The effectiveness and safety of Chinese herbal Jieyu Anshen Decoction monotherapy or in combination with Western medicine for mental disorders: A systematic review and meta-analysis of randomized controlled trials

Background: Mental disorders are a major global health challenge. While Western medicine (WM) is the primary treatment, its limitations create a need for complementary and alternative therapies. Objective: Evaluate the effectiveness and safety of Chinese herbal medicine Jieyu Anshen Decoction (JYASD) in treating mental disorders, both as monotherapy and in combination with WM. Methods: Eight databases were searched from their inception to October 2024. Randomized controlled trials (RCTs) on JYASD for mental disorders were included. Meta-analysis was performed, and Risk of bias and evidence quality were assessed. Results: A total of 95 RCTs involving 8188 participants were included, comparing JYASD with 23 types of WM across four categories of mental disorders. For adjuvant therapy, JYASD combined with paroxetine showed superior effectiveness in treating depressive disorder (RR = 1.18, 95 % CI: 1.13–1.23) and anxiety disorders (RR = 1.30, 95 % CI: 1.17–1.44), with significant improvements in HAMD and HAMA scores compared with WM monotherapy. For schizophrenia, JYASD combined with aripiprazole showed positive effects compared with WM monotherapy (RR = 1.21, 95 % CI: 1.11–1.31). For monotherapy, JYASD was as effective as paroxetine and more than fluoxetine for depressive disorder, while showing significant advantage over estazolam for sleep disorders (RR = 1.15, 95 % CI: 1.07–1.23). Both adjuvant therapy and JYASD alone had significantly fewer adverse events than WM alone, especially with paroxetine (RR = 0.13, 95 % CI: 0.05–0.33). Conclusion: JYASD shows promising therapeutic value in treating mental disorders, both as monotherapy and adjuvant therapy, with favorable safety profiles and stable therapeutic effects.