Reviewer's report
Title:Efficacy of transoral fundoplication for treatment of chronic
gastroesophageal reflux disease incompletely controlled with high-dose
proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover
study
Version:1Date:16 September 2014
Reviewer: Beat Peter Müller-Stich
Reviewer's report:
The authors present a nice manuscript on a randomized controlled comparison of
transoral fundoplication (TF) to high dose proton pump inhibitor therapy (PPI).
Additionally, a cross over design allows for findings on the durability of TF over a
period of 12 months. Unfortunately, the follow-up period is short and any form of
blinding seems to be missing. Therefore, the authors have to deal with observer
bias and placebo effect. Additionally, the authors missed to compare TF to
laparoscopic fundoplication, which theirselves described as the gold standard.
This is a pity because at least patient blinding for six months would have been
easy by a shame endoscopy and observer bias could have been eliminated by
assessor blinding.
I would therefore suggest the following revision:
Major compulsory revisions
1. A paragraph on blinding should be added in the method section; the authors
should state if they had applied any form of blinding, and if not why not.
2. The conclusions in the discussion section should be weakened against the
background of a potential observer bias and placebo effect. They should focus
the interpretation of their results on the objective findings like pH-metry results
and endoscopic findings more than on symptomatic improvement. And they
should state that any symptomatic improvement might be the result of a placebo
effect.
3. Any comparison with laparoscopic fundoplication e.g. in terms of side-effects
should be omitted in the discussion section because no surgical control group
was used in this study. Therefore, the authors cannot conclude that TF is a better
alternative to laparoscopic fundoplication in terms of post-fundoplication
symptoms as long as they have not compared the two methods.
Minor essential revisions
4. For the EsophyX device the company should be mentioned (in parentheses)
on page 4
5.P-values should be added in Table 2
6. In the heading of Table 3 there is a typing error; an ‘I’ is missing in the first
parentheses (PPIs instead of PPs).
7. Abbreviations should be explained separately in every Table and Figure.
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:Efficacy of transoral fundoplication for treatment of chronic
gastroesophageal reflux disease incompletely controlled with high-dose
proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover
study
Version:1Date:16 September 2014
Reviewer: Beat Peter Müller-Stich
Reviewer's report:
The authors present a nice manuscript on a randomized controlled comparison of
transoral fundoplication (TF) to high dose proton pump inhibitor therapy (PPI).
Additionally, a cross over design allows for findings on the durability of TF over a
period of 12 months. Unfortunately, the follow-up period is short and any form of
blinding seems to be missing. Therefore, the authors have to deal with observer
bias and placebo effect. Additionally, the authors missed to compare TF to
laparoscopic fundoplication, which theirselves described as the gold standard.
This is a pity because at least patient blinding for six months would have been
easy by a shame endoscopy and observer bias could have been eliminated by
assessor blinding.
I would therefore suggest the following revision:
Major compulsory revisions
1. A paragraph on blinding should be added in the method section; the authors
should state if they had applied any form of blinding, and if not why not.
2. The conclusions in the discussion section should be weakened against the
background of a potential observer bias and placebo effect. They should focus
the interpretation of their results on the objective findings like pH-metry results
and endoscopic findings more than on symptomatic improvement. And they
should state that any symptomatic improvement might be the result of a placebo
effect.
3. Any comparison with laparoscopic fundoplication e.g. in terms of side-effects
should be omitted in the discussion section because no surgical control group
was used in this study. Therefore, the authors cannot conclude that TF is a better
alternative to laparoscopic fundoplication in terms of post-fundoplication
symptoms as long as they have not compared the two methods.
Minor essential revisions
4. For the EsophyX device the company should be mentioned (in parentheses)
on page 4
5.P-values should be added in Table 2
6. In the heading of Table 3 there is a typing error; an ‘I’ is missing in the first
parentheses (PPIs instead of PPs).
7. Abbreviations should be explained separately in every Table and Figure.
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:Efficacy of transoral fundoplication for treatment of chronic
gastroesophageal reflux disease incompletely controlled with high-dose
proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover
study
Version:1Date:16 September 2014
Reviewer: Beat Peter Müller-Stich
Reviewer's report:
The authors present a nice manuscript on a randomized controlled comparison of
transoral fundoplication (TF) to high dose proton pump inhibitor therapy (PPI).
Additionally, a cross over design allows for findings on the durability of TF over a
period of 12 months. Unfortunately, the follow-up period is short and any form of
blinding seems to be missing. Therefore, the authors have to deal with observer
bias and placebo effect. Additionally, the authors missed to compare TF to
laparoscopic fundoplication, which theirselves described as the gold standard.
This is a pity because at least patient blinding for six months would have been
easy by a shame endoscopy and observer bias could have been eliminated by
assessor blinding.
I would therefore suggest the following revision:
Major compulsory revisions
1. A paragraph on blinding should be added in the method section; the authors
should state if they had applied any form of blinding, and if not why not.
2. The conclusions in the discussion section should be weakened against the
background of a potential observer bias and placebo effect. They should focus
the interpretation of their results on the objective findings like pH-metry results
and endoscopic findings more than on symptomatic improvement. And they
should state that any symptomatic improvement might be the result of a placebo
effect.
3. Any comparison with laparoscopic fundoplication e.g. in terms of side-effects
should be omitted in the discussion section because no surgical control group
was used in this study. Therefore, the authors cannot conclude that TF is a better
alternative to laparoscopic fundoplication in terms of post-fundoplication
symptoms as long as they have not compared the two methods.
Minor essential revisions
4. For the EsophyX device the company should be mentioned (in parentheses)
on page 4
5.P-values should be added in Table 2
6. In the heading of Table 3 there is a typing error; an ‘I’ is missing in the first
parentheses (PPIs instead of PPs).
7. Abbreviations should be explained separately in every Table and Figure.
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