Reviewer ’s report  
 
Title: A non -interventional, observational study of a fixed combination of peps in and amino acid  
hydrochloride in patients with functional dyspepsia  
 
Version: 0 Date: 03 Sep 2017  
 
Reviewer: Rita Busuttil  
 
Reviewer's report:  
 
This manuscript describes the results of an observational su rveillance study looking at the effects 
of Enzynoform on patients with Functional dyspepsia. The study is well reported but there were 
some points which require further clarification and/or discussion.  
 
 
 
 
1) Weight of the patients was considered in an all inclusive manner. It would be more 
meaningful to divide this into gender groups.  
 
 
 
2) The inclusion/exclusion criteria is a little difficult to follow - as is the the number of 
patients being included in each  study parameter. The manuscript would benefit from a 
table outlining inclusion/exclusion criteria and number of samples within each group.  
 
 
3) Should the  subset of patients not meeting the Rome III criteria be analysed separately?  
 
 
4) Was the H.pylori statu s of the patients known? Was there any correlation with the 
results?  
 
 
5) Some patients showed a worsening of symptoms while on treatment. Can the authors 
suggest a reason why? Was this correlated with their baseline GIS score?  
 
 
6) Table 1. 72 patients had ba seline and week 6 data. However 73 patients had week 6. Is it 
reasonable to analyse data of patients where baseline values were not available?  
 
 
7) How many patients were included in the analysis for Table 2?  
 
 
8) Fig 1 is difficult to read - and it is difficul t to see the number of patients who improve or 
regress during treatment.  
 
 
9) Can the authors describe what happened in those patients with the highest baseline GIS 
scores?  
 
 
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
Does the work include the necessary contr ols? 
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are 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 speci fy what aspects require further 
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quali ty of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
 
 
 
 
 
 
 
 
 
Declaration 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 this  
manuscript, 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 f or 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 in terests  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my report to the autho rs and, if the manuscript is accepted for publication, my named report  
including 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 Commons  
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments  
which I do not wish to be included in my named report can be included as confidential comments  
to the editors, which will not be published.  
 
I declare that I have no competing interests   
Reviewer ’s report  
 
Title: A non -interventional, observational study of a fixed combination of peps in and amino acid  
hydrochloride in patients with functional dyspepsia  
 
Version: 0 Date: 03 Sep 2017  
 
Reviewer: Rita Busuttil  
 
Reviewer's report:  
 
This manuscript describes the results of an observational su rveillance study looking at the effects 
of Enzynoform on patients with Functional dyspepsia. The study is well reported but there were 
some points which require further clarification and/or discussion.  
 
 
 
 
1) Weight of the patients was considered in an all inclusive manner. It would be more 
meaningful to divide this into gender groups.  
 
 
 
2) The inclusion/exclusion criteria is a little difficult to follow - as is the the number of 
patients being included in each  study parameter. The manuscript would benefit from a 
table outlining inclusion/exclusion criteria and number of samples within each group.  
 
 
3) Should the  subset of patients not meeting the Rome III criteria be analysed separately?  
 
 
4) Was the H.pylori statu s of the patients known? Was there any correlation with the 
results?  
 
 
5) Some patients showed a worsening of symptoms while on treatment. Can the authors 
suggest a reason why? Was this correlated with their baseline GIS score?  
 
 
6) Table 1. 72 patients had ba seline and week 6 data. However 73 patients had week 6. Is it 
reasonable to analyse data of patients where baseline values were not available?  
 
 
7) How many patients were included in the analysis for Table 2?  
 
 
8) Fig 1 is difficult to read - and it is difficul t to see the number of patients who improve or 
regress during treatment.  
 
 
9) Can the authors describe what happened in those patients with the highest baseline GIS 
scores?  
 
 
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
Does the work include the necessary contr ols? 
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are 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 speci fy what aspects require further 
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quali ty of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
 
 
 
 
 
 
 
 
 
Declaration 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 this  
manuscript, 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 f or 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 in terests  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my report to the autho rs and, if the manuscript is accepted for publication, my named report  
including 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 Commons  
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments  
which I do not wish to be included in my named report can be included as confidential comments  
to the editors, which will not be published.  
 
I declare that I have no competing interests   
Please review this paper.
user
Reviewer ’s report  
 
Title: A non -interventional, observational study of a fixed combination of peps in and amino acid  
hydrochloride in patients with functional dyspepsia  
 
Version: 0 Date: 03 Sep 2017  
 
Reviewer: Rita Busuttil  
 
Reviewer's report:  
 
This manuscript describes the results of an observational su rveillance study looking at the effects 
of Enzynoform on patients with Functional dyspepsia. The study is well reported but there were 
some points which require further clarification and/or discussion.  
 
 
 
 
1) Weight of the patients was considered in an all inclusive manner. It would be more 
meaningful to divide this into gender groups.  
 
 
 
2) The inclusion/exclusion criteria is a little difficult to follow - as is the the number of 
patients being included in each  study parameter. The manuscript would benefit from a 
table outlining inclusion/exclusion criteria and number of samples within each group.  
 
 
3) Should the  subset of patients not meeting the Rome III criteria be analysed separately?  
 
 
4) Was the H.pylori statu s of the patients known? Was there any correlation with the 
results?  
 
 
5) Some patients showed a worsening of symptoms while on treatment. Can the authors 
suggest a reason why? Was this correlated with their baseline GIS score?  
 
 
6) Table 1. 72 patients had ba seline and week 6 data. However 73 patients had week 6. Is it 
reasonable to analyse data of patients where baseline values were not available?  
 
 
7) How many patients were included in the analysis for Table 2?  
 
 
8) Fig 1 is difficult to read - and it is difficul t to see the number of patients who improve or 
regress during treatment.  
 
 
9) Can the authors describe what happened in those patients with the highest baseline GIS 
scores?  
 
 
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
Does the work include the necessary contr ols? 
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are 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 speci fy what aspects require further 
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quali ty of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
 
 
 
 
 
 
 
 
 
Declaration 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 this  
manuscript, 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 f or 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 in terests  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my report to the autho rs and, if the manuscript is accepted for publication, my named report  
including 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 Commons  
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments  
which I do not wish to be included in my named report can be included as confidential comments  
to the editors, which will not be published.  
 
I declare that I have no competing interests   
assistant