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.

Repurposing metformin as a potential treatment for inflammatory bowel disease: Evidence from cell to the clinic.

Inflammatory bowel disease (IBD) comprises a group of intestinal disorders, including ulcerative colitis and Crohn's disease. Currently, the incidence and prevalence of IBD are increasing globally. Although both biologic agents and small molecule drugs have been available for treatment of IBD patients, approximately one third of treated patients do not respond to these treatments. Therefore, novel therapy or repurposing of drugs have been extensively studied to obtain an effective therapy for IBD patients. Among these drugs, metformin has been reported to exert beneficial effects in many organs via its anti-inflammatory effect. Additionally, evidence from cellular to clinical models of IBD demonstrated significant positive effects of metformin on inflammatory pathways, oxidative stress, gut barrier integrity, and gut microbiota. In this review, the beneficial effects of metformin on IBD are comprehensively summarized and discussed using the results of in vitro, in vivo, and clinical studies. Increased understanding of these protective effects and the underlying mechanisms may pave the way for effective use of metformin in IBD patients.

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.

Enterolith at the ileocecal valve mimicking a subepithelial mass.

A 32-year-old woman presented with chronic constipation for three years. Colonoscopy revealed a 2.5 cm subepithelial tumor-like lesion at the ileocecal (IC) valve with protrusion of the lesion into the lumen. A CT scan of the abdomen showed an oval-shape laminated calcified lesion adhered to the IC valve and several gallstones. An exploratory laparotomy to enterotomy with stone extraction and open cholecystectomy was performed. Operative findings showed stone erosion into the ileal wall with the lesion being covered with colonic mucosa. Pathologic examination of stones from the intestinal wall revealed an enterolith. The case exemplifies the infrequent cause of a subepithelial lesion of the gastrointestinal tract and a rare presentation of an enterolith as a subepithelial lesion within the terminal ileal wall.

Degos-like lesions as a cutaneous manifestation of cytomegalovirus infection: A rare and serious complication in a patient with drug-induced hypersensitivity syndrome.

Cytomegalovirus causes a myriad of clinical features, potentially affecting any organ system, significantly increasing morbidity and even mortality. Vascular endothelial cell infection by cytomegalovirus has been implicated in the development of vasculopathy, possibly accounting for the clinical association between cytomegalovirus and vascular thrombosis. In contrast with visceral organ involvement, the cutaneous manifestations of cytomegalovirus are variable and rarely described. Malignant atrophic papulosis, commonly known as Degos disease, is an unusual small vessel arteriopathy with a pathognomonic clinical appearance of atrophic porcelain-white central papules surrounded by telangiectatic erythema. As with the arterial occlusive process, Degos disease may be idiopathic or secondary to autoimmune disorders or viral infection. All in all, cytomegalovirus-related Degos-like presentation has never been described. This report describes a case in which disseminated cytomegalovirus disease developed 4 weeks after the onset of drug-induced hypersensitivity syndrome with prominent Degos-like skin lesions. Our case highlights a rare example of Degos-like lesions occurring due to cytomegalovirus disease and emphasizes the importance of early recognition of the characteristic cutaneous eruption as a diagnostic clue leading to the prompt management of this life-threatening infection.

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.

Utility of Forward-View Echoendoscopy for Transcolonic Fine-Needle Aspiration of Extracolonic Lesions: An Institutional Experience.

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. CONCLUSION: FV-EUS in combination with fluoroscopic guidance is an easy, safe, and effective technique for FNA of extracolonic lesions in the lower abdomen.