Comparative clinical trial of S-pantoprazole versus racemic pantoprazole in the treatment of gastro-esophageal reflux disease

Table 1 Baseline demographic variables

Variable	Reference group	Test group
n	182	187
Male: Female	115:67	114:73
Mean age ± SD (yr)	42.3 ± 11.7	42 ±12.3

Table 2 Efficacy in the reference (racemic pantoprazole 40 mg, n = 182) and test (S-pantoprazole 20 mg, n = 187) groups

Symptoms		d 0		d 14		d 28		P3
		Ref	Test	Ref	Test	Ref	Test
Heart burn	Mean ± SD	1.8 ± 0.8	1.9 ± 0.8	1.2 ± 0.8	1.2 ± 0.9	0.6 ± 0.9	0.6 ± 0.8	< 0.0001
	Median (Percentile 25th, 75th)	2 (1.2)	2 (1.3)	1 (1.2)2	1 (0.5.2)1	0 (0.1)2	0 (0.1)1
Regurgitation	Mean ± SD	1.6 ± 0.9	1.7 ± 0.9	1.1 ± 0.8	1 ± 0.8	0.5 ± 0.8	0.4 ± 0.6	< 0.0001
	Median (Percentile 25th, 75th)	2 (1.2)	2 (1.2)	1 (0.2)2	1 (0.2)1	0 (0.1)2	0 (0.1)1
Bloating	Mean ± SD	1.4 ± 0.9	1.4 ± 1	0.9 ± 0.9	0.8 ± 0.8	0.5 ± 0.8	0.3 ± 0.6	< 0.0001
	Median (Percentile 25th, 75th)	1 (1.2)	2 (1.2)	1 (0.2)2	1 (1.2)1	0 (0.1)2	1 (1.1)1
Nausea	Mean ± SD	1.4 ± 1	1.3 ± 1	0.8 ± 0.9	0.7 ± 0.8	0.4 ± 0.8	0.4 ± 0.7	< 0.0001
	Median (Percentile 25th, 75th)	2 (0.2)	1 (0.2)	1 (0.2)2	0 (0.1)1	0 (0.0.25)2	0 (0.1)1
Dysphagia	Mean ± SD	0.3 ± 0.6	0.5 ± 0.8	0.2 ± 0.6	0.2 ± 0.5	0.1 ± 0.4	0.1 ± 0.4	< 0.001
	Median (Percentile 25th, 75th)	0 (0.0)	0 (0.1)	0 (0.0)	0 (0.0)1	0 (0.0)	0 (0.0)1

^1,2 Dunn’s multiple comparisons test; ³P value for ANOVA (Friedman’s test).

Table 3 Between-group efficacy in improvement of symptoms

Decrease compared to baseline (d 0) in score	Patients showing improvement in symptoms (n)
	Heart burn				Regurgitation				Bloating
	On d 14		On d 28		On d 14		On d 28		On d 14		On d 28
	Ref	Test	Ref	Test	Ref	Test	Ref	Test	Ref	Test	Ref	Test
Decrease by 1	89	93	56	71	90	111	76	86	62	81	69	65
Decrease by 2	9	21	61	67	6	12	52	52	11	14	36	38
Decrease by 3	0	1	11	15	0	2	8	20	3	2	9	21
Patients who improved (n)	98	115	128	153	96	125	136	158	76	97	114	124
Patients with symptoms (n)	172	179	172	179	165	170	165	170	149	143	149	143
Fisher’s test, P	0.19		0.01		0.004		0.004		0.004		0.03

Table 5 Findings of GI endoscopy

	Number of patients with findings (n)
	d 0		d 28
	Esophagitis	Erosions	Esophagitis	Erosions
Ref	17	6	7	6
Test	21	2	7	3
Fisher’s test, P	0.77	0.12	1	0.27

Table 4 Absolute risk reduction (95%CI for differences between proportions), relative risk reduction (RRR) and number needed to treat (NNT)

Symptoms, d	Absolute risk reduction1 (95% CI for difference in improvement) (%)	RRR (%)	NNT
Heartburn, d 28	+ 11.1 (2.7-19.4)	15	9
Acid regurgitation, d 14	+ 15.3 (5.3-25.0)	26	7
Acid regurgitation, d 28	+ 10.5 (3.6-17.5)	13	10
Bloating, d 14	+ 16.8 (5.7-27.9)	33	6
Bloating, d 28	+ 10.2 (1.4-19.0)	13	10

¹Significant differences in favor of test group were analyzed.