Methods | Cross‐over trial of omega‐6 PUFA, dexamphetamine and placebo | |
Participants | Inclusion criteria: children of normal intelligence aged between 6 and 12 years with a DSM III diagnosis of ADHD by a child psychiatrist, a score of at least 18 on the Conners hyperactivity index and a score of at least 24 on the first 6 items of David's Hyperkinetic Rating scale Median age: 9 years, gender: all 18 were boys, loss to follow‐up: unclear, 18 participants completed Exclusion criteria: psychoactive drug use in the preceding week or history of seizures Baseline scores: not stated Setting: Ohio, US |
|
Interventions | Cross‐over trial of omega‐6 PUFA, d‐amphetamine and placebo for 1 month each. All were given as 4 capsules twice daily for 1 month. Omega‐6 PUFA Efamol® capsules: contained 500 mg evening primrose oil which provides 350 mg linoleic acid and 40 mg gamma linolenic acid, 13 IU vitamin E as preservative Dextroamphetamine: a 10 or 15 mg time‐released capsule Placebo: paraffin oil |
|
Outcomes | ADHD symptoms Teacher‐rated Conners total score and hyperactivity index at 2 and 4 weeks |
|
Notes | ||
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 | Unclear risk | Placebo was described as matched |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Behavioural ratings were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated |
Selective reporting (reporting bias) | High risk | Unclear what other outcomes were used. A parent rating of the Conners scale appears to have been used but was not reported because it was "noncontributory". |
Other bias | Unclear risk | Baseline characteristics of each group were not reported. Results for a Psychiatrists' Global Rating were reported but this scale was not described. Study funded by Efamol Research Institute. |