A RANDOMIZED TRIAL COMPARING MESALAZINE AND PREDNISOLONE FOAM ENEMAS IN PATIENTS WITH ACUTE DISTAL ULCERATIVE-COLITIS

Distal ulcerative colitis can be treated with oral or rectal mesalazin e, or both. A foam enema preparation has been developed and its effica cy investigated. The aim of this study was to evaluate the efficacy an d safety of mesalazine foam enemas compared with prednisolone foam ene mas in the treatment of patients with acute distal ulcerative colitis. Patients aged over 18 years presenting with a relapse of distal ulcer ative colitis were randomly allocated treatment with mesalazine foam e nema (n=149 evaluable patients) and prednisolone foam enema (n=146 eva luable patients) for four weeks. A randomised multicentre investigator blind parallel group trial was conducted. It was found that after fou r weeks of treatment, clinical remission was achieved by 52% of mesala zine treated patients and 31% of patients treated with prednisolone (p <0.001). There was a trend in favour of more patients in the mesalazin e group achieving sigmoidoscopic remission (40% v 31%, p=0.10). Histol ogical remission was achieved by 27% and 21% of patients receiving mes alazine and prednisolone respectively. Symptoms improved in both treat ment groups. Significantly more mesalazine patients had no blood in th eir stools after four weeks of treatment (67% v 40%, p<0.001). Prednis olone treated patients had significantly fewer days with liquid stools than mesalazine patients, with a median of 0 and 1 days respectively by week 4 (p=0.001). In this study mesalazine foam enema was superior to prednisolone foam enema with regards to clinical remission, this wa s supported by favourable trends in sigmoidoscopic and histological re mission rates. Both treatments were well tolerated.