Epigastric pain syndrome: What can traditional Chinese medicine do? A randomized controlled trial of Biling Weitong Granules

Table 1 Baseline characteristics of study population in a full analysis set

	Placebo group, n = 120	BLWT group, n = 118	P value
Sex, n			0.8656
Male/female	45/75	43/75
Age in yr, mean ± SD	37.78 ± 13.96	37.95 ± 13.38	0.9256
Body height in cm,
mean ± SD	166.69 ± 7.98	165.46 ± 7.33	0.214
Body weight in kg,
mean ± SD	62.93 ± 13.05	61.22 ± 11.06	0.2765
Education background, n (%)			0.9256
Illiteracy	1 (0.83)	1 (0.85)
Primary school	5 (4.17)	4 (3.39)
Middle school	19 (15.83)	25 (21.19)
High school	19 (15.83)	18 (15.25)
Junior college	16 (13.33)	14 (11.86)
College	16 (13.33)	19 (16.1)
Higher than college	44 (36.67)	37 (31.36)

BLWTG: Biling Weitong Granules.

Table 2 Baseline disease conditions in two groups, mean ± SD

	Placebo group, n = 120	BLWTG group, n = 118	P value
Total epigastric pain score	4.63 ± 0.73	4.61 ± 0.72	0.8748
VAS score of the severity of epigastric pain	6.17 ± 1.14	6.25 ± 1.2	0.6257
Frequency of epigastric pain, d/wk	4.14 ± 1.73	4.08 ± 1.67	0.7964
Total FD clinical score	28.18 ± 9.02	29.07 ± 9.33	0.458
FDDQL score	58.91 ± 13.78	57.15 ± 15.35	0.3518

BLWTG: Biling Weitong Granules; FD: Functional dyspepsia; FDDQL: Functional Digestive Disorders Quality of Life Questionnaire; VAS: Visual analog score.

Table 3 Analysis of clinical response for epigastric pain in a full analysis set, n (%)

	Placebo group, n = 120	BLWTG group, n = 118	P value
Total			< 0.0001
Responsive	34 (28.33)	101 (85.59)
Not responsive	86 (71.67)	17 (14.41)
Baseline VAS score, 4 ≤ VAS < 7
Responsive	27( 30.34)	77 (88.51)	< 0.0001
Not responsive	62 (69.66)	10 (11.49)
Baseline VAS score, 7 ≤ VAS ≤ 10
Responsive	7 (22.58)	24 (77.42)	< 0.0001
Not responsive	24 (77.42)	7 (22.58)

BLWTG: Biling Weitong Granules; VAS: Visual analog score.

Table 4 Rate of abdominal pain resolution in two groups, n (%)

	Placebo group, n = 120	BLWTG group, n = 118	P value
Resolution rate			< 0.0001
Resolved	18 (15)	82 (69.49)
Not resolved	102 (85)	36 (30.51)

BLWTG: Biling Weitong Granules.

Table 5 Total epigastric pain score (mean ± SD) in functional dyspepsia patients in a full analysis set

	Placebo group, n = 120	BLWTG group, n = 118	P value
Baseline	4.63 ± 0.73	4.61 ± 0.72	0.8748
Week 1	4.43 ± 1.17	4.03 ± 1.28	0.0125
Week 2	3.65 ± 1.63	3.2 ± 1.59	0.0335
Week 3	3.67 ± 1.42	2.81 ± 1.46	< 0.0001
Week 4	3.45 ± 1.48	2.38 ± 1.7	< 0.0001
Week 5	3.23 ± 1.75	1.84 ± 1.71	< 0.0001
Week 6	3.19 ± 1.56	1.32 ± 1.5	< 0.0001

BLWTG: Biling Weitong Granules.

Table 6 Total functional dyspepsia clinical score (mean ± SD) in two groups in a full analysis set

	Placebo group, n = 120	BLWTG group, n = 118	P value
Baseline	28.18 ± 9.02	29.07 ± 9.33	0.458
Week 2	23.8 ± 9.15	20.53 ± 9.77	0.0085
Week 4	20.69 ± 9.96	14.12 ± 8.45	< 0.0001
Week 6	20.52 ± 9.31	7.76 ± 6.67	< 0.0001

BLWTG: Biling Weitong Granules.

Table 7 Functional Digestive Disorders Quality of Life Questionnaire total score and scores of different dimensions (6-wk baseline) (mean ± SD) in a full analysis set

	Placebo group, n = 120	BLWTG group, n = 118	P value
Total score	3.93 ± 14.78	20.14 ± 15.7	< 0.0001
Daily activities	4.72 ± 18.61	19.58 ± 19.16	< 0.0001
Anxiety	6.42 ± 22.51	25.24 ± 21.49	< 0.0001
Diet	11.77 ± 74.07	20.51 ± 20.59	0.2498
Sleep	1.06 ± 18.34	19.1 ± 20.27	< 0.0001
Discomfort	4.86 ± 17.34	21.46 ± 18.15	< 0.0001
Coping with disease	0.45 ± 17.28	15.13 ± 18.72	< 0.0001
Control of disease	6.45 ± 23.65	23.62 ± 25.25	< 0.0001
Stress	7.03 ± 23.5	18.77 ± 22.52	0.0003

BLWTG: Biling Weitong Granules.

Table 8 Use of Talcid tablets during the observation period in a full analysis set

	Placebo group	BLWTG group	P value
Use rate, n (%)
Number of users	29 (24.37)	9 (7.63)	0.0003
Number of non-users	90 (75.63)	109 (92.37)

BLWTG: Biling Weitong Granules.