levamisol não previne lesões de estomatite aftosa recorrente: um ensaio clínico randomizado, duplo-cego e controlado por placebo levamisole does not prevent lesions of recurrent aphthous stomatitis: a double-blind placebo-controlled clinical trial

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ID: 242878
2009
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Abstract
OBJETIVO: Avaliar a eficácia e a segurança do levamisol no tratamento profilático da afta recorrente, utilizando um protocolo de estudo duplo-cego. MÉTODOS: Quatorze pacientes receberam doses decrescentes de levamisol por via oral por seis meses (dose inicial de 150mg três vezes por semana). Dez pacientes receberam placebo. As avaliações foram mensais. RESULTADOS: Houve tendência à diminuição do número de crises nos dois grupos, mas sem diferenças entre ambos. O número de lesões diminuiu significantemente nos grupos levamisol e placebo, mas na comparação entre eles a diferença não foi significante. A duração das lesões diminuiu significantemente no grupo placebo, porém ao compará-lo com o grupo levamisol a diferença não foi significante durante todo o tratamento. A intensidade da dor foi significantemente menor nos dois grupos, mas ao compará-los a dor foi significantemente menor no grupo placebo. A avaliação global final mostrou melhora em 50% dos pacientes do grupo levamisol e em 70% do Placebo, sem diferença significante entre os dois tratamentos. Não foi observada diferença na frequência de efeitos colaterais entre os grupos. CONCLUSÃO: Levamisol, como usado nesse protocolo, é uma droga segura. Comparado ao placebo, levamisol não é efetivo no tratamento profilático da afta recorrente. O efeito placebo é importante em desordens nas quais fatores emocionais afetam a recorrência ou a expressão de sintomas.
OBJECTIVE: to utilize a double-blind protocol to provide clarification about the safety and effectiveness of levamisole in the treatment of recurrent aphthous stomatitis. METHODS: Fourteen patients took a decreasing dose of oral levamisole for six months (initial dose 150mg three times a week) and ten others were placebo control patients. All were evaluated monthly. RESULTS: The number of crises had a tendency to decrease in both groups, but without a difference between groups. The number of lesions diminished significantly in the two groups, but upon comparison the difference was not significant. Duration of the lesions diminished significantly in the placebo, however when compared to the levamisole group, difference was not significant during treatment. The intensity of pain was significantly lower in the two groups, but upon comparison, pain was significantly lower in the placebo group. The final global evaluation showed improvement in 50% of patients of the levamisole group and in 70% of the placebo, without a significant difference between treatments. No difference in the frequency of collateral effects was observed between groups. CONCLUSIONS: Levamisole, as used in this protocol, is a safe drug. When compared with the placebo, levamisole is not effective in the prophylactic treatment of recurrent aphthous stomatitis. The placebo effect is important in diseases where emotional factors affect recurrence or expression of symptoms.
Reference Key
weckx2009revistalevamisol Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors ;Luc Louis Maurice Weckx;Cleonice Hitomi Watashi Hirata;Marilda Aparecida Milanez Morgado de Abreu;Vilma Ciorla Fillizolla;Olga Maria Panhoca da Silva
Journal acta crystallographica section e
Year 2009
DOI
10.1590/S0104-42302009000200014
URL
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0104-42302009000200014
Keywords
randomized controlled trial aphthous stomatitis placebo effect therapymedicine (general) estomatite aftosa

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