Objective: Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD.
Design: A randomized, double-blind, placebo-controlled trial.
Setting: University-affiliated tertiary medical center.
Participants: 120 children newly diagnosed with ADHD, meeting DSM-IV criteria.
Intervention: Random assignment to the herbal treatment group (n = 80) or control group (placebo; n = 40); 73 patients in the treatment group (91%) and 19 in the control group (48%) completed the 4-month trial.
Outcome measure: Test of Variables of Attention (TOVA) administered before and after the treatment period; overall score and 4 subscales.
Results: The treatment group showed substantial, statistically significant improvement in the 4 subscales and overall TOVA scores, compared with no improvement in the control group, which persisted in an intention-to-treat analysis.
Conclusions: The well-tolerated CHP demonstrated improved attention, cognition, and impulse control in the intervention group, indicating promise for ADHD treatment in children.