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Original Article
Efficacy of psychotropic drugs in functional dyspepsia: systematic review and meta-analysis
  1. Alexander C Ford1,2,
  2. Pavit Luthra1,
  3. Jan Tack3,
  4. Guy E Boeckxstaens3,
  5. Paul Moayyedi4,
  6. Nicholas J Talley5
  1. 1Leeds Gastroenterology Institute, St. James's University Hospital, Leeds, UK
  2. 2Leeds Institute of Biomedical and Clinical Sciences, University of Leeds, Leeds, UK
  3. 3Translational Research Center for Gastrointestinal Disorders (TARGID), University Hospital Leuven, Catholic University Leuven, Leuven, Belgium
  4. 4Gastroenterology Division, McMaster University, Health Sciences Center, Hamilton, Ontario, Canada
  5. 5Faculty of Health, University of Newcastle, Callaghan, New South Wales, Australia
  1. Correspondence to Dr Alex Ford, Leeds Gastroenterology Institute, St. James's University Hospital, Room 125, 4th Floor, Bexley Wing, Beckett Street, Leeds LS9 7TF, UK; alexf12399{at}


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. We performed a systematic review and meta-analysis of randomised controlled trials (RCTs).

Design MEDLINE, EMBASE, EMBASE Classic, PsychINFO and the Cochrane Controlled Trials Register were searched (up to June 2015) for RCTs recruiting adults with FD comparing psychotropic drugs with placebo. We contacted authors directly to maximise trial eligibility and minimise risk of bias for studies. Dichotomous symptom data were pooled to obtain relative risk (RR) of remaining symptomatic after therapy, with 95% CIs.

Results The search identified 2795 citations; 13 RCTs (1241 patients) were eligible. Ten trials were at low risk of bias. The RR of FD symptoms not improving with psychotropic drugs versus placebo was 0.78 (95% CI 0.68 to 0.91) (number needed to treat=6; 95% CI 4 to 16). However, benefit was limited to antipsychotics and tricyclic antidepressants. When only studies that excluded individuals with coexistent mood disorder were considered, there was no benefit. Total numbers of adverse events and adverse events leading to withdrawal were significantly more common, with a number needed to harm of 21 for both.

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 cannot be made. More data from high quality RCTs are required to support their use in the treatment of FD.


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