bluuebunny/crossref_metadata_2025_split huggingface dataset:
Low‐dose famotidine and effervescent cimetidine in healthy subjects: a placebo‐controlled overnight pH study
Authors: Reilly  , Grimley  , Usselmann  , Cottrell  , Mann  , Raskin  , Nwokolo  
Published: March 2003

Background:Amongst the low‐dose H2‐receptor antagonists available for the self‐medication of dyspepsia, both famotidine 10 mg and cimetidine 200 mg have been shown to raise intragastric pH, but there is a delay after ingestion before significant effects can be demonstrated. A new effervescent preparation of cimetidine 200 mg releases an acid buffer which has a more rapid effect on intragastric pH.Aim:To investigate the relative abilities of low‐dose famotidine and effervescent cimetidine to raise intragastric pH after a single postprandial evening dose.Methods:Twenty‐four healthy subjects (12 men, 12 women, median age 32 years) completed a three‐period crossover trial of famotidine 10 mg, effervescent cimetidine 200 mg and placebo. After a standard meal was given at 18.30 h to subjects fasted for 5.5 h, drug or placebo was given at 19.30 h. Intragastric pH was recorded with combined glass electrodes from 18.00 to 07.30 h by digital recorders.Results:Over the 12 h post‐dose period the mean area under the pH/time curve (AUC ) after famotidine 10 mg was 3.73, after cimetidine 200 mg effervescent 2.79, and after placebo 2.07. Over the same period the median pH and percentage of time that recordings were above pH 3 were 3.45 and 52.5 after famotidine 10 mg, 2.40 and 33.8 after cimetidine 200 mg effervescent, and 1.68 and 15.9 after placebo. Both active treatments were significantly different from placebo by each measure (P < 0.001), and famotidine 10 mg was significantly more effective than cimetidine 200 mg effervescent by each measure over the 0–12 h period (P < 0.001). Comparisons of mean AUCs for each 15 min period after dosing showed that decrease in acidity was significantly greater after cimetidine 200 mg effervescent than after famotidine 10 mg for the first 60 min. In the later post‐dose period only famotidine 10 mg raised pH for all time points to 12 h, whilst the effect of effervescent cimetidine 200 mg was detectable to ≈ 8 h.Conclusions:Inhibition of gastric acidity over the 12 h post‐dose period was significantly greater and endured longer after famotidine 10 mg than after effervescent cimetidine 200 mg, but for the 60 min period immediately after dosing the effect on intragastric pH was significant following effervescent cimetidine 200 mg but not famotidine 10 mg. This suggests effervescent formulations of H2‐receptor antagonists with an acid buffer have a more rapid effect on intragastric pH than film‐coated tablets.
Colchicine in chronic hepatitis B: a pilot study
Authors: Floreani  , Lobello  , Brunetto  , Aneloni  , Chiaramonte  
Published: March 2003

Rationale:Because of its antifibrotic and anti‐inflammatory effects, colchicine has been proposed as a treatment for liver disease. Early in vitro studies have demonstrated that colchicine blocks mitosis in the metaphase and inhibits DNA synthesis.Aim:A pilot study of hepatitis B virus (HBV)‐related/HBV‐DNA+ve chronic liver disease.Patients:Nine biopsy‐proven chronic hepatitis patients (three with cirrhosis) entered the study. Two of them were HBeAg+ve and seven were antiHBe+. All patients were HBV‐DNA+ve/antiHBc IgM+ve (index values of anti‐HBc IgM ranged from 0.370 to 1.200). All of them had a major contraindication to interferon therapy or refused antiviral treatment. The known persistence of positive HBsAg ranged from 2 to 21 years.Methods:After informed consent, the patients received 1 mg colchicine a day orally for 5 days‐a‐week over 6 months. Testing for liver enzymes and viral markers was performed at the baseline and after 3 and 6 months.Results:None of the patients experienced side‐effects during the treatment. The two HBeAg+ve patients seroconverted to anti‐HBe with a normalization of AST/ALT during therapy. Among the seven antiHBe+ve patients, four had a complete normalization of transaminases (one patient cleared the HBsAg with seroconversion to anti‐HBs). Six of the nine patients were HBV‐DNA‐ve at the end of therapy and were still negative after 12 months of follow‐up.Conclusion:These preliminary results suggest that colchicine might have an antiviral activity in HBV‐DNA+ve chronic liver disease, and it could be regarded as an alternative therapy to interferon.
A randomized trial in primary biliary cirrhosis comparing ursodeoxycholic acid in daily doses of either 10 mg/kg or 20 mg/kg
Authors: Hoogstraten H. J. F. Van , Smet M. B. M. De , Renooij  , Breed  , Engels  , Ouden‐Muller J. W. Den , Rijk  , Smit  , Zwertbroek  , Hop  , Henegouwen G. P. Van Berge , Schalm  , Buuren H. R. Van ,   REPRESENTING THE DUTCH MULTICENTRE PBC STUDY GROUP
Published: March 2003

Background:Ursodeoxycholic acid (UDCA) prolongs transplantation‐free survival in primary biliary cirrhosis (PBC). However, the optimal therapeutic dose has not been established.Aim:To compare the effects of UDCA administered in daily doses of 10 vs. 20 mg/kg on symptoms, liver biochemistry and biliary UDCA enrichment.Methods:A 6‐month multicentre randomized open controlled trial was conducted to assess the effects of an increase in the dose of UDCA to 20 mg/kg/day vs. continuation of 10 mg/kg/day for patients who had not achieved biochemical normalization during treatment for at least 6 months with the 10 mg/kg dose. Clinical and laboratory evaluations were performed at entry and at 3‐month intervals. The percentage UDCA in duodenal bile was assessed at entry and at 6 months.Results:Sixty‐one patients were enrolled. No side‐effects of UDCA were observed. Within the 20 mg/kg/day group significant decreases were found for alkaline phosphatase (− 8%; P = 0.003), aspartate aminotransferase (− 11%; P = 0.01), alanine aminotransferase (− 17%; P < 0.001), γ‐glutamyl transferase␣(− 34%; P < 0.001), immunoglobulin M (− 11%; P = 0.002) and cholesterol (− 8.1%; P < 0.001). In the 10 mg/kg group none of these parameters differed significantly from baseline. No significant differences between dose groups for symptom scores or serum bilirubin were found. Biliary enrichment with UDCA increased from 37% to 46% in the 20 mg/kg group (P = 0.02) while remaining stable in the 10 mg/kg group.Conclusions:Liver biochemistry improved in PBC patients receiving UDCA 20 mg/kg/day compared to a dose of 10 mg/kg/day. Both doses were equally well tolerated. These results indicate that UDCA 10 mg/kg/day is a suboptimal dose for treating PBC.
Eradication ofHelicobacter pyloriwith lansoprazole, roxithromycin and metronidazole—an open pilot study
Authors: Pohle  , Stoll  , Kirchner  , Heep  , Lehn  , Bock  , Domschke  
Published: March 2003

Background:The most extensively studiedHelicobacter pylorieradication regimen comprises omeprazole, clarithromycin and metronidazole. Macrolide antibiotics other than clarithromycin should achieve similar efficacy, but they have not yet been thoroughly tested.Aim:To determine the efficacy and safety of a triple therapy regimen using lansoprazole, roxithromycin, and metronidazole on the basis of multicentre out‐patient care in an open pilot study.Methods:163 patients with duodenal ulcer and provenH. pyloriinfection received lansoprazole 30 mg b.d., roxithromycin 300 mg b.d. and metronidazole 500 mg b.d. for 7 days followed by another 7 days of lansoprazole 30 mg once daily.H. pyloristatus was determined by urease quick test, histology, microbiology and13C‐urea breath test before starting and at least 4 weeks after completing treatment.Results:150 patients were available for evaluation;H. pyloriwas successfully eradicated in 84.7% (127/150) as determined by urease quick test, 78.0% (117/150) by histology, 81.3% (109/134) by13C‐urea breath test; and in 75.3% (113/150), at least two tests were negative. Side‐effects were reported in 34 patients (most commonly diarrhoea and changes in liver function tests), in two cases the study medication was interrupted. Prior to treatment, 23% of theH. pyloriisolates were resistant against metronidazole and 3.4% against roxithromycin. After unsuccessful treatment, 84% of the isolates were resistant against metronidazole and 21% against roxithromycin. Primary resistance to metronidazole increased the chance of treatment failure approximately sevenfold (7% vs. 53%).Conclusions:ForH. pylorieradication, the combination of lansoprazole, roxithromycin and metronidazole proved to be as safe as other current triple therapy regimens, while a comparison of efficacy rates yet remains to be assessed in prospective controlled trials. The metronidazole‐resistantH. pyloriis not rare in Germany and, in the present study, has strongly influenced treatment success.
Review article: gender‐related differences in functional gastrointestinal disorders
Authors: Mayer E.A. , Naliboff B. , Lee O. , Munakata J. , Chang L. 
Published: March 2003

Many functional gastrointestinal disorders and other chronic visceral pain disorders such as interstitial cystitis and chronic pelvic pain are more common in women than in men. In irritable bowel syndrome (IBS) there is a 2 : 1 female to male ratio in prevalence of symptoms in community samples. Female irritable bowel syndrome patients are more likely to be constipated, complain of abdominal distension and of certain extracolonic symptoms.While animal studies have clearly demonstrated gender‐related differences in pain perception and antinociceptive mechanisms, unequivocal evidence for gender‐related differences in human pain perception or modulation has only been provided recently. Gender‐related differences may be related to constant differences in the physiology of pain perception, such as structural or functional differences in the visceral afferent pathways involved in pain transmission or modulation, and/or they may be related to fluctuations in female sex hormones.Preliminary evidence suggests that female irritable bowel syndrome patients show specific perceptual alterations in regards to rectosigmoid balloon distension and that they show differences in regional brain activation measured by positron emission tomography. This preliminary evidence suggests that gender‐related differences in symptoms and in the perceptual responses to visceral stimuli exist in IBS patients and can be detected using specific stimulation paradigms and neuroimaging techniques.
Combination therapy of pentoxifylline and TNFα monoclonal antibody in dextran sulphate‐induced mouse colitis
Authors: Murthy  , Cooper  , Yoshitake  , Meyer  , Meyer  , Murthy  
Published: March 2003

Background:Tumour necrosis factor‐alpha (TNFα) has been suspected of playing an important role in the pathogenesis of inflammatory bowel diseases, and has become a target for the treatment of these diseases. Open‐label, placebo controlled studies have shown that engineered CDP571 and chimeric anti‐TNF antibody (cA2) provide a significant benefit in Crohn’s disease. Since these antibodies have to be used repeatedly to maintain remission in inflammatory bowel disease, there is a concern that their use may compromise host defence and produce toxic side‐effects.Methods:We evaluated the combined use of mouse specific TNFα mab (25 μg/mouse, Endogen) and pentoxifylline (PF, 100 mg/kg/day, p.o., TNFα release inhibitor) in the DSS (3% dextran sulphate solution) model of mouse colitis. Colitis was induced by the feeding of 3% DSS for three cycles. The study groups were: Group I: single injection of rat anti‐mouse IgG, Group II: single injection of TNFα mab, Group III: daily PF for three cycles, Group IV: single injection of TNFα mab + PF for three cycles, Group V: TNFα mab at the beginning of each cycle (three injections) and Group VI: TNFα mab (three injections) + daily PF for three cycles. Daily disease activity (DAI) was measured throughout the study. At the end of each cycle, colon tissue was processed for histology, myeloperoxidase (MPO) and plasma TNFα.Results:Mice treated with a single injection of TNFα alone or TNFα mab + PF showed significantly lower DAI, inflammation scores and ulcer index compared with the IgG treated group. Mice treated with TNFα mab + PF had no ulcers. Multiple injections of TNFα mab or TNFα mab + PF showed greater inhibition in DAI and cytokines in the first two cycles. However, in the third cycle, multiple injections of TNFα mab showed adverse proinflammatory effects.Conclusion:The simultaneous administration of pentoxifylline and TNFα mab may enhance therapeutic outcomes in inflammatory bowel disease and reduce the side‐effects associated with the repeated use of TNFα mab.
Is routine histological evaluation an accurate test for Helicobacter pylori infection?
Authors: MACONI  , VAGO  , GALLETTA  , IMBESI  , SANGALETTI  , PARENTE  , CUCINO  , BONETTO  , PORRO G. BIANCHI 
Published: March 2003

Aim: To compare the diagnostic accuracy of routine histology for Helicobacter pylori infection, with histology by an expert pathologist, and to compare histology with the rapid urease test (RUT), 13C‐urea breath test, IgG serology and culture of antrum and corpus specimens, in a consecutive series of untreated patients presenting for upper oesophago‐gastro‐duodenoscopy.Materials and Methods: One‐hundred and fifteen consecutive patients underwent multiple tests for H. pylori infection: rapid urease test, 13C‐urea breath test, IgG serology and histology and culture on antrum and corpus biopsy specimens. Histology was first evaluated by the pathologists in a routine examination, and then blindly reviewed by an expert pathologist with a special interest in gastrointestinal pathology. The patients were considered to be H. pylori‐positive if two or more tests were positive.Results: Eighty‐one patients (70.4%) were found to be H. pylori positive. 13C‐urea breath test and IgG serology showed the best sensitivity and specificity (100%). Both the antral and body cultures, and the rapid urease test had the highest specificity (100%). Histological diagnosis after re‐evaluation by an expert pathologist showed a high sensitivity (98.8%) and specificity (100%), and was better than routine histology (sensitivity 92.6%; specificity 90.3%). The accuracy of the rapid urease test was greater than that of routine histology, and the combination of these two tests improved the sensitivity of H. pylori detection to up to 100%.Conclusion: All diagnostic tests usually utilised in clinical practice have a sensitivity higher than 90%. In patients who were not pre‐treated with antisecretory agents or antibiotics, the sensitivity of histological diagnosis, however, seems to be influenced by the accuracy of the histological examination. The sensitivity of routine histology, but not of revised histological diagnosis, is improved by an additional rapid urease test.
A new mesalazine gel enema in the treatment of left‐sided ulcerative colitis: a randomized controlled multicentre trial
Authors: GIONCHETTI  , ARDIZZONE  , BENVENUTI  , BIANCHI PORRO  , BIASCO  , CESARI  , D'ALBASIO  , DE FRANCHIS  , MONTELEONE  , PALLONE  , RANZI  , TRALLORI  , VALPIANI  , VECCHI  , CAMPIERI  
Published: March 2003

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.
Immunosuppressive therapy for ulcerative colitis: results of a nation‐wide survey among consultant physician members of the British Society of Gastroenterology
Authors: STACK  , WILLIAMS  , STEVENSON  , LOGAN  
Published: March 2003

Background: The role of immunosuppressive therapy in ulcerative colitis remains controversial. There is little information available on how frequently immunosuppressives are used, the circumstances, dose and duration of use and perceived benefit.Methods: A postal survey was sent to consultant gastroenterologist members of the British Society of Gastroenterology.Results: Questionnaires were returned by 81% of the 496 UK consultants approached. Azathioprine use was frequent, with 93% reporting previous use and 86% use within the past year. Although 95% usually prescribed a ≤ 2 mg/kg dose, only 39% were prepared to prescribe higher doses. There was marked variation in duration of use, with 46% using azathioprine for < 2 years and 17% continuing it for 4 years or longer. Consultants with more experience of azathioprine in ulcerative colitis used it at higher maintenance doses for longer periods, and in patients with less extensive disease. Cyclosporin use was reported by 47% of those caring for ulcerative colitis patients, with 36% having used it at least once in the past year. However, 65% of users estimated that fewer than 50% of patients subsequently avoided colectomy. On stopping cyclosporin only 21% always introduced an alternative immunosuppressive, while 23% never did so. Potentially serious side‐effects attributable to azathioprine and cyclosporin were reported by 36% and 45% of users of each drug, respectively.Conclusions: This survey reveals considerable variation in the amount and pattern of immunosuppressive use in ulcerative colitis, with serious side‐effects commonly seen. There is a pressing need for further randomized controlled trials to provide reliable evidence as to how immunosuppressive therapy should be used in ulcerative colitis.
A multicentre evaluation of the laser assisted ratio analyser (LARA): a novel device for measurement of 13CO2 in the 13C‐urea breath test for the detection of Helicobacter pylori infection
Authors: Cave D. R. , Veldhuyzen van Zanten S. , Carter E. , Halpern E. F. , Klein S. , Prather C. , Stolte M. , Laine L. 
Published: March 2003

Background: The laser assisted ratio analyser (LARA) was developed as a novel device to measure 13CO2 in the urea breath test for the detection of H. pylori infection. The analyser was tested in a prospective multicentre study in 444 patients in North America (Phase 1) followed by second study involving 160 patients (Phase 2).Methods: Patients undergoing endoscopy for clinical indications had antral and gastric biopsies taken for histological examination, culture and CLO test. One hour after endoscopy, a baseline breath sample was obtained, 100 mg of 13C‐urea were ingested and breath samples were obtained at 30 and 60 min post ingestion. Data obtained with the LARA were compared with the results of culture, rapid urease testing and central pathology in two different combinations {reference standards}. The study was conducted in two phases: in Phase 2, a modification was made to the LARA that improved the removal of water vapour from the breath sample.Results: In Phase I, data from 331 patients were analysed using a cut off of (delta) 7.8 ± 0.8, the sensitivity of the method was 91.7% and the specificity was 86.5%, using the reference standard of 2 of 3 tests (CLO, culture or histology) being positive. Positive and negative predictive values were, respectively, 85.2% and 92.5%. In Phase 2 of the study, 160 patients were enrolled and 141 patients were analysed using the same standards. We used the same reference standards but with a cut off of (delta) 6.1 ± 0.6. The sensitivity and specificity increased to 96.8% and 98.6%, respectively. Positive and negative predictive values were, respectively, 98.4% and 97.3%. The detection rates for H. pylori were similar in patients with peptic ulcer or H. pylori associated gastritis.Conclusions: The LARA provides an accurate non‐invasive means of detecting 13CO2 in the 13C‐urea breath test for H. pylori in a multicentre clinical environment that compares well with invasive ‘gold standard’ methods.
Evaluation of treatment regimens to cure Helicobacter pylori infection—a meta‐analysis
Authors: Laheij  , Rossum L. G. M. Van , Jansen  , Straatman  , Verbeek  
Published: March 2003

Objective: To assess effectiveness of treatment to cure Helicobacter pylori infection.Data Synthesis: Meta‐analysis of 666 manuscripts (full papers, abstracts, letters to the editor) identified through Medline and a manual search (1986 to January 1998). Data were overviewed by regression analysis with weighted random effects models.Subjects: 53 228 patients with H. pylori infection.Interventions: Patients were treated with 132 different medication combinations.Main outcome measure: Cure of H. pylori infection per protocol and intention‐to‐treat basis at least 28 days after treatment.ResultsThe nationality of the patients and therapeutic regimen have a significant impact on the results, after correction for the heterogeneity in the precision of the cure rate caused by different study sizes and random effect for study. On the basis of the original sample size, cure rates of 80–85% were achieved using combinations of a proton‐pump inhibitor or ranitidine bismuth citrate with two antibiotics including clarithromycin, amoxycillin and metronidazole or tinidazole. Comparable cure rates were also achieved using a combination of a proton‐pump inhibitor or H2‐receptor antagonist with bismuth subcitrate or tripotassium dicitrato bismuthate, metronidazole and tetracycline. The dose of clarithromycin influenced cure rates. Treatment duration did not influence the outcome.ConclusionSeveral therapeutic regimens are eligible to cure H. pylori infection. However, none of the medication combinations were able to cure H. pylori infection in more than 85% of the patients assessed by intention‐to‐treat. The countries in which the studies were performed also had a significant impact on eradication rates.