No Gender Differences in Pain Perception and Medication after Lumbar Spine Sequestrectomy—A Reanalysis of a Randomized Controlled Clinical Trial

Round 1

Reviewer 1 Report

The manuscript provides an in-depth analysis of two studies already published by the same study group. The debated topic is widely present in literature with a controversy still far to be solved. In the present form the manuscript, although examining results from the most relevant papers on gender-related pain perception in spine surgery, represents another article discussing data on a relatively small patient sample to be considered worthy of note more than the available literature. Moreover methods section presents some bias regarding the types of disc herniation included in the study, which should be better described hopefully according to an anatomical classification (PMID: 28534073), and the preoperative duration of symptoms. A review meta-analysis, even associated with a single-center experience, would have been more welcome, especially considering the contradictory results obtained, compared to other studies in this field. 

Author Response

The manuscript provides an in-depth analysis of two studies already published by the same study group. The debated topic is widely present in literature with a controversy still far to be solved.

Comment: Thank you very much for your valuable appraisal. Indeed the topic is highly relevant. However, please note that the present study is based on only one study already published, while the first publication is on the study protocol. We have rephrased the respective part to be more precise.

 In the present form the manuscript, although examining results from the most relevant papers on gender-related pain perception in spine surgery, represents another article discussing data on a relatively small patient sample to be considered worthy of note more than the available literature.

Comment: Thank you for positively placing the manuscript in the context of the available evidence. We have acknowledged your comment on the small patient sample and have discussed this issue in more detail.

Moreover methods section presents some bias regarding the types of disc herniation included in the study, which should be better described hopefully according to an anatomical classification (PMID: 28534073 ), and the preoperative duration of symptoms.

Comment: Thank you for pointing out this methodological weakness and for providing the reference, which we have included in the methods section together with the respective results. We now believe that we have covered the topic of anatomical classification sufficiently. 

A review meta-analysis, even associated with a single-center experience, would have been more welcome, especially considering the contradictory results obtained, compared to other studies in this field.

Comment: Indeed a review meta-analysis should be the very next step when looking at this controversial topic. As this manuscript reports the results of a single center study, we only have included this part in the discussion part as a further important and necessary work to do. We hope this will satisfy your very important critical point.  

Reviewer 2 Report

I thank you for the excellent opportunity to read this article.

General Statement and Summary

I read with great interest and attention this article entitled "Are there gender differences in pain perception and medication after lumbar spine sequestrectomy? – A reanalysis of a randomized controlled clinical trial" submitted for publication in the journal JCM. In this article, the authors conducted a re-analysis of a randomized controlled clinical trial of patients who underwent monosegmental lumbar sequestrectomy for lumbar disc herniation. Studies were conducted on their gender differences, pain perception, pain severity, and pain medication intake. The 88 patients included in the statistical analysis were analyzed and divided according to gender differences: 42 male patients and 46 female patients. In general, the characteristics of the studied respondents such as age, sex, duration of surgery, body mass index were approximately the same. There were no significant gender differences in pain perception and pain management. 

The authors also reported their limitations in the study sample, where the efficacy study was as an adjunct to standard treatment in the postoperative period with the analgesic homeopathic drug Hypericum perforatum. 

Author Response

I read with great interest and attention this article entitled "Are there gender differences in pain perception and medication after lumbar spine sequestrectomy? – A reanalysis of a randomized controlled clinical trial" submitted for publication in the journal JCM. In this article, the authors conducted a re-analysis of a randomized controlled clinical trial of patients who underwent monosegmental lumbar sequestrectomy for lumbar disc herniation. Studies were conducted on their gender differences, pain perception, pain severity, and pain medication intake. The 88 patients included in the statistical analysis were analyzed and divided according to gender differences: 42 male patients and 46 female patients. In general, the characteristics of the studied respondents such as age, sex, duration of surgery, body mass index were approximately the same. There were no significant gender differences in pain perception and pain management.

The authors also reported their limitations in the study sample, where the efficacy study was as an adjunct to standard treatment in the postoperative period with the analgesic homeopathic drug Hypericum perforatum.

Comment: Thank you for you valuable summary of our manuscript. We have included some of your summary points in the abstract and the conclusion section.

Reviewer 3 Report

The authors described the gender difference on pain perception btween male and female. The data presented here is interesting and important in spine surgery and pain management fields.  There is one question to the authors.

 Is there no influence of  Hypericum perforatum on pain accessment?  Is the comparison of mixed patients including  Hypericum perforatum and placebo arms appropriate?

Author Response

The authors described the gender difference on pain perception btween male and female. The data presented here is interesting and important in spine surgery and pain management fields.  There is one question to the authors.

Is there no influence of  Hypericum perforatum on pain accessment?

Comment: Thank you for pointing out this important issue which might have influenced our analysis. As published, there was no significant influence of  Hypericum perforatum on pain accessment. We have pointed out this issue in more detail in the discussion part.

 Is the comparison of mixed patients including  Hypericum perforatum and placebo arms appropriate?

Comment: Again a very important point. As this was a randomized clinical trial, patients receiving Hypericum perforatum or placebo did not differ with respect to sociodemographic data such as age and gender. Thus, a reanalysis of this study with mixed patients  is appropriate. However, we have included this point in our discussion part to avoid confusion of the readers. 

Round 2

Reviewer 1 Report

The authors have appropriately answered to the criticisms, modifying the manuscript accordingly. The manuscript now appears sufficiently improved.

Author Response

The authors have appropriately answered to the criticisms, modifying the manuscript accordingly. The manuscript now appears sufficiently improved.

Response: Thank you very much!

English language and style are fine/minor spell check required

Response: We again went through the manuscript again and identified some language errors, which we corrected.