ABSTRACT
The response of active Crohn's disease to sulphasalazine (4-6 g per day) has been studied in a placebo-controlled trial. The study was carried out at two hospitals. From August 1977 to August 1979 all patients with established Crohn's disease were examined for their eligibility for the trial. A nine-item index of inflammatory activity was used as the primary measure of response. The variables in this index were serum albumin, ESR, body weight released to height, abdominal mass, temperature, stool consistency, bowel resection, and extraintestinal symptoms related to Crohn's disease. A favourable response to therapy was defined as a decrease of the activity index with 25% or more at the end of the trial period, compared with the initial value. Twenty-six patients (13 in each treatment group) have been followed up for six months. The response of active Crohn's disease to sulphasalazine was significantly better than to placebo.
Subject(s)
Crohn Disease/drug therapy , Sulfasalazine/therapeutic use , Adolescent , Adult , Clinical Trials as Topic , Double-Blind Method , Female , Humans , Male , Middle Aged , Random AllocationABSTRACT
An objective and quantitative standard of inflammatory activity for patients with Crohn's disease was developed. This Activity Index (AI) was derived from data of 63 patients with Crohn's disease who had been submitted to a total of 85 clinical examinations. On the basis of 18 predictor variables three physicians gave an overall evaluation of the severity of inflammatory activity in each patient. Stepwise multiple regression analysis was used to investigate which combination of variables contributed most to the overall evaluation. The combination of the following nine variables gave a very good correlation (r = 0.95) with the overall evaluation: serum albumin, ESR, body weight related to length, abdominal mass, sex, temperature, stool consistency, bowel resection, and extraintestinal symptoms related to Crohn's disease. This combination of variables expressed in a score that was used as an activity index proved to be very useful in the assessment of disease activity and of the effect of therapy. Index values below 100 are associated with inactive disease, values between 100 and 150 can be regarded as indicating slight inflammatory activity, values between 150 and 210 as indicating moderate, and values above 210 as indicating severe-to-very-severe inflammatory activity.
