ATLANTIS: Amitriptyline at Low-dose and Titrated for Irritable Bowel Syndrome as Second-line Treatment: A Double-blind Placebo-controlled Trial
We want to find out whether a tablet called amitriptyline helps people with irritable bowel syndrome (IBS). Amitriptyline will be prescribed by a GP, at a low dose, when other treatments (e.g. changes to diet) have not worked. We are interested in its effect on both the symptoms of IBS and costs of managing it.
The study will run from September 2018 to July 2022.
About 1 in 10 people report on-going tummy pain or bloating and changes in bowel habit. These are typical symptoms of IBS. IBS is a long-term condition. It causes discomfort and distress, reducing people’s quality of life. There is no cure and it can be difficult to treat. IBS is also expensive, because people often visit their GP, take time off work, or need to see specialists.
Amitriptyline can be used to treat IBS at a low dose. Amitriptyline is also used in higher doses to treat depression. We believe it helps with IBS because it relieves pain and changes bowel activity, rather than because it affects mood. Small studies of amitriptyline have shown promising results and guidelines suggest trying it when people with IBS have ongoing symptoms. We are unsure whether the drug benefits people with IBS who are looked after by their GP, as there has been no large study.
GPs will invite people who have tried other treatments (such as fibre supplements or anti-spasm tablets), but still have IBS symptoms, to take part. We will check that people are suitable by doing a telephone questionnaire and blood tests at their GP practice.
People will be given either amitriptyline or dummy (placebo) tablets. A computer will randomly decide who gets which tablets. People will be asked to take the tablets for 6 months, in addition to their GP’s usual treatment for IBS. They will also get an advice sheet about the role of diet in IBS. People will not be aware which treatment they get.
After 6 months participants will be able to continue the treatment, if they wish. We will follow people up at 12 weeks, and 6 and 12 months. We will ask people to fill out questionnaires about their IBS symptoms, mood, and, quality of life. We will look at how many prescriptions for other drugs have been given to people, and how many tests or referrals have been asked for by their GP. We will also record any side effects and problems during treatment.
As we will need over 500 people, the study will take place across 75 UK general practices. We will also interview participants and GPs about their experience of being in the trial.
Study team, funder and contact details
Local Investigators: Dr Matthew Ridd
University of Leeds: Professor Alexander Ford (Co-CI), Professor Amanda Farrin, Professor Robbie Foy, Dr Sarah Alderson, Miss Delia Muir, Professor Elspeth Guthrie, Miss Suzanne Hartley, Mr Matthew Chaddock
University of Southampton: Hazel Everitt (Co-CI), Felicity Bishop
Funder: NIHR Health Technology Assessment (16/162/01)
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