Trial Outcomes & Findings for The Primary Symptoms of GERD(Gastroesophageal Reflux Disease) in Chinese Outpatients in Gastroenterology Department (NCT NCT02506634)
NCT ID: NCT02506634
Last Updated: 2020-01-13
Results Overview
GERD can be diagnosed by more than one different criteria (i.e."reflux esophagitis on endoscopy"; "positive acid exposure time (AET) on reflux monitoring";"Either reflux esophagitis on endoscopy or positive AET on reflux monitoring") in a single participant. When different criteria was used to diagnose GERD, the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom.
COMPLETED
374 participants
over 3 years
2020-01-13
Participant Flow
Four hundred consecutive patients with upper gastrointestinal (GI) symptoms were screened, 19 patients who didn't meet the inclusion criteria and 7 patients with major motility disorders on high resolution manometry were excluded. Thus, a total of 374 patients were finally enrolled in the current study.
The current study was a single Arm study where all participants with upper GI symptoms were enrolled and tested for gastro-esophageal reflux disease (GERD) via endoscopy and 24-hour reflux monitoring. Participants were then given proton pump inhibitor(PPI) treatment and the course was decided base on the endoscopy findings.
Participant milestones
| Measure |
Patients With Upper GI Symptoms
Participants were stratified at baseline based on their main gastrointestinal symptoms and then evaluated for GERD using different methods. They also recieved PPI treatment (Esomeprazole MUPS, 20 mg, bid, 4 or 8 weeks) and finished GERDQ.
|
|---|---|
|
Overall Study
STARTED
|
374
|
|
Overall Study
Participants Who Were Diagnosed as GERD
|
154
|
|
Overall Study
Participants Who Received PPI Treatment
|
357
|
|
Overall Study
Participants Who Finished GERDQ
|
342
|
|
Overall Study
COMPLETED
|
357
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients With Predominant Heartburn
n=87 Participants
Patients with predominant heartburn were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
|
Patients With Predominant Regurgitation
n=82 Participants
Patients with predominant regurgitation were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
|
Patients With Predominant Chest Pain
n=63 Participants
Patients with predominant chest pain were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
|
Patients With Predominant Dysphagia
n=12 Participants
Patients with predominant dysphagia were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
|
Patients With Predominant Epigastric Pain
n=35 Participants
Patients with predominant epigastric pain were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
|
Patients With Predominant Epigastric Burning
n=29 Participants
Patients with predominant epigastric burning were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
|
Patients With Predominant Postprandial Fullness
n=64 Participants
Patients with predominant postprandial fullness were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
|
Patients With Predominant Early Satiety
n=2 Participants
Patients with predominant early satiety were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ.
|
Total
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.90 years
STANDARD_DEVIATION 12.25 • n=87 Participants
|
40.96 years
STANDARD_DEVIATION 14.06 • n=82 Participants
|
43.27 years
STANDARD_DEVIATION 10.70 • n=63 Participants
|
41.83 years
STANDARD_DEVIATION 13.29 • n=12 Participants
|
42.54 years
STANDARD_DEVIATION 14.56 • n=35 Participants
|
43.83 years
STANDARD_DEVIATION 14.34 • n=29 Participants
|
39.88 years
STANDARD_DEVIATION 13.31 • n=64 Participants
|
30.50 years
STANDARD_DEVIATION 12.02 • n=2 Participants
|
42.88 years
STANDARD_DEVIATION 12.31 • n=374 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=87 Participants
|
40 Participants
n=82 Participants
|
32 Participants
n=63 Participants
|
7 Participants
n=12 Participants
|
24 Participants
n=35 Participants
|
18 Participants
n=29 Participants
|
31 Participants
n=64 Participants
|
2 Participants
n=2 Participants
|
196 Participants
n=374 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=87 Participants
|
42 Participants
n=82 Participants
|
31 Participants
n=63 Participants
|
5 Participants
n=12 Participants
|
11 Participants
n=35 Participants
|
11 Participants
n=29 Participants
|
33 Participants
n=64 Participants
|
0 Participants
n=2 Participants
|
178 Participants
n=374 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
22.22 kg/m^2
STANDARD_DEVIATION 3.21 • n=87 Participants
|
22.07 kg/m^2
STANDARD_DEVIATION 3.17 • n=82 Participants
|
22.69 kg/m^2
STANDARD_DEVIATION 3.42 • n=63 Participants
|
21.20 kg/m^2
STANDARD_DEVIATION 3.22 • n=12 Participants
|
21.95 kg/m^2
STANDARD_DEVIATION 3.31 • n=35 Participants
|
22.78 kg/m^2
STANDARD_DEVIATION 3.05 • n=29 Participants
|
21.39 kg/m^2
STANDARD_DEVIATION 2.81 • n=64 Participants
|
17.98 kg/m^2
STANDARD_DEVIATION 1.12 • n=2 Participants
|
22.09 kg/m^2
STANDARD_DEVIATION 3.15 • n=374 Participants
|
PRIMARY outcome
Timeframe: over 3 yearsPopulation: GERD is diagnosed based on different criteria among 374 enrolled patients, and then the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom.
GERD can be diagnosed by more than one different criteria (i.e."reflux esophagitis on endoscopy"; "positive acid exposure time (AET) on reflux monitoring";"Either reflux esophagitis on endoscopy or positive AET on reflux monitoring") in a single participant. When different criteria was used to diagnose GERD, the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom.
Outcome measures
| Measure |
GERD Patients With Predominant Epigastric Pain
The life quality of GERD patients with predominant epigastric pain will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Epigastric Burning
The life quality of GERD patients with predominant epigastric burning will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Postprandial Fullness
The life quality of GERD patients with predominant postprandial fullness will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Early Satiety
The life quality of GERD patients with predominant early satiety will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients Defined by Reflux Esophagitis on Endoscopy
n=79 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Positive AET on Reflux Monitoring
n=111 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Either Endoscopy or Reflux Monitoring
n=154 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
Patients With Predominant Dysphagia
The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant dysphagia will be calculated.
|
|---|---|---|---|---|---|---|---|---|
|
The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department
Regurgitation
|
—
|
—
|
—
|
—
|
23 Participants
|
30 Participants
|
38 Participants
|
—
|
|
The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department
Chest pain
|
—
|
—
|
—
|
—
|
9 Participants
|
16 Participants
|
23 Participants
|
—
|
|
The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department
Dysphagia
|
—
|
—
|
—
|
—
|
2 Participants
|
4 Participants
|
4 Participants
|
—
|
|
The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department
Heartburn
|
—
|
—
|
—
|
—
|
19 Participants
|
30 Participants
|
42 Participants
|
—
|
|
The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department
Epigastric pain
|
—
|
—
|
—
|
—
|
9 Participants
|
5 Participants
|
11 Participants
|
—
|
|
The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department
Epigastric burning
|
—
|
—
|
—
|
—
|
4 Participants
|
11 Participants
|
13 Participants
|
—
|
|
The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department
Postprandial fullness
|
—
|
—
|
—
|
—
|
13 Participants
|
15 Participants
|
23 Participants
|
—
|
|
The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department
Early satiety
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: over 3 yearsPopulation: Among 374 enrolled patients presented with different main symptom, the percentage of patients with reflux esophagitis was calculated.
The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with different main symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated.
Outcome measures
| Measure |
GERD Patients With Predominant Epigastric Pain
n=35 Participants
The life quality of GERD patients with predominant epigastric pain will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Epigastric Burning
n=29 Participants
The life quality of GERD patients with predominant epigastric burning will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Postprandial Fullness
n=64 Participants
The life quality of GERD patients with predominant postprandial fullness will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Early Satiety
n=2 Participants
The life quality of GERD patients with predominant early satiety will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients Defined by Reflux Esophagitis on Endoscopy
n=87 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Positive AET on Reflux Monitoring
n=82 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Either Endoscopy or Reflux Monitoring
n=63 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
Patients With Predominant Dysphagia
n=12 Participants
The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant dysphagia will be calculated.
|
|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms
|
9 Participants
|
4 Participants
|
13 Participants
|
0 Participants
|
19 Participants
|
23 Participants
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: over 3 yearsPopulation: Among 374 enrolled patients presented with different main symptom, the percentage of patients with pathological acid reflux was calculated.
The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with different main baseline symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated.
Outcome measures
| Measure |
GERD Patients With Predominant Epigastric Pain
n=35 Participants
The life quality of GERD patients with predominant epigastric pain will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Epigastric Burning
n=29 Participants
The life quality of GERD patients with predominant epigastric burning will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Postprandial Fullness
n=64 Participants
The life quality of GERD patients with predominant postprandial fullness will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Early Satiety
n=2 Participants
The life quality of GERD patients with predominant early satiety will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients Defined by Reflux Esophagitis on Endoscopy
n=87 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Positive AET on Reflux Monitoring
n=82 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Either Endoscopy or Reflux Monitoring
n=63 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
Patients With Predominant Dysphagia
n=12 Participants
The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant dysphagia will be calculated.
|
|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms
|
5 Participants
|
11 Participants
|
15 Participants
|
0 Participants
|
30 Participants
|
30 Participants
|
16 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: over 3 yearsPopulation: The analysis population for this outcome measure was patients with a GERD diagnosis by either reflux esophagitis on upper endoscopy or positive acid exposure time(AET) on reflux monitoring.
The life quality of GERD patients with different main symptoms before PPI test will be measured via the MOS 36-item short form health survey (SF-36), in which higher scores mean a better quality of life. Its maximum score is 796.5, and the minimum score is 36.5.
Outcome measures
| Measure |
GERD Patients With Predominant Epigastric Pain
n=11 Participants
The life quality of GERD patients with predominant epigastric pain will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Epigastric Burning
n=13 Participants
The life quality of GERD patients with predominant epigastric burning will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Postprandial Fullness
n=23 Participants
The life quality of GERD patients with predominant postprandial fullness will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Early Satiety
The life quality of GERD patients with predominant early satiety will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients Defined by Reflux Esophagitis on Endoscopy
n=42 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Positive AET on Reflux Monitoring
n=38 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Either Endoscopy or Reflux Monitoring
n=23 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
Patients With Predominant Dysphagia
n=4 Participants
The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant dysphagia will be calculated.
|
|---|---|---|---|---|---|---|---|---|
|
The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms
|
581.15 score on a scale
Standard Deviation 193.52
|
545.8 score on a scale
Standard Deviation 176.79
|
618.18 score on a scale
Standard Deviation 152.35
|
—
|
565.04 score on a scale
Standard Deviation 163.59
|
582.55 score on a scale
Standard Deviation 128.87
|
606.35 score on a scale
Standard Deviation 134.44
|
706.67 score on a scale
Standard Deviation 18.35
|
SECONDARY outcome
Timeframe: over 3 yearsPopulation: This outcome measure is the sensitivity of PPI test for GERD diagnosis, so the whole analysis population would be patients who finished PPI treatment. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.
The sensitivity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD.
Outcome measures
| Measure |
GERD Patients With Predominant Epigastric Pain
The life quality of GERD patients with predominant epigastric pain will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Epigastric Burning
The life quality of GERD patients with predominant epigastric burning will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Postprandial Fullness
The life quality of GERD patients with predominant postprandial fullness will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Early Satiety
The life quality of GERD patients with predominant early satiety will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients Defined by Reflux Esophagitis on Endoscopy
n=160 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Positive AET on Reflux Monitoring
n=197 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Either Endoscopy or Reflux Monitoring
The percentage of GERD patients with different predominant symptom will be calculated.
|
Patients With Predominant Dysphagia
The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant dysphagia will be calculated.
|
|---|---|---|---|---|---|---|---|---|
|
The Sensitivity of PPI Test for Diagnosis of GERD
|
—
|
—
|
—
|
—
|
0.64 Percentage of true positive
|
0.51 Percentage of true positive
|
—
|
—
|
SECONDARY outcome
Timeframe: over 3 yearsPopulation: This outcome measure is the specificity of PPI test for GERD diagnosis, so the whole analysis population would be patients who finished PPI treatment. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.
The specificity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD.
Outcome measures
| Measure |
GERD Patients With Predominant Epigastric Pain
The life quality of GERD patients with predominant epigastric pain will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Epigastric Burning
The life quality of GERD patients with predominant epigastric burning will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Postprandial Fullness
The life quality of GERD patients with predominant postprandial fullness will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Early Satiety
The life quality of GERD patients with predominant early satiety will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients Defined by Reflux Esophagitis on Endoscopy
n=160 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Positive AET on Reflux Monitoring
n=197 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Either Endoscopy or Reflux Monitoring
The percentage of GERD patients with different predominant symptom will be calculated.
|
Patients With Predominant Dysphagia
The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant dysphagia will be calculated.
|
|---|---|---|---|---|---|---|---|---|
|
The Specificity of PPI Test for Diagnosis of GERD
|
—
|
—
|
—
|
—
|
0.40 Percentage of true negative
|
0.62 Percentage of true negative
|
—
|
—
|
SECONDARY outcome
Timeframe: over 3 yearsPopulation: This outcome measure is the sensitivity of GERDQ for GERD diagnosis, so the whole analysis population would be patients who finished GERDQ. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.
The sensitivity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD.
Outcome measures
| Measure |
GERD Patients With Predominant Epigastric Pain
The life quality of GERD patients with predominant epigastric pain will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Epigastric Burning
The life quality of GERD patients with predominant epigastric burning will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Postprandial Fullness
The life quality of GERD patients with predominant postprandial fullness will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Early Satiety
The life quality of GERD patients with predominant early satiety will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients Defined by Reflux Esophagitis on Endoscopy
n=153 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Positive AET on Reflux Monitoring
n=189 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Either Endoscopy or Reflux Monitoring
The percentage of GERD patients with different predominant symptom will be calculated.
|
Patients With Predominant Dysphagia
The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant dysphagia will be calculated.
|
|---|---|---|---|---|---|---|---|---|
|
The Sensitivity of GERDQ for Diagnosis of GERD
|
—
|
—
|
—
|
—
|
0.84 Percentage of true positive
|
0.43 Percentage of true positive
|
—
|
—
|
SECONDARY outcome
Timeframe: over 3 yearsPopulation: This outcome measure is the specificity of GERDQ for GERD diagnosis, so the whole analysis population would be patients who finished GERDQ. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.
The specificity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD.
Outcome measures
| Measure |
GERD Patients With Predominant Epigastric Pain
The life quality of GERD patients with predominant epigastric pain will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Epigastric Burning
The life quality of GERD patients with predominant epigastric burning will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Postprandial Fullness
The life quality of GERD patients with predominant postprandial fullness will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients With Predominant Early Satiety
The life quality of GERD patients with predominant early satiety will be measured via the MOS 36-item short form health survey (SF-36).
|
GERD Patients Defined by Reflux Esophagitis on Endoscopy
n=153 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Positive AET on Reflux Monitoring
n=189 Participants
The percentage of GERD patients with different predominant symptom will be calculated.
|
GERD Patients Defined by Either Endoscopy or Reflux Monitoring
The percentage of GERD patients with different predominant symptom will be calculated.
|
Patients With Predominant Dysphagia
The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant dysphagia will be calculated.
|
|---|---|---|---|---|---|---|---|---|
|
The Specificity of GERDQ for Diagnosis of GERD
|
—
|
—
|
—
|
—
|
0.24 Percentage of true negative
|
0.63 Percentage of true negative
|
—
|
—
|
Adverse Events
Patients Who Received PPI Treatment
Serious adverse events
| Measure |
Patients Who Received PPI Treatment
n=357 participants at risk
The frequency of adverse events among patients who received PPI treatment was calculated.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.28%
1/357 • Number of events 1 • over 3 years
|
Other adverse events
| Measure |
Patients Who Received PPI Treatment
n=357 participants at risk
The frequency of adverse events among patients who received PPI treatment was calculated.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
11/357 • over 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
2.8%
10/357 • over 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
9/357 • over 3 years
|
|
Gastrointestinal disorders
Bitter taste
|
1.4%
5/357 • over 3 years
|
|
General disorders
Fatigue
|
1.7%
6/357 • over 3 years
|
|
Gastrointestinal disorders
Nausea
|
1.4%
5/357 • over 3 years
|
|
General disorders
Headache
|
1.1%
4/357 • over 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place