However , benefit was limited to antipsychotics and tricyclic antidepressants .
Conclusions Psychotropic drugs may be an effective treatment for FD , but the effect appears to be limited to antipsychotics and tricyclic antidepressants with fewer trials for other agents , meaning that firm conclusions for efficacy can not be made .
Objective Functional dyspepsia ( FD ) is a chronic gastroduodenal disorder .
Individuals with FD demonstrate visceral hypersensitivity , abnormal central pain processing , and low mood , but it is unclear whether psychotropic drugs are an effective treatment for the condition .
Treatment of functional dyspepsia with sertraline: a double-blind randomized placebo-controlled pilot study.
AIM To evaluate sertraline , a selective serotonin reuptake inhibitor in the treatment of patients with functional dyspepsia . METHODS Consecutive tertiary hospital patients with a clinical diagnosis of functional dyspepsia ( FD ) according to the Rome II criteria with a Hong Kong dyspepsia index ( HKDI ) of greater than 16 were recruited . Patients commenced enrolment prior to the inception of the Rome III criteria for functional dyspepsia . All patients were ethnic Chinese , had a normal upper endoscopy and were Helicobacter pylori negative prior to enrolment . Study patients were r and omized to receive sertraline 50 mg or placebo daily for 8 wk . HKDI symptom scores , quality of life , hospital anxiety and depression ( HAD ) scale and global symptom relief were evaluated before , during and after treatment . Adverse effects were monitored during and after treatment . RESULTS A total of 193 patients were r and omized in the intention to treat ( ITT ) , and 150 patients were included in the per protocol ( PP ) analysis . In both the ITT and PP , there was no difference in the primary outcome of global dyspepsia symptoms between the sertraline and placebo groups at week 8 . In the ITT analysis , 98 and 95 patients were r and omized to the sertraline and placebo groups respectively . A total of 43 patients withdrew from the study ( 22.3 % ) by week 8 , with 23 of the 24 drop-outs in the sertraline group occurring prior to week 4 ( 95.8 % ) . In contrast , in the placebo arm , 11 of 19 patients dropped out by week 4 ( 57.9 % ) . Utilizing the last response carried forward to account for the drop-outs , there were no differences between the sertraline and placebo groups at baseline in terms of the HKDI , HKDI 26.08 ± 6.19 vs 26.70 ± 5.89 , P = 0.433 ; and at week 8 , HKDI 22.41 ± 6.36 vs 23.25 ± 7.30 , P = 0.352 respectively . In the PP analysis , 74 and 76 patients were r and omized to the sertraline and placebo groups respectively . At baseline , there were no statistically significant differences between the sertraline and placebo groups , HKDI 25.83 ± 6.313 vs 27.19 ± 5.929 respectively , P = 0.233 ; however by week 8 , patients in the sertraline group demonstrated a statistically significant difference in their Hong Kong Dyspepsia Index compared to placebo , HKDI 20.53 ± 6.917 vs 23.34 ± 7.199 , P = 0.02 , respectively ) . There was also no statistically significant difference in overall quality of life measures or the HAD scale related to treatment in either the ITT or PP analysis at week 8 . CONCLUSION This pilot study , the first to examine sertraline , a selective serotonin reuptake inhibitor , for the management of FD , did not find that it was superior to placebo
However , benefit was limited to antipsychotics and tricyclic antidepressants .
Conclusions Psychotropic drugs may be an effective treatment for FD , but the effect appears to be limited to antipsychotics and tricyclic antidepressants with fewer trials for other agents , meaning that firm conclusions for efficacy can not be made .
Objective Functional dyspepsia ( FD ) is a chronic gastroduodenal disorder .
Individuals with FD demonstrate visceral hypersensitivity , abnormal central pain processing , and low mood , but it is unclear whether psychotropic drugs are an effective treatment for the condition .