| Objective:Evaluating the clinical efficacy and safety of Shugan Jieyu capsule in the treatment of depression through comprehensive literature searches.Methods:Collecting literature of randomized controlled trials and quasi-randomized controlled trials about Shugan Jieyu capsule to evaluate its treatment of depression systematically; searching Medline (to Feb.2013), The Cochrane Central Register of Controlled Trials(to Feb.2013), VIP database(to Feb.2013), Wanfang database(to Feb.2013),CNKI database(to Feb.2013) by computer in accordance with search strategy developed;manually searching relevant journals and conference proceedings; checking the list of references and relevant reviews;selecting eligible literature according to the inclusion and exclusion criteria and extracting data independently by two reviewers, assessing these papers in the light of the Cochrane Handbook5.1, testing heterogeneity and having meta analysis through Cochrane Revman5.2software and by STATA11.0getting Bias analysis and other related statistics.Results:There are52potentially relevant literatures retrieved. By reading title, abstract and full text of literature31papers are excluded including23duplicate papers, one paper of non-randomized controlled trials, one paper is an animal experiment,one paper of no generally accepted diagnostic indicators,5papers of error outcomes data. Finally21papers of randomized controlled trials including1965patients are involved in the systematic evaluation and the21papers of randomized controlled trials are included in the meta-analysis. All study sites are in China and published in Chinese. The results of Meta-analysis show as follows:1. There is no statistical difference for the second-,four-and six-weeks clinical efficacy of the experimental group compared with the control group.2. There is no statistical difference on the HAMD score between the experimental group and the control group one week later; the experimental group can reduce the HAMD score of patients after the second week [MD=0.82,95%Cl(0.17,1.47)](P=0.01) and after the forth week [MD=1.13,95%Cl(0.51,1.75)](P=0.0003) as well as after the sixth week[MD=1.01,95%Cl(0.42,1.77)](P=0.001).3. Compared with the control group the HAMA score of patients of experimental group doesn’t reduHAMA score between the experimental group and the control group after fortce after the second week[MD=-0.09,95%CI (-0.15,-0.03)](P=0.005); there is no significant difference on h week [MD=2.15,95%CI(-1.26,5.56)](P=0.22) and after sixth week[MD=1.10,95%CI (-2.05,4.25)](P=0.49).4. Between the experimental group and the control group there is no significant difference on the SI score [MD=-0.43,95%CI(-0.90,0.04)](P=0.07) and on the GI score[MD=0.15,95%CI (-0.09,0.39)](P=0.22).5. Compared with the control group, the experimental group can significantly reduce the TCM syndrome score of patients in forth week [MD=4.67,95%CI (4.35,5.18)](<0.00001) and the TCM symptom score in sixth week:[MD=6.29,95%CI (3.93,8.66)](P<0.00001).6. Other outcome:a study comparing Shugan Jieyu capsule with paroxetine on the TCM clinical efficacy for the treatment of depression shows that the significant efficiency and efficiency of experimental group are66.67%and90.00%respectively; the significant efficiency and efficiency of control group was30.00%and66.67%respectively; and the double of significant efficiency of two groups is8.08and P <0.01, the double of two sets of efficiency is4.81which means there is significant difference (P<0.05). One study shows that Shugan Jieyu capsule comparing with paroxetine hydrochloride significantly improves cognitive function and increases its memory quotient (MQ)(P<0.01) of patients with depression. Another study compares the compliance between Shugan Jieyu capsules and Deanxit for treatment of depression, and the results show that there is no any statistically difference in efficacy for the two groups in the second week after treatment(P>0.05) and there is statistically difference in efficacy in the forth and sixth week (P<0.05). Another study comparing the improvement of the SDS score evaluating treatment of depression between sertraline and Shugan Jieyu capsule shows that it’s significantly different in efficacy for the two groups in the first two weeks after treatment(p<0.05)and not significantly different in the forth and sixth week after treatment(p>0.05). A study compares the HAMD score on the treatment of depression between only fluoxetine and Shugan Jieyu capsule combined with fluoxetine after the eighth week and12th week of treatment. The results show it’s statistically significant (p<0.05).7. Compared with the control group, the experimental group can reduce the occurrence of adverse events [RR=0.50,95%CI(0.29,0.85)](P=0.010), and the adverse reactions include dizziness, headache, nausea, loss of appetite, gastrointestinal discomfort, constipation, diarrhea, bloating, dry mouth. It mainly shows the gastrointestinal reactions which often appear at the beginning of treatment, and medication may gradually disappear in a few days without making special treatment and there is also no serious adverse reactions.Conclusions:The systematic appraisal included in the study outcome is the consistency, the published bias is less likely, and Meta analysis prompted Shugan Jieyu capsule can improve the HAMD score, HAMA score, TCM symptom score of patients with depression, and it has slight adverse reactions. But the quality evaluation of the included studies is not pretty high and the sample size is small, which may affect its reliability. |
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