Efficacy of Fenoverine and Trimebutine in the Management of Irritable Bowel Syndrome: Multicenter Randomized Double-blind Non-inferiority Clinical Study / 대한소화기학회지
The Korean Journal of Gastroenterology
;
: 278-287, 2013.
Artigo
em Coreano
| WPRIM
| ID: wpr-171345
ABSTRACT
BACKGROUND/AIMS:
Antispasmodic agents have been used in the management of irritable bowel syndrome. However, systematic reviews have come to different conclusions about the efficacy in irritable bowel syndrome. Fenoverine acts as a synchronizer of smooth muscle in modulating the intracellular influx of calcium. We compared fenoverine with trimebutine for the treatment of patients with IBS.METHODS:
A multicenter, randomized, double-blind, non-inferiority clinical study was conducted to compared fenoverine with trimebutine. Subjects were randomized to receive either fenoverine (100 mg three times a day) or trimebutine (150 mg three times a day) for 8 weeks. A total of 197 patients were analyzed by the intention-to-treat approach. The primary endpoint was the proportion of patients who had 30% reduction in abdominal pain or discomfort measured by bowel symptom scale (BSS) score at week 8 compared to the baseline. The secondary endpoints were changes of abdominal bloating, diarrhea, constipation, overall and total scores of BSS, and overall satisfaction.RESULTS:
At week 8, fenoverine was shown to be non-inferior to trimebutine (treatment difference, 1.76%; 90% CI, -10.30-13.82; p=0.81); 69.23% (54 of 78 patients) of patients taking fenoverine and 67.47% (56 of 83 patients) of patients taking trimebutine showed 30% reduction in abdominal pain or discomfort compared to the baseline. There results of the secondary endpoints were also comparable between the fenoverine group and the trimebutine group.CONCLUSIONS:
Fenoverine is non-inferior to trimebutine for treating IBS in terms of both efficacy and tolerability.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Parassimpatolíticos
/
Fenotiazinas
/
Trimebutina
/
Índice de Gravidade de Doença
/
Esquema de Medicação
/
Dor Abdominal
/
Método Duplo-Cego
/
Resultado do Tratamento
/
Constipação Intestinal
/
Síndrome do Intestino Irritável
Tipo de estudo:
Ensaio Clínico Controlado
Limite:
Adulto
/
Feminino
/
Humanos
/
Masculino
Idioma:
Coreano
Revista:
The Korean Journal of Gastroenterology
Ano de publicação:
2013
Tipo de documento:
Artigo
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