Methods | Cross‐over trial of omega‐6 PUFA versus placebo | |
Participants | Inclusion criteria: children with scores on the Attention Problem subscale of the Revised Behavior Problem Checklist (RBPC) and Inattention subscale of the Conners Teacher questionnaire above the 90th percentile (n = 26). Five additional children from another study diagnosed with DSM III ADD by a child psychiatrist were also included. Exclusion criteria: not stated. Mean age: 8.86 years; gender: 27 boys and 4 girls; loss to follow‐up: 1/31 Baseline IQ 101.07; Conners inattention subscale: 3.08, hyperactivity: 2.80; RBPC attention problem scale: 20.42, motor excess: 6.23 Setting: Auckland, New Zealand |
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Interventions | Cross‐over trial of 4 weeks of omega‐6 PUFA or placebo, 1 week washout and 4 weeks of alternate. Three capsules of PUFA or placebo were to be taken twice daily. Omega‐6 PUFA: Efamol capsules contained 360 mg linoleic acid and 45 mg gamma‐linoleic acid Placebo: 500 mg of liquid paraffin |
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Outcomes | ADHD symptoms Parent rated RBPC subscales: attention; motor excess Teacher rated Conners Questionnaire subscales: inattention; hyperactivity and ADD‐H Comprehensive Teacher Rating Scale (ACTeR) subscales: attention, hyperactivity Behaviour Parent‐rated RBPC subscales: conduct; socialised aggression; anxiety‐withdrawal; psychotic behaviour Teacher‐rated Conners Questionnaire subscales: conduct; tension/anxiety and ACTeR subscales: social skills, oppositional behaviour All scales were measured at 4 weeks |
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Notes | Variances were not reported therefore data could not be included in a meta‐analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The authors stated that the trial was double‐blind and that the intervention and control were given as "indistinguishable capsules" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Capsules "indistinguishable" and parent and teacher‐rated scales used |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | One child lost to follow‐up in the placebo group |
Selective reporting (reporting bias) | Low risk | Data were reported for all outcomes |
Other bias | Unclear risk | It was not clear whether the additional 5 children included in the trial would have met the original inclusion criteria. Baseline characteristics of each group were not reported. The trial was funded by Efamol Research Inc. |