Association of Multiple Medications With the Severity of Dyspepsia

• Conditions: Dyspepsia

• Registration Number: NCT05503940
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

Dyspepsia is a very common gastrointestinal disease. Some medications, were associated with higher frequent incidences of dyspepsia, including non-steroid anti-inflammatory drugs (NSAIDs), Bisphosphonates, Tetracyclines, et al. Multiple medications were suggested to be strongly relate to adverse drug events (ADEs), adverse drug reactions (ADRs), drug-drug interactions, and drug-disease interactions, which may cause gastrointestinal(GI) dysfunction or injury to the GI mucosa. However, it was unclear whether multiple medications was associated with more severe symptoms of dyspepsia and dyspepsia-based score systems.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-02
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. aged ≥18 years old
2. Patients who met broad criteria of dyspepsia

Exclusion Criteria

1. organ failure defined by Marshall standard
2. severe psychiatric illnesses
3. suspected or identified bowel obstruction
4. known malignancy
5. pregnancy or lactation
6. unable to provide consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of patients with severe dyspepsia judged by patients	1 day	Patients rated the severity of dyspepsia as mild, moderate, and severe by themselves

Secondary Outcome Measures

Name	Time	Method
Global Overall Symptom score (GOSS)	1 days	The GOSS consists of 10 cardinal items (epigastric pain, epigastric discomfort, Heartburn, acid regurgitation, upper abdominal bloating, belching, nausea, early satiety, postprandial fullness, other epigastric symptoms(eg. epigastric burning). Each item can be scored from 1 (no) to 7 (worst).
subtypes of functional dyspepsia	6 months	functional dyspepsia was classified into three subgroups：(1) Postprandial Distress Syndrome, defined as Bothersome postprandial fullness or/and Bothersome early satiation. (2) Bothersome epigastric pain AND/OR Bothersome epigastric burning. (3) mixed syndrome, defined when postprandial distress syndrome and epigastric pain syndrome presented simultaneously.
Quality of Life scores	1 day	Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionnaire.PROMIS Global-10 is a newly validated 10-question survey used to assess health care-related quality of life measures for the general population.; It's a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient and a better quality of life.
Functional dyspepsia	1 days	Functional dyspepsia was defined by Rome IV criteria. Patients diagnosed as Rome IV criteria met the following criteria: by one or more of the following symptoms: postprandial fullness, early satiation, epigastric pain, and epigastric burning that are unexplained after a routine clinical evaluation, Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
organic upper gastrointestinal (GI) diseases.	1 day	All included patients underwent upper GI endoscopy and abdominal ultrasound and H. Pylori test. Barrett's esophagus, esophageal candidiasis, esophageal cancer, gastric ulcer, gastric erosion, gastric cancer, duodenal ulcer, duodenal erosion, cholecystitis, pancreatitis and biliary stones were classified as organic upper GI diseases.
Short Form of Nepean Dyspepsia Index (SF-NDI)	1 day	The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50.
Functional dyspepsia symptom diary (FDSD) score	1 days	The FDSD consists of 5 cardinal items (burning in the stomach, stomach pain, bloating, postprandial fullness, and early satiety) and 3 supplementary items (nausea, burping/belching rating, and burping/belching bother). Each item can be scored from 0 (no) to 10 (worst). Total Symptom Score includes the 5 cardinal items and ranges from 0 to 50
Hospital anxiety and depression scale	1 day	Anxiety and depression of patients are assessed by using Hospital Anxiety and Depression Scale.It contains 14 items (7 anxiety and 7 depression), which assess symptoms experienced during the past week on a 0-3 scale. A subscore of \> 8 for depression or anxiety would indicate a clinical case.
Number of Participants with other functional gastrointestinal diseases	1 day	Other functional gastrointestinal diseases，such as irritable bowel syndrome(IBS) or functional heartburn，etc.

Trial Locations

Locations (4)

Xijing 986 Hospital; 🇨🇳 Xi'an, Shaanxi, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China

The Second Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China