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. 2023 Mar 6;2023(3):MR000055. doi: 10.1002/14651858.MR000055.pub2

Rief 2012.

Study characteristics
Methods Type: preclinical
Design: parallel and 2 × 3 + 1 factorial design with a separate no treatment group as well as 6 groups separated by the following factors.
  1. Active placebo or standard placebo

  2. 100% drug expectation, 50% drug expectation, or 100% placebo expectation


Objective: to investigate the effects of manipulating the expectation of receiving an active drug, and of medication‐associated bodily sensations, to estimate the influence of these RCT‐typical features.
Treatment duration: instant (single dose)
Follow‐up duration (including treatment duration): 20 minutes
Washout between cross‐over periods: NA
Data Country: Germany
Condition: experimental heat pain
Number of people randomised: 144 volunteers included, unclear how many were randomised to each group. 57 randomised to each placebo type.
Number of people analysed: 57 for each placebo type
Comparisons Active placebo: capsaicin (0.014 %) in sesame oil
Standard placebo: sesame oil
Experimental intervention: none
Administration: intranasal
Outcomes Participant‐reported outcome: pain threshold (in degrees centigrade)
Observer‐reported outcome: none
Harm outcome: none
Co‐intervention outcome: none
Terminology for active placebo "Active placebo" a priori
Scores and unpleasantness of the active placebo Adequacy: NA
Risk of therapeutic effect: 2
Unpleasant/neutral/pleasant: unpleasant
Funding and conflicts of interest Non‐industry funding. Trial authors declared no conflicts of interest.
Notes  
Risk of bias
Item Authors' judgement Support for judgement
Free from risk of bias arising from the randomisation process Unclear No indication of problems with baseline differences. No other information.
Free from risk of bias in selection of the reported result
All outcomes Unclear No information.