CONTROLLED TRIAL OF ANTI-TUBERCULOUS CHEMOTHERAPY FOR 2 YEARS IN CROHNS-DISEASE

One hundred and thirty patients with active symptoms of Crohn's diseas e were treated in a double blind randomised controlled trial with rifa mpicin, isoniazid, and ethambutol, or identical placebos for up to two years. All other treatment considered necessary was continued. Analys es were based on 126 patients, 63 in each treatment group. Thirty seve n in the active and 30 in the placebo group had previous surgical proc edures. There was no difference in concomitant treatment between the t wo groups. Thirty in the active and 46 in the placebo groups were taki ng corticosteroids at entry to the trial. Forty eight of 63 patients i n the active and 49 of 63 in the placebo group, completed at least 12 months' therapy. Reasons for early withdrawal included pregnancy, adve rse reaction, and failure to comply. There was no significant differen ce in the mean number of months completed between the two groups. Nine teen adverse reactions were recorded for 17 patients in the active gro up compared with three reactions in patients on placebo. All of the ni ne patients withdrawn early because of adverse reactions were in the a ctive group. Fifteen patients on active treatment and 14 on placebo ha d surgery during the trial with no difference in the type of surgery r equired between the groups. Radiological assessments based on 98 patie nts at the end of the trial showed no significant differences between groups in changes of extent of disease. More patients developed strict ures on placebo compared with active treatment but without a statistic ally significant difference. No differences were found between groups for the total prednisolone dose or the number of days on which prednis olone dose was 10 mg or above. Serial measurements of body weight and Crohn's disease activity index (CDAI) together with blood values for a lbumin, haemoglobin, white cell count, and platelets showed no consist ent differences between groups. There were occasional significant diff erences for some of these values between groups, which were not sustai ned. The trial provides little evidence of tangible benefit from the t rial treatment.