Efficacy of the four weeks treatment of omeprazole plus mosapride combination therapy compared with that of omeprazole monotherapy in patients with proton pump inhibitor-refractory gastroesophageal reflux disease: a randomized controlled trial

Figures & data

Figure 1 Participants flow diagram.

Table 1 Baseline characteristics of patients

	Control group (n=22)	Combination group (n=22)	P-value
Age, mean (SD), y	53.14 (11.94)	49.18 (13.84)	0.316‡
Female gender, n (%)	16 (72.7)	15 (68.2)	0.741†
BMI, mean (SD), kg/m^2	23.42 (5.02)	24.16 (4.08)	0.231‡
Comorbid diseases
Diabetes mellitus, n (%)	4 (18.2)	6 (27.3)	0.472†
Hypertension, n (%)	7 (31.8)	7 (31.8)	1.000†
Dyslipidemia, n (%)	10 (45.5)	8 (36.4)	0.540†
History of smoking			1.000†
Non-smoker/ex-smoker, n (%)	22 (100)	21 (95.5)
Current smoker, n (%)	0 (0)	1 (0.5)
History of alcohol drinking			0.233†
Non-drinker/ex-drinker, n (%)	22 (100)	19 (86.4)
Current drinker, n (%)	0 (0)	3 (13.6)
Coffee consumption, n (%)	14 (63.6)	10 (45.5)	0.364†
Endoscopic findings
LA classification			0.698†
Grade A, n (%)	2 (9.1)	1 (4.5)
Grade B, n (%)	2 (9.1)	1 (4.5)
NERD, n (%)	18 (81.8)	20 (91.0)
Sliding hiatal hernia, n (%)	3 (13.6)	6 (27.3)	0.457†
Duration of symptoms, mean (SD), months	25.68 (18.62)	35.77 (21.25)	0.107‡
Pre-treatment medication
H2RA, n (%)	1 (4.5)	6 (27.3)	0.095†
Prokinetic agent, n (%)	7 (31.8)	7 (31.8)	1.000†
Antiflatulence, n (%)	10 (45.5)	11 (50.0)	0.763†
Antacid, n (%)	12 (54.5)	11 (50.0)	0.763†
Antispasmodic, n (%)	2 (9.1)	6 (27.3)	0.240†
Tricyclic antidepressant, n (%)	3 (13.6)	2 (9.1)	1.000†

Notes: †Fisher’s exact test or Chi-square test. ‡Mann-Whitney U-test or Independent t-test.

Abbreviations: BMI, body mass index; LA classification, Los Angeles classification; NERD, non-erosive reflux disease; H2RA, histamine 2 receptor antagonist; Combination group, omeprazole 20 mg once daily combined with mosapride 5 mg three times daily; Control group, omeprazole 20 mg once daily combined with placebo three times daily; SD, standard deviation.

Figure 2 Reduction of the FSSG score after 4 weeks of treatment between the omeprazole monotherapy group and the omeprazole plus mosapride combination therapy group.

Table 2 Clinical symptoms at pre-treatment and post-treatment between the omeprazole monotherapy group and the omeprazole plus mosapride combination therapy group

FSSG score	Pre-treatment		P-value‡	Post-treatment		P-value‡
	Control group (n=22)	Combination group (n=22)		Control group (n=22)	Combination group (n=22)
Reflux score	8.91±4.64	10.36±3.35	0.240	5.45±3.20	6.45±3.57	0.334
Dysmotility score	8.00±4.15	10.00±4.74	0.144	5.77±4.70	5.91±5.32	0.929
Total score	16.91±7.57	20.36±6.78	0.118	11.23±7.02	12.36±7.46	0.606

Notes: Data are shown as mean ± standard deviation. ‡Independent t-test.

Abbreviations: FSSG, frequency scale for the symptoms of gastroesophageal reflux disease; Combination group, omeprazole 20 mg once daily combined with mosapride 5 mg three times daily; Control group, omeprazole 20 mg once daily combined with placebo three times daily.

Table 3 The number of symptom-free days of the patients during the study period

Symptoms	Control group (n=20)	Combination group (n=21)	P-value‡
Heartburn-free days	7.00 (1.00–14.00)	6.50 (4.25–10.75)	0.564
Regurgitation-free days	5.00 (1.50–15.00)	5.50 (2.25–10.75)	0.265
Night-time heartburn-free days	3.00 (0.00–11.00)	7.00 (2.00–10.25)	0.586

Notes: Data are shown as median (25th-75th interquartile range). ‡Mann-Whitney U-test.

Table S1 FSSG questionnaire

Table S2 Diary

Day	Date	Heartburn symptoms	Regurgitation symptoms	Night-time heartburn symptoms
1		yes/no	yes/no	yes/no
2		yes/no	yes/no	yes/no
3		yes/no	yes/no	yes/no
4		yes/no	yes/no	yes/no
5		yes/no	yes/no	yes/no
6		yes/no	yes/no	yes/no
7		yes/no	yes/no	yes/no
8		yes/no	yes/no	yes/no
9		yes/no	yes/no	yes/no
10		yes/no	yes/no	yes/no
11		yes/no	yes/no	yes/no
12		yes/no	yes/no	yes/no
13		yes/no	yes/no	yes/no
14		yes/no	yes/no	yes/no
15		yes/no	yes/no	yes/no
16		yes/no	yes/no	yes/no
17		yes/no	yes/no	yes/no
18		yes/no	yes/no	yes/no
19		yes/no	yes/no	yes/no
20		yes/no	yes/no	yes/no
21		yes/no	yes/no	yes/no
22		yes/no	yes/no	yes/no
23		yes/no	yes/no	yes/no
24		yes/no	yes/no	yes/no
25		yes/no	yes/no	yes/no
26		yes/no	yes/no	yes/no
27		yes/no	yes/no	yes/no
28		yes/no	yes/no	yes/no