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BACKGROUND AND AIMS: The use of steroids was recently extended to the various forms of ulcerative rectocolitis by the introduction of topical formulations, above all steroids with an hepatic "first pass" devoid of systemic interference. The aim of this study was to evaluate the efficacy and tolerability of Beclomethasone dipropionate (BDP) in a rectal foam formulation, in the treatment of patients suffering from ulcerative colitis. METHODS: The experimental protocol took the form of a 28-day open prospective trial using BDP rectal foam in patients suffering from ulcerative colitis. Endoscopic, histological, clinical and tolerability parameters were evaluated. The centres taking part in the trial collected data for 60 cases out of a total of 80 patients enrolled in the study, of both sexes and aged between 20 and 81 years old, suffering from proctosigmoiditis (46.7%) and ulcerative rectocolitis (53.3%). RESULTS: Endoscopic parameters showed an improvement after 28 days of treatment in 74.5% of patients; a clinical improvement was achieved in 65.2% of cases. In percentage terms of the mean value of all the improved parameters, histological parameters were altered in 56.9% of patients. With regard to tolerability 82% of patients judged the treatment to be good/excellent. CONCLUSIONS: In conclusion, in line with recent reports regarding other pharmaceutical forms of BDP, including the use of rectal foam, these data confirm the efficacy and tolerability of this molecule and emphasise the validity of its use in the treatment of ulcerative colitis and proctosigmoiditis.

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The authors assessed the efficacy and tolerability of BDP in an open protocol using rectal enemas and suppositories and in a double-blind protocol vs mesalazine using rectal enemas. A total of 47 patients suffering from ulcerous rectocolitis were enrolled in the study and treated for 42 days while undergoing endoscopic, histologic and clinical controls. In conclusion, the authors affirm that BDP may represent a useful new therapeutic instrument in the treatment of slight to moderately severe forms of inflammatory intestinal disease.

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Patient age (over 65), and lithiasis of the common bile duct are two factors which increase the morbidity and mortality rate in emergency surgery for biliary lithiasis. Normally, calculi in the CBD can be cleared by means of supraduodenal or transduodenal access. In both cases, however, complications are frequent in high risk patients. Treatment of gallstones can be modified to achieve a reduction in the morbidity and mortality rate. This study presents an initial survey of 4 elderly patients, presenting with acute gallbladder disease and CBD stones, treated with surgical cholecystectomy and contemporary perioperative endoscopic papillotomy and CBD clearance. The underlying rationale and the good initial results support this combined surgical and endoscopic approach.

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A prospective, single-blind study was carried out in 30 patients with obstructive peripheral artery disease to investigate the haemorheological properties of fructose-1,6-diphosphate (FDP). Patients were allocated at random to receive 7 to 10-days' treatment with either 10 g or 10% FDP twice daily or saline. Measurements were made on entry and at the end of treatment of whole blood and plasma viscosity, erythrocyte deformability and aggregation, and lower limb blood flow was evaluated by Doppler technique. FDP treatment was associated with a reduction in whole blood viscosity (24%) and red blood cell aggregation index (27%), and an improvement in red blood cell deformability (42%) (p less than 0.01). No significant changes were observed in the control group. Plasma viscosity did not change in either treatment group. Limb blood flow increased (p less than 0.05) only in patients treated with FDP; the improvement was more pronounced in the most severely affected side (30%). No untoward events were observed or reported in any of the patients studied.

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Sixty out-patients with acute or sub-acute irritable colon were randomly allocated to receive a single intravenous dose of 50 mg tiropramide, 50 mg trimebutine maleate or 10 mg octilonium bromide. Before and after injection, multiple colonic manometry was performed, monitoring tonus, intensity and frequency of sinusoid contraction waves, transitories and vibrations, as well as the voluntary contraction capacity. Significant variations in tonus were not observed with any drug, but, while tiropramide left unmodified the voluntary contractile ability, a significant inhibition was observed with trimebutine and octilonium. The overall power of spontaneous colonic contractions did not vary significantly with tiropramide, whereas some decrease was observed with trimebutine, and a substantial one with octilonium. Moreover, while with tiropramide and, to a lesser extent, with trimebutine there was a significant redistribution of muscular power so as to increase phasic propulsion waves and to decrease the ineffective transitory and vibrational contractions, with octilonium only a decreased wave amplitude was recorded without alteration of the frequency of transient spasms. Based on these observations, tiropramide was evaluated as being at least as effective an antispasmodic as octilonium and at least as effective a synchronizer as trimebutine, while setting itself aside from both reference drugs as it was the only one to act contemporarily as both an antispasmodic and a synchronizer.

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The following trials were carried out to evaluate the antispasmodic effect of sintropium bromide in a group of 30 patients. The antispasmodic effect on the gastroduodenal system was observed endoscopically. The results were compared by means of double blind tests carried out using placebo and rociverine. The effect in a group of 10 patients was examined by X-ray of the digestive tract. The effect on another group of 20 patients suffering from abdominal colic was clinically evaluated. Sintropium bromide has a prompt anticholinergic action and for this reason may be used in the treatment of painful conditions of the bile, gastro-enteric and renal tracts, and also during the course of endoscopic examinations.

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A double-blind, placebo-controlled study was carried out in 40 out-patients with endoscopically confirmed hypertrophic or erosive gastritis, without ulcer, to assess the effectiveness and tolerance of treatment with equine antisera (antidiencephalon and anti-stomach tissue). Patients were assigned at random to receive a single dose in suppository form on 2 days a week for 6 weeks of both antisera (anti-diencephalon on Days 1 and 4, anti-stomach tissue on Days 2 and 5) or placebo (saline solution). No other anti-ulcer treatment was allowed except standard antacid tablets, the consumption of which was recorded and used as an evaluation parameter. Endoscopy, haematology and haematochemistry were performed before and after treatment; symptoms (daytime and night-time pain, heartburn and dyspepsia) and possible adverse reactions were scored 0 to 4 in order of increasing severity before treatment and after 1, 2, 4 and 6 weeks. Five patients in the placebo group had to be withdrawn from the trial at the second week because of therapeutic failure. This proportion was significantly in favour of the antisera group, as was the proportion of patients endoscopically healed and the extent and rate of symptomatic improvement. Concomitant antacid consumption rapidly and significantly decreased in the antisera but not in the placebo group. Signs of intolerance were not observed with either treatment, nor were there any significant alterations in haematology or haematochemistry. In particular, the immune titre of patients did not increase after treatment, thus indicating that the administered heterologous proteins did not elicit an immunization of the patients against horse protein.(ABSTRACT TRUNCATED AT 250 WORDS)

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Thirty-nine adult out-patients with dyspepsia and endoscopically proven gastritis and/or duodenitis without ulcer, completed a double-blind, placebo controlled, 8-week clinical trial of either Acidrine (twenty-one patients) or placebo (eighteen patients), at a daily dosage of 2 tablets t.i.d. Treatment with Acidrine resulted in a significant improvement in symptoms and in the endoscopic appearance of the gastritis and duodenitis when compared with placebo.

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The effectiveness of pirenzepine in the prevention of duodenal ulcer relapses was assessed by means of a double-blind controlled trial versus cimetidine. Seventy duodenal ulcer out-patients endoscopically healed after a 6-week treatment with either pirenzepine or cimetidine were admitted to the trial. The former pirenzepine patients were treated again with pirenzepine: 1 tablet at breakfast and 2 tablets at bedtime (75 mg daily). The former cimetidine patients were treated again with cimetidine: 2 tablets at bedtime (400 mg daily). They received one placebo tablet at breakfast. Both treatments lasted 12 months. Tablets of a mild antacid were permitted only if necessary to relieve severe ulcer pain and heartburn. Patients underwent clinical and endoscopic assessments after 4, 8 and 12 months of treatment and whenever ulcer symptoms lasted more than 4-5 consecutive days. Only 47 out of the 70 patients that entered the trial underwent all clinical and endoscopic controls. Sixteen out of 23 patients on pirenzepine (70%) and 17 out of 24 patients on cimetidine (71%) did not relapse after 12 months. The difference is not statistically significant. Both treatments were well tolerated. The results show that pirenzepine was as effective as cimetidine in the prevention of duodenal ulcer relapses when administered at a dosage of 75 mg daily (of which 50 mg at bedtime) for one year.

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A double-blind trial was carried out in 30 patients with peptic ulcers to assess the effects of treatment with a gastrin-receptor antagonist, proglumide, compared with a histamine H2-blocker, cimetidine. Patients received either 1200 mg proglumide or 1200 mg cimetidine per day for 28 days. The results showed that both drugs significantly reduced clinical symptoms and gastric secretion. In patients treated with cimetidine there was a significant increase in blood gastrin levels and marked hypertrophy and hyperplasia of the antral mucosa was observed in almost all patients. No such changes were found in the patients treated with proglumide.

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