Reviewer's report
Title:Effects of omeprazole on symptoms and quality of life in Japanese patients
with reflux esophagitis: Final results of OMAREE, a large-scale clinical
experience investigation
Version: 1Date:25 September 2010
Reviewer: Alan Thomson
Reviewer's report:
Effects of omeprazole on symptoms and quality of life in Japanese patients with
reflux esophagitis: final results of OMAREE, a large-scale clinical experience
investigation
This is a report of clinical experience of 9967 persons in Japan who had
endoscopically demonstrated erosive esophagitis, treated with different doses of
omeprazole, or with a variety of other medications (eg antacids, protectants,
H2-receptor antagonists), and were assessed at 4 and 8 weeks of treatment
using the Quality of Life in Reflux and Dyspepsia Questionnaire (QOLRAD).
The paper was prepared by persons employed by Astra.
Comments and Suggestions
# Abstract
• It would be useful in the abstract how the findings reported in this paper
generally agreed with other reports in the literature.
# Background
• Lines 4-8. It is well accepted that endoscopic findings of reflux esophagitis (RE)
do not correspond to symptoms, it would be helpful to add references on the
following:
- is this also the case in Japan
- is this also the case for NERD (normal endoscopy reflux disease)
- what is the correlation between QOLRAD and RE symptoms or grade of
esophagitis (normal, or LA A to D).
# Methods
• Page 6, line 18: please clarify what medications patients were treated with for
maintenance therapy for a month prior to being placed on omeprazole (eg,
H2-RA maintenance switched to omeprazole?).
• For newly diagnosed patients with RE, how long was the interval before
treatment was initiated with omeprazole?
• Page 8, line 15: please define “a satisfactory improvement” (in subjective
symptoms, and was the same definition used throughout?)
# Results
• Page 10, line 3. please clarify: were only about 5 patients referred for study
from each medical institution (10,704 patients # 2143 medical institutions)?
• Please clarify what proportion of subjects were “new RE patients” versus “new
onset of recurrent GERD”?
• Few subjects had “heartburn” (none shown in Figure 1), and yet they all had
RE. please explain.
• What was the distribution of RE, LA grades A to D?
• Were patients suffering from nighttime symptoms?
• Was “headache” reported in the omeprazole-treated persons?
# Discussion
• Please discuss how the generalizability of this study might vary for other
groups, especially given the possible differences in BMI, smoking and H.pylori,
and the possibly unfamiliar term, “heavy feeling in the stomach”.
• Page 14, line 12: how do QOLRAD and QOLRAD-J differ?
- Was there a difference in QOLRAD-J depending on grade of RE (LA A to D)?
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Reviewer's report
Title:Effects of omeprazole on symptoms and quality of life in Japanese patients
with reflux esophagitis: Final results of OMAREE, a large-scale clinical
experience investigation
Version: 1Date:25 September 2010
Reviewer: Alan Thomson
Reviewer's report:
Effects of omeprazole on symptoms and quality of life in Japanese patients with
reflux esophagitis: final results of OMAREE, a large-scale clinical experience
investigation
This is a report of clinical experience of 9967 persons in Japan who had
endoscopically demonstrated erosive esophagitis, treated with different doses of
omeprazole, or with a variety of other medications (eg antacids, protectants,
H2-receptor antagonists), and were assessed at 4 and 8 weeks of treatment
using the Quality of Life in Reflux and Dyspepsia Questionnaire (QOLRAD).
The paper was prepared by persons employed by Astra.
Comments and Suggestions
# Abstract
• It would be useful in the abstract how the findings reported in this paper
generally agreed with other reports in the literature.
# Background
• Lines 4-8. It is well accepted that endoscopic findings of reflux esophagitis (RE)
do not correspond to symptoms, it would be helpful to add references on the
following:
- is this also the case in Japan
- is this also the case for NERD (normal endoscopy reflux disease)
- what is the correlation between QOLRAD and RE symptoms or grade of
esophagitis (normal, or LA A to D).
# Methods
• Page 6, line 18: please clarify what medications patients were treated with for
maintenance therapy for a month prior to being placed on omeprazole (eg,
H2-RA maintenance switched to omeprazole?).
• For newly diagnosed patients with RE, how long was the interval before
treatment was initiated with omeprazole?
• Page 8, line 15: please define “a satisfactory improvement” (in subjective
symptoms, and was the same definition used throughout?)
# Results
• Page 10, line 3. please clarify: were only about 5 patients referred for study
from each medical institution (10,704 patients # 2143 medical institutions)?
• Please clarify what proportion of subjects were “new RE patients” versus “new
onset of recurrent GERD”?
• Few subjects had “heartburn” (none shown in Figure 1), and yet they all had
RE. please explain.
• What was the distribution of RE, LA grades A to D?
• Were patients suffering from nighttime symptoms?
• Was “headache” reported in the omeprazole-treated persons?
# Discussion
• Please discuss how the generalizability of this study might vary for other
groups, especially given the possible differences in BMI, smoking and H.pylori,
and the possibly unfamiliar term, “heavy feeling in the stomach”.
• Page 14, line 12: how do QOLRAD and QOLRAD-J differ?
- Was there a difference in QOLRAD-J depending on grade of RE (LA A to D)?
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Please review this paper.
user
Reviewer's report
Title:Effects of omeprazole on symptoms and quality of life in Japanese patients
with reflux esophagitis: Final results of OMAREE, a large-scale clinical
experience investigation
Version: 1Date:25 September 2010
Reviewer: Alan Thomson
Reviewer's report:
Effects of omeprazole on symptoms and quality of life in Japanese patients with
reflux esophagitis: final results of OMAREE, a large-scale clinical experience
investigation
This is a report of clinical experience of 9967 persons in Japan who had
endoscopically demonstrated erosive esophagitis, treated with different doses of
omeprazole, or with a variety of other medications (eg antacids, protectants,
H2-receptor antagonists), and were assessed at 4 and 8 weeks of treatment
using the Quality of Life in Reflux and Dyspepsia Questionnaire (QOLRAD).
The paper was prepared by persons employed by Astra.
Comments and Suggestions
# Abstract
• It would be useful in the abstract how the findings reported in this paper
generally agreed with other reports in the literature.
# Background
• Lines 4-8. It is well accepted that endoscopic findings of reflux esophagitis (RE)
do not correspond to symptoms, it would be helpful to add references on the
following:
- is this also the case in Japan
- is this also the case for NERD (normal endoscopy reflux disease)
- what is the correlation between QOLRAD and RE symptoms or grade of
esophagitis (normal, or LA A to D).
# Methods
• Page 6, line 18: please clarify what medications patients were treated with for
maintenance therapy for a month prior to being placed on omeprazole (eg,
H2-RA maintenance switched to omeprazole?).
• For newly diagnosed patients with RE, how long was the interval before
treatment was initiated with omeprazole?
• Page 8, line 15: please define “a satisfactory improvement” (in subjective
symptoms, and was the same definition used throughout?)
# Results
• Page 10, line 3. please clarify: were only about 5 patients referred for study
from each medical institution (10,704 patients # 2143 medical institutions)?
• Please clarify what proportion of subjects were “new RE patients” versus “new
onset of recurrent GERD”?
• Few subjects had “heartburn” (none shown in Figure 1), and yet they all had
RE. please explain.
• What was the distribution of RE, LA grades A to D?
• Were patients suffering from nighttime symptoms?
• Was “headache” reported in the omeprazole-treated persons?
# Discussion
• Please discuss how the generalizability of this study might vary for other
groups, especially given the possible differences in BMI, smoking and H.pylori,
and the possibly unfamiliar term, “heavy feeling in the stomach”.
• Page 14, line 12: how do QOLRAD and QOLRAD-J differ?
- Was there a difference in QOLRAD-J depending on grade of RE (LA A to D)?
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
assistant