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. 2023 Mar 27;2023(3):CD009885. doi: 10.1002/14651858.CD009885.pub3

Gadow 1990.

Study characteristics
Methods 6‐week double‐blind, cross‐over trial in which participants received the following in random order:
  • LD‐MPH

  • MD‐MPH

  • placebo


Furthermore, a single case report from the trial is described
Participants Number of participants screened: not stated
Number of participants included: 11 (11 boys, 0 girls)
Number of participants followed up: between 9 and 10, depending on ratings
Number of withdrawals: 1‐2
Diagnosis of ADHD: DSM‐III (type not stated)
Age: mean not reported (range 5.9‐11.9 years)
Case report: 10 years of age
IQ: > 75
Stimulant‐naive: 6
Ethnicity: not stated
Country: USA
Setting: outpatient clinic
Comorbidity: disruptive behaviour disorder
Comedication: not reported
Other sociodemographics: children represented a full range of socioeconomic backgrounds
 
Inclusion criteria
  • Boys

  • 5‐12 years of age

  • ADHD diagnosis according to DSM‐III

  • Scored above research cut‐off (> 7) on the Aggression scale of IOWA CTRS, or were considered aggressive by their classroom teacher and were above cut‐off on ≥ 1 other conduct problem scale

  • Scored ≥ 15 on the Abbreviated Teacher Rating Scale

  • Above cut‐off on the Oppositional DIsorder or CD Index of the Parent or Teacher Version of the Stony Brook Child Psychiatric Checklist, Version 3


Exclusion criteria
  • IQ < 70

  • Psychosis, pervasive developmental disorder, dangerous to self or others

  • Seizure disorder, major organic brain dysfunction, medical illness, contraindication to medication treatment

Interventions Participants were randomly assigned to 1 of 6 possible drug condition orders of LD‐MPH (0.3 mg/kg) and MD‐MPH (0.6 mg/kg) (upper limit 25 mg) and placebo
Mean MPH dosage: not stated
Administration schedule: twice/d, morning, noon, 3.5 h apart, 7 d/week
Duration of each medication condition: 2 weeks
Washout before trial initiation: yes
Titration period: when MD was not preceded by LD condition, the child was gradually built up to MD. Data from these titration days were excluded from the analyses
Treatment compliance: pill count, no further information
Outcomes ADHD symptoms
  • Conners' Abbreviated Teacher Rating Scale

  • Conners' Abbreviated Parent Rating Scale


Non‐serious AEs
  • Stimulant Side Effects Checklist: rated systematically

Notes Sample calculation: no information
Ethics approval: no information
Comment from trial authors
  • Sample size was small, which decreased the probability of detecting clinically significant group differences between treatment conditions


Key conclusion of trial authors
  • Results of this trial indicate that MPH‐induced improvements in the classroom behaviour of aggressive hyperactive boys are associated with concomitant changes in the demeanour of classmates sitting in close proximity to the drug‐treated child


Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no
Any withdrawals due to AEs: no
Funding source: Ciba Pharmaceutical Company supplied MPH placebo
Email correspondence with trial authors: July 2013. Emailed first trial author twice to get additional information (funding, ethics approval, etc.) and data from the trial. Trial authors not able to provide us with additional data
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Dose schedules were assigned on a random basis
Allocation concealment (selection bias) Low risk Medication and placebo pills were identical and were dispensed to parents and school nurses in dated, sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes Low risk Parents, teachers, observers, treating physicians and children were blinded to dose and order
Blinding of outcome assessment (detection bias)
All outcomes Low risk Parents, teachers, observers, treating physicians and children were blinded to dose and order
Incomplete outcome data (attrition bias)
All outcomes Low risk For classroom analyses, data on 10 boys were analysed, and for lunch room analyses, data on 9 boys were analysed
Selection bias (e.g. titration before randomisation → exclusion): no
Selective reporting (reporting bias) Unclear risk No protocol identified. Email sent to first trial author. No answer; therefore not able to get information