The Efficacy Of Tandospirone On Functional Dyspepsia Patients With Anxiety And Related Serum Inflammatory Cytokine Changes

OBJECTIVE:To investigate the clinical efficacy and safety of tandospirone in patients with functional dyspepsia(FD)with anxiety,and to explore its possible mechanism underlying.METHODS:One-hundred cases of FD patients with anxiety were randomly divided into tandospirone group(n=53)and placebo group(n=47),plus 100 healthy volunteers were recruited as control.Before and after treatment,serum of FD patients were collected for detecting IL-6,IL-10 and TNF-a levels.Besides,blood samples of volunteers were collected and measured as control.Meanwhile,gastrointestinal symptom score(GIS)[1]and Hamilton Anxiety Scale(HAMA)[2]were performed in all FD patients.All side effects were recorded during this trial.RESULTS:After treatment,the GIS scores of both groups were significantly lower than those before treatment,while patients in tandospirone group presented more obviously GIS scores changes than placebo group;eight weeks of treatment significantly decreased the HAMA scores of both groups,and tandospirone group showed much greater amelioration rate than placebo group;FD patients showed higher IL-6 but lower IL-10 levels than healthy volunteers,while tandospirone treatment significantly decreased IL-6 and enhanced IL-10 expressions;Both groups exhibited slight adverse reactions after the treatment of tandospirone or placebo.CONCLUSION:Tandospirone effectively improved gastrointestinal symptoms and anxiety status in FD patients with similar side effects as placebo treatment,which might due to the amelioration of inflammatory cytokine levels.