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©The Author(s) 2017.
World J Gastroenterol. Aug 14, 2017; 23(30): 5589-5601
Published online Aug 14, 2017. doi: 10.3748/wjg.v23.i30.5589
Published online Aug 14, 2017. doi: 10.3748/wjg.v23.i30.5589
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 |
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) |
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 |
- Citation: Lv L, Wang FY, Ma XX, Li ZH, Huang SP, Shi ZH, Ji HJ, Bian LQ, Zhang BH, Chen T, Yin XL, Tang XD. Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study. World J Gastroenterol 2017; 23(30): 5589-5601
- URL: https://www.wjgnet.com/1007-9327/full/v23/i30/5589.htm
- DOI: https://dx.doi.org/10.3748/wjg.v23.i30.5589