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.