Comparison of efficacy and safety of complementary and alternative therapies for essential hypertension with anxiety or depression disorder

Xueyan Han; Xinxin Liu; Fengxing Zhong; Yiguo Wang; Qiming Zhang

doi:10.1371/journal.pone.0254699

Peer Review History

Original SubmissionFebruary 21, 2021
20 May 2021 Decision Letter - Ismaeel Yunusa, Editor PONE-D-21-05843 Comparison of efficacy and safety of complementary and alternative therapies for essential hypertension with anxiety or depression disorder A Bayesian network meta-analysis protocol PLOS ONE Dear Dr. Zhang, 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. Please submit your revised manuscript by Jul 04 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're 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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Resubmit along with PRISMA-P checklist Journal Requirements: When submitting your revision, we need you to address these additional requirements. 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 https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2) We note you have included a table to which you do not refer in the text of your manuscript. Please ensure that you refer to Table 1 in your text; if accepted, production will need this reference to link the reader to the Table. [Note: HTML markup is below. Please do not edit.] 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: Partly ******** 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 ****** 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: No ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 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: Dr. Xueyan Han and co-workers aimed to perform a systematic review and Bayesian network meta-analysis (NMA) method for the first time to gather randomized controlled trials (RCTs) related to complementary and alternative therapies in the treatment of hypertension with anxiety or depression disorder and rank efficacy and safety, to provide a reference basis for the treatment hypertension with anxiety or depression disorder. I have several concerns. 1. In the results of the Abstract, the authors wrote that “This NMA will comprehensively compare and rank the efficacy and safety of a series of complementary and alternative therapies in treating EH with anxiety or depression disorder”. Could the authors provide how many methods for therapy in treating EH with anxiety or depression disorder were planned to compare? 2. In Literature screening and data extraction of methods, could the authors consider providing the Kapa value between the two researchers? 3. In subgroup analysis and sensitivity analysis of Methods, the authors wrote that "the methods of sensitivity analysis include excluding unpublished studies………." but this could be erroneous to do, because the authors included studies that were published from the initial state to February 2021. Please revise. 4. In network meta-analysis of statistical analysis, the authors didn’t write what model was used to synthesis the data while the MCMC method was just a method used to estimate the unknown parameters. Please revise. 5. In the section on publication bias, the authors didn’t write which method was planned to use for testing the publishing bias. Please revise. ****** 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 [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. 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Revision 1
30 Jun 2021 Author Response Thank you so much for your time and efforts! We profoundly appreciate your comments toward the improvement of the paper and we hope what we have addressed the majority of your comments. Responses to your comments along with a description of the changes made on the manuscript are given below. - Additional Editor Comments (if provided) Point. Please submit a revised version addressing reviewer comments based on guidance from PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols). Resubmit along with PRISMA-P checklist Response: Thank you very much for your carefulness and comment! We revised PRISMA-P addressing reviewer comments based on guidance from PRISMA-P and resubmitted a revised version of PRISMA-P. - Journal Requirements: When submitting your revision, we need you to address these additional requirements. Point 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 https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Response 1: Thank you very much for your suggestion! We carefully checked PLOS ONE's style requirements, including those for file naming, to make sure that our manuscripts met the requirements. Point 2. We note you have included a table to which you do not refer in the text of your manuscript. Please ensure that you refer to Table 1 in your text; if accepted, production will need this reference to link the reader to the Table. Response 2: Thank you very much for your carefulness and comment! We have made changes to ensure that Table 1 is explicitly referenced in the manuscript. "Take PubMed as an example, and the retrieval strategy is shown in Table 1." In line 169-170. - Reviewer #1 Point 1. In the results of the Abstract, the authors wrote that “This NMA will comprehensively compare and rank the efficacy and safety of a series of complementary and alternative therapies in treating EH with anxiety or depression disorder”. Could the authors provide how many methods for therapy in treating EH with anxiety or depression disorder were planned to compare? Response 1: Thank you very much for your comments on our manuscript! For essential hypertension with anxiety or depression disorder, on the basis of conventional antihypertensive drugs, complementary and alternative therapies, such as Chinese herbal medicines, yoga, music therapy, biological-based therapies, five-animal frolics exercise, acupuncture, massage, cognitive-behavioral therapy, relaxation training, traditional Chinese medicine, tai chi, qigong, moxibustion, mindfulness meditation, etc., can be compared with antihypertensive drugs combined (or not combined) with western medicines with anti-anxiety or anti-depression. They can also be used without conventional hypotensive drugs. These complementary and alternative methods can be found in interventions of inclusion criteria of Methods. Point 2. In literature screening and data extraction of methods, could the authors consider providing the Kapa value between the two researchers? Response 2: Thank you very much for your suggestion! In literature screening and data extraction of methods, we think that providing the Kapa value between the two researchers is more objective and reasonable, and we have decided to adopt your suggestion. For the revised details, please refer to the line 182-184 of the revised manuscript. "The level of agreement between the two researchers will be analysed by using the Kappa value, and if the value is greater than 0.60, it means substantial/almost perfect agreement." Point 3. In subgroup analysis and sensitivity analysis of Methods, the authors wrote that "the methods of sensitivity analysis include excluding unpublished studies………." but this could be erroneous to do, because the authors included studies that were published from the initial state to February 2021. Please revise. Response 3: Thank you very much for your carefulness and comment! We are sorry for our carelessness. We have deleted "excluding unpublished studies". Point 4. In network meta-analysis of statistical analysis, the authors didn’t write what model was used to synthesis the data while the MCMC method was just a method used to estimate the unknown parameters. Please revise. Response 4: Thank you very much for your carefulness and comment! Considering your comment, we have further improved this part. "We will use I2 or p–value to determine the types of model. If I2 > 50% or p ≤ 0.05, it indicates that there is heterogeneity, and we will use the random-effect model. If I2 ≤ 50% or p > 0.05, we will use the fixed-effect model. When there is heterogeneity, we will probe the sources of heterogeneity through sensitivity analysis or subgroup analysis." In line 204-208. Point 5. In the section on publication bias, the authors didn’t write which method was planned to use for testing the publishing bias. Please revise. Response 5: Thank you very much for your carefulness and comment! Considering your comment, we have improved the content of evaluation publication bias. "The included data will be tested by Begg´s and Egger´s funnel plot to evaluate whether there are publication bias and the effect of small sample size. If the included studies are concentrated near the midline and symmetrically distributed, it shows that the publication bias has little influence on this research. On the contrary, there will be publication bias." For the revised details, please refer to the line 232-236 in the revised manuscript. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0254699.r002
2 Jul 2021 Decision Letter - Ismaeel Yunusa, Editor Comparison of efficacy and safety of complementary and alternative therapies for essential hypertension with anxiety or depression disorder A Bayesian network meta-analysis protocol PONE-D-21-05843R1 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. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. 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 help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- 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. Kind regards, Ismaeel Yunusa, PharmD, PhD Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0254699.r003
Formally Accepted
7 Jul 2021 Acceptance Letter - Ismaeel Yunusa, Editor PONE-D-21-05843R1 Comparison of efficacy and safety of complementary and alternative therapies for essential hypertension with anxiety or depression disorder A Bayesian network meta-analysis protocol Dear Dr. Zhang: I'm 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 let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, 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. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Ismaeel Yunusa Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0254699.r004

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