Reviewer's report
Title:Treatment with Pirfenidone for two years decreases fibrosis, cytokine levels
and enhances CB2 expression in patients with chronic hepatitis C: open-label
clinical trial
Version:2Date:23 December 2013
Reviewer: Chao-Hung Hung
Reviewer's report:
Major Compulsory Revisions
In this manuscript, the authors aimed to assess whether two-year treatment with
pirfenidone influence necro-inflammation, fibrosis and steatosis, as well as serum
markers in patients with chronic hepatitis C (CHC). They found that pirfenidone
for two years benefits CHC patients and improves inflammation, fibrosis and
steatosis. Although their data seem logical, there are several issues that should
be further reconsidered or corrected.
1. The major criticism raised is the high rate (18%) of early termination from this
study. What happened in these subjects with early discontinuation? Was there
any severe adverse effect associated with study medication? What were the
causes for the mortality?
2. Intention-to-treat analyses should be performed, including liver biochemistry,
clinical status, and serum biomarkers.
3. The authors should provide the statistical analyses on the Child-pugh status
and quality of life between before and after treatment (table 2).
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests
Reviewer's report
Title:Treatment with Pirfenidone for two years decreases fibrosis, cytokine levels
and enhances CB2 expression in patients with chronic hepatitis C: open-label
clinical trial
Version:2Date:23 December 2013
Reviewer: Chao-Hung Hung
Reviewer's report:
Major Compulsory Revisions
In this manuscript, the authors aimed to assess whether two-year treatment with
pirfenidone influence necro-inflammation, fibrosis and steatosis, as well as serum
markers in patients with chronic hepatitis C (CHC). They found that pirfenidone
for two years benefits CHC patients and improves inflammation, fibrosis and
steatosis. Although their data seem logical, there are several issues that should
be further reconsidered or corrected.
1. The major criticism raised is the high rate (18%) of early termination from this
study. What happened in these subjects with early discontinuation? Was there
any severe adverse effect associated with study medication? What were the
causes for the mortality?
2. Intention-to-treat analyses should be performed, including liver biochemistry,
clinical status, and serum biomarkers.
3. The authors should provide the statistical analyses on the Child-pugh status
and quality of life between before and after treatment (table 2).
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests
Please review this paper.
user
Reviewer's report
Title:Treatment with Pirfenidone for two years decreases fibrosis, cytokine levels
and enhances CB2 expression in patients with chronic hepatitis C: open-label
clinical trial
Version:2Date:23 December 2013
Reviewer: Chao-Hung Hung
Reviewer's report:
Major Compulsory Revisions
In this manuscript, the authors aimed to assess whether two-year treatment with
pirfenidone influence necro-inflammation, fibrosis and steatosis, as well as serum
markers in patients with chronic hepatitis C (CHC). They found that pirfenidone
for two years benefits CHC patients and improves inflammation, fibrosis and
steatosis. Although their data seem logical, there are several issues that should
be further reconsidered or corrected.
1. The major criticism raised is the high rate (18%) of early termination from this
study. What happened in these subjects with early discontinuation? Was there
any severe adverse effect associated with study medication? What were the
causes for the mortality?
2. Intention-to-treat analyses should be performed, including liver biochemistry,
clinical status, and serum biomarkers.
3. The authors should provide the statistical analyses on the Child-pugh status
and quality of life between before and after treatment (table 2).
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests
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