I've seen in this over and over in my career in Pain Medicine: The Doctor
is the Drug. Doesn't matter if you're talking about manual therapy, PT, psychotherapy, acupuncture, opioids, neuromodulation, or regen med.
Primum non nocere.
Patient: Do you believe _____ works?
Doctor: ...I believe that
you believe and that's almost like believing...
"After all, if Hall is right that clinician warmth is especially effective with a certain genotype, then, as she wrote in the paper presenting her findings from the I.B.S./sham-acupuncture study, it is also true that a different group will “derive minimum benefit” from “empathic attentions.” Should medical rituals be doled out according to genotype, with warmth and caring withheld in order to clear the way for the drugs? And if she is correct that a certain ensemble of neurochemical events underlies the placebo effect, then what is to stop a drug company from manufacturing a drug — a real drug, that is — that activates the same process pharmacologically? Welcomed back into the medical fold, the placebo effect may raise enough mischief to make Kaptchuk rue its return, and bewilder patients when they discover that their doctor’s bedside manner is tailored to their genes."
Blinding protocols, treatment credibility, and expectancy: methodologic issues in clinical trials of osteopathic manipulative treatment. - PubMed - NCBI
J Am Osteopath Assoc. 2006 Aug;106(8):457-63.
Blinding protocols, treatment credibility, and expectancy: methodologic issues in clinical trials of osteopathic manipulative treatment.
Licciardone JC1,
Russo DP.
Author information
Abstract
CONTEXT:
In testing an experimental new drug or therapy, the gold standard in biomedical research for determining treatment efficacy is the randomized controlled trial (RCT). In pharmaceutical trials, inert placebos are an easily administered control that facilitates blinded comparisons. In clinical trials that study the effects of manual interventions, researchers must carefully consider their use of treatment control models. Choosing credible controls that will minimize bias in osteopathic manipulative treatment (OMT) clinical trials poses unique challenges to researchers because of heterogeneous OMT methods and practice.
OBJECTIVE:
To compare the treatment credibility of sham manipulative treatment and untreated controls to active OMT.
METHODS:
Subjects recruited for an OMT clinical trial for chronic low back pain completed a treatment-credibility rating scale comparing two written descriptions of the study interventions offered. The scale was administered to subjects before trial entry and at 6-month follow-up. Scale scores were used to compute credibility ratios for both intervention protocols (ie, OMT vs sham manipulative treatment). Repeated measures analysis of variance was used to assess changes in the credibility ratio over time, including the measurement of study group and time main effects, as well as study group x time interaction effects.
RESULTS:
Subjects (N=91) perceived OMT as a more credible therapeutic option than sham manipulative treatment both at trial entry and at 6-month follow-up (P<.05). Among subjects completing the study protocol (n=66), there were no changes in perceived credibility of the study interventions over time. There were no significant differences in the credibility ratio among study groups (P=.64) or over time (P=.79). In addition, there were no significant study group x time interactions (P=.59).
CONCLUSIONS:
In clinical trials, OMT may be perceived by subjects as a more credible treatment alternative than many control procedures. Treatment credibility can interact with subject expectations and study design in complex ways. When analyzing the treatment effects of OMT, investigators must consider the effects of these two subjective elements when competing interventions are offered and subjects are asked to self-report data. Study design should be optimized to equalize these effects among interventions.
"When blinded assessment is used, it is essential that investigators regularly test the integrity of the study protocols by assessing subjects and study personnel for their level of knowledge regarding treatment allocation. When operator blinding is not possible, the study design should control for investigator bias (if only partially) using independent evaluators to provide masked assessment. When subject blinding is not possible, the study design should control for expectation bias (if only partially) by regularly assessing the integrity of blinding protocols, evaluating any changes in treatment credibility and subject expectations, and ensuring adequate randomization."