ABSTRACT
INTRODUCTION: In China, Wuling capsule, a traditional Chinese medicine consisting of Wuling mycelia of Xylaria nigripes (Kl.) Sacc (a rare type of fungus), is used to treat major depressive disorders. A meta-analysis of randomised controlled trials was performed to compare the efficacy and safety of Wuling capsule alone with Wuling capsule-antidepressant combination in the treatment of major depressive disorders. METHODS: Two assessors independently selected studies, extracted data, and conducted quality assessment and data synthesis. Standard mean difference, risk ratio (RR) ± 95% confidence interval (CI), the number needed to treat, and the number needed to harm were analysed. RESULTS: A total of 12 randomised controlled trials (880 patients; mean age ± standard deviation, 39.7 ± 12.5 years; male patients, 41%) were identified, including 4 trials with Wuling capsule alone (n = 340) and 8 with Wuling capsule-antidepressant (sertraline, mianserin, mirtazapine, and paroxetine) combination (n = 540). The mean length of trial was 5.7 ± 1.3 weeks. Meta-analysis of symptomatic improvement at last-observation endpoint and study-defined response and remission revealed no significant differences between the Wuling capsule alone and antidepressant monotherapy. The Wuling capsule-antidepressant cotreatment was superior to antidepressant monotherapy in symptomatic improvement at last-observation endpoint (standard mean difference: -0.46, p = 0.001) as well as study-defined response (68.4% vs. 56.0%, RR = 1.23; p = 0.03) and remission (46.5% vs. 34.5%, RR = 1.35; p = 0.05). Wuling capsule was associated with fewer adverse drug reactions than antidepressant monotherapy. CONCLUSIONS: Adjunctive Wuling capsule may augment the effects of antidepressants and may be associated with fewer adverse drug reactions. More large-scale and rigorously designed randomised controlled trials with large sample size are warranted to clarify the effectiveness of Wuling capsule for major depressive disorders.
