Coase warned, “If you torture the data long enough, it will confess.Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder associated with a wide range of impairments. Coincidentally (although as skeptics, we do not believe in coincidence), the initial statistical team was changed when data were sold to the French pharmaceutical company applying for the marketing authorization in France. Although he cited us,3 he overlooked the evidence we provided indicating that the Bacloville article4 was published without acknowledging major changes to the initial protocol, affecting the primary outcome. Second, Dr Andrade should have warned readers that Bacloville’s results are most questionable, lacking robustness. To the Editor: Dr Andrade’s analysis of the Bacloville trial in a recent Clinical and Practical Psychopharmacology column, in which he concluded that “individualized treatment with high-dose baclofen (30-300 mg/d) may be a useful second-line approach in heavy drinkers” and that “baclofen may be particularly useful in patients with liver disease,” deserves comment.1įirst, Andrade failed to recall that the first pivotal trial of baclofen, ALPADIR (NCT01738282 320 patients, as with Bacloville), was negative (see Braillon et al2). Future meta-analyses examining the effects of amphetamine and methylphenidate derivatives on irritability as a continuous measure, as well as head-to-head trials between methylphenidate and amphetamine derivatives examining effects on irritability, will be important to replicate the findings of this meta-analysis.īaclofen, a French Exception, Seriously Harms Alcohol Use Disorder Patients Without Benefit 01, k = 5, I 2 = 0%).Ĭonclusions: This meta-analysis suggests an increased risk of irritability may be confined to amphetamine-derived psychostimulants. 004, k = 32, I 2 = 50%), whereas amphetamine derivatives were associated with a significantly increased risk of irritability (RR = 2.90, z = 2.5, P =. Methylphenidate derivatives were associated with a significantly decreased risk of irritability compared to placebo (risk ratio = 0.89, z = − 2.87, P =. The relative risk of irritability significantly differed between psychostimulant classes (test for subgroup differences χ 2 1 = 7.6, P =. Results: From 92 potentially eligible trials, the meta-analysis identified 32 trials involving 3,664 children with ADHD that reported data on irritability as a side effect. Stratified subgroup analysis and meta-regression were used to examine the effects of stimulant type, dosage, duration of use, and trial design on the measured risk of irritability. Trials were excluded if (1) they required additional psychiatric or medical comorbidity in addition to ADHD, (2) they involved fewer than 20 subjects (parallel group trials), or (3) children received psychostimulant medication for less than 1 week.ĭata Extraction: A fixed-effects meta-analysis was used to examine the risk ratio of irritability reported as a side effect in children treated with psychostimulants compared to placebo. The goal o f t his study was to quantify the risk of irritability as a side effect of psychostimulant treatment for ADHD.ĭata Sources and Study Selection: A PubMed search was conducted on August 18, 2013, to identify all double-blind, randomized, placebo-controlled trials published in English examining the efficacy of psychostimulant medications in the treatment of children with ADHD. However, psychostimulants have been demonstrated as an effective treatment in reducing irritability and aggression in children with attention-deficit/hyperactivity disorder (ADHD). Objective: Irritability is listed as a common side effect of psychostimulant medications.
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