A multicentre double-blind study was conducted to evaluate the efficacy and tolerability of 1 g or 1.5 g mesalazine daily compared with placebo in 94 patients with mild to moderate distal proctosigmoiditis (less than 20 cm). The study end point was the determination of clinical, endoscopic, and histologic remission rates at 4 weeks. Eleven patients, nine receiving placebo and two receiving 1.5 g mesalazine, withdrew during trial, mostly because of worsening of symptoms. At 4 weeks clinical remission was achieved in 7 of 31 (39%) patients with placebo, in 22 of 32 (69%) patients in the 1 g mesalazine group, and 23 of 31 (74%) patients in the 1.5 g mesalazine group. No serious clinical or biochemical side effect of treatment was reported. Mesalazine suppositories are safe, well tolerated, and very effective in patients with active distal proctosigmoiditis: 500 mg twice daily appears a suitable dose regimen.

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Background Recent data indicate that 5‐aminosalicylic acid (5‐ASA) is most effective in preventing relapse of Crohn's disease in patients with a short duration of remission before enrolment. Aim To evaluate the efficacy of oral 5‐ASA treatment, started immediately after achieving steroid‐induced remission, in preventing clinical relapses of Crohn's disease. Methods Patients with active Crohn's disease, achieving remission on steroids, were randomized to oral 5‐ASA 3 g/day or placebo, while steroids were tapered over 6 weeks. The trial was terminated after interim analysis showed a slightly higher relapse rate in the 5‐ASA group, and the calculated probability of seeing a statistically significant difference by completing the study was minimal. Results Final analysis included 117 patients (58 taking 5‐ASA and 59 taking placebo; follow‐up 9.2 ± 6.5 months). Cumulative relapse rates at 6 and 12 months were 34% and 58% in 5‐ASA patients and 31% and 52% in placebo patients, respectively (rate difference + 0.095; 95% CI = −0.085– + 0.274). Subgroups analysis showed that 5‐ASA was equally ineffective in patients with ileal, colonic or ileocolonic disease. Conclusions Contrary to previous results, in our study early introduction of treatment with oral 5‐ASA did not prevent relapse in Crohn's disease patients treated with steroids to induce remission.

Reduced bone mineral density (BMD) has been reported in ulcerative colitis (UC), but there are no data concerning body composition (fat and lean mass) in such patients. We used whole body dual-energy X-ray absorptiometry (Hologic QDR 1000 W) at baseline and after 6 years of follow-up to study bone density, and fat and lean mass in 43 outpatients with mild UC (21 men, mean age 36 years, range 21-57 years, and 22 women, mean age 35 years, range 23-45 years at baseline; disease extent: 2 proctitis, 18 proctosigmoiditis, 8 left colitis, 5 substantial colitis, 10 pancolitis; mean disease duration 8 years, range 2-18 years; no hospitalization; few relapses during the follow-up) and 111 healthy volunteers matched by sex, age and body mass index. There were 5 drop-outs. We observed no significant difference in BMD, or fat and lean mass between the male patients and controls at baseline or after 6 years. The total lean mass (Z-score = -3.2, p = 0.001) and trunk lean mass (Z-score = -2.01, p = 0.03) of the female patients were lower than those of the controls at baseline, whereas their limb lean mass was higher at both the beginning and the end of the study (Z-score = 2.14, p = 0.03; Z-score = 2.8, p = 0.004, respectively). At baseline there was a significant negative correlation between lifetime steroid intake (enteral and parenteral) and lumbar spine BMD, obtained as whole body subregion (r = -0.53, p = 0.0006). After 6 years there was a significant negative correlation in women between whole body and lumbar spine BMD and both steroid intake (r = -0.53, p = 0.01; and r = -0.62, p = 0.003) and the number of relapses (r = -0.49, p = 0.02; and r = -0.44, p = 0.05). Mild UC thus does not represent a risk factor for osteopenia per se. The differences in lean mass between the female patients and controls do not seem to be clinically relevant.

In a previous report we published the immediate results of a 3-month placebo-controlled trial (n = 34) showing that cyclosporin (n = 37) has a beneficial therapeutic effect in active chronic Crohn's disease. Here we report on the final outcome of the patients. During the 3-month tapering-off period eight initially improved patients (36%) in the cyclosporin group worsened, as did six (55%) in the placebo group. The therapeutic gain of cyclosporin treatment was consistently significant during this period. It ranged from 22% to 25% (95% confidence limits, 2-46%). An outcome ranking showed that 7 patients of the cyclosporin group (19%) were substantially improved, 7 (19%) moderately improved, and 23 (62%) not improved after the tapering off. In contrast, no significant differences were seen during the 6-month follow-up period. Four patients of the cyclosporin group (11%) were substantially improved, 3 (8%) moderately improved, and 30 (81%) not improved at final follow-up. Significant interactions between cyclosporin and prednisolone treatment were demonstrated both at the end of the initial treatment period and at the end of the tapering-off period. We conclude that a short course of cyclosporin treatment does not result in long-term improvement in active chronic Crohn's disease.