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. 2012 Jul 11;2012(7):CD007986. doi: 10.1002/14651858.CD007986.pub2
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
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
Outcomes ADHD symptoms
Parent and teacher‐rated Conners Rating Scales (revised: long form): inattentive and hyperactive‐impulsive subscales measured at 12 weeks
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.