Effectiveness of an 'half elemental diet' as maintenance therapy for Crohn's disease: A randomized-controlled trial.
BACKGROUND
Although thiopurines have a proven role in maintenance therapy for Crohn's disease, an alternative therapy is needed for patients intolerant or resistant to thiopurines.


OBJECTIVE
To evaluate the effectiveness of home enteral nutrition as a maintenance therapy regimen in which half of the daily calorie requirement is provided by an elemental diet and the remaining half by a free diet. We refer to this home enteral nutrition therapy as 'half elemental diet'.


METHODS
Between 2002 and 2005, 51 patients in remission from two hospitals were randomly assigned to a half elemental diet group (n = 26) or a free diet group (n = 25). The primary outcome measure of this study was the occurrence of relapse over the 2-year period.


RESULTS
The relapse rate in the half elemental diet group was significantly lower [34.6% vs. 64.0%; multivariate hazard ratio 0.40 (95% CI: 0.16-0.98)] than that in the free diet group after a mean follow-up of 11.9 months. Compliance was similar in the two groups. No adverse event occurred in any of the patients throughout the study.


CONCLUSIONS
This randomized-controlled trial shows the effectiveness of an half elemental diet, which is a promising maintenance therapy for Crohn's disease patients.
Takagi
S
S
Division of Gastroenterology, Department of Internal Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan. stakagi@int3.med.tohoku.ac.jp
Utsunomiya
K
K
Kuriyama
S
S
Yokoyama
H
H
Takahashi
S
S
Iwabuchi
M
M
Takahashi
H
H
Takahashi
S
S
Kinouchi
Y
Y
Hiwatashi
N
N
Funayama
Y
Y
Sasaki
I
I
Tsuji
I
I
Shimosegawa
T
T
D000328:Adult; D003424:Crohn Disease / Q000178:diet therapy*; D004750:Enteral Nutrition / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D005526:Food, Formulated; D006801:Humans; D008297:Male; D010288:Parenteral Nutrition / Q000379:methods; D012008:Recurrence; D016896:Treatment Outcome