Hongru Wang, Chunping An
In conclusion, this study preliminarily confirmed that Zaoren Anshen capsule may have significant potential as an adjuvant treatment for schizophrenia, and it showed good safety and the potential to improve symptoms, cognitive function, and quality of life. However, due to the methodological limitations of the included studies, this conclusion is uncertain, and higher-quality future studies are needed to provide conclusive evidence.
OBJECTIVE: To evaluate the efficacy and safety of Zaoren Anshen capsule in the adjuvant treatment of schizophrenia.
METHODS: From the beginning of the study until August 2025, we conducted a comprehensive search of Chinese and English databases, including China National Knowledge Infrastructure (CNKI), VIP, Wanfang, CBM, Chinese Medical Association Journal Database, PubMed, Cochrane Library, Web of Science, and Embase, to identify relevant randomized controlled trials (RCTs). Literature screening, data extraction, and quality assessment were carried out in accordance with established criteria. The primary outcome was a change in PANSS total and subscale scores. Secondary outcomes included improvements in MoCA and GQOLI-74 scores, as well as the overall clinical response rate and safety protocols. Meta-analysis was performed using RevMan 5.4.
RESULTS: There were seven RCTs with a total of 608 patients. A meta-analysis revealed that the combined treatment with Zaoren Anshen capsules could significantly lower the PANSS total score [MD = -7.80, 95% CI(-9.74, -5.85), p < 0.00001] and the dimension scores (positive, negative, and general pathology) (p < 0.001) when compared to the conventional treatment. It significantly enhanced the clinical overall effective rate [RR ＝ 1.24, 95% CI (1.14, 1.35), p < 0.00001], MoCA score [MD = 4.06, 95% CI (3.44,4.68), p < 0.00001] and GQOLI-74 score [MD = 9.40, 95% CI (6.74, 12.05), p < 0.00001]. There was no significant difference in the occurrence of adverse responses between the two groups [RR ＝ 0.90, 95% CI (0.38, 2.13), p = 0.81].
CONCLUSION: In conclusion, this study preliminarily confirmed that Zaoren Anshen capsule may have significant potential as an adjuvant treatment for schizophrenia, and it showed good safety and the potential to improve symptoms, cognitive function, and quality of life. However, due to the methodological limitations of the included studies, this conclusion is uncertain, and higher-quality future studies are needed to provide conclusive evidence.