Table 3B.

RCT of Kampo medicine for constipation.

References	Study design	Subjects (n)	Age, years (mean ± SD)	Disease/symptom	Kampo formulation	Comparator	Outcome	Adverse reaction
Arita et al. (50)	RCT subanalysis	34	77.5 ± 11.9 78.7 ± 12.1	Functional constipation	DKT added to conventional therapy	Conventional therapy	The total neurogenic bowel dysfunction score, Gastrointestinal Symptom Rating Scale-constipation subscale score, and gas volume score at baseline were significantly correlated with the change in these scores.	N/A
Numata et al. (49)	RCT	34	78.1 ± 11.6	Functional constipation	DKT added to conventional therapy	Conventional therapy	The frequency of bowel movements, feeling of incomplete evacuation, and need for enema/disimpaction were significantly improved by DKT. The gas volume score was also significantly reduced by DKT.	Liver dysfunction (low level)
Horiuchi et al. (51)	RCT	22	69.2 ± 13/68.9 ± 16	Chronic constipation	Regular dose of DKT added to sennoside	Half of regular dose of DKT added to sennoside	The addition of DKT reduced abdominal bloating and pain in chronic constipation patients receiving stimulant laxatives with decreasing the bowel gas volume.	None
Miyoshi et al. (52)	DB-RCT	146	65 patients over 60 years	Constipation	Regular dose of DKZT	Low dose of DKZT or placebo	DKZT was significantly effective for constipation compared to the placebo.	No significant difference between groups.

DKT, daikenchuto; DKZT, daiokanzoto; N/A, not assigned.