Title: The effectiveness of combining ursodeoxycholic acid with vitamin D in treating patients
with primary biliary cholangitis and its impact on hepatic fibrosis: A Randomized Trial
Version: 2 Date: 30 Mar 2025
Reviewer:  Dawei Ding
Reviewer's report:
Reviewer
Decision: major revision
Dear Dr Zhang,
Your manuscript, "The effectiveness of combining ursodeoxycholic acid with vitamin D in
treating patients with primary biliary cholangitis and its impact on hepatic fibrosis",
has now been assessed.
1 Why use Paris-I and Toronto criteria to assess biochemical responses? These two evaluation
criteria are relatively lenient, and the current treatment targets for PBC patients are ALP (e.g.,
upper limit of normal) and bilirubin (e.g., 0.6 is the upper limit of normal) to lower levels?
2 Does the section 'Changes in clinical symptoms, biochemical and immunological indicators,
and liver stiffness values before treatment in the experimental and control groups' present
baseline data? If so, why is the term 'changes' used? If it is indeed baseline data, I believe it should
be placed before the section 'The study analyzed changes in clinical symptoms, biochemical and
immunological indexes, and liver hardness values before and after treatment in both the test and
control groups.'
3 Is there a difference in the anti-gp210 antibody positivity rate between the two groups at
baseline, given that anti-gp210 antibodies are associated with the prognosis of PBC patients?
4 How is the sample size determined for each group? Why do you think the sample size in each
group is sufficient?
5 A prospective study of initial combination therapy with fenofibrate (PMID: 36892506.) The
primary outcome was the biochemical response rate (based on the Barcelona criteria) at 12
months. In the UDCA-fenofibrate group, 81.4% (69.9%-92.9%) of patients achieved the primary
outcome, compared to 64.3% (51.9%-76.8%) in the UDCA-only group (P = 0.048). In this study,
after 1 year of treatment, the UDCA-vitamin D group showed an 86.7% biochemical response
rate, while the UDCA-only group had 63.3%. The response rate in the UDCA-vitamin D group
was slightly higher than in the UDCA-fenofibrate group. Do you believe vitamin D could replace
fenofibrate? Or might combining vitamin D with fenofibrate yield even better results? Based
on our center’s experience, adding vitamin D may not improve the biochemical response rate
compared to UDCA monotherapy.
6 We recommend that the discussion section focus on the implications of this study findings and
their clinical significance for the management of PBC patients.
Dawei Ding
Xijing Hospital of Digestive Diseases, The Air Force Military Medical University
Title: The effectiveness of combining ursodeoxycholic acid with vitamin D in treating patients
with primary biliary cholangitis and its impact on hepatic fibrosis: A Randomized Trial
Version: 2 Date: 30 Mar 2025
Reviewer:  Dawei Ding
Reviewer's report:
Reviewer
Decision: major revision
Dear Dr Zhang,
Your manuscript, "The effectiveness of combining ursodeoxycholic acid with vitamin D in
treating patients with primary biliary cholangitis and its impact on hepatic fibrosis",
has now been assessed.
1 Why use Paris-I and Toronto criteria to assess biochemical responses? These two evaluation
criteria are relatively lenient, and the current treatment targets for PBC patients are ALP (e.g.,
upper limit of normal) and bilirubin (e.g., 0.6 is the upper limit of normal) to lower levels?
2 Does the section 'Changes in clinical symptoms, biochemical and immunological indicators,
and liver stiffness values before treatment in the experimental and control groups' present
baseline data? If so, why is the term 'changes' used? If it is indeed baseline data, I believe it should
be placed before the section 'The study analyzed changes in clinical symptoms, biochemical and
immunological indexes, and liver hardness values before and after treatment in both the test and
control groups.'
3 Is there a difference in the anti-gp210 antibody positivity rate between the two groups at
baseline, given that anti-gp210 antibodies are associated with the prognosis of PBC patients?
4 How is the sample size determined for each group? Why do you think the sample size in each
group is sufficient?
5 A prospective study of initial combination therapy with fenofibrate (PMID: 36892506.) The
primary outcome was the biochemical response rate (based on the Barcelona criteria) at 12
months. In the UDCA-fenofibrate group, 81.4% (69.9%-92.9%) of patients achieved the primary
outcome, compared to 64.3% (51.9%-76.8%) in the UDCA-only group (P = 0.048). In this study,
after 1 year of treatment, the UDCA-vitamin D group showed an 86.7% biochemical response
rate, while the UDCA-only group had 63.3%. The response rate in the UDCA-vitamin D group
was slightly higher than in the UDCA-fenofibrate group. Do you believe vitamin D could replace
fenofibrate? Or might combining vitamin D with fenofibrate yield even better results? Based
on our center’s experience, adding vitamin D may not improve the biochemical response rate
compared to UDCA monotherapy.
6 We recommend that the discussion section focus on the implications of this study findings and
their clinical significance for the management of PBC patients.
Dawei Ding
Xijing Hospital of Digestive Diseases, The Air Force Military Medical University
Please review this paper.
user
Title: The effectiveness of combining ursodeoxycholic acid with vitamin D in treating patients
with primary biliary cholangitis and its impact on hepatic fibrosis: A Randomized Trial
Version: 2 Date: 30 Mar 2025
Reviewer:  Dawei Ding
Reviewer's report:
Reviewer
Decision: major revision
Dear Dr Zhang,
Your manuscript, "The effectiveness of combining ursodeoxycholic acid with vitamin D in
treating patients with primary biliary cholangitis and its impact on hepatic fibrosis",
has now been assessed.
1 Why use Paris-I and Toronto criteria to assess biochemical responses? These two evaluation
criteria are relatively lenient, and the current treatment targets for PBC patients are ALP (e.g.,
upper limit of normal) and bilirubin (e.g., 0.6 is the upper limit of normal) to lower levels?
2 Does the section 'Changes in clinical symptoms, biochemical and immunological indicators,
and liver stiffness values before treatment in the experimental and control groups' present
baseline data? If so, why is the term 'changes' used? If it is indeed baseline data, I believe it should
be placed before the section 'The study analyzed changes in clinical symptoms, biochemical and
immunological indexes, and liver hardness values before and after treatment in both the test and
control groups.'
3 Is there a difference in the anti-gp210 antibody positivity rate between the two groups at
baseline, given that anti-gp210 antibodies are associated with the prognosis of PBC patients?
4 How is the sample size determined for each group? Why do you think the sample size in each
group is sufficient?
5 A prospective study of initial combination therapy with fenofibrate (PMID: 36892506.) The
primary outcome was the biochemical response rate (based on the Barcelona criteria) at 12
months. In the UDCA-fenofibrate group, 81.4% (69.9%-92.9%) of patients achieved the primary
outcome, compared to 64.3% (51.9%-76.8%) in the UDCA-only group (P = 0.048). In this study,
after 1 year of treatment, the UDCA-vitamin D group showed an 86.7% biochemical response
rate, while the UDCA-only group had 63.3%. The response rate in the UDCA-vitamin D group
was slightly higher than in the UDCA-fenofibrate group. Do you believe vitamin D could replace
fenofibrate? Or might combining vitamin D with fenofibrate yield even better results? Based
on our center’s experience, adding vitamin D may not improve the biochemical response rate
compared to UDCA monotherapy.
6 We recommend that the discussion section focus on the implications of this study findings and
their clinical significance for the management of PBC patients.
Dawei Ding
Xijing Hospital of Digestive Diseases, The Air Force Military Medical University
assistant