BackgroundHyperprolactinaemia is a common antipsychotic (AP)-induced adverse effect, particularly in female patients.AimsThis meta-analysis examined the efficacy and safety of adjunctive aripiprazole in preventing AP-related hyperprolactinaemia in patients with first-episode schizophrenia.MethodsPubMed, PsycINFO, EMBASE, Cochrane Library, WanFang and China Journal Net databases were searched to identify eligible randomised controlled trials (RCTs). Primary outcomes were the reductions of serum prolactin level and prolactin-related symptoms. Data were independently extracted by two reviewers and analysed using RevMan (V.5.3). Weighted/standardised mean differences (WMDs/SMDs)±95% CIs were reported.ResultsIn the five RCTs (n=400), the adjunctive aripiprazole (n=197) and the control groups (n=203) with a mean of 11.2 weeks of treatment duration were compared. The aripiprazole group had a significantly lower endpoint serum prolactin level in all patients (five RCTs, n=385; WMD: −50.43 ng/mL (95% CI: −75.05 to −25.81), p<0.00001; I²=99%), female patients (two RCTs, n=186; WMD: −22.58 ng/mL (95% CI: −25.67 to −19.49), p<0.00001; I²=0%) and male patients (two RCTs, n=127; WMD: −68.80 ng/mL (95% CI: −100.11 to −37.49), p<0.0001). In the sensitivity analysis for the endpoint serum prolactin level in all patients, the findings remained significant (p<0.00001; I²=96%). The aripiprazole group was superior to the control group in improving negative symptoms as assessed by the Positive and Negative Syndrome Scale (three RCTs, n=213; SMD: −0.51 (95% CI: −0.79 to −0.24), p=0.0002; I²=0%). Adverse effects and discontinuation rates were similar between the two groups.ConclusionsAdjunctive aripiprazole appears to be associated with reduced AP-induced hyperprolactinaemia and improved prolactin-related symptoms in first-episode schizophrenia. Further studies with large sample sizes are needed to confirm these findings.