Multicenter clinical observation on the effect and safety of Xiaoerzhili syrup treatment for attention deficit/hyperactivity disorder in children

Abstract

Objective To observe and evaluate the clinical efficacy and safety of Xiaoerzhili syrup in attention deficit/hyperactivity disorder(ADHD) in children. Methods This study was performed by a multicenter self-controlled clinical observation trial.A total of 1 833 children with ADHD selected from 18 clinical centers from June 2013 to December 2015 were treated by Xiaoerzhili syrup for 6 months, and the clinical efficacy and safety were evaluated.Chinese Version of ADHD Rating Scale-Ⅳ-Parent(ADHDRS-Ⅳ-P) and Clinical Global Impression (CGI) were used to evaluate the clinical efficacy, and the registration form of side reaction and the questionnaire of drug safety grade were used to assess the safety. Results Compared with the scores before treatment, the total scores of ADHDRS-Ⅳ-P, attention deficit subscale scores and hyperactivity impulsivity subscale scores decreased with statistically significant differences after treatment with Xiaoerzhili syrup in the total ADHD group, male ADHD group, female ADHD group, mild ADHD group, moderate ADHD group and severe ADHD group(all P 0.05). According to the results of CGI- I, the proportion of improved obviously and above were 80.98% (1 379 cases), 79.95% (1 089 cases) and 85.05% (290 cases), in the total population group, male group and female group, respectively.The side effects of drugs were found in six male cases.After treatment, safety problems were not found in the analysis of the safety evaluation. Conclusion Xiaoerzhili syrup treatment is effective in children with ADHD treatment, and security problems are not found. Key words: Attention deficit/hyperactivity disorder; Xiaoerzhili syrup; Efficacy; Safety; Child