An open-label study to elucidate the effects of standardized Bacopa monnieri extract in the management of symptoms of attention-deficit hyperactivity disorder in children.

CONTEXT

Attention-deficit hyperactivity disorder (ADHD) is a clinically heterogeneous disorder of inattention, hyperactivity, and impulsivity or difficulty in controlling behavior. Psychostimulant medications remain the mainline treatment for children with ADHD; however, the average response rate to these medications is 70%, and up to 30% of children do not respond to these medications or are unable to tolerate such potential adverse effects as nausea, insomnia, and weight loss.

OBJECTIVE

The study investigated the effectiveness of standardized Bacopa monnieri extract (SBME) in ameliorating the severity of the symptoms of ADHD in children.

DESIGN

The clinical trial was conducted as an open-label study.

SETTING

The study was conducted at the Center for Research in Mental Retardation (CREMERE) in Mumbai, India, from 2008 to 2010.

PARTICIPANTS

Thirty-one children were participants in the trial. They were 6-12 y of age, with an age of onset of ADHD before 7 y of age, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD.

INTERVENTION

The children received SBME at a dose of 225 mg/d for a period of 6 mo. The specific SBME used in the study was BacoMind (M/s Natural Remedies, Bangalore, India).

OUTCOME MEASURES

Subsequent to the screening of participants, the research team administered the Parent Rating Scale to assess the ADHD symptom scores at baseline, and the team administered it again at the end of the 6 mo of treatment.

RESULTS

SBME significantly reduced the subtests scores of ADHD symptoms, except for social problems. The symptom scores for restlessness were reduced in 93% of children, whereas improvement in self-control was observed in 89% of the children. The attention-deficit symptoms were reduced in 85% of children. Similarly, symptom scores for learning problems, impulsivity, and psychiatric problems were reduced for 78%, 67%, and 52% of children, respectively. It was observed that 74% of the children exhibited up to a 20% reduction, while 26% of children showed between a 21% and a 50% reduction in the total subtests scores.

CONCLUSION

Standardized extract of B monnieri was found to be effective in alleviating the symptoms of ADHD and was well-tolerated by the children.