Title: The effect of melatonin on irritable bowel syndrome patients with and without sleep
disorders: a randomized double-blinded placebo-controlled trial study
Version: 2 Date: 12 Jan 2023
Reviewer:  Jie Liu
Reviewer's report:
It is a very good RCT evaluating the therapeutic effect of melatonin on IBS. But I think some
issues should be addressed.
1.Sample size: the authors should report the detailed data about previous study by Lu et al.11,
such as (total effective rate: 86.0% vs 83.6%).
2.Inclusion and exclusion criteria: the authors must tell us if medications that could potentially
affect sleep quality were excluded
3.Patients: it is amazing for me that no patients were drop out for 8 weeks. In addition, a total
of 136 patients were enrolled, but there are 68 patients combined with sleep disorders. It means
that 50% of IBS patients were combined with sleep disorders? Please report this data in relavant
references.
4.Analysis: normal distribution of quantitative parameters can be presented by x±s, but the non-
distributed data should be presented by interquartile ranges.
5.Results: the data presented in Table 2. is insufficient. The authors can report the parameters
post treatment to avoid non-distributed data. In additon, it is intersting to explore the effect of
melatonin on IBS with and without sleep disorder: between Melatonin-receiving sub-group in
Group with sleep disorders and Melatonin-receiving sub-group in Group without sleep disorders.
6.Reference interpretation in Discussion is not enough. It is necessary to compare the parameters
in the current study with references.
Title: The effect of melatonin on irritable bowel syndrome patients with and without sleep
disorders: a randomized double-blinded placebo-controlled trial study
Version: 2 Date: 12 Jan 2023
Reviewer:  Jie Liu
Reviewer's report:
It is a very good RCT evaluating the therapeutic effect of melatonin on IBS. But I think some
issues should be addressed.
1.Sample size: the authors should report the detailed data about previous study by Lu et al.11,
such as (total effective rate: 86.0% vs 83.6%).
2.Inclusion and exclusion criteria: the authors must tell us if medications that could potentially
affect sleep quality were excluded
3.Patients: it is amazing for me that no patients were drop out for 8 weeks. In addition, a total
of 136 patients were enrolled, but there are 68 patients combined with sleep disorders. It means
that 50% of IBS patients were combined with sleep disorders? Please report this data in relavant
references.
4.Analysis: normal distribution of quantitative parameters can be presented by x±s, but the non-
distributed data should be presented by interquartile ranges.
5.Results: the data presented in Table 2. is insufficient. The authors can report the parameters
post treatment to avoid non-distributed data. In additon, it is intersting to explore the effect of
melatonin on IBS with and without sleep disorder: between Melatonin-receiving sub-group in
Group with sleep disorders and Melatonin-receiving sub-group in Group without sleep disorders.
6.Reference interpretation in Discussion is not enough. It is necessary to compare the parameters
in the current study with references.
Please review this paper.
user
Title: The effect of melatonin on irritable bowel syndrome patients with and without sleep
disorders: a randomized double-blinded placebo-controlled trial study
Version: 2 Date: 12 Jan 2023
Reviewer:  Jie Liu
Reviewer's report:
It is a very good RCT evaluating the therapeutic effect of melatonin on IBS. But I think some
issues should be addressed.
1.Sample size: the authors should report the detailed data about previous study by Lu et al.11,
such as (total effective rate: 86.0% vs 83.6%).
2.Inclusion and exclusion criteria: the authors must tell us if medications that could potentially
affect sleep quality were excluded
3.Patients: it is amazing for me that no patients were drop out for 8 weeks. In addition, a total
of 136 patients were enrolled, but there are 68 patients combined with sleep disorders. It means
that 50% of IBS patients were combined with sleep disorders? Please report this data in relavant
references.
4.Analysis: normal distribution of quantitative parameters can be presented by x±s, but the non-
distributed data should be presented by interquartile ranges.
5.Results: the data presented in Table 2. is insufficient. The authors can report the parameters
post treatment to avoid non-distributed data. In additon, it is intersting to explore the effect of
melatonin on IBS with and without sleep disorder: between Melatonin-receiving sub-group in
Group with sleep disorders and Melatonin-receiving sub-group in Group without sleep disorders.
6.Reference interpretation in Discussion is not enough. It is necessary to compare the parameters
in the current study with references.
assistant