Randomized Controlled Trial
Copyright ©The Author(s) 2024.
World J Clin Cases. Jun 26, 2024; 12(18): 3482-3490
Published online Jun 26, 2024. doi: 10.12998/wjcc.v12.i18.3482
Table 1 Baseline characteristics of the participants, n (%)
Variable
Treatment group (n = 50)
Control group (n = 50)
P value
Age (yr)64.2 ± 8.763.8 ± 9.20.82
Sex (male/female)32/1831/190.88
Smoking history (pack-years)28.4 ± 12.627.8 ± 13.20.79
BMI (kg/m2)23.5 ± 3.223.7 ± 3.40.76
Comorbidities
Hypertension18 (36.0)16 (32.0)0.67
Diabetes12 (24.0)14 (28.0)0.59
Coronary heart disease10 (20.0)11 (22.0)0.79
GOLD stage
II18 (36.0)17 (34.0)0.83
III22 (44.0)23 (46.0)0.85
IV10 (20.0)10 (20.0)1.00
Anthonisen type
I32 (64.0)31 (62.0)0.84
II14 (28.0)15 (30.0)0.81
III4 (8.0)4 (8.0)1.00
TCM syndrome score18.6 ± 3.418.8 ± 3.60.78
Medication use
Bronchodilators50 (100.0)50 (100.0)1.00
Corticosteroids48 (96.0)47 (94.0)0.66
Antibiotics46 (92.0)45 (90.0)0.72
Oxygen therapy22 (44.0)21 (42.0)0.86
Table 2 The serum C-reactive protein level in the treatment and control groups
GroupCRP in serum (mg/L)
Mean difference (95%CI)P value
Baseline
End of treatment
Change
Treatment32.6 ± 14.218.4 ± 9.6-14.2 ± 8.4(-12.6 to -4.2)< 0.001
Control31.8 ± 13.824.6 ± 11.2-7.2 ± 7.6
Table 3 The serum interleukin-6 and tumor necrosis factor-alpha levels in the treatment and control groups
IL-6 in serum (pg/mL)
TNF-α in serum (pg/mL)
Group
Baseline
End of treatment
Change
Baseline
End of treatment
Change
Treatment38.4 ± 16.220.8 ± 10.4-17.6 ± 9.68.6 ± 3.26.4 ± 2.8-2.2 ± 1.2
Control37.6 ± 15.828.4 ± 12.8-9.2 ± 8.88.4 ± 3.07.2 ± 2.6-1.2 ± 0.8
Mean difference (95%CI)-12.8 (-18.4 to -7.2)-1.6 (-2.4 to -0.8)
P value< 0.001< 0.001
Table 4 The sputum C-reactive protein, interleukin-6 and tumor necrosis factor-alpha levels in the treatment and control groups

CRP in sputum (mg/L)
IL-6 in sputum (pg/mL)
TNF-α in sputum (pg/mL)
Group
Baseline
End of Treatment
Change
Baseline
End of Treatment
Change
Baseline
End of Treatment
Change
Treatment42.8 ± 18.420.4 ± 12.0-22.4 ± 13.246.2 ± 19.622.8 ± 14.4-23.4 ± 11.212.6 ± 4.88.8 ± 3.6-3.8 ± 2.4
Control41.2 ± 17.632.8 ± 15.2-8.4 ± 10.444.8 ± 18.436.8 ± 16.8-8.0 ± 9.612.2 ± 4.610.4 ± 3.8-1.8 ± 1.6
Mean difference (95%CI)-16.2 (-22.8 to -9.6)-18.6 (-26.2 to -11.0)-2.2 (-3.2 to -1.2)
P value< 0.001< 0.001< 0.001
Table 5 Lung ventilation function parameters in the treatment and control groups

FEV1 (L)
FEV1 (% predicted)
FVC (L)
FVC (% predicted)
PEF (L)
PEF (% predicted)
Group
Baseline
End of treatment
Change
Baseline
End of treatment
Change
Baseline
End of treatment
Change
Baseline
End of treatment
Change
Baseline
End of treatment
Change
Baseline
End of treatment
Change
Treatment1.2 ± 0.41.6 ± 0.50.4 ± 0.238.4 ± 12.851.2 ± 16.012.8 ± 6.42.4 ± 0.83.2 ± 1.00.8 ± 0.472.4 ± 18.484.8 ± 22.412.4 ± 8.82.6 ± 1.03.8 ± 1.21.2 ± 0.658.4 ± 18.476.8 ± 22.418.4 ± 12.4
Control1.2 ± 0.41.4 ± 0.40.2 ± 0.236.8 ± 12.444.8 ± 12.86.4 ± 4.82.4 ± 0.82.8 ± 0.80.4 ± 0.270.8 ± 18.078.4 ± 20.46.4 ± 4.82.4 ± 0.83.0 ± 0.80.6 ± 0.456.8 ± 16.468.0 ± 18.08.4 ± 8.0
Mean difference
(95%CI)
0.2 (0.1 to 0.3)6.4 (4.2 to 8.6)0.4 (0.2 to 0.6)6.0 (4.0 to 8.0)0.6 (0.4 to 0.8)10.0 (6.8 to 13.2)
P value< 0.001< 0.001< 0.001< 0.001< 0.001< 0.001