Tianeptine vs amitriptyline for the treatment of irritable bowel syndrome with diarrhea: a multicenter, open-label, non-inferiority, randomized controlled study
Neurogastroenterology & Motility, 06/15/2012
Sohn W et al. – Tianeptine is not inferior to amitriptyline for treating irritable bowel syndrome with diarrhea (IBS–D) in terms of both efficacy and tolerability.Methods
- The authors 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.
- 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).