Itopride for gastric volume, gastric emptying and drinking capacity in functional dyspepsia

Table 1 Distribution of age and gender by intervention arm n = 31

Variable	Itopride	Placebo	P value
Age mean (SD)	34.2 (6.4)	31.9 (8.5)	0.40
Gender n (%)
Male	10 (66.7)	11 (68.8)	1.001
Female	5 (33.3)	5 (31.3)
Hb (g/dL) mean (SD)	13.6 (2.3)	14.1 (1.7)	0.50
WBC (× 10 Eq/L) mean (SD)	8.1 (2.0)	7.7 (1.9)	0.52
Platelet count (× 10 Eq/L) mean (SD)	257.3 (59.5)	250.5 (57.2)	0.75
Creatinine (mg/mL) median (IQR)	0.9 (0.5)	0.8 (0.3)	0.05
SGPT (IU/L) median (IQR)	20 (9.0)	25.5 (17.0)	0.09
Prolactin level (mg/mL) (IQR)	7.3 (3.6)	5.7 (2.7)	0.29
QT interval mean (SD)	394.1 (21.6)	399.2 (22.9)	0.53

¹Fischer Exact test. WBC: White blood cell; IQR: Interquartile range.

Table 2 Mean volumes to measure gastric accommodation by scintigraphy using ANCOVA adjusted for age and gender

Mean (± SE)	Itopride	Placebo
Change in volume (post-pre) using scintigraphy
Fasting	-22.2 (± 15.4)	7.5 (± 14.9)
20 min	-201.7 (± 102.4)	-31.5 (± 99.1)
30 min	0.14 (± 22.8)	-36.4 (± 22.1)
40 min	-27.6 (± 32.2)	-37.4 (± 31.2)
50 min	-60.0 (± 31.2)	-3.0 (± 30.2)
60 min	-3.1 (± 36.5)	15.0 (± 35.4)
90 min	3.8 (± 29.8)	-31.8 (± 28.8)
120 min	16.7 (± 28.9)	23.3 (± 28.0)
Effect on gastric emptying on 13C labeled octanoic acid breath test (post-pre)	0.4 (± 0.4)	0.2 (± 0.4)
Effect on drinking capacity (post-pre)	22.5 (± 18.1)	36.0 (17.5)
Change in Symptom score (post-pre)	-5.8 (1.0)	-4.7 (0.9)

Table 3 Median Symptom score along with interquartile range at baseline and end of four weeks (placebo vs itopride) n = 31

Symptoms	Baseline			End of four weeks
	Itopride	Placebo	P value	Itopride	Placebo	P value
Epigastric pain	3.0 (1.0)	4.0 (2.0)	0.18	2.0 (1.0)	2.0 (1.0)	0.83
Epigastric discomfort	2.0 (1.0)	1.0 (1.0)	0.03	1.0 (1.0)	1.0 (1.0)	0.22
Heart burn	1.0 (3.0)	1.0 (1.8)	0.37	1.0 (1.0)	1.0 (1.0)	0.74
Upper abdominal pain	3.0 (2.0)	1.5 (2.5)	0.32	2.0 (1.0)	1.5 (1.0)	0.51
Belching	1.0 (1.0)	1.0 (0.0)	0.10	1.0 (1.0)	1.0 (0.0)	0.02
Nausea	2.0 (1.0)	1.0 (0.0)	0.04	1.0 (1.0)	1.0 (0.0)	0.08
Early satiety	2.0 (2.0)	2.0 (3.0)	0.56	1.0 (1.0)	1.0 (0.0)	0.34
Postprandial Fullness	2.0 (3.0)	2.0 (2.8)	0.82	1.0 (1.0)	1.0 (1.0)	0.25
Total Symptom score	19.0 (9.0)	16.5 (5.0)	0.41	12.0 (3.0)	11.5 (4.5)	0.71