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

Tirosh 1993a.

Study characteristics
Methods 16‐day, double‐blind, cross‐over, counterbalanced trial with 2 interventions:
  • MPH

  • placebo

Participants Number of participants screened: not stated
Number of participants included: 20 (16 boys, 4 girls)
Number of participants followed up: 20
Number of withdrawals: 0
Diagnosis of ADHD: DSM‐III (ADD 30%, ADHD 70%)
Age: mean 9.3 years (range 7‐12)
IQ: mean 102 (SD 11)
MPH‐naive: 100%
Ethnicity: not stated
Country: Israel
Setting: outpatient clinic
Comorbidity: no
Comedication: no
Other sociodemographics: middle (12), upper‐middle (5) and low (3) socioeconomic status of parents
Inclusion criteria
  • DSM‐III diagnosis of ADHD

  • 7‐12 years old


Exclusion criteria
  • MPH before trial

  • Neurological, sensory or physical health problems

Interventions Participants were randomly assigned to 1 of 2 possible drug condition orders of MPH and placebo
MPH dose range: 0.3 mg/kg ‐0.5 mg/kg
Administration schedule: twice daily
Duration of each medication condition: 8 days
Washout before trial initiation: no (participants were MPH‐naive)
Titration period: no
Treatment compliance: parents were asked to bring their packages of tablets back for pill count; no data
Outcomes ADHD symptoms
  • Abbreviated Parent Rating Scale (APRS), weekly

  • Teacher Rating Scale (TRS), weekly

Notes Sample calculation: no
Ethics approval: yes
Key conclusions of trial authors
  • Teacher Rating Scale: placebo‐drug difference correlated more significantly with outcome measures than did the baseline drug difference

  • Trial underlines the validity of a multi‐measure placebo/drug trial in evaluating the efficacy of MPH for children with attention deficit disorder


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: none
Email correspondence with trial authors: August 2013. Trial author stated that data were discarded (Ramstad 2013d [pers comm]).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation with a table of random numbers
Allocation concealment (selection bias) Low risk Look‐alike placebo tablets were supplied by the hospital pharmacy and were similarly administered
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blind
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No information
Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias) Unclear risk No protocol available