|Treatment of inflammatory neuropathy with dexamethasone plus B-vitamins: a clinical evaluation|
|Tratamento de neuropatia inflamatória com a associação de dexametasona e vitaminas B: uma avaliação clínica|
|Head of the Neurosurgery Service - HUPE. Master in Neurology - UFRJ. Professor and Coordinator of Neurosurgery - FCM-UERJ.|
|Carlos Pereira Nunes|
|Associate Professor of Internal Medicine - UNIFESO. Associate Professor - IPGMCC.|
|Carlos Alfredo Franco Cardoso|
|Professor and Chairman of Biochemistry - UNIFESO. Coordinator of Biological Sciences - UNIFESO.|
|Flavia de Paoli|
|Professor and Chairman of Pharmacology - UNIFESO.|
|Márcia Gonçalves Ribeiro|
|Associate Professor - UFRJ.|
|Neurology - INDC-UFRJ. Training in Pain Management - NYU Pain Center.|
Professor and Chairman of Immunology - UNIFESO. Professor and Chairman of Clinical Immunology - IPGMCC.
Researcher in Microbiology and Immunology - UNIFESO.
Staff Physician - Hospital Municipal Miguel Couto.
Address for correspondence:
Departamento de Imunologia e Microbiologia - UNIFESO
Prof. Mauro Geller
Av. Alberto Torres, 111
CEP 25964-004 - Teresópolis - RJ
Recebido para publicação em 05/2009.
Aceito em 05/2009.
© Copyright Moreira Jr. Editora.
Todos os direitos reservados.
Indexado na Lilacs Virtual sob nº LLXP: S0034-72642009002100005
|Unitermos: Inflammatory neuropathy, dexamethasone sodium phosphate, thiamine hydrochloride, pyridoxine hydrochloride, cyanocobalamin|
|Unterms: neuropatia inflamatória, fosfato dissódico de dexametasona, cloridrato de tiamina, cloridrato de piridoxina, cianocobalamina|
Numeração de páginas na revista impressa: 169 à 173
Data are n or means (± SD).
Data are means (±SD) or repeated-measures ANOVA
Sixty-one patients were enrolled in this study. The demographic data of the patient population is summarized in Table 1. Of the total patients, 50 (81.97%) reported previous treatment of the inflammatory neuropathy, while 11 (18.03%) reported no previous treatment.
Table 2 summarizes the results of the safety evaluations. There were no clinically significant changes from Pretreatment to the Final Visit in the physical evaluations performed (weight, pulse, and blood pressure). The adverse events (AEs) recorded during the study are presented in Table 3. A total of 29 patients (47.54%) presented 86 AEs during the study. Of these, 6 patients (20.69%) presented 1 AE, 8 (27.59%) patients presented 2 AEs, 5 (17.24%) patients presented 3 AEs, 5 (17.24%) patients presented 4 AEs, while 1 (3.45%) patient presented 5 AE, and 4 (13.79%) patients presented 6 AEs. Of the total adverse events, 81 (94.2%) were resolved before the Final Visit, and 5 (5.8%%) were ongoing at the end of the study.
Of the total adverse events reported, 64 (74.4%) were directly related the intramuscular administration of the study medication. The majority of the adverse events were classified as mild, and lasted less than ten minutes. The five AEs classified as “severe” related to pain at the injection site of the study medication, none of which lasted longer than 3 minutes. One patient was withdrawn from the study due to worsening of a previously existing condition (intraocular hypertension). The alterations in laboratory exams observed in 2 patients were not considered clinically significant.
The results of the efficacy evaluations are presented in Table 4. We observed clinically significant improvements from the Pretreatment assessment to the Final Visit in all of the efficacy evaluations performed.
The results of this study confirm the efficacy and safety of the use of the combination of dexamethasone and the B-vitamins in terms of significant pain relief and anti-inflammatory activity.
Although a large number of adverse events were recorded during this study, most were directly related to the intramuscular administration of the study medication. Those that were not directly related to the study drug administration were mild or moderate in severity, and were resolved by the end of the study. The safety profile and risks of adverse reactions to the glucocorticoids, including dexamethasone, is well known. The adverse effects reported during the study could be attributed to the dexamethasone component of the study medication(21). While there are reports of adverse events associated with B-vitamin use in the literature, the B vitamins used in this study are considered safe at the doses employed(27).
The findings of this study are in conformity with those in the literature regarding the therapeutic benefit of the combination of dexamethasone with the B-vitamins, although the mechanism by which these effects are exerted remains unclear(22-26). The results of this study mirrored those of a previously reported trial of a similar drug combination and trial design(28). The addition of thiamine, pyridoxine, and cyanocobalamin to dexamethasone could enable administration of lower concentrations of dexamethasone in the treatment of neuropathic pain.
The results of the efficacy evaluations carried out during the study demonstrated clinically significant improvement in pain and mobility in the treated patient population. These results are encouraging in light of the challenge faced by healthcare providers in the treatment and management of neuropathic pain.
Based on the results of this study, we conclude that the combination of dexamethasone with thiamine, pyridoxine, and cyanocobalamin at the doses employed in this study, is both safe and effective in the treatment of the signs and symptoms of inflammatory neuropathy.
The authors would like to thank Evolution Consultancy for clinical protocol development and statistical evaluations. Thanks also to Luiza Lisboa Carramenha and Filipe Augusto Carvalho de Paula, Breno Lorch, and Flavia Kuperman for CRF handling and for clinical review.
Foi realizada uma avaliação da combinação das vitaminas B1, B6, e B12 com a dexametasona no tratamento dos sinais e sintomas de neuropatia inflamatória dos membros superiores e inferiores, em um estudo clínico aberto. Os pacientes foram submetidos a um período de tratamento de 9 dias com três doses do medicamento do estudo em intervalos de três dias, junto com uma série de avaliações clínicas e laboratoriais, antes da primeira dose do medicamento do estudo e em cada uma das seguintes três visitas ao centro do estudo. As avaliações de eficácia em cada visita do estudo incluíram uma escala de dor de 100mm e questionários da condição global e da satisfação realizadas pelo paciente e o médico investigador.
As avaliações de eficácia incluíram uma comparação de alterações aos exames laboratoriais em cada visita, bem como a incidência, severidade, duração e resultado de eventos adversos. Foi incluído na pesquisa um total de sessenta e um pacientes. Uma melhora clinicamente significativa foi observada em todas as medidas de eficácia utilizadas, do pré-tratamento até as avaliações de final de estudo.
Não foram observadas alterações clinicamente significativas nas avaliações clínicas realizadas durante o período de tratamento. Com base nos resultados desta pesquisa clínica, concluímos que a combinação de dexametasona com as vitaminas B é segura e eficaz no tratamento dos sinais e sintomas de neuropatia inflamatória.
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