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: 09 Mar 2025
Reviewer's report:
Abulitifu Y et al conducted a randomized interventional trial for PBC patients to evaluate the
efficacy of vitamin D as the combination agent to improve treatment response of UDCA. Overall,
the protocol and presentation lacked scientific rigorousness and quality, being required for the
report of clinical trial.
Major concerns;
1. Introduction, Page 3, lane 19: male to female ration should be updated to previous literatures.
2. Introduction, Page 4, lane 6-8: Two sentences are redundantly and very vaguely written.
3. Introduction, Page 4, lane 14: What does it mean late stage UDCA therapy?
4. Endpoints: Primary, secondary, tertial, and surrogate endpoints should be defined clearly.
5. Endpoints: What definition were implemented for the improvement of symptoms, including
itch and malaise?
6. Methods: After the second allocation, followed by randomization, surrogate endpoints were
compared between experimental and control groups. What was the aim for such comparison?
Was it to evaluate the difference in the efficacy of vitamin D between the 1st and the 2nd year
of UDCA treatment?
7. In Figure 4-8: Groups in comparison for statistical analysis were hard to be realized. All
figures should be completely revised to give readers clear understanding.
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: 09 Mar 2025
Reviewer's report:
Abulitifu Y et al conducted a randomized interventional trial for PBC patients to evaluate the
efficacy of vitamin D as the combination agent to improve treatment response of UDCA. Overall,
the protocol and presentation lacked scientific rigorousness and quality, being required for the
report of clinical trial.
Major concerns;
1. Introduction, Page 3, lane 19: male to female ration should be updated to previous literatures.
2. Introduction, Page 4, lane 6-8: Two sentences are redundantly and very vaguely written.
3. Introduction, Page 4, lane 14: What does it mean late stage UDCA therapy?
4. Endpoints: Primary, secondary, tertial, and surrogate endpoints should be defined clearly.
5. Endpoints: What definition were implemented for the improvement of symptoms, including
itch and malaise?
6. Methods: After the second allocation, followed by randomization, surrogate endpoints were
compared between experimental and control groups. What was the aim for such comparison?
Was it to evaluate the difference in the efficacy of vitamin D between the 1st and the 2nd year
of UDCA treatment?
7. In Figure 4-8: Groups in comparison for statistical analysis were hard to be realized. All
figures should be completely revised to give readers clear understanding.
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: 09 Mar 2025
Reviewer's report:
Abulitifu Y et al conducted a randomized interventional trial for PBC patients to evaluate the
efficacy of vitamin D as the combination agent to improve treatment response of UDCA. Overall,
the protocol and presentation lacked scientific rigorousness and quality, being required for the
report of clinical trial.
Major concerns;
1. Introduction, Page 3, lane 19: male to female ration should be updated to previous literatures.
2. Introduction, Page 4, lane 6-8: Two sentences are redundantly and very vaguely written.
3. Introduction, Page 4, lane 14: What does it mean late stage UDCA therapy?
4. Endpoints: Primary, secondary, tertial, and surrogate endpoints should be defined clearly.
5. Endpoints: What definition were implemented for the improvement of symptoms, including
itch and malaise?
6. Methods: After the second allocation, followed by randomization, surrogate endpoints were
compared between experimental and control groups. What was the aim for such comparison?
Was it to evaluate the difference in the efficacy of vitamin D between the 1st and the 2nd year
of UDCA treatment?
7. In Figure 4-8: Groups in comparison for statistical analysis were hard to be realized. All
figures should be completely revised to give readers clear understanding.
assistant