Taylor 1987.
Study characteristics | ||
Methods | Double‐blind, randomised, placebo‐controlled, cross‐over trial with 2 arms
Each treatment period lasted for 3 weeks with a washout period of 1 week planned between treatments and up‐titration to optimum dosage during the 3 weeks |
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Participants | Number of participants screened: 64 Number of participants included: 39 (all boys). Of these, 26 had an ADHD diagnosis according to DSM‐III Number of participants followed up: 38 Number of withdrawals: 1 Diagnosis of ADHD: DSM‐III (n = 26; type not stated) The following data reflect the whole trial (n = 38) Age: mean 8.6 years (range 6‐10) IQ: all > 65; mean 93.4 MPH‐naive: 100% Ethnicity: not stated Country: UK Setting: outpatient clinic Comorbidity: no attentive or restless behaviour, but antisocial, disruptive or aggressive in conduct (n = 6), hyperactive but not antisocial or aggressive (n = 9), with both hyperactive and disruptive behaviour (n = 23), CD (n = 7), relationship problems (n = 2) and disturbance of emotions specific to childhood (n = 3) Comedication: not stated Other sociodemographics: 40% from broken homes Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 2 possible drug condition orders of MPH and placebo Mean MPH dosage: 9 received doses from 0.2 mg/kg to 0.5 mg/kg, 21 from 0.5 mg/kg to 0.9 mg/kg and 8 from 0.9 mg/kg to 1.4 mg/kg Administration schedule: time points not stated Duration of each medication condition: 3 weeks Washout before trial initiation: all were stimulant‐naive Medication‐free period between interventions: 1 week Titration period: a flexible dosage regimen was used after randomisation. Each child began with 5 mg daily, with dosage adjustments made at 2‐ to 3‐day intervals. The optimum dosage was assessed for each child, in the light of clinical response and the occurrence of side effects, to a maximum of 30 mg daily Treatment compliance: compliance with medication was rated as good or very good in 89% |
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Outcomes |
ADHD symptoms
Serious AEs
Non‐serious AEs
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Notes | Sample calculation: no Ethics approval: not stated Comment from trial authors
Key conclusion of trial authors
Comments from review authors
Inclusion of MPH responders only/exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no; all MPH treatment‐naive Any withdrawals due to AEs: yes; 1 in the placebo group Funding source: partially funded by grant from CIBA Ltd., which provided medicine and placebo Email correspondence with trial authors: October 2013. We received from trial authors no supplemental information regarding data. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Children were randomly allocated to receive drug first or placebo first. This was carried out by pharmacy staff, who knew only the name and identifying number of each case |
Allocation concealment (selection bias) | Low risk | Allocation was carried out by pharmacy staff, who knew only the name and identifying number of each case |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Tablets were dispensed to a trial member, who did not know what they contained and handed them to parents |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Psychiatrist supervising treatment also assessed and recorded side effects, physical findings and parents’ general impressions at the end of each treatment; other assessors of outcomes were blinded to the treatment given but also to possible clues arising from physical effects of the drug. Behavioural measures were carried out independently of one another by investigators blind to results of the other tests and to teacher ratings |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were missing for 3 children: 1 child had missing data on the Parental Account of Childhood Symptoms because he had been taken into care, and 2 children had missing data on the CTRS hyperactivity factor because they had been excluded from school. Method of imputation not described Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Unclear risk | No protocol identified |