Methotrexate: a useful alternative in Crohn's disease?

Results Of 125 patients assessed, 38 patients refused consent. Of 76 eligible patients, 23 were enrolled from the previous randomised trial and 53 from an open label study. At 40 weeks, 65% (26/40) of methotrexate treated patients remained in remission compared with 39% (14/36) of those receiving placebo injections (p=0.04, absolute reduction in risk of relapse 26%, 95% confidence intervals 4–48%). Median duration of remission on placebo was 22 weeks compared with more than 40 weeks for those receiving methotrexate. Twenty eight per cent (11/40) of the methotrexate group required prednisone compared with 58% (21/36) of those in the placebo group (p=0.01). Nausea and vomiting occurred more frequently in the methotrexate group (40% v 25%) but other side eVects were equally common in the two groups. No patient had leucopenia that was severe enough to require withholding methotrexate and none of the patients in the methotrexate group suVered a severe adverse event.