Impact of active placebo controls on estimated drug effects in randomised trials: a systematic review of trials with both active placebo and standard placebo

Laursen, David Rt; Nejstgaard, Camilla Hansen; Bjørkedal, Espen; Frost, Anders Dreyer; Hansen, Morten; Paludan-Müller, Asger Sand; Prosenz, Julian; Werner, C.; Hróbjartsson, Asbjørn

doi:10.1002/14651858.mr000055.pub2

Cited by 2 publications

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“…In reference to this, a Cochrane systematic review of conventional antidepressive medicine found unblinding to be a possible inflator of effect size ( Moncrieff et al, 2004 ). Furthermore, did another Cochrane meta-analysis found that the use of active placebo in trials on conventional antidepressive medicine was associated with a smaller effect size, when compared to trials who used standard placebo ( Laursen et al, 2023 ).…”

Section: Introductionmentioning

confidence: 99%

“…However, a recent Cochrane meta-analysis that compared trials utilizing inactive and active placebo failed to find any difference in drug effects. However, the results were imprecise, and the confidence interval (CI) was compatible with a difference ranging from important to irrelevant, and in the sensitivity analysis of low risk trials did they found a difference in drug effects ( Laursen et al, 2023 ).…”

Section: Introductionmentioning

confidence: 99%

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Risk of bias in randomized clinical trials on psychedelic medicine: A systematic review

et al. 2023

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Background: The classical psychedelics, psilocybin, peyote, ayahuasca/ N,N-dimethyltryptamine, and lysergic acid diethylamide are considered promising new treatments for psychiatric illnesses, such as depression, anxiety, addiction, and obsessive-compulsive disorders. However, their profound and characteristic subjective effects raise concern for distinctive biases in randomized clinical trials. Methods: We performed a systematic literature search to identify all clinical trials on classical psychedelics with patient populations to examine descriptive data and determine the risk of bias. Two independent reviewers searched three databases (PubMed, Embase, and APA PsycNet) and extracted information on study design, study population, use of active or inactive placebo, dropouts, evaluation of blinding of intervention, and reporting of expectancy and therapeutic alliance. Results: We included 10 papers reporting on 10 unique trials. The trials generally included populations that were predominantly white and highly educated. The trials had small samples and considerable dropout. Blinding was either unsuccessful or not reported regardless of type of placebo. Few trials published protocols, statistical analysis plans (SAPs), and outcomes relating to psychotherapy fidelity. All trials but one were rated as high risk of bias. Conclusion: Successful blinding of intervention is a significant challenge in this field. To better accommodate this, we suggest that future trials use a parallel-group design and utilize an active placebo on a psychedelic-naïve population. Future trials should publish trial protocol and SAPs, use clinician-rated outcomes accessed by a blinded rater, evaluate blinding of intervention, and consider measuring expectancy and therapeutic fidelity.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Risk of bias in randomized clinical trials on psychedelic medicine: A systematic review

et al. 2023

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Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)

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et al. 2023

Cochrane Database of Systematic Reviews

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Impact of active placebo controls on estimated drug effects in randomised trials: a systematic review of trials with both active placebo and standard placebo

Abstract: Trusted evidence. Informed decisions. Better health. Cochrane Database of Systematic ReviewsImpact of active placebo controls on estimated drug e ects in randomised trials: a systematic review of trials with both active placebo and standard placebo (Review)

Cited by 2 publications

References 63 publications

Risk of bias in randomized clinical trials on psychedelic medicine: A systematic review

Risk of bias in randomized clinical trials on psychedelic medicine: A systematic review

Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)

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