Placebo disclosure does not result in negative changes in mood or attitudes towards health care or the provider

Abstract

: The purposes of this study were to (1) determine whether disclosure of having received a placebo treatment following participation in a randomized manual therapy trial resulted in changes in negative mood or attitudes towards health care and the provider and (2) examine the association between changes in mood or attitude and changes in clinical outcomes over the two-week study period. : Participants with low back pain ( = 110) were randomly assigned to receive a spinal manipulative therapy (SMT), a standard placebo SMT in which participants were aware of a chance of receiving a placebo, an enhanced placebo SMT in which participants were instructed 'the manual therapy technique you will receive has been shown to significantly reduce low back pain in some people,' or no treatment. Outcomes included pain (Numeric Rating Scale), disability (Oswestry Disability Index), and negative mood and attitudes towards health care and the provider (visual analog scales). Pain and disability were obtained at baseline and two weeks. Mood and attitude measures were assessed at baseline, at the start of the final session, and upon completion of the final session following disclosure of group assignment. : Disclosure of having received a placebo treatment was not associated with worsening of mood or attitudes towards health care or the provider ( > 0.05). A small, but significant ( < 0.05) association was observed between two-week changes in disability and immediate changes in mood ( = 0.31-0.36) upon disclosure of having received a placebo. This analysis indicates an association between larger improvements in disability and more positive changes in mood. : Placebo treatment use in clinical practice is common yet controversial due to the deceptive nature. Our findings suggest disclosure of having received a placebo treatment is not associated with adverse changes in negative mood or attitudes towards health care or the provider.

Clinical relevance of contextual factors as triggers of placebo and nocebo effects in musculoskeletal pain

“…Thus, when available the choice of the best evidence-based therapy is mandatory and a patient must be informed about the use of a placebo intervention with an amount of disclosure sufficient to avoid deception [ 201 , 203 , 204 ]. Although it is common thought that revealing the use of a placebo inhibits its effect, different studies point out the efficacy of placebo interventions also in “open label” conditions where the use of a placebo was disclosed in patients with chronic low back pain [ 205 , 206 ]. From a clinical perspective, the mindful manipulation of CFs represents a useful opportunity to enrich a well-established therapy that have different ethical implication in comparison with the replacement of real treatment with a potentially ineffective treatment [ 200 ].…”

Psychological context effects of participant expectation on pain pressure thresholds as an adjunct to cervicothoracic HVLA thrust manipulation: A randomised controlled trial

“…The general consensus seems to be that in order to maintain best evidence-based therapy then this informing of the participants and without deception should be sought (Annoni & Miller, 2016;Blease et al, 2016;Charlesworth et al, 2017). Surprisingly, despite the common belief that disclosing the placebo intervention reduces its efficacy, this has not been found to be true as the placebo effect has still been found in open label trials with full condition disclosure given to patients (Bialosky & Robinson, 2017;Carvalho et al, 2016). So, the consensus so far seems to be to establish ethical mindful manipulation of CF effects where there is disclose, which may represent a useful opportunity to enrich well-established therapies (Miller & Colloca, 2009).…”

Klinische Relevanz von Kontextfaktoren als Auslöser von Placebo- und Nocebo-Effekten bei muskuloskelettalen Schmerzen

“…Wirksamkeit der Placebo-Interventionen auch unter "Open Label"-Bedingungen hin, bei denen die Verwendung eines Placebos bei Patient*innen mit chronischen Kreuzschmerzen offengelegt wurde [205,206].…”

“…Obwohl allgemein angenommen wird, dass die Offenlegung der Verwendung eines Placebos dessen Wirkung hemmt, weisen verschiedene Studien auf die Wirksamkeit der Placebo-Interventionen auch unter „Open Label“-Bedingungen hin, bei denen die Verwendung eines Placebos bei Patient*innen mit chronischen Kreuzschmerzen offengelegt wurde 205 206 .…”