Gow 2012.
Study characteristics | ||
Methods |
Design: parallel trial Comparison: omega‐3 PUFA vs placebo |
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Participants |
Inclusion criteria: 1. male adolescents; 2. aged 12 to 17 years; 3. with Conners Parent and Teachers Rating scores of 65 or more; 4. meeting DSM‐IV criteria for ADHD (using Children’s Interview of Psychiatric Symptoms (ChIPS)) Exclusion criteria: 1. IQ of 70 or less; 2. diagnosis of autism; 3. learning disorders; 4. serious mental health conditions; 5. taken omega‐3 supplements in the previous 6 months; 6. history of diabetes or other metabolic disorder influencing fatty acid metabolism; 7. not living in a family home or residential school; 8. under special diets; 9. not in school during the intervention; 10. serious or chronic disease; 11. low coagulation function; 12. abnormal blood tests; 13. using medications: alpha tocopherol, selected anticoagulants (aspirin, warfarin, heparin), cyclosporine, clopidogrel, etretinate and topical steroids, cholesterol‐lowering medications (atorvastatin, lovastatin, and simvastatin), NSAIDs, dalteparin, dipyrdamole, enoxaparin, ticlopedine; 14. known allergy for fish product derivatives, vitamin E derivatives, and gelatine Number of participants: 29 Mean age: not stated Gender: 29 boys and 0 girls ADHD subtypes: not stated Using ADHD drugs at baseline: 21 were medication naïve Baseline scores: SDQ hyperactivity/concentration (ADHD) scores: 1.41 Setting: special schools in London and Kent, UK, 2004 to 2008 Funding: sponsored by Vifor Pharma, for approving a grant to King’s College London; also part funding and support from the Mother and Child and Letten Foundations |
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Interventions |
Intervention (no. of participants not stated): omega‐3 PUFA for 12 weeks; Equazen eye q (dose of active: x 6 daily; each containing 400 mg of fish oil and 100 mg of evening primrose oil with the following active ingredients: EPA (93 mg), DHA (29 mg), gamma‐linolenic acid (10 mg), and vitamin E (1.8 mg)). The 7 participants on medication had a washout of 48 hours. Control (no. of participants not stated): placebo for 12 weeks; identical placebo containing medium‐chain triglycerides |
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Outcomes |
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Notes | Outcome data were not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: Randomisation into groups was carried out by the Mental Health & Neuroscience Clinical Trials Unit based at the Institute of Psychiatry, KCL. |
Allocation concealment (selection bias) | Unclear risk | Comment: not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: not stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not stated |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: number of participants lost to follow up was unclear |
Selective reporting (reporting bias) | Unclear risk | Comment: no outcome data reported |
Other bias | High risk | Comment: Sponsored in part by sponsored by Vifor Pharma, which produced PUFA supplements. |