Polyacrylamide Injection vs. Polylactic Acid in HIV Related Lipodystrophy: A RCT Systematic Review

Round 1

Reviewer 1 Report

The authors present a systematic literature review conducted in accordance with PRISMA guidelines. The topic is very controversial, as many surgeons, including myself, have battled the consequences of polyacrilamid and polylactic acid complications, which are often severe. This makes the paper interesting, as the author raise the issue of complications well, yet some statements regarding the safety of the procedure should be amended. 

 

Specifically: Line 69. The procedure itself is not safe. It is rather "minimally invasive", but not safe: due to risk of arterial and venous embolism, cutaneous necrosis, etc. Please change this statement.

Further: it is important to state that PLA is approved in many countries, while polyacrilamid is not due to risk of migration, fibrosis and even delayed embolism. 

Line 95: While not a mistake, I find it may confuse the average reader "lipodystrophy reduction" - I would suggest writing "lipodystrophy correction".

Line 104: Why did you limit to english articles? The study gels have been thoroughly discussed in international literature (Polish, Russian, Swedish, Chinese, etc.). In fact, poorer countries have larger issues with polyacrylamid injections, including other dangerous jells, such as vaseline. This is a comment, no action is needed from the authors.

The main issue I have is with the search strategy: the resulting two studies are too few and may be too biased in their nature to perform form an adequate conclusion. This topic is extremely fragile and should be undertaken with appropriate caution. I would suggest the authors expand their search criteria to include other types of studies (including case series, reports, retrospective, etc.) - which may help form an evidence based conclusion. 

The results fall short of valuable information: long term adverse effects (mentioned in discussion and limitations), which are frequently discussed in literature are not presented . This needs to be corrected, along with the addition of other types of studies, for the paper to be appropriate. 

Lines 213-214. I completely disagree with this statement! And so will many plastic and reconstructive surgeons. 

Lines 270 - >>>: study evaluation results should be in results section.

In conclusion, the efficacy of these procedures in HIV patients is limited. More so, the main adverse effects occur after a long time (5-10 years!), which raises the issue of long-term debilitating complications not discussed in the results of these papers. 

Lines 304 - 309: this is what I was talking about. And there are many more such publications. PAG is dangerous and should not be used. This does not diminish the importance of this study, but in its current form it falls short of making evidence based conclusions.

I believe that the authors should completely refocus their study to find long-term follow up results from these fillers. Short term studies do not offer the true clinical insights required to make a statement. The authors undertook an important and controversial topic, which needs to be addressed properly prior to further consideration.

 

 

Author Response

Dear Reviewer

 

Thank you for your time, we proceeded to change sentences and words as you suggested.

Limitation was on English language, in fact we reviewed an Italian and a French article

Our objective was to do a systematic review of randomized controlled trials, this therefore excluded other kind of articles.

As we showed in the study selection during our research we found studies that we also cited in the article, that might appear to meet the inclusion criteria but then didn’t have an appropriate randomization or belonged to other kind of articles, for the same reason we couldn’t use in our review articles that had a follow up of 5-10 years, in literature articles that have such a long time of evaluation are case series, case report and others but none of them was CRT.

Reviewer 2 Report

In this paper the authors have reviewed polyacrylamide injection vs polylactic acid in HIV related lipodystrophy. The population with these difficulties is increasing in the world and it is necessary to focus on methods that will help in clinical work. The authors themselves have clinical experience according to the citations in the references. Experience can make a significant contribution to the value of results especially supported by research work. As stated in the conclusion, additional research and time are needed to be able to find concrete conclusions.

Author Response

dear reviewer thank you for your time 

Reviewer 3 Report

The review is focused on a very interesting pathology that can affect the life quality of the HIV patients.

I recommend to review the abstract and to put in a clearly overview the findings.

Minor spell check required.

Line 137 Cochrane Library not Chocrane Library

From my point of view, the inclusion criteria must be modified in order to include a wide range of articles on this topic. 

Author Response

Dear Reviewer 

Thank you for your time and suggestions

Our objective was to do a systematic review of randomized controlled trials, this therefore excluded other kind of articles.

As we showed in the study selection during our research we found studies that we also cited in the article, that might appear to meet the inclusion criteria but then didn’t have an appropriate randomization or belonged to other kind of articles.

Round 2

Reviewer 1 Report

Dear authors, it is unfortunate that you did not take my suggestions to revise the manuscript extensively in regard to study design, which I believe is flawed. Therefore, I believe the manuscript in current form is not of sufficient value. I hope this does not discourage you, and urge you to make the amendments I previously suggested, including correction of study design, inclusion of further studies.