Title: Bowel Frequency (night) and Urgent Defecation are Improved by Budesonide Foam in
Patients with Ulcerative Colitis: a retrospective observational study
Version: 3 Date: 06 May 2022
Reviewer's report:
I am very pleased to have had the opportunity to review this manuscript.
This retrospective study investigates the effectiveness of budesonide foam in ulcerative colitis
from the perspective of urgent and nocturnal defecation. Due to the difficulty in evaluating the
efficacy of budesonide foam, the study was not conducted as a clinical trial. Nevertheless, the
authors have investigated its clinical efficacy. This manuscript needs to be revised as follows:
Major revisions:
Material and Methods:
# Budesonide foam is often used in on demand cases. As stated in the Limitations section,
frequency of use and adherence are important conditions that might have affected the results
of this study and could be a concern for many readers. Therefore, it should be specified in the
Material and Methods section.
Results:
# This study includes patients with Mayo endoscopic subscore 3 who show severe ulcerative
colitis endoscopically. Was the effect of PSL and Biologics used in combination on these patients
not strong? Or did budesonide foam alone improve patients with MES 3?
# Only three UC patients were evaluated endoscopically, as shown in Figure 8. Is Figure 8
necessary?
# Figure 5 shows a significant difference between baseline and the complete clinical remission
rate in W2 and W6. This study excludes UC patients who are in complete clinical remission in
the first place. Is the complete clinical remission rate significance test in this study statistically
significant?
Minor revisions:
# Include a description for each abbreviation used in Table 1.
# The CRP unit "mg/ dl" in Table 1 should be listed as a variable.
# Please add the unit of age in Table 1.
# Is Mean + SD in Figures 2–8 meant to be Mean ± SD?
# Please correct "quality of life" on page 5, line 40 to "QOL".
# Please correct "sub-score" on page 6, line 62 to "subscore".
# Please correct "mayo" on Page 9, line 117 to "Mayo".
Title: Bowel Frequency (night) and Urgent Defecation are Improved by Budesonide Foam in
Patients with Ulcerative Colitis: a retrospective observational study
Version: 3 Date: 06 May 2022
Reviewer's report:
I am very pleased to have had the opportunity to review this manuscript.
This retrospective study investigates the effectiveness of budesonide foam in ulcerative colitis
from the perspective of urgent and nocturnal defecation. Due to the difficulty in evaluating the
efficacy of budesonide foam, the study was not conducted as a clinical trial. Nevertheless, the
authors have investigated its clinical efficacy. This manuscript needs to be revised as follows:
Major revisions:
Material and Methods:
# Budesonide foam is often used in on demand cases. As stated in the Limitations section,
frequency of use and adherence are important conditions that might have affected the results
of this study and could be a concern for many readers. Therefore, it should be specified in the
Material and Methods section.
Results:
# This study includes patients with Mayo endoscopic subscore 3 who show severe ulcerative
colitis endoscopically. Was the effect of PSL and Biologics used in combination on these patients
not strong? Or did budesonide foam alone improve patients with MES 3?
# Only three UC patients were evaluated endoscopically, as shown in Figure 8. Is Figure 8
necessary?
# Figure 5 shows a significant difference between baseline and the complete clinical remission
rate in W2 and W6. This study excludes UC patients who are in complete clinical remission in
the first place. Is the complete clinical remission rate significance test in this study statistically
significant?
Minor revisions:
# Include a description for each abbreviation used in Table 1.
# The CRP unit "mg/ dl" in Table 1 should be listed as a variable.
# Please add the unit of age in Table 1.
# Is Mean + SD in Figures 2–8 meant to be Mean ± SD?
# Please correct "quality of life" on page 5, line 40 to "QOL".
# Please correct "sub-score" on page 6, line 62 to "subscore".
# Please correct "mayo" on Page 9, line 117 to "Mayo".
Please review this paper.
user
Title: Bowel Frequency (night) and Urgent Defecation are Improved by Budesonide Foam in
Patients with Ulcerative Colitis: a retrospective observational study
Version: 3 Date: 06 May 2022
Reviewer's report:
I am very pleased to have had the opportunity to review this manuscript.
This retrospective study investigates the effectiveness of budesonide foam in ulcerative colitis
from the perspective of urgent and nocturnal defecation. Due to the difficulty in evaluating the
efficacy of budesonide foam, the study was not conducted as a clinical trial. Nevertheless, the
authors have investigated its clinical efficacy. This manuscript needs to be revised as follows:
Major revisions:
Material and Methods:
# Budesonide foam is often used in on demand cases. As stated in the Limitations section,
frequency of use and adherence are important conditions that might have affected the results
of this study and could be a concern for many readers. Therefore, it should be specified in the
Material and Methods section.
Results:
# This study includes patients with Mayo endoscopic subscore 3 who show severe ulcerative
colitis endoscopically. Was the effect of PSL and Biologics used in combination on these patients
not strong? Or did budesonide foam alone improve patients with MES 3?
# Only three UC patients were evaluated endoscopically, as shown in Figure 8. Is Figure 8
necessary?
# Figure 5 shows a significant difference between baseline and the complete clinical remission
rate in W2 and W6. This study excludes UC patients who are in complete clinical remission in
the first place. Is the complete clinical remission rate significance test in this study statistically
significant?
Minor revisions:
# Include a description for each abbreviation used in Table 1.
# The CRP unit "mg/ dl" in Table 1 should be listed as a variable.
# Please add the unit of age in Table 1.
# Is Mean + SD in Figures 2–8 meant to be Mean ± SD?
# Please correct "quality of life" on page 5, line 40 to "QOL".
# Please correct "sub-score" on page 6, line 62 to "subscore".
# Please correct "mayo" on Page 9, line 117 to "Mayo".
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