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Authors' reply
Correspondence Address:
Kabir Sardana
466, Sector 28, Noida, UP - 201 303
India
How to cite this article: Sardana K, Garg V K. Authors' reply. Indian J Dermatol Venereol Leprol 2009;75:511-513 |
Sir,
We are thankful to the author [1],[2] for evincing interest in our article. [3]
- Firstly we focused on newer approaches in scleroderma. Dexamethasone-cyclophosphamide pulse (DCP) therapy is by no means a new approach.
- The evidence against use of steroids is overwhelming. The mountain of evidence from textbooks, and guidelines of medicine, rheumatolology and dermatology detailing the evidence against the use of steroids except for alveolitis, mycocarditis and sometimes for renal involvement [4],[5],[6],[7],[8],[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22] [Table - 1].
- Steroids have multitude of side effects which add to the already multisystem damage of scleroderma. [13],[14],[15]
- Skin improvement, which is a tool observed by most Indian case reports, is the most nonspecific tool to monitor improvement.Steroids per se have no role to play in the skin pathology of progressive systemic sclerosis (PSS). [4],[5],[6],[7],[8] Glucocorticoids are not effective in improving or preventing skin induration and the progression of systemic sclerosis (SSc; also known as scleroderma). [14]
- The most crucial aspects is that evidence-based double blinded trial has never shown steroids to be disease modifying [Table - 1]. [4],[5],[6],[7],[8],[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22]
- To complicate the matter, the disease has a well known spontaneous resolution and the trial has to be factored in any reported trial that shows results. [8],[15],[16],[17],[18] In other words, a disease in the resolving phase will show a false response to any drug.
- The evidence for cyclophosphamide is there, but as yet the results of the largest multicentric, multiregional (SCOT) trial is awaited and only after that we can comment on the therapeutic role of cyclophosphamide. [7],[12],[13],[15],[16],[17],[18]
Also, all our references were of evidence-based double blinded trials, whereas the references alluded by the author [4],[5],[6],[7],[8],[9],[10] are not.
Secondly, the indexed literature does not contain references 4, 6, and 8, referred by the author.
And case reports are not in any way considered as evidence even in the Cochrane registry of controlled trials, and most of the data reported by the author do not meet the standards of the Cochrane guidelines.
Lastly, the author has excluded two articles reporting the side-effects, which have been reported from India. [20],[21] This highlights the risks involved in the indiscriminate use of this form of therapy.
In view of the huge data from scientific journals, specialty books and international guidelines, [4],[5],[6],[7],[8],[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[22] the obstinate persistence of DCP pulse in scleroderma is purely a individual perception which is beyond scientific purview as its role has not been mentioned in any evidence-based data.
The summary guidelines on steroids gleaned from the wealth of data are given below [Table - 2].
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