RESUMO
OBJECTIVE: To determine if modafinil can improve fatigue in patients with post-polio syndrome. METHODS: We used a randomized, placebo-controlled crossover trial. Intervention with modafinil (400 mg/day) and placebo occurred over 6-week periods. Primary endpoint (fatigue) was assessed using the Fatigue Severity Scale as the main outcome measure. Other measures included the Visual Analog Scale for Fatigue and the Fatigue Impact Scale. Secondary endpoint (health-related quality of life) was assessed using the 36-Item Short-Form. Analysis of variance for repeated measures was applied to assess treatment, period, and carryover effects. RESULTS: Thirty-six patients were randomized, 33 of whom (mean age: 61 years) completed required interventions. Treatment with modafinil was safe and well-tolerated. After adjusting for periods and order effects, no difference was observed between treatments. CONCLUSION: Based on the utilized measures of outcome modafinil was not superior to placebo in alleviating fatigue or improving quality of life in the studied post-polio syndrome population.
Assuntos
Compostos Benzidrílicos/uso terapêutico , Estimulantes do Sistema Nervoso Central/uso terapêutico , Fadiga/tratamento farmacológico , Síndrome Pós-Poliomielite/complicações , Idoso , Idoso de 80 Anos ou mais , Compostos Benzidrílicos/efeitos adversos , Estimulantes do Sistema Nervoso Central/efeitos adversos , Estudos Cross-Over , Método Duplo-Cego , Fadiga/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modafinila , Efeito Placebo , Qualidade de Vida , Índice de Gravidade de Doença , Falha de TratamentoRESUMO
Functional inhibition of the drug liver metabolism seems to start at early subclinical stages of cholecystitis. Antipyrine++ level in the initial saliva sample drops significantly and continues to change with growing structural impairment of the biliary system in progression of chronic noncalculous cholecystitis into calculous one.
