Raz 2009a.
Study characteristics | ||
Methods |
Design: parallel trial Comparison: omega‐3/omega‐6 PUFA vs placebo |
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Participants |
Inclusion criteria: 1. children aged 7 to 13 years; 2. with a written diagnosis of ADHD from a child psychiatrist, neurologist, paediatrician, or clinical psychologist Exclusion criteria: 1. use of ADHD medication in the past month; 2. use of EFA supplements in the past 3 months; 3. presence of pervasive developmental disorder, seizure disorder, schizophrenia, major depression, or bipolar disorder Number of participants: 63 Mean age: 10.5 years Gender: 38 boys and 25 girls at follow‐up ADHD subtypes: combined = 44; inattentive = 29; hyperactive = 27 Using ADHD drugs at baseline: 0% Baseline scores: parent‐rated DSM‐IV attention subscale: PUFA = 4.05, placebo = 4.43; parent‐rated DSM‐IV hyperactivity‐impulsivity subscale: PUFA = 3.29, placebo = 3.14; teacher‐rated Conners ADHD: PUFA = 3.85, placebo = 3.71 Setting: Bar‐Ilan University, Tel‐Hashomer Israel and Hillel‐Yaffe Medical Center, Hadera, Israel, 2007 Funding: not stated |
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Interventions |
Intervention (32 participants): omega‐3/omega‐6 PUFA for 7 weeks; an oral soft gel capsule containing 240 mg of linoleic acid, 60 mg of alpha‐linolenic acid, 95 mg of mineral oil, and 5 mg of alpha‐tocopherol, given twice daily Control (31 participants): placebo for 7 weeks; 500 mg of ascorbic acid as an oral tablet twice daily |
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Outcomes |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: The method of randomisation was not described except that participants were matched for gender and age and then randomised within each pair. |
Allocation concealment (selection bias) | Unclear risk | Comment: assignment of treatments was based on study number |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: The authors described the trial as double‐blind. However, active and control interventions were different i.e. soft gel capsules and tablets respectively. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: The researchers, teachers, parents and children were all directly involved in data collection, and all were blinded to treatment allocation until the end of the study. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: data reported for 63/78 enrolled participants who remained in the trial at 7 weeks, loss to follow‐up: 15/78 |
Selective reporting (reporting bias) | High risk | Comment: The authors stated that the Conners subscales were "found to be unreliable" (p169), but not how this was demonstrated. These data were not reported. |
Other bias | Low risk | Comment: There were no statistically significant differences between groups in stimulant use, co‐morbidities, inattention, hyperactivity/impulsivity, EFA deficiency score or blood biochemistry. |