Clinical efficacy of comprehensive therapy based on traditional Chinese medicine patterns on patients with pneumoconiosis: a pilot double-blind, randomized, and placebo-controlled study
1. Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province & Education Ministry of China, Henan University of Chinese Medicine, Zhengzhou 450046, China 2. Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou 450046, China 3. Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China 4. Department of Pneumoconiosis, Henan Hospital for Occupational Diseases, Zhengzhou 450052, China 5. Department of Respiratory Diseases, Jiaozuo Coal Industry Group Co., Ltd. Central Hospital, Jiaozuo 454000, China 6. Department of Pneumoconiosis, Yima Coal Industry Group Co., Ltd. General Hospital, Yima 472300, China
Effective therapy options for pneumoconiosis are lacking. Traditional Chinese medicine (TCM) presents a favorable prospect in the treatment of pneumoconiosis. A pilot study on TCM syndrome differentiation can evaluate the clinical efficacy and safety of TCM and lay a foundation for further clinical research. A double-blind, randomized, and placebo-controlled trial was conducted for 24 weeks, in which 96 patients with pneumoconiosis were randomly divided into the control and treatment groups. Symptomatic treatment was conducted for the two groups. The treatment group was treated with TCM syndrome differentiation, and the control group was treated with placebo. The primary outcomes were the six-minute walking distance (6MWD) and the St. George Respiratory Questionnaire (SGRQ) score. The secondary outcomes were the modified British Medical Research Council Dyspnea Scale (mMRC), Chronic Obstructive Pulmonary Disease Assessment Test (CAT), Hospital Anxiety and Depression Scale (HADS), and pulmonary function. Only 83 patients from the 96 patients with pneumoconiosis finished the study. For the primary outcome, compared with the control groups, the treatment group showed a significantly increased 6MWD (407.90 m vs. 499.51 m; 95% confidence interval (CI) 47.25 to 135.97; P <0.001) and improved SGRQ total score (44.48 vs. 25.67; 95% CI −27.87 to −9.74; P <0.001). The treatment group also significantly improved compared with the control group on mMRC score (1.4 vs. 0.74; 95% CI −1.08 to −0.23; P =0.003), CAT score (18.40 vs. 14.65; 95% CI −7.07 to −0.43; P =0.027), and the total symptom score (7.90 vs. 5.14; 95% CI −4.40 to −1.12; P <0.001). No serious adverse events occurred. This study showed that TCM syndrome differentiation and treatment had a favorable impact on the exercise endurance and quality of life of patients with pneumoconiosis.
. [J]. Frontiers of Medicine, 2022, 16(5): 736-744.
Jiansheng Li, Hulei Zhao, Yang Xie, Jieya Li, Qingwei Li, Xuexin Chen, Weiyu Zhang. Clinical efficacy of comprehensive therapy based on traditional Chinese medicine patterns on patients with pneumoconiosis: a pilot double-blind, randomized, and placebo-controlled study. Front. Med., 2022, 16(5): 736-744.
Ginseng, Chinese Magnoliavine Fruit, Epimedium Herb, Rose-Boot, Tendrilleaf Fritillary Bulb, Tree Peony Root Bark, Coix Seed, Perilla Seed
Tab.1
Fig.1
Variable
ITT analysis
PP analysis
Treatment group (N=48)
Control group (N=48)
Treatment group (N=43)
Control group (N=40)
Age, year, mean±SD
53.96±9.01
57.40±10.13
54.40±9.18
57.23±10.75
Disease type
Anthracosis, n (%)
34 (70.83)
34 (70.83)
32 (74.42)
27 (67.50)
Silicosis, n (%)
8 (16.67)
9 (18.75)
6 (13.95)
9 (22.50)
Anthracosilicosis, n (%)
6 (12.50)
5 (10.42)
5 (11.63)
4 (10.00)
Course of disease, month, median (IQR)
57.00 (31.50,117.00)
65.00 (24.00,156.75)
49.00 (29.00,120.0)
60.00 (24.00,156.75)
Western medicine treatment
Symptomatic treatment, n (%)
15 (31.25)
15 (31.25)
12 (27.91)
12 (30.00)
Cetylcysteine, n (%)
10 (22.83)
11 (22.92)
9 (20.93)
8 (20.00)
Tiotropium, n (%)
4 (8.33)
10 (22.83)
2 (4.65)
9 (22.50)
Doxofylline, n (%)
0 (0.00)
2 (4.17)
0 (0.00)
1 (2.50)
Tetrandrine, n (%)
10 (22.83)
12 (25.00)
10 (23.26)
9 (22.50)
Pulmonary function, mean±SD
FEV1 (L)
2.67±0.95
2.61±1.07
2.76±0.73
2.63±1.17
FVC (L)
3.54±1.24
3.54±1.15
3.59±0.91
3.57±1.25
FEV1/FVC (%)
74.47±10.28
73.17±12.05
76.45±8.07
73.15±13.18
FEV1%
83.05±29.39
80.04±31.74
86.74±21.49
81.18±33.92
PEF (L/s)
7.13±2.61
7.16±2.75
7.36±2.42
7.20±2.90
DLCO (mL/mmHg/min)
7.45±2.50
7.22±1.76
7.75±2.20
7.35±1.73
Tab.2
Variable
ITT analysis
PP analysis
Treatment group (N=48)
Control group (N=48)
Treatment group (N=43)
Control group (N=40)
Hypertension disease, n (%)
4 (8.33)
4 (8.33)
4 (9.30)
4 (10.00)
Amlodipine, n (%)
1 (2.08)
0 (0.00)
1 (2.33)
0 (0.00)
Captopril, n (%)
1 (2.08)
0 (0.00)
1 (2.33)
0 (0.00)
Nimodipine, n (%)
0 (0.00)
1 (2.08)
0 (0.00)
1 (2.50)
Indapamide, n (%)
1 (2.08)
0 (0.00)
1 (2.33)
0 (0.00)
Nifedipine, n (%)
2 (4.17)
2 (4.17)
2 (4.65)
2 (5.00)
Valsartan, n (%)
0 (0.00)
1 (2.08)
0 (0.00)
1 (2.50)
Chronic obstructive pulmonary disease, n (%)
0 (0.00)
1 (2.08)
0 (0.00)
1 (2.50)
Tiotropium, n (%)
0 (0.00)
1 (2.08)
0 (0.00)
1 (2.50)
Diabetes, n (%)
2 (4.17)
3 (6.25)
2 (4.65)
3 (7.50)
Acarbose, n (%)
0 (0.00)
1 (2.08)
0 (0.00)
1 (2.50)
Metformin, n (%)
1 (2.08)
2 (4.17)
1 (2.33)
2 (5.00)
Gliclazide, n (%)
0 (0.00)
2 (4.17)
0 (0.00)
2 (5.00)
Insulin glargine, n (%)
1 (2.08)
0 (0.00)
1 (2.33)
0 (0.00)
Gastric Ulcer, n (%)
1 (2.08)
0 (0.00)
1 (2.33)
0 (0.00)
Omeprazole, n (%)
1 (2.08)
0 (0.00)
1 (2.33)
0 (0.00)
Cimetidine, n (%)
1 (2.08)
0 (0.00)
1 (2.33)
0 (0.00)
Tab.3
Variable
Treatment group (N=43)
Control group (N=40)
95% CI for the difference
Statistics
Pa
Pre
Post
Pre
Post
6MWD, mb
447.12±108.23
499.51±99.39
437.31±107.66
407.90±103.72
91.61 (47.25 to 135.97)
16.883
< 0.001
SGRQ symptoms scoreb
50.47±22.68
36.94±22.25
55.15±17.93
47.75±20.27
−10.811 (−20.13 to −1.49)
5.328
0.024
SGRQ activity scoreb
44.76±23.63
28.20±23.30
46.61±23.87
47.53±25.31
−19.33 (−29.95 to −8.71)
13.125
0.001
SGRQ impacts scoreb
36.59±27.44
20.27±18.53
43.56±26.19
41.18±24.45
−20.92 (−30.35 to −11.49)
19.464
< 0.001
SGRQ total scoreb
41.25±24.16
25.67±18.94
45.63±23.37
44.48±22.54
−18.81 (−27.87 to −9.74)
17.025
< 0.001
Tab.4
Variable
Treatment group (N=48)
Control group (N=48)
95% CI for the difference
Statistics
Pa
Pre
Post
Pre
Post
6MWD, mb
439.25±111.96
486.19±109.14
432.53±102.40
407.08±100.12
79.10 (36.66 to 121.55)
13.693
< 0.001
SGRQ symptoms scoreb
51.55±24.99
34.22±22.52
53.90±17.97
45.33±21.38
−11.11 (−20.01 to −2.21)
6.143
0.015
SGRQ activity scoreb
46.43±25.60
25.26±23.68
47.98±22.31
42.60±27.34
−17.34 (−27.71 to −6.98)
11.040
0.001
SGRQ impacts scoreb
38.69±28.55
18.63±18.17
44.48±24.60
37.58±25.02
−18.95 (−27.81 to −10.08)
18.014
< 0.001
SGRQ total scoreb
43.08±25.80
23.42±19.11
46.43±21.80
40.39±24.06
−16.97 (−25.78 to −8.17)
14.644
< 0.001
Tab.5
Variable
Treatment group (N=48)
Control group (N=48)
95% CI for the difference
Statistics
Pa
Pre
Post
Pre
Post
mMRC scoreb
1.46±0.87
0.90±1.08
1.37±0.98
1.45±1.01
−0.56 (−0.98 to −0.14)
6.881
0.010
CAT scoreb
17.00±9.26
15.42±9.54
18.37±7.65
17.9±6.47
−2.48 (−5.78 to 0.82)
2.221
0.140
HADS-anxiety scoreb
7.00±3.88
4.35±3.56
7.17±3.47
6.06±3.72
−1.71 (−3.19 to −0.23)
5.276
0.024
HADS-depression scoreb
6.50±4.38
5.27±4.04
7.38±3.31
5.56±3.73
−0.29 (−1.28 to 1.87)
0.135
0.714
Tab.6
Variable
Treatment group (N=43)
Control group (N=40)
95% CI for the difference
Statistics
Pa
Pre
Post
Pre
Post
mMRC scoreb
1.37±0.76
0.74±0.93
1.35±1.05
1.40±1.01
−0.66 (−1.08 to −0.23)
9.526
0.003
CAT scoreb
16.33±8.29
14.65±8.52
18.08±8.03
18.40±6.44
−3.75 (−7.07 to −0.43)
5.05
0.027
HADS-anxiety scoreb
6.79±3.78
4.86±3.42
7.00±3.65
6.75±3.38
−1.89 (−3.38 to −0.40)
6.398
0.013
HADS-depression scoreb
6.29±4.10
5.88±3.81
7.22±3.50
6.15±3.50
−0.27 (−1.87 to 1.34)
0.109
0.742
Tab.7
Variable
Treatment group (N=48)
Control group (N=48)
95% CI for the difference
Statistics
Pa
Pre
Post
Pre
Post
Cough scoreb
1.00 (1.00,2.00)
0.50 (0.00,1.00)
2.00 (1.00,2.00)
1.00 (1.00,2.00)
0.00 (0.00 to 0.00)
1.771
0.077
Expectoration scoreb
1.00 (1.00,2.00)
1.00 (0.00,1.00)
1.00 (1.00,2.00)
1.00 (1.00,2.00)
0.00 (−1.00 to 0.00)
2.429
0.015
Wheezing scoreb
2.00 (1.00,2.00)
1.00 (0.00,2.00)
1.00 (1.00,2.00)
1.00 (1.00,2.00)
0.00 (−1.00 to 0.00)
3.508
< 0.001
Chest tightness scoreb
2.00 (1.00,2.00)
1.00 (0.25,1.00)
1.00 (1.00,2.00)
1.00 (1.00,2.00)
0.00 (−1.00 to 0.00)
2.408
0.016
Shortness of breath scoreb
1.50 (1.00,2.00)
1.00 (0.00,1.00)
1.00 (1.00,2.00)
1.00 (1.00,2.00)
0.00 (−1.00 to 0.00)
2.380
0.017
Fatigue scoreb
2.00 (1.00,2.00)
1.00 (0.00,1.00)
1.00 (1.00,2.00)
1.00 (1.00,1.00)
0.00 (−1.00 to 0.00)
2.822
0.005
Cyanosis scoreb
1.00 (0.00,1.00)
0.00 (0.00,1.00)
1.00 (0.00,1.00)
1.00 (0.00,1.00)
0.00 (0.00 to 0.00)
1.117
0.264
Total clinical symptom scorec
8.83±3.57
5.58±4.20
8.73±3.19
8.06±3.35
−2.48 (−4.02 to −0.94)
10.222
0.002
Tab.8
Variable
Treatment group (N=43)
Control group (N=40)
95% CI for the difference
Statistics
Pa
Pre
Post
Pre
Post
Cough scoreb
1.00 (1.00,2.00)
0.00 (0.00,1.00)
2.00 (1.00,2.00)
1.00 (1.00,2.00)
0.00 (−1.00 to 0.00)
1.896
0.058
Expectoration scoreb
1.00 (1.00,2.00)
1.00 (0.00,1.00)
1.00 (0.00,2.00)
1.00 (1.00,2.00)
0.00 (−1.00 to 0.00)
2.339
0.019
Wheezing scoreb
2.00 (1.00,2.00)
1.00 (0.00,1.00)
1.00 (1.00,2.00)
1.00 (1.00,2.00)
−1.00 (−1.00 to 0.00)
3.331
0.001
Chest tightness scoreb
2.00 (1.00,2.00)
1.00 (0.00,1.00)
1.00 (1.00,2.00)
1.00 (1.00,2.00)
0.00 (−1.00 to 0.00)
2.033
0.042
Shortness of breath scoreb
1.00 (1.00,2.00)
1.00 (0.00,1.00)
1.00 (1.00,2.00)
1.00 (1.00,2.00)
0.00 (−1.00 to 0.00)
2.008
0.045
Fatigue scoreb
2.00 (1.00,2.00)
1.00 (0.00,1.00)
1.00 (1.00,2.00)
1.00 (0.25,1.75)
−1.00 (−1.00 to 0.00)
3.009
0.003
Cyanosis scoreb
1.00 (0.00,1.00)
0.00 (0.00,1.00)
1.00 (0.00,1.00)
1.00 (0.00,1.00)
0.00 (0.00 to 0.00)
1.286
0.198
Total clinical symptom scorec
8.72±3.38
5.14±3.88
8.60±3.30
7.90±3.60
−2.76 (−4.40 to −1.12)
11.159
< 0.001
Tab.9
Variable
Treatment group (N=48)
Control group (N=48)
95% CI for the difference
Statistics
Pa
Pre
Post
Pre
Post
Physical function scoreb
75.00 (46.25,85.00)
75.0 0 (55.00,85.00)
60.00 (45.00,85.00)
60 (50.00,80.00)
0.00 (−5.00 to 10.00)
−0.735
0.462
Role physical scoreb
12.50 (0.00,75.00)
0.00 (0.00,100.00)
0.00 (0.00, 75.00)
0.00 (0.00,50.00)
0.00 (0.00 to 0.00)
−1.726
0.084
Bodily pain scoreb
62.00 (52.00,84.00)
74.00 (62.00,100)
62.00 (52.00,74.00)
74.00 (62.00,96.00)
0.00 (0.00 to 10.00)
−1.038
0.229
General health scoreb
37.50 (26.25,50.00)
51.00 (35.00,64.25)
40.00 (26.25,50.00)
35.00 (30.00,45.00)
10.00 (5.00 to 15.00)
−3.159
0.002
Vitality scoreb
50.00 (45.00,63.75)
55.50 (50.00,65.00)
50.00 (45.00,63.75)
50.00 (50.00,60.00)
0.00 (0.00 to 5.00)
0.682
0.495
Social functionb
62.50 (50.00,87.50)
75.00 (53.13,87.50)
75.00 (50.00,87.50)
62.50 (50.00,87.50)
0.00 (0.00 to 12.50)
−0.992
0.321
Role emotional scoreb
33.00 (0,100.00)
33.30 (0.00,100.00)
0.00 (0.00,66.70)
0.00 (0.00,66.70)
0.00 (0.00 to 0.00)
0.242
0.808
Mental health scoreb
52.00 (48.00,60.00)
52.00 (48.00,56.00)
52.00 (49.00,56.00)
52.00 (52.00,56.00)
0.00 (−4.00 to 0.00)
0.844
0.398
Health change score
25.00 (25.00,50.00)
50.00 (25.00,75.00)
25.00 (20.00,50.00)
50.00 (25.00,50.00)
0.00 (0.00 to 25.00)
−1.137
0.255
Tab.10
Variable
Treatment group (N=43)
Control group (N=40)
95% CI for the difference
Statistics
Pa
Pre
Post
Pre
Post
Physical function scoreb
75.00 (55.00,85.00)
80.00 (60.00,85.00)
60.00 (41.25, 88.75)
65.00 (46.25,80.00)
0.00 (−5.00 to 10.00)
−0.549
0.583
Role physical scoreb
25.00 (0.00,75.00)
0.00 (0.00,100.00)
0.00 (0.00, 75.00)
0.00 (0.00,50.00)
0.00 (0.00 to 25.00)
−1.707
0.088
Bodily pain scoreb
62.00 (52.00,84.00)
74.00 (62.00,100.00)
62.00 (52.00,81.50)
74.00 (62.00,100.00)
0.00 (0.00 to 10.00)
0.872
0.383
General health scoreb
40.00 (30.00,50.00)
55.00 (35.00,65.00)
40.00 (21.25, 50.00)
35.00 (30.00,45.00)
10.00 (5.00 to 17.00)
−3.061
0.002
Vitality scoreb
50.00 (45.00,65.00)
55.00 (50.00,65.00)
50.00 (45.00,65.00)
50.00 (50.00,60.00)
0.00 (−5.00 to 5.00)
−0.656
0.512
Social functionb
62.00 (50.00,87.00)
75.00 (62.00,87.00)
75.00 (50.00,87.00)
62.50 (50.00,87.50)
0.00 (0.00 to 12.50)
−0.961
0.337
Role emotional scoreb
33.30 (0,100.00)
33.30 (0.00,100.00)
0.00 (0.00,91.68)
0.00 (0.00,100.00)
0.00 (0.00 to 0.00)
−0.264
0.792
Mental health scoreb
52.00 (48.00,60.00)
52.00 (48.00,56.00)
52.00 (52.00,59.00)
56.00 (52.00,56.00)
0.00 (−4.00 to 0.00)
0.815
0.415
Health change score
25.00 (25.00,50.00)
50.00 (25.00,75.00)
25.00 (25.00,50.00)
50.00 (25.00,50.00)
0.00 (0.00 to 25.00)
−1.137
0.255
Tab.11
Variable
Treatment group (N=48)
Control group (N=48)
95% CI for the difference
Statistics
Pa
Pre
Post
Pre
Post
FEV1 (L)b
2.67±0.95
2.65±0.82
2.61±1.07
2.62±0.77
0.03 (−0.29 to 0.36)
0.045
0.832
FVC (L)b
3.54±1.24
3.63±1.08
3.54±1.15
3.60±1.01
0.03 (−0.39 to 0.46)
0.025
0.875
FEV1/FVC(%)b
74.47±10.28
72.99±10.34
73.17±12.05
72.97±11.47
0.02 (−4.41 to 4.44)
0.000
0.994
FEV1%b
83.05±29.39
82.51±24.88
80.04±31.74
82.08±26.54
0.43 (−9.99 to 10.86)
0.007
0.934
PEF (L/s)b
7.13±2.61
6.75±2.36
7.16±2.75
6.99±2.38
−0.24 (−1.20 to 0.73)
0.237
0.628
DLCO (mL/mmHg/min)b
7.45±2.50
8.68±5.43
7.22±1.76
8.31±4.25
0.38 (−1.60 to 2.35)
0.143
0.706
Tab.12
Variable
Treatment group (N=43)
Control group (N=40)
95% CI for the difference
Statistics
Pa
Pre
Post
Pre
Post
FEV1 (L)b
2.76±0.73
2.71±0.61
2.63±1.17
2.64±0.83
0.07 (−0.24 to 0.39)
0.206
0.651
FVC (L)b
3.59±0.91
3.66±0.73
3.57±1.25
3.65±1.10
0.10 (−0.40 to 0.41)
0.002
0.966
FEV1/FVC (%)b
76.45±8.07
74.22±8.45
73.15±13.18
72.47±12.17
1.76 (−2.79 to 6.30)
0.589
0.445
FEV1%b
86.74±21.49
85.29±17.11
81.18±33.92
83.48±27.92
1.81 (−8.23 to 11.84)
0.129
0.721
PEF (L/s)b
7.36±2.42
7.00±2.09
7.20±2.90
7.07±2.44
−0.07 (−1.06 to 0.92)
0.020
0.889
DLCO (mL/mmHg/min)b
7.75±2.20
9.13±5.46
7.35±1.73
8.66±4.51
0.47 (−1.72 to 2.67)
0.184
0.669
Tab.13
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