Aurantii Fructus Immaturus Flavonoid tablets for functional dyspepsia: A multicenter, double-blind, dose-exploring IIb randomized controlled trial

Table 1 Demographics and baseline characteristics, mean ± SD/n (%)

Variables		High-dose group, n = 67	Median-dose group, n = 66	Low-dose group, n = 67	Placebo group, n = 67	Statistics	P value
Age (years)		40.51 ± 12.98	40.86 ± 13.95	41.56 ± 13.80	39.24 ± 12.87	F = 0.35	0.788
Gender	Male	21 (31.34)	22 (33.33)	29 (43.28)	30 (44.78)	χ2 = 3.962	0.266
	Female	46 (68.66)	44 (66.67)	38 (56.72)	37 (55.22)
Height (cm)		162.84 ± 7.68	163.03 ± 6.75	164.16 ± 8.54	163.76 ± 8.59	F = 0.414	0.745
Weight (kg)		59.25 ± 8.05	61.31 ± 8.07	59.43 ± 8.33	60.63 ± 9.25	F = 0.903	0.441
Source	Outpatient	67 (100.00)	66 (100.00)	67 (100.00)	67 (100.00)
Duration (months)	N (N miss)	45 (22)	51 (15)	51 (16)	49 (18)	H = 3.000	0.392
	Median (P25, P75)	28.10 (14.90, 48.10)	24.60 (12.90, 42.60)	25.40 (11.80, 55.30)	22.70 (10.90, 32.10)
Western medicine treatment history	No	48 (71.64)	51 (77.27)	53 (79.10)	53 (79.10)	Fisher’s exact test	0.727
	Yes	19 (28.36)	15 (22.73)	14 (20.90)	14 (20.90)
TCM treatment history	No	48 (71.64)	48 (72.73)	52 (77.61)	52 (77.61)	Fisher’s exact test	0.801
	Yes	19 (28.36)	18 (27.27)	15 (22.39)	15 (22.39)
Comorbidities	No	56 (83.58)	51 (77.27)	64 (95.52)	60 (89.55)	Fisher’s exact test	0.012
	Yes	11 (16.42)	15 (22.73)	3 (4.48)	7 (10.45)
Smoking history	No	60 (89.55)	59 (89.39)	64 (95.52)	58 (86.57)	Fisher’s exact test	0.321
	Yes	7 (10.45)	7 (10.61)	3 (4.48)	9 (13.43)
Physical examination	Normal	67 (100.00)	66 (100.00)	67 (100.00)	66 (98.51)	Fisher’s exact test	> 0.999
	Abnormal	0 (0.00)	0 (0.00)	0 (0.00)	1 (1.49)
TCM syndrome patterns	Liver-stomach disharmony	28 (41.79)	21 (31.82)	17 (25.37)	20 (29.85)	H = 11.431	0.247
	Spleen-stomach damp-heat	16 (23.88)	20 (30.30)	28 (41.79)	24 (35.82)
	Food stagnation	13 (19.40)	9 (13.64)	9 (13.43)	6 (8.96)
	Spleen-stomach weakness	10 (14.93)	16 (24.24)	13 (19.40)	17 (25.37)
Postprandial fullness	0 points	0 (0.00)	0 (0.00)	1 (1.49)	0 (0.00)	H = 2.198	0.531
	1 point	11 (16.42)	10 (15.15)	13 (19.40)	12 (17.91)
	2 points	38 (56.72)	38 (57.58)	39 (58.21)	43 (64.18)
	3 points	18 (26.87)	18 (27.27)	14 (20.90)	12 (17.91)
Early satiety	0 points	1 (1.49)	0 (0.00)	2 (2.99)	0 (0.00)	H = 2.672	0.446
	1 point	20 (29.85)	24 (36.36)	26 (38.81)	22 (32.84)
	2 points	35 (52.24)	35 (53.03)	33 (49.25)	39 (58.21)
	3 points	11 (16.42)	7 (10.61)	6 (8.96)	6 (8.96)
Upper abdominal burning sensation	0 points	7 (10.45)	6 (9.09)	8 (11.94)	4 (5.97)	H = 0.780	0.854
	1 point	28 (41.79)	28 (42.42)	25 (37.31)	30 (44.78)
	2 points	27 (40.30)	28 (42.42)	30 (44.78)	23 (34.33)
	3 points	5 (7.46)	4 (6.06)	4 (5.97)	10 (14.93)
Upper abdominal pain visual analog scale	Median (P25, P75)	5.00 (4.00, 6.00)	5.00 (4.00, 5.00)	4.00 (3.00, 5.20)	4.00 (3.00, 6.00)	H = 0.947	0.423
Gastric emptying rate (%)	N (N miss)	17 (50)	17 (49)	17 (50)	17 (50)	F = 0.962	0.419
		31.46 ± 9.14	29.43 ± 10.72	31.94 ± 7.30	34.92 ± 10.69
Gastric half-emptying time (hours)	N (N miss)	17 (50)	17 (49)	17 (50)	17 (50)	F = 1.707	0.175
		3.64 ± 1.07	4.07 ± 2.04	3.38 ± 0.95	3.09 ± 0.85

TCM: Traditional Chinese medicine.

Table 2 Changes of postprandial 2-hour gastric emptying rate (%) and gastric half-emptying time (hours) before and after treatment, mean ± SD

Outcomes		High-dose group	Median-dose group	Low-dose group	Placebo group	F value	P value
Gastric emptying rate	N (N miss)	17 (50)	15 (51)	17 (50)	15 (52)	1.10	0.355
		5.78 ± 9.83	5.01 ± 10.07	4.24 ± 10.99	-0.35 ± 10.13
	MD (95%CI) vs placebo	6.13 (-3.49, 15.75)	5.35 (-4.56, 15.27)	4.58 (-5.04, 14.20)
Gastric half-emptying time	N (N miss)	17 (50)	15 (51)	17 (50)	15 (52)	1.02	0.389
		-0.75 ± 1.05	-0.75 ± 2.40	-0.23 ± 1.21	0.01 ± 0.96
	MD (95%CI) vs placebo	-0.77 (-2.17, 0.64)	-0.76 (-2.21, -0.69)	-0.24 (-1.65, 1.16)

CI: Confidence interval; MD: Mean difference.