Effect of clinician-patient communication on compliance with flupentixol-melitracen in functional dyspepsia patients

Abstract

Aim: To explore whether clinician-patient communication affects adherence to psychoactive drugs in functional dyspepsia (FD) patients with psychological symptoms.

Methods: A total of 262 FD patients with psychological symptoms were randomly assigned to four groups. The patients in Groups 1-3 were given flupentixol-melitracen (FM) plus omeprazole treatment. Those in Group 1 received explanations of both the psychological and gastrointestinal (GI) mechanisms of the generation of FD symptoms and the effects of FM. In Group 2, only the psychological mechanisms were emphasized. The patients in Group 3 were not given an explanation for the prescription of FM. Those in Group 4 were given omeprazole alone. The primary endpoints of this study were compliance rate and compliance index to FM in Groups 1-3. Survival analyses were also conducted. The secondary end points were dyspepsia and psychological symptom improvement in Groups 1-4. The correlations between the compliance indices and the reductions in dyspepsia and psychological symptom scores were also evaluated in Groups 1-3.

Results: After 8 wk of treatment, the compliance rates were 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 vs Group 3, P = 0.033). The compliance index (Group 1 vs Group 2, P = 0.002; Group 1 vs Group 3, P = 0.024) with the FM regimen was significantly higher in Group 1 than in Groups 2 and 3. The survival analysis revealed that the patients in Group 1 exhibited a significantly higher compliance rate than Groups 2 and 3 (Group 1 vs 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 Group 4, 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: Group 1 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 greater than those in Groups 2-4. The compliance indices were positively correlated with the reduction in symptom scores in Groups 1-3.

Conclusion: Appropriate clinician-patient communication regarding the reasons for prescribing psychoactive drugs that emphasizes both the psychological and GI mechanisms might improve adherence to FM in patients with FD.

Trial registration: ClinicalTrials.gov NCT01851863.

Keywords: Anxiety; Compliance; Depression; Functional dyspepsia; Psychoactive drug.

Figures

Figure 1

Survival analysis based on adherence to flupentixol-melitracen treatment among patients with functional dyspepsia. The survival analysis was calculated as the number of patients who remained therapy-compliant for each day of the study. Group 1 exhibited a significantly higher compliance rate than did those in Groups 2 and 3 (Group 1 vs Group 2, P = 0.002; Group 1 vs Group 3, P = 0.018).

Figure 2

Mean changes from baseline leeds dyspepsia questionnaire scores in functional dyspepsia patients based on the intent-to-treat population. aP < 0.05, bP < 0.01 vs Group 1. FD: Functional dyspepsia; LDQ: Leeds dyspepsia questionnaire.

Figure 3

Mean changes from baseline hospital anxiety and depression scale scores in functional dyspepsia patients based on the intent-to-treat population. A: Changes in the anxiety subscale; B: Changes in the depression subscale. aP < 0.05, bP < 0.01 vs Group 1. FD: Functional dyspepsia; HADS: Hospital anxiety and depression scale.