Rabeprazole vs esomeprazole in non-erosive gastro-esophageal reflux disease: A randomized, double-blind study in urban Asia

Table 1 Demographic and baseline characteristics of patients enrolled.

Number of subjects enrolled	Total 127	Rabeprazole 63	Esomeprazole 64	P
Gender (%)
Female	62 (48.8)	25 (39.7)	37 (57.8)	P = 0.0511
Male	65 (51.2)	38 (60.3)	27 (42.2)
Race (%)
Chinese	101 (79.5)	52 (82.5)	49 (76.6)	P = 0.8721
Malay	9 (7.1)	4 (6.3)	5 (7.8)
Indian	15 (11.8)	6 (9.5)	9 (14.1)
Other	2 (1.6)	1 (1.6)	1 (1.6)
Age (yr)
Mean (SD)	38.9 (10.6)	39.3 (11.2)	38.4 (10.0)	P = 0.6292
History of GERD symptoms (yr)
Mean (SD)	3.6 (4.5)	3.2 (4.2)	3.9 (4.7)	P = 0.3732
Tobacco use, N (%)
Yes	11 (8.7)	4 (6.3)	7 (10.9)	P = 0.2431
No	116 (91.3)	59 (93.7)	57 (89.1)
Alcohol use, N (%)
Yes	20 (15.7)	9 (14.3)	11 (17.2)	P = 0.4861
No	107 (84.3)	54 (85.7)	53 (82.8)
Previous medication for reflux disease
Yes	77 (60.6)	35 (55.6)	42 (65.6)	P = 0.2791
No	50 (39.4)	28 (44.4)	22 (34.4)
H pylori status
Positive	50	24 (45.3)	26 (44.0)
Negative	62	29 (54.7)	33 (56.0)	P = 0.953
(Not available	15	10	5

Test¹ Fisher’s exact test; Test²t-test; Test³χ² test

Table 2 Summary of efficacy and safety results (including important subgroup analyses).

Parameter	Rabeprazole 10 mg (d)	Esomeprazole 20 mg (d)	P	Result
Primary efficacy variables
Time to 24-h symptom-free interval-HB	8.5 d	9 d	0.265	NS
Time to 24-h symptom-free interval-RG	6.0 d	7.5 d	0.405	NS
Secondary efficacy variables
Time to 48-h symptom-free interval-HB	9.5 d	8.5 d	0.373	NS
Time to 48-h symptom-free interval-RG	8.5 d	11 d	0.271	NS
W1-W4-satisfactory relief DT or NT-HB			>0.05	NS
W1-W4-satisfactory relief DT or NT-RG			>0.05	NS
W1-W4-satisfactory relief DT-HB & RG4			0.0454	Rabeprazole superior4
W1-W4-complete relief DT or NT-HB			>0.05	NS
W1-W4-complete relief DT or NT-RG			>0.05	NS
W1-W4-belching	-0.41	-0.42	0.631	NS
W1-W4-early satiety	-0.26	-0.32	0.178	NS
W1-W4-bloating	-0.46	-0.54	0.608	NS
W1-W4-nausea	-0.23	-0.27	0.319	NS
W1-W4-vomiting	-0.34	-0.21	0.808	NS
Symptom severity score-D1-5-DT HB	P<0.05 (D2-5)1	P<0.05 (D3-5)1		NS2
Symptom severity score-D1-5-NT HB	P<0.05 (D2-5)1	NS1		NS3
Symptom severity score-D1-5-DT RG	P<0.05 (D1-5)1	P<0.05 (D1-5)1		NS
Symptom severity score-D1-5-NT RG	P<0.05 (D5 only)1	P<0.05 (D2 only)1		NS
Patient’s global evaluation (%)	96.4	87.9	0.823	NS
Antacid use-weekly average	0.15	0.16	0.887	NS
Antacid use-% antacid free	85.7	84.9	0.848	NS
Safety
Adverse events	22	18.2	>0.05	NS

HB-heartburn; RG-regurgitation; DT-day-time; NT-night-time; W1-wk 1; w4-wk 4;

¹Compared to baseline;

²Rabeprazole statistically superior compared to baseline/pre-treatment from d 2 to 5 and esomeprazole statistically superior compared to baseline/pre-treatment from d 3 to 5;

³Rabeprazole statistically superior compared to baseline/pre-treatment from d 2 to 5 and esomeprazole not statistically superior compared to baseline/pre-treatment from d 1 to 5;

⁴Subgroup analysis.