TY - JOUR
T1 - Tianeptine vs amitriptyline for the treatment of irritable bowel syndrome with diarrhea
T2 - A multicenter, open-label, non-inferiority, randomized controlled study
AU - Sohn, W.
AU - Lee, O. Y.
AU - Kwon, J. G.
AU - Park, K. S.
AU - Lim, Y. J.
AU - Kim, T. H.
AU - Jung, S. W.
AU - Kim, J. I.
PY - 2012/9
Y1 - 2012/9
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
UR - http://www.scopus.com/inward/record.url?scp=84865440164&partnerID=8YFLogxK
U2 - 10.1111/j.1365-2982.2012.01945.x
DO - 10.1111/j.1365-2982.2012.01945.x
M3 - Article
C2 - 22679908
AN - SCOPUS:84865440164
SN - 1350-1925
VL - 24
SP - 860-e398
JO - Neurogastroenterology and Motility
JF - Neurogastroenterology and Motility
IS - 9
ER -