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临床试验/NCT06151067
NCT06151067已完成不适用

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

Evangelic Hospital Kalk Cologne1 个研究点 分布在 1 个国家目标入组 458 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
458
试验地点
1
主要终点
Anxiety and depression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with symptoms of reflux who present at the consultation hour at the department of General, Visceral, Tumor and Transplantation Surgery of the University Hospital of Cologne
  • Patients who underwent Upper GI Endoscopy, High-Resolution Manometry and pH-Impedance testing who completed the HADS questionnaire were included into the study.

排除标准

  • Patients without knowledge of the German language
  • Patients who did not complete the HADS questionnaire
  • Patients who did not complete all diagnostic testing

结局指标

主要结局

Anxiety and depression

时间窗: During diagnostic workup of patients with gastroesophageal reflux disease as baseline characteristics

Anxiety and depression are evaluated during diagnostic workup of patients using the HADS questionnaire. In evaluating the HADS scores were grouped into subscales of HADS-A of =8 and \>8 as "anxious" and those on the subscale of HADS-D of 8 and over 8 as "depressed". It is differentiated between mildly (HADS score on the subscale 8-10), moderately (HADS 11 - 14) and severely (HADS 15 - 21) anxious or depressed.

次要结局

未报告次要终点

研究者

发起方
Evangelic Hospital Kalk Cologne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Leers

Prof. Dr. med. Jessica Leers

Evangelic Hospital Kalk Cologne

研究点 (1)

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