Tianeptine vs amitriptyline for the treatment of irritable bowel syndrome with diarrhea: A multicenter, open-label, non-inferiority, randomized controlled study

W. Sohn, O. Y. Lee, J. G. Kwon, K. S. Park, Y. J. Lim, T. H. Kim, Sung Woo Jung, J. I. Kim

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background Tricyclic antidepressants have good efficacy in irritable bowel syndrome with diarrhea (IBS-D), but their clinical use is limited by considerations of tolerability. Tianeptine, another antidepressant, acts as a selective serotonin reuptake enhancer. We compared tianeptine with amitriptyline for the treatment of patients with IBS-D. Methods We undertook a multicenter, randomized, open-label, non-inferiority clinical study that compared tianeptine with amitriptyline, each in combination with probiotics, for the treatment of IBS-D. Subjects were randomized to receive tianeptine (37.5mg)/probiotics (Bacillus subtilis + Streptococcus faecium) or amitriptyline (10mg)/probiotics (Bacillus subtilis + Streptococcus faecium) for 4weeks. A total of 228 patients were analyzed by the intention-to-treat approach. The primary efficacy endpoint was the proportion of patients who had global relief of IBS symptoms at week 4. The secondary efficacy endpoints were intensity of abdominal pain/discomfort, stool frequency/consistency, quality of life, and overall satisfaction with treatment. Key Results At week 4, non-inferiority of the tianeptine group to the amitriptyline group (treatment difference -15.1%; 95% CI -26.6% to -3.8%) was shown, with 81.1% (99 of 122 patients) of the patients in the tianeptine group and 66.0% (70 of 106 patients) in the amitriptyline group reporting global relief of IBS symptoms. The secondary endpoints also demonstrated non-inferiority of the tianeptine group to the amitriptyline group. Adverse events such as dry mouth and constipation were significantly lower in the tianeptine group than the amitriptyline group (P<0.05). Conclusions & Inferences Tianeptine is not inferior to amitriptyline for treating IBS-D in terms of both efficacy and tolerability.

Original languageEnglish
JournalNeurogastroenterology and Motility
Volume24
Issue number9
DOIs
Publication statusPublished - 2012 Sep 1

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tianeptine
Amitriptyline
Irritable Bowel Syndrome
Diarrhea
Probiotics
Enterococcus faecium
Therapeutics
Bacillus subtilis
Tricyclic Antidepressive Agents

Keywords

  • Amitriptyline
  • Antidepressant
  • Irritable bowel syndrome
  • Tianeptine

ASJC Scopus subject areas

  • Physiology
  • Endocrine and Autonomic Systems
  • Gastroenterology

Cite this

Tianeptine vs amitriptyline for the treatment of irritable bowel syndrome with diarrhea : A multicenter, open-label, non-inferiority, randomized controlled study. / Sohn, W.; Lee, O. Y.; Kwon, J. G.; Park, K. S.; Lim, Y. J.; Kim, T. H.; Jung, Sung Woo; Kim, J. I.

In: Neurogastroenterology and Motility, Vol. 24, No. 9, 01.09.2012.

Research output: Contribution to journalArticle

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abstract = "Background Tricyclic antidepressants have good efficacy in irritable bowel syndrome with diarrhea (IBS-D), but their clinical use is limited by considerations of tolerability. Tianeptine, another antidepressant, acts as a selective serotonin reuptake enhancer. We compared tianeptine with amitriptyline for the treatment of patients with IBS-D. Methods We undertook a multicenter, randomized, open-label, non-inferiority clinical study that compared tianeptine with amitriptyline, each in combination with probiotics, for the treatment of IBS-D. Subjects were randomized to receive tianeptine (37.5mg)/probiotics (Bacillus subtilis + Streptococcus faecium) or amitriptyline (10mg)/probiotics (Bacillus subtilis + Streptococcus faecium) for 4weeks. A total of 228 patients were analyzed by the intention-to-treat approach. The primary efficacy endpoint was the proportion of patients who had global relief of IBS symptoms at week 4. The secondary efficacy endpoints were intensity of abdominal pain/discomfort, stool frequency/consistency, quality of life, and overall satisfaction with treatment. Key Results At week 4, non-inferiority of the tianeptine group to the amitriptyline group (treatment difference -15.1{\%}; 95{\%} CI -26.6{\%} to -3.8{\%}) was shown, with 81.1{\%} (99 of 122 patients) of the patients in the tianeptine group and 66.0{\%} (70 of 106 patients) in the amitriptyline group reporting global relief of IBS symptoms. The secondary endpoints also demonstrated non-inferiority of the tianeptine group to the amitriptyline group. Adverse events such as dry mouth and constipation were significantly lower in the tianeptine group than the amitriptyline group (P<0.05). Conclusions & Inferences Tianeptine is not inferior to amitriptyline for treating IBS-D in terms of both efficacy and tolerability.",
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AU - Lee, O. Y.

AU - Kwon, J. G.

AU - Park, K. S.

AU - Lim, Y. J.

AU - Kim, T. H.

AU - Jung, Sung Woo

AU - Kim, J. I.

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N2 - Background Tricyclic antidepressants have good efficacy in irritable bowel syndrome with diarrhea (IBS-D), but their clinical use is limited by considerations of tolerability. Tianeptine, another antidepressant, acts as a selective serotonin reuptake enhancer. We compared tianeptine with amitriptyline for the treatment of patients with IBS-D. Methods We undertook a multicenter, randomized, open-label, non-inferiority clinical study that compared tianeptine with amitriptyline, each in combination with probiotics, for the treatment of IBS-D. Subjects were randomized to receive tianeptine (37.5mg)/probiotics (Bacillus subtilis + Streptococcus faecium) or amitriptyline (10mg)/probiotics (Bacillus subtilis + Streptococcus faecium) for 4weeks. A total of 228 patients were analyzed by the intention-to-treat approach. The primary efficacy endpoint was the proportion of patients who had global relief of IBS symptoms at week 4. The secondary efficacy endpoints were intensity of abdominal pain/discomfort, stool frequency/consistency, quality of life, and overall satisfaction with treatment. Key Results At week 4, non-inferiority of the tianeptine group to the amitriptyline group (treatment difference -15.1%; 95% CI -26.6% to -3.8%) was shown, with 81.1% (99 of 122 patients) of the patients in the tianeptine group and 66.0% (70 of 106 patients) in the amitriptyline group reporting global relief of IBS symptoms. The secondary endpoints also demonstrated non-inferiority of the tianeptine group to the amitriptyline group. Adverse events such as dry mouth and constipation were significantly lower in the tianeptine group than the amitriptyline group (P<0.05). Conclusions & Inferences Tianeptine is not inferior to amitriptyline for treating IBS-D in terms of both efficacy and tolerability.

AB - Background Tricyclic antidepressants have good efficacy in irritable bowel syndrome with diarrhea (IBS-D), but their clinical use is limited by considerations of tolerability. Tianeptine, another antidepressant, acts as a selective serotonin reuptake enhancer. We compared tianeptine with amitriptyline for the treatment of patients with IBS-D. Methods We undertook a multicenter, randomized, open-label, non-inferiority clinical study that compared tianeptine with amitriptyline, each in combination with probiotics, for the treatment of IBS-D. Subjects were randomized to receive tianeptine (37.5mg)/probiotics (Bacillus subtilis + Streptococcus faecium) or amitriptyline (10mg)/probiotics (Bacillus subtilis + Streptococcus faecium) for 4weeks. A total of 228 patients were analyzed by the intention-to-treat approach. The primary efficacy endpoint was the proportion of patients who had global relief of IBS symptoms at week 4. The secondary efficacy endpoints were intensity of abdominal pain/discomfort, stool frequency/consistency, quality of life, and overall satisfaction with treatment. Key Results At week 4, non-inferiority of the tianeptine group to the amitriptyline group (treatment difference -15.1%; 95% CI -26.6% to -3.8%) was shown, with 81.1% (99 of 122 patients) of the patients in the tianeptine group and 66.0% (70 of 106 patients) in the amitriptyline group reporting global relief of IBS symptoms. The secondary endpoints also demonstrated non-inferiority of the tianeptine group to the amitriptyline group. Adverse events such as dry mouth and constipation were significantly lower in the tianeptine group than the amitriptyline group (P<0.05). Conclusions & Inferences Tianeptine is not inferior to amitriptyline for treating IBS-D in terms of both efficacy and tolerability.

KW - Amitriptyline

KW - Antidepressant

KW - Irritable bowel syndrome

KW - Tianeptine

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