Botulinum toxin A in postherpetic neuralgia: a parallel, randomized, double-blind, single-dose, placebo-controlled trial.
Τίτλος | Botulinum toxin A in postherpetic neuralgia: a parallel, randomized, double-blind, single-dose, placebo-controlled trial. |
Publication Type | Journal Article |
Year of Publication | 2013 |
Authors | Apalla, Z., Sotiriou E., Lallas A., Lazaridou E., & Ioannides D. |
Journal | Clin J Pain |
Volume | 29 |
Issue | 10 |
Pagination | 857-64 |
Date Published | 2013 Oct |
ISSN | 1536-5409 |
Λέξεις κλειδιά | Aged, Botulinum Toxins, Type A, Double-Blind Method, Female, Humans, Male, Neuralgia, Postherpetic, Pain Measurement, Placebo Effect, Treatment Outcome |
Abstract | OBJECTIVES: Cumulative evidence support a beneficial effect of botulinum toxin A (BTX-A) in postherpetic neuralgia (PHN). We aimed to assess efficacy, safety, and tolerability of BTX-A in the management of PHN, performing a randomized, double-blind, single-dose, placebo-controlled trial.METHODS: Thirty adults with PHN were randomized either to BTX-A or placebo. Severity of pain was evaluated by patients using a visual analogue scale (VAS) and quality of sleep was assessed using a 5-item questionnaire. Primary outcome was reduction in VAS score, with a greater than 50% reduction being considered clinically significant. Secondary outcomes were reduction in sleep score and maintenance of VAS score after treatment, with over 50% maintenance considered clinically meaningful.RESULTS: Thirteen patients from the experimental arm achieved an at least 50% reduction in VAS score, compared with none of the placebo patients (NNT=1.2, 95% CI, 2-1; ARR=0.87, 95% CI, 055-096; P<0.001). BTX-A patients showed significant reduction in VAS pain scores between baseline and week 2, which persisted for a median period of 16 weeks. BTX-A patients showed significant reduction in sleep scores between baseline and week 2, which remained unchanged until 16th week (P<0.001). Treatment was well tolerated.DISCUSSION: Data confirm that BTX-A is effective and well tolerated in the treatment of PHN. |
DOI | 10.1097/AJP.0b013e31827a72d2 |
Alternate Journal | Clin J Pain |
PubMed ID | 23370074 |