Tianeptine vs amitriptyline for the treatment of irritable bowel syndrome with diarrhea: a multicenter, open-label, non-inferiority, randomized controlled study
- Authors
- Sohn, W.; Lee, O. Y.; Kwon, J. G.; Park, K. S.; Lim, Y. J.; Kim, T. H.; Jung, S. W.; Kim, J. I.
- Issue Date
- 9월-2012
- Publisher
- WILEY
- Keywords
- Amitriptyline; antidepressant; irritable bowel syndrome; tianeptine
- Citation
- NEUROGASTROENTEROLOGY AND MOTILITY, v.24, no.9, pp.860 - +
- Indexed
- SCIE
SCOPUS
- Journal Title
- NEUROGASTROENTEROLOGY AND MOTILITY
- Volume
- 24
- Number
- 9
- Start Page
- 860
- End Page
- +
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/107495
- DOI
- 10.1111/j.1365-2982.2012.01945.x
- ISSN
- 1350-1925
- 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 (37.5 mg)/probiotics (Bacillus subtilis + Streptococcus faecium) or amitriptyline (10 mg)/probiotics (Bacillus subtilis + Streptococcus faecium) for 4 weeks. 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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