Reviewer's report
Title:Randomised, Double-blind, Placebo-controlled Trial of Oral Budesonide for
Prophylaxis of Acute Intestinal Graft-versus-Host Disease after Allogeneic Stem
Cell Transplantation ( PROGAST)
Version:2Date:23 October 2013
Reviewer: Martin Gramatzki
Reviewer's report:
This study is clearly structured. However, the authors should have outlined the
incidence, severity and particularly the treatment of acute GvHD besides the
gastrointestinal tract involvement. It is very likely that acute GvHD such as of the
skin or the liver has occurred in a substantial number of patients, partly also
leading to systemic immunosuppression. This could have strongly influenced the
incidence and degree of intestinal GvHD and thereby the outcome of the study.
If, as indicated, the rate of infectious complications was higher in the budesonide
group, it would be of interest if there is a correlation with the degree of GvHD in
those patients receiving immunosuppression.
Another important aspect would be whether infectious complications especially of
the intestinal tract have been found more frequently in the budesonide group
than in the placebo group.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I declare that I have no competing interests.
Reviewer's report
Title:Randomised, Double-blind, Placebo-controlled Trial of Oral Budesonide for
Prophylaxis of Acute Intestinal Graft-versus-Host Disease after Allogeneic Stem
Cell Transplantation ( PROGAST)
Version:2Date:23 October 2013
Reviewer: Martin Gramatzki
Reviewer's report:
This study is clearly structured. However, the authors should have outlined the
incidence, severity and particularly the treatment of acute GvHD besides the
gastrointestinal tract involvement. It is very likely that acute GvHD such as of the
skin or the liver has occurred in a substantial number of patients, partly also
leading to systemic immunosuppression. This could have strongly influenced the
incidence and degree of intestinal GvHD and thereby the outcome of the study.
If, as indicated, the rate of infectious complications was higher in the budesonide
group, it would be of interest if there is a correlation with the degree of GvHD in
those patients receiving immunosuppression.
Another important aspect would be whether infectious complications especially of
the intestinal tract have been found more frequently in the budesonide group
than in the placebo group.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I declare that I have no competing interests.
Please review this paper.
user
Reviewer's report
Title:Randomised, Double-blind, Placebo-controlled Trial of Oral Budesonide for
Prophylaxis of Acute Intestinal Graft-versus-Host Disease after Allogeneic Stem
Cell Transplantation ( PROGAST)
Version:2Date:23 October 2013
Reviewer: Martin Gramatzki
Reviewer's report:
This study is clearly structured. However, the authors should have outlined the
incidence, severity and particularly the treatment of acute GvHD besides the
gastrointestinal tract involvement. It is very likely that acute GvHD such as of the
skin or the liver has occurred in a substantial number of patients, partly also
leading to systemic immunosuppression. This could have strongly influenced the
incidence and degree of intestinal GvHD and thereby the outcome of the study.
If, as indicated, the rate of infectious complications was higher in the budesonide
group, it would be of interest if there is a correlation with the degree of GvHD in
those patients receiving immunosuppression.
Another important aspect would be whether infectious complications especially of
the intestinal tract have been found more frequently in the budesonide group
than in the placebo group.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I declare that I have no competing interests.
assistant