The association of Helicobacter pylori infection with serum lipid profiles: An evaluation based on a combination of meta-analysis and a propensity score-based observational approach

Takeshi Shimamoto; Nobutake Yamamichi; Kenta Gondo; Yu Takahashi; Chihiro Takeuchi; Ryoichi Wada; Toru Mitsushima; Kazuhiko Koike

doi:10.1371/journal.pone.0234433

Peer Review History

Original SubmissionJanuary 7, 2020
6 Apr 2020 Decision Letter - Paolo Magni, Editor PONE-D-19-35830 The association of Helicobacter pylori infection with serum lipid profiles: Evaluation based on a combination of systematic review and meta-analysis, along with the average treatment effects using a propensity score-based observational approach PLOS ONE Dear Dr. Yamamichi, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. The Authors are invited to address all reviewer's comments We would appreciate receiving your revised manuscript by May 30, 2020. When you are ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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Please include additional information regarding the survey or questionnaire used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed a questionnaire as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information. 3. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. 4. Please amend either the title on the online submission form (via Edit Submission) or the title in the manuscript so that they are identical. 5. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. 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Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The paper by Shimamoto et al describes a combination of a clinical study and a meta-analysis on the association between H. pylori infection and plasma lipid profile. The study is significant, relatively novel and well executed. There are only few minor issues in this study that require further clarification. Specific comments: 1. May I suggest a much shorter title 2. anti-H. pylori antibody titre – is there any proven relationship between the titre and severity of infection, either author’s own data or finding by others (in the latter case, please provide a reference)? 3. Please provide details on how the plasma lipids were measured 4. Was duration of the infection taken into consideration? 5. p. 15 Discussion: “H. pylori infection has a significant effect on the serum lipid profile”. I suggest to be more careful in suggesting causation. This is a clinical study discovering associations and you can’t exclude a possibility that plasma lipid levels have an effect on probability and severity of the infection or both have a common cause. 6. p.16 Discussion “study participants were healthy individuals” – what is the definition of healthy if they carry an infection? ****** 6. 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Revision 1
18 May 2020 Author Response < Editor’s comments> 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at http://www.journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and http://www.journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf. As the editor pointed out, in accordance with the manuscript body formatting guidelines of PloS ONE and we modified the whole text, especially Abstract and Reference. 2. Please include additional information regarding the survey or questionnaire used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed a questionnaire as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information. In specific terms, we used the medical care system specific to Japan to evaluate physical activity and dietary habits such as walking, the number of meals and mealtime. We provided sufficient details in the manuscript (On page 7, line 17). Additionally, we show the translation of the questionnaire on specific health examination and their content as reference material, in the following reference materials. We listed them in reference numbers 32 and 33. Specific Health Checkups and Specific Health Guidance (reference number 32) https://www.mhlw.go.jp/english/wp/wp-hw3/dl/2-007.pdf Questionnaire on specific health examination in English (reference number 33) http://eng.amda-imic.com/oldpage/amdact/PDF/eng/spe-he-ex-e.pdf 3. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. As the editor pointed out, in accordance with the sharing data publicly of PloS ONE and we prepared the minimal anonymized data set. 4. Please amend either the title on the online submission form (via Edit Submission) or the title in the manuscript so that they are identical. As the editor pointed out, we amend the title. The previous title: The association of Helicobacter pylori infection with serum lipid profiles: Evaluation　based on a combination of systematic review and meta-analysis, along with the effect size using a propensity　score-based observational approach The current title: The association of Helicobacter pylori infection with serum lipid profiles: an evaluation　based on a combination of meta-analysis and a propensity score-based observational approach 5. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. As the editor pointed out, we described them in the new text (on page 17, line 11). < Reviewer’s comments> 1. May I suggest a much shorter title. As per the reviewer’s suggestion, we shortened a title. (On page 1, line 1). The previous title: The association of Helicobacter pylori infection with serum lipid profiles: Evaluation based on a combination of systematic review and meta-analysis, along with the effect size using a propensity score-based observational approach The current title: The association of Helicobacter pylori infection with serum lipid profiles: an evaluation based on a combination of meta-analysis and a propensity score-based observational approach 2. anti-H. pylori antibody titre - is there any proven relationship between the titre and severity of infection, either author's own data or finding by others (in the latter case, please provide a reference)? 　If we consider atrophic gastritis as the severity of infection, we have reported that the association of anti-H. pylori antibody titer with the diagnosis of atrophic gastritis (Yamamichi et al., 2016). For details of the paper, please refer to the following Web page of the journal Gastric Cancer. https://link.springer.com/article/10.1007/s10120-015-0515-y To provide a simple explanation, as shown in Fig. 3 in this paper, our evidence indicates that the anti-H. pylori antibody titer of the presence of atrophic gastritis was considerably more expensive than the absence of atrophic gastritis, although there is no hard biological evidence at this time to support this hypothesis. 3. Please provide details on how the plasma lipids were measured As the reviewer pointed out, we described them in the new text (on page 8, line 17). 4. Was duration of the infection taken into consideration? As the reviewer pointed out, we consider the issue of the duration of the infection is the subject for further study. However, the timing of infection establishment of H. pylori is very difficult because the infection of H. pylori is more common in their early childhood with weak immune systems. There is inadequate evidence to prove that it is possible to pseudo-fix a reasonable time for the duration of the infection, for example, three years old. Additionally, the route of contamination of H. pylori remains to be completely elucidated. Therefore, in this paper, it is difficult to consider the duration of the infection. 5. p. 15 Discussion: "H. pylori infection has a significant effect on the serum lipid profile". I suggest to be more careful in suggesting causation. This is a clinical study discovering associations and you can't exclude a possibility that plasma lipid levels have an effect on probability and severity of the infection or both have a common cause. As per the reviewer’s suggestion, we changed the contestation from a description of unquestionable evidence to a description of potential evidence. However, from examining the analyses, we are now convinced that chronic H. pylori infection can lead to increased levels of serum LDL-C and TC and also can lead to a reduced level of serum HDL-C. (on page 16 , line 4). 6. p.16 Discussion "study participants were healthy individuals" - what is the definition of healthy if they carry an infection? Healthy individuals of this study are characterized by without a history of severe past and present disease and have not any subjective symptoms. In other words, the subjects who underwent a comprehensive medical examination are generally healthy subjects. As the reviewer pointed out, we described a rich description of generally healthy subjects in the new text. Additionally, we changed a description of the subjects from "healthy individual" to "generally healthy subject" and defined. (on page 16, line 7). https://doi.org/10.1371/journal.pone.0234433.r002
27 May 2020 Decision Letter - Paolo Magni, Editor The association of Helicobacter pylori infection with serum lipid profiles: an evaluation based on a combination of meta-analysis and a propensity score-based observational approach PONE-D-19-35830R1 Dear Dr. Nobutake Yamamichi, We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. With kind regards, Paolo Magni Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: (No Response) ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No https://doi.org/10.1371/journal.pone.0234433.r003
Formally Accepted
29 May 2020 Acceptance Letter - Paolo Magni, Editor PONE-D-19-35830R1 The association of Helicobacter pylori infection with serum lipid profiles: an evaluation based on a combination of meta-analysis and a propensity score-based observational approach Dear Dr. Yamamichi: I am pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Prof. Paolo Magni Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0234433.r004

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