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.

     

Treatment of Cholesterol Gallstones with Chenic acid

Twenty-five patients were treated with chenie acid over the past three years. Asymptomatic or with mild nonspecific symptoms of "gallbladder dyspepsia" patients with radiolucent gallstones in functioning gallbladders were selected for this therapeutical trial. Clinical evaluation, liver tests and cholecystograms were performed periodically. In the functioning gallbladders the stone size (diameter of the largest stones) was measured during each standard cholecystography and classified as: smaller, less than 10 mm. and larger, more than 10 mm. Eight patients (with small gallstones) were treated less than six months and only one has had a partial dissolution. Of the 17 patients treated more than six months, the gallstones (small size) completely disappeared in nine (52.9%), most of them before 18 months of treatment and became partially smaller in three (17.6%) before 24 months of therapy. No change at all was observed in five patients between 18 and 24 months of treatment. In two of the nine patients in whom the cholecystograms demonstrated complete dissolution of gallstones, reappearance of small radiolucent gallstones was observed again six months after the drug was discontinued but reinstatement of chenic acid therapy again produced, after three months, complete dissolution of the gallstones. In our experience, therapy with chenie acid, with a daily dose of 750 mg. does not cause significant side-effects and offers a rational, effective, safe alternative to surgical treatment in a selected group of patients depending upon a reasonable clinical judgment.     

Analysis of High Frequency QRS Potential During Exercise Testing in Patients with Coronary Artery Disease and in Healthy Subjects

High resolution ECG waveforms from leads V₃, V₄, V₅, and V₆ were analyzed in two groups of male subjects before, during, and following treadmill exercise testing. Group A included 32 coronary artery disease (CAD) patients, with arteriographically proven > 75% obstruction of at least two main coronary arteries, and group B included 30 healthy subjects, without history or symptoms of CAD. Signal averaging and filtering techniques ware used in order to enhance the signal-to-noise ratio of the recorded ECG. The averaged QRS waveforms were filtered between 150 and 250 Hz. QRS complexes of the four leads were combined to form a “precordial average complex” (PAC). The PAC signals were examined for each subject at different stages of the exercise test and two parameters were computed: the root mean square (RMS) voltage; and the peak amplitude. The values of RMS and peak amplitudes measured at each stage of the exercise test were normalized to the values at rest. Normalized RMS (NRMS) values at peak exercise, immediately after peak exercise, and during the recovery phase were found to be higher for the healthy subjects than for the CAD group (1.17 ± 0.31 vs 0.94 ± 0.26, P < 0.008 at peak exercise, 1.13 ± 0.24 vs 0.84 ± 0.19, P < 0.001 after peak exercise, 1.08 ± 0.22 vs 0.94 ± 0.17, P < 0.007 during recovery). Cut-off NRMS value of one had a sensitivity of 81.3% and a specificity of 70.0% in differentiating CAD patients from healthy subjects in the examined groups. Normalized peak amplitude (NAMP) values exhibited similar behavior, with higher values for the healthy subjects than for the CAD group (1.23 ± 0.48 vs 0.94 ± 0.36, P < 0.03 at peak exercise, 1.20 ± 0.34 vs 0.83 ± 0.28, P < 0.001 after peak exercise, 1.10 ± 0.29 vs 0.94 ± 0.23, P < 0.02 during recovery). Specificity of 73.3% and sensitivity of 71.8% were found using a postpeak NAMP cut-off value of 1. In conclusion, the present study shows that using high frequency ECG may contribute to identifying patients with CAD. Further studies in larger groups of patients are required to better define the true predictive value of the method described for the diagnosis of CAD.