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

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.