AIM To explore whether clinician-patient communicationaffects adherence to psychoactive drugs infunctional dyspepsia (FD) patients with psychologicalsymptoms.METHODS: A total of 262 FD patients with psychologicalsymptoms were randomly assigned tofour groups. The patients in Groups 1-3 were givenflupentixol-melitracen (FM) plus omeprazole treatment.Those in Group 1 received explanations of both thepsychological and gastrointestinal (GI) mechanisms ofthe generation of FD symptoms and the effects of FM.In Group 2, only the psychological mechanisms wereemphasized. The patients in Group 3 were not given anexplanation for the prescription of FM. Those in Group4 were given omeprazole alone. The primary endpointsof this study were compliance rate and complianceindex to FM in Groups 1-3. Survival analyses were alsoconducted. The secondary end points were dyspepsiaand psychological symptom improvement in Groups1-4. The correlations between the compliance indicesand the reductions in dyspepsia and psychologicalsymptom scores were also evaluated in Groups 1-3.RESULTS: After 8 wk of treatment, the compliance rateswere 67.7% in Group 1, 42.4% in Group 2 and 47.7%in Group 3 (Group 1 vs Group 2, P = 0.006; Group 1 vsGroup 3, P = 0.033). The compliance index (Group 1vs Group 2, P = 0.002; Group 1 vs Group 3, P = 0.024)with the FM regimen was significantly higher in Group 1than in Groups 2 and 3. The survival analysis revealedthat the patients in Group 1 exhibited a significantly higher compliance rate than Groups 2 and 3 (Group 1vs Group 2, P = 0.002; Group 1 vs Group 3, P = 0.018).The improvement in dyspepsia (Group 1 vs Group 2, P 〈0.05; Group 1 vs Group 3, P 〈 0.05; Group 1 vs Group4, P 〈 0.01) and psychological symptom scores (anxiety:Group 1 vs Group 2, P 〈 0.01; Group 1 vs Group 3, P 〈0.05; Group 1 vs Group 4, P 〈 0.01; depression: Group1 vs Group 2, P 〈 0.01; Group 1 vs Group 3, P 〈 0.01;Group 1 vs Group 4, P 〈 0.01) in Group 1 were greaterthan those in Groups 2-4.