Table 2B.

RCT of Kampo medicine for COPD.

References	Study design	Subjects (n)	Age, years (range or mean ± SD) Kampo group/control group	Disease/symptom	Kampo formulation	Comparator	Outcome	Adverse reaction
Sasaki et al. (26)	RCT (envelope)	19	62–83/65–88	Chronic respiratory disease	BAK	Bromhexine hydrochloride	The BAK group showed improved loosening of phlegm after 2 and 4 weeks.	None
Kato et al. (28)	RCT (envelope)	31	66.7 ± 7.1/66.7 ± 6.4	COPD	SHT + smoking cessation	No Kampo, only smoking cessation	SHT improved the clinical symptoms of patients with COPD for 6 months, and chest X-ray or CT findings at 24 months.	N/A
Shinozuka et al. (30)	RCT	35	73 ± 1	COPD	HET + bronchodilators	Bronchodilators	In the HET group, serum CRP and TNF-α significantly decreased, and serum albumin level was significantly increased.	N/A
Tatsumi et al. (31)	RCT (envelope)	71	Elderly	COPD	HET + conventional therapy	Conventional therapy	In the HET group, body weight significantly increased for 6 months, and St. George's Respiratory Questionnaire score decreased, indicating that quality of life improved. The number of common cold and acute exacerbations was significantly lower. CRP, TNF-α, and IL-6 decreased, and serum prealbumin increased.	None
Mukaida et al. (27)	Crossover RCT	24 (23)	Group A: 76.2 ± 8.5/group B: 79.2 ± 2.6	COPD	BAK	No Kampo	BAK significantly improved VAS scores for cough frequency in group A. VAS scores for cough intensity in each group tended to improve. BAK improved scores of cough severity significantly.	Serum ALP elevation in two participants

ALP, alkaline phosphatase; BAK, bakumondoto; COPD, chronic obstructive pulmonary disease; CRP, C-reactive protein; CT, computed tomography; HET, hochuekkito; IL, interleukin; SHT, seihaito; TNF-α, tumor necrosis factor-α; VAS, visual analog scale; N/A, not assigned.