Reviewer's report
Title:Rifaximin for maintenance therapy in antibiotic-dependent pouchitis
Version: 1Date:11 January 2008
Reviewer: Tanja Kuehbacher
Reviewer's report:
The authors of the study "rifaximin for maintenance therapy in
antibiotic-dependent pouchitis" investigated the efficacy and safety of rifaximin in
maintaining remission in antibiotic-dependent pouchitis. Therefore they
investigated a cohort of fifty-one patients with chronic antibiotic-dependent
pouchitis in an open label historical study. 33 (65%) patients remained in
remission after three months, the primary endpoint of the study. In total, only two
patients successfully continued maintenance for 24 months.
There are several limitations of the study, which were discussed clearly by the
authors themselves: 1. the character of the study performed: with a historical
cohort open-label study there are too many biases to conclude the effectiveness
of rifaximin. 2. The aim of the study was to investigate the efficacy and tolerability
of rifaximin in maintaining symptomatic and endoscopic remission in patients with
antibiotic-dependent pouchitis, but only in 30 of the 51 patients the endoscopic
data were complete. 3. The primary endpoint with a follow-up at three months
after beginning maintenance therapy with rifaximin was too short to conclude the
efficacy and safety of rifaximin as a long-term treatment for maintaining remission
in antibiotic-dependent pouchitis. Especially, comparison with studies with
probiotic agents should be avoided, regarding the character of the studies as
randomized, placebo-controlled studies with follow-ups of 12 months at least.4.
The doses of rifaximin used in this study are not standardized. 5. I agree with the
authors, that further investigations with a prolonged follow-up, randomized,
placebo-controlled trial with standardized doses of medication and endoscopic
examinations in all patients are needed to adequately determine the efficacy and
safety of rifaximin for maintaining remission in antibiotic-dependent pouchitis.
In summary, even so the study has its limitations; I would consider it for
publication, because: 1. this study polarizes and therefore stimulates scientific
discussions. 2. Due to the lack of studies in this field, a study with an interesting
and provoking thesis can lead to further studies with a randomized
placebo-controlled setting and e.g. a comparison with other agents e.g.
probiotics.
Nevertheless the authors should change the conclusion of their abstract before
the study can be accepted for publication. Due to all the limitations, which the
authors themselves discuss rifaximin should not be considered to be effective
and safe for long-term treatment in maintaining remission in antibiotic-dependent
pouchitis without some limitations.
What next?: Accept after minor essential revisions
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 interestsÂ´below.
Reviewer's report
Title:Rifaximin for maintenance therapy in antibiotic-dependent pouchitis
Version: 1Date:11 January 2008
Reviewer: Tanja Kuehbacher
Reviewer's report:
The authors of the study "rifaximin for maintenance therapy in
antibiotic-dependent pouchitis" investigated the efficacy and safety of rifaximin in
maintaining remission in antibiotic-dependent pouchitis. Therefore they
investigated a cohort of fifty-one patients with chronic antibiotic-dependent
pouchitis in an open label historical study. 33 (65%) patients remained in
remission after three months, the primary endpoint of the study. In total, only two
patients successfully continued maintenance for 24 months.
There are several limitations of the study, which were discussed clearly by the
authors themselves: 1. the character of the study performed: with a historical
cohort open-label study there are too many biases to conclude the effectiveness
of rifaximin. 2. The aim of the study was to investigate the efficacy and tolerability
of rifaximin in maintaining symptomatic and endoscopic remission in patients with
antibiotic-dependent pouchitis, but only in 30 of the 51 patients the endoscopic
data were complete. 3. The primary endpoint with a follow-up at three months
after beginning maintenance therapy with rifaximin was too short to conclude the
efficacy and safety of rifaximin as a long-term treatment for maintaining remission
in antibiotic-dependent pouchitis. Especially, comparison with studies with
probiotic agents should be avoided, regarding the character of the studies as
randomized, placebo-controlled studies with follow-ups of 12 months at least.4.
The doses of rifaximin used in this study are not standardized. 5. I agree with the
authors, that further investigations with a prolonged follow-up, randomized,
placebo-controlled trial with standardized doses of medication and endoscopic
examinations in all patients are needed to adequately determine the efficacy and
safety of rifaximin for maintaining remission in antibiotic-dependent pouchitis.
In summary, even so the study has its limitations; I would consider it for
publication, because: 1. this study polarizes and therefore stimulates scientific
discussions. 2. Due to the lack of studies in this field, a study with an interesting
and provoking thesis can lead to further studies with a randomized
placebo-controlled setting and e.g. a comparison with other agents e.g.
probiotics.
Nevertheless the authors should change the conclusion of their abstract before
the study can be accepted for publication. Due to all the limitations, which the
authors themselves discuss rifaximin should not be considered to be effective
and safe for long-term treatment in maintaining remission in antibiotic-dependent
pouchitis without some limitations.
What next?: Accept after minor essential revisions
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 interestsÂ´below.
Please review this paper.
user
Reviewer's report
Title:Rifaximin for maintenance therapy in antibiotic-dependent pouchitis
Version: 1Date:11 January 2008
Reviewer: Tanja Kuehbacher
Reviewer's report:
The authors of the study "rifaximin for maintenance therapy in
antibiotic-dependent pouchitis" investigated the efficacy and safety of rifaximin in
maintaining remission in antibiotic-dependent pouchitis. Therefore they
investigated a cohort of fifty-one patients with chronic antibiotic-dependent
pouchitis in an open label historical study. 33 (65%) patients remained in
remission after three months, the primary endpoint of the study. In total, only two
patients successfully continued maintenance for 24 months.
There are several limitations of the study, which were discussed clearly by the
authors themselves: 1. the character of the study performed: with a historical
cohort open-label study there are too many biases to conclude the effectiveness
of rifaximin. 2. The aim of the study was to investigate the efficacy and tolerability
of rifaximin in maintaining symptomatic and endoscopic remission in patients with
antibiotic-dependent pouchitis, but only in 30 of the 51 patients the endoscopic
data were complete. 3. The primary endpoint with a follow-up at three months
after beginning maintenance therapy with rifaximin was too short to conclude the
efficacy and safety of rifaximin as a long-term treatment for maintaining remission
in antibiotic-dependent pouchitis. Especially, comparison with studies with
probiotic agents should be avoided, regarding the character of the studies as
randomized, placebo-controlled studies with follow-ups of 12 months at least.4.
The doses of rifaximin used in this study are not standardized. 5. I agree with the
authors, that further investigations with a prolonged follow-up, randomized,
placebo-controlled trial with standardized doses of medication and endoscopic
examinations in all patients are needed to adequately determine the efficacy and
safety of rifaximin for maintaining remission in antibiotic-dependent pouchitis.
In summary, even so the study has its limitations; I would consider it for
publication, because: 1. this study polarizes and therefore stimulates scientific
discussions. 2. Due to the lack of studies in this field, a study with an interesting
and provoking thesis can lead to further studies with a randomized
placebo-controlled setting and e.g. a comparison with other agents e.g.
probiotics.
Nevertheless the authors should change the conclusion of their abstract before
the study can be accepted for publication. Due to all the limitations, which the
authors themselves discuss rifaximin should not be considered to be effective
and safe for long-term treatment in maintaining remission in antibiotic-dependent
pouchitis without some limitations.
What next?: Accept after minor essential revisions
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 interestsÂ´below.
assistant