UMIN-CTR 臨床試験登録情報の閲覧

結果：34名の被験者（平均年齢；78.1 ± 11.6歳、男性：女性 = 17:17）が参加した。介入群と対照群の群間比較において便秘臨床スコアCSSの総得点はいずれも介入群が対照群よりも有意に低下していた（いずれもp < 0.01）。CSSの下位尺度では排便頻度、残便感、下剤・浣腸・摘便の必要性において介入群が有意な低下を示した（各々、p < 0.01、 p = 0.049、 p = 0.03）。さらに、採血では介入群においてCGRPは増加傾向を示したが群間比較、群内比較ともに有意差は認められなかった（p = 0.08、 p = 0.15）。腸管ガス量は対照群と比較し介入群において有意に減少した（p = 0.03）。大建中湯投与による注目すべき副反応は認められなかった。

Poststroke patients with functional constipation, assessed by the Rome III criteria, from 6 hospitals were recruited in a study on the effects of the traditional Japanese medicine Daikenchuto (DKT) on constipation. Thirty-four patients (17 men and 17 women; mean age: 78.1 years) were randomly assigned to 2 groups; all patients received conventional therapy for constipation, and patients in the DKT group received 15g/day of DKT for 4 weeks. Constipation scoring system (CSS) points and the gas volume score (GVS) (the measure of the intestinal gas volume calculated from plain abdominal radiographs) were recorded before and after a 4-week observation period. The total score on the CSS improved significantly in the DKT group compared to the control (p < 0.01 ). In addition, scores for some CSS subcategories (frequency of bowel movements, feeling of incomplete evacuation, and need for enema/disimpaction) significantly improved in the DKT group (p < 0.01, p = 0.049, and p = 0.03, resp.). The GVS was also significantly reduced in the DKT group compared to the control ( p = 0.03). DKT in addition to conventional therapy is effective in treating functional constipation in poststroke patients.