Efficacy and safety of pinaverium bromide as an add-on therapy in refractory dyspepsia: A randomized controlled trial.

Background and Aim: Functional dyspepsia (FD) remains a therapeutic challenge, and the efficacy of antispasmodic agents as adjunctive therapy is not well established. This study aimed to evaluate the efficacy and safety of pinaverium bromide added to omeprazole in treating refractory FD. Methods: We conducted a randomized, placebo-controlled trial in patients with refractory dyspepsia. Participants were randomly assigned to receive pinaverium (50 mg, 3 times/day, n = 36) or placebo (n = 36) in addition to omeprazole for 8 weeks. The primary endpoint was the responder rate for adequate relief. Secondary outcomes included the Global Overall Symptom Scale (GOSS), quality of life, and safety profile. Results: No statistically significant differences were observed in the adequate relief response rate between the pinaverium bromide and control group at week 2 (58.3% vs. 62.9%, P = 0.697), week 4 (62.9% vs. 78.1%, P = 0.173), week 6 (64.7% vs. 75.0%, P = 0.363), and week 8 (64.7% vs. 75.0%, P = 0.363). Additionally, there were no significant differences observed in the decline of symptom score between the two groups at week 4 (8.4 ± 7.6 vs. 7.7 ± 7.1, P = 0.702) and week 8 (10.9 ± 8.2 vs. 8.4 ± 7.2, P = 0.196). Similarly, there were no significant differences in terms of quality of life between the two groups. Adverse event rates were also comparable between the two groups. Conclusion: Pinaverium bromide was found to be safe in the treatment of refractory dyspepsia, but it did not demonstrate a significant benefit in improving symptoms.

Randomised clinical trial: the effects of pregabalin vs placebo on functional dyspepsia.

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.

Efficacy and Safety of Clidinium/Chlordiazepoxide as an Add-on Therapy in Functional Dyspepsia: A Randomized, Controlled, Trial.

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.

Impact of Fecal Hb Levels on Advanced Neoplasia Detection and the Diagnostic Miss Rate For Colorectal Cancer Screening in High-Risk vs. Average-Risk Subjects: a Multi-Center Study.

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.

The Optimal Cut-Off Level of The Fecal Immunochemical Test For Colorectal Cancer Screening in a Country with Limited Colonoscopy Resources: A Multi-Center Study from Thailand

Background: Selecting the cut-off point for the fecal immunochemical test (FIT) for colorectal cancer (CRC) screening programs is of prime importance. The balance between the test performance for detecting advanced neoplasia and the available colonoscopy resources should be considered. We aimed to identify the optimal cut-off of FIT for advanced neoplasia in order to minimize colonoscopy burden. Methods: We conducted a multi-center study in 6 hospitals from diverse regions of Thailand. Asymptomatic participants, aged 50-75 years, were tested with one-time quantitative FIT (OC-SENSOR, Eiken Chemical Co.,Ltd., Tokyo, Japan) and all participants underwent colonoscopy. We assessed test performance in detecting advanced neoplasia (advanced adenoma and CRC) and measured the burden of colonoscopy with different cut-offs [25 (FIT25), 50 (FIT50), 100 (FIT100), 150 (FIT150), and 200 (FIT200)ng/ml]. Results: Among 1,479 participants, advanced neoplasia and CRC were found in 137 (9.3%) and 14 (0.9%), respectively. From FIT25 to FIT200, the positivity rate decreased from 18% to 4.9%. For advanced neoplasia, an increased cut-off decreased sensitivity from 42.3% to 16.8% but increased specificity from 84.2% to 96.3%. The increased cut-off increased the positive predictive value (PPV) from 21.5% to 31.5%. However, all cut-off points provided a high negative predictive value (NPV) (>90%). For CRC, the miss rate for FIT25 to FIT 150 was the same (n=3, 21%), whereas that with FIT200 increased to 35% (n=5). Conclusions: In a country with limited-colonoscopy resources, using FIT150 may be preferred because it offers both high PPV and NPV for advanced neoplasia detection. It could also decrease colonoscopy workload, while maintaining a CRC miss rate similar to those with lower cut-offs.

Thailand Consensus on Helicobacter pylori Treatment 2015.

Management of Helicobacter pylori infection is an important aspect of many upper gastrointestinal tract diseases, such as chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. The Thailand Consensus on H. pylori treatment 2015 consisted of 22 national experts who took active roles, discussed all important clinical information and investigated clinical aspects in four workshops, focuising on: (1) Diagnosis (2) Treatment (3) Follow-up after eradication and (4) H. pylori infection and special conditions. Experts were invited to participate on the basis of their expertise and contribution to H. pylori works and/or consensus methodology. The results of each workshop were taken to a final consensus vote by all experts. Recommendations were developed from the best evidence and availability to guide clinicians in management of this specific infection associated with variety of clinical outcomes.

Clinical features and prognostic factors for liver cancer from a referral center in northern Thailand.

BACKGROUND: Primary liver cancer included hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA), is the leading cancer with high mortality in Thailand. We aim to evaluate the overall survival and predictor of mortality in patients with HCC and CCA. MATERIAL AND METHOD: We reviewed medical records of 786 patients with liver mass between July 2007 and June 2010, 287 patients were HCC and 449 patients were CCA. The overall survival and prognostic variables for survival were analyzed. RESULTS: The mean age of HCC patients and CCA patient were 53.8 years and 59.2 years. Male was predominant, 85% and 74% in HCC and CCA. By BCLC staging for HCC, patients at early stage (A), intermediate stage (B), advanced stage (C), and terminal stage (D) were 40 (13.9%), 105 (36.6%), 95 (33.1%), and 43 (15.0%). Among 449 CCA patients, 143 (31.8%) were intrahepatic type and 306 (68.2%) were ductal type. The mean follow-up time for HCC and CCA patients were 20.1 and 16.7 months. The 1-year, 2-year, and 3-year survival of HCC and CCA were 55%, 34%, 31.3% and 54%, 21.2%, 19.1%, respectively. Predictor of death in HCC patients included portal vein thrombosis and did not receive any treatment (p < 0.05). Meanwhile, the predictor of death in CCA patient included intrahepatic type, total bilirubin > 2 mg/dl, CA 19-9 > 100, and unresectable tumor (p< 0.05). CONCLUSION: The survival of patients who received any type of treatment was much better than in the past. Still, in patients with advanced disease whom only supportive treatments were provided, the prognosis is grave.

An open-labeled study of rebamipide treatment in chronic gastritis patients with dyspeptic symptoms refractory to proton pump inhibitors.

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.

Per rectal portal scintigraphy as a useful tool for predicting esophageal variceal bleeding in cirrhotic patients.

AIM: To investigate potential roles of per rectal portal scintigraphy in diagnosis of esophageal varices and predicting the risk of bleeding. METHODS: Fifteen normal subjects and fifty cirrhotic patients with endoscopically confirmed esophageal varices were included. Patients were categorized into bleeder and non-bleeder groups according to history of variceal bleeding. All had completed per rectal portal scintigraphy using (99m)Technetium pertechnetate. The shunt index was calculated from the ratio of (99m)Technetium pertechnetate in the heart and the liver. Data were analyzed using Student's t-test and receiver operating characteristics. RESULTS: Cirrhotic patients showed a higher shunt index than normal subjects (63.80 +/- 25.21 vs 13.54 +/- 6.46, P < 0.01). Patients with variceal bleeding showed a higher shunt index than those without bleeding (78.45 +/- 9.40 vs 49.35 +/- 27.72, P < 0.01). A shunt index of over 20% indicated the presence of varices and that of over 60% indicated the risk of variceal bleeding. CONCLUSION: In cirrhotic patients, per rectal portal scintigraphy is a clinically useful test for identifying esophageal varices and risk of variceal bleeding.