Title: Bowel Frequency (night) and Urgent Defecation are Improved by Budesonide Foam in
Patients with Ulcerative Colitis: a retrospective observational study
Version: 3 Date: 18 Apr 2022
Reviewer's report:
Budesonide formulations have a low risk of side effects and are often used casually as remission
induction therapy, but in practice the timing of drug withdrawal and efficacy determination is
often confusing. This paper is very interesting in that it also discusses the timing of the efficacy
determination of budesonide.
To improve the manuscript, some modifications are needed.
Major
1. Are steroid-dependent or resistant patients included in the target cases? If so, is it as effective
as other patients?
2. Among the exclusions shown in Figure 1, only steroids and Bio during induction of remission
are listed. The use of remission induction therapies such as tacrolimus and G-CAP should also
be investigated.
3. Is the timing of administration of the budesonide form constant for all?
4. Why did you set the observation period for treatment with budesonide forms at 2 and 6 weeks?
5. Of the 102 patients included, what about patients with overlapping symptoms, such as 36
patients with nocturnal defecation symptoms and 45 patients with urgent defecation symptoms?
6. In lines 76-77, " SCCAI 0, # 2, and # 3 were defined as complete clinical remission,
clinical remission, and active UC, respectively" Please provide any references to support your
classification.
7. In lines 112-113, "Clinical efficacy of budesonide foam for UC patients with residual clinical
symptoms even in the remission score (SCCAI 1 or 2) )". In SCCAI, which is evaluated based
on clinical symptoms, it is not surprising that symptoms remain at SCCAI 1 or 2.
The statement "residual clinical symptoms even in the remission score (SCCAI 1 or 2)" seems
incongruous.
8. Although the SCCAI is used as a score, the scores for nocturnal defecation and tightness of
bowel movements are low (1-2 points), and an increase or decrease in the SCCAI score alone
may not lead to an evaluation of the improvement rate of tightness of bowel movements and
nocturnal defecation.
9. In line 121, "No adverse events were seen in any subject during this study." Please state what
adverse events were seen. For example, liver problems, hypertension, hyperlipidemia, etc. as
described in the attached document.
Minor
10. In lines 68-69, it is stated that noctual and urgent defection were evaluated as sub-items of the
SCCAI. In the paper that defined the SCCAI (Walmsley RS et al. Gut. 1998 Jul;43(1):29-32.),
noctual defecation (noctual in this paper) is referred to as "bowel frequency (night). It would be
better to change it to that notation.
11. It is desirable to summarize Figure 2-4 as Figure 2A-C and Figure 5-7 as Figure 3A-C.
12. The paper in Reference No. 24 is "J Gastroenterol" instead of "Gastroenterol".
Title: Bowel Frequency (night) and Urgent Defecation are Improved by Budesonide Foam in
Patients with Ulcerative Colitis: a retrospective observational study
Version: 3 Date: 18 Apr 2022
Reviewer's report:
Budesonide formulations have a low risk of side effects and are often used casually as remission
induction therapy, but in practice the timing of drug withdrawal and efficacy determination is
often confusing. This paper is very interesting in that it also discusses the timing of the efficacy
determination of budesonide.
To improve the manuscript, some modifications are needed.
Major
1. Are steroid-dependent or resistant patients included in the target cases? If so, is it as effective
as other patients?
2. Among the exclusions shown in Figure 1, only steroids and Bio during induction of remission
are listed. The use of remission induction therapies such as tacrolimus and G-CAP should also
be investigated.
3. Is the timing of administration of the budesonide form constant for all?
4. Why did you set the observation period for treatment with budesonide forms at 2 and 6 weeks?
5. Of the 102 patients included, what about patients with overlapping symptoms, such as 36
patients with nocturnal defecation symptoms and 45 patients with urgent defecation symptoms?
6. In lines 76-77, " SCCAI 0, # 2, and # 3 were defined as complete clinical remission,
clinical remission, and active UC, respectively" Please provide any references to support your
classification.
7. In lines 112-113, "Clinical efficacy of budesonide foam for UC patients with residual clinical
symptoms even in the remission score (SCCAI 1 or 2) )". In SCCAI, which is evaluated based
on clinical symptoms, it is not surprising that symptoms remain at SCCAI 1 or 2.
The statement "residual clinical symptoms even in the remission score (SCCAI 1 or 2)" seems
incongruous.
8. Although the SCCAI is used as a score, the scores for nocturnal defecation and tightness of
bowel movements are low (1-2 points), and an increase or decrease in the SCCAI score alone
may not lead to an evaluation of the improvement rate of tightness of bowel movements and
nocturnal defecation.
9. In line 121, "No adverse events were seen in any subject during this study." Please state what
adverse events were seen. For example, liver problems, hypertension, hyperlipidemia, etc. as
described in the attached document.
Minor
10. In lines 68-69, it is stated that noctual and urgent defection were evaluated as sub-items of the
SCCAI. In the paper that defined the SCCAI (Walmsley RS et al. Gut. 1998 Jul;43(1):29-32.),
noctual defecation (noctual in this paper) is referred to as "bowel frequency (night). It would be
better to change it to that notation.
11. It is desirable to summarize Figure 2-4 as Figure 2A-C and Figure 5-7 as Figure 3A-C.
12. The paper in Reference No. 24 is "J Gastroenterol" instead of "Gastroenterol".
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: 18 Apr 2022
Reviewer's report:
Budesonide formulations have a low risk of side effects and are often used casually as remission
induction therapy, but in practice the timing of drug withdrawal and efficacy determination is
often confusing. This paper is very interesting in that it also discusses the timing of the efficacy
determination of budesonide.
To improve the manuscript, some modifications are needed.
Major
1. Are steroid-dependent or resistant patients included in the target cases? If so, is it as effective
as other patients?
2. Among the exclusions shown in Figure 1, only steroids and Bio during induction of remission
are listed. The use of remission induction therapies such as tacrolimus and G-CAP should also
be investigated.
3. Is the timing of administration of the budesonide form constant for all?
4. Why did you set the observation period for treatment with budesonide forms at 2 and 6 weeks?
5. Of the 102 patients included, what about patients with overlapping symptoms, such as 36
patients with nocturnal defecation symptoms and 45 patients with urgent defecation symptoms?
6. In lines 76-77, " SCCAI 0, # 2, and # 3 were defined as complete clinical remission,
clinical remission, and active UC, respectively" Please provide any references to support your
classification.
7. In lines 112-113, "Clinical efficacy of budesonide foam for UC patients with residual clinical
symptoms even in the remission score (SCCAI 1 or 2) )". In SCCAI, which is evaluated based
on clinical symptoms, it is not surprising that symptoms remain at SCCAI 1 or 2.
The statement "residual clinical symptoms even in the remission score (SCCAI 1 or 2)" seems
incongruous.
8. Although the SCCAI is used as a score, the scores for nocturnal defecation and tightness of
bowel movements are low (1-2 points), and an increase or decrease in the SCCAI score alone
may not lead to an evaluation of the improvement rate of tightness of bowel movements and
nocturnal defecation.
9. In line 121, "No adverse events were seen in any subject during this study." Please state what
adverse events were seen. For example, liver problems, hypertension, hyperlipidemia, etc. as
described in the attached document.
Minor
10. In lines 68-69, it is stated that noctual and urgent defection were evaluated as sub-items of the
SCCAI. In the paper that defined the SCCAI (Walmsley RS et al. Gut. 1998 Jul;43(1):29-32.),
noctual defecation (noctual in this paper) is referred to as "bowel frequency (night). It would be
better to change it to that notation.
11. It is desirable to summarize Figure 2-4 as Figure 2A-C and Figure 5-7 as Figure 3A-C.
12. The paper in Reference No. 24 is "J Gastroenterol" instead of "Gastroenterol".
assistant