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Abstract
BackgroundHigh placebo response in attention deficit hyperactivity disorder (ADHD) can reduce medication–placebo differences, jeopardizing the development of new medicines. This research aims to (1) determine placebo response in ADHD, (2) compare the accuracy of meta-regression and MetaForest in predicting placebo response, and (3) determine the covariates associated with placebo response.MethodsA systematic review with meta-analysis of randomized, placebo-controlled clinical trial investigating pharmacological interventions for ADHD was performed. Placebo response was defined as the change from baseline in ADHD symptom severity assessed according to the 18-item, clinician-rated, DSM-based rating scale. The effect of study design–, intervention–, and patient–related covariates in predicting placebo response was studied by means of meta-regression and MetaForest.ResultsNinety-four studies including 6614 patients randomized to placebo were analyzed. Overall, placebo response was −8.9 points, representing a 23.1% reduction in the severity of ADHD symptoms. Cross-validated accuracy metrics for meta-regression were R2 = 0.0012 and root mean squared error = 3.3219 for meta-regression and 0.0382 and 3.2599 for MetaForest. Placebo response among ADHD patients increased by 63% between 2001 and 2020 and was larger in the United States than in other regions of the world.ConclusionsStrong placebo response was found in ADHD patients. Both meta-regression and MetaForest showed poor performance in predicting placebo response. ADHD symptom improvement with placebo has markedly increased over the last 2 decades and is greater in the United States than the rest of the world.
Highlights
Randomized, placebo-controlled clinical trial (RPCCT) is the gold standard method for determining the efficacy of therapeutic interventions
We report the results of a systematic review and meta-analysis investigating placebo response in Attention Deficit Hyperactivity Disorder (ADHD)
We found that meta-regression and MetaForest had low accuracy in predicting placebo response
Summary
Randomized, placebo-controlled clinical trial (RPCCT) is the gold standard method for determining the efficacy of therapeutic interventions. Because high placebo response can reduce medication–placebo differences, the large placebo response in RPCCTs of psychiatric medications (Walsh et al, 2002; Vieta and Cruz, 2008; Agid et al, 2013; Rutherford et al, 2014) might be an important factor in the high RPCCT failure rate. To overcome this reduction in medication–placebo differences, multi-center trials are usually needed. ADHD symptom improvement with placebo has markedly increased over the last 2 decades and is greater in the United States than the rest of the world
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