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Tianeptine vs amitriptyline for the treatment of irritable bowel syndrome with diarrhea: a multicenter, open‐label, non‐inferiority, randomized controlled study
Author(s) -
Sohn W.,
Lee O. Y.,
Kwon J. G.,
Park K. S.,
Lim Y. J.,
Kim T. H.,
Jung S. W.,
Kim J. I.
Publication year - 2012
Publication title -
neurogastroenterology and motility
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.489
H-Index - 105
eISSN - 1365-2982
pISSN - 1350-1925
DOI - 10.1111/j.1365-2982.2012.01945.x
Subject(s) - tianeptine , amitriptyline , irritable bowel syndrome , tolerability , medicine , diarrhea , abdominal pain , randomized controlled trial , adverse effect , gastroenterology , antidepressant , hippocampus
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.