Effect of citalopram on chest pain in patients with achalasia

Achalasia is a motility disorder of the esophagus. Disappearance of myenteric
neurons in the esophageal wall leads to failure of relaxation of the lower
esophageal sphincter (LES) and impaired peristalsis. Symptoms of achalasia
include dysphagia, regurgitation, chest pain and weight loss due to the stasis
of food and liquids in the esophagus. There is no cure for achalasia, the
treatment focuses on decreasing the resting pressure of the LES to improve
esophageal emptying. This can be achieved by pneumodilatation, surgical myotomy
or per-oral endoscopic myotomy (POEM); all are safe and effective treatments
for patients with achalasia. These treatments effectively diminish the symptoms
dysphagia and regurgitation, however have little effect on the occurrence of
chest pain. The management of recurrent chest pain in achalasia patients is
challenging as 1) the underlying mechanism of chest pain in achalasia is
unknown and 2) evidence-based pharmacological options are currently not
available. Antidepressants are used in the treatment of pain-predominant
functional disorders such as fibromyalgia, irritable bowel syndrome and several
functional esophageal disorders including pain in achalasia. Antidepressants
modulate esophageal sensation and reduce functional chest pain, however,
although these are often prescribed this has not been studied in patients with
achalasia.

This study has been transitioned to CTIS with ID 2024-517701-81-01 check the CTIS register for the current data.

To assess the effect of citalopram on chest pain in patients with achalasia and
to evaluate the effect of citalopram on esophageal sensitivity.

A single centre, double-blind placebo-controlled randomized trial

Daily 20 mg of citalopram or a placebo for a period of 6 weeks.

We evaluate that treatment with citalopram on chest pain in patients with
achalasia is effective and safe. Citalopram is already prescribed for achalasia
patients with functional chest pain (off-label). This study is comparable with
daily clinical practice only now set up in a placebo-controlled randomized
trial. The burden of participating patients will be one extra hospital visit,
filling out questionnaires two times and report their chest pain in a symptom
diary during the treatment period of six weeks. The dose of citalopram in this
study is 20 mg, which is a low dose for adults. Therefore, it is associated
with no or only minor side effects. No extra investigations are necessary, for
all other investigations are part of the normal work-up for these patients
except the tests described in the optional sub-study.