PONE-D-22-04435Efficacy and safety of traditional Chinese medicine nasal irrigation on chronic rhinosinusitis recovery after endoscopic sinus surgery：A protocol for a systematic review and meta-analysisPLOS ONE

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Additional Editor Comments:

please revise the manuscript according to the comments of the reviewers

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Partly

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: No

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Reviewer #1: Yes

Reviewer #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The paper is interesting minor corrections could be improve the overall quality:

English editing should be performed.

I should change the titile in PLOS ONE

Efficacy and safety of traditional Chinese'' Effectiveness of traditiona..a systematic review..

Abstract

we used..not We will use Review Manager 5.3 software

Introduction

- Pediatric chronic rhinosinusitis (CRS) is a common disorder that carries significant morbidity. The diagnosis requires sinus symptoms that persist despite standard medical therapy greater than 3 months. Viral infections, allergies, and anatomic differences in children lead to chronic obstruction of the osteomeatal complex. The diagnosis is a conglomeration of multiple phenotypes and endotypes. As such, the diagnosis and management are complex. The emerging potential treatment options of CRS, including anti-immunoglobulin E, interleukin-5, and interleukin-4 receptor alpha subunit. please discuss and cite doi:10.1007/s11882-018-0792-8

- line 63, An interesting systematic review on single-nucleotide polymorphisms and risk-related chronic rhinosinusitis reporting the gene variation implicated in the pathogenesis of chronic inflammation and polyps. 12 papers with 9127 patients, of which 2739 CRS cases and 6388 controls were found. The major comorbidities reported related to chronic rhinosinusitis were atopy in 4555 (49.9%), asthma in 4594 (50.33%), Samter Triad in 448 (4.9%) and eosinophilia in 391 subjects (4.28%). please cite doi:10.1111/coa.13870

- line 67, Endoscopic treatment represents the best therapeutic option that the surgeon can offer for invasiveness and safety, allowing quick post-surgical recovery, less postoperative pain and fewer complications. please discuss and cite doi:10.1007/s00405-021-06724-6

- line 72, Nasal saline irrigation (NSI) plays an important role in the treatment of chronic rhinosinusitis (CRS). It is a beneficial low-risk treatment that serves an adjunctive function in the medical and surgical management of CRS. NSI is hypothesized to function by thinning mucous, improving mucociliary clearance, decreasing edema, and reducing antigen load in the nasal and sinus cavities. Although its use in CRS is nearly universal, significant variety exists with regard to delivery volume, delivery pressure, frequency of use, duration of use, composition, and hygiene recommendations. Evidence is limited regarding the most optimal methods of NSI delivery. In addition, use of NSI has recently come under increasing scrutiny due to potential associations with cases of primary amebic meningoencephalitis. An interestin review provided a clinical update summarizing use of NSI for treatment of CRS, including current recommendations for use, and data regarding overall efficacy, available delivery devices, solution composition, and hygiene. please discuss and cite doi:10.1002/alr.22330

Methods

- please adpat pictos framework

- All verbs in the text must be edited in the third person. For now we write '' We can do the research ... and changing it also in the past: a research has been carried out

Discuss the bias analysis and majors tools used.

Discussion

line 199, The inflammatory nasal mucosa therefore loses the function of mucociliary clearance, humidification and filter, the patient has nasal obstruction and does not respond over time even to standard medical therapy. please discuss and cite doi:10.1007/s00405-022-07267-0

Reviewer #2: This protocol is an interesting proposal of research concerning a widespread postoperative issue after Endoscopic Sinus Surgery for chronic rhinosinusitis.

However, there are some major limitations about this topic and this specific protocol.

First, TCM nasal irrigations are not clearly and accurately defined in a unique composition. This means that it can be difficult to compare a control group to an intervention group, because the intervention must be a precisely defined medication.

Second, possible disadvantages or complications related to the use of TCM irrigations are not mentioned (i.e. infections) but they are paramount when evaluating the indications to the interventions.

Further comments are pointed out below:

- Abstract, lines 24-25: do the Authors mean “after endoscopic sinus susrgery (ESS) for chronic rhinosinusitis (CRS)”? please correct if affirmative

- Introduction, line 65: I would consider to list every single drug category indicated in CRS or in alternative do not list them at all.

- Line 74: “has the characteristics of more minor side effects and easy operation” please revise the English form and the overall concept of the sentence

- Citation 8 and 9 have the same title but different Author; reference nr. 9 is not available in the international databases, the nr. 8 is a Chinese language article; please consider international and English language references. The same comment is related also to References nr. 10, 12, 13, 14, 15, 16 (not available in the international literature or non existent / incorrect DOI)

- Line 80: please replace “has” with “causes”

- Line 87: long-term use is not the point, please clarify the use of intranasal topical corticosteroids in the postoperative period

- In the section Inclusion criteria please state the chronological eligibility criteria of the studies

- Methods, Line 118: it is not clear what “simultaneously” means, consider explaining or removing it.

- Interventions section: control group should not include no treatment nor irrigations with glucocorticoids or antibiotics, but only saline irrigation in the postoperative time, while interventions should be represented only by saline irrigations with TCM.

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Reviewer #1: No

Reviewer #2: No

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Efficacy and safety of traditional Chinese medicine nasal irrigation on chronic rhinosinusitis recovery after endoscopic sinus surgery：A protocol for a systematic review and meta-analysis

PONE-D-22-04435R1

Dear Dr. Zhang,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Giannicola Iannella, M.D

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

the authors well improved the manuscript after reviewers comments.

Reviewers' comments: