Summary Background Currently, central neuromodulators are among the therapeutic options for the treatment of functional dyspepsia (FD). Pregabalin, a gabapentinoid, is a neuromodulator that could potentially improve visceral hypersensitivity in FD patients. Aim To assess the efficacy and safety of pregabalin for the treatment of FD Methods We performed a randomised placebo‐controlled study including FD patients who did not respond to proton pump inhibitors. Patients were randomly assigned to receive pregabalin (75 mg daily) or placebo for 8 weeks. The primary outcome was an adequate relief response rate. The secondary outcomes were improvement in quality of life, pain scores in divided categories, and safety profile. Results Of 72 patients enrolled, 34 received pregabalin and 38 received placebo. The self‐reported adequate relief rates in the pregabalin and placebo groups were 70.6% and 42.1% at week 4 (P = 0.02), and 70.6% and 44.7% at week 8 (P = 0.03), respectively. The reduction in global symptoms in the pregabalin and placebo groups were 11.7 ± 10.6 and 3.7 ± 8.9 points at week 4 (P < 0.01) and 15.1 ± 12.2 and 8.0 ± 10.2 points at week 8 (P = 0.01), respectively. Pregabalin improved the overall quality of life (P = 0.03). The most common adverse event with pregabalin was dizziness, occurring in 51.6% of patients. Conclusions Pregabalin led to significant alleviation of dyspeptic symptoms, especially in patients with predominant epigastric pain . Thaiclinicaltrials.org #TCTR20200404002.
To assess the efficacy of rebamipide therapy in chronic gastritis patients with refractory dyspeptic symptoms, we enrolled 30 patients with chronic gastritis nonresponsive to the antisecretory medications, proton pump inhibitors. Upper gastrointestinal endoscopy was performed in all patients to confirm and evaluate the severity of gastritis by gastric mucosal injury score and the histology by the updated Sydney system before and after treatment with rebamipide 300 mg daily for 8 weeks. At the end of the study, significant improvement in the scores for symptoms (epigastralgia, stomach heaviness, and abdominal fullness) and endoscopic mucosal injury were observed for all patients. The degrees of neutrophil activity in antrum and mononuclear cell inflammation in both body and antrum significantly decreased from baseline. Improvement of gastritis might be the mechanism by which rebamipide prevents gastric mucosal inflammation. In conclusion, rebamipide treatment improved symptom, endoscopic, and histologic features of chronic gastritis in patients with refractory dyspeptic symptoms.
Background/Aims The treatment of refractory functional dyspepsia (FD) is a challenge. Clidinium/chlordiazepoxide is a combination of antispasmodic and anxiolytic drugs that has been used as an adjunct treatment for FD in clinical practice with limited supporting evidence of efficacy. The aim of the study is to assess the efficacy and safety of clidinium/chlordiazepoxide as an adjunct treatment to a proton pump inhibitor (PPI) in refractory dyspepsia. Methods We performed a study of patients who met the Rome IV criteria for FD who failed to respond to PPIs. Patients were randomly assigned to groups that received clidinium/chlordiazepoxide or placebo as an add-on treatment to PPI for 4 weeks. The primary outcome was the rate of responders, which was defined as a > 50% reduction in dyspepsia symptom score after 4 weeks of treatment. The secondary outcomes were an improvement in the quality of life and the safety profile. Results Between March 2017 and February 2018, 78 patients were enrolled. The rates of responders in the clidinium/chlordiazepoxide group and placebo groups were 41.03 % and 5.13% at week 4 (P < 0.001). The clidinium/chlordiazepoxide group also showed significant improvement in overall quality of life over placebo. However, the clidinium/chlordiazepoxide group had more frequent drowsiness than the placebo group (30.27% vs 6.52%, P = 0.034). There were no major adverse events in either group. Conclusions Clidinium/chlordiazepoxide significantly improved dyspeptic symptoms and quality of life. This combination may be used as an add-on therapy in FD patients without major adverse events.
Obstructive jaundice has been known to cause severe hemodynamic disturbance. The present study was therefore designed to assess the cardiac involvement in jaundiced patients. The multiple-gated blood pool cardioscintigraphic studies were done in 9 jaundiced patients who had either cholestatic or obstructive jaundice (mean total bilirubin 29.30 +/- 3.30 mg/dL), and in 8 normal volunteers (total bilirubin less than 1 mg%). None of the patients had evidences of obvious cirrhosis, intrinisic heart disease, or septicemia. Following intravenous dobutamine there was comparable change of blood pressure and heart rate in both groups. However the response of left ventricular ejection fraction (LVEF) to dobutamine (10 micrograms/kg/min x 5 min) was strikingly blunted in the jaundiced patients as compared to that seen in the normal controls (3.56 +/- 0.9 vs. 12.7 +/- 2.2%, p less than 0.005). Our present data thus show that there is blunted myocardial contractile response to the inotropic stimulation in jaundiced patients. Such myocardial refractoriness to beta-1 stimulation may contribute to the susceptibility of jaundiced patients to postoperative shock and acute renal failure.
Objectives:The Asia-Pacific Colorectal Screening (APCS) scoring system was developed to identify high-risk subjects for advanced neoplasia. However, the appropriate fecal immunochemical test (FIT) cutoff for high-risk population may be different from that of average-risk population. We aimed to evaluate the FIT performance at different cutoffs in high-risk subjects undergoing colorectal cancer (CRC) screening.Methods:We prospectively enrolled asymptomatic subjects aged 50–75 years. Using the APCS score, subjects were stratified into either the average-risk or high-risk groups. All subjects were tested with one-time quantitative FIT and underwent colonoscopy. We compared the FIT performance for advanced neoplasia between two groups using different cutoffs (5 (FIT5), 10 (FIT10), 20 (FIT20), 30 (FIT30), and 40 (FIT40) μg Hb/g feces).Results:Overall, 1,713 subjects were recruited, and 1,222 (71.3%) and 491 (28.7%) were classified as average-risk and high-risk, respectively. Advanced neoplasia was detected in 90 (7.4%) of the average-risk subjects and 65 (13.2%) of the high-risk subjects. In the high-risk group, by decreasing the cutoff from FIT40 to FIT5, the sensitivity increased by 33.8 percentage points with decreased specificity by 11 percentage points. In the average-risk group, the sensitivity increased by 20 percentage points with decreased specificity by 9.6 percentage points. At the lowest cutoff (FIT5), the number of needed colonoscopies to find one advanced neoplasia was 2.8 and 6.1 for the high-risk and average-risk groups, respectively.Conclusions:Using an appropriate FIT cutoff for CRC screening in high-risk subjects could improve CRC screening performance and reduce the unnecessary colonoscopies. To maintain high sensitivity and specificity for advanced neoplasia, the optimal cutoff FIT in the high-risk subjects should be lower than that in the average-risk subjects.
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