Efficacy of mesalazine or beclomethasone dipropionate enema or their combination in patients with distal active ulcerative colitis.

OBJECTIVE: Mesalazine or Beclomethasone dipropionate (BDP) enema have been shown effective in treatment of distal active ulcerative colitis (UC). This study was aimed to determine whether the combination of topical mesalazine and BDP is superior to topical mesalazine or BDP used alone in patients with distal active UC. PATIENTS AND METHODS: One-hundred and twenty patients with clinical, endoscopic and histological diagnosis of distal active UC were randomly assigned to a regimen with mesalazine tablets 2.4 g/day associated to either mesalazine enema 4 g/day (group A, n=40), BDP 3 mg/60 ml every day (group B, n=40) or the combination treatment with the two compounds in a single administration (group C, n=40) for eight weeks. After four weeks of treatment all patients underwent clinical controls but only 109 patients returned back for clinical, endoscopic and histological controls at the end of the treatment period. RESULTS: After eight weeks, complete remission rates were of 52%, 47% and 65% respectively, in group A, B and C. From baseline to 4 and 8 weeks the CAI score decreased significantly in all the three groups (p < 0.0001). CONCLUSIONS: All the three combinations achieved equivalent results in terms of symptoms in inducing symptoms relief and mucosa healing in distally active UC.

Efficacy and safety of endoscopic retrograde cholangiopancreatography (ERCP) performed in patients with Periampullary duodenal diverticula (PAD).

BACKGROUND AND AIM: Periampullary diverticula (PAD) are found in 9-32% of patients who undergo endoscopic retrograde cholangiopancreatography (ERCP). PAD are acquired lesions which are rare in patients <40 years, but increasing with age. Several endoscopic studies have revealed an association between PAD and common bile duct (CBD) stones. The presence of a papilla located in the diverticula is also frequent (6.8-54.9%) and represents a restrictive factor for successful cannulation. MATERIALS AND METHODS: A retrospective analysis has been made of data related to the patients with PAD treated at our GI Unit (small center with low case volume), who underwent ERCP in the period 1st January 2010 to 31st March 2014. For each patient were analyzed data regarding sex, age at diagnosis, indication to ERCP, cannulation rate, endoscopic treatment and complications. PAD were classified in 3 different types according to the position of the major papilla. RESULTS: A total of 647 ERCPs have been performed of which 77 (16.5%) in pts with PAD (48 F, 29 M, mean age: 78.3 years; range: 48-95). PAD type I (inside the diverticulum) were found in 22 pts (28.6 %), Type II (in the margin of the diverticulum or between two PADs) in 36 pts (46.7 %) of which 12 cases between two PADs, type III (near the diverticulm) in 19 pts (24.7 %). The indication for ERCP were: 72 CBD stones (93.5%), 3 cholangiocarcinoma (3.9%) and 2 pancreatic head cancer (2.6%). In cases of difficult cannulation, precut was performed in 12 pts (15.6%). Deep CBD cannulation and endoscopic sphincterotomy (ES) was achieved in 70 cases (90.9%). The other 7 case of failure were all in patients with CBD stones. Complete clearance of CBD stones was achieved in 57 patients (87.7%) (57/65 ERCP/ES). Stent placement was necessary in 8 cases (12.3%) (8/65 ERCP/ES), due to multiple large stones. The adverse events related to ERCP/ES included 4 intraprocedural bleeding (5.7%) (4/70 ERCP/ES) and 1 mild pancreatitis (1.4%) (1/70 ERCP/ES), all managed conservatively. CONCLUSIONS: Our data show that ERCP is a safe procedure also in patients with PAD, with a good success rate and low complications.

Large symptomatic simple hepatic cyst with gastric compression treated with percutaneous drainage.

Nonparasitic hepatic cysts consist of a heterogeneous group of disorders, which differ in etiology, prevalence, and manifestations. Simple hepatic cysts are considered nonparasitic ones. These are a result of congenital anomalies of the biliary system, and these may be single or multiple. Generally, hepatic cysts are incidentally found during occasional laparotomy or laparoscopy, necropsy, and even during routine ultrasound or computerized tomography (CT) scan. Nowadays, with improving diagnostic techniques, hepatic cysts are becoming more common. Generally these lesions are asymptomatic. However, if they grow, they may become symptomatic. Symptoms depend on the size and location. When symptoms developed, these must be treated. Compressive complications due to local "liver mass" effect include: portal hypertension, edema due to caval compression, jaundice and arrhythmia and duodenal obstruction. Gastric extrinsic compression by liver cysts has been poorly described. Herein, we present a case of a female in whom percutaneous drainage of a large simple hepatic cysts not complicated was performed in order to reduce signs of gastric compression.

Patient with chest pain refractory to proton pump inhibitor: report of a case of eosinophilic esophagitis.

Eosinophilic esophagitis (EoE) is the most common form of gastrointestinal disorders associated with eosinophilia. Typically, an inappropriate accumulation of eosinophils is found in the esophageal mucosa. EoE can be well managed and treated with several options that include an elimination diet, drug therapy (oral and topical steroids) and esophageal dilatations. We herein, report a case of a 49-year-old male affected by EoE associated to chest pain, treated with proton pump inhibitor without clinical response. The patient suffered from long lasting postprandial fullness and gastroesophageal reflux disease-like symptoms. He had a history of episodic asthmatic attacks and allergic rhinitis but had not dysphagia or food impaction. The patient recovered completely after an adequate treatment.

Quality of life in ulcerative colitis patients treated medically versus patients undergoing surgery.

OBJECTIVES: Approximately one third of patients with ulcerative colitis (UC) require surgery. AIM: Aim of this study was to assess the quality of life (QoL) of UC patients who have undergone surgery with ileorectal anastomosis (IRA) or ileal pouch-anal anastomosis (IPAA) compared to UC patients not operated. PATIENTS AND METHODS: Fifty consecutive UC patients for each group observed between 1988-2010 were included. To all patients was administered a self completed questionnaire with four different scores: intestinal symptoms (IS), systemic symptoms (SS), emotional function (EF), social function (SF) and an overall QoL score. RESULTS: Overall QoL score and three dimensions (SS, EF, SF) resulted not significantly different in the three groups, except for IS that resulted worst in the IRA-Group. According to the activity of disease it appeared that UC and IRA patients with mild activity had an overall QoL score similar to patients with complicated IPAA. A higher statistically different score of overall QoL was observed in patients with UC and IRA with moderate/severe disease. CONCLUSIONS: Results of the study demonstrate that overall QoL score is poorer in patients with UC and IRA with mild activity and in patients with complicated IPAA and is worst in patients with UC and IRA with moderate/severe activity.

Azathioprine treatment in inflammatory bowel disease patients: type and time of onset of side effects.

BACKGROUND: Azathioprine (AZA) and 6-mercaptopurine (6-MP), purine analogues, are the immunosuppressant drugs most frequently used for inducing and maintaining remission in inflammatory bowel disease (IBD). The occurrence of adverse effects is a major drawback in the use of these drugs, and short- and long-term toxicity represent a major limitation to their use. AIM: The present study investigated the prevalence, type and time of onset of AZA-related adverse events, in a cohort of IBD patients in a single referral Centre. PATIENTS AND METHODS: The records of consecutive IBD outpatients, referred to our Institution between 1987-2009, were retrospectively evaluated. RESULTS: We reviewed 2014 patients, in whom AZA was prescribed in 302 of them, 139 (46%) with ulcerative colitis (UC) and 163 (54%) with Crohn's disease (CD). Side-effects were complained by 98 (32.4%) out of 302 patients, 50 UC and 48 CD, (36% UC vs 29.4% CD, p = 0.26). In 20 (20.4%) patients, 11 UC and 9 CD, side-effects recovered after dosage reduction whilst in 78 (79.6%), 39 UC and 39 CD, the treatment was discontinued (dose-dependent side-effects in 42 patients and dose-independent in 36). Overall, side-effects were observed after a mean period of 14.5 ± 7.8 months (range 0.5-123) of AZA treatment. The majority (76%) of the dose-dependent adverse events were reported between 12-18 months after the beginning of treatment. CONCLUSIONS: The prevalence of side effects leading to withdrawal of AZA treatment, in our series of Italian patients, was higher respect to data reported in the literature (25.8%).

Simultaneous primary gastric and duodenal MALT lymphoma presenting with gastrointestinal bleeding.

The gastrointestinal tract, particularly the stomach, is the most common site of mucosa-associated lymphoid tissue lymphoma (MALToma). Many studies describe primary MALT lymphoma arising from the gastric mucosa, especially in association with Helicobacter pylori infection. On the contrary, primary MALT duodenal lymphoma is a very rare neoplasm. We report a case of a patient with gastrointestinal bleeding in whom primary gastric and duodenal MALT lymphoma were occurred simultaneously.

Prevalence of intestinal metaplasia in the distal esophagus in patients endoscopically suspected for short Barrett's esophagus.

The clinical importance of Barrett's esophagus is related to its correlation to adenocarcinoma. The diagnosis is based on histologic demonstration of specialized intestinal metaplasia in the distal esophagus. The aim of this study was to assess the prevalence of intestinal metaplasia of the distal esophagus in a population submitted to gastroscopy not selected for reflux disease, and with columnar lined distal esophagus between 0.5 and 2 cm. Four biopsies in the distal esophagus were done in 224 patients undergoing routine gastroscopy. Patients were not selected for gastroesophageal reflux. Other clinical parameters were recorded to assess any possible association. In four Centers 224 patients received endoscopy with biopsies demonstrating specialized intestinal metaplasia in 21% of cases. No association was present among the patients with esophagitis or hiatal hernia, as well as with reflux symptoms. A significant association was present in over 70 (females), as well as with the presence of antral intestinal metaplasia demonstrated in 45 patients by gastric biopsies. No other significant associations were present. Biopsy samplings can diagnose the presence of intestinal metaplasia during endoscopy in patients endoscopically suspected for Barrett's esophagus: at present there is not clear evidence to promote this screening to achieve mortality reduction of esophageal adenocarcinoma.

Beta-lactamase inhibition with clavulanic acid supplementing standard amoxycillin-based triple therapy does not increase Helicobacter pylori eradication rate.

BACKGROUND: Antibiotic resistance is the main reason of failure for H. pylori eradication and beta-lactamases produced by resistant H. pylori strains is a possible mechanism underlying ineffectiveness of an amoxycillin-based triple therapy. AIM: To investigate the benefit of using clavulanic acid associated with amoxycillin compared with amoxycillin alone in a standard triple therapy. METHODS: A total 172 H. pylori-positive dyspeptic patients were randomised to a daily treatment with esomeprazole (20 mg bid), clarithromycin (500 mg bid) and either amoxycillin plus clavulanic acid (1 g bid) or amoxycillin (1 g bid) alone for 1 week. H. pylori status was defined by histology and urea breath test at entry and following 8 weeks from the end of therapy by urea breath test and antigen faecal assessment. RESULTS: At intention-to-treat and per-protocol analysis eradication rates achieved by amoxycillin plus clavulanic acid (72 and 78%) were higher, but not significantly, than those achieved by amoxycillin alone triple therapy (62 and 72%). Compliance was good, side-effects mild and with a similar incidence in both regimens. CONCLUSIONS: Clavulanic acid supplemented to amoxycillin-based standard triple therapy does not significantly increase the H. pylori eradication rate with standard triple therapy.

One-week once-daily triple therapy with esomeprazole, levofloxacin and azithromycin compared to a standard therapy for Helicobacter pylori eradication.

BACKGROUND: Primary antibiotic-resistance and poor compliance are the main causes of Helicobacter pylori eradication failure of standard regimens. AIM: To investigate eradication rate, patient compliance and tolerability of a 1-week once-daily levofloxacin plus azithromycin triple therapy versus the standard twice-daily triple therapy. PATIENTS AND METHODS: A total of 164 H. pylori-positive patients were randomised to either esomeprazole 20mg, levofloxacin 500 mg and azithromycin 500 mg once-daily (ELAz) or esomeprazole 20mg, clarithromycin 500 mg and amoxycillin 1g twice-daily (ECA) for 1 week. H. pylori infection was defined at entry by histology and urea breath test; cure of infection was determined both by negative urea breath test and H. pylori stool antigens. RESULTS: H. pylori eradication rates of ELAz and ECA were similar at intention-to-treat (both 65%) and per-protocol analyses (70% versus 76%, respectively). Incidence of poor compliance was lower, although not significantly, in patients randomised to ELAz than to ECA (4% versus 10%); tolerability was significantly higher for ELAz than for ECA (88% versus 70%; P=0.01). CONCLUSIONS: Once-daily levofloxacin plus azithromycin-based triple therapy achieves an H. pylori eradication rate comparable to that of standard twice-daily triple therapy, but is associated with higher patient compliance and might even be better tolerated.

Appropriateness of immunosuppressive drugs in inflammatory bowel diseases assessed by RAND method: Italian Group for IBD (IG-IBD) position statement.

INTRODUCTION: Despite the explosion of biological therapies, the old immunosuppressants continue to play a pivotal role in the management of inflammatory bowel diseases. AIM: To assess the appropriateness of immunosuppressants-azathioprine, 6-mercaptopurine, methotrexate, cyclosporine A, tacrolimus (FK506), mycophenolate mofetil and thalidomide-in the treatment of inflammatory bowel disease by using RAND/University of California Appropriateness Method. METHODS: The RAND method consists of a combination of evidence from the literature and experts' opinions. Appropriateness has been defined to mean that the expected health benefit exceeds the expected negative consequences by a sufficiently wide margin. A panel of 10 experts from the Italian Group for Inflammatory Bowel Disease has rated, in two rounds, on a scale from 1 to 9, the appropriateness of each indication selected by the Promoter Centre, on the basis of their own clinical experience. An indication was considered appropriate if the median of the panelists' ratings fell within the area 7-9, inappropriate in the area 1-3 and uncertain in the area 4-6. A total of 2781 indications were grouped into 13 categories (mild to moderate Crohn's disease; severe Crohn's disease; fistulizing Crohn's disease; steroid-dependant and -resistant Crohn's disease; maintenance of remission induced by medical treatment in Crohn's disease; maintenance of remission induced by surgery in Crohn's disease; mild to moderate ulcerative colitis; severe ulcerative colitis; steroid-dependant and -resistant ulcerative colitis; maintenance of remission induced by medical treatment in ulcerative colitis; extra-intestinal manifestations in inflammatory bowel disease; pregnancy and inflammatory bowel disease; azathioprine-resistant or -intolerant inflammatory bowel disease patients). RESULTS: Of the 2781 scenarios, 212 (7.6%) were rated appropriate, 645 (23.2%) uncertain and 1924 (69.2%) inappropriate. The most relevant results were: in steroid-dependant or -resistant Crohn's disease, azathioprine, 6-mercaptopurine and methotrexate were defined as appropriate in 25 (86.2%) and 14 (48.3%) of the 29 scenarios respectively; in Crohn's disease, azathioprine and 6-mercaptopurine were defined as appropriate combined with Infliximab (bridge therapy); in steroid-dependant or -resistant ulcerative colitis, azathioprine and 6-mercaptopurine were defined as appropriate in 45 (77.6%) out of 58 scenarios, while methotrexate was defined appropriate only after previous azathioprine failure; in severe ulcerative colitis, cyclosporine A was defined as appropriate only after previous failure with steroids; in azathioprine-intolerant or -resistant inflammatory bowel disease patients, methotrexate was appropriate in 20 (66.7%) out of 30 scenarios; it is inappropriate to stop azathioprine treatment before conception in the presence of active disease. The use of FK506, mycophenolate mofetil and Thalidomide resulted as inappropriate or uncertain. CONCLUSIONS: Results of this study show that only azathioprine, 6-mercaptopurine and methotrexate are appropriate in the treatment of inflammatory bowel diseases. Cyclosporine A was found to be appropriate only in severe ulcerative colitis after the failure of steroids. FK506, mycophenolate mofetil and Thalidomide resulted as inappropriate but experience with these agents is somewhat limited.

Comparison of two different daily dosages (2.4 vs. 1.2 g) of oral mesalazine in maintenance of remission in ulcerative colitis patients: 1-year follow-up study.

BACKGROUND: Mesalazine as maintenance therapy in ulcerative colitis is used worldwide and has been proven to be effective. However, the optimal dosage remains to be defined. AIM: To establish whether daily treatment with 2.4 g of oral mesalazine is more effective than 1.2 g in preventing disease relapse. METHODS: A total of 156 patients with ulcerative colitis in remission were randomly treated for 1 year with 2.4 (n = 80) or 1.2 (n = 76) g/day of mesalazine. Activity of disease was assessed by periodical clinical, endoscopic and histological examinations. RESULTS: After 12 months, 24 of 80 patients (30%) on 2.4 g and 20 of 76 patients (26%) on 1.2 g were still in remission (P = N.S.). Patients in 2.4 g group remained in remission for a longer time than those in 1.2 g group (P < 0.001). Among clinical variables considered in the study, course of disease prior to enrollment (< or = 3 or > 3 relapses/year) was found to influence response to therapy. CONCLUSIONS: A daily dosage of 2.4 g of oral mesalazine seems to better at preventing and delaying relapses of ulcerative colitis than 1.2 g. The course of disease seems to be crucial in choosing the optimal dosage of mesalazine in a maintenance regimen.

Increased thrombin generation and circulating levels of tumour necrosis factor-alpha in patients with chronic Helicobacter pylori-positive gastritis.

BACKGROUND: Conflicting data have been reported concerning the relationship between Helicobacter pylori infection and coronary heart disease. AIM: To evaluate clotting system activation and plasma levels of tumour necrosis factor-alpha, a procoagulant cytokine, in patients with H. pylori-positive and -negative gastritis. METHODS: Three groups of patients were identified: 38 with H. pylori-positive gastritis, 18 with H. pylori-negative gastritis, and 40 H. pylori-negative controls with normal gastric mucosa. Plasma levels of prothrombin fragment 1 + 2 (F1 + 2) and tumour necrosis factor-alpha were assayed. Patients were also controlled after 2 and 6 months following standard H. pylori eradication treatment. RESULTS: At baseline, fragment 1 + 2 and tumour necrosis factor-alpha levels in H. pylori-positive patients were significantly higher than those in H. pylori-negative patients with gastritis (P < 0.05 and P < 0.01, respectively). After H. pylori eradication, fragment 1 + 2 and tumour necrosis factor-alpha levels showed a significant decrease at 2 months (P = 0.03 and P = 0.02, respectively) and a further reduction at 6 months, reaching levels observed in H. pylori-negative patients and controls. CONCLUSIONS: The increase thrombin generation rate and the correlation of plasma fragment 1 + 2 and tumour necrosis factor-alpha levels in H. pylori-positive patients suggest a role for inflammation in mediating the relationship between H. pylori infection and activation of the clotting system.

Diffuse febrile dermatosis in a patient with active ulcerative colitis under treatment with steroids and azathioprine: a case of Sweet's syndrome. Case report and review of literature.

Ulcerative colitis is an inflammatory bowel disease often associated with extra-intestinal manifestations, such as dermatological disorders. Of these, the most frequent are erythema nodosum and pyoderma gangrenosum, the two neutrophilic forms of dermatosis. Another is Sweet' s syndrome, which results in a sudden eruption of tender, raised erythematous or violaceous plaques/papules or nodules, less frequent vesicles, pustules or bullae, involving face, neck, arms and trunk. This skin disorder is frequently observed in patients with leukaemia or connective tissue diseases, while it is very rare in patients with inflammatory bowel disease. The present report deals with the case of a febrile diffuse skin eruption in a 53-year-old patient with moderately active ulcerative colitis after few days' treatment with steroids and azathioprine. At first, the dermatosis was addressed to an idiosyncrasy to azathioprine, which was, therefore, promptly discontinued. Histological examination of skin biopsies revealed the presence of features typical of a Sweet's syndrome. The eruption gradually improved as well as the patient's general condition, until complete regression was achieved following steroid treatment.

Azathioprine or methotrexate in the treatment of patients with steroid-dependent or steroid-resistant ulcerative colitis: results of an open-label study on efficacy and tolerability in inducing and maintaining remission.

BACKGROUND: The role of azathioprine and methotrexate in inducing and maintaining remission in patients with ulcerative colitis is still controversial. AIM: To evaluate the efficacy and tolerability of these two drugs in a series of patients with steroid-dependent or steroid-resistant active ulcerative colitis. METHODS: Forty-two patients were treated with a daily dose of azathioprine (2 mg/kg) and, if intolerant or not responding, with methotrexate (12.5 mg/week intramuscularly), and their efficacy was established by clinical, endoscopic and histological examinations at 6 months. Patients achieving clinical remission continued with treatment and were followed up. RESULTS: Of the 42 patients on azathioprine, 10 experienced early side-effects requiring withdrawal from treatment, 22 (69%) achieved complete remission, six (19%) achieved improvement and four (12%) obtained no substantial benefit. Methotrexate, administered to eight patients intolerant to and two patients resistant to azathioprine, induced complete remission in six patients (60%) and improvement in four (40%). During follow-up, a larger number of patients on azathioprine relapsed in comparison with patients on methotrexate [16/28 (57%) vs. 2/10 (20%), respectively; P < 0.05]. Only minor side-effects were observed on both treatments. CONCLUSIONS: Azathioprine is effective in patients with steroid-dependent or steroid-resistant ulcerative colitis. Methotrexate seems to be a good alternative in patients intolerant to or not responding to azathioprine.

Oral and topical 5-aminosalicylic acid (mesalazine) in inducing and maintaining remission in mild-moderate relapse of ulcerative colitis: one-year randomised multicentre trial.

BACKGROUND: The association of oral 5-aminosalicylic acid (mesalazine) and enema is effective in treatment of mild-moderate forms of ulcerative colitis. However no study has been aimed at determining optimal duration of this association in active ulcerative colitis. AIM: To determine whether longer duration of therapy: 1. increases the rate of patients achieving remission, and 2. reduces relapse rate during the maintenance period in patients in remission. PATIENTS AND METHODS: A total of 149 patients, (89 male, 60 female), were randomly assigned to a regimen with 5-aminosalicylic acid tablets 2.4 g/day associated with 5-aminosalycilic enema 2 g/day for a 4-week (n = 73) or 8-week regimen (n = 76). After this acute therapy, patients were submitted to clinical, endoscopic and histological examinations and those in remission were assigned to a follow-up (maintenance) period with oral mesalazine alone at a dosage of 1.2 g/day. A clinical visit, including laboratory tests, at 6 months and an endoscopic-histological control at 12 months were carried out to exclude symptoms and endoscopic-histological signs of activity. Relapse of disease, i.e., presence of clinical symptoms or abnormal laboratory tests, was confirmed by endoscopy and histology. RESULTS: At end of acute phase, clinical, endoscopic and histological remission was comparable in the two groups: 42/76 (55%), in the 4-week, and 47/73 patients (64%), in the 8-week regimen. No difference was found stratifying patients according to extension of disease. Of these 89 patients in remission, 75 (34 from 4-week regimen; 41 from 8-week regimen) completed 12 months' follow-up. At end of follow-up, a similar percentage of patients in the 4-week regimen (50%) and 8-week regimen (51%) were still in remission. No significant difference between cumulative relapse rates of the two groups was found. Stratifying patients according to extension of disease, in the 8-week regimen group, those with left-sided colitis showed a higher remission rate than that of patients with diffuse colitis (66% versus 35%, p < 0.05). All regimens were well tolerated by most patients during the entire study period. CONCLUSIONS: An additional 4 weeks of topical treatment does not increase the remission rate in patients with mild-moderate active ulcerative colitis but seems to reduce the probability of relapse in patients with left-sided colitis.

Discrepancy between polymerase chain reaction assay and Western blot analysis in the assessment of CagA status in dyspeptic patients.

BACKGROUND: Infection with CagA-positive Helicobacter pylori may be diagnosed by detecting cagA gene by polymerase chain reaction assay (PCR) or serum antibodies against CagA by Western blot analysis. The aim of this study is to evaluate whether results of PCR and Western blot analysis are in agreement in CagA status assessment. PATIENTS AND METHODS: Thirty-six dyspeptic patients with unknown H. pylori status underwent upper gastrointestinal endoscopy to assess the presence of mucosal lesions and to collect six gastric biopsies (three from the antrum and three from the body) for evaluation of H. pylori infection (rapid urease test, histology and PCR for ureA gene) and gastritis. CagA status was assessed by PCR (cagA gene) on two biopsy specimens and by Western blot analysis of serum (CagA-antibodies) in each patient. RESULTS: At endoscopy, nine patients showed normal mucosa, 15 a duodenal ulcer and 12 antral erosions. Twenty-eight patients were found to be H. pylori-positive and eight H. pylori-negative. Of the 28 H. pylori-positive patients, 17 were CagA-positive and five were CagA-negative by both methods, five were CagA-positive by Western blot analysis but not by PCR and one was CagA-positive by PCR but not by Western blot analysis. Of the eight H. pylori-negative patients, none was CagA-positive by PCR, while six were CagA-positive by Western blot analysis. Therefore, the two tests agreed in only 24 patients (67%). In those patients in whom the PCR and Western blot analysis were not in agreement, the histological features appear to suggest that the results of the Western blot analysis should be considered false positives or false negatives. CONCLUSIONS: PCR and Western blot analysis failed to provide comparable data in many cases. Western blot analysis seems to be more likely to give misleading results than PCR. Thus, PCR seems to be the method of choice to assess CagA status.

Sulphasalazine and 5-aminosalicylic acid in long-term treatment of ulcerative colitis: report on tolerance and side-effects.

BACKGROUND: Use of sulphasalazine in ulcerative colitis patients is hampered by a variety of side-effects, including male infertility. 5-aminosalicylic acid is better tolerated and has been increasingly used to treat patients intolerant/allergic to sulphasalazine but it may also be associated with side-effects. AIM: To evaluate tolerance of long-term treatment with sulphasalazine and 5-aminosalicylic acid in ulcerative colitis. METHODS: Side-effects to sulphasalazine (2-3 g/day) and 5-aminosalicylic acid (1.2-2.4 g/day) were recorded in 685 patients: 410 patients received only sulphasalazine, 130 only 5-aminosalicylic acid, and 145 both drugs. In patients with side-effects to sulphasalazine, a desensitisation protocol (rechallenge) was attempted to improve tolerance, and patients still presenting side-effects after desensitisation were switched to 5-aminosalicylic acid. Male fertility was also assessed in 42 males on sulphasalazine and on 5-aminosalicylic acid. RESULTS: Side-effects were observed in 110/555 patients (20%) on sulphasalazine and in 18/275 patients (6.5%) on 5-aminosalicylic acid during a median period of follow-up of 7 and 5 years, respectively. Desensitisation was achieved in 40% of patients intolerant to sulphasalazine. 5-aminosalicylic acid intake induced side-effects in 2/130 patients (1.5%) who had not taken sulphasalazine before versus 4/91 patients (4%) tolerating sulphasalazine and 12/54 patients (22%) intolerant/allergic to sulphasalazine, the difference in incidence of side-effects in the two latter groups being statistically significant (4.4% vs 20.8%, p=0. 001). Fertility was found to be affected in all patients on sulphasalazine but improved when put onto 5-aminosalicylic acid. CONCLUSIONS: 5-aminosalicylic acid should be considered the drug of choice in the treatment of ulcerative colitis bearing in mind that intolerance or allergy may occur in a few patients also on this drug.