In order to evaluate the efficacy and tolerability of mesalazine (5-ASA) in the prophylaxis of simptomatic relapses, of major complications and of microhemmorrhagic phenomena in diverticular disease of the large intestine (MDC), prospective clinical study was conducted on patients with light- moderate symptomatic MDC under treatment with sulbactam-ampicillin 1.5 g/12 h.i.m. and rifaximine 400 mg/12 h per os for 7 days. Follow-up period of 5 years with seriated checkups and laboratory and instrumentation controls. End points are represented by the relapse on inflammation and/or by the occurrence of major complications. On enrolment, 166 patients were randomized to receive mesalazine (Pentacol® tablets - SOFAR S.p.A.) 400 mg b.i.d. per os for 8 weeks (81 patients; group M) or no supplementary treatment (85 patients; group C). After 4 years of follow-up, 44 patients dropped out of the study (9 because of major complications, 3 for massive hemorrhage, and 32 drop outs). Symptomatic relapses occurred in 51 patients (12 M; 39 C), while minor diverticular hemorrhages occurred in 43 patients (12 M; 31 C), with an estimated probability of remaining free respectively from symptomatic relapse (p=0.00005) and from microhemorrhagic phenomena (p=0.001) decisively in favor of the group treated with mesalazine. The duration of abdominal pain due to diverticolitis was also shorter in patients of group M (p=0.0002), while the incidence of major complications and side effects was comparable in the two groups. In conclusion, supplementary treatment with mesalazine in patients affected with MDC - at a follow-up limited to 48 months - proved to be well tolerated and effective in reducing the frequency of symptomatic relapses and microhemorrhagic phenomena and in reducing the duration of abdominal pain.
|Translated title of the contribution||Therapeutic and prophylactic role of mesalazine (5-ASA) in symptomatic diverticular disease of the large intestine. 4 Year follow-up results|
|Number of pages||8|
|Journal||Minerva Gastroenterologica e Dietologica|
|Publication status||Published - 1999|
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