Factors associated with mood disorders and the efficacy of the targeted treatment of functional dyspepsia: A randomized clinical trial

Abstract

Background: Patients with functional dyspepsia (FD) are often accompanied by mood disorders (MDs). This study aimed to identify factors associated with MDs in patients with FD and evaluate the efficacy of targeted treatment plans.

Methods: Relevant scales were used to assess MDs. Patients with FD having MDs and acid reflux were treated with flupentixol and melitracen (FM) and acid-suppressive therapy (AST) (histamine-2 receptor antagonists (H2RAs) (group A) or proton pump inhibitors (PPIs) (group B)), and those without acid reflux (group C) did not receive AST. Patients with FD without MDs were randomly administered H2RAs (group D) or PPIs (group E). The primary endpoints were factors associated with MDs and improvement in gastrointestinal (GI) symptoms and MDs in patients with FD.

Results: A total of 362 patients with FD were enrolled in this study. Patients with FD having high GI score and low education were found prone to MDs. At week 2, the remission rate of overall GI symptoms and depression was significantly higher in group B than that in groups A and C [GI: 72.72% (32/44) vs. 47.73% (21/44) and 72.72% (32/44) vs. 38.94% (44/113), all P < 0.05; depression: 72.22% (26/36) vs. 41.67% (15/36) and 72.22% (26/36) vs. 41.57% (37/89), all P < 0.05]. Furthermore, the remission rate of overall GI symptoms was significantly higher in group E than that in group D [60.29% (41/68) vs. 42.65% (29/68), P < 0.05]. At week 8, similar efficacies and adverse reactions were observed in these groups.

Conclusion: The risk factors for MDs were high GI scores and low literacy rates. Thus, targeted treatment (FM+PPIs for patients with MDs; PPIs for patients without MDs) can improve the efficacy of patients with FD.

Clinical trial registration: www.chictr.org.cn, identifier ChiCTR2100053126.

Keywords: H2RAs; PPIs; dyspepsia; efficacy; psychotropic medications.

Figure 1

Flowchart of the recruitment and assignment of patients with functional dyspepsia. PHQ-9, patient health questionnaire-9; GAD-7, generalized anxiety disorder-7; Group A: flupentixol and melitracen + nizatidine; Group B: flupentixol and melitracen + rabeprazole; Group C: flupentixol and melitracen. PP, per protocol.

Figure 2

Improvement of global gastrointestinal symptoms in the patients with functional dyspepsia of different subtypes combined with mood disorders at 2, 4 and 8 weeks of treatment. (A) PDS subtype; (B) EPS subtype; (C) overlapping subtype. Group A: flupentixol and melitracen + nizatidine; Group B: flupentixol and melitracen + rabeprazole; Group C: flupentixol and melitracen. PDS, postprandial distress syndrome; EPS, epigastric pain syndrome; Overlapping subtype: one or two symptoms of both PDS and EPS. *P < 0.05, **P < 0.01, ***P < 0.001: vs. 2 weeks of treatment in the same group. ^#P < 0.05: vs. 4 weeks of treatment in the same group. ^♦P < 0.05: group B (19/28) vs. group C (24/68) at 2 weeks of treatment.

Figure 3

Improvement of depression in the study population. Comparison of the remission rates of general depression (A) and different degrees of depression (B) in groups A, B and C at 2, 4 and 8 weeks of treatment. Group A: flupentixol and melitracen + nizatidine; Group B: flupentixol and melitracen + rabeprazole; Group C: flupentixol and melitracen. N1, N2 and N3 correspond to the number of patients with mild, moderate and moderate/severe depression, respectively. *P < 0.05, **P < 0.01, ***P < 0.001: vs. 2 weeks of treatment in the same group. ^##P < 0.01: vs. 4 weeks of treatment in the same group; ^‡P < 0.05: vs. group A at 2 weeks of treatment, ^§P < 0.05: vs. group C at 2 weeks of treatment. ^††P < 0.05: group B [100% (6/6)] vs. group C [26.32% (5/19)] in treating moderate depression at week 2. Ns: no significance between groups A, B and C.

Figure 4

Relief of overall gastrointestinal symptoms in the patients with functional dyspepsia of different subtypes without mood disorders at 2, 4 and 8 weeks of treatment. Group D: nizatidine, Group E: rabeprazole. N4, N5 and N6 correspond to the number of patients with postprandial distress syndrome (PDS), epigastric pain syndrome (EPS) and overlapping subtype (one or two symptoms of PDS and EPS), respectively. **P < 0.01, ***P < 0.001: vs. 2 weeks of treatment in the same group; ^#P < 0.05: vs. 4 weeks of treatment in the same group; ^||P < 0.05: group E vs. group D at 2 weeks of treatment; ^‡‡P < 0.05: group E vs. group D at 4 weeks of treatment.

Figure 5

Relief of major gastrointestinal symptoms in patients with functional dyspepsia without mood disorders at 8 weeks of treatment. The numbers at the top and bottom of each column correspond to the remission rate and the number of patients with the respective symptom (before treatment). Group D: nizatidine; Group E: rabeprazole.