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.

Thailand guideline 2020 for medical management of gastroesophageal reflux disease.

Gastroesophageal reflux disease (GERD) is one of the most prevalent and bothersome functional gastrointestinal disorders worldwide, including in Thailand. After a decade of the first Thailand GERD guideline, physician and gastroenterologist encountered substantially increase of patients with GERD. Many of them are complicated case and refractory to standard treatment. Concurrently, the evolution of clinical characteristics as well as the progression of investigations and treatment have developed and changed tremendously. As a member of Association of Southeast Asian Nations, which are developing countries, we considered that the counterbalance between advancement and sufficient economy is essential in taking care of patients with GERD. We gather physicians from university hospitals, as well as internist and general practitioners who served in rural area, to make a consensus in this updated version of GERD guideline focusing in medical management of GERD. This clinical practice guideline was constructed adhering with standard procedure. We categorized the guideline in to four parts including definition, investigation, treatment, and long-term follow up. We anticipate that this guideline would improve physicians' proficiency and help direct readers to choose investigations and treatments in patients with GERD wisely. Moreover, we wish that this guideline would be applicable in countries with limited resources as well.

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.

Human fascioliasis presenting as liver abscess: clinical characteristics and management.

BACKGROUND: Human fascioliasis, caused by the liver flukes F. hepatica, and F. gigantica, is a neglected tropical disease that causes health problems in many regions of the world. This disease can be classified as either acute or chronic based depending on the clinical manifestations and laboratory findings. METHODS: We retrospectively reviewed the demographic data, clinical features, radiologic manifestations, and the response to specific treatment of patients diagnosed with hepatic fascioliasis as well as fasciola liver abscess in Thailand. RESULTS: A total of 175 patients were included in the study, 126 patients were females (72%), while the mean age was 47.8 years (16-84 years). The most common symptoms were abdominal pain (74.9%), weight loss (29.1%) and fever (28%). Peripheral eosinophilia was observed in 92% of patients. The typical radiologic findings discovered conglomerated hypodensity which are rim-enhancing lesions located in the subcapsular and peripheral region of the liver. Most of patients were improved after a single dose of triclabendazole treatment. Adding antibiotic had no statistical impact on treatment outcome (p = 0.78). CONCLUSIONS: Human fascioliasis presents with a wide clinical spectrum; therefore, a high index of suspicion is required to establish a correct diagnosis. Clinicians need to be aware of hepatic fascioliasis when patients in such endemic areas present as hypereosinophilia and typical liver imaging. Prompt specific treatments will contribute towards a satisfactory outcome in patients.

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.