Methods | Parallel trial of omega‐3 PUFA versus a dietary supplement | |
Participants | Inclusion criteria: children diagnosed with DSM IV ADHD‐combined type by a physician or psychologist Exclusion criteria: serious pre‐existing medical or psychological condition or stimulant medication other than Ritalin Mean age: 8.4 years, gender (at follow‐up): 44 boys and 7 girls, loss to follow‐up: 9/60 Baseline scores: not stated Setting: US |
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Interventions | This was the second of 2 12‐week trials. In this second trial an omega‐3 PUFA in combination with a dietary supplement (given to the group who received a single dietary supplement in trial 1) was compared to a double dose of the dietary supplement (placebo group in trial 1). Both were given twice a day for 12 weeks. Omega‐3 PUFA Flax seed (rich in omega‐3 PUFA) 100 mg plus single dietary supplement: Ginkgo biloba 10 mg, Melissa officialis 200 mg, grapine 30 mg, dimethylaminoethanol 35 mg, l‐glutamine 100 mg Double dietary supplement: Ginkgo biloba 20 mg, Melissa officialis 400 mg, grapine 60 mg, dimethylaminoethanol 70 mg, l‐glutamine 200mg |
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Outcomes | ADHD symptoms Parent and teacher‐rated Conners Rating Scales (revised: long form): inattentive and hyperactive‐impulsive subscales measured at 12 weeks |
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Notes | Participant numbers were not reported | |
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 | Parents and teachers did not know what the participant was allocated until the trial was completed. Only the trial physician had access to this information. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Data collectors did not know what the participants were allocated until the trial was completed |
Incomplete outcome data (attrition bias) All outcomes | High risk | 9 children were lost to follow‐up but it is not clear what sample numbers were used in the analysis |
Selective reporting (reporting bias) | Low risk | All outcomes appear to have been reported |
Other bias | Unclear risk | Baseline characteristics of each group were not reported. The PUFA group had received an additional 12 weeks of dietary supplement before this second trial was started. |