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Journal of Chinese Integrative Medicine ›› 2009, Vol. 7 ›› Issue (3): 212-217.doi: 10.3736/jcim20090303

• Original Clinical Research • Previous Articles     Next Articles

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

Wen-yan Gao,  Yi-fan Lin , Shan-quan Chen, Yu-ping Lu, Zhuo Yang, Yang Gong, Yang Liu, Li-xin Wang, Chang-hong Wang   

  1. Department of Traditional Chinese Medicine, General Hospital of Shenyang Military Command, Shenyang 110016, Liaoning Province, China
  • Received:2008-08-25 Accepted:2009-01-04 Online:2009-03-20 Published:2009-03-15


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.

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.

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.

Changjishu soft elastic capsule is effective and safe for treatment of D-IBS patients with liver-qi stagnation and spleen deficiency syndrome

Key words: Changjishu soft elastic capsule, Irritable bowel syndrome, Liver qi stagnation, Spleen deficiency, Treatment outcome, Safety

Figure 1

Test flow chart"

[1] Duan N, Lin SR . Evaluation and progress of drug treatment for digestive diseases: the memoir of experts round table conference on rational use of drug for digestive diseases[J]. Zhongguo Yi Yuan Yong Yao Ping Jia Yu Fen Xi, 2008,8(8):561-564
段宁, 林三仁 . 消化系统疾病药物治疗进展与评价——消化系统合理用药专家圆桌会议纪要[J]. 中国医院用药评价与分析, 2008,8(8):561-564
[2] Clinical Services Committee of the British Society of Gastroenterology. New guidelines for diagnosis and treatment of adult irritable bowel syndrome[J]. Xian Dai Xiao Hua Ji Jie Ru Zhen Liao, 2007,l2(2):141
英国胃肠病临床服务协会. 成人肠易激综合征诊治新指南[J]. 现代消化及介入诊疗, 2007,l2(2):141
[3] Friedel D, Thomas R, Fisher RS . Ischemic colitis during treatment with alosetron[J]. Gastroenterology, 2001,120(2):557-560
doi: 10.1053/gast.2001.21177
[4] Miller DP, Alfredson T, Cook SF, Sands BE, Walker AM . Incidence of colonic ischemia, hospitalized complications of constipation and bowel surgery in relation to use of alosetron hydrochloride[J]. Am J Gastroenterol, 2003,98(5):1117-1122
doi: 10.1111/j.1572-0241.2003.07418.x
[5] Branch Association for Diseases of Digestive System, Chinese Medical Association. A consensus view of the diagnosis and treatment of irritable bowel syndrome[J]. Zhonghua Xiao Hua Za Zhi, 2003,23(7):724
中华医学会消化病学分会. 肠易激综合征诊治共识意见[J]. 中华消化杂志, 2003,23(7):724
[6] Zheng XY. Guidelines for clinical research on Chinese new herbal medicines(trial implementation)[M]. Beijing: China Medical Pharmaceutical Science & Technology Publishion House,2002:139- 143, 364-366
郑筱萸 . 中药新药临床研究指导原则(试行)[M]. 北京: 中国医药科技出版社,2002:139- 143, 364-366
[7] State Food and Drug Administration. Technical require-ments of research on Chinese new herbal medicines. 1999: 34-37. Chinese.
国家食品药品监督管理局. 中药新药研究的技术要求. 1999: 34-37.
[8] Xu XY, Wang AY, Wang DH, Wang DN . Efficacy of glutamine compound in treatment of diarrhea-predominant irritable bowel syndrome[J]. Zhongguo Yi Shi Jin Xiu Za Zhi, 2003,30(6):17-18
徐秀英, 王爱瑶, 王德华, 王丹宁 . 复方谷氨酰胺治疗腹泻型肠易激综合征的疗效观察[J]. 中国医师进修杂志, 2003,30(6):17-18
[9] Su H, Sheng JQ, Chen ZM, Li AQ, Yan W, Yu DL, Zhang YH, Li SR . Clinical efficacy of glutamine compound enteric capsules in the treatment of diarrhea-predominant irritable bowel syndrome[J]. Wei Chang Bing Xue Za Zhi, 2006,11(10):602-604
苏惠, 盛剑秋, 晨智敏, 李爱琴, 闫伟, 余东亮, 张英辉, 李世荣 . 复方谷氨酰胺肠溶胶囊对腹泻为主型肠易激综合征的临床疗效观察[J]. 胃肠病学杂志, 2006,11(10):602-604
[10] Naliboff BD, Chang L, Munakata J, Mayer EA . Towards an integrative model of irritable bowel syndrome[J]. Prog Brain Res, 2000,( 122):413-423
[11] Wang WA, Qian JM, Pan GZ . Pathogenesis of irritable bowel syndrome[J]. Wei Chang Bing Xue He Gan Bing Xue Za Zhi, 2001,10(2):99-102
王伟岸, 钱家鸣, 潘国宗 . 肠易激综合征的发病机制[J]. 胃肠病学和肝病学杂志, 2001,10(2):99-102
[12] Chen WX, Shi ZP, Dou YR, Lu Y . Effects of modified Tongxieyaofang Decoction on isolated colon of irritable bowel syndrome[J]. Zhong Yao Yao Li Yu Lin Chuang, 2008,24(3):3-4
陈文星, 时贞平, 窦银荣, 陆茵 . 痛泻要方治疗肠易激综合征的肠肌体内外调节作用[J]. 中药药理与临床, 2008,24(3):3-4
[13] Sun X, Cai G, Wang WJ . Observation on intestinal flora in patients of irritable bowel syndrome after treatment of Chinese integrative medicine[J]. J Chin Integr Med, 2004,2(5):340-342
孙旭, 蔡淦, 王文健 . 肠易激综合征中西医结合治疗前后肠道菌群状况观察[J]. 中西医结合学报, 2004,2(5):340-342
[14] Corazziari E, Bytzer P, Delvaux M, Holtmann G, Malagelada JR, Morris J, Muller-Lissner S, Spiller RC, Tack J, Whorwell PJ . Clinical trial guidelines for pharmacological treatment of irritable bowel syndrome[J]. Aliment Pharmacol Ther, 2003,18(6):569-580
doi: 10.1046/j.1365-2036.2003.01709.x
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