Effectiveness And Safety Of Wuling Capsule For Post Stroke Depression: A Systematic Review

ObjectiveTo systematically review the efficacy and safety of Wuling Capsule for patients with post stroke depression and provide evidence for future clinical research and application.MethodsPub Med(from 1966 to November 2013), The Cochrane Library(Issue 4, 2013), EMBASE(from 1966 to November 2013), CBM(Chinese Biomedicine Database, from 1978 to November 2013), CNKI(China National Knowledge Infrastructure, from 1994 to November 2013), VIP(Chinese Scientific Journals Database, from 1989 to November 2013), and Wanfang Database(from 1998 to November 2013) were electronically searched for randomized controlled trials(RCTs) on Wuling Capsule for patients with depression after stroke. Meanwhile, relevant data were retrieved by hand search and data from pharmaceutical factories were collected. Two reviewers screened citations, extracted data and assessed the methodological quality independently. Then, meta-analysis was performed using Rev Man 5.3 software.Results1. Search Results We initially identified 113 records of which 18 RCTs(nonplacebo-controlled trials) involving 1683 patients were enrolled. There were 3 trials comparing Wuling capsule with no treatment control and 15 trials comparing Wuling capsule plus other antidepressants(Deanxit, Fluoxetine, Sertraline, Paroxetine, Citalopram or Mirtazapine) with the former antidepressants alone. The quality of the included studies were generally moderate.2. The results of Meta analysis(1) The results of meta analysis(17 studies, 1263 patients) showed that HAMD scores decreased significantly in Wuling Capsule used alone or integrated with other antidepressants and in favor of Wuling capsule from onset time to 4 weeks [SMD=-0.87, 95%CI(-1.25,-0.5), P<0.0001], 8 weeks [SMD=-1.22, 95%CI(-1.86,-0.59), P=0.0002], 12 weeks [SMD=-0.62, 95%CI(-1.09,-0.15), P=0.01], overall effect [SMD=-0.9, 95%CI(-1.16,-0.63), P<0.00001];(2) Metaanalysis(12 studies, 991 patients) showed that, the effectiveness rate of the the Wuling capsule group was significantly higher than that of the control group [RR=1.20, 95%CI(1.14,1.27), P<0.00001)];(3) The result of meta analysis(3 studies, 470 patients) showed that there is no difference between the Wuling capsule group and the control group in the incidence of heart palpitations [RR=0.87,95%CI(0.43,1.78), P<0.00001].Conclusion1. Implications for practice Current studies show that Wuling capsule appeared to present certain antipressant effect compared to no treatment control. Patients treated with Wuling Capsule may lead to lower HAMD scores, higher effective rate and less adverse effects. However, due to the limited quantity and quality of the included studies, the effectiveness and safety of Wuling Capsule in the treatment of PSD could not be fully substantiated, further studies that verify the effects of Wuling Capsule for post stroke depression are warranted.2. Implications for research In future research, the standard criteria for diagosising PSD should be used and long-term follow-up for participants is suggested. Based on purpose and hypothesis of the trial, primary and secondary outcome should be defined clearly.