Bjørkedal 2011.
Study characteristics | ||
Methods | Type: preclinical Design: 4‐period cross‐over and 2 × 2 factorial design (balanced placebo design), as follows.
For analysis, we combined 1 with 2 (all standard placebo groups) and 3 with 4 (all active placebo groups). Objective: to test whether side effects of drugs (atropine) can enhance expectancies and placebo responses Treatment duration: instant (single oral dose) Follow‐up duration (including treatment duration): 30 minutes per period Washout between cross‐over periods: minimum 24 hours |
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Data | Country: Norway Condition: experimental laser‐induced heat pain Number of people randomised: 23 (to a sequence of 4 interventions, i.e. 92 units). Number of people analysed: 20 (80 units), as 3 subjects did not find the stimulus painful. |
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Comparisons | Active placebo: caffeine (4 mg/kg) in grapefruit juice Standard placebo: grapefruit juice Experimental intervention: no matched experimental treatment. However, placebo intervention supplied with information explaining it was a placebo or a painkiller. Administration: oral |
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Outcomes | Participant‐reported outcome: pain on NRS of 0–10, assessed at 30 minutes Observer‐reported outcome: laser‐evoked potentials with EEG recordings, including N2 and P2 amplitudes and latencies, assessed at 30 minutes Harm outcome: none Co‐intervention outcome: none |
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Terminology for active placebo | "Active placebo" a priori. However, in some cases the trial authors also refer to"active placebo" as the combination of active placebo drug with information that they are receiving a painkiller (group 4). | |
Scores and unpleasantness of the active placebo | Adequacy: NA
Risk of therapeutic effect: 2 Unpleasant/neutral/pleasant: unpleasant |
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Funding and conflicts of interest | No industry funding. Trial authors declared no conflicts of interest. | |
Notes | Access to individual participant data with 20 measurements for each participant for each intervention | |
Risk of bias | ||
Item | Authors' judgement | Support for judgement |
Free from risk of bias arising from the randomisation process | Yes | Information from trial author: random draw of sealed, opaque envelopes containing an ID. Remote telephone contact with trial author who matched the ID with sequence. 23/24 possible treatment sequences used. |
Free from risk of bias in selection of the reported result All outcomes | Yes | Trial author provided access to all study data. |