The Efficacy And Adverse Events Of Flupentixol-melitracen Combined With PPI In The Patients Of Epigastric Pain Syndrome: A Meta-analysis

Background:Functional dyspepsia (FD) is defined by the presence of chronic gastroduodenal symptoms in the absence of organicor systemic disease that explains them, and a negative upperendoscopy. Functional dyspepsia (FD) is a highly prevalent and challenging disorder which impacts patients’quality of life and poses a considerable socioeconomic burden.According to the Rome III consensus, FD can be subdivided into PDS (postprandial distress syndrome)and EPS (epigastric pain syndrome).In the clinical practice, PPIs are the initial therapy of choice for EPS, while it often has poor therapeutic effects. Related researches point out that compared with PDS, the proportion of anxiety and depression is more serious among EPS patients. So except the PPIs for the treatment of EPS, we should also focus on the impact of mental psychological factors to the treatment. In recent years, Flupentixol-melitracen began to gradually applied to clinical adjuvant treatment of FD, there are some researches about Flupentixol-melitracen combined with PPI in the treatment in EPS. In order to evaluate the efficacy and adverse events of combination of Flupentixol-melitracen and PPIs, we perform this meta-analysis to provide a more rigorous evidence for evidence-based medicine.Objective:To evaluate the efficacy and adverse events of Flupentixol-melitracen combined with PPI in the patients of EPS.Methods:Randomized controlled trials of Flupentixol-melitracen combined with PPI in the treatment of epigastric pain syndrome were searched in PubMed、Embase、 Web of Science、Google scholor and Cochrane Library、China Academic Literature Full-text Database、Chinese VIP Full-text Database、Wanfang medical Full-text Database to the date of December 31,2015. We evaluate the primary endpoint of effective rate after treatment, and other endpoints include the improvement of anxiety and depression, and the incidence rate of adverse events (AEs) during the treatment and follow-up.Results:There are totally 12 papers included in this research, which are published from 2010 to 2015. As for the quality,10 of them are graded as B, the others are. graded as C. Flupentixol-melitracen combined with PPI could obviously improve the effective rate in the patients of EPS than in the PPI only group (RR=1.31,95% CI[1.23,1.41], P<0.00001), and relieve anxiety and depression (SMD=-0.97,95% CI[-1.22,-0.72]; SMD=-0.71,95% CI[-0.96,-0.46], P<0.00001). But the rate of adverse events is increased (RR=2.00,95% CI[1.13,3.53], P=0.02). The subgroup analysis shows that the effective rate is increased either Flupentixol-melitracen combined with omeprazo-le or esomeprazole (RR=1.33,95% CI[1.21, 1.46]; RR=1.27,95% CI[[1.14,1.42], P<0.0001); The effective rate is increased when treated for 4 weeks (RR=1.23,95% CI[1.05,1.44], P=0.009), when compared with 8 weeks treatment, the effective rate of 4 weeks treatment is lower (RR=0.50,95% CI[0.40,0.62], P<0.00001).Conclusion:Flupentixol-melitracen combined with PPI can improve the effective rate in the patients of EPS significantly and relieve anxiety and depression in these patients. Combined treatments works after 4 weeks treatment, but it is more effective when treated for 8 weeks. Although the rate of adverse events is increased, the related symptoms are mild. This meta-analysis shows that combined using of Flupentixol-melitracen and PPI is effective and safety in the treatment of EPS.