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At least 1,081 records · Page 60Linked to original sources
PubMed2005

Rehabilitation of spinal cord injury in France: a nationwide multicentre study of incidence and regional disparities.

STUDY DESIGN: Multicentre retrospective 1-year survey during 2000. OBJECTIVES: To describe the network of physical medicine and rehabilitation units in France that care for people with traumatic spinal cord injuries (SCI), and secondly, to evaluate the incidence of SCI persons who have postinjury rehabilitation care. SETTING: Every rehabilitation unit involved in rehabilitation of SCI patients in metropolitan France. METHODS: During the first phase of the survey, a questionnaire was used to list the rehabilitation units that treat SCI people among a total of 380 centres. An additional survey was then carried out on a sample of 30 units that did not answer this questionnaire. In the second phase, the units involved were asked about the number of SCI patients received for a first rehabilitation stay during the year 2000 and their demographic and clinical characteristics. The incidence was calculated on the basis of the population census in metropolitan France aged 15 years, above. RESULTS: Of the 275 respondent units, 148 declared that they treat SCI people on a regular or occasional basis. The survey on the sample of 30 randomly selected nonrespondents enabled us to estimate that 10% of the 105 nonrespondent units were concerned. Among the 148 units contributing to the study, 131 identified all the SCI patients received during the year 2000. After a series of adjustments, an extrapolation for all of metropolitan France leads to an annual incidence of 19.4 SCI persons per million inhabitants, or 934 new cases per year. CONCLUSION: This is the first nationwide survey aiming to estimate the incidence of SCI patients in France. The finding is based on the incidence of SCI persons treated in rehabilitation units. It therefore concerns the incidence of patients who will remain severely disabled.

Female↗
PubMed2005

Bowel management in patients with spinal cord injury -- a multicentre study of the German speaking society of paraplegia (DMGP).

STUDY DESIGN: A descriptive, cross-sectional, multicentre design was used. OBJECTIVE: To analyse bowel management in patients with spinal cord injury (SCI) especially the occurrence of unplanned bowel evacuations and duration of planned bowel evacuation. SETTING: In total, 29 rehabilitation facilities for SCI patients in Austria, Germany, the Netherlands and Switzerland, with a total of 837 hospitalized SCI patients. METHOD: Data were collected by nurses within 1 week in November 2001 using a quantitative questionnaire containing 14 questions. For data analysis, a chi (2)-test was used for differences in the outcome of bowel evacuation procedures associated with different interventions. Stepwise multiple logistic regression was used to analyse the relationship between the outcome of bowel management and the interventions as well as intervening factors. RESULTS: More unplanned bowel evacuations were associated with usage of oral laxatives (n=444, P<0.001) as well as bowel evacuation every day (n=270, P<0.05) or every second day (n=368, P<0.05). The outcome of less unplanned bowel evacuations was associated with manual removal of stool combined with digital stimulation (n=35, P<0.05) and spontaneous bowel evacuations (n=104, P<0.001). Short duration of bowel evacuation (<60 min) was associated with manual removal of stool (n=64, P<0.05), the sitting position at defecation (n=494, P<0.001) and low frequency of bowel evacuation (>or=3 days) (n=638, P<0.05). Duration >60 min was associated with the use of oral laxatives (n=444, P<0.001) and complete loss of sensory function (n=349, P<0.05). Stool of hard consistency was associated with the manual removal of stool (n=64, P<0.001), the manual removal of stool in combination with digital stimulation (n=53, P<0.001) and the sitting position at defecation (n=494, P<0.05). Stool of soft consistency (n=341) was associated with the complete motor lesion (n=443, P<0.05). CONCLUSION: Manual removal of stool was combined with low risk of unplanned bowel evacuations and short duration of evacuation time. These results are useful to improve the outcomes of bowel management in SCI patients.

Administration, Oral↗
PubMed2006

A multicentre follow-up of clinical aspects of traumatic spinal cord injury.

STUDY DESIGN: Prospective, multicentred follow-up (FU) observational study. OBJECTIVES: Prospectively evaluate survival, complications, re-admissions and maintenance of clinical outcome in people experiencing traumatic spinal cord injury (SCI). SETTING: Seven spinal units and 17 rehabilitation centres participating in the previous GISEM (ie Italian Group for the Epidemiological Study of Spinal Cord Injuries) study. METHOD: A total of 511 persons with SCI, discharged between 1997 and 1999 after their first hospitalisation, were enrolled. A standardised questionnaire was administered via telephone. RESULTS: Of the 608 persons originally enrolled, 36 died between discharge and follow-up (mean 3.8+/-0.64 years). Of the remainder, 403 completed telephone interviews, 72 refused to participate and 97 could not be contacted. More than half of the patients interviewed (53.6%) experienced at least one SCI-related clinical problem in the 6 months preceding interview; the most frequent being urological complications (53.7%). At least one re-admission was recorded in 56.8% of patients between discharge and FU interview. Of the patients interviewed, 70.5% reported bowel autonomy and 86% bladder management autonomy. On multivariate analysis, lack of bowel/bladder autonomy was the most common variable with a strong predicting value for mortality, occurrence of complications and re-admissions. CONCLUSION: Re-admission and major complications seem common after SCI and should be considered when planning facilities. Failure to obtain bowel/bladder autonomy upon discharge from rehabilitation proved to be the most common predictive factor of poor outcome during the period between discharge and FU interview.

Activities of Daily Living↗
PubMed2006

The ALIAS (ALbumin In Acute Stroke) Phase III randomized multicentre clinical trial: design and progress report.

High-dose human ALB (albumin) therapy is highly neuroprotective in animal models of ischaemic stroke. A recently completed 82-subject pilot-phase dose-escalation trial has shown that ALB is safe, with strong preliminary suggestions of possible efficacy. We are now proceeding to a large randomized, double-blinded, placebo-controlled multicentre trial funded by the NIH (National Institutes of Health), the ALIAS (Albumin In Acute Stroke) Phase III Trial, which is designed to ascertain definitively whether high-dose ALB therapy confers neuroprotection in subjects with acute ischaemic stroke treated within 5 h of stroke onset. The primary efficacy outcome measure is a favourable outcome, defined as an NIHSS (NIH Stroke Scale) score of 0-1 or a modified Rankin Scale score of 0-1 at 3 months post-randomization. Separate randomization (1:1) to ALB or placebo therapy will be carried out in two cohorts of 900 subjects each, one that receives standard-of-care thrombolytic therapy and the other that does not. Approx. 60 North American clinical sites will participate. Subject enrollment is expected to commence in July 2006.

Humans↗
PubMed2002

European Concerted Action on Anticoagulation (ECAA): multicentre international sensitivity index calibration of two types of point-of-care prothrombin time monitor systems.

A multicentre modified World Health Organization (WHO)-type international sensitivity index (ISI) calibration has been performed at 10 European Concerted Action on Anticoagulation (ECAA) national laboratories using non-citrated whole-blood on two point-of-care test (POCT) prothrombin time (PT) monitor systems, CoaguChek Mini and TAS PT-NC, using single lots of test cards/strips. The relevant species (human and rabbit) WHO international reference preparations (IRPs) were tested with the manual PT technique on citrated plasma from the same blood donations. The ISI was calculated from the slope of the orthogonal regression line relating log PT (POCT) to log PT (IRP). The mean ISI of the CoaguChek Mini system was 1.75 and 1.13 with the prothrombin time non-citrated Thrombolytic Assessment System (TAS PT-NC). With the CoaguChek Mini system, seven out of 10 calibrations exceeded the current 3% WHO recommended limit for the coefficient of variation (CV) of the slope with conventional PT testing, whereas with the TAS PT-NC system, it was eight out of 10. All the POCT calibrations had a CV of the slope <5%. It is suggested that this level of precision be adopted as the limit of acceptability of calibration of these monitor systems. In these circumstances, the modified WHO-type ISI calibration appeared to be satisfactory for the POCT whole-blood monitors.

Animals↗
PubMed2001

Multicentre study of detection and false-negative rates in sentinel node biopsy for breast cancer.

BACKGROUND: Sentinel node biopsy has recently evolved as a means of staging the axilla in breast cancer with minimal surgical trauma. The aim of this prospective multicentre study was to identify factors that influenced the detection and false-negative rates during the learning phase. METHODS: Data on all 498 sentinel node biopsies performed between August 1997 and December 1999 in Sweden were collected. RESULTS: A sentinel node was found in 450 patients (90 per cent). Preoperative scintigraphy visualized 83 per cent of all sentinel nodes. The detection rate was higher with same-day injection of tracer than with injection the day before (96 versus 86 per cent; P < 0.01). Dye injected less than 5 min or more than 30 min before the start of the operation lowered the detection rate (less than 60 per cent versus more than 65 per cent; P = 0.02). The detection rate varied from 61 to 100 per cent between surgeons. The false-negative rate was 11 per cent. The presence of multiple tumour foci and a high S-phase fraction increased the risk of a false-negative sentinel node, whereas the number of operations performed by each surgeon was less important. CONCLUSION: Training of the individual surgeon influenced the detection rate, as did timing of tracer and dye injection. The false-negative rate seemed to be related to biological factors.

Adult↗
PubMed2003

Multicentric adenomatoid tumors involving uterus, ovary, and appendix.

A case of large, and multicentric adenomatoid tumors involving the uterus, right ovary and appendix is described. The uterine tumor was exceptionally large, about 15 cm in maximal diameter, and located in the right fundal region of the uterus with a short, thick pedicle as in a subserous pedunculated uterine fibroid.

Adenomatoid Tumor↗
PubMed1997

A United States multicentre trial of dual and proton pump inhibitor-based triple therapies for Helicobacter pylori.

BACKGROUND: One-week proton pump inhibitor-based triple therapies are very popular in the US despite limited US data documenting efficacy. We assessed 1-week proton pump inhibitor triple therapies for Helicobacter pylori, and compared them to dual antibiotic therapies (to assess benefit of omeprazole) and to omeprazole-amoxycillin (to assess benefit of clarithromycin) in a large, randomized, US multicentre study. METHODS: Healthy subjects who were H. pylori-positive by rapid serological test and 13C-urea breath test were randomly assigned to (i) omeprazole (O) 20 mg b.d. + amoxycillin (A) 1 g t.d.s. for 14 days (OA); (ii) A 1 g b.d. + clarithromycin (C) 500 mg b.d. for 7 days (AC); (iii) C 250 mg b.d. + metronidazole (M) 500 mg b.d. for 7 days (CM); (iv) O 20 mg b.d. + C 250 mg b.d. + M 500 mg b.d. for 7 days (MOC); or (v) O 20 mg b.d. + C 500 mg b.d. + A 1 g b.d. for 7 days (OAC). Repeat breath tests were done at 6 weeks to assess H. pylori status. RESULTS: Three hundred and two H. pylori-positive subjects at 25 centres received medication. Intention-to-treat cure rate was significantly higher for OAC (82%) than for MOC (67%), CM (59%), AC (18%) or OA (58%), Per-protocol cure rates were 85% for OAC and 75% for MOC. Discontinuation of therapy due to a side-effect occurred in 0-3% of each study group. CONCLUSIONS: One-week twice-daily triple therapy with omeprazole, amoxycillin and clarithromycin provides the best rate of eradication of the five regimens studied. However, treatment in the US for 7 days may be unable to achieve eradication rates of > or = 90% with proton pump inhibitor-based triple therapy.

Adult↗
PubMed1998

Comparison of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of active gastric ulcer--a European multicentre study. The European Rabeprazole Study Group.

BACKGROUND: Rabeprazole sodium is the newest member of a class of substituted benzimidazole molecules known as proton pump inhibitors. Other proton pump inhibitors have been shown to be effective in healing active, benign gastric ulcers. METHODS: In this randomized, double-blind, multicentre study, conducted at 25 European sites, rabeprazole and omeprazole were compared in patients with active gastric ulcers. Two hundred and twenty-seven patients with active benign gastric ulcer were randomized to receive either rabeprazole 20 mg (n = 113) or omeprazole 20 mg (n = 114) once daily for 3 or 6 weeks, with healing monitored by endoscopy. RESULTS: After 3 weeks, complete healing (ITT analysis) was documented in 58% of patients given rabeprazole and 61% in patients given omeprazole (N.S.). After 6 weeks the healing rates were identical in both groups at 91%. Rabeprazole-treated patients had numerically greater symptom relief at all 12 points of comparison. The differences significantly favoured rabeprazole at week 3 for daytime pain improvement (P = 0.023) and at week 6 for pain frequency (P = 0.006) and complete resolution of night pain (P = 0.022). Both drugs were well-tolerated over the 6-week treatment course. Mean changes from baseline to end-point in fasting serum gastrin were comparable. No significant differences in laboratory parameters were seen. CONCLUSION: In this study, rabeprazole produced healing rates comparable to omeprazole at weeks 3 and 6, but provided more consistent and occasionally significantly superior symptom improvement. Both treatments were well-tolerated.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1998

A randomized trial in primary biliary cirrhosis comparing ursodeoxycholic acid in daily doses of either 10 mg/kg or 20 mg/kg. Dutch Multicentre PBC Study Group.

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), gamma-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.

Adult↗
PubMed1998

First line treatment with omeprazole provides an effective and superior alternative strategy in the management of dyspepsia compared to antacid/alginate liquid: a multicentre study in general practice.

BACKGROUND: Many patients who present with dyspepsia are prescribed antacid/alginates as their first line and often mainstay therapy. This multicentre study was designed to assess whether early introduction of acid inhibition is an effective strategy in dyspepsia management. METHODS: Dyspeptic patients (n = 674) were randomized to receive either omeprazole 10 mg o.m. or antacid/alginate liquid 10 mL q.d.s. for 4 weeks in an open, parallel group study. RESULTS: Complete relief of the most common symptom at entry, heartburn, was greater in the omeprazole-treated group compared with the antacid/alginate-treated group (64 vs. 30%, respectively, at 4 weeks; P < 0.0001). The percentage of patients who met the stringent health target of complete relief of overall symptoms was higher in the omeprazole-treated group (41% at 4 weeks) compared with the antacid/alginate group (16% at 4 weeks; P < 0.0001). Comparisons of quality of life scores between treatments favoured the omeprazole group at 2 and 4 weeks for both the Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale (each P < or = 0.0009). In addition, a greater proportion of patients rated omeprazole to be more effective in symptom relief and more convenient to use (each P = 0.0001) than antacid/alginate. CONCLUSION: This study demonstrates that, compared to antacid/alginate liquid 10 mL q.d.s., omeprazole 10 mg o.m. is more effective in the management of dyspepsia symptoms and is the patients' preferred treatment.

Adult↗
PubMed1999

Comparison of rabeprazole 20 mg versus omeprazole 20 mg in the treatment of active duodenal ulcer: a European multicentre study.

BACKGROUND: Rabeprazole sodium is the newest member of a class of substituted benzimidazole molecules known as proton pump inhibitors. Other proton pump inhibitors have been shown to be effective in healing active duodenal ulcer. METHOD: This randomized, double-blind, multicentre study, conducted at 25 European sites, compared the efficacy and tolerability of rabeprazole and omeprazole in patients with active duodenal ulcers. One hundred and two patients with active duodenal ulcer received rabeprazole 20 mg and 103 patients omeprazole 20 mg once daily for 2 or 4 weeks, with ulcer healing monitored by endoscopy. RESULTS: After 2 weeks, complete ulcer healing was documented in 69% of patients given rabeprazole 20 mg and in 62% of patients given omeprazole 20 mg (N.S.). After 4 weeks, healing rates were 98% in the rabeprazole group and 93% in the omeprazole group (P = 0.083). Rabeprazole-treated patients had significantly greater improvement in daytime pain symptom relief than those treated with omeprazole at the conclusion of the study (P = 0.038). Both drugs were well tolerated over the 4-week treatment period. Mean changes from baseline to end-point in fasting serum gastrin were significantly greater in the rabeprazole group, but at end-point mean values were well within normal limits for both groups. No clinically meaningful changes or other between-group differences were observed in laboratory parameters. CONCLUSION: In this study, rabeprazole produced healing rates equivalent to omeprazole at weeks 2 and 4, and provided significantly greater improvement in daytime pain. Both treatments were well tolerated.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1999

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.

Adolescent↗
PubMed1999

A double-blind, randomized, multicentre, crossover study to prove equivalence of pancreatin minimicrospheres versus microspheres in exocrine pancreatic insufficiency.

BACKGROUND: Modern pancreatin preparations consist of enteric-coated microspheres to protect the enzymes from gastric acid. There are, however, no clinical trials comparing different sizes of pancreatin microspheres with regard to fat excretion and fat intake. AIM: To prove both equivalent efficacy and safety of conventional pancreatin microspheres and smaller pancreatin minimicrospheres in patients with exocrine insufficiency due to chronic pancreatitis. METHODS: In this prospective, randomized, double-blind, multicentre, crossover trial, patients with a stool fat excretion of > 7.5 g/day during a placebo period were randomly assigned either to the minimicrosphere/microsphere treatment sequence or vice versa. The primary end-point was the coefficient of fat absorption, which was calculated from fat excretion and fat intake during the course of a standardized diet. Stool weight, clinical symptoms and the safety of the preparations were also evaluated. RESULTS: Thirty-seven patients entered the study, of whom 23 fulfilled the criteria for the crossover period. In the per protocol analysis (n=18), the 90% confidence intervals for the coefficient of fat absorption of both crossover periods lay entirely within the equivalence range (P=0.02). The intention-to-treat analysis revealed similar results, but the equivalence range was slightly missed (P=0.07). Similar results were obtained for the secondary parameters and the reported adverse events. CONCLUSIONS: Pancreatin minimicrospheres have been shown to be equally effective as microspheres in improving the coefficient of fat absorption in patients with exocrine insufficiency due to chronic pancreatitis.

Adult↗
PubMed1999

Laser assisted ratio analyser 13C-urea breath testing, for the detection of H. pylori: A prospective diagnostic European multicentre study.

BACKGROUND: Novel technology based on laser optogalvanic spectroscopy called the LARA (Laser Assisted Ratio Analyser) system was developed to measure 12C/13C ratios in breath samples using stable 13C isotopes, to detect Helicobacter pylori infection. AIM: To determine the sensitivity and specificity of the 13C-LARA-urea breath test in the detection of H. pylori infection in a prospective European multicentre trial; FDA-and EMEA-approved. METHODS: Consecutive dyspeptic patients underwent diagnostic gastroscopy with biopsies for culture and histopathology, to detect H. pylori infection (gold standard). Subsequently, the LARA-urea breath test was performed using either a system without a cold trap (part I) or a system with a cold trap (part II). In both instances baseline, 30-min and 60-min breath samples were collected. The optimum cut-off level for 12C/13C ratios was determined by Receiver Operator Characteristics analysis. RESULTS: In part I, 544 out of 604 patients were evaluable (low CO2: 47; withdrawn: 13). 284 out of 544 patients (52%) were H. pylori-positive according to the gold standard. The sensitivity of the LARA-urea breath test was 95% and the specificity 94%. In part II, 257 out of 272 were evaluable (low CO2: 14; withdrawn: 1). Sensitivity and specificity were 93% and 96%, respectively. CONCLUSION: The LARA-technology represents an accurate and non-invasive testing system for the detection of H. pylori infection. Its major advantages are the use of stable 13C isotope, the high throughput of samples and the easy means of collecting, storing and transporting the samples, thus making the system convenient to both patient and clinician.

Adolescent↗
PubMed2000

Comparison of lansoprazole-based triple and dual therapy for treatment of Helicobacter pylori-related duodenal ulcer: an Asian multicentre double-blind randomized placebo controlled study.

BACKGROUND: [corrected] In Asian countries with limited resources, clarithromycin-based triple therapy may not be readily available. There are also few direct comparisons of different regimens in Asia. AIM: To compare two lansoprazole-based non-clarithromycin triple therapies and one dual therapy in a prospective double-blind placebo-controlled study of Helicobacter pylori eradication and duodenal ulcer healing. METHODS: Fourteen centres in Asia participated in this study. Patients with acute duodenal ulcer who were H. pylori-positive were recruited. They were randomized to receive: (a) lansoprazole 30 mg b.d., amoxycillin 1 g b.d. and metronidazole 500 mg b.d. for 2 weeks (LAM-2 W), or (b) LAM for 1 week and placebo (LAM-1 W), or (c) lansoprazole 30 mg b.d., amoxycillin 1 g b.d. and placebo for 2 weeks (LA-2 W). Upper endoscopy was repeated at week 6 to check for duodenal ulcer healing. Symptoms and side-effects were recorded. RESULTS: A total of 228 patients were recruited, and two patients took less than 50% of the drugs. H. pylori eradication rates (intention-to-treat) were 68 out of 82 (83%) with LAM-2 W, 55 out of 71 (78%) with LAM-1 W and 43 out of 75 (57%) with LA-2 W. There were significant differences (P=0. 001) in eradication rates when comparing either LAM-2 W or LAM-1 W with LA-2 W. The eradication rate in patients with metronidazole resistant H. pylori strains were significantly lower than those with metronidazole sensitive strains (P=0.0001). The duodenal ulcer healing rates at week 6 were 85%, 85% and 72% in LAM-2 W, LAM-1 W and LA-2 W, respectively (P=0.065). Side-effects occurred in 13%, 11% and 9% in LAM-2 W, LAM-1 W and LA-2 W, respectively. H. pylori eradication and initial ulcer size were factors affecting duodenal ulcer healing. CONCLUSIONS: This Asian multicentre study showed that 1-week lansoprazole-based triple therapy without clarithromycin has similar efficacy in H. pylori eradication and ulcer healing compared with a 2-week regimen. Both triple therapies were significantly better than dual therapy in H. pylori eradication. Therefore, 1-week lansoprazole-based triple therapy is as safe and effective as 2-week therapy in eradication of H. pylori infection and healing of duodenal ulcer in these Asian centres.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2001

A multicentre study on eradication of Helicobacter pylori using four 1-week triple therapies in China.

BACKGROUND: Short-term proton pump inhibitor-based triple therapies for the eradication of Helicobacter pylori are used widely. The eradication rates vary greatly from country to country and from region to region. AIM: To assess the efficacy at eradicating H. pylori of 1-week regimens containing three medications: omeprazole (O) or colloidal bismuth subcitrate (B), furazolidone (F) or metronidazole (M), and amoxicillin (A) or clarithromycin (C). METHODS: A multicentre study involving 20 hospitals in different regions of China. A total of 892 patients with H. pylori-positive non-ulcer dyspepsia or healed duodenal ulcer confirmed by endoscopy were recruited to receive, randomly, one of four regimens: OMC, OFC, OFA, and BFC, b.d. for 7 days. 13C-urea breath test was performed 4-8 weeks after completion of treatment. RESULTS: The eradication rates with per protocol/intention-to-treat analyses were: OMC (n=217/219) 66%/65%; OFC (n=227/229) 69%/69%; OFA (n=223/225) 87%/86%; and BFC (n=214/219) 80%/78%. The eradication rate (per protocol analysis) in duodenal ulcer (79%) was higher than that in non-ulcer dyspepsia (73%, P=0.033). Patient compliance was good. The adverse events of the four regimens were mild, and mainly gastrointestinal. CONCLUSIONS: The omeprazole, furazolidine and amoxicillin regimen achieves a high H. pylori eradication rate in different geographical regions of China.

Adolescent↗
PubMed2003

Oral beclometasone dipropionate in the treatment of extensive and left-sided active ulcerative colitis: a multicentre randomised study.

AIM: To explore the efficacy and safety of the topically acting steroid beclometasone dipropionate (BDP) in an oral controlled release formulation in the treatment of extensive or left-sided ulcerative colitis. METHODS: In a multicentre, randomised, parallel-group, single-blind study, patients with active mild to moderate ulcerative colitis were randomised to a 4-week treatment with BDP 5 mg/day o.d. vs. 5-ASA 0.8 g t.d.s. The primary efficacy variable was the decrease of Disease Activity Index (DAI) (clinical symptoms and endoscopic appearance of mucosa). Safety was evaluated by monitoring adverse events, vital signs, haematochemical parameters and adrenal function. RESULTS: One hundred and seventy-seven patients were enrolled and randomly treated with BDP (n = 90) or 5-ASA (n = 87). Mean DAI score decreased in both treatments groups (P < 0.0001 vs. baseline for both groups). Clinical remission was achieved in 63.0% of patients in the BDP group vs. 62.5% in the 5-ASA group. A significant DAI score improvement (P < 0.05) in favour of BDP was observed in patients with extensive disease. Both treatments were well tolerated. Mean plasma cortisol levels were significantly reduced vs. baseline in BDP recipients, but without signs of pituitary-adrenal function depletion. CONCLUSION: Oral BDP gave an overall treatment result in patients with active ulcerative colitis without signs of systemic side-effects.

Administration, Oral↗