Reviewer's report
Title:Oral bisphosphonates do not increase the risk of severe upper
gastrointestinal complications: a nested case-control study
Version: 1Date:6 May 2013
Reviewer: Kazumasa Miyake
Reviewer's report:
Comments
This is a nested-control study, having clinical significance, suggesting that the
use of bisphosphonates unlikely is causally associated with the onset of serious
GI complications.
But I think this paper needs “Major Compulsory Revisions”.
- Major Compulsory Revisions
# Although this study indicated the risk of bisphosphonates for serious GI
complications using a number of sensitivity analyses, the details in numbers of
factors such as UGIC, current or past exposures of BPs, seem not to be enough.
# Current exposure was defined as the last day of coverage of BPs therapy
within 30 days prior the index date. However, in evaluating drug-associated GI
complications, the period within 30 days seems to be too long and invalid as
“Current exposure”. Was the period justified on what grounds or evidences?
# Gastroprotective agents should consist of some types, such as proton pump
inhibitors, histamine H2 receptor antagonists, prostaglandins.
In addition, it has been reported that nitrogen-containing bisphosphonates
increase gastric damage with depends on higher pH through acid supressants in
the rat.
1)Aliment Pharmacol Ther 14#1215#1223, 2000
2)J Gastroenterol Hepatol 19#512#520, 2004
How were gastroprotective agents defined?
# In “Results”, Figure 4 seems to be needed further explanation.
# This study did not offer the risk for UGIC associated with not only BPs but also
even antithrombotic agents and BPs co-therapied with NSAIDs.
Does this mean that routine clinical practice in your country has adequately
avoided the risks for any drugs-associated UGIC, but not these drugs do not
increase the risk.
# Ref [38] should have indicated the increase in the risk for gastroduodenal
ulcers with co-administration of BPs in patients on long-term NSAIDs therapy, but
not a positive association between use of BPs and the risk of gastroduodenal
ulcers.
Level of interest: An article of limited interest
Quality of written English: Not suitable for publication unless extensively edited
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
'I declare that I have no competing interests'
Reviewer's report
Title:Oral bisphosphonates do not increase the risk of severe upper
gastrointestinal complications: a nested case-control study
Version: 1Date:6 May 2013
Reviewer: Kazumasa Miyake
Reviewer's report:
Comments
This is a nested-control study, having clinical significance, suggesting that the
use of bisphosphonates unlikely is causally associated with the onset of serious
GI complications.
But I think this paper needs “Major Compulsory Revisions”.
- Major Compulsory Revisions
# Although this study indicated the risk of bisphosphonates for serious GI
complications using a number of sensitivity analyses, the details in numbers of
factors such as UGIC, current or past exposures of BPs, seem not to be enough.
# Current exposure was defined as the last day of coverage of BPs therapy
within 30 days prior the index date. However, in evaluating drug-associated GI
complications, the period within 30 days seems to be too long and invalid as
“Current exposure”. Was the period justified on what grounds or evidences?
# Gastroprotective agents should consist of some types, such as proton pump
inhibitors, histamine H2 receptor antagonists, prostaglandins.
In addition, it has been reported that nitrogen-containing bisphosphonates
increase gastric damage with depends on higher pH through acid supressants in
the rat.
1)Aliment Pharmacol Ther 14#1215#1223, 2000
2)J Gastroenterol Hepatol 19#512#520, 2004
How were gastroprotective agents defined?
# In “Results”, Figure 4 seems to be needed further explanation.
# This study did not offer the risk for UGIC associated with not only BPs but also
even antithrombotic agents and BPs co-therapied with NSAIDs.
Does this mean that routine clinical practice in your country has adequately
avoided the risks for any drugs-associated UGIC, but not these drugs do not
increase the risk.
# Ref [38] should have indicated the increase in the risk for gastroduodenal
ulcers with co-administration of BPs in patients on long-term NSAIDs therapy, but
not a positive association between use of BPs and the risk of gastroduodenal
ulcers.
Level of interest: An article of limited interest
Quality of written English: Not suitable for publication unless extensively edited
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
'I declare that I have no competing interests'
Please review this paper.
user
Reviewer's report
Title:Oral bisphosphonates do not increase the risk of severe upper
gastrointestinal complications: a nested case-control study
Version: 1Date:6 May 2013
Reviewer: Kazumasa Miyake
Reviewer's report:
Comments
This is a nested-control study, having clinical significance, suggesting that the
use of bisphosphonates unlikely is causally associated with the onset of serious
GI complications.
But I think this paper needs “Major Compulsory Revisions”.
- Major Compulsory Revisions
# Although this study indicated the risk of bisphosphonates for serious GI
complications using a number of sensitivity analyses, the details in numbers of
factors such as UGIC, current or past exposures of BPs, seem not to be enough.
# Current exposure was defined as the last day of coverage of BPs therapy
within 30 days prior the index date. However, in evaluating drug-associated GI
complications, the period within 30 days seems to be too long and invalid as
“Current exposure”. Was the period justified on what grounds or evidences?
# Gastroprotective agents should consist of some types, such as proton pump
inhibitors, histamine H2 receptor antagonists, prostaglandins.
In addition, it has been reported that nitrogen-containing bisphosphonates
increase gastric damage with depends on higher pH through acid supressants in
the rat.
1)Aliment Pharmacol Ther 14#1215#1223, 2000
2)J Gastroenterol Hepatol 19#512#520, 2004
How were gastroprotective agents defined?
# In “Results”, Figure 4 seems to be needed further explanation.
# This study did not offer the risk for UGIC associated with not only BPs but also
even antithrombotic agents and BPs co-therapied with NSAIDs.
Does this mean that routine clinical practice in your country has adequately
avoided the risks for any drugs-associated UGIC, but not these drugs do not
increase the risk.
# Ref [38] should have indicated the increase in the risk for gastroduodenal
ulcers with co-administration of BPs in patients on long-term NSAIDs therapy, but
not a positive association between use of BPs and the risk of gastroduodenal
ulcers.
Level of interest: An article of limited interest
Quality of written English: Not suitable for publication unless extensively edited
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
'I declare that I have no competing interests'
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