (5 procedures and 11 clinical applications), the practitioner’s characteristics and beliefs (2 procedures and 4 clinical applications), the healthcare setting (8 procedures and 13 clinical applications), treatment characteristics (8 procedures and 14 clinical applications) and the patient—practitioner interaction (7 procedures and 18 clinical applications).

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Imperfect Placebos Are Common In Low Back Pain Trials:

By |October 20, 2016|Placebo|

Imperfect Placebos Are Common In Low Back Pain Trials: A Systematic Review Of The Literature

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SOURCE:   Eur Spine J. 2008 (Jul); 17 (7): 889–904

L. A. C. Machado, S. J. Kamper, R. D. Herbert,
G. Maher, and J. H. McAuley

Back Pain Research Group,
Musculoskeletal Division,
The George Institute for International Health,
Missenden Rd, P.O. Box M201,
Camperdown, NSW, 2050, Australia.


The placebo is an important tool to blind patients to treatment allocation and therefore minimise some sources of bias in clinical trials. However, placebos that are improperly designed or implemented may introduce bias into trials. The purpose of this systematic review was to evaluate the adequacy of placebo interventions used in low back pain trials. Electronic databases were searched systematically for randomised placebo-controlled trials of conservative interventions for low back pain. Trial selection and data extraction were performed by two reviewers independently. A total of 126 trials using over 25 different placebo interventions were included. The strategy most commonly used to enhance blinding was the provision of structurally equivalent placebos. Adequacy of blinding was assessed in only 13% of trials. In 20% of trials the placebo intervention was a potentially genuine treatment. Most trials that assessed patients’ expectations showed that the placebo generated lower expectations than the experimental intervention.

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Placebo Effects In Trials Evaluating 12 Selected Minimally Invasive Interventions

By |October 19, 2016|Placebo|

Placebo Effects In Trials Evaluating 12 Selected Minimally Invasive Interventions: A Systematic Review And Meta-Analysis

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SOURCE:   BMJ Open. 2015 (Jan 30); 5 (1): e007331

Robin Holtedahl, Jens Ivar Brox, Ole Tjomsland

Department of Physical Medicine and Rehabilitation,
Oslo University Hospital,
Oslo, Norway.


OBJECTIVES:   To analyse the impact of placebo effects on outcome in trials of selected minimally invasive procedures and to assess reported adverse events in both trial arms.

DESIGN:   A systematic review and meta-analysis.

DATA SOURCES AND STUDY SELECTION:   We searched MEDLINE and Cochrane library to identify systematic reviews of musculoskeletal, neurological and cardiac conditions published between January 2009 and January 2014 comparing selected minimally invasive with placebo (sham) procedures. We searched MEDLINE for additional randomised controlled trials published between January 2000 and January 2014.

DATA SYNTHESIS:   Effect sizes (ES) in the active and placebo arms in the trials’ primary and pooled secondary end points were calculated. Linear regression was used to analyse the association between end points in the active and sham groups. Reported adverse events in both trial arms were registered.

RESULTS:   We included 21 trials involving 2,519 adult participants. For primary end points, there was a large clinical effect (ES≥0.8) after active treatment in 12 trials and after sham procedures in 11 trials. For secondary end points, 7 and 5 trials showed a large clinical effect. Three trials showed a moderate difference in ES between active treatment and sham on primary end points (ES ≥0.5) but no trials reported a large difference. No trials showed large or moderate differences in ES on pooled secondary end points. Regression analysis of end points in active treatment and sham arms estimated an R(2) of 0.78 for primary and 0.84 for secondary end points. Adverse events after sham were in most cases minor and of short duration.

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Spinal Manipulation: The Right Choice For Relieving Low Back Pain

By |April 24, 2013|Chiropractic Care, Low Back Pain, Placebo, Randomized Controlled Trial, Spinal Manipulation|

Spinal Manipulation: The Right Choice for Relieving Low Back Pain

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Spinal High-velocity Low Amplitude Manipulation in Acute Nonspecific Low Back Pain: A Double-blinded Randomized Controlled Trial in Comparison With Diclofenac and Placebo

Spine 2013 (Apr 1); 38 (7): 540–548

von Heymann, Wolfgang J. Dr. Med; Schloemer, Patrick Dipl. Math; Timm, Juergen Dr. RER, NAT, PhD; Muehlbauer, Bernd Dr. Med

Competence Center for Clinical Studies; and †Institute for Biometrics, University of Bremen, Bremen, Germany


Thanks to Dynamic Chiropractic for access to these Key Findings from the study

  • “There was a clear difference between the treatment groups: the subjects [receiving] spinal manipulation showed a faster and quantitatively more distinct reduction in the RMS” (compared to subjects receiving diclofenac therapy).

  • “Subjects [also] noticed a faster and quantitatively more distinct reduction in [their] subjective estimation of pain after manipulation. … A similar observation was made when comparing the somatic part of the SF-12 inventory … indicating that the subjects experienced better quality of life after the spinal manipulation compared to diclofenac.”

  • “The rescue medication was calculated both for the mean cumulative dose (numbers of 500 mg paracetamol tablets) and for the number of days on which rescue medication was taken. … In the diclofenac arm, the patients on average took almost 3 times as many tablets and the number of days [taking the tablets] was almost twice as high” compared to patients in the manipulation arm. While the authors note that these results were not significant due to large between-individual variations (meaning a few patients could have taken many tablets, throwing off the overall totals), it still suggests that value of spinal manipulation vs. drug therapy (because even if both patient groups had taken the same amount of rescue medication for the same number of days, it wouldn’t discount the fact that patients in the manipulation group showed significant improvement on outcome variables compared to patients in the diclofenac group).

The Abstract (more…)

The Placebo, the Sensory Trick and Chiropractic

By |September 27, 2012|Chiropractic Care, Placebo, Spinal Manipulation|

The Placebo, the Sensory Trick and Chiropractic

The Chiro.Org Blog


SOURCE:   Chiropractic J. Australia 2004 (Jun); 34 (2): 58–62

Brian S. Budgell, DC, MSc

School of Health Sciences,
Faculty of Medicine,
Kyoto University, Kyoto, Japan


Thanks to Dr. Brian S. Budgell and Dr. Rolf Peters, editor of the Chiropractic Journal of Australia for permission to republish this Full Text article, exclusively at Chiro.Org!


Background:   As standards for randomised, controlled, clinical trials in medicine evolve, there is debate about whether the RCT model of investigation is appropriate for chiropractic and other forms of so-called “complementary and alternative medicine.” There may be some question as to whether the use of placebo interventions can be justified ethically and scientifically given that experimental treatments must eventually compete in a marketplace where there is often already a clinical alternative which is more effective than placebo. Beyond these concerns, design of an appropriate placebo for chiropractic trials is particularly problematic since the therapeutic component of overall chiropractic treatment may be difficult to isolate.

Objective:   To compare placebo interventions in current use in chiropractic clinical research with simple somatic stimuli that produce significant physiological effects in a selected group of patients (those suffering from dystonia).

Methods:   A literature search was made using MEDLINE, with the key words dystonia, sensory trick and geste antagoniste. Articles were reviewed for descriptions of these stimuli. The stimuli were compared, in terms of site and modality, with placebo interventions used in recent chiropractic clinical trials.

Results:   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.

Conclusions:   Caution should be used in assuming that control (placebo) procedures used in chiropractic clinical trials—procedures that involve physical contact or positioning of patients—lack specific effects on neuromusculoskeletal symptomatology.

INDEX TERMS: (MeSH)   PLACEBO, SENSORY TRICK, GESTE ANTAGONISTE, CHIROPRACTIC

You may also want to refer to our:

The Problem with Placebos/Shams Page


INTRODUCTION:

In common parlance, the placebo may be thought of as a sham treatment given to placate the gullible or troublesome patient. In medical practice, it is more often thought of as medication, most often a pill, which has no specific action against the complaint for which it is prescribed. More recently, standards for design of clinical research have demanded more rigorous definition of what has been called “the imaginary term in medicine’s algebraic formula.” [1]

For purposes of pharmacological research, it is possible to select placebo substances that appear, with a very high level of probability, to be physiologically inert in humans, or at least to have no specific action against a disorder that is the target of investigation. Nonetheless, various studies have indicated that such supposedly inert substances may be associated with impressive levels of therapeutic effects, sometimes rivalling the medications, which are known to have specific pharmacological effects. [2]

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The Chiropractic Care of Patients with Asthma: A Systematic Review of the Literature to Inform Clinical Practice

By |March 19, 2012|Asthma, Chiropractic Care, Placebo, Spinal Manipulation|

The Chiropractic Care of Patients with Asthma: A Systematic Review of the Literature to Inform Clinical Practice

The Chiro.Org Blog


SOURCE:   Clinical Chiropractic 2012 (Mar); 15 (1): 23–30

Joel Alcantara, Joey D. Alcantara, Junjoe Alcantara

International Chiropractic Pediatric Association,
Media, 327 N Middletown Rd,
Media, PA 19063, USA


Introduction   Estimates place some 300 million people worldwide suffer from asthma with 180,000 deaths attributed to the disease. The financial burden from Asthma in Western countries ranges from $300 to $1,300 per patient per year. In the United States, asthma medication costs between $1 billion and $6.2 billion per annum. With an increasing prevalence of 50% every decade, there is no question that the burden of asthma is tremendous. The prevalence of complementary and alternative medicine (CAM) use amongst adult asthmatics ranges from 4% to 79% whilst, in children, it ranges from 33% to 89%. Of the various practitioner-based CAM therapies, chiropractic stands as the most popular for both children and adults. As with other chiropractors, the authors aspire to the principles of evidence-based practice in the care of asthma sufferers. Recent systematic reviews of the literature places into question the effectiveness of chiropractic. To assuage the discord between our clinical experience and those of our patients with the dissonant literature, we performed a systematic review of the literature on the chiropractic care of patients with asthma.

Methods   Our systematic review utilized the following databases for the years indicated: MANTIS [1965–2010]; Pubmed [1966–2010]; ICL [1984–2010]; EMBASE [1974–2010], AMED [1967–2010], CINAHL [1964–2010], Index to Chiropractic Literature [1984–2010], Alt-Health Watch [1965–2010] and PsychINFO [1965–2010]. Inclusion criteria for manuscript review were manuscripts of primary investigation/report published in peer-reviewed journals in the English language involving the care of asthmatic patients.

Results   The studies found span of research designs from non-experimental to true experimental studies consisting of 3 randomized controlled clinical trials (RCTs), 10 case reports, 3 case series, 7 cohort studies, 3 survey studies, 5 commentaries8 and 6 systematic reviews. The lower level design studies provide some measure of evidence on the effectiveness of chiropractic care for patients with asthma while a critical appraisal of 3 RCTs revealed questionable validity of the sham SMTs involved and hence the conclusions and interpretations derived from them. The RCTs on chiropractic and asthma are arguably comparison trials rather than controlled clinical trials per se.

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Asthma and Chiropractic Page

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