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This multicentre, randomized controlled study sought to evaluate amitriptyline (tricyclic antidepressant) at low-dose and titrated for irritable bowel syndrome (IBS) as a second-line intervention in outpatient care.
Low-dose amitriptyline, when titrated and used as a second-line option, markedly reduces IBS symptom severity and is safe and well-tolerated in primary care patients who do not respond to first-line therapies.
This multicentre, randomized controlled study sought to evaluate amitriptyline (tricyclic antidepressant) at low-dose and titrated for irritable bowel syndrome (IBS) as a second-line intervention in outpatient care.
The ATLANTIS trial (Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment) was conducted across 55 general practices in England. Adults aged 18 or older with ongoing IBS symptoms (Rome IV criteria) of any subtype and an IBS Severity Scoring System (IBS-SSS) score ≥75, despite dietary modifications and first-line treatments, were eligible. Volunteers also had negative coeliac serology, normal full blood count and C-reactive protein, and no suicidal ideation.
In total, 463 subjects (mean age 48.5 years; 68% female) were randomly assigned to get low-dose oral amitriptyline (starting at 10 mg daily; n=232) or placebo (n=231) for 6 months, with titration up to 30 mg daily over 3 weeks based on symptom response and tolerability. The key endpoint was IBS-SSS score assessment at 6 months. Effectiveness analyses followed the intention-to-treat principle, while safety analyses included all volunteers who received at least 1 dose.
At 6 months, intention-to-treat analysis illustrated a remarkable improvement in IBS-SSS with low-dose amitriptyline compared to placebo (-27.0). Discontinuation occurred in 46 subjects (20%) in the amitriptyline group—30 (13%) owing to adverse events—and 59 subjects (26%) in the placebo group—20 (9%) owing to adverse events. Overall, 5 severe adverse reactions were reported (2 in the amitriptyline arm and 3 in the placebo arm), along with 5 serious adverse events not related to the study medication.
Titrated low-dose amitriptyline proved more efficient than placebo as a second-line therapy in primary care, demonstrating good safety and tolerability. General practitioners are encouraged to prescribe low-dose amitriptyline to IBS sufferers unresponsive to initial treatments, supported by patient-friendly titration tools.
The Lancet
Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in primary care (ATLANTIS): a randomised, double-blind, placebo-controlled, phase 3 trial
Alexander C Ford et al.
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