title: Nutritional therapy versus 6-mercaptopurine as maintenance therapy in patients with Crohn's disease.
abstract: BACKGROUND
  6-Mercaptopurine is often used as maintenance therapy in patients with Crohn's disease. However, toxicities like myelosuppression limit its clinical benefit.
  
  
  OBJECTIVE
  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.
authors.affiliation: Centre for Gastroenterology and Inflammatory Bowel Disease Research, Hamamatsu South Hospital, Hamamatsu, Japan. hanai@hamamatsu-minami.com
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Hanai
authors.forename: Takayuki
authors.initials: T
authors.lastname: Iida
authors.forename: Ken
authors.initials: K
authors.lastname: Takeuchi
authors.forename: Hajime
authors.initials: H
authors.lastname: Arai
authors.forename: Osamu
authors.initials: O
authors.lastname: Arai
authors.forename: Jinrou
authors.initials: J
authors.lastname: Abe
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Tanaka
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Maruyama
authors.forename: Kentarou
authors.initials: K
authors.lastname: Ikeya
authors.forename: Ken
authors.initials: K
authors.lastname: Sugimoto
authors.forename: Toshio
authors.initials: T
authors.lastname: Nakamura
authors.forename: Kouichi
authors.initials: K
authors.lastname: Nakamura
authors.forename: Fumitoshi
authors.initials: F
authors.lastname: Watanabe
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D003424:Crohn Disease / Q000178:diet therapy* / Q000188:drug therapy*; D005526:Food, Formulated / Q000009:adverse effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D060046:Maintenance Chemotherapy; D008297:Male; D015122:Mercaptopurine / Q000009:adverse effects / Q000627:therapeutic use*; D019804:Mesalamine / Q000627:therapeutic use; D012008:Recurrence; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007166:Immunosuppressive Agents; D019804:Mesalamine; D015122:Mercaptopurine