Side effects can enhance treatment response through expectancy effects: an experimental analgesic randomized controlled trial.

Details

Serval ID
serval:BIB_FF15132B745A
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Side effects can enhance treatment response through expectancy effects: an experimental analgesic randomized controlled trial.
Journal
Pain
Author(s)
Berna C., Kirsch I., Zion S.R., Lee Y.C., Jensen K.B., Sadler P., Kaptchuk T.J., Edwards R.R.
ISSN
1872-6623 (Electronic)
ISSN-L
0304-3959
Publication state
Published
Issued date
06/2017
Peer-reviewed
Oui
Volume
158
Number
6
Pages
1014-1020
Language
english
Notes
Publication types: Journal Article ; Randomized Controlled Trial
Publication Status: ppublish
Abstract
In randomized controlled trials, medication side effects may lead to beliefs that one is receiving the active intervention and enhance active treatment responses, thereby increasing drug-placebo differences. We tested these hypotheses with an experimental double-blind randomized controlled trial of a nonsteroidal anti-inflammatory drug with and without the addition of atropine to induce side effects. One hundred healthy volunteers were told they would be randomized to either combined analgesics that might produce dry mouth or inert placebos. In reality, they were randomized double blind, double-dummy to 1 of the 4 conditions: (1) 100 mg diclofenac + 1.2 mg atropine, (2) placebo + 1.2 mg atropine, (3) 100 mg diclofenac + placebo, or (4) placebo + placebo, and tested with heat-induced pain. Groups did not differ significantly in demographics, temperature producing moderate pain, state anxiety, or depression. Analgesia was observed in all groups; there was a significant interaction between diclofenac and atropine, without main effects. Diclofenac alone was not better than double-placebo. The addition of atropine increased pain relief more than 3-fold among participants given diclofenac (d = 0.77), but did not enhance the response to placebo (d = 0.09). A chain of mediation analysis demonstrated that the addition of atropine increased dry mouth symptoms, which increased beliefs that one had received the active medication, which, in turn, increased analgesia. In addition to this indirect effect of atropine on analgesia (via dry mouth and beliefs), analyses suggest that among those who received diclofenac, atropine directly increased analgesia. This possible synergistic effect between diclofenac and atropine might warrant future research.

Keywords
Adolescent, Adult, Anti-Inflammatory Agents, Non-Steroidal/administration & dosage, Anticipation, Psychological, Atropine/administration & dosage, Atropine/adverse effects, Diclofenac/administration & dosage, Double-Blind Method, Female, Humans, Male, Pain/drug therapy, Pain/psychology, Pain Measurement/drug effects, Placebo Effect, Treatment Outcome, Xerostomia/chemically induced, Xerostomia/psychology, Young Adult
Pubmed
Web of science
Create date
14/02/2017 11:03
Last modification date
20/08/2019 17:29
Usage data