Review for 10.1186/s12876-020-01399-5 (2020)

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?
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Unable to assessDoes the work include the necessary controls?
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Unable to assessAre the conclusions drawn adequately supported by the data shown?
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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
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AcceptableDeclaration of competing interests
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