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ARTICLES: R. Y. Yuan, J. J. Sheu, J. M. Yu, W. T. Chen, I. J. Tseng, H. H. Chang, and C. J. Hu Botulinum toxin for diabetic neuropathic pain: A randomized double-blind crossover trial Neurology 2009; 72: 1473-1478 [Abstract] [Full text] [PDF]

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Botulinum toxin for diabetic neuropathic pain: A randomized double-blind crossover trial

Josh Torgovnick, Edward Arsura, Nitin K. Sethi   (20 July 2009)

Reply from the authors

Chaur-Jong Hu, Rey-Yue Yuan and Jau-Jiuan Sheu   (20 July 2009)

Reply from the Editorialist

Stuart C. Apfel   (20 July 2009)

Botulinum toxin for diabetic neuropathic pain: A randomized double-blind crossover trial 20 July 2009
Josh Torgovnick, Saint Vincent's Hospital and Medical Centers 170 West 12th Street, New York, NY 10011, Edward Arsura, Nitin K. Sethi Send Correspondence to journal: Re: Botulinum toxin for diabetic neuropathic pain: A randomized double-blind crossover trial drjosh49{at}msn.com Josh Torgovnick, et al.	We are skeptical of the benefits of botulinum toxin type A (BoNT/A) in treating neuropathic pain. [1] We also believe that Apfel’s accompanying editorial was too positive regarding this study involving only 18 patients. [2] Sleep problems and quality of life scores have nothing in common with results of the visual analog scale (VAS) and these are our patients’ major concerns. In addition, the pattern of injections is not related to the areas where our patients complain about pain including the toes and balls of the feet. Furthermore, data have shown that injection sites followed the pain. [3,4] Yuan et al.’s study would have benefited by having independent funding rather than relying on the largess of Allergan for the BoNT/A. BoNT/A has proven indications, but the drive to expand them is industry driven and is reminiscent of the marketing strategy of Neurontin. Given its cost and mode of use, larger studies funded by unrelated sources should be pursued. References 1. Yuan RY, Sheu JJ, Yu JM, et al. Botulinum toxin for diabetic neuropathic pain: a randomized double-blind crossover trial. Neurology 2009;72:1473-1478. 2. Apfel SC. Botulinum toxin for neuropathic pain? Neurology 2009;72:1456-1457. 3. Ranoux D, Attal N, Morain F, Bouhassira D. Botulinum toxin type A induces direct analgesic effects in chronic neuropathic pain. Ann Neurol 2008;64:274–284. 4. Piovesan EJ, Teive HG, Kowacs PA, Della Coletta MV, Werneck LC, Silberstein SD. An open study of botulinum A toxin treatment of trigeminal neuralgia. Neurology 2005;65:1306–1308. Disclosure: The authors report no disclosures.
Reply from the authors 20 July 2009
Chaur-Jong Hu, Department of Neurology, Taipei Medical University-Shuang Ho Hospital Taipei County, Taiwan, Rey-Yue Yuan and Jau-Jiuan Sheu Send Correspondence to journal: Re: Reply from the authors chaurjongh{at}tmu.edu.tw Chaur-Jong Hu, et al.	We thank Torgovnick et al. for their comments and would like to address their concerns. First, we surveyed the quality of sleep and life because they are both affected by neuropathic pain. Most patients with diabetic neuropathy complain about sleep interference caused by pain. Sleep disturbance in turn increases the pain sensation and decreases quality of life. [5] We wanted to explore neuropathic pain in life quality among diabetic patients. Second, the effects of BoNT/A on foot sensation were unclear before this study. If BoNT/A impaired all sensory modalities, including proprioception over toes and balls of the feet, participants might have gait disturbance including sensory ataxia. This possibility concerned our IRB when we submitted our proposal. In addition, intradermal injection was not easy due to the skin thickness of these regions. We agree with Torgovnick et al. that toes and balls of the feet or ‘following the pain’ method should be the first consideration in subsequent trials. [3,4] Finally, Allergan was not involved during the complete course of this double-blinded study. We searched for novel resolutions of patient problems based on scientific knowledge and academic interest. To create new indications of BoNT/A for neuropathic pain, larger clinical trials are needed regardless of funding sources. References 5. Parish JM. Sleep-related problems in common medical conditions. Chest. 2009;135:563-572. Disclosure: The authors report no disclosures.
Reply from the Editorialist 20 July 2009
Stuart C. Apfel, Albert Einstein College of Medicine 218 Walker Place, West Hempstead, NY 11552 Send Correspondence to journal: Re: Reply from the Editorialist apfel{at}aecom.yu.edu Stuart C. Apfel	Although Torgovnick et al. comment that my editorial was too positive regarding this small study, [1] I acknowledged this limitation and highlighted the need to conduct larger, carefully designed, multi-center, clinical trials. [2] The optimism of the editorial was based on the fact that the results of two independent studies were largely in agreement. [1,3] This does not constitute proof of efficacy, but should encourage others to conduct larger, appropriately designed clinical trials. The authors further imply that the source of funding for this study may have biased the results. That is always a concern with private funding of any research. However, without such funding, vital clinical and basic science research would not secure sponsorship. Extensive regulatory oversight of pharmaceutical industry research provides strict—if not stricter— quality control and transparency than the academic setting, where peer review is largely the only check and balance on researchers struggling to “publish or perish”. Disclosure: Dr. Apfel, in his capacity as founder and principal of Parallax Clinical Research, has served as a paid consultant for Tolerx Inc., Acambis Pharmaceuticals, Asubio Pharmaceuticals, Cara Pharmaceuticals, Eisai Pharmaceuticals, ITI Pharmaceuticals, and Elite Pharmaceuticals, and has served as Chief Medical Officer for and received stock options from Elite Pharmaceuticals.