A Cochrane review included 5 RCTs with a total of 437 patients with dementia. All studies involved institutionalised patients with Alzheimer's disease or vascular dementia having agitation and aggression. The average age ranged between 80.4 years and 85.0 years. The studies varied in the type of valproic acid preparation used, the treatment time varied between 6 and 14 weeks. Meta-analysis of 3 studies (n=223) showed no improvement in agitation among valproate treated patients. An examination of individual studies showed adverse effects such as falls, gastrointestinal disorders, infections and decreased platelet counts to be significantly more frequent among valproate patients.
Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment, high drop-out rate in the largest trial), inconsistency (heterogeneity in patients, interventions and outcomes) and imprecise results (small studies).