Methods | Parallel trial of omega‐3 PUFA versus placebo | |
Participants | Inclusion criteria: children aged between 7 and 12 years with a diagnosis of ADHD combined type meeting DSM IV criteria, inclusive of any neuropsychiatric comorbidity, and had been evaluated for pharmacological treatment Exclusion criteria: mental retardation (IQ < 70), autism, major depression, epileptic seizure during the preceding 2 years, other neurological or endocrine disorders, fish allergy, severely impaired hearing or vision, severe sleeping disorder, psychotic symptoms or ongoing psychoactive, anticonvulsant or stimulant medication. If the child had taken a PUFA, a washout period of 10 weeks was required. Age: 7 to 12 years, gender: not stated, loss to follow‐up: 17/109 Baseline parent‐rated Conners score: placebo 46.0; PUFA 51.0; teacher‐rated: placebo 43.5, PUFA 49.7 Setting: 8 Child and Adolescent Psychiatric and Paediatric clinics, Sweden |
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Interventions | Omega‐3 PUFA (PlusEPA® Minami Nutrition, Belgium): 1 capsule daily containing 500 mg eicosapentaenoic acid (EPA), 2.7 mg docosahexaenoic acid (DHA), 10 mg vitamin E for 15 weeks. All took the supplement for at least 70 days. Placebo: 1 placebo capsule (rape seed oil and medium chain triglycerides) daily for 15 weeks |
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Outcomes | ADHD symptoms Parent and Teacher Conners Rating Scale total, inattentive and hyperactive‐impulsive subscales Behaviour Parent and Teacher Conners Rating Scale oppositionality subscales Side effects: nausea, diarrhoea, nose bleed All scales measured at 15 weeks |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were assigned a study number and randomised in blocks of 4 according to a computer‐generated code |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo and PUFA were in "identical" capsules |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Capsules "identical" and parent and teacher‐rated scales used |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The authors reported that ITT analysis was done on 92 participants but this did not include "17 drop‐outs" |
Selective reporting (reporting bias) | Low risk | All outcomes appear to have been reported |
Other bias | Unclear risk | Minami Nutrition sponsored the study |