Randomized Clinical Trial
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World J Gastroenterol. Aug 28, 2014; 20(32): 11422-11428
Published online Aug 28, 2014. doi: 10.3748/wjg.v20.i32.11422
Efficacy of tandospirone in patients with irritable bowel syndrome-diarrhea and anxiety
Ling Lan, Yu-Long Chen, Hao Zhang, Bai-Ling Jia, Yan-Jun Chu, Jin Wang, Shi-Xiao Tang, Guo-Dong Xia
Ling Lan, Hao Zhang, Bai-Ling Jia, Department of Gastroenterology, the People’s Hospital, Zhengzhou University, Zhengzhou 450003, Henan Province, China
Yu-Long Chen, Yan-Jun Chu, Jin Wang, Department of Gastroenterology, the First Affiliated Hospital, Zhengzhou University, Zhengzhou 450052, Henan Province, China
Shi-Xiao Tang, Guo-Dong Xia, Department of Gastroenterology, the First Affiliated Hospital, Luzhou Medical College, Luzhou 646000, Henan Province, China
Author contributions: Chen YL and Lan L designed the research study; Lan L and Jia BL performed the research and wrote the paper; Chu YJ and Wang J collected the data and performed statistical analysis; Tang SX and Xia GD collected the data; all authors had approved the final version of the manuscript, including the authorship list.
Correspondence to: Yu-Long Chen, Professor, Department of Gastroenterology, the First Affiliated Hospital, Zhengzhou University, No. 1 Jianshe East Road, Zhengzhou 450052, China. yulongchen@hotmail.com
Telephone: +86-371-65580603 Fax: +86-371-65964376
Received: December 22, 2013
Revised: April 3, 2014
Accepted: May 28, 2014
Published online: August 28, 2014
Abstract

AIM: To investigate the efficacy of tandospirone in patients with irritable bowel syndrome-diarrhea (IBS-D) and anxiety in a prospective, randomized, controlled study.

METHODS: Two hundred patients with IBS-D and moderate anxiety were randomized to receive pinaverium and tandospirone (arm A) or pinaverium and placebo (arm B). Tandospirone or placebo was given thrice daily at a fixed dose of 10 mg and pinaverium was given thrice daily at a fixed dose of 50 mg. The duration of treatment was 8 wk. Patients were assessed for abdominal pain and diarrhea. Anxiety was evaluated using the Hamilton Rating Scale for Anxiety (HAM-A). The primary study endpoints were response rates for abdominal pain and diarrhea. The secondary study endpoints were response rates for anxiety. Adverse events were also evaluated.

RESULTS: One hundred and seventy of 200 patients (82 patients in arm A and 88 patients in arm B) completed the study. Demographic and baseline characteristics of the 200 participants were comparable in the two arms. At week 8, the overall response rate for abdominal pain and diarrhea was 52.0% for arm A and 37.0% for arm B (P < 0.05). The HAM-A score showed that the response rate was 61.0% for arm A and 21.0% for arm B (P < 0.01). The treatments were well tolerated and no significant adverse events were reported.

CONCLUSION: Tandospirone is effective and can be combined with pinaverium in IBS-D patients with anxiety.

Keywords: Irritable bowel syndrome, Anxiety, Tandospirone, Efficacy, Safety

Core tip: Irritable bowel syndrome (IBS) is associated with psychological stress, anxiety and depression, which may contribute to perpetuating the condition. IBS-diarrhea (IBS-D), an isotype of IBS, is often accompanied by anxiety, and conventional therapy is unfavorable. IBS-D may respond positively to anti-anxiety/-depression therapies. However, existing medications are not sufficiently effective for patients with IBS-D. To our knowledge, few randomized, controlled and multi-center studies have focused on the efficacy of anti-anxiety agents in IBS-D patients. This is a prospective, randomized, controlled study to evaluate the efficacy of tandospirone in patients with combined IBS-D and anxiety.