Re: A controlled clinical trial with pirfenidone in the treatment of pathological skin scarring caused by burns in pediatric patients.
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ABSTRACT: Pathologic skin scarring reversion remains a big challenge for surgeons, as disfiguring scars have a dramatic influence on patient's quality of life. A controlled clinical trial was conducted to evaluate 8% pirfenidone (PFD) gel administered topically 3 times a day during 6 months to 33 pediatric patients with hypertrophic scars caused by burns. A total of 30 patients with hypertrophic scars with identical Vancouver Scar Scale values were treated with pressure therapy and included as controls. Improvements were evaluated by Vancouver Scar Scale and a Visual Analog Scale. Safety parameters were determined by the presence of adverse events and monitoring laboratory and hematology parameters. Patients treated with PFD during 6 months presented a continuous monthly statistically significant scar regression in comparison with the initial Vancouver measurement (P = <0.001). PFD group showed a higher improvement of all scar features as compared with control group treated with pressure therapy (P = <0.001). In the PFD group, 9 of 33 patients (27%) had their scores decreased in Vancouver classification by more than 55%, 22 patients (67%) had a 30% to 45% decrease, whereas 2 patients (6%) had a 30% decrease or less. Control group treated with pressure therapy showed a slight improvement in 16% of cases on an average. Patients did not show serious adverse effects or laboratory alterations throughout the study. Topical administration of 8% PFD gel 3 times a day is more effective and safe in the treatment of hypertrophic scars caused by burns in children, as compared with standard pressure therapy.Annals of plastic surgery 06/2011; 68(1):22-8. · 1.29 Impact Factor
I am writing about the paper by Armendariz-Borunda J, Lyra-Gonzalez I, Medina-
Preciado D, Gonzalez-García I, et al on their clinical trial of treating pediatric burn scars
with Pifenidone gel.1
Besides their scientific claims, the authors make several ethical claims. I have no opinion
about the validity of the scientific claims; however, I am concerned about the authors’
1. The authors claim that they had no financial conflict of interest.
Annals of Plastic Surgery’s “Instructions for Authors” clearly state, “Authors
must state all possible conflicts of interest in the manuscript, including financial,
consultative, institutional, and other relationships that might lead to bias or
conflict of interest. If there is no conflict of interest, this should also be explicitly
stated as “none declared”. These authors’ conflicts of interest and funding
statement was “None declared”. As the FDA has not approved Pirfenidone for use
in the United States, I was curious to discover where the gel form, reported in this
paper, was available. A Google search for “Pirfenidone gel” showed that two of
the authors, including the corresponding author, applied for a US patent on this
product in 2008 and had applied for a Mexican patent on the product in 2007.2 I
believe that Annals’ readers are entitled to know that fact when formulating their
opinions about the validity of this work.
2. The authors claimed that they complied with the ethical requirements of the
Declaration of Helsinki.
Although the Annals of Plastic Surgery does not require that submissions comply
with the Declaration of Helsinki, these authors claimed that this research did
indeed comply. Article 19 of the Declaration clearly states, “Every clinical trial
must be registered in a publicly accessible database before recruitment of the first
subject”.3 The paper lacked any trial registration information and my search of the
primary clinical trial databases yielded 19 registered trials, but none were either
by these authors or on this subject.4
Please afford the authors the opportunity to respond to these concerns so that Annals’
readers can weigh their responses and make individual appraisals of the validity of this
1 Armendariz-Borunda J, Lyra-Gonzalez I, Medina-Preciado D, Gonzalez-García I, Martinez-Fong D,
Miranda RA, Magaña-Castro R, Peña-Santoyo P, Garcia-Rocha S, Bautista CA, Godoy J, Flores-
Montana J, Floresvillar-Mosqueda J, Armendariz-Vazquez O, Lucano-Landeros MS, Vazquez-Del
Mercado M, Sanchez-Parada MG. A controlled clinical trial with pirfenidone in the treatment of
pathological skin scarring caused by burns in pediatric patients. Ann Plast Surg. 2012 Jan;68:22-28.
2 http://www.google.com/patents/US20110224265 [Accessibility verified January 10, 2012]
3 http://www.wma.net/en/30publications/10policies/b3/ [Accessibility verified January 10, 2012]
4 http://www.controlled-trials.com/mrct/ [Accessibility verified January 10, 2012]