Reviewer’ s report
Title: A randomized crossover trial to assess therapeutic efficacy and cost reduction of acid
ursodeoxycholic manufactured by the university hospital for the treatment of primary biliarycholangitis
Version: 0Date: 25 Oct 2019
Reviewer's report:
Please include all comments for the authors in this box rather than uploading your report as an
attachment. Please only upload as attachments annotated versions of manuscripts, graphs,supporting materials or other aspects of your report which cannot be included in a text format.Please overwrite this text when adding your comments to the authors.The authors performed a prospective, randomized, crossover study in patients with PBC with theaim to reduce the cost of UDCA treatment. 30 patients under treatment with commercial UDCA instable doses were randomized in groups A and B, 15 patients in each arm. The groups were treatedfor 12 weeks anf after, the UDCA formulation was changed following for another 12 weeks ofcontinous therapy (tablets and capsules/capsules and tablets). LFTs were performed at time T0, T1and T2: ALP, GGT, AST/ALT, total bilirubin, and adverse events were recorded. The authorsconclude that the economy to the hospital using drug manipulation was about 66.1%.The manuscript is interesting, but I am not sure that the design of the study is robust enough todraw any conclusion. In particular, I have the following concerns:1. Did the authors calculate the power of the sample size?2. How did the authors assess the adherence to the treatment?
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Unable to assessDoes the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
Unable to assessAre the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
Unable to assessAre you able to assess any statistics in the manuscript or would you recommend an
additional statistical review?If an additional statistical review is recommended, please specify what aspects require further
assessment in your comments to the editors.
I recommend additional statistical review
Quality of written English
Please indicate the quality of language in the manuscript:
AcceptableDeclaration of competing interests
Please complete a declaration of competing interests, considering the following questions:
1. Have you in the past five years received reimbursements, fees, funding, or salary from an
organisation that may in any way gain or lose financially from the publication of thismanuscript, either now or in the future?
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose
financially from the publication of this manuscript, either now or in the future?
3. Do you hold or are you currently applying for any patents relating to the content of the
manuscript?
4. Have you received reimbursements, fees, funding, or salary from an organization that holds
or has applied for patents relating to the content of the manuscript?
5. Do you have any other financial competing interests?6. Do you have any non-financial competing interests in relation to this paper?
If you can answer no to all of the above, write 'I declare that I have no competing interests' below.
If your reply is yes to any, please give details below.
I declare that I have no competing interestI agree to the open peer review policy of the journal. I understand that my name will be included
on my report to the authors and, if the manuscript is accepted for publication, my named reportincluding any attachments I upload will be posted on the website along with the authors'responses. I agree for my report to be made available under an Open Access Creative CommonsCC-BY license (http://creativecommons.org/licenses/by/4.0/). I understand that any commentswhich I do not wish to be included in my named report can be included as confidential commentsto the editors, which will not be published.
I agree to the open peer review policy of the journal
Reviewer’ s report
Title: A randomized crossover trial to assess therapeutic efficacy and cost reduction of acid
ursodeoxycholic manufactured by the university hospital for the treatment of primary biliarycholangitis
Version: 0Date: 25 Oct 2019
Reviewer's report:
Please include all comments for the authors in this box rather than uploading your report as an
attachment. Please only upload as attachments annotated versions of manuscripts, graphs,supporting materials or other aspects of your report which cannot be included in a text format.Please overwrite this text when adding your comments to the authors.The authors performed a prospective, randomized, crossover study in patients with PBC with theaim to reduce the cost of UDCA treatment. 30 patients under treatment with commercial UDCA instable doses were randomized in groups A and B, 15 patients in each arm. The groups were treatedfor 12 weeks anf after, the UDCA formulation was changed following for another 12 weeks ofcontinous therapy (tablets and capsules/capsules and tablets). LFTs were performed at time T0, T1and T2: ALP, GGT, AST/ALT, total bilirubin, and adverse events were recorded. The authorsconclude that the economy to the hospital using drug manipulation was about 66.1%.The manuscript is interesting, but I am not sure that the design of the study is robust enough todraw any conclusion. In particular, I have the following concerns:1. Did the authors calculate the power of the sample size?2. How did the authors assess the adherence to the treatment?
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Unable to assessDoes the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
Unable to assessAre the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
Unable to assessAre you able to assess any statistics in the manuscript or would you recommend an
additional statistical review?If an additional statistical review is recommended, please specify what aspects require further
assessment in your comments to the editors.
I recommend additional statistical review
Quality of written English
Please indicate the quality of language in the manuscript:
AcceptableDeclaration of competing interests
Please complete a declaration of competing interests, considering the following questions:
1. Have you in the past five years received reimbursements, fees, funding, or salary from an
organisation that may in any way gain or lose financially from the publication of thismanuscript, either now or in the future?
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose
financially from the publication of this manuscript, either now or in the future?
3. Do you hold or are you currently applying for any patents relating to the content of the
manuscript?
4. Have you received reimbursements, fees, funding, or salary from an organization that holds
or has applied for patents relating to the content of the manuscript?
5. Do you have any other financial competing interests?6. Do you have any non-financial competing interests in relation to this paper?
If you can answer no to all of the above, write 'I declare that I have no competing interests' below.
If your reply is yes to any, please give details below.
I declare that I have no competing interestI agree to the open peer review policy of the journal. I understand that my name will be included
on my report to the authors and, if the manuscript is accepted for publication, my named reportincluding any attachments I upload will be posted on the website along with the authors'responses. I agree for my report to be made available under an Open Access Creative CommonsCC-BY license (http://creativecommons.org/licenses/by/4.0/). I understand that any commentswhich I do not wish to be included in my named report can be included as confidential commentsto the editors, which will not be published.
I agree to the open peer review policy of the journal
Please review this paper.
user
Reviewer’ s report
Title: A randomized crossover trial to assess therapeutic efficacy and cost reduction of acid
ursodeoxycholic manufactured by the university hospital for the treatment of primary biliarycholangitis
Version: 0Date: 25 Oct 2019
Reviewer's report:
Please include all comments for the authors in this box rather than uploading your report as an
attachment. Please only upload as attachments annotated versions of manuscripts, graphs,supporting materials or other aspects of your report which cannot be included in a text format.Please overwrite this text when adding your comments to the authors.The authors performed a prospective, randomized, crossover study in patients with PBC with theaim to reduce the cost of UDCA treatment. 30 patients under treatment with commercial UDCA instable doses were randomized in groups A and B, 15 patients in each arm. The groups were treatedfor 12 weeks anf after, the UDCA formulation was changed following for another 12 weeks ofcontinous therapy (tablets and capsules/capsules and tablets). LFTs were performed at time T0, T1and T2: ALP, GGT, AST/ALT, total bilirubin, and adverse events were recorded. The authorsconclude that the economy to the hospital using drug manipulation was about 66.1%.The manuscript is interesting, but I am not sure that the design of the study is robust enough todraw any conclusion. In particular, I have the following concerns:1. Did the authors calculate the power of the sample size?2. How did the authors assess the adherence to the treatment?
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Unable to assessDoes the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
Unable to assessAre the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
Unable to assessAre you able to assess any statistics in the manuscript or would you recommend an
additional statistical review?If an additional statistical review is recommended, please specify what aspects require further
assessment in your comments to the editors.
I recommend additional statistical review
Quality of written English
Please indicate the quality of language in the manuscript:
AcceptableDeclaration of competing interests
Please complete a declaration of competing interests, considering the following questions:
1. Have you in the past five years received reimbursements, fees, funding, or salary from an
organisation that may in any way gain or lose financially from the publication of thismanuscript, either now or in the future?
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose
financially from the publication of this manuscript, either now or in the future?
3. Do you hold or are you currently applying for any patents relating to the content of the
manuscript?
4. Have you received reimbursements, fees, funding, or salary from an organization that holds
or has applied for patents relating to the content of the manuscript?
5. Do you have any other financial competing interests?6. Do you have any non-financial competing interests in relation to this paper?
If you can answer no to all of the above, write 'I declare that I have no competing interests' below.
If your reply is yes to any, please give details below.
I declare that I have no competing interestI agree to the open peer review policy of the journal. I understand that my name will be included
on my report to the authors and, if the manuscript is accepted for publication, my named reportincluding any attachments I upload will be posted on the website along with the authors'responses. I agree for my report to be made available under an Open Access Creative CommonsCC-BY license (http://creativecommons.org/licenses/by/4.0/). I understand that any commentswhich I do not wish to be included in my named report can be included as confidential commentsto the editors, which will not be published.
I agree to the open peer review policy of the journal
assistant