Difference between active agent and placebo band
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Methods: a systematic review of randomized trials with both standard and active placebo control groups. For included trials, we will extract basic trial data and outcome results. From each trial, we will extract one of each of the following outcome types: a patient-reported outcome continuous preferred , an observer-reported outcome continuous preferred , a dichotomous harms outcome.
We will select two time points for each outcome: earliest post-treatment and latest follow-up. Also, we will assess attrition rate and co-intervention use. Based on the selected outcomes above, we will convert the outcome data to standardized mean differences SMD for active placebo versus standard placebo. The primary analysis is the analysis for patient-reported outcomes at earliest post-treatment.
The remaining analyses are secondary analyses. Results and conclusions: we will present results and conclusions at the Colloquium. Patient or healthcare consumer involvement: none Poster file:. In reviewing the literature, we identified seven studies that allowed a test of additivity.
Of these, four found evidence against additivity, while the remaining three studies found results consistent with additivity. While the limited available data are somewhat mixed, the evidence suggests that at least under some conditions the assumption of additivity does not hold in placebo analgesia. The concordance between mechanisms of the active analgesic and placebo analgesia may influence whether additivity occurs or not. However, more research using factorial designs is needed to disentangle the relationship between placebo analgesia and the active effect of analgesic treatments.
The primary aim of an RCT is to isolate any improvement that is directly attributable to the specific agent being tested, above and beyond any improvement that may occur simply as a result of the treatment process itself, such as the placebo effect. The placebo effect is the portion of therapeutic improvement not directly attributable to the active effect of a treatment, instead being a product of contextual and psychobiological components following the receipt of a treatment Benedetti,