Efficacy and safety of lansoprazole combined with flupentixol-melitracen for functional dyspepsia: A randomized, double-blinded, placebo-controlled clinical trial

Table 1 Baseline characteristics, n (%)/median (interquartile range)

	LPZ + FM (n = 92)	LPZ + placebo (n = 91)	P value
Age, years	45.5 (12.2)	45.0 (12.3)	0.764
Body mass index, kg/m2	21.6 (2.7)	21.8 (2.6)	0.647
Sex			0.832
Female	55 (59.8)	53 (58.2)
Male	37 (40.2)	38 (41.8)
Education level			0.717
Primary school	35 (38.0)	37 (40.7)
High school or above	57 (62.0)	54 (59.3)
Duration of functional dyspepsia, months	12.0 (6.0-33.5)	13.0 (6.0-28.0)	0.730
Functional dyspepsia subtypes			0.628
Overlap	63 (68.5)	59 (64.8)
PDS	20 (21.7)	25 (27.5)
EPS	9 (9.8)	7 (7.7)
Clinical scores
LPDS-PDS	2.0 (1.3-3.0)	2.0 (1.3-2.7)	0.645
LPDS-EPS	1.0 (0.5-2.0)	1.0 (0.0-1.5)	0.165
SF-NDI	27.5 (19.3-34.0)	27 (20.0-34.0)	0.938
PHQ-9	7.0 (3.0-13.0)	8.0 (3.0-14.0)	0.939
GAD-7	5.0 (2.0-10.8)	5.0 (2.0-10.0)	0.948
PSQI	8.0 (5.0-12.0)	8.0 (5.0-12.0)	0.981

LPZ: Lansoprazole; FM: Flupentixol-melitracen; PDS: Postprandial distress syndrome; EPS: Epigastric pain syndrome; PHQ-9: Patient Health Questionnaire-9; GAD-7: Generalized Anxiety Disorder-7; PSQI: Pittsburgh Sleep Quality Index; LPDS: Leuven Postprandial Distress Scale; SF-NDI: Short Form Nepean Dyspepsia Index.

Table 2 Model-estimated clinical outcomes over time between flupentixol-melitracen and placebo groups

Variables	Time points	LPZ + FM	LPZ + placebo	B	95%CI	P value
LPDS-PDS	T1	2.0 (1.8-2.2)	1.9 (1.7-2.1)
	T2	1.0 (0.8-1.2)	1.4 (1.2-1.6)	-0.38	-0.64 to -0.11	0.006
	T3	1.0 (0.8-1.2)	1.3 (1.1-1.5)	-0.30	-0.57 to -0.04	0.026
	T4	1.1 (0.9-1.2)	1.4 (1.2-1.6)	-0.35	-0.61 to -0.09	0.009
LPDS-EPS	T1	1.1 (1.0-1.3)	1.0 (0.8-1.1)
	T2	0.5 (0.4-0.7)	0.7 (0.5-0.8)	-0.13	-0.33 to 0.06	0.181
	T3	0.5 (0.4-0.7)	0.7 (0.6-0.9)	-0.19	-0.38 to 0.00	0.049
	T4	0.6 (0.4-0.7)	0.7 (0.6-0.9)	-0.16	-0.36 to -0.04	0.109
SF-NDI	T1	27.3 (25.3-29.4)	27.4 (25.3-29.4)
	T2	15.7 (13.9-17.6)	18.8 (17.0-20.7)	-3.11	-5.74 to -0.48	0.021
	T3	14.9 (13.1-16.7)	18.2 (16.4-20.0)	-3.33	-5.89 to -0.77	0.011
	T4	15.5 (13.6-17.3)	18.8 (16.9-20.6)	-3.27	-5.89 to -0.65	0.015
PHQ-9	T1	8.5 (7.2-9.9)	8.6 (7.3-9.9)
	T2	3.2 (2.3-4.1)	5.3 (4.3-6.2)	-2.08	-3.36 to -0.80	0.002
	T3	3.1 (2.2-4.0)	4.8 (3.9-5.7)	-1.69	-2.93 to -0.46	0.008
	T4	3.2 (2.3-4.1)	5.3 (4.3-6.2)	-2.10	-3.38 to -0.82	0.001
GAD-7	T1	6.7 (5.5-7.9)	6.6 (5.4-7.8)
	T2	2.9 (2.0-3.7)	4.4 (3.6-5.3)	-1.55	-2.75 to -0.35	0.012
	T3	2.9 (2.1-3.7)	4.1 (3.2-4.9)	-1.16	-2.33 to 0.00	0.050
	T4	3.0 (2.1-3.8)	4.5 (3.6-5.3)	-1.48	-2.70 to -0.27	0.017
PSQI	T1	8.7 (7.8-9.6)	8.7 (7.7-9.6)
	T2	6.2 (5.3-7.0)	7.4 (6.6-8.3)	-1.28	-2.47 to -0.08	0.036
	T3	6.1 (5.3-6.9)	7.2 (6.3-8.0)	-1.07	-2.24 to 0.10	0.074
	T4	6.2 (5.3-7.0)	7.3 (6.5-8.1)	-1.15	-2.32 to 0.03	0.056

LPZ: Lansoprazole; FM: Flupentixol-melitracen; CI: Confidence interval; LPDS: Leuven Postprandial Distress Scale; PDS: Postprandial distress syndrome; EPS: Epigastric pain syndrome; PHQ-9: Patient Health Questionnaire-9; GAD-7: Generalized Anxiety Disorder-7; PSQI: Pittsburgh Sleep Quality Index; SF-NDI: Short Form Nepean Dyspepsia Index.

Table 3 Summary of treatment-emergent adverse events, n (%)

TEAEs1	LPZ + FM (n = 92)	LPZ + placebo (n = 91)
Patients with any TEAEs	30 (32.6)	21 (23.1)
Drowsiness	11 (12.0)	4 (4.4)
Dry mouth	7 (7.6)	5 (5.5)
Diarrheal	6 (6.5)	7 (7.7)
Insomnia	4 (4.3)	2 (2.2)
Nausea	4 (4.3)	3 (3.3)
Constipation	1 (1.1)	3 (3.3)

¹A patient was counted only once, even if the same event was reported multiple times by the patient.

LPZ: Lansoprazole; FM: Flupentixol-melitracen; TEAEs: Treatment-emergent adverse events.