Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06151067 |
| Other study ID # |
GERD_HADS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
Evangelic Hospital Kalk Cologne |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
Introduction:
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). In the diagnosis of the reflux disease the
DeMeester score is used as a measure of esophageal acid exposure time. Important differential
diagnosis are benign functional disorders of the esophagus such as is functional heartburn or
functional dysphagia. Comorbid symptoms of anxiety and depression are common: 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. The results
are inconsistent: In younger patients (18 - 40 years) with gastroesophageal reflux disease
(GERD) the prevalence of anxiety and depression is higher than in those without GERD. There
is an independent association between GERD, anxiety and current depression. Patients with
anxiety are more likely to experience GERD symptoms and these symptoms seem to be more severe
in anxious patients. Anxiety and depression intensify symptom perception. Patients with GERD
have a higher incidence of anxiety, depression and sleep disturbances than those without
GERD, and there is an association between psychosocial disorders and an increased risk of
anxiety. Thus, there is a an interaction between GERD and psychosocial disorders, which has
been discussed as the "psychoemotional effects of GERD". GERD is considered to be an
independent source of stress.
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. Furthermore, the modulation of
anxiety on the severity of reflux symptoms such as fullness, heartburn and dysphagia is
examined.
2. Methods Statement of ethics The present study was conducted according to Declaration of
Helsinki principles and was approved by the Ethics Committee of the Medical Faculty of the
University of Cologne. All patients provided their online informed consent. The study has not
been registered in any study register.
Study design We conducted a prospective observational cohort study with one measurement time
on admission.
Participants We enrolled all patients who were referred to the "Reflux and swallowing
problems center" of the Clinic for General and Visceral Surgery of the University Hospital
Cologne, Germany, between January 2020 and July 2021. Only patients were included for
analysis who completed the HADS-D. All patients underwent gastrointestinal function
diagnostics with esophagogastroduodenoscopy, 24-hour pH-metry, high-resolution manometry and
esophagography. Psychometric data were collected using the HADS. The criteria for indication
for surgery were positive DMS, presence of hiatal hernia, changes in the esophagus due to
reflux such as Barrett esophagus or inflammation, poor tolerance of medication, low level of
symptom control through medication and lifestyle, decreased quality of life, long duration of
the disease and substantial comorbidities. Not all criteria needed to be fullfied.
Questionnaires We used the HADS in its German version for assessing anxiety (HADS-A) and
depression levels (HADS-D). Self-report is used to assess the severity of anxious and
depressive symptoms during the past week, which is recorded on two subscales with seven items
each, each item ranging from 0 - 3, adding up to a maximal total score of 21. For both
subscales a cutoff score for caseness of > 8 is recommended (27).
Data analysis In evaluating the HADS scores we labeled scores on the subscales of HADS-A of 8
and over 8 as "anxious" and those on the subscale of HADS-D of 8 and over 8 as "depressed".
We differentiated between mildly (HADS score on the subscale 8-10), moderately (HADS 11 - 14)
and severely (HADS 15 - 21) anxious or depressed.
The DMS was determined using 24h pH impedance testing which included the following values in
the score: percentage of time with esophageal pH < 4 of the total measurement period,
percentage of time with pH < 4 during the waking phase (upright position), percentage of time
with pH < 4 during sleep phase (supine position), total number of reflux episodes during the
measurement period, number of reflux episodes with duration > 5 min, duration of the longest
reflux episode.
In evaluating the DMS we labeled scores as negative (physiological) (< 14.72) or positive
(pathological) (> 14.72). The positive scores were differentiated into mild (14.72 - 30),
moderate (30 - 80) and severe (<80).
Statistical Analysis Statistical analysis was performed using IBM SPSS Statistics. Continuous
variables were presented as mean and standard deviation, categorical data as frequencies with
percentages. To identify differences between two groups, an independent samples T-test was
performed for parametric data, whereas a Mann-Whitney U test was performed for non-parametric
data. Furthermore, a Chi-square test for independence or Fischer's Exact test respectively
was performed in case of categorical data. Correlation between parameters was investigated
using Pearson correlation coefficient for parametric data and Spearman correlation
coefficient for non-parametric data. A p-value < 0.05 was considered statistically
significant.
