[Effects of Changjishu soft elastic capsule in treatment of diarrhea-predominant irritable bowel patients with liver-qi stagnation and spleen deficiency syndrome: a randomized double-blinded controlled trial].

OBJECTIVE: To evaluate the efficacy and safety of Changjishu soft elastic capsule, a new Chinese herbal medicine for smoothing liver, invigorating spleen and regulating qi activity, on diarrhea-predominant irritable bowel syndrome (D-IBS) patients with liver-qi stagnation and spleen deficiency syndrome. METHODS: A randomized, double-blinded, and positive control method was adopted. One hundred and four cases of D-IBS conforming to the inclusive criteria were randomly divided into treatment group (78 cases) and control group (26 cases). Patients in the treatment group were treated with Changjishu soft elastic capsule, four capsules once daily and three times a day. Patients in the control group were treated with glutamine compound enteric capsule, three capsules once daily and three times a day. After 21-day treatment, the efficacy of Changjishu soft elastic capsule was evaluated by the changes of single symptom such as abdominal pain or discomfort, defecation frequency, and stool characteristics. The safety of Changjishu elastic capsule was assessed by laboratory data and adverse events. RESULTS: Abdominal pain or discomfort scores at days 7, 14, 21 and the declined score at day 21 in the treatment group significantly decreased as compared with the control group (P < 0.05). Defecation frequency score at day 14 and the declined score at day 21 in the treatment group significantly decreased as compared with the control group (P < 0.05). Stool characteristics score and the declined score at day 21 in the treatment group significantly decreased as compared with those of the control group (P < 0.05). Rugitus scores and the declined scores at days 14 and 21 significantly decreased as compared with the control group (P < 0.05). The total response rates in the treatment and control groups were 71.62% and 40.91%, and the recovery rates were 20.27% and 13.64%, respectively. There existed significant differences between the two groups in therapeutic effect (P < 0.01). The therapeutic effect of Changjishu elastic capsule was better than that of glutamine compound enteric capsule. Side effects and adverse events were not found in the two groups. CONCLUSION: Changjishu soft elastic capsule is effective and safe for treatment of D-IBS patients with liver-qi stagnation and spleen deficiency syndrome.