Objectives:Montessori based activity are supposed to be an effective nonpharmacological intervention in the treatment of agitation in western countries. However, most studies conducted to evaluate the effectiveness of Montessori based activities on agitation in Asian patients were small sample size, as well as inconsistent outcomes, which may limit the reliability of the conclusions. The present pooled analysis, hence, was conducted to evaluate the effectiveness of the activity on agitation related with dementia in Asian patients with dementia.Design:Prospective randomized clinical studies were included, of which available data was extracted. Outcomes of physical aggressive behaviors, physical nonaggressive behaviors, and verbal aggressive behaviors were pooled for the analysis by weighted mean differences.Data sources:Medline, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), WanFang, and China Science and Technology Journal Database (VIP)Eligibility criteria:Prospective, randomized, controlled clinical studies, conducted to evaluate the effectiveness of the activity on agitation related with dementia in Asian patients with dementia.Data extraction and synthesis:Available data including baseline characteristics and interested outcomes from the included literature were extracted independently by 2 investigators. Measuring scales including CMAI and NOSIE were adopted for the efficacy comparison between Montessori based activity and standard activity. Weighted mean difference was used for the pooled analysis.Results:A total of 460 participants were included in the present meta-analysis. The pooled mean difference agitation for Montessori based activity was –3.86 (95% CI: –7.38 to –0.34, P = 0.03) comparing to standard activity. The pooled mean differences for physical aggressive behaviors, physical nonaggressive behaviors, and verbal aggressive behaviors in Montessori based activity group were –0.82 (95% CI: –1.10 to –0.55; P < 0.00001), –0.81 (95% CI: –1.68 to 0.55; P = 0.07), and 0.38 (95% CI: –0.92 to 1.68; P = 0.57).Conclusions:Montessori based activities may reduce the frequency of agitation, especially in physical aggressive behaviors comparing to standard activities in Asian patients with dementia. However, the effectiveness of Montessori based activities on reduction of subcategorized agitated behaviors including physical nonaggressive behaviors, and verbal aggressive behaviors may not be reliable as physical aggressive behaviors.