Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study

Table 1 Rome III diagnostic criteria for functional dyspepsia

Functional dyspepsia	Subtype
The last 3 mo with symptom onset at least 6 mo before diagnosis, and must include:	Postprandial distress syndrome
1 One or more of:	Must include one or both of the following:
a, Bothersome postprandial fullness	1 Bothersome postprandial fullness, occurring after ordinary sized meals, at least several times per week
b, Early satiation	2 Early satiation that prevents finishing a regular meal, at least several times per week
c, Epigastric pain	Supportive criteria
d, Epigastric burning	1 Upper abdominal bloating or postprandial nausea or excessive belching can be present
AND	2 EPS may coexist
2 No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms

Table 2 Traditional Chinese medicine diagnostic criteria for stuffiness and fullness

	Spleen-deficiency and Qi-stagnation
Primary symptoms	Abdominal distension, with obviously postprandial distress
	Anorexia or little appetite
Secondary symptoms	Nausea; acid reflux/heartburn; loose stools; fatigue/exhausted
	Fat tongue with slightly white coating
	Weak pulse

The diagnosis will be established when the participant conforms to all primary symptoms and any two of the secondary symptoms.

Table 3 Inclusion and exclusion criteria

Inclusion criteria

1 Age 18-70 yr, Chinese reading and writing ability

2 Meeting the Rome III diagnostic criteria for PDS

3 Having the symptom of “spleen-deficiency and Qi-stagnation”, “spleen-deficiency and damp-obstruction”, “spleen-Yang deficiency”.

4 Signing the informed consent form

Exclusion criteria

1 Combined with GI ulcer, erosive gastritis, atrophic gastritis, severe dysplasia of gastric mucosa or suspicious malignant lesion

2 Having overlap syndrome combined with gastroesophageal reflux disease or irritable bowel syndrome

3 Having alarm symptoms (weight loss, black or tar stool, dysphagia, etc.)

4 Having serious structural disease (disease of heart, lung, liver or kidney) or mental illness

5 History of surgery related with the gastrointestinal tract, except for appendectomy more than six months ago

6 Taking drugs which may affect the gastrointestinal tract, such as nonsteroidal anti-inflammatory drugs and aspirin

7 Allergy to the experimental medication

8 Difficulties in attending the trial (paralysis, serious mental illness, dementia, renal diseases, stroke, coronary atherosclerotic heart diseases, diabetes or mental diseases, illiteracy, etc.)

9 Pregnant or breastfeeding

10 Refusing to sign the informed consent form

Table 4 Components of the Xiangsha Liujunzi granules

Scientific name	Part used	Proportion of ingredients (100%)
Astragalus mongholicus	Root	12
Codonopsis pilosula	Root	12
Rhizoma Atractylodis Macrocephalae	Rhizome	12
Poria cocos	Sclerotium	12
Fructus Aurantii	Fruit	12
Amomum villosum	Fruit	6.4
Ligusticum chuanxiong Hort	Sclerotium	9.6
Rhizoma corydalis	Rhizoma	9.6
Medicated Leaven	Fermentation products	12
Glycyrrhiza uralensis Fisch	Root	2.4

Table 5 Subject characteristics (n = 202) n (%)

Characteristic		Placebo group (n = 67)	CHM group (n = 135)
Gender	Female	86 (63.7)	43 (64.2)
Age	mean ± SD	43.89 ± 13.32	44.33 ± 12.41
	20-29	12 (17.9)	21 (15.6)
	30-39	18 (26.9)	28 (20.7)
	40-49	8 (11.9)	31 (22.9)
	50-59	17 (25.4)	28 (20.7)
	60+	12 (17.9)	21 (15.6)
Level of education	Primary school	5 (7.5)	9 (6.7)
	Junior school	6 (8.9)	22 (16.3)
	Senior school	15 (22.4)	23 (17)
	Degree or above	41 (61.2)	81 (60)

CHM: Chinese herbal medicine.

Table 6 Gastric emptying rates of proximal and distal stomach

Time	Placebo (n = 67)	CHM (n = 135)	t	P value
0 wk
GE rate of proximal stomach
30 min	32.85 ± 19.27	30.91 ± 16.67	0.653	0.515
60 min	49.26 ± 18.67	49.46 ± 17.74	-0.066	0.947
90 min	66.37 ± 14.63	63.72 ± 17.51	0.948	0.344
120 min	76.54 ± 13.97	75.39 ± 13.91	0.487	0.627
GE rate of distal stomach
30 min	15.68 ± 35.26	6.81 ± 37.61	1.576	0.117
60 min	32.49 ± 30.82	26.91 ± 33.36	1.124	0.263
90 min	49.26 ± 25.93	41.84 ± 33.59	1.555	0.122
120 min	61.61 ± 21.85	57.52 ± 27.02	1.053	0.294
4 wk
GE rate of proximal stomach
30 min	28.48 ± 13.13	36.31 ± 10.78	-4.195	0.000
60 min	47.21 ± 16.76	56.92 ± 10.27	-4.722	0.000
90 min	59.59 ± 17.71	72.92 ± 16.94	-6.919	0.000
120 min	71.47 ± 16.94	82.31 ± 7.35	-5.888	0.000
GE rate of distal stomach
30 min	7.03 ± 35.40	-24.34 ± 34.02	5.707	0.000
60 min	26.94 ± 31.39	40.83 ± 16.37	-3.871	0.000
90 min	50.06 ± 21.97	56.90 ± 15.35	-2.406	0.017
120 min	61.89 ± 15.26	67.66 ± 13.41	-2.578	0.011

CHM: Chinese herb medicine; GE: Gastric emptying.