Clinical and Experiential Outcomes of Photobiomodulation Therapy as a Treatment for Fibromyalgia: A Scoping Review in Response to NICE Recommendations

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

See attached document

Comments for author File: Comments.pdf

Author Response

First of all, congratulations for the work done, then I will mention a number of changes and recommendations in order to obtain clearer and more accurate information.

Author response: Thank you for the time taken to review the manuscript

Abstract/Keywords

Avoid the use of abbreviations in the abstract. The keywords must be different from those included in the title. Introduction Its ok.

Authors response: Thank you. This has been changed.

Materials and Methods

Joanna Briggs Institute do not have to be abbreviated as it only appears twice in the manuscript.

Authors response: Thank you. This has been changed.

Figure 1 is blurred, replace it with a better quality one and without the grammatical marks of the word processor from which you have taken the screenshot.

Authors response: Thank you. This has been changed.

I do not understand the reason for the inclusion of the table headers in figure 2, they are not necessary and do not clarify anything.

Authors response: Thank you. This has been changed.

 

Results

Figure 3 is blurred, replace it with a better quality one.

Authors response: Thank you. This has been changed.

 

In Table 1, when you put the author of the paper before the reference, you should write for example, Armagan et al. (2006) [31], check and correct all related issues in all tables.

Author response: We have added brackets to the references and corrected. Thank you for identifying this.

It would be interesting to apply scales to assess the risk of bias in the included studies, such as the PEDro scale or the RoB 2, which would give greater weight to the results presented.

Author response: We agree that it would provide better support and understanding of the literature base. We have added an assessment of quality but more importantly a summary of the levels of evidence which includes quality as part of the criteria. Thank you for this comment.  

Discussion/Conclusion

They are ok. Congratulations on the work done, especially the in-depth analysis of the papers included. The results presented provide a great deal of information on these papers. In general, it is a good work with hardly any errors in which it can be seen that attention to detail has been paid. Great job

Author response: thank you.

Reviewer 2 Report

Comments and Suggestions for Authors

I appreciated the opportunity to review this paper about Photobiomodulation Therapy as a treatment for fibromyalgia, specifically addressing gaps identified in NICE guidelines.

I just have some suggestion that I think can help improve the manuscript:

• The authors should better explain the methodology, indeed it should been better explained how qualitative data were categorized and analyzed.
• It could be useful to provide more detail on how PBMT compares to other fibromyalgia treatments and also it should be stressed the need for Real World evidence trials and clinical studies. 

Author Response

I appreciated the opportunity to review this paper about Photobiomodulation Therapy as a treatment for fibromyalgia, specifically addressing gaps identified in NICE guidelines.

I just have some suggestion that I think can help improve the manuscript:

• The authors should better explain the methodology, indeed it should been better explained how qualitative data were categorized and analyzed.
• Author response: Thank you we have added in technical terms that identify this with references.
• It could be useful to provide more detail on how PBMT compares to other fibromyalgia treatments and also it should be stressed the need for Real World evidence trials and clinical studies. 
• Author response: We have updated this and added in the importance of this need

Reviewer 3 Report

Comments and Suggestions for Authors

Dear authors,

This study provides a comprehensive scoping review of photobiomodulation therapy (PBMT) for fibromyalgia (FM), an area of increasing interest. However, there are several critical areas where improvements are needed to strengthen the manuscript’s clarity, rigor, and impact. Below are specific recommendations for revisions:

 

#1. Weak Discussion of Heterogeneity in the Evidence

The manuscript mentions the heterogeneity of existing studies but does not clearly specify which aspects contribute to this heterogeneity (e.g., treatment protocols, outcome measures, study populations). Without this detail, readers may struggle to fully grasp the significance of the issue.

#2. Inadequate Discussion of NICE Recommendations

The manuscript suggests that NICE may have overlooked available data when deciding not to recommend PBMT. However, this argument lacks a thorough examination of NICE’s evaluation criteria. The discussion should include a detailed analysis of why NICE does not currently recommend PBMT and clarify how this study contributes new insights. Additionally, in the Discussion section, the placement of PBMT within NICE’s evidence review is not sufficiently addressed. The study should analyze key factors influencing NICE’s decision (e.g., lack of evidence, risk of bias, uncertainty about long-term efficacy) and explicitly state how this review addresses these gaps. The Discussion should also propose directions for future research that could lead to changes in NICE’s recommendations.

#3. Lack of Clarity in Research Objectives

The stated objectives include "mapping the evidence" and "identifying evidence gaps," but the specific methodology to achieve these goals and the expected outcomes remain unclear. The manuscript should explicitly define whether the primary aim is merely to summarize the literature or to build a foundation for policy recommendations.

#4. Unclear Inclusion Criteria

The manuscript states that all participants diagnosed with FM were included, but it does not specify the diagnostic criteria used (e.g., ACR 1990, 2010, 2016). This omission raises concerns about the consistency of study selection.

#5. Lack of Clarity in Outcome Measure Selection

While the manuscript discusses NICE-recommended outcome measures (e.g., pain reduction, quality of life, physical function), it lacks sufficient detail on which specific measures were adopted. There is also ambiguity regarding how standardized outcomes (e.g., FIQR, VAS, BPI) were compared and evaluated across studies.

#6. Insufficient Data Synthesis

Results are categorized by study type, but it is unclear how different studies are integrated to reach overall conclusions. The manuscript does not adequately explain how quantitative and qualitative data were synthesized and interpreted together.

#7. Lack of Long-Term Impact Assessment

Some studies include follow-ups at six months, but there is little discussion of how long PBMT’s effects persist or the recurrence rate after treatment. Strengthening the discussion of long-term efficacy is necessary.

#8. Insufficient Discussion of Limitations in the Evidence

Although the manuscript frequently describes PBMT as "promising," it lacks an in-depth discussion of the heterogeneity and methodological limitations of the included studies. A more explicit acknowledgment of biases and the limitations of the current evidence is needed.

#9. Insufficient Discussion of Clinical Implementation

The manuscript suggests that PBMT should be integrated into the UK’s standard treatment, but it does not provide clear guidelines on the conditions under which it would be applicable or which patient populations would benefit most. More concrete recommendations are needed to influence healthcare policy.

#10. Lack of Comparison with Other Treatments

When evaluating PBMT’s efficacy, the manuscript lacks a comparative perspective with conventional treatments (e.g., pharmacotherapy, physiotherapy, psychological therapy). It should clarify to what extent PBMT is superior or inferior to existing treatments.

#11. Overly Optimistic Conclusion

The manuscript states that "current evidence suggests the efficacy of PBMT." However, considering methodological limitations and potential biases, a more cautious conclusion would be appropriate. Phrasing such as "further high-quality research is needed" would be more suitable.

#12. Unclear Basis for Policy Recommendations

The manuscript suggests that cost-effectiveness data should be collected and that PBMT should be incorporated into standard treatment. However, it does not provide sufficient evidence to support these claims. It should specify what data are currently lacking and present this as a future research agenda. Furthermore, it should explicitly outline what types of studies are necessary to justify a revision of NICE guidelines.

Author Response

Dear authors,

This study provides a comprehensive scoping review of photobiomodulation therapy (PBMT) for fibromyalgia (FM), an area of increasing interest. However, there are several critical areas where improvements are needed to strengthen the manuscript’s clarity, rigor, and impact. Below are specific recommendations for revisions:

 Author response: We would like to thank the reviewer for their extensive comments for the improvement of the paper.

#1. Weak Discussion of Heterogeneity in the Evidence

The manuscript mentions the heterogeneity of existing studies but does not clearly specify which aspects contribute to this heterogeneity (e.g., treatment protocols, outcome measures, study populations). Without this detail, readers may struggle to fully grasp the significance of the issue.

Author response: Thank you for this comment. Further details and considerations have been added to the limitation section.

#2. Inadequate Discussion of NICE Recommendations

The manuscript suggests that NICE may have overlooked available data when deciding not to recommend PBMT. However, this argument lacks a thorough examination of NICE’s evaluation criteria. The discussion should include a detailed analysis of why NICE does not currently recommend PBMT and clarify how this study contributes new insights. Additionally, in the Discussion section, the placement of PBMT within NICE’s evidence review is not sufficiently addressed. The study should analyze key factors influencing NICE’s decision (e.g., lack of evidence, risk of bias, uncertainty about long-term efficacy) and explicitly state how this review addresses these gaps. The Discussion should also propose directions for future research that could lead to changes in NICE’s recommendations.

Author response: Thank you. As per reviewer 1’s recommendations we have added quality appraisal of evidence and levels of evidence assessment which enabled further consideration of how NICE guidance may be updated directly and identification of the future research needed. We have added a section to the discussion to consider this.  

#3. Lack of Clarity in Research Objectives

The stated objectives include "mapping the evidence" and "identifying evidence gaps," but the specific methodology to achieve these goals and the expected outcomes remain unclear. The manuscript should explicitly define whether the primary aim is merely to summarize the literature or to build a foundation for policy recommendations.

Author response: This has been changed for clarity. Thank you.

#4. Unclear Inclusion Criteria

The manuscript states that all participants diagnosed with FM were included, but it does not specify the diagnostic criteria used (e.g., ACR 1990, 2010, 2016). This omission raises concerns about the consistency of study selection.

Author response: Thank you for identifying this. We have clarified this in the review.

#5. Lack of Clarity in Outcome Measure Selection

While the manuscript discusses NICE-recommended outcome measures (e.g., pain reduction, quality of life, physical function), it lacks sufficient detail on which specific measures were adopted. There is also ambiguity regarding how standardized outcomes (e.g., FIQR, VAS, BPI) were compared and evaluated across studies.

Author response: Thank you for this comment. We have performed two meta-analysis and believe this provides further context for the reader around these measures and deepens the discussion.

#6. Insufficient Data Synthesis

Results are categorized by study type, but it is unclear how different studies are integrated to reach overall conclusions. The manuscript does not adequately explain how quantitative and qualitative data were synthesized and interpreted together.

Author response: The qualitative is currently inadequate and couldn’t be integrated into the evidence. This is explained alongside a call for more qualitative research.

#7. Lack of Long-Term Impact Assessment

Some studies include follow-ups at six months, but there is little discussion of how long PBMT’s effects persist or the recurrence rate after treatment. Strengthening the discussion of long-term efficacy is necessary.

Author response: Thank you for this comment. We have provided a point around this for future research, we have noted the current limited findings and identified if clinically meaningful changes occurred at this point for FIQR and VAS pain.

#8. Insufficient Discussion of Limitations in the Evidence

Although the manuscript frequently describes PBMT as "promising," it lacks an in-depth discussion of the heterogeneity and methodological limitations of the included studies. A more explicit acknowledgment of biases and the limitations of the current evidence is needed.

Author response: Thank you for this point. Reviewer 2 brought this up and further quality assessment has been undertaken as well as level of evidence assessment.

#9. Insufficient Discussion of Clinical Implementation

The manuscript suggests that PBMT should be integrated into the UK’s standard treatment, but it does not provide clear guidelines on the conditions under which it would be applicable or which patient populations would benefit most. More concrete recommendations are needed to influence healthcare policy.

Author response: A discussion paragraph has been more exacting on this now and we have been specific about the recommendations reach into a specific population group and duration of intervention. Thank you for this point.

#10. Lack of Comparison with Other Treatments

When evaluating PBMT’s efficacy, the manuscript lacks a comparative perspective with conventional treatments (e.g., pharmacotherapy, physiotherapy, psychological therapy). It should clarify to what extent PBMT is superior or inferior to existing treatments.

Author response: Thank you for this comment we have added some information in.

#11. Overly Optimistic Conclusion

The manuscript states that "current evidence suggests the efficacy of PBMT." However, considering methodological limitations and potential biases, a more cautious conclusion would be appropriate. Phrasing such as "further high-quality research is needed" would be more suitable.

Author response: This has been updated.

#12. Unclear Basis for Policy Recommendations

The manuscript suggests that cost-effectiveness data should be collected and that PBMT should be incorporated into standard treatment. However, it does not provide sufficient evidence to support these claims. It should specify what data are currently lacking and present this as a future research agenda. Furthermore, it should explicitly outline what types of studies are necessary to justify a revision of NICE guidelines.

Authors response: Thank you for these comments changes have been made to account for these.

Round 2

Reviewer 1 Report

Comments and Suggestions for Authors

Abstract/Keywords

Some key words are still repeated with the title

Author Response

Thank you for taking the time to help develop this scoping review. We have provided a response to your comments below.

 

Reviewer 1's comments

 Abstract/Keywords: Some key words are still repeated with the title

Author: Thank you for this comments. These have been revised to include the two outcomes that were identified in meta-analysis and the term laser therapy. Thank you for your past comments to help develop the article.

Reviewer 3 Report

Comments and Suggestions for Authors

Thank you for your thorough revision of the manuscript. I have carefully reviewed the revised version and appreciate the efforts you made to address the comments and concerns raised in the previous round. All of my concerns have been fully resolved, and I have no further comments at this time.

Author Response

Thank you for taking the time to help develop this scoping review. We have provided a response to your comments below.

Reviewer 3's comments

Thank you for your thorough revision of the  manuscript. I have carefully reviewed the revised version and appreciate the efforts you made to address the comments and concerns  raised in the previous round. All of my concerns have been fully  resolved, and I have no further comments at this time.

Author response: Thank you for helping the development of the article.