Double-blind, placebo-controlled comparison of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastro-oesophageal reflux disease

Background:

Rabeprazole sodium is the most recent 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 oesophagitis.

Methods:

In this randomised, double-blind, multicentre study, conducted at 27 European sites, the efficacy and safety of rabeprazole and omeprazole were compared in patients with erosive or ulcerative gastro-oesophageal reflux disease (GERD).100 patients received rabeprazole 20 mg, and 102 patients omeprazole 20 mg once daily for 4 or 8 weeks, with healing monitored by endoscopy.

Results:

Overall GERD healing rates observed and evaluated at weeks 4 and 8 were equivalent. Four-week healing rates for rabeprazole and omeprazole were 81%–81% and 92%–94% for 8-week healing. Rabeprazole-treated patients had similar relief of the frequency and intensity of heartburn to those treated with omeprazole. Both drugs were well tolerated over the 8-week treatment period. Mean changes in fasting serum gastrin were comparable. No significant differences in laboratory parameters were seen. Biopsies for argyrophil ECL cell histology at the end-point revealed a similar distributions of hyperplasia grades to those at baseline in both groups. Biopsies of body and antral mucosa for other parameters were similar between treatments for Helicobacter pylori colonization, presence or degree of inflammation, atrophy or intestinal metaplasia at the end-point.

Conclusion:

In this study, GERD healing rates following rabeprazole 20 mg once daily were equivalent to those obtained with omeprazole 20 mg once daily. Both treatments resulted in a comparable relief of the frequency and intensity of heartburn associated with this disease, and both were well tolerated.

     

Development of diurnal bladder control in severely and profoundly mentally handicapped residents

ABSTRACT. At two time points, separated by an interval of 7 years, the level of diurnal bladder control of 198 severely and profoundly mentally handicapped individuals was assessed. A slight, but statistically significant increase of bladder control between the two time points was found. Difference scores of level of control were submitted to an ANOVA. Age at admission and duration of institutionalization proved to be related to individuals' level of diurnal bladder control. The results were discussed in relation to the use of toilet training procedures with mentally handicapped individuals.     

Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study

Summary. Background: Traditionally, patients with pulmonary embolism (PE) are initially treated in the hospital with low molecular weight heparin (LMWH). The results of a few small non‐randomized studies suggest that, in selected patients with proven PE, outpatient treatment is potentially feasible and safe. Objective: To evaluate the efficacy and safety of outpatient treatment according to predefined criteria in patients with acute PE. Patients and Methods: A prospective cohort study of patients with objectively proven acute PE was conducted in 12 hospitals in The Netherlands between 2008 and 2010. Patients with acute PE were triaged with the predefined criteria for eligibility for outpatient treatment, with LMWH (nadroparin) followed by vitamin K antagonists. All patients eligible for outpatient treatment were sent home either immediately or within 24 h after PE was objectively diagnosed. Outpatient treatment was evaluated with respect to recurrent venous thromboembolism (VTE), including PE or deep vein thrombosis (DVT), major hemorrhage and total mortality during 3 months of follow‐up. Results: Of 297 included patients, who all completed the follow‐up, six (2.0%; 95% confidence interval [CI] 0.8–4.3) had recurrent VTE (five PE [1.7%] and one DVT [0.3%]). Three patients (1.0%, 95% CI 0.2–2.9) died during the 3 months of follow‐up, none of fatal PE. Two patients had a major bleeding event, one of which was fatal intracranial bleeding (0.7%, 95% CI 0.08–2.4). Conclusion: Patients with PE selected for outpatient treatment with predefined criteria can be treated with anticoagulants on an outpatient basis. (Dutch Trial Register No 1319; http://www.trialregister.nl/trialreg/index.asp ).     

Effectiveness of functional progressive resistance exercise strength training on muscle strength and mobility in children with cerebral palsy: a randomized controlled trial

Aim To evaluate the effectiveness of functional progressive resistance exercise (PRE) strength training on muscle strength and mobility in children with cerebral palsy (CP). Method Fifty‐one children with spastic uni‐ and bilateral CP; (29 males, 22 females; mean age 10y 5mo, SD 1y 10mo, range 6y 0mo–13y 10mo; Gross Motor Function Classification System levels I–III) were randomized to the intervention group (n=26) or the control group (n=25, receiving usual care). The intervention group trained for 12 weeks, three times a week, on a five‐exercise circuit, which included a leg‐press and functional exercises. The training load progressively increased based on the child’s maximum level of strength, determined by the eight‐repetition maximum. Muscle strength (measured with hand‐held dynamometry and a six‐repetition maximum leg‐press test), mobility (measured with the Gross Motor Function Measure, two functional tests, and a mobility questionnaire), and spasticity (measured by the appearance of a catch) were evaluated before, during, directly after, and 6 weeks after the end of training by two blinded research assistants. Results Directly after training, there was a statistically significant effect (p<0.05) on muscle strength (knee extensors +12% [0.56N/kg; 95% confidence interval {CI} 0.13–0.99]; hip abductors +11% [0.27N/kg; 95% CI 0.00–0.54]; total +8% [1.30N/kg; 95% CI 0.56–2.54]; six‐repetition maximum +14% [14%; 95% CI 1.99–26.35]), but not on mobility or spasticity. A detraining effect was seen after 6 weeks. Interpretation Twelve weeks of functional PRE strength training increases muscle strength up to 14%. This strength gain did not lead to improved mobility.