Bu-Fei Yi-Shen Granules Reduce Acute Exacerbations in Patients with GOLD 3–4 COPD: A Randomized Controlled Trial

Figures & data

Table 1 Components of Bu-Fei Yi-Shen Granules

Chinese Name	Latin Name	Parts of the Substances	Amount (g)
Ren Shen	Radix Ginseng	Root	9
Huang Qi	Astragalus membranaceus (Fisch.) Bunge	Root	15
Jiu Yu Rou	Cornus officinalis Sieb. et Zucc.	Sarcocarp	12
Gou Qi Zi	Lycium chinense Mill.	Fruit	12
Wu Wei Zi	Schisandra chinensis	Fruit	9
Yin Yang Huo	Epimedium brevicornu Maxim	Whole herb	9
Zhe Bei Mu	Fritillaria thunbergii Miq	Bulb	9
Chi Shao	Paeoniae Radix Rubra	Root	9
Di Long	Pheretima	Drying body	12
Chao Zi Su Zi	Perilla frutescens	Seed	9
Ai Di Cha	Japanese Ardisia Herb	Dried whole grass	15
Chen Pi	Citrus reticulata Blanco	Peel of fruit	12

Figure 1 Study trial procedure.

Figure 2 Procedures for each patient in the study.

Table 2 Summary of Discontinuities/Dropouts/ Withdraw for the Two Groups

Groups	Total	Against Protocol	Efficacy Deficiency	Unknown Reason	COVID-2019	Other Reasons	Data Deficiency
Experimental group	39	21	2	7	3	3	3
Control group	29	17	1	4	1	3	3

Table 3 Baseline Characteristics of Included COPD Patients^§

Characteristics	Experimental Group	Control Group	t/χ^2/F	P
Average age—years*	65.07±7.89	65.33±7.82	−0.28	0.776
Male sex — no. (%)	135(84.375)	141(96.34)	0.32	0.572
Han nationality— no. (%)	158(98.75)	164(100.0)	2.06	0.151
BMI*	22.10±3.56	22.18±3.37	0.32	0.571
Heart rate	82.68±13.93	83.65±12.97	−0.65	0.516
Systolic pressure*	127.70±13.51	125.74±13.29	1.32	0.189
Diastolic pressure*	79.49±8.25	79.21±8.46	0.30	0.768
Marrige
Unmarried — no. (%)	7(4.375)	1(0.61)	0.31	0.577
Married — no. (%)	139(86.875)	151(92.07)
Divorce — no. (%)	12(7.5)	10(6.10)
Widow or widower — no. (%)	2(1.25)	2(1.22)
Education levels
Illiteracy/ Semiliterate — no. (%)	21(13.125)	19(11.585)	0.03	0.866
Primary school — no. (%)	30(18.75)	39(23.780)
Junior middle school — no. (%)	53(33.125)	46(28.049)
Senior middle school — no. (%)	40(25)	42(25.610)
Junior college — no. (%)	11(6.875)	10(6.10)
Undergraduate — no. (%)	5(3.125)	8(4.878)
Occupations
Civil servants — no. (%)	2(1.25)	3(1.829)	1.01	0.314
Professionals — no. (%)	3(1.875)	3(1.829)
Workers — no. (%)	4(2.5)	3(1.829)
Farmers — no. (%)	78(48.75)	87(53.049)
Retirement — no. (%)	58(36.25)	53(32.927)
Others — no. (%)	15(9.375)	15(9.146)
Patients with smoking — no. (%)	116(72.50)	129(78.659)	2.04	0.154
Patients with drinking — no. (%)	67(41.875)	65(39.634)	0.21	0.650
Diseases duration— months*	108.20±87.16	110.18±88.15	−0.20	0.840
Annual numbers of acute exacerbation*	1.12±1.39	0.99±1.15	0.83	0.410
mMRC Scores *	1.99±0.88	2.03±0.79	−0.42	0.674
6MWT—m*	358.39±101.68	370.05±91.86	1.02	0.314
Symptoms and signs total scores*	10.27±3.04	10.23±3.28	0.085	0.932
CAT total scores*	16.96±7.44	16.26±6.99	0.80	0.422
SF-36 scores*
PF	53.88±19.63	51.89±20.22	0.80	0.371
RP	21.88±34.88	20.27±30.53	0.19	0.660
BP	81.73±20.77	83.43±20.56	0.55	0.461
GH	35.88±15.95	35.80±15.52	0.00	0.965
VT	60.13±16.71	59.15±17.44	0.27	0.607
SF	70.86±29.76	72.03±26.74	0.14	0.710
RE	49.17±43.27	45.73±42.29	0.52	0.470
MH	63.85±17.62	61.37±17.56	1.62	0.205
HT	39.22±22.89	36.28±21.68	1.41	0.236
mCOPD-PRO total scores*	2.05±0.55	1.97±0.57	1.16	0.246
mESQ-COPD total scores*	1.92±0.63	1.88±0.65	0.49	0.625
Lung function*
FEV 1— L	0.95±0.33	0.96±0.32	−0.41	0.684
FVC— L	2.22±0.64	2.32±0.63	−1.40	0.163
FEV1%—%	34.39±8.66	34.87±9.43	−0.44	0.660
Concomitant medication*
Seretide	9	8	2.57	0.63
Spiriva	32	33
Symbicort	28	33
Spiriva+Symbicort	4	7
Spiriva+Seretide	3	8

Notes: *Plus–minus values are means ±SD. ^§ Data analysis have been performed based on FAS. And there were no statistical differences between the two groups in any characteristic at baseline.

Figure 3 Comparison of differences between groups regarding AEs.

Figure 4 Comparison of differences between groups regarding pulmonary function. Pulmonary function, including FEV1, FVC, and FEV1%, were collected and evaluated. (A-C) represent intergroup differences in FEV1, FVC, and FEV1%, respectively. Lower values reflect worse pulmonary function.

Figure 5 Comparison of differences between groups regarding signs and symptoms. Signs and symptoms, including cough, expectoration, wheezing, chest tightness, shortness of breath, fatigue, cyanosis scores, and total scores were calculated and compared between the groups (represented in A, B, C, D, E, F, G, and H, respectively). Lower scores reflect better signs and symptoms.

Figure 6 Comparison of differences between groups regarding 6MWD.

Figure 7 Comparison of differences between groups regarding CAT, mCOPD-PRO, and mESQ-COPD.

Figure 8 Comparison of differences between groups regarding SF-36.

Figure 9 Comparison of differences between groups on mMRC.