TY - JOUR
T1 - Methotrexate in chronic active Crohn's disease
T2 - A double-blind, randomized, Israeli multicenter trial
AU - Oren, Ran
AU - Moshkowitz, Menachem
AU - Odes, Shmuel
AU - Becker, Stuart
AU - Keter, Daniel
AU - Pomeranz, Itamar
AU - Shirin, Chaim
AU - Reisfeld, Ilan
AU - Broide, Efrat
AU - Lavy, Alexandra
AU - Fich, Alexander
AU - Eliakim, Rami
AU - Patz, Julian
AU - Villa, Yael
AU - Arber, Nadir
AU - Gilat, Tuvia
PY - 1997/12
Y1 - 1997/12
N2 - Background: At present only one large controlled study has indicated that patenteral methotrexate may be effective in chronic active Crohn's disease (CD). Aim: To evaluate the effectiveness of oral methotrexate in chronic steroid-dependent CD. Patients: Patients with active CD, who have received steroids and/or immunosuppressives for at least 4 months during the preceding 12 months and with a current Harvey-Bradshaw index of ≥7 were studied. Methods: Methotrexate (12.5 mg weekly) or 6-mercaptopurine (50 mg daily), or placebo were given during the 9 months of the trial in addition to steroids and 5-aminosalicylic acid as clinically indicated. Results: Eighty-four patients were included (methotrexate, 26 patients; 6-mercaptopurine, 32 patients; placebo, 26 patients). The proportion of patients entering first remission as well as the proportions of patients relapsing after first remission were not significantly different between the groups. The mean Harvey-Bradshaw index and the mean monthly steroid dose were also similar. However, when each patient was evaluated as his or her own control, the reduction in steroid dose, the general well being, and the reduction in abdominal pain were significantly better in the methotrexate treated patients. Conclusions: Methotrexate at a weekly oral dose of 12.5 mg was found to be moderately better than 6-mercaptopurine and placebo in patients with chronic active CD.
AB - Background: At present only one large controlled study has indicated that patenteral methotrexate may be effective in chronic active Crohn's disease (CD). Aim: To evaluate the effectiveness of oral methotrexate in chronic steroid-dependent CD. Patients: Patients with active CD, who have received steroids and/or immunosuppressives for at least 4 months during the preceding 12 months and with a current Harvey-Bradshaw index of ≥7 were studied. Methods: Methotrexate (12.5 mg weekly) or 6-mercaptopurine (50 mg daily), or placebo were given during the 9 months of the trial in addition to steroids and 5-aminosalicylic acid as clinically indicated. Results: Eighty-four patients were included (methotrexate, 26 patients; 6-mercaptopurine, 32 patients; placebo, 26 patients). The proportion of patients entering first remission as well as the proportions of patients relapsing after first remission were not significantly different between the groups. The mean Harvey-Bradshaw index and the mean monthly steroid dose were also similar. However, when each patient was evaluated as his or her own control, the reduction in steroid dose, the general well being, and the reduction in abdominal pain were significantly better in the methotrexate treated patients. Conclusions: Methotrexate at a weekly oral dose of 12.5 mg was found to be moderately better than 6-mercaptopurine and placebo in patients with chronic active CD.
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AN - SCOPUS:0030784425
SN - 0002-9270
VL - 92
SP - 2203
EP - 2209
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 12 SUPPL.
ER -