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A reply to Dr Chaudhari et al comments
- A Karmarkar (26 February 2007)
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Lidocaine patch 5% for the treatment of CRPS II
- Dr. Maheshwar K. Chaudhari, Dr. Michael Serpell, Dr. Michael Basler, North Glasgow Hospitals NHS Trust, Glasgow (16 February 2007)
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A Karmarkar
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We thank Dr Chaudhari et al for their comments about our case report and welcome the opportunity to reply. We would like to stress that this is a case report and not a clinical trial in which case it would be logical to classify them in to levels of evidence i.e. I- IV. We have not claimed in this case report that we are the first to show the effectiveness of 5% lidoderm patches for non-post herpetic conditions. In fact we have acknowledged the study done by Devers et al. for neuropathic pain conditions. We have highlighted that the use of these patches for CRPS was outside of UK licence and that it would not be sensible to lose the opportunity of pain relief provided by lidoderm patches for facilitating functional restoration. Although many pain medications are used outside their licence, the use of lidoderm patches for management of non post herpetic neuralgia remains scanty. Their use might increase in the future with an increasing body of evidence and if they get cheaper. Pain is a subjective phenomenon and the effect it has on every individual is variable. Dr Chaudhari et al have rightly pointed out the lack of multidimensional pain scales but we think that pain relief with functional restoration for a young patient takes precedence over any forms of pain measuring tools. We have speculated the role of 5% lidoderm patches in the management of CRPS and have acknowledged that it needed further investigation. It would be interesting to know the results of your retrospective study which you have submitted to the British Pain Society for poster presentation. This will also increase our knowledge and experience in managing a resistant condition as CRPS. We do not agree that only level I or II evidence should be published in international journals. Case reports are designed to share experiences of managing rare or difficult cases which is exactly what we have tried to project in our case report. Conflict of Interest:None declared |
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Dr. Maheshwar K. Chaudhari , Dr. Michael Serpell, Dr. Michael Basler, North Glasgow Hospitals NHS Trust, Glasgow
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We were surprised that a case report ‘Management of complex regional pain syndrome type II using lidoderm 5% patches’ by Dr. Karmarkar and Dr. Lieberman, was worthy of publication in the BJA 98(2): 261-1 (2007). The case report interprets effectiveness of lidociane patch 5% based on the pain relief at two weeks follow-up in a chronic pain patient Whilst we acknowledge that it is important to publicize successful outcomes with new treatments for resistant pain conditions, this single case report (level IV evidence) adds little to what we already know and contains a number of methodological flaws. It was open label, of short duration, had no withdrawal phase and the primary outcome was inadequate. The placebo effect itself can provide pain relief for several weeks, and temporal fluctuations are common even in “stable” chronic pain conditions. This is why the European Medicines Agency recommends at least 12 weeks duration for the study of drugs.1 The pain scale used is not clearly stated, but it seems it was a uni-dimensional visual analogue scale. Again, the EMEA recommend the use of a multi-dimensional tool, which captures both physical and social function and Quality of Life. A lot of these criticisms can be addressed by using n of 1 trials. These are easily done, even by GPs in the Australian outback!! 2 Although lidocaine patch 5% is only licensed in the UK for the treatment of post-herpetic neuralgia, its use for the treatment of non post-herpetic neuropathic pain conditions is not uncommon. There are studies (prospective, double-blind, randomised) demonstrating its effectiveness in various non-postherpetic neuropathic pain conditions (including CRPS II). 3-5 We conducted a retrospective study looking at the effectiveness of the lidocaine patch 5% in the treatment of non-postherpetic neuropathic pain conditions. Our study (38 patients) showed that lidocaine patches were effective in a variety of non-post herpetic neuropathic pain conditions (including CRPS II and focal neuropathy) for a period of several years. This has been submitted to the British Pain Society for poster presentation in April 2007. In order to provide the best level of evidence based medicine, we need to encourage pain specialists and publishers to accept only evidence of the highest possible standard. We would welcome an invitation to submit our work (level III evidence) to the BJA, to further improve the body of evidence on this matter! References – 1 Guidelines on clinical investigation of medicinal products intended for the treatment of neuropathic pain. European Medicines Agency, Evaluation of Medicines for Human Use. 2005. 2 Nikles CJ, Glasziou PP, Del Mar CB, Duggan CM, clavarino A, Yelland MJ. Preliminary experiences with a single-patient trials service in general practice. Med J Aust 2000, 173: 100-103. 3 Davers A, Galer BS. Topical lidocaine patch relieves a variety of neuropathic pain conditions: An open lable study. Clincal Journal of Pain, September 2000, 16(3):205-8. 4 Meier T, Faust M, Hueppe M, Schmucker P. Reduction of chronic pain for non-post herpetic peripheral neuropathies after topical treatment with a lidocaine patch. Schmerz, June 2004, 18(3): 172-8. 5 Meier T, Wasner G, Faust M, Kuntzer T, Ochsner F, Hueppe M. Efficacy of lidocaine patch 5% in the treatment of focal peripheral neuropathic pain syndromes: a randomised, double-blind, placebo-controlled study. Pain, November 2003, 106(1-2):151-8. Conflict of Interest:None declared |
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