NCT06151067

Important Correlation Between Anxiety and Reflux Symptoms in Patients With Gastroesophageal Reflux Disease

Completed Last updated 30 November 2023

What this trial tests

trial testing High-Resolution Manometry, Upper-GI endoscopy, pH-Impedance testing in GERD - Gastro-Esophageal Reflux Disease in 458 participants. Completed in 30 June 2022.

Timeline

1 January 2020

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	Evangelic Hospital Kalk Cologne
Status	Completed
Study type	OBSERVATIONAL
Enrollment	458
Start date	1 January 2020
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across Germany

Drugs / interventions tested

• High-Resolution Manometry, Upper-GI endoscopy, pH-Impedance testing

Conditions studied

• GERD - Gastro-Esophageal Reflux Disease — all drugs for GERD - Gastro-Esophageal Reflux Disease →
• Anxiety Disorders — all drugs for Anxiety Disorders →

Sponsor

Evangelic Hospital Kalk Cologne

Who can join

18 and older, any sex, with GERD - Gastro-Esophageal Reflux Disease or Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gastroesophageal reflux disease (GERD) is one of the most common gastroenterological disorders with a reported prevalence of 10% to 20% percent in Europe and the USA and less than 5% in Asia. GERD manifests as heartburn, regurgitation, retrosternal pain, cough, and in some cases dysphagia and holds the possible complication of a Barrett´s esophagus. GERD can appear as non-erosive (NERD) or erosive (ERD). Comorbid symptoms of anxiety and depression are common in GERD patients: The association between anxiety or depression and reflux symptoms has been investigated in previous studies under the aspects of whether existing reflux symptomatology leads to increased anxiety and depression or whether anxiety and depression lead to more severe reflux symptoms. There is a an interaction between GERD and psychosocial disorders.

A long duration of GERD was associated with higher levels of anxiety and depression, and women were more likely to have these symptoms. In patients with Barrett's esophagus, a complication of GERD in which the mucosal cells of the esophagus, under constant exposure to stomach acid, change into a different type of cell normally found in the intestinal tract, rates of anxiety and depression have been reported to be three to five times higher than in the general population.

Anxiety and depression as well as adverse events in life are also independent risk factors for NERD. Patients with NERD show an increased risk for anxiety compared with patients with ERD.

The reporting of somatic symptoms is multifactorial and influenced by psychosocial factors such as socioeconomic status, sex and mental distress. A high somatic symptom load is known to increase anxiety related to health issues, psychological distress and health care utilization. The increased sensation to visceral stimuli in which anxiety and depression play an important role has been discussed as visceral hypersensitivity.

Several studies of patients with reflux symptoms have used the Hopsital Anxiety and Depression Scale (HADS) score as a measure of anxiety and depression and have reported higher anxiety scores than depression scores for this cohort.

The aim of this study was to assess anxiety and depression levels of patients with physiological as well as with pathological DeMeester scores. Further the modulation of anxiety on the severity of reflux symptoms such as fullness, heartburn and dysphagia is examined.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Association Between Anxiety and Reflux Symptoms in Patients With Gastroesophageal Reflux Disease: A Prospective Cohort Study.
   Henning M, Lindgen K, Paul D, Fuchs C, et al · · 2024 · cited 5× · PMID 39659314 · DOI 10.7759/cureus.73391