In a randomized multicenter trial the efficacy of treatment of active
Crohn's disease by means of a liquid defined formula diet (
DFD) was tested and compared with a combination of 6-methyl-prednisolone and
sulfasalazine. A total of 95 patients participated in the study. By the end of 6 weeks, among 44 patients randomized to
drug treatment, 32 showed improvement of the
Crohn's disease activity index (CDAI) as compared with 21 of 51 patients receiving oral
DFD (p less than 0.05). The proportion of withdrawals in the
DFD group (29 of 51) was sevenfold higher than in the
drug group (4 of 44). However, most patients (20 of 29) receiving
DFD withdrew because of the unpalatability of the liquid diet. Analysis of patients in each group who finished the study showed equal effectiveness of
DFD and the
drug regimen. In these subsets of patients the CDAI decreased from 280.8 +/- 90.6 to 151.7 +/- 86.5 (
DFD) and from 263.7 +/- 86.3 to 129.3 +/- 63.7 (
drug), respectively. Improvement of
inflammation factors was similar in both groups at the end of the study, although improvement was delayed in the
DFD group. In conclusion, our data show a superiority of the
drug combination over
DFD in the treatment of
Crohn's disease under the conditions of this trial. The results do suggest, however, that
DFD offers a therapeutic alternative to
prednisolone and
sulfasalazine in a subgroup of patients, which has to be closer characterized in further studies.