Randomized Clinical Trial
Copyright ©The Author(s) 2023.
World J Clin Cases. Feb 6, 2023; 11(4): 830-843
Published online Feb 6, 2023. doi: 10.12998/wjcc.v11.i4.830
Table 1 All ingredients of the different treatment group
Group
Ingredient
ControlWarm boiled water
XDDahuang (Rhubarb) 6 g, Houbu (Magnolia officinalis) 6 g and Zhishi (Immature Bitter Orange) 12 g
MXDDahuang (Rhubarb) 6 g, Houbu (Magnolia officinalis) 6 g, Zhishi (Immature Bitter Orange) 12 g, Huangqi (Astragalus) 20 g, Ruxiang (Frankincense) 6 g and Moyao (Myrrh) 6 g
Table 2 Basic characteristics of the participants
Characteristics/group
Control (n = 53)
XD (n = 54)
MXD (n = 55)
P value
Age (yr)57.19 ± 13.1955.44 ± 15.7554.53 ± 15.360.640
Sex0.782
  Male23 (43.4%)26 (48.1%)24 (43.6%)
  Female30 (56.6%)28 (51.9%)31 (56.4%)
BMI (kg/m2)23.84 ± 1.8523.78 ± 2.0124.06 ± 1.640.701
Concomitant disease0.917
  Yes30 (56.6%)28 (51.9%)29 (52.7%)
  No23 (43.4%)26 (48.1%)26 (47.3%)
Operation mode0.997
  Laparoscopic cholecystectomy45 (84.9%)46 (85.2%)47 (85.5%)
  Laparoscopic cholecystectomy and choledocholithotomy8 (15.1%)8 (14.85%)8 (14.5%)
Operation time (min)176.70 ± 47.02178.89 ± 47.13173.09 ± 49.360.816
Intraoperative blood loss (mL)37.36 ± 22.8037.04 ± 19.9736.36 ± 19.940.969
Table 3 Recovery of gastrointestinal function after biliary surgery
Parameters
Control (n = 53)
XD (n = 54)
MXD (n = 55)
P value
Bowel sounds (times/min)
  2 h before surgery4.66 ± 0.684.39 ± 0.864.42 ± 0.790.144
  0 h after surgery0.02 ± 0.1410.06 ± 0.2310.15 ± 0.361,20.035
  6 h after surgery2.21 ± 1.3213.11 ± 1.571,23.24 ± 1.621,20.001
  12 h after surgery3.77 ± 1.6616.74 ± 1.991,27.65 ± 2.151,2,30.000
  24 h after surgery3.95 ± 1.1414.85 ± 1.391,25.18 ± 1.531,20.000
Time of first flatus (h)24.00 ± 11.0319.70 ± 10.21217.40 ± 5.3120.003
Time of first defecation (h)55.75 ± 26.9536.91 ± 15.20234.42 ± 12.920.000
Table 4 Diet after biliary surgery
Parameters
Control (n = 53)
XD (n = 54)
MXD (n = 55)
P value
Postoperative drinking time (h)11.11 ± 7.268.88 ± 3.9317.21 ± 3.2010.076
Postoperative liquid diet time (h)15.72 ± 8.9812.74 ± 5.47110.35 ± 4.2410.049
Postoperative semi-liquid diet time (h)27.92 ± 15.1622.53 ± 9.33117.98 ± 6.831,20.028
Postoperative normal diet time (h)100.94 ± 39.0494.80 ± 35.8681.69 ± 29.07 0.333
Table 5 Physical activity after biliary surgery
Activity indicators
Control (n = 53)
XD (n = 54)
MXD (n = 55)
P value
Activity time (min)
  1 d after surgery27.06 ± 8.2928.50 ± 8.9533.76 ± 12.411,20.107
  2 d after surgery41.73 ± 11.5948.07 ± 14.57157.02 ± 19.911,20.157
  3 d after surgery50.94 ± 12.0061.91 ± 21.73163.64 ± 19.6310.201
  4 d after surgery59.24 ± 12.8168.75 ± 19.5478.08 ± 35.1410.130
  5 d after surgery77.40 ± 21.7785.17 ± 27.8188.80 ± 22.320.481
Activity distance (m)
  1 d after surgery256.70 ± 94.97284.57 ± 80.77344.35 ± 134.011,20.127
  2 d after surgery397.19 ± 123.24480.70 ± 163.851630.60 ± 177.831,20.050
  3 d after surgery505.19 ± 151.09571.75 ± 177.87730.21 ± 200.951,20.013
  4 d after surgery651.82 ± 181.59742.75 ± 195.40782.69 ± 159.860.219
  5 d after surgery788.27 ± 236.58792.50 ± 195.48937.10 ± 145.730.162
Table 6 Incidence of complications after biliary surgery
Parameters
Control (n = 53)
XD (n = 54)
MXD (n = 55)
P value
Incision complications2 (3.77%)1 (1.85%)1 (1.82%)0.761
Intra-abdominal infection 1 (1.89%)0 (0%)0 (0%)0.761
Deep-vein thrombosis0 (0%)0 (0%)0 (0%)1.000
Bile leakage1 (1.89%)1 (1.85%)0 (0%)0.599
Nausea and vomiting 12 (22.64%)3 (5.56%)12 (3.64%)10.001
Bloating11 (20.75%)4 (7.41%)13 (5.45%)10.009
Table 7 Incidence of functional diarrhea in perioperative period
Parameters
Control (n = 53)
XD (n = 54)
MXD (n = 55)
P value
1d before surgery2 (3.77%)14 (25.93%)16 (10.91%)1,20.003
1d after surgery1 (1.89%)9 (16.67%)16 (10.91%)10.035
2 d after surgery0 (0%)8 (14.81%)15 (9.09%)10.017
3 d after surgery2 (3.77%)4 (7.41%)2 (3.64%)0.595
4 d after surgery1 (1.89%)2 (3.70%)1 (1.82%)0.777
5 d after surgery2 (3.77%)1 (1.85%)2 (3.64%)0.816
Table 8 Levels of the indicators for acute inflammatory stress response and substance P in the perioperative period of biliary tract surgery
Indicators
Control (n = 53)
XD (n = 54)
MXD (n = 55)
P value
IL-6 (pg/mL)
  1 d before surgery4.89 ± 1.244.43 ± 1.464.26 ± 2.620.203
  1 d after surgery17.42 ± 6.67110.63 ± 9.991,29.08 ± 8.631,20.000
  2 d after surgery11.09 ± 3.5719.80 ± 6.5116.13 ± 3.601,2,30.000
  5 d after surgery8.49 ± 2.3117.22 ± 2.1717.22 ± 3.3910.487
IL-10 (pg/mL)
  1 d before surgery1.29 ± 0.501.25 ± 0.461.24 ± 0.230.798
  1 d after surgery1.27 ± 0.491.20 ± 0.611.21 ± 0.500.761
  2 d after surgery1.21 ± 0.511.23 ± 0.501.19 ± 0.370.942
  5 d after surgery1.33 ± 0.551.45 ± 0.531.39 ± 0.420.865
CRP (ng/mL)
  1 d before surgery6.19 ± 1.775.69 ± 2.405.59 ± 1.870.273
  1 d after surgery16.85 ± 7.73110.84 ± 8.381,28.02 ± 3.441,2,30.000
  2 d after surgery17.90 ± 17.36114.41 ± 11.3618.83 ± 2.841,2,30.001
  5 d after surgery10.33 ± 3.11110.49 ± 1.458.52 ± 2.680.170
SAA (ng/mL)
  1 d before surgery426.21 ± 48.96415.64 ± 40.60411.00 ± 47.390.214
  1 d after surgery9492.64 ± 1738.1617807.52 ± 936.931,26953.98 ± 1228.381,2,30.000
  2 d after surgery14792.13 ± 6501.47110573.74 ± 4074.711,29341.03 ± 1888.411,20.000
  5 d after surgery7817.09 ± 550.5217396.66 ± 611.0216911.41 ± 1464.1410.132
Substance P (pg/mL)
  1 d before surgery40.73 ± 21.5335.61 ± 19.7936.14 ± 31.120.501
  1 d after surgery33.60 ± 16.05137.30 ± 16.0749.25 ± 41.491,2,30.009
  2 d after surgery28.23 ± 11.12145.58 ± 24.071,251.73 ± 26.871,20.000
  5 d after surgery28.29 ± 11.9027.55 ± 23.9935.48 ± 23.700.653
Table 9 Spearman correlation between indicators of gastrointestinal function and inflammation on the second day after surgery (r, p)
Parameters
IL-6
IL-10
CRP
SAA
Substance P
Bowel sounds at 12 h after surgery(0.25, ≤ 0.001)(-0.03, 0.74)(-0.22, ≤ 0.001)(-0.33, ≤ 0.001)(0.31, ≤ 0.001)
Time of first flatus(0.20, 0.01)(0.05, 0.55)(0.35, ≤ 0.001)(0.16, 0.04)(-0.23, ≤ 0.001)
Time of first defecation(0.14, 0.07)(0.04, 0.59)(0.30, ≤ 0.001)(0.24, ≤ 0.001)(-0.25, ≤ 0.001)
Postoperative liquid diet time(0.19, 0.01)(-0.02, 0.81)(0.27, ≤ 0.001)(0.08, 0.33)(-0.10, 0.23)
Postoperative semi-liquid diet time(0.09, 0.25)(-0.00, 0.98)(0.29, ≤ 0.001)(0.11, 0.15)(-0.15, 0.06)
Substance P(-0.20, 0.01)(-0.15, 0.06)(-0.15, 0.05)(-0.24, ≤ 0.001)(1.00, ≤ 0.001)