Reviewer's report
Title:Symptom profile in partial responders to a proton pump inhibitor compared
with treatment-naive patients with gastroesophageal reflux disease: a post hoc
analysis of two study populations
Version:1Date:6 June 2014
Reviewer: Edoardo Savarino
Reviewer's report:
Summary and Comments
The article entitled "Symptom profile in partial responders to a proton pump
inhibitor compared with treatment-naïve patients with gastroesophageal reflux
disease: a post hoc analysis of two study populations” by Vakil et al. is a
post-hoc analysis whether differences in terms of symptom profiles exist in partial
PPI responders vs. treatment-naïve patients with gastroesophageal reflux
disease (GERD).
The main results of the investigation is that gastrointestinal symptom patterns in
partial PPI responders were similar to those in treatment-naïve GERD patients,
but partial PPI responders experienced more severe reflux symptoms (heartburn
and regurgitation) on PPI therapy than did patients with GERD not treated with
PPIs. Thus, the authors concluded that the main symptom burden of patients
with GERD who are partial responders to a PPI continues to be heartburn and
regurgitation.
Current study is clear and well written. Also the main idea of the study is
interesting and the conclusion appear somehow surprising since recent data
(Gut. 2012 Apr;61(4):501-6, Gut. 2009 Sep;58(9):1185-91) underlined that
concomitant functional gastrointestinal disorders play a major role in favouring
PPI partial response or refractoriness, more than the persisting presence of
heartburn and regurgitation. Thus, it is really interesting from my clinical point of
view.
Minor Compulsory Revisions:
1. Methods. A major limitation of the PRO validation study is that symptoms relief
has been evaluated after a short PPI trial (4 weeks). Indeed, 12 weeks
represents, to date, the best time interval before defining patients as responders
or non-responders to PPI therapy (Gut 2012, 61(9):1340–322 1354). Moreover, it
is not clear if PPI was given at single or double dose. Also in the Diamond study
the duration of PPI trial was too short and at low dosing. Please, clarify and
discuss.
2. Discussion. Given the final conclusion on the relevance of heartburn and
regurgitation in favouring partial PPI response, the role of weakly acidic or bile
reflux should be more emphasized in the discussion section
3. Discussion. I would eliminate the term “well-defined” patients population since
the criteria used to define GERD are different in the two studies as well as the
criteria used to define patients as partial responders (see above)
4. References. There are few important and more recent articles about the
overlap between GERD andfunctional GI disorders that have not been cited (J
Gastroenterol. 2014 Apr;49(4):628-37 ; Gut. 2009 Sep;58(9):1185-91; Nat Rev
Gastroenterol Hepatol. 2013 Mar;10(3):175-86; World J Gastroenterol. 2013 Sep
21;19(35):5787-97)
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests'
Reviewer's report
Title:Symptom profile in partial responders to a proton pump inhibitor compared
with treatment-naive patients with gastroesophageal reflux disease: a post hoc
analysis of two study populations
Version:1Date:6 June 2014
Reviewer: Edoardo Savarino
Reviewer's report:
Summary and Comments
The article entitled "Symptom profile in partial responders to a proton pump
inhibitor compared with treatment-naïve patients with gastroesophageal reflux
disease: a post hoc analysis of two study populations” by Vakil et al. is a
post-hoc analysis whether differences in terms of symptom profiles exist in partial
PPI responders vs. treatment-naïve patients with gastroesophageal reflux
disease (GERD).
The main results of the investigation is that gastrointestinal symptom patterns in
partial PPI responders were similar to those in treatment-naïve GERD patients,
but partial PPI responders experienced more severe reflux symptoms (heartburn
and regurgitation) on PPI therapy than did patients with GERD not treated with
PPIs. Thus, the authors concluded that the main symptom burden of patients
with GERD who are partial responders to a PPI continues to be heartburn and
regurgitation.
Current study is clear and well written. Also the main idea of the study is
interesting and the conclusion appear somehow surprising since recent data
(Gut. 2012 Apr;61(4):501-6, Gut. 2009 Sep;58(9):1185-91) underlined that
concomitant functional gastrointestinal disorders play a major role in favouring
PPI partial response or refractoriness, more than the persisting presence of
heartburn and regurgitation. Thus, it is really interesting from my clinical point of
view.
Minor Compulsory Revisions:
1. Methods. A major limitation of the PRO validation study is that symptoms relief
has been evaluated after a short PPI trial (4 weeks). Indeed, 12 weeks
represents, to date, the best time interval before defining patients as responders
or non-responders to PPI therapy (Gut 2012, 61(9):1340–322 1354). Moreover, it
is not clear if PPI was given at single or double dose. Also in the Diamond study
the duration of PPI trial was too short and at low dosing. Please, clarify and
discuss.
2. Discussion. Given the final conclusion on the relevance of heartburn and
regurgitation in favouring partial PPI response, the role of weakly acidic or bile
reflux should be more emphasized in the discussion section
3. Discussion. I would eliminate the term “well-defined” patients population since
the criteria used to define GERD are different in the two studies as well as the
criteria used to define patients as partial responders (see above)
4. References. There are few important and more recent articles about the
overlap between GERD andfunctional GI disorders that have not been cited (J
Gastroenterol. 2014 Apr;49(4):628-37 ; Gut. 2009 Sep;58(9):1185-91; Nat Rev
Gastroenterol Hepatol. 2013 Mar;10(3):175-86; World J Gastroenterol. 2013 Sep
21;19(35):5787-97)
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests'
Please review this paper.
user
Reviewer's report
Title:Symptom profile in partial responders to a proton pump inhibitor compared
with treatment-naive patients with gastroesophageal reflux disease: a post hoc
analysis of two study populations
Version:1Date:6 June 2014
Reviewer: Edoardo Savarino
Reviewer's report:
Summary and Comments
The article entitled "Symptom profile in partial responders to a proton pump
inhibitor compared with treatment-naïve patients with gastroesophageal reflux
disease: a post hoc analysis of two study populations” by Vakil et al. is a
post-hoc analysis whether differences in terms of symptom profiles exist in partial
PPI responders vs. treatment-naïve patients with gastroesophageal reflux
disease (GERD).
The main results of the investigation is that gastrointestinal symptom patterns in
partial PPI responders were similar to those in treatment-naïve GERD patients,
but partial PPI responders experienced more severe reflux symptoms (heartburn
and regurgitation) on PPI therapy than did patients with GERD not treated with
PPIs. Thus, the authors concluded that the main symptom burden of patients
with GERD who are partial responders to a PPI continues to be heartburn and
regurgitation.
Current study is clear and well written. Also the main idea of the study is
interesting and the conclusion appear somehow surprising since recent data
(Gut. 2012 Apr;61(4):501-6, Gut. 2009 Sep;58(9):1185-91) underlined that
concomitant functional gastrointestinal disorders play a major role in favouring
PPI partial response or refractoriness, more than the persisting presence of
heartburn and regurgitation. Thus, it is really interesting from my clinical point of
view.
Minor Compulsory Revisions:
1. Methods. A major limitation of the PRO validation study is that symptoms relief
has been evaluated after a short PPI trial (4 weeks). Indeed, 12 weeks
represents, to date, the best time interval before defining patients as responders
or non-responders to PPI therapy (Gut 2012, 61(9):1340–322 1354). Moreover, it
is not clear if PPI was given at single or double dose. Also in the Diamond study
the duration of PPI trial was too short and at low dosing. Please, clarify and
discuss.
2. Discussion. Given the final conclusion on the relevance of heartburn and
regurgitation in favouring partial PPI response, the role of weakly acidic or bile
reflux should be more emphasized in the discussion section
3. Discussion. I would eliminate the term “well-defined” patients population since
the criteria used to define GERD are different in the two studies as well as the
criteria used to define patients as partial responders (see above)
4. References. There are few important and more recent articles about the
overlap between GERD andfunctional GI disorders that have not been cited (J
Gastroenterol. 2014 Apr;49(4):628-37 ; Gut. 2009 Sep;58(9):1185-91; Nat Rev
Gastroenterol Hepatol. 2013 Mar;10(3):175-86; World J Gastroenterol. 2013 Sep
21;19(35):5787-97)
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests'
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