Reviewer's report
Title:Prediction of response to PPI therapy and factors influencing treatment
outcome in patients with GORD: a prospective pragmatic trial
Version: 1Date:25 February 2011
Reviewer: Leonardo Marzio
Reviewer's report:
This is a observational study on the effect of lansoprazole 40 mg o.i.d. on an
unselected population of patients suffering of symptoms suggestive of GORD.
Two major points must have been identified. The first is the lack of criteria used
for selecting the studied population (based only of physician’s judgment) and the
second the absence of a control group.
First point: The diagnosis of GORD although was confirmed in those having
oesophagitis it could not be confirmed in those having a normal appearance of
the oesophago-gastric junction. These patients although could be classified ad
having NERD could also be classified as having symptoms suggestive of GORD
with any evidence of GORD. They could be affected by hypersensitive
esophagus or simply by functional dyspepsia. The lack of specificity in selecting
these patients could also justify the lack of response to treatment in this
soubgroup. The ReQuest questionary that was administered after enrolling, could
have been used to enroll patients into the study. At least all patients enrolled
should have been affected by regurgitation and heartburn and scored. This is not
specified in the study.
Second point: the lack of a control group or a group with different dosage of
lansoprazole does not contribute to answer the question whether patients who
did not respond to treatment because of insufficient amount of the drug or
intercurrence with other disease condition or simply because the were not
affected either by GORD. In a similar recent study from Germany a larger
population of patients suffering from GORD well responded to lansoprazole 20 or
40 mg daily with only a 3% of patients having symptoms after 4 weeks of
treatment (Efficacy and tolerability of pantoprazole in the treatment of
gastroesophageal reflux disease.Gillessen A. MMW Fortschr Med. 2010 Apr
8;152 Suppl 1:21-9. German)
Minor points
Title: PPI therapy is too generic, pantoprazole 40 mg daily is more appropriate.
Page 2 Abstract, Results: “Poorer treatment response” It should be specified
what poor response mean in term of percent reduction of basal symptoms score
or else.
Page 4, line 7. Methods: “Thus patients were enrolled on the basis of having
symptoms considered by the investigating physician to justify a diagnosis of
GORD” This is a too generic statement, more specific criteria must be described.
Otherwise the enrolled patients in particular those with normal oesophagus at
endoscopy could be affected by diseases other than NERD. In the reviewer
opinion these patients should be excluded by the study.
Page 5 line 1: “At enrollment of the patient, the investigator enquired about the
presence of symptoms that would be consistent with IBS” in the reviewer’s
opinion it should be specified what criteria were used by the enrolling physician
to identify GORD.
Page 7, line 6. By definition healthy individuals should be free from any
gastrointestinal symptoms. It is not clear how a questionnaire that evaluate
symptoms can be applied to an healthy individual even if someone may affirm
that even healthy individuals may experience GORD-like symptoms from time to
time probably in some part of the world. This issue cannot be assumed as a
general statement. In the reviewer’s opinion, to consider the symptom’s threshold
the one recorded by healthy individuals may be misleading (healthy individuals
do not have symptoms) it would be better to consider the percent reduction of
initial symptoms score at each visit.
Page 10. Response rates. The overall response rate seems to be quite low at 4
and 8 weeks in comparison to the data from similar recently published studies
probably because the limit of 1.6 on ReQuestTM-GI was arbitrary set too low or
more simply because many patients selected were not affected by GORD.
It would be important to insert data on basal ReQuestTM-GI score (in absolute
values) and data at 4 and 8 weeks (absolute and percent values) in the overall
population and subdivide those with ERD from NERD in order to see if those with
ERD match with those with higher symptoms score and vice versa with NERD.
Discussion
The discussion is too long and not focused. This work is an open label not
controlled study that examine the effect of lansoprazole 40 mg daily on the
symptoms score in an unselected population of patients with symptoms
suggestive of GORD but at least in part of them without any evidence of GORD.
The results cannot be extended generically to all PPI.
Page 15, line 5. The clinical history of uncomplicated GORD that is the basis of
study enrollment has not been specified.
Page 15, last paragraph. A better way to determine symptomatic relief is
considered to have occurred if the total ReQuest™ score falls below the GORD
symptom threshold (see Bardhan et al Aliment Pharmacol Ther
2007;25:1461-9)or the level at which symptoms no longer impair quality of life.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Reviewer's report
Title:Prediction of response to PPI therapy and factors influencing treatment
outcome in patients with GORD: a prospective pragmatic trial
Version: 1Date:25 February 2011
Reviewer: Leonardo Marzio
Reviewer's report:
This is a observational study on the effect of lansoprazole 40 mg o.i.d. on an
unselected population of patients suffering of symptoms suggestive of GORD.
Two major points must have been identified. The first is the lack of criteria used
for selecting the studied population (based only of physician’s judgment) and the
second the absence of a control group.
First point: The diagnosis of GORD although was confirmed in those having
oesophagitis it could not be confirmed in those having a normal appearance of
the oesophago-gastric junction. These patients although could be classified ad
having NERD could also be classified as having symptoms suggestive of GORD
with any evidence of GORD. They could be affected by hypersensitive
esophagus or simply by functional dyspepsia. The lack of specificity in selecting
these patients could also justify the lack of response to treatment in this
soubgroup. The ReQuest questionary that was administered after enrolling, could
have been used to enroll patients into the study. At least all patients enrolled
should have been affected by regurgitation and heartburn and scored. This is not
specified in the study.
Second point: the lack of a control group or a group with different dosage of
lansoprazole does not contribute to answer the question whether patients who
did not respond to treatment because of insufficient amount of the drug or
intercurrence with other disease condition or simply because the were not
affected either by GORD. In a similar recent study from Germany a larger
population of patients suffering from GORD well responded to lansoprazole 20 or
40 mg daily with only a 3% of patients having symptoms after 4 weeks of
treatment (Efficacy and tolerability of pantoprazole in the treatment of
gastroesophageal reflux disease.Gillessen A. MMW Fortschr Med. 2010 Apr
8;152 Suppl 1:21-9. German)
Minor points
Title: PPI therapy is too generic, pantoprazole 40 mg daily is more appropriate.
Page 2 Abstract, Results: “Poorer treatment response” It should be specified
what poor response mean in term of percent reduction of basal symptoms score
or else.
Page 4, line 7. Methods: “Thus patients were enrolled on the basis of having
symptoms considered by the investigating physician to justify a diagnosis of
GORD” This is a too generic statement, more specific criteria must be described.
Otherwise the enrolled patients in particular those with normal oesophagus at
endoscopy could be affected by diseases other than NERD. In the reviewer
opinion these patients should be excluded by the study.
Page 5 line 1: “At enrollment of the patient, the investigator enquired about the
presence of symptoms that would be consistent with IBS” in the reviewer’s
opinion it should be specified what criteria were used by the enrolling physician
to identify GORD.
Page 7, line 6. By definition healthy individuals should be free from any
gastrointestinal symptoms. It is not clear how a questionnaire that evaluate
symptoms can be applied to an healthy individual even if someone may affirm
that even healthy individuals may experience GORD-like symptoms from time to
time probably in some part of the world. This issue cannot be assumed as a
general statement. In the reviewer’s opinion, to consider the symptom’s threshold
the one recorded by healthy individuals may be misleading (healthy individuals
do not have symptoms) it would be better to consider the percent reduction of
initial symptoms score at each visit.
Page 10. Response rates. The overall response rate seems to be quite low at 4
and 8 weeks in comparison to the data from similar recently published studies
probably because the limit of 1.6 on ReQuestTM-GI was arbitrary set too low or
more simply because many patients selected were not affected by GORD.
It would be important to insert data on basal ReQuestTM-GI score (in absolute
values) and data at 4 and 8 weeks (absolute and percent values) in the overall
population and subdivide those with ERD from NERD in order to see if those with
ERD match with those with higher symptoms score and vice versa with NERD.
Discussion
The discussion is too long and not focused. This work is an open label not
controlled study that examine the effect of lansoprazole 40 mg daily on the
symptoms score in an unselected population of patients with symptoms
suggestive of GORD but at least in part of them without any evidence of GORD.
The results cannot be extended generically to all PPI.
Page 15, line 5. The clinical history of uncomplicated GORD that is the basis of
study enrollment has not been specified.
Page 15, last paragraph. A better way to determine symptomatic relief is
considered to have occurred if the total ReQuest™ score falls below the GORD
symptom threshold (see Bardhan et al Aliment Pharmacol Ther
2007;25:1461-9)or the level at which symptoms no longer impair quality of life.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Please review this paper.
user
Reviewer's report
Title:Prediction of response to PPI therapy and factors influencing treatment
outcome in patients with GORD: a prospective pragmatic trial
Version: 1Date:25 February 2011
Reviewer: Leonardo Marzio
Reviewer's report:
This is a observational study on the effect of lansoprazole 40 mg o.i.d. on an
unselected population of patients suffering of symptoms suggestive of GORD.
Two major points must have been identified. The first is the lack of criteria used
for selecting the studied population (based only of physician’s judgment) and the
second the absence of a control group.
First point: The diagnosis of GORD although was confirmed in those having
oesophagitis it could not be confirmed in those having a normal appearance of
the oesophago-gastric junction. These patients although could be classified ad
having NERD could also be classified as having symptoms suggestive of GORD
with any evidence of GORD. They could be affected by hypersensitive
esophagus or simply by functional dyspepsia. The lack of specificity in selecting
these patients could also justify the lack of response to treatment in this
soubgroup. The ReQuest questionary that was administered after enrolling, could
have been used to enroll patients into the study. At least all patients enrolled
should have been affected by regurgitation and heartburn and scored. This is not
specified in the study.
Second point: the lack of a control group or a group with different dosage of
lansoprazole does not contribute to answer the question whether patients who
did not respond to treatment because of insufficient amount of the drug or
intercurrence with other disease condition or simply because the were not
affected either by GORD. In a similar recent study from Germany a larger
population of patients suffering from GORD well responded to lansoprazole 20 or
40 mg daily with only a 3% of patients having symptoms after 4 weeks of
treatment (Efficacy and tolerability of pantoprazole in the treatment of
gastroesophageal reflux disease.Gillessen A. MMW Fortschr Med. 2010 Apr
8;152 Suppl 1:21-9. German)
Minor points
Title: PPI therapy is too generic, pantoprazole 40 mg daily is more appropriate.
Page 2 Abstract, Results: “Poorer treatment response” It should be specified
what poor response mean in term of percent reduction of basal symptoms score
or else.
Page 4, line 7. Methods: “Thus patients were enrolled on the basis of having
symptoms considered by the investigating physician to justify a diagnosis of
GORD” This is a too generic statement, more specific criteria must be described.
Otherwise the enrolled patients in particular those with normal oesophagus at
endoscopy could be affected by diseases other than NERD. In the reviewer
opinion these patients should be excluded by the study.
Page 5 line 1: “At enrollment of the patient, the investigator enquired about the
presence of symptoms that would be consistent with IBS” in the reviewer’s
opinion it should be specified what criteria were used by the enrolling physician
to identify GORD.
Page 7, line 6. By definition healthy individuals should be free from any
gastrointestinal symptoms. It is not clear how a questionnaire that evaluate
symptoms can be applied to an healthy individual even if someone may affirm
that even healthy individuals may experience GORD-like symptoms from time to
time probably in some part of the world. This issue cannot be assumed as a
general statement. In the reviewer’s opinion, to consider the symptom’s threshold
the one recorded by healthy individuals may be misleading (healthy individuals
do not have symptoms) it would be better to consider the percent reduction of
initial symptoms score at each visit.
Page 10. Response rates. The overall response rate seems to be quite low at 4
and 8 weeks in comparison to the data from similar recently published studies
probably because the limit of 1.6 on ReQuestTM-GI was arbitrary set too low or
more simply because many patients selected were not affected by GORD.
It would be important to insert data on basal ReQuestTM-GI score (in absolute
values) and data at 4 and 8 weeks (absolute and percent values) in the overall
population and subdivide those with ERD from NERD in order to see if those with
ERD match with those with higher symptoms score and vice versa with NERD.
Discussion
The discussion is too long and not focused. This work is an open label not
controlled study that examine the effect of lansoprazole 40 mg daily on the
symptoms score in an unselected population of patients with symptoms
suggestive of GORD but at least in part of them without any evidence of GORD.
The results cannot be extended generically to all PPI.
Page 15, line 5. The clinical history of uncomplicated GORD that is the basis of
study enrollment has not been specified.
Page 15, last paragraph. A better way to determine symptomatic relief is
considered to have occurred if the total ReQuest™ score falls below the GORD
symptom threshold (see Bardhan et al Aliment Pharmacol Ther
2007;25:1461-9)or the level at which symptoms no longer impair quality of life.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
assistant