RESUMO
In order to evaluate the efficacy and tolerability of mesalazine (5-ASA) in the prophylaxis of symptomatic relapses, of major complications and of microhemorrhagic 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 enrollment, 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.