Randomised clinical trial: mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease--a double-blind, randomised, placebo-controlled study.

BACKGROUND: Placebo-controlled studies in maintaining remission of symptomatic uncomplicated diverticular disease (SUDD) of the colon are lacking. AIM: To assess the effectiveness of mesalazine and/or probiotics in maintaining remission in SUDD. METHODS: A multicentre, double-blind, placebo-controlled study was conducted. Two hundred and ten patients were randomly enrolled in a double-blind fashion in four groups: Group M (active mesalazine 1.6 g/day plus Lactobacillus casei subsp. DG placebo), Group L (active Lactobacillus casei subsp. DG 24 billion/day plus mesalazine placebo), Group LM (active Lactobacillus casei subsp. DG 24 billion/day plus active mesalazine), Group P (Lactobacillus casei subsp. DG placebo plus mesalazine placebo). Patients received treatment for 10 days/month for 12 months. Recurrence of SUDD was defined as the reappearance of abdominal pain during follow-up, scored as ≥5 (0: best; 10: worst) for at least 24 consecutive hours. RESULTS: Recurrence of SUDD occurred in no (0%) patient in group LM, in 7 (13.7%) patients in group M, in 8 (14.5%) patients in group L and in 23 (46.0%) patients in group P (LM group vs. M group, P = 0.015; LM group vs. L group, P = 0.011; LM group vs. P group, P = 0.000; M group vs. P group, P = 0.000; L group vs. P group, P = 0.000). Acute diverticulitis occurred in six group P cases and in one group L case (P = 0.003). CONCLUSION: Both cyclic mesalazine and Lactobacillus casei subsp. DG treatments, particularly when given in combination, appear to be better than placebo for maintaining remission of symptomatic uncomplicated diverticular disease. (ClinicalTrials.gov: NCT01534754).

[Pharmacokinetics of the biliary excretion of some chemotherapeutic agents in patients with biliary disease]. / Farmacocinetica dell'escrezione biliare di alcuni chemioterapici in pazienti con patologia biliare.

The authors have assessed the concentration of 7 antibiotics in the bile of patients undergoing biliary surgery or carriers of a T tube in the common bile duct. 1 hour preoperatively, 122 patients were administered with the following chemotherapeutic agents: Cefoxitin 2 g i.v.; Cefamandole 2 g i.v.; Ceftriaxone 1 g i.v.; Clindamycin 600 mg i.v.; Amikacin 500 mg i.v.; Gentamycin 160 mg i.v.; Norfloxacin 400 mg by mouth; 30 patients showed obstructive jaundice or obstructed cystic duct. Samples of bile were withdrawn from gallbladder and common bile duct. The same antibiotics were administered to 81 patients carrying a T tube. Samples of bile and serum were collected at baseline and every 30 minutes for 4 hours and subsequently at 12 and 24 hours following administration. 18 patients showed altered liver function tests. The chemotherapeutic agents were tested by the microbiological assay as well as by HPLC. Mean concentration in the gallbladder bile was: Cefoxitin 209 +/- 86 micrograms/ml; Cefamandole 436 +/- 108 micrograms/ml; Ceftriaxone 482.7 +/- 214.84 micrograms/ml; Clindamycin 64 +/- 22 micrograms/ml; Amikacin 5 +/- 1.4 micrograms/ml; Gentamycin 4 +/- 2 micrograms/ml; Norfloxacin 22 +/- 14 micrograms/ml. In the bile of jaundiced patients or with non-visualized gallbladder no antibiotics were detected.(ABSTRACT TRUNCATED AT 250 WORDS)