| Background Schizophrenia, as a common chronic mental disorder, although second-generation antipsychotic drugs have shown significant efficacy in alleviating positive symptoms, the widespread cognitive dysfunction among patients remains a challenge in clinical treatment. Traditional Chinese medicine has unique advantages in the treatment of mental disorders. However, the current clinical research on the combination of Wendan Decoction and antipsychotic drugs for schizophrenia varies in quality, and there is a lack of systematic evaluations on its cognitive function improvement effect and safety. Objective To systematically evaluate the effect of modified Wendan Decoction combined with antipsychotic drugs on the symptoms of schizophrenia and the improvement of patients' cognitive functions, providing evidence-based support for the clinical application of Wendan Decoction. Methods Literature searches were conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP Information, China Biomedical Literature Service System, China Clinical Trial Registry, PubMed, Web of Science, the Cochrane Library, and Embase to collect randomized controlled trials (RCTs) of modified Wendan Decoction combined with antipsychotic drugs for the treatment of schizophrenia. The search period was from the establishment of the databases to March 19, 2026. The quality of the included literature was evaluated using the Cochrane Interventions Manual 6.3. Meta-analysis was performed using RevMan 5.3 software. Results A total of 11 studies were included, involving 1 130 patients with schizophrenia. Among them, 566 cases were in the study group (receiving modified Wendan Decoction combined with antipsychotic drugs), and 564 cases were in the control group (receiving antipsychotic drugs only). Meta-analysis showed that the effective rate of improvement in psychotic symptoms in the study group was higher than that in the control group (RR=1.21，95% CI: 1.15–1.27, P＜0.01). In terms of psychotic symptoms, the Positive and Negative Symptom Scale (PANSS) positive symptom score (MD=-3.69, 95% CI: -5.87~-1.51, P<0.01) and PANSS total score (MD=-9.20, 95% CI: -11.80–-6.59, P<0.01) of the study group were lower than those of the control group. In cognitive function assessments, the Mini-Mental State Examination (MMSE) score (MD=2.51, 95% CI: 1.33–3.68, P<0.01) and the LOTCA score (MD=11.85, 95% CI: 2.55–21.15, P=0.010) of the study group were higher than those of the control group, and the Wisconsin Card Sorting Test (WCST) score was lower than that of the control group (MD=-9.34, 95% CI: -12.57–-6.11, P<0.01). The levels of brain-derived neurotrophic factor (BDNF) (SMD=1.34, 95% CI: 0.63~2.05, P<0.01) and nerve growth factor (NGF) (MD=6.94, 95% CI: 4.00–9.89, P<0.01) of the study group were higher than those of the control group. In terms of safety, there was no statistically significant difference in the incidence of adverse reactions between the two groups (RR=0.60, 95% CI: 0.31–1.18, P=0.14). Conclusion The modified Wendan Decoction combined with antipsychotic drugs may be more effective in improving the positive symptoms of schizophrenia and the cognitive function of patients than using antipsychotic drugs alone, and it also has a good neurotrophic regulatory effect. [Funded by Postgraduate Education Reform and Quality Improvement Project of Henan Province (number, YJS2023AL060); Key Scientific Research Projects of Colleges and Universities in Henan Province of China (number, 24B320018, 25B310004)]
【Keywords】 Wendan Decoction; Antipsychotic drugs; Schizophrenia; Cognitive function; Systematic review |