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

Lufi 1997.

Study characteristics
Methods Cross‐over trial with 2 interventions:
  • MPH

  • placebo


Phases: participants randomly assigned to 3 weeks of MPH, 3 weeks of placebo. No washout. Assessment at baseline and by the end of each phase
Participants Number of participants screened: not stated
Number of participants included: 20 (18 boys, 2 girls)
Number of participants followed up: 20
Number of withdrawals: 0
Diagnosis of ADHD: DSM‐IV (subtype not stated)
Age: mean 9.23 years (± 1.62, range 7.17‐12.42)
IQ: > 70
MPH‐naive: 100%
Ethnicity: not stated
Country: Israel
Setting: outpatient clinic
Comorbidity: none
Comedication: no
Other sociodemographics: none
Inclusion criteria
  • IQ > 70

  • Treatment‐naive


Exclusion criteria
  • Implicitly stated: gross physical impairment, intellectual deficits, major disease or serious psychological problems, and not receiving any psychological treatment prior to taking part in the research

Interventions Participants were randomly assigned to 1 of 2 possible drug condition orders of 10 mg MPH and placebo
Mean MPH dosage: 10 mg/d
Administration schedule: mornings
Duration of each medication condition: 3 weeks
Washout before trial initiation: all participants were treatment‐naive
Medication‐free period between interventions: none
Titration period: none
Treatment compliance: not stated
Outcomes ADHD symptoms
  • CTRS


General behaviour
  • Global Teacher Ratings: rating scale from 1‐10 constructed specifically for this trial (assessment before ingestion of medication, after 3 weeks of 1st medication period, after 3 weeks of 2nd medication period)

Notes Sample calculation: not stated
Ethics approval: not stated
Comment from trial authors
  • Strong placebo effect


Key conclusions of trial authors
  • MPH improved classroom behaviour as compared with no treatment

  • Placebo influence had almost the same effect as medication

  • Neither of these treatments significantly improved cognitive functioning and personality characteristics of the child with ADHD


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: not declared
Email correspondence with trial authors: September 2013. We obtained supplemental information/data from trial authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomised
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias)
All outcomes Low risk "Everyone involved in the assessment phase ...was blind to the type of medication..."
All medications (both placebo and MPH) were given in identical capsules to prevent recognition of the true medication
Blinding of outcome assessment (detection bias)
All outcomes Low risk "...the parents, the teacher, the child and the psychologist who tested the child did not know what kind of medication the child was taking..."
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No information
Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias) Unclear risk No protocol identified