Title: Evaluation of Post-market Adverse Events of Lubiprostone: A Real-World Adverse Event
Analysis from the FAERS Database
Version: 4 Date: 28 Apr 2025
Reviewer:  Sheza Malik
Reviewer's report:
Thank you for submitting the revised version of your manuscript titled "Evaluation of Post-
market Adverse Events of Lubiprostone: A Real-World Adverse Event Analysis from the
FAERS Database."
We greatly appreciate the diligent and thoughtful revisions made in response to the reviewers'
and editorial comments. Your detailed point-by-point responses and the improvements
implemented in the revised manuscript have substantially strengthened the quality, clarity, and
scientific rigor of your work. Specifically, we commend the following enhancements:
Comprehensive Acknowledgement of FAERS Limitations: You have appropriately discussed
the limitations of spontaneous reporting databases, including underreporting, reporting biases,
and lack of causality, thus ensuring responsible interpretation of findings.
Detailed Methodological Clarifications: Clear descriptions of data extraction, de-duplication
methods, signal detection thresholds across multiple algorithms (ROR, PRR, BCPNN, EBGM),
and data cleaning procedures have greatly improved methodological transparency.
Robust Contextualization within Existing Literature: The discussion now thoughtfully compares
your findings with prior clinical trial data, approved labeling information, and previous
pharmacovigilance reports, situating your study within the broader safety landscape for
lubiprostone.
Balanced Interpretation of Rare Signals: The conclusions have been appropriately tempered
to highlight that findings are hypothesis-generating, and not indicative of confirmed causality,
particularly regarding rare events like ischemic colitis and gastric fistula.
Enhanced Discussion Organization and Clarity: The Discussion has been restructured to better
summarize key findings, discuss novel signals in context, and flow logically from general
findings to implications and limitations.
Improved Language, Terminology, and Formatting: The manuscript now uses standard medical
terminology, maintains consistency in abbreviations, and presents data in a more reader-friendly
manner across tables and figures.
Additional Analysis and Data Presentation: Subgroup analyses by sex and age, expanded
evaluation of gastrointestinal side effects, and explicit mention of dose-related differences in
adverse events have all enriched the results.
Title: Evaluation of Post-market Adverse Events of Lubiprostone: A Real-World Adverse Event
Analysis from the FAERS Database
Version: 4 Date: 28 Apr 2025
Reviewer:  Sheza Malik
Reviewer's report:
Thank you for submitting the revised version of your manuscript titled "Evaluation of Post-
market Adverse Events of Lubiprostone: A Real-World Adverse Event Analysis from the
FAERS Database."
We greatly appreciate the diligent and thoughtful revisions made in response to the reviewers'
and editorial comments. Your detailed point-by-point responses and the improvements
implemented in the revised manuscript have substantially strengthened the quality, clarity, and
scientific rigor of your work. Specifically, we commend the following enhancements:
Comprehensive Acknowledgement of FAERS Limitations: You have appropriately discussed
the limitations of spontaneous reporting databases, including underreporting, reporting biases,
and lack of causality, thus ensuring responsible interpretation of findings.
Detailed Methodological Clarifications: Clear descriptions of data extraction, de-duplication
methods, signal detection thresholds across multiple algorithms (ROR, PRR, BCPNN, EBGM),
and data cleaning procedures have greatly improved methodological transparency.
Robust Contextualization within Existing Literature: The discussion now thoughtfully compares
your findings with prior clinical trial data, approved labeling information, and previous
pharmacovigilance reports, situating your study within the broader safety landscape for
lubiprostone.
Balanced Interpretation of Rare Signals: The conclusions have been appropriately tempered
to highlight that findings are hypothesis-generating, and not indicative of confirmed causality,
particularly regarding rare events like ischemic colitis and gastric fistula.
Enhanced Discussion Organization and Clarity: The Discussion has been restructured to better
summarize key findings, discuss novel signals in context, and flow logically from general
findings to implications and limitations.
Improved Language, Terminology, and Formatting: The manuscript now uses standard medical
terminology, maintains consistency in abbreviations, and presents data in a more reader-friendly
manner across tables and figures.
Additional Analysis and Data Presentation: Subgroup analyses by sex and age, expanded
evaluation of gastrointestinal side effects, and explicit mention of dose-related differences in
adverse events have all enriched the results.
Please review this paper.
user
Title: Evaluation of Post-market Adverse Events of Lubiprostone: A Real-World Adverse Event
Analysis from the FAERS Database
Version: 4 Date: 28 Apr 2025
Reviewer:  Sheza Malik
Reviewer's report:
Thank you for submitting the revised version of your manuscript titled "Evaluation of Post-
market Adverse Events of Lubiprostone: A Real-World Adverse Event Analysis from the
FAERS Database."
We greatly appreciate the diligent and thoughtful revisions made in response to the reviewers'
and editorial comments. Your detailed point-by-point responses and the improvements
implemented in the revised manuscript have substantially strengthened the quality, clarity, and
scientific rigor of your work. Specifically, we commend the following enhancements:
Comprehensive Acknowledgement of FAERS Limitations: You have appropriately discussed
the limitations of spontaneous reporting databases, including underreporting, reporting biases,
and lack of causality, thus ensuring responsible interpretation of findings.
Detailed Methodological Clarifications: Clear descriptions of data extraction, de-duplication
methods, signal detection thresholds across multiple algorithms (ROR, PRR, BCPNN, EBGM),
and data cleaning procedures have greatly improved methodological transparency.
Robust Contextualization within Existing Literature: The discussion now thoughtfully compares
your findings with prior clinical trial data, approved labeling information, and previous
pharmacovigilance reports, situating your study within the broader safety landscape for
lubiprostone.
Balanced Interpretation of Rare Signals: The conclusions have been appropriately tempered
to highlight that findings are hypothesis-generating, and not indicative of confirmed causality,
particularly regarding rare events like ischemic colitis and gastric fistula.
Enhanced Discussion Organization and Clarity: The Discussion has been restructured to better
summarize key findings, discuss novel signals in context, and flow logically from general
findings to implications and limitations.
Improved Language, Terminology, and Formatting: The manuscript now uses standard medical
terminology, maintains consistency in abbreviations, and presents data in a more reader-friendly
manner across tables and figures.
Additional Analysis and Data Presentation: Subgroup analyses by sex and age, expanded
evaluation of gastrointestinal side effects, and explicit mention of dose-related differences in
adverse events have all enriched the results.
assistant