Meta-analysis: long-term therapy with rifaximin in the management of uncomplicated diverticular disease.

BACKGROUND: Diverticular disease of the colon is a common gastrointestinal disease. Although most patients remain asymptomatic for their whole life, about 20-25% present symptoms related to 'diverticular disease'. Several randomised trials verified efficacy of a poorly absorbed antibiotic, such as rifaximin-α (rifaximin), in soothing symptoms and preventing diverticulitis. AIM: To evaluate the long-term efficacy administration of rifaximin plus fibre supplementation vs. fibre supplementation alone, on symptoms and complications, in patient with symptomatic uncomplicated diverticular disease. METHODS: Pertinent studies were selected from the Medline, and the Cochrane Library Databases, references from published articles and reviews. Conventional meta-analysis according to DerSimonian and Laird method was used for the pooling of the results. The outcomes were 1- year complete symptom relief, and 1- year complication incidence. The rate difference (RD, with 95% CI) and the Number Needed to Treat (NNT) were used as measure of the therapeutic effect on each outcome. RESULTS: Four prospective randomised trials including 1660 patients were selected. The pooled RD for symptom relief was 29.0% (rifaximin vs. control; 95% CI 24.5-33.6%; P<0.0001; NNT=3). The pooled RD for complication rate was -1.7% in favour of rifaximin (95% CI -3.2 to -0.1%; P=0.03; NNT=59). When considering only acute diverticulitis, the pooled RD in the treatment group was -2% (95% CI -3.4 to -0.6%; P=0.0057; NNT=50). CONCLUSIONS: In symptomatic uncomplicated diverticular disease, treatment with rifaximin plus fibre supplementation is effective in obtaining symptom relief and preventing complications at 1 year.

Seasonal variations in onset of symptoms in Crohn's disease.

BACKGROUND: Seasonal variations in onset of symptoms have been reported in ulcerative colitis but not in Crohn's disease. AIM.: To investigate whether our inflammatory bowel diseases patients presented seasonal variations in onset of symptoms. PATIENTS AND METHODS: Patients with a diagnosis of inflammatory bowel diseases established between 1995 and May 2004, and consecutively observed from June 2003 to May 2004, were included in the study. Onset of symptoms (year, season and month) was recorded. Expected onsets with a uniform distribution during the year were calculated and compared to observed onsets. STATISTICAL ANALYSIS: chi-square test, odds ratio (95% confidence interval). RESULTS: Overall 425 inflammatory bowel diseases patients were enrolled. Onset of symptoms (year and season) was established in 353/425 patients (83%; 150 Crohn's disease; 203 ulcerative colitis). Onset of symptoms in inflammatory bowel diseases patients as a whole occurred more frequently in spring-summer compared to autumn-winter (odds ratio 1.39; 95% confidence interval 1.03-1.87; p<0.03). This variation was observed in Crohn's disease (odds ratio 1.59; 95% confidence interval 1.00-2.51; p<0.05) and a similar trend, although not significant, was observed in ulcerative colitis (odds ratio 1.27; 95% confidence interval 0.86-1.88; p=0.27). CONCLUSIONS: These data indicate that onset of Crohn's disease symptoms occurred more frequently during spring-summer. A similar trend was observed in ulcerative colitis. Environmental factors, such as associated infections, smoking, use of drugs and seasonal changes in immune function may be responsible for triggering the clinical onset of inflammatory bowel diseases.

Acute ischaemic colitis following intravenous cocaine use.

Intestinal ischaemia is an uncommon complication of recreational cocaine abuse. We report the case of a 36-year-old male who underwent emergency surgery for acute abdomen. At laparotomy, the transverse colon appeared markedly oedematous, dilated and with subserosal haemorrhage. Segmental resection was performed and microscopic examination of the resected specimen showed focal necrosis of the mucosa with a patchy polymorphonuclear and mononuclear infiltrate. The submucosa was markedly thickened due to oedema; focal haemorrhage was observed and blood vessels were dilated but showed no structural abnormalities or thrombosis. These findings were consistent with ischaemic colitis. No risk factors for intestinal ischaemia were present but the patient stated that he had injected cocaine i.v. the day before the onset of symptoms. He was not a cocaine abuser but occasionally sniffed, smoked or injected cocaine. Cocaine use should be considered in the aetiological diagnosis of intestinal ischaemia in young patients.

Correlation of various Crohn's disease activity indexes in subgroups of patients with primarily inflammatory or fibrostenosing clinical characteristics.

Several activity indexes, including clinical variables, laboratory variables or both, have been proposed to assess the activity and severity of Crohn's disease (CD). Although activity indexes are commonly used in clinical trials, doubts exist as to whether it is correct to group together and quantify under the same numerical expression the very heterogeneous clinical manifestations of CD. The aim of our study was to try to establish a correlation between clinical and laboratory activity indexes of CD in subgroups of patients with primarily inflammatory or primarily fibrostenosing clinical characteristics. At least two activity indexes were calculated among 232 outpatient examinations in 61 CD patients. Indexes were classified as clinical, laboratory, or both. A close correlation was observed when indexes calculated on clinical variables were compared or when those that include only or prevalently laboratory parameters were compared. Conversely, the correlation between clinical and laboratory indexes tended to be poor. Taking into consideration the subgroups of patients, the correlation between clinical and laboratory indexes was high in primarily inflammatory disease but low in the primarily fibrostenosing form. The clinical activity of CD does not always reflect the quantity of inflammation measured by laboratory parameters. This is particularly true in primarily fibrostenosing disease. Different clinical patterns of CD should always be considered in the attempt to quantify with an activity index the activity and severity of disease.

Severe ulcerative colitis, dural sinus thrombosis, and the lupus anticoagulant.

Thromboembolic disease is a well-recognized but very uncommon complication of inflammatory bowel disease. The mechanisms of the increased risk of thrombosis are not well understood: although several coagulation abnormalities have been described in inflammatory bowel disease patients, it is not clear whether they actually contribute to hypercoagulation or whether they are nonspecific markers of inflammation. Antiphospholipid antibodies (anticardiolipin antibodies and/or lupus anticoagulant) have recently been associated with an increased risk of thrombosis, particularly cerebrovascular disease in young patients. We report the case of a 33-yr-old female with severe ulcerative colitis at first attack who developed thrombosis of the superior and inferior longitudinal dural sinuses. No risk factors for thrombosis or coagulation abnormalities were observed; however, lupus anticoagulant was detected in the serum. The patient was successfully treated with osmotic agents, prophylactic anticonvulsant, and antiplatelet therapy, combined with i.v. steroids. After 6 months, the colitis is in remission, and the neurological recovery is good even if not yet complete.

Efficacy of rifaximin in the treatment of symptomatic diverticular disease of the colon. A multicentre double-blind placebo-controlled trial.

BACKGROUND AND AIMS: In a recent open trial we have shown the efficacy of long term intermittent administration of a poorly absorbable antibiotic (rifaximin) in obtaining symptomatic relief in uncomplicated diverticular disease of the colon. The aim of this double-blind placebo-controlled trial was to test our previous observations. METHODS: One hundred and sixty-eight outpatients with symptomatic uncomplicated diverticular disease were treated with fibre supplementation (glucomannan 2 g/day) plus rifaximin 400 mg b.d. for 7 days every month (84 patients), or with glucomannan 2 g/day plus placebo two tablets b.d. for 7 days every month (84 patients). Clinical evaluation was performed at admission and at three-month intervals for 12 months. RESULTS: After 12 months, 68.9% of the patients treated with rifaximin were symptom-free or mildly symptomatic, compared to 39.5% in the placebo group (P = 0.001). Symptoms such as bloating and abdominal pain or discomfort were primarily affected by antibiotic treatment when compared with placebo (P < 0.001). CONCLUSION: Rifaximin appears to be of some advantage in obtaining symptomatic relief in diverticular disease of the colon when compared with fibre supplementation alone.

Efficacy of rifaximin on symptoms of uncomplicated diverticular disease of the colon. A pilot multicentre open trial. Diverticular Disease Study Group.

Diverticular disease of the colon is a common health problem in western societies. Most patients with colonic diverticula are asymptomatic; it has been estimated that only 20% of individuals harboring diverticula will develop symptoms and signs of illness and a minority will develop major complications. Although the efficacy of a high fiber diet in the management of symptomatic uncomplicated diverticular disease is still controversial, bran and bulking agents are commonly used. Antibiotics are used to treat major inflammatory complications of diverticular disease but apparently there is no rationale for the use of antibiotics in uncomplicated disease where an inflammatory component is by definition excluded. In a multicenter open trial, 217 patients with symptomatic uncomplicated diverticular disease were treated with glucomannan (110 pts) or with glucomannan plus a poorly absorbable antibiotic (rifaximin 400 mg bid for 7 days each month) (107 pts). Clinical evaluation was performed bimonthly for 12 months using a global score system for 8 clinical variables. After 12 months, patients treated with glucomannan plus rifaximin showed a 63.9% reduction of the score as compared to 47.6% in patients treated with glucomannan only (p < 0.001). Cyclic administration of rifaximin appears to be of some advantage in obtaining symptomatic relief in uncomplicated diverticular disease.

[Sulglycotide combined with H2-antagonists in the prevention of duodenal ulcer recurrence. Multicenter study]. / Sulglicotide in associazione agli H2-antagonisti nella prevenzione della recidiva ulcerosa duodenale. Studio multicentrico.

The aim of the present study was to evaluate the role of sulglycotide, a molecule with gastroprotective properties, in monotherapy and in association with H2-antagonists in the maintenance treatment of duodenal ulcer. The study was performed using a fully randomized experimental design. Following endoscopic confirmation, 626 patients with healed duodenal ulcer were treated for 6 months with sulglycotide 200 mg tid (293 patients) or sulglycotide + H2-antagonists (333 patients). After 2, 4 and 6 months patients underwent a clinical control whereas an endoscopic control was performed after 6 months. The cumulative percentage of recidivation was 3.6% in the sulglycotide + H2-antagonist treated group, whereas the group treated with sulglycotide alone showed a recidivation rate of 15.4% (p < 0.001). These findings suggest the utility of combined sulglycotide and H2-antagonist treatment in the maintenance therapy for duodenal ulcer.

Usefulness of fecal alpha 1-antitrypsin clearance and fecal concentration as early indicator of postoperative asymptomatic recurrence in Crohn's disease.

The aim of this study was to evaluate in Crohn's disease the possible usefulness of alpha 1-antitrypsin clearance and fecal concentration in the early detection of postoperative asymptomatic recurrence. Eleven adult patients with small bowel Crohn's disease undergoing elective resection were enrolled in the study and prospectively followed for one year. Three, six, and 12 months after surgery the alpha 1-antitrypsin clearance and fecal concentration were measured, and the disease activity was assessed. All patients were free of active symptoms throughout the study. One year after surgery small bowel radiology was performed in all patients. Radiographic evidence of recurrent macroscopic disease was found in five of the 11 patients. Three months after surgery both alpha 1-antitrypsin clearance and fecal concentration were significantly lower (P less than 0.01) than before surgery. There was no difference at this time between patients with recurrence and those with no recurrence. In patients with recurrence both alpha 1-antitrypsin clearance and fecal concentration significantly increased at six months in comparison with the values at three months (P less than 0.02). Both measurements were significantly higher at six and 12 months in this group of patients than in those with no recurrence and in normal controls (P less than 0.01). At six and 12 months alpha 1-antitrypsin clearance was above the upper normal limit in all patients with recurrence. We conclude that fecal alpha 1-antitrypsin clearance is a noninvasive, inexpensive, sensitive marker of asymptomatic recurrence in CD patients who are under regular supervision after surgery.