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.

Background/Aims: Non-invasive tissue sampling from the lower intra-abdominal and pelvic cavity is challenging. The role of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in this situation is not well-established because of the limitations of the curved linear-array echoendoscopy-EUS for colonic insertion. The aim of this study was to report our institutional experience of transcolonic EUS-FNA using forward-viewing therapeutic linear echoendoscopy-EUS (FV-EUS) in combination with fluoroscopic guidance. Methods: Medical records of 13 patients who underwent transcolonic EUS-FNA of extracolonic lesions using FV-EUS in combination with fluoroscopic guidance at Aichi Cancer Center Hospital, Nagoya, Japan from June 2015 to November 2018 were retrospectively reviewed. Results: Using FV-EUS under fluoroscopic guidance, the FNA procedure could be performed successfully in all patients (100% technical success), with a median procedure time of 31 minutes. The sensitivity, specificity, and accuracy of EUS-FNA for detecting malignant lesions in this study were 91%, 100%, and 92%, respectively. There were no adverse events associated with the EUS-FNA procedure. Conclusions: FV-EUS in combination with fluoroscopic guidance is an easy, safe, and effective technique for FNA of extracolonic lesions in the lower abdomen.

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.

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