A new mesalazine gel enema in the treatment of left-sided ulcerative colitis: a randomized controlled multicentre trial.

BACKGROUND: A new mesalazine rectal gel preparation (without propellant gas) has been recently developed to improve topical treatment in distal ulcerative colitis. AIM: To evaluate the efficacy, safety and patient tolerability of mesalazine gel enema compared with mesalazine foam enema in the treatment of patients with acute left-sided ulcerative colitis. METHODS: In a randomized multicentre investigator-blind parallel group trial, 103 patients with mild to moderate left-sided colitis or proctosigmoiditis were randomly allocated to mesalazine 2 g gel enema (n = 50 evaluable patients) and mesalazine 2 g foam enema (n = 53 evaluable patients) for 4 weeks. Clinical symptoms, endoscopic and histological findings were assessed at entry, 2 and 4 weeks. Patients' evaluation of treatment tolerability and acceptability was assessed at 2 and 4 weeks. RESULTS: After 4 weeks of treatment, clinical remission was achieved by 76% of mesalazine gel enema-treated patients and 69% of patients treated with mesalazine foam enema (P = 0.608). Endoscopic remission rates at week 4 were 51 and 52% for the mesalazine gel and foam enemas, respectively (P = 0.925). Histological remission was achieved by 30% of patients in both groups. Patients reported that the new mesalazine gel preparation was significantly better tolerated than the foam enema. Patients in the foam group had significantly more difficulty in retention (25% vs. 6%, P < 0.05), abdominal bloating (50% vs. 26%, P < 0.005) and discomfort during administration (48% vs. 26%, P < 0.05). CONCLUSION: The new mesalazine gel enema is efficacious and significantly better tolerated than the mesalazine foam enema.

Strategy for the retreatment of failed Helicobacter pylori eradication therapy: a case series.

BACKGROUND: Helicobacter pylori eradication therapy can be unsuccessful in 5 to 20% of patients. AIM: To investigate the validity of a strategy using triple therapies for the retreatment of patients with eradication failure, avoiding retreatment with antibiotics prone to induce resistance after use in the first treatment. PATIENTS AND METHODS: From a consecutive sampling of 108 patients still Helicobacter pylori-positive after a first course of antibiotic-based treatment, 74 (68.5%) agreed to a second course of triple therapy. Group 1 (N = 17): treatment failures on an imidazole (1)-based therapy were retreated with clarithromycin (C)-based regimen; Group 2 (N = 28): failures on a C-based therapy with an I-based regimen; Group 3 (N = 7): failures on an IC-based therapy using an I-based regimen and Group 4 (N = 22): failures on a non-I/non-C based therapy with either an I-based, C-based or IC-based regimen. The presence of Helicobacter pylori was assessed by histology and the CLO-test at study entry and two months after stopping therapy. RESULTS: Nine patients were withdrawn from the study (12.2%) due to a lack of end point endoscopy. Helicobacter pylori was cured after the second course of therapy in all but seven patients [10.7% failure by Per Protocol analysis, 21.6% by Intention-To-Treat analysis]. No statistically significant differences were found between the four groups (Group 1: 92.9% PP, 76.5% ITT; Group 2: 90.9% PP, 71.4% ITT; Group 3: PP and ITT 85.7%; Group 4: PP and ITT 86.4%). Minor adverse events were experienced in nine, none of whom required withdrawal from the drug therapy. CONCLUSIONS: A second course of triple therapy with alternate antibiotics effectively eradicated Helicobacter pylori, with only very few treatment failures. This suggests that the therapeutic strategy employed may be recommended.

Optimal PPI-based triple therapy for the cure of Helicobacter pylori infection: a single center comparison of four 14-day schedules.

BACKGROUND: Helicobacter pylori eradication is accomplished using a wide array of drugs combined in a multitude of dosage schedules. The aim of the present study was to define the best 14-day eradication schedule using a PPI plus either two antibiotics or one antibiotic and bismuth. MATERIAL AND METHODS: For this study, 367 subjects (198 males, 169 females, age 22-87 years) with document H. pylori infection of the stomach were recruited from out-patients of the Gastroenterology Department of the Venezia Hospital. In all patients, H. pylori infection was identified by histology and the CLO-test. Patients were treated as follows: 1) PPI (P) plus clarithromycin (C) 250 mg plus amoxicillin (A) 1000 mg bid (P + C + A); 2) P plus C plus bismuth subcitrate (B) 120 mg qid (P + C + B); 3) P plus C plus tinidazole (T) 500 mg bid (P + C + T); and 4) P plus A plus T bid (P + A + T). After two months, an upper gastrointestinal endoscopy was repeated for end point histological evaluation and the CLO- test. Positivity of one of the two methods was considered sufficient to define H. pylori as "not eradicated". STATISTICS: Chi-squared test and Fisher exact test. RESULTS: Thirty-three subjects dropped out (six due to adverse events). P + C + B was proven significantly less effective than P + C + A, P + C + T and P + A + T, eradication rates being, respectively, 75.0%, 90.5%, 87.6%, 92.0%, (p = .005, per protocol analysis). CONCLUSIONS: All PPI-based triple therapies tested in this study were effective in curing H. pylori infection; however, P + C + B resulted in rates too low (< 85%) to be recommended. P + C + A and P + A + T resulted in the high cure rates and thus may be considered the treatment of choice.

Helicobacter pylori infection, cigarette smoking and alcohol consumption. A histological and clinical study on 286 subjects.

UNLABELLED: Helicobacter pylori (Hp) is connected with active/chronic gastritis, gastric gastric and duodenal ulcer. It is not known whether exogenous factors are involved in Hp infection. The aim of this prospective study, performed on 286 consecutive subjects undergoing upper gastrointestinal endoscopy, was to evaluate the influence of smoking and alcohol consumption on Hp infection. For each patient the following parameters were taken into account: sex, age, smoking (no, < 10, > 10 cig/day) and alcohol (no, < 40, > 40 g ethanol/day) intake, antiulcer therapy (no, H2-blockers, omeprazole, sucralfate), presence of gastric or duodenal ulcer (DU). At least two biopsies from both the antrum and the corpus were obtained for histological examination; the gastritis was classified and scored according to the Sydney system. STATISTICS: chi-squared test (corrected), Fisher's exact test. RESULTS: 43 pts had Hp (27M, 16F; age 57.8 yrs, range 23-91), 47 Hp ++ (25M, 22F; age 61.1, range 19-86), 81 Hp + (48H, 33F; age 56, range 16-84), 115 Hp- (75M, 40F; age 57.8, range 19-84). Hp infection was found to be significantly correlated with presence of ulcer symptoms, gastritis, lymphoid follicles and, among DU patients, with active DU. The other parameters considered did not influence Hp infection. In conclusion smoking habits and alcohol consumption do not affect Hp infection of the stomach.

[L-carnitine chloride and potassium chloride in the treatment of a case of non-traumatic rhabdomyolysis without myoglobinuria caused by the ingestion of liquorice]. / L. carnetina cloruro e KCl nel trattamento di un caso di rabdomiolisi atraumatica senza mioglobinuria da ingestione di liquerizia.

The case is described of a 56 year old patient admitted to hospital with rhabdomyolysis without myoglobinuria and caused by hypokalaemia following the ingestion of liquorice. The patient was treated with L. Carnitine chloride and KCl.