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: 4 Date: 26 May 2025
Reviewer's report:
The authors did significant work to improve the paper  but some additional  changes are needed
to render the manuscript acceptable for publication.
1) In the Abstract and in the Result section it shoud be clearly stated where data description
come from the second year of the study  and after the second randomisation .
It should be added a sentence like " In the second year of the study  after the second
randomisation" in page 3, line 45 before "the response rate........".
Similarly  in the Result section , page 14, line 233. The same also in  the legend of table 6
2) Patients and methods. It should be clearly stated that in both inclusion and exclusion criteria
several points refer to inclusion or exclusion from the analysis, i.e, inclusion criteria #3 and #4
and exclusion criteria #5 and #6. Therefore, also the flowchart for patient selection reported in
figure 1 should be  changed.
3) In table 4 and table 6, where  the two study groups are compared , the changes from baseline
should be reported, rather than the absolute values
4) All the tables should be evaluated independently from the text. Therefore it should be clearly
indicated when data are expresses as  mean +/- SD rather than median (Q25, Q75).
Minor Points
a) Page 7, lines 131 and 132. The English language appears to be inadequate
b) Table 1 : "% of obese patients" instead of "BMI(Obese), kg/m2, n(%)"
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: 4 Date: 26 May 2025
Reviewer's report:
The authors did significant work to improve the paper  but some additional  changes are needed
to render the manuscript acceptable for publication.
1) In the Abstract and in the Result section it shoud be clearly stated where data description
come from the second year of the study  and after the second randomisation .
It should be added a sentence like " In the second year of the study  after the second
randomisation" in page 3, line 45 before "the response rate........".
Similarly  in the Result section , page 14, line 233. The same also in  the legend of table 6
2) Patients and methods. It should be clearly stated that in both inclusion and exclusion criteria
several points refer to inclusion or exclusion from the analysis, i.e, inclusion criteria #3 and #4
and exclusion criteria #5 and #6. Therefore, also the flowchart for patient selection reported in
figure 1 should be  changed.
3) In table 4 and table 6, where  the two study groups are compared , the changes from baseline
should be reported, rather than the absolute values
4) All the tables should be evaluated independently from the text. Therefore it should be clearly
indicated when data are expresses as  mean +/- SD rather than median (Q25, Q75).
Minor Points
a) Page 7, lines 131 and 132. The English language appears to be inadequate
b) Table 1 : "% of obese patients" instead of "BMI(Obese), kg/m2, n(%)"
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: 4 Date: 26 May 2025
Reviewer's report:
The authors did significant work to improve the paper  but some additional  changes are needed
to render the manuscript acceptable for publication.
1) In the Abstract and in the Result section it shoud be clearly stated where data description
come from the second year of the study  and after the second randomisation .
It should be added a sentence like " In the second year of the study  after the second
randomisation" in page 3, line 45 before "the response rate........".
Similarly  in the Result section , page 14, line 233. The same also in  the legend of table 6
2) Patients and methods. It should be clearly stated that in both inclusion and exclusion criteria
several points refer to inclusion or exclusion from the analysis, i.e, inclusion criteria #3 and #4
and exclusion criteria #5 and #6. Therefore, also the flowchart for patient selection reported in
figure 1 should be  changed.
3) In table 4 and table 6, where  the two study groups are compared , the changes from baseline
should be reported, rather than the absolute values
4) All the tables should be evaluated independently from the text. Therefore it should be clearly
indicated when data are expresses as  mean +/- SD rather than median (Q25, Q75).
Minor Points
a) Page 7, lines 131 and 132. The English language appears to be inadequate
b) Table 1 : "% of obese patients" instead of "BMI(Obese), kg/m2, n(%)"
assistant