BACKGROUND:6-Mercaptopurine is often used as maintenance therapy in patients with Crohn's disease. However, toxicities like myelosuppression limit its clinical benefit. AIMS: To evaluate the efficacy of elemental diet versus 6-mercaptopurine as maintenance therapy in Crohn's disease. METHODS:Ninety-five eligible patients with Crohn's disease activity index ≤150 were randomly assigned to: 6-mercaptopurine (0.5-1.5mg/kg/day, n=30); Elental as an elemental diet (≥900 kcal/day, n=32); none (control, n=33). In the three groups, patients were and remained on 5-aminosalicylic acid (2250-3000 mg/day). Patients were observed for 2 years and the rate of relapse (Crohn's disease activity index ≥200) was monitored. RESULTS: At 24 months, the fractions of patients who had maintained remission were 60%, 46.9% and 27.2% for 6-mercaptopurine, Elental and the control groups, respectively. Log-rank test showed better efficacy for 6-mercaptopurine (P=0.0041) and Elental (P=0.0348) versus control. No significant difference was found between 6-mercaptopurine and Elental. Further, in the 6-mercaptopurine group, 2 patients experienced liver injury and one developed alopecia. CONCLUSIONS: This 24 months comparison study showed that Elental as maintenance therapy in Crohn's disease patients was as effective as 6-mercaptopurine. Elental should be useful for long-term maintenance therapy in Crohn's disease. This is the first comparison study evaluating nutritional therapy versus 6-mercaptopurine.
RCT Entities:
BACKGROUND:6-Mercaptopurine is often used as maintenance therapy in patients with Crohn's disease. However, toxicities like myelosuppression limit its clinical benefit. AIMS: To evaluate the efficacy of elemental diet versus 6-mercaptopurine as maintenance therapy in Crohn's disease. METHODS: Ninety-five eligible patients with Crohn's disease activity index ≤150 were randomly assigned to: 6-mercaptopurine (0.5-1.5mg/kg/day, n=30); Elental as an elemental diet (≥900 kcal/day, n=32); none (control, n=33). In the three groups, patients were and remained on 5-aminosalicylic acid (2250-3000 mg/day). Patients were observed for 2 years and the rate of relapse (Crohn's disease activity index ≥200) was monitored. RESULTS: At 24 months, the fractions of patients who had maintained remission were 60%, 46.9% and 27.2% for 6-mercaptopurine, Elental and the control groups, respectively. Log-rank test showed better efficacy for 6-mercaptopurine (P=0.0041) and Elental (P=0.0348) versus control. No significant difference was found between 6-mercaptopurine and Elental. Further, in the 6-mercaptopurine group, 2 patients experienced liver injury and one developed alopecia. CONCLUSIONS: This 24 months comparison study showed that Elental as maintenance therapy in Crohn's diseasepatients was as effective as 6-mercaptopurine. Elental should be useful for long-term maintenance therapy in Crohn's disease. This is the first comparison study evaluating nutritional therapy versus 6-mercaptopurine.