Acupuncture for military veterans with posttraumatic stress disorder and related symptoms after combat exposure: Protocol for a scoping review of clinical studies (2024)

. 2023 Apr 21;18(4):e0273131. doi: 10.1371/journal.pone.0273131

Hye-Bin Seung

1,#, Jungtae Leem

2,#, Hui-Yong Kwak

3, Chan-Young Kwon

4, Sang-Ho Kim

5,*

Editor: Juan-Luis Castillo-Navarrete6

PMCID: PMC10120924PMID: 37083860

Abstract

Posttraumatic stress disorder is caused by traumatic events such as death, serious injury, and sexual violence. Military personnel and veterans are at high risk for posttraumatic stress disorder. Conventional posttraumatic stress disorder treatments have certain limitations. Complementary and integrative medicine treatments, especially acupuncture, are potential novel first-line treatments that may overcome these limitations. We aim to investigate the current status of the available clinical evidence related to acupuncture treatment for posttraumatic stress disorder in war veterans. We will follow the scoping review process as previously described. The study question is as follows: "Which types of clinical research designs, study types, study durations, adverse events, and clinical outcomes have been reported regarding acupuncture therapy for posttraumatic stress disorder in military veterans?" We will perform a comprehensive search of Medline, Excerpta Medica dataBASE, Cochrane Central Register of Controlled Trials, Web of Science, Scopus databases, Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, and PsycArticles databases, as well as Chinese, Korean, and Japanese databases, from inception to June 2022. Data from the included studies will be collected and descriptively analyzed in relation to our research question. The extracted data will be collated, synthesized, and summarized according to the analytical framework of a scoping review. The protocol of this study adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews to ensure the clarity and completeness of our reporting in all phases of this scoping review (Protocol registration: https://osf.io/t723f/). The findings of this scoping review will provide fundamental data that will help researchers identify appropriate research questions and design further studies on the use of acupuncture for PTSD management in military veterans. These results will be helpful for developing disaster site-specific research protocols for future clinical trials on this topic.

Introduction

Posttraumatic stress disorder (PTSD) occurs in individuals who have been exposed to one or more traumatic events such as death, serious injury, or sexual violence [1]. The clinical presentation of PTSD includes fear-based reexperiencing, emotional and behavioral symptoms, anhedonic or dysphoric mood states, and dissociative symptoms [1]. Active-duty military personnel and veterans often experience or witness terrorist attacks, violent crimes and abuse, natural disasters, serious accidents, or violent personal assaults [2], making them extremely vulnerable to PTSD [3]. Lifetime prevalence of PTSD has been estimated from 1.3%–8.8% [4]. Among Vietnam War veterans, 30.9% were diagnosed with PTSD [5]. In addition, 12.9% of Iraq veterans and 7.1% of Afghanistan veterans reportedly have PTSD [6]. PTSD is usually associated with comorbidities such as depression, anxiety, and substance use disorders [7]. In veterans with PTSD, suicidal ideation was reportedly 23.8% and suicide attempts were 6.8% owing to military combat trauma [8]. Furthermore, PTSD is related to chronic pain [9], cardiovascular disease [10], metabolic syndrome, and elevated C-reactive protein levels [11]. Many military personnel from around the world have been on the battlefield in civil and local wars and counterterrorism [12]. The conflict in Ukraine started in Donbas in 2014 when Russia annexed Crimea and has recently escalated to an all-out war. A study has already been published examining PTSD caused by the war in Donbas [13]. Furthermore, enormous mental health consequences are expected for the people of Ukraine [14].

Most clinical guidelines recommend cognitive behavioral therapy (CBT) and selective serotonin reuptake inhibitors as first-line psychological and pharmacological therapies, respectively, for patients with PTSD [15]. However, CBT has a limitation in that it is time consuming and costly, requires training to perform treatments [16], and is difficult to use owing to low accessibility [17]. Although internet-based CBT may be an option to increase access to treatment, it may not be suitable for patients who are uncomfortable with technology [18]. Only two medications have been approved by the Food and Drug Administration for the treatment of PTSD in adults (sertraline and paroxetine) [19]. Selective serotonin reuptake inhibitors inhibit cytochrome P450 enzymes in the liver and may cause several adverse effects such as extrapyramidal symptoms, serotonin syndrome, QT prolongation, congenital malformations, and hyponatremia [20]. Stigma exists in military culture, along with treatment barriers such as costs and low accessibility to mental health care [21]. PTSD tends to be more prominent among personnel who meet the criteria for a mental health problem [22].

Recently, complementary and integrative medicine treatments for patients with PTSD have gained increased attention [23]. Acupuncture is a nonpharmacological therapy involving the insertion of needles into specific points on the body or ear, known as acupuncture points. The use of acupuncture in veterans is a promising complementary and integrative medicine approach [24]. Specific forms of auricular acupuncture, such as the National Acupuncture Detoxification Association (NADA) protocol and battlefield acupuncture (BFA), are used in the health management of military personnel. The NADA protocol, which consists of five standard auricular acupuncture points, was originally designed to help acute heroin addiction, although it is also used for a broad range of mental health problems [25]. The NADA protocol was effective in improving PTSD-induced insomnia in combat veterans [26]. BFA, which is a safe, fast, and easily applied acupuncture treatment, has been proven effective for treating a variety of pain conditions [27]. Evidence suggests that BFA can help with chronic pain and sleep disturbances in veterans [28]. Sleep disturbances are a core feature of PTSD and can affect its progression [29]. Furthermore, chronic pain in veterans with PTSD is associated with many negative health-related outcomes, such as disability, depression, sleep disturbance, catastrophizing beliefs, and lower function [30]. Therefore, although BFA has mainly been used for pain, it has the potential to alleviate PTSD symptoms in veterans through pain control and improved sleep.

A scoping review is more appropriate than a systematic review when the research explores a broad range of questions, such as which research design was adopted in the topic of interest, and can help to identify major concepts and characteristics in the existing literature as well as knowledge gaps [31]. As studies on acupuncture for PTSD in veterans have not been actively conducted, our research team determined that a scoping review method with a wider view of the relevant field may be more appropriate for this study than a systematic review of randomized controlled studies.

We aim to explore the clinical research designs used in studies conducted on acupuncture treatment for war veterans with PTSD. We will also focus on detailed methodological characteristics, such as treatment regimens, participant characteristics, and frequently used outcomes. This study will enable us to identify any research gaps between clinical studies and the needs of physicians regarding clinical evidence. The results of our scoping review can be used as fundamental data for identifying the appropriate research questions in research planning of future clinical studies and systematic reviews.

Materials and methods

Study design and registration

We follow the scoping review process described by Arksey and O’Malley [32], Levac et al., and Tricco et al. [33,34] as well as the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews criteria. This review protocol was registered with the Open Science Framework (https://osf.io/t723f/) on July 23, 2022.

Stage 1: Identifying the study questions

This stage is based on a preliminary literature search of published clinical evidence. Agreement among the research team members was required to obtain better scoping review research questions. The research team comprises three specialists in neuropsychiatry (SHK, CYK, and HYK), a specialist in clinical research on traditional East Asian medicine (JL), and an undergraduate researcher (HBS). All members of the research team agreed on the concepts and revisions of the research questions. In our scoping review, we will attempt to answer the following questions:

  1. What are the characteristics (e.g., research design and target population) of studies on the use of acupuncture for PTSD management in military veterans?

  2. Which clinical outcomes were adopted in previous studies on PTSD management in military veterans?

  3. What is the regimen of acupuncture therapy for PTSD management in military veterans?

  4. What have previous studies reported on with respect to the effectiveness and safety of using acupuncture for treating PTSD in military veterans?

Stage 2: Identifying relevant studies

Information sources

We will restrict this review to peer-reviewed studies on acupuncture for PTSD. A literature search will be conducted from inception to June 2022. The following databases will be searched: Medline (via PubMed), Excerpta Medica dataBASE, Cochrane Central Register of Controlled Trials, Web of Science, Scopus, Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, PsycArticles, China National Knowledge Infrastructure, Wanfang, VIP, Oriental Medicine Advanced Searching Integrated System, Korea Citation Index, and Citation Information by NII. We will also consider gray literature searches such as conference proceedings and doctoral dissertations using Google Scholar. The reference lists of the relevant reviews and retrieved articles will be manually searched. Attempts will be made to contact the authors of published papers for which electronic files cannot be accessed. This search strategy was developed through consultation with a clinical researcher, an expert on literature review, and a specialist on psychiatric diseases. Search terms will comprise disease (PTSD due to war exposure) and intervention terms (acupuncture). A combination of various synonyms and related medical subject headings will be used in the search strategy. The search terms and strategies are detailed in S1 Table.

Eligibility criteria: Study types

Clinical research studies examining the effects of acupuncture in patients with PTSD (military veterans) will be included. The following types of clinical research studies will be included in this review: randomized controlled clinical trials, quasi-randomized controlled trials, nonrandomized controlled trials, single-arm trials, case series, cross-sectional studies, and feasibility studies

We will exclude case reports with less than three patients [35], literature reviews, and preclinical studies. Moreover, we will review the reference articles of each systematic review.

Eligibility criteria: Types of participants

Military veterans with PTSD and related symptoms after combat exposure will be included. We will include studies that used standardized diagnostic criteria for PTSD (such as those presented in the Diagnostic and Statistical Manual of Mental Disorders and the International Classification of Diseases). We will also include studies that used cut-off values from validated PTSD evaluation tools (such as the PTSD Checklist, Impact of Event Scale-Revised, and Clinician-Administered PTSD Scale) as the inclusion criteria for participants. Furthermore, we will include PTSD with comorbid medical illnesses such as tinnitus or traumatic brain injury.

Eligibility criteria: Intervention types

Various acupuncture therapies include manual acupuncture, electroacupuncture, bee-venom acupuncture, pharmacopuncture, warm-needle acupuncture, fire needle acupuncture, and acupotomy. However, we will not include acupressure therapy in this study, and we will not restrict the concomitant treatment. With the exception of East Asian traditional medicine interventions, such as herbal medicine, moxibustion, cupping, and tui-na, any type of control group intervention will be included. The treatment period, dosage, and acupuncture treatment frequency will not be restricted.

Eligibility criteria: Outcome measurements

We will also consider various symptoms after the diagnosis of PTSD. We will not restrict the types of outcome variables. The outcomes will be categorized according to a previous study [36] as follows: 1) outcomes related to psychological aspects (anxiety, fear, anger, irritability, guilt, shame, apathy, distrust, sadness, frustration, alienation, loss of confidence, and mourning); 2) outcomes related to somatic aspects (insomnia, palpitation, pain, anorexia, and fatigue); and 3) outcomes related to cognitive aspects (decreased memory, difficulty making decisions, repeated recall of traumatic events, and difficulty concentrating). In terms of safety, we will also investigate the incidence of adverse events and dropout rates.

Stage 3: Study selection

The inclusion and exclusion criteria were developed with the consensus of the research team. Two reviewers (HBS and HYK) will independently conduct the article selection process. After eliminating duplicate publications in the first phase, the titles and abstracts of the screened articles will be reviewed for inclusion. For potential articles in the second screening phase, the full text will be reviewed to determine whether the article meets the inclusion criteria. The reasons for inclusion and exclusion will be recorded for each article according to the predetermined criteria. In cases of discrepancies, an agreement will be achieved through mediation by the independent researcher. Details of the study selection process are shown in Fig 1.

Fig 1. Flowchart of identification and screening for the eligible studies.

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Stage 4: Charting the data

A data extraction sheet was prepared by the study team after the pilot test. After multiple iterations, a standard data extraction form was created. The following items will be collected from the included studies: 1) general information, such as the first author’s name, country, publication year, and research design; 2) participants’ demographic data, such as age, sex, number of participants (initial and final), diagnostic criteria, and disease duration and severity; 3) detailed information on interventions such as type of acupuncture, acupuncture points, treatment dosage (number, frequency), treatment period, and details of control/concomitant interventions; and 4) outcome variables. Data regarding effects, safety, and research findings will also be extracted.

Two reviewers (HBS and HYK) will separately undertake the data extraction using the described method and will crosscheck the data from all included articles. Any disagreement will be resolved through discussion until consensus with a third researcher (SHK).

Stage 5: Collating, summarizing, and reporting the results

The extracted data will be collated, synthesized, and summarized according to the analytical framework of the scoping review.

In the qualitative analysis stage, we will provide information on the included studies, including the author’s name, country, publication year, combat details, number of participants, sex, age, research design, and type of treatment/control group interventions. In a second table titled “Detailed information of acupuncture treatment,” we will provide detailed information regarding interventions such as type of acupuncture, location of acupuncture points, number of treatments, treatment frequency, treatment period, and details of control/concomitant interventions. In a third table titled “Effects and safety of acupuncture treatment for PTSD and related symptoms,” the results of every outcome from the included studies will be presented along with the conclusion of each study. The number of adverse events will also be presented. In addition, we will provide a table titled “Research map” to visualize the status of current research and frequently used outcomes to assist with future research planning. The findings of our study may help researchers and practitioners identify knowledge gaps in the literature regarding acupuncture for PTSD.

Ethics and dissemination

This study does not require ethical approval because we will retrieve and analyze data from previously published studies, in which informed consent was obtained by the primary investigators. This scoping review will be published in a peer-reviewed journal.

Discussion

PTSD due to active military combat trauma is very common among military personnel and veterans [26]. However, PTSD treatments have many limitations [1522]. As an alternative, complementary and integrative medicine, including acupuncture, may be considered for the treatment of PTSD [23]. Acupuncture, such as BFA, is widely used for soldiers [27,28]. To date, there have been no comprehensive reviews of acupuncture therapy for PTSD in military personnel and veterans. Therefore, we will perform the first scoping review. Our review will summarize the treatment regimens, participant characteristics, and frequently used outcomes, and will also identify knowledge gaps to assist in the planning of future studies. Because acupuncture is a non-psychological and non-pharmacological intervention, it may help overcome barriers to PTSD treatment, such as stigma in the military culture, high costs, and low accessibility to mental health care [37]. The fundamental data obtained in this scoping review will contribute to the designing of future studies that aim to collect evidence on the effectiveness and safety of acupuncture-based treatments for PTSD in military veterans. Furthermore, the findings from this review will also be helpful to clinicians who want to use acupuncture to manage PTSD in this population. Nevertheless, this study has some limitations. First, consultation, which is both the last step of scoping registration and an optional sixth step, cannot be planned. This is because it is difficult and unethical to verify the results of this review by creating an artificial war environment for patients with PTSD. Second, although we will perform a comprehensive search, related studies published in languages other than English, Korean, Chinese, and Japanese may be excluded.

For further dissemination, the research findings will be submitted to an appropriate scientific journal. This study will also be presented at a neuropsychiatric academic conference. Moreover, we will develop an e-leaflet to provide the key findings of our review to the research community via social network services.

Conclusions

The findings of this scoping review will provide fundamental data that will help researchers identify appropriate research questions and design further studies on the use of acupuncture for PTSD management in military veterans. These results will be helpful for developing disaster site-specific research protocols for future clinical trials on this topic.

Supporting information

S1 Checklist. PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist: Recommended items to address in a systematic review protocol*.

(DOC)

Click here for additional data file. (82.5KB, doc)

S1 Table. Search terms used in each database.

(DOCX)

Click here for additional data file. (28.6KB, docx)

Data Availability

No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

Funding Statement

This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT) (No. 2021R1F1A105928211). SHK has received this fund. The funding source had no input in the interpretation or publication of the study results. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ※ MSIT: Ministry of Science and ICT.

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Juan-Luis Castillo-Navarrete

2 Oct 2022

PONE-D-22-21401

Acupuncture for military veterans with posttraumatic stress disorder and related symptoms after combat exposure: Protocol for a scoping review of clinical studies

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Additional Editor Comments:

In relation to the work, which is very thorough, there are minor revisions and adjustments that need to be made. These are indicated by the reviewers' comments. Please do not consider the indications raised by a reviewer in relation to the delivery of results and analysis of these. Now, if there are preliminary results or an approximation to them, it will be very convenient to include them.

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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: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

Reviewer #2:Partly

**********

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: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

Reviewer #2: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

Reviewer #2: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:- Should include Web of Science and Scopus databases.

- “We will also consider gray literature searches using Google Scholar” → Be specific on the types of documents that will be used in gray literature.

- “as well studies that did not use diagnostic criteria” → At least, medical diagnostic will be the minimum to include cases.

- “With the exception of East Asian traditional medicine interventions, such as herbal medicine, moxibustion, cupping, and tui-na, any type of control group intervention will be included.” → Explain this exclusion.

- Update the PRISMA flowchart to 2020 version.

Reviewer #2:Recommendations for authors:

Revise verb tenses in the abstract.

There are several parts in the manuscript that require english review.

The abstract is expected to describe the main results of the study.

The conclusion presented in the abstract is not specific to the topic of this study, i.e., Acupuncture for military veterans with posttraumatic stress 2 disorder and related symptoms after combat exposure. The current conclusion is very generic, and could even be used as a template for any other study, it does not provide a solid conclusion derived from the subject of the review.

Regarding the research questions the authors could have incorporated: some questions about (a) theoretical aspects of the research; (b) limitations reported by previous studies, (c) aspects referred to the measurement instruments; (d) the effect size of the interventions. All these questions would be important to incorporate, in order to advance from only a descriptive component of the review and to be able to carry out analyses, for example, of the effectiveness of the interventions. The above, considering the objective specified by the authors in L114 is "We aim to explore the clinical research designs that have been used in studies conducted on acupuncture treatment for war veterans with PTSD." In addition, these questions should be incorporated because the authors state in L164 "Eligibility criteria: study types", that they will especially consider: "Clinical research studies examining the effects of acupuncture in patients with PTSD (military 166 veterans) will be included (see in L165 and L166).

The method does not consider the reference databases Wos and Scopus.

In the method, specifically in the phase "Stage 2: Identifying relevant studies" (L147) "Information sources" (L148), the authors indicate in lines 156 and L157, that they will consider "The reference lists of the relevant systematic reviews and retrieved articles will be manually searched". At this point, a concern arises about the originality of the work. They should include in the introduction the previous existing systematic reviews on the subject and perhaps make a table with the following information: citation, objective of the previous systematic review, keywords, search period, databases consulted and main results. This would allow understanding the value of the review by clearly identifying the contributions that the authors will make in relation to the objectives and findings of previous reviews. However, in the discussion of the manuscript the authors point out that there are no reviews of this type. This generates an inconsistency in the arguments (see L248 and L249) "there have been no comprehensive reviews of acupuncture therapy for PTSD in military personnel and veterans. Therefore, we will perform the first scoping review."

In line 162 the authors point out that there is a supplementary material with "The search terms and strategies are detailed in S1 Supplementary digital content". When downloading this file, in the search algorithm tables, there are only the keywords with their synonyms and the respective booleans used, e.g. OR, AND etc., but there is no syntax for each search, i.e. the filters applied in each database, e.g. disciplinary area. Finally, it is also not specified whether iterations will be performed in each database and with which different combination. This biases the possibility of replicating the study; the keywords and year of search are not enough, since there are multiple possible combinations that are not clarified by the authors.

Figure 1 is empty. But, in addition, it is not the latest version of the PRISMA RSL process which were the guidelines on which the authors based themselves as stated in the method. The Flowchart acts only has 3 phases, not 5. Therefore the method is outdated (authors are suggested to revise. https://www.prisma-statement.org//PRISMAStatement/FlowDiagram

It is necessary to present the results of the review with an exhaustive discussion of each one of them. Only describing a protocol with important limitations that do not allow its replicability is insufficient to contribute to the generation of knowledge in the area.

The authors need to make a profound change in the presentation of their manuscript for it to be considered for publication. In its current state, it does not have sufficient complexity and scientific novelty.

**********

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Reviewer #1:No

Reviewer #2:Yes:Fabiola Sáez Delgado

**********

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PLoS One. 2023 Apr 21;18(4):e0273131. doi: 10.1371/journal.pone.0273131.r002

24 Oct 2022

Response to the Reviewers’ Comments

Title: Acupuncture for military veterans with posttraumatic stress disorder and related symptoms after combat exposure: Protocol for a scoping review of clinical studies

Emily Chenette

Editor-in-Chief

PLOS ONE

Dear Editor Juan-Luis Castillo-Navarrete, Ph.D:

I wish to re-submit the manuscript titled “Acupuncture for military veterans with posttraumatic stress disorder and related symptoms after combat exposure: Protocol for a scoping review of clinical studies.” The manuscript ID is PONE-D-22-21401.

We thank you and the reviewers for your thoughtful suggestions and insights. The manuscript has benefited from these insightful suggestions. I look forward to working with you and the reviewers to move this manuscript closer to publication in the PLOS ONE.

The manuscript has been rechecked and the necessary changes have been made in accordance with the reviewers’ suggestions. The responses to all comments have been prepared and attached herewith/given below.

Thank you for your consideration. I look forward to hearing from you.

� Response to Comments from the academic editor

Comment #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 for your comment. I have reviewed manuscript carefully to meet style requirements. I changed some parts (marked in yellow).

I delete keywords. And I moved Ethics and dissemination to methods section.

“The search terms and strategies are detailed in S1 Table.”

“Conclusions”

“Supporting information

S1 Table. Search terms used in each database.

S2 Table. PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist: recommended items to address in a systematic review protocol*

Comment #2:

Thank you for stating the following financial disclosure:

"This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT) (No. 2021R1F1A105928211). SHK has received this fund. The funding source had no input in the interpretation or publication of the study results. ※ MSIT: Ministry of Science and ICT"

Please state what role the funders took in the study. If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."

If this statement is not correct you must amend it as needed.

Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf.

Response #2:

I added the funders’ role in the financial disclosure.

“This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT) (No. 2021R1F1A105928211). SHK has received this fund. The funding source had no input in the interpretation or publication of the study results. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.”

Comment #3:

Thank you for stating the following in your Competing Interests section:

"The authors of this work have nothing to disclose."

Please complete your Competing Interests on the online submission form to state any Competing Interests. If you have no competing interests, please state "The authors have declared that no competing interests exist.", as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now

This information should be included in your cover letter; we will change the online submission form on your behalf.

Response #3:

I changed the statement of Competing Interests. I changed the previous statement to this in the cover letter.

"The authors have declared that no competing interests exist."

[cover letter] “This manuscript has not been published or presented elsewhere in part or in entirety and is not under consideration by another journal. No ethical approval is needed for our manuscript because data from previously published studies, in which informed consent was obtained by the primary investigators, will be retrieved and analyzed. We have read and understood your journal’s policies, and we believe that neither the manuscript nor the study violates any of these. The authors have declared that no competing interests exist.”

Comment #4:

We note that this manuscript is a systematic review or meta-analysis; our author guidelines therefore require that you use PRISMA guidance to help improve reporting quality of this type of study. Please upload copies of the completed PRISMA checklist as Supporting Information with a file name “PRISMA checklist”.

Response #4:

I provided PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist: recommended items to address in a systematic review protocol*as Supporting Information (S2 table).

Comment #5:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Response #5:

I have checked all reference lists. There are no retracted papers. I also have corrected information of some references such as issue and page.

Comment #6: Additional Editor Comments:

In relation to the work, which is very thorough, there are minor revisions and adjustments that need to be made. These are indicated by the reviewers' comments. Please do not consider the indications raised by a reviewer in relation to the delivery of results and analysis of these. Now, if there are preliminary results or an approximation to them, it will be very convenient to include them.

Response #6:

Thank you for your careful comment. I prepared the responses to all comments from reviewers as below.

� Response to Comments from Reviewer 1

Comment #1:

Should include Web of Science and Scopus databases.

Response #1:

According to your suggestion, I added Wos and Scopus to the searching database of abstract, method section, and Search terms used in each database (S1 Table).

Comment #2:

“We will also consider gray literature searches using Google Scholar” → Be specific on the types of documents that will be used in gray literature.

Response #2:

We will also consider gray literature searches such as conference proceedings and doctoral dissertations using Google Scholar.[Page 8]

Comment #3:

“as well studies that did not use diagnostic criteria” → At least, medical diagnostic will be the minimum to include cases.

Response #3:

I changed those sentences for clarity as below:

“We will include studies that used standardized diagnostic criteria for PTSD (such as those presented in the Diagnostic and Statistical Manual of Mental Disorders and the International Classification of Diseases). We will also include studies that used cut-off values from validated PTSD evaluation tools (such as the PTSD Checklist, Impact of Event Scale-Revised, and Clinician-Administered PTSD Scale) as the inclusion criteria for participants.” [Page 9]

Comment #4:

“With the exception of East Asian traditional medicine interventions, such as herbal medicine, moxibustion, cupping, and tui-na, any type of control group intervention will be included.” → Explain this exclusion.

Response #4:

We want to compare the effectiveness of acupuncture for PTSD management in military veterans with usual conventional therapy (medication or psychotherapy) or sham-acupuncture or wait-list group. Therefore, we have excluded East Asian traditional medicine interventions such as herbal medicine, moxibustion, cupping, and tui-na.

Comment #5:

Update the PRISMA flowchart to 2020 version.

Response #5:

I have updated the PRISMA flowchart to 2020 version (S1 Fig) as your comment.

� Response to Comments from Reviewer 2

Comment #1:

#1. Revise verb tenses in the abstract.

Response #1:

I revised verb tenses as bellows (marked in yellow):

“Methods: ….The study question is as follows…”

Comment #2:

2. There are several parts in the manuscript that require english review.

Response #2:

I have attached the certification of editing for manuscript. I have received extensive editing again for this revision.

Comment #3:

#3. The abstract is expected to describe the main results of the study. The conclusion presented in the abstract is not specific to the topic of this study, i.e., Acupuncture for military veterans with posttraumatic stress 2 disorder and related symptoms after combat exposure. The current conclusion is very generic, and could even be used as a template for any other study, it does not provide a solid conclusion derived from the subject of the review.

Response #3:

Thank you for insightful comment. According to your suggestion, I did re-write the conclusion.

“The findings of this scoping review will provide fundamental data that will help researchers identify appropriate research questions and design further studies on the use of acupuncture for PTSD management in military veterans. These results will be helpful for developing disaster site-specific research protocols for future clinical trials on this topic. (marked in yellow).” [page 3, 13]

Comment #4:

#4. Regarding the research questions the authors could have incorporated: some questions about (a) theoretical aspects of the research; (b) limitations reported by previous studies, (c) aspects referred to the measurement instruments; (d) the effect size of the interventions. All these questions would be important to incorporate, in order to advance from only a descriptive component of the review and to be able to carry out analyses, for example, of the effectiveness of the interventions. The above, considering the objective specified by the authors in L114 is "We aim to explore the clinical research designs that have been used in studies conducted on acupuncture treatment for war veterans with PTSD." In addition, these questions should be incorporated because the authors state in L164 "Eligibility criteria: study types", that they will especially consider: "Clinical research studies examining the effects of acupuncture in patients with PTSD (military 166 veterans) will be included (see in L165 and L166).

Response #4:

I have incorporated previous research questions as below (marked in yellow):

1. Which clinical research designs were adopted in studies on acupuncture for PTSD management in military veterans?

2. What is the most frequently used type of acupuncture therapy for PTSD management in military veterans?

3. Which clinical outcomes were adopted in previous studies on PTSD management in military veterans?

4. What types of adverse events occurred after acupuncture therapy for PTSD in military veterans?

5. How long should acupuncture treatment be administered for PTSD management?

6. Which populations were the target in previous PTSD acupuncture studies?

=>

1. What are the characteristics (e.g., research design and target population) of studies on the use of acupuncture for PTSD management in military veterans?

2. Which clinical outcomes were adopted in previous studies on PTSD management in military veterans?

3. What is the regimen of acupuncture therapy for PTSD management in military veterans?

4. What have previous studies reported on with respect to the effectiveness and safety of using acupuncture for treating PTSD in military veterans? [page 7]

Comment #5:

#5. The method does not consider the reference databases Wos and Scopus.

Response #5:

According to your suggestion, I added Wos and Scopus in the searching database of abstract and method section (marked in yellow).

Information sources

We will restrict this review to peer-reviewed studies on acupuncture for PTSD. A literature search will be conducted from inception to June 2022. The following databases will be searched: Medline (via PubMed), Excerpta Medica dataBASE, Cochrane Central Register of Controlled Trials, Web of Science, Scopus, Allied and Complementary Medicine Database, [page 8]

Comment #6:

#6. In the method, specifically in the phase "Stage 2: Identifying relevant studies" (L147) "Information sources" (L148), the authors indicate in lines 156 and L157, that they will consider "The reference lists of the relevant systematic reviews and retrieved articles will be manually searched". At this point, a concern arises about the originality of the work. They should include in the introduction the previous existing systematic reviews on the subject and perhaps make a table with the following information: citation, objective of the previous systematic review, keywords, search period, databases consulted and main results. This would allow understanding the value of the review by clearly identifying the contributions that the authors will make in relation to the objectives and findings of previous reviews. However, in the discussion of the manuscript the authors point out that there are no reviews of this type. This generates an inconsistency in the arguments (see L248 and L249) "there have been no comprehensive reviews of acupuncture therapy for PTSD in military personnel and veterans. Therefore, we will perform the first scoping review."

Response #6:

To our knowledge, there are no comprehensive reviews regarding this topic. I changed those sentences for clarity as below (marked in yellow):

The reference lists of the relevant reviews and retrieved articles will be manually searched". [page 8]

Comment #7:

#7. In line 162 the authors point out that there is a supplementary material with "The search terms and strategies are detailed in S1 Supplementary digital content". When downloading this file, in the search algorithm tables, there are only the keywords with their synonyms and the respective booleans used, e.g. OR, AND etc., but there is no syntax for each search, i.e. the filters applied in each database, e.g. disciplinary area. Finally, it is also not specified whether iterations will be performed in each database and with which different combination. This biases the possibility of replicating the study; the keywords and year of search are not enough, since there are multiple possible combinations that are not clarified by the authors.

Response #7:

Thank you for your comment. I added syntax to each search terms of EMBASE and PsycARTICLES (marked in yellow).

Comment #8:

#8. Figure 1 is empty. But, in addition, it is not the latest version of the PRISMA RSL process which were the guidelines on which the authors based themselves as stated in the method. The Flowchart acts only has 3 phases, not 5. Therefore the method is outdated (authors are suggested to revise. https://www.prisma-statement.org//PRISMAStatement/FlowDiagram

Response #8:

I have updated the PRISMA flowchart to 2020 version (S1 Fig) as your comment.

Comment #9:

#9. It is necessary to present the results of the review with an exhaustive discussion of each one of them. Only describing a protocol with important limitations that do not allow its replicability is insufficient to contribute to the generation of knowledge in the area.

Response #9:

Discussion

PTSD due to active military combat trauma is very common among military personnel and veterans [2–6]. However, PTSD treatments have many limitations [15–22]. As an alternative, complementary and integrative medicine, including acupuncture, may be considered for the treatment of PTSD [23]. Acupuncture, such as BFA, is widely used for soldiers [27,28]. To date, there have been no comprehensive reviews of acupuncture therapy for PTSD in military personnel and veterans. Therefore, we will perform the first scoping review. Our review will summarize the treatment regimens, participant characteristics, and frequently used outcomes, and will also identify knowledge gaps to assist in the planning of future studies Because acupuncture is a non-psychological and non-pharmacological intervention, it may help overcome barriers to PTSD treatment, such as stigma in the military culture, high costs, and low accessibility to mental health care [37]. The fundamental data obtained in this scoping review will contribute to the designing of future studies that aim to collect evidence on the effectiveness and safety of acupuncture-based treatments for PTSD in military veterans. Furthermore, the findings from this review will also be helpful to clinicians who want to use acupuncture to manage PTSD in this population.[Page 12,13]

37. Bisson JI, van Gelderen M, Roberts NP, Lewis C. Non-pharmacological and non-psychological approaches to the treatment of PTSD: results of a systematic review and meta-analyses. European Journal of Psychotraumatology. 2020 Dec 31;11(1):1795361.

Comment #10:

#10. The authors need to make a profound change in the presentation of their manuscript for it to be considered for publication. In its current state, it does not have sufficient complexity and scientific novelty.

Response #10:

This study followed the existing scoping review protocol methodology. However, since the subject of this review is a new topic that has not been studied, we hope that the results of review will contribute to conducting novel study in the future.

Attachment

Submitted filename: Response to Reviewers_20221024.docx

Click here for additional data file. (409.7KB, docx)

Juan-Luis Castillo-Navarrete

27 Oct 2022

Acupuncture for military veterans with posttraumatic stress disorder and related symptoms after combat exposure: Protocol for a scoping review of clinical studies

PONE-D-22-21401R1

Dear Dr. Sang-Ho Kim,

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,

Juan-Luis Castillo-Navarrete, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Considering the interesting and novelty of the study protocol, we look forward to the results obtained, which we hope will also be published in PLOS ONE.

Reviewers' comments:

Juan-Luis Castillo-Navarrete

14 Apr 2023

PONE-D-22-21401R1

Acupuncture for military veterans with posttraumatic stress disorder and related symptoms after combat exposure: Protocol for a scoping review of clinical studies

Dear Dr. Kim:

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. Juan-Luis Castillo-Navarrete

Academic Editor

PLOS ONE

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 Checklist. PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist: Recommended items to address in a systematic review protocol*.

    (DOC)

    Click here for additional data file. (82.5KB, doc)

    S1 Table. Search terms used in each database.

    (DOCX)

    Click here for additional data file. (28.6KB, docx)

    Attachment

    Submitted filename: Response to Reviewers_20221024.docx

    Click here for additional data file. (409.7KB, docx)

    Data Availability Statement

    No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

    Acupuncture for military veterans with posttraumatic stress disorder and related symptoms after combat exposure: Protocol for a scoping review of clinical studies (2024)

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