{"title":"Efficacy and safety of elobixibat in patients with chronic constipation-A randomized, multicenter, double-blind, placebo-controlled, parallel-group study from India.","authors":"Piyush Agarwal, Brajesh Kumar Jha, Jaganmohan Somagoni, Srinivas Shenoy B, Vipul Modh, Sanketh Kumar Chakilam, Vinay Kumar, Mukewar Shrikant Vasantrao, Mukesh Kalla, Anumula Kavitha, Omesh Goyal, Ashima Bhatia","doi":"10.1007/s12664-024-01719-7","DOIUrl":"10.1007/s12664-024-01719-7","url":null,"abstract":"<p><strong>Background: </strong>Elobixibat is a locally acting ileal bile acid transporter (IBAT) inhibitor that relieves functional constipation in patients by accelerating colonic transit. In this study, we aimed at determining the efficacy and safety of elobixibat for short-term treatment (two weeks) of chronic constipation in Indian patients.</p><p><strong>Methods: </strong>The present study was a randomized, double-blind, parallel-group, placebo-controlled, phase III study to evaluate efficacy and safety of elobixibat. The study planned to enroll patients with chronic constipation of at least six months' duration, satisfying Rome IV criteria for functional constipation. Following a run-in of approximately 14 days to confirm eligibility and determine baseline frequency of spontaneous bowel movements (SBMs), eligible patients were randomized 1:1 either to elobixibat or to placebo groups. The change in weekly frequency of spontaneous bowel movements (SBMs) at the end of treatment (week two) over baseline was the primary efficacy endpoint in this trial. Primary efficacy analyses were based on the modified intention-to-treat (mITT) population. This trial is registered at CTRI (Clinical Trial Registry of India).</p><p><strong>Results: </strong>Between April 2023 and December 2023, 150 patients were randomized into the two-week trial. In mITT population (n = 146 [elobixibat = 75 and placebo = 71]), the least square mean (LSM) difference between elobixibat (3.83) and placebo (2.68) was 1.15 (95% CI, 0.31, 1.99) demonstrating a statistically significant improvement (p = 0.008) in weekly frequency of SBMs (week two over baseline) with the use of elobixibat. The proportions of patients with a complete spontaneous bowel movement (CSBM) \"response\" was significantly higher with elobixibat (49.33%) compared to the placebo (26.76%) treatment (difference 22.57% [95% CI, 8.36%, 36.78%] [p = 0.005]). The most common adverse event (AE) was abdominal pain (elobixibat = 6 patients [7.89%] vs. placebo = 3 patients [4.05%]).</p><p><strong>Conclusions: </strong>Elobixibat was well tolerated and improved bowel movement frequency within two weeks of treatment in Indian patient population with chronic constipation.</p><p><strong>Clinical trial registry number: </strong>CTRI/2022/10/046690.</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"336-344"},"PeriodicalIF":2.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12141165/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rescue cannulation techniques in difficult biliary access-A comprehensive review.","authors":"Pardhu Bharat Neelam, Harshal S Mandavdhare","doi":"10.1007/s12664-024-01718-8","DOIUrl":"10.1007/s12664-024-01718-8","url":null,"abstract":"<p><p>Selective biliary cannulation is the prerequisite for successful biliary interventions. In the setting of cannulation failure, various rescue cannulation techniques are used for achieving selective biliary access. The various rescue cannulation techniques are (1) free-hand techniques (precut papillotomy and fistulotomy); (2) wire-guided techniques (transpancreatic sphincterotomy [TPS] and double guidewire [DGW]) and (3) endoscopic ultrasound (EUS)-guided technique (EUS-guided rendezvous for biliary access). The morphology of the papilla is the best guide to select the rescue technique. For classic and pendulous down facing papilla, pre-cut fistulotomy is preferable while for irregular ridged type, pre-cut papillotomy is suitable, while for small flat type, a very cautious pre-cut papillotomy may be utilized only by experts in pre-cut techniques. When an inadvertent pancreatic duct cannulation occurs, TPS is the preferred technique for all except small flat type of papilla where DGW is preferable to avoid perforation. We review the literature comparing these techniques to assess their efficacy and safety. Finally, we provide an algorithm that can be used to select the best rescue technique.</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"286-297"},"PeriodicalIF":2.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Santhosh E Kumar, Gayathiri K Chellaiya, Kunwar A Singh, Reka Karuppusami, Dolly Daniel, Vinoi G David, Sukesh C Nair, Santosh Varughese, Joy Mammen, Elwyn Elias, Chundammanil E Eapen, Uday G Zachariah, Ashish Goel
{"title":"Centrifugal technique of plasma exchange and low-dose steroid to treat very severe alcoholic hepatitis patients: A retrospective analysis.","authors":"Santhosh E Kumar, Gayathiri K Chellaiya, Kunwar A Singh, Reka Karuppusami, Dolly Daniel, Vinoi G David, Sukesh C Nair, Santosh Varughese, Joy Mammen, Elwyn Elias, Chundammanil E Eapen, Uday G Zachariah, Ashish Goel","doi":"10.1007/s12664-024-01569-3","DOIUrl":"10.1007/s12664-024-01569-3","url":null,"abstract":"<p><strong>Background: </strong>Low-volume plasma exchange (PLEX) and low-dose steroid improve survival in severe alcoholic hepatitis. We aimed to compare one-year survival of very severe alcoholic hepatitis (VSAH) patients treated with centrifugal PLEX (cPLEX), membrane PLEX (mPLEX) or standard medical treatment (SMT).</p><p><strong>Methods: </strong>We retrospectively analyzed survival in consecutive VSAH patients treated at our department from November 2017 to September 2021. PLEX patients received low-volume PLEX along with low-dose steroid (tab. prednisolone 10 mg or 20 mg daily). To adjust for baseline differences between the three treatment (cPLEX, mPLEX or SMT) groups, propensity score (PS) matching was done. Acute-on-chronic liver failure (ACLF) was defined as per European Association for the Study of the Liver (EASL). The primary study outcome was one-year transplant-free survival of PS-matched VSAH patients treated with cPLEX compared to SMT.</p><p><strong>Results: </strong>Of 101 PLEX-eligible VSAH patients, 30 patients were treated with cPLEX, 21 with mPLEX and 50 with SMT. On comparing 30 PS-matched patients each in the cPLEX group vs. the SMT group, transplant-free survival in the cPLEX group was 86.7% at one month, 70% at three months and 52.4% at one year and in the SMT group was 33.3% at one month, 23.3% at three months and 16.7% at one year with hazard ratio (HR [95% CI]) in favor of the cPLEX group (0.29 [0.15-0.56], p < 0.001). Total 21 patients each (PS-matched) in cPLEX and mPLEX groups were compared and one-year survival was better with cPLEX (0.33 [0.16-0.69], p = 0.001). The sub-group analysis of VSAH (PS-matched cohort) patients with ACLF also showed better survival with cPLEX compared to SMT (0.38 [0.17-0.83], p = 0.003) and compared to mPLEX (0.43 [0.17-0.95], p = 0.03).</p><p><strong>Conclusion: </strong>Better one-year transplant-free survival was noted among PS-matched VSAH patients treated with cPLEX (and low-dose steroid) compared to SMT (without steroid).</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"345-354"},"PeriodicalIF":2.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141283645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Hepatomegaly and hyperlipidemia in a toddler.","authors":"Gautham Pai, Divya Achutha","doi":"10.1007/s12664-024-01609-y","DOIUrl":"10.1007/s12664-024-01609-y","url":null,"abstract":"","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"381-383"},"PeriodicalIF":2.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141081330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mukundkumar V Patel, Dhruvkumar M Patel, Dhara K Patel, Maitri M Patel, Lalitkumar B Patel, Vahin M Patel
{"title":"Inflammatory bowel diseases presenting as pyrexia of unknown origin without bowel symptoms: A case series.","authors":"Mukundkumar V Patel, Dhruvkumar M Patel, Dhara K Patel, Maitri M Patel, Lalitkumar B Patel, Vahin M Patel","doi":"10.1007/s12664-024-01620-3","DOIUrl":"10.1007/s12664-024-01620-3","url":null,"abstract":"","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"399-402"},"PeriodicalIF":2.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Pyrexia in inflammatory bowel disease: Drug fever due to mesalamine as a cause.","authors":"Parna Pathak, Shankar Roy, Rajinder Kumar, Sapna Pahil, Vikas Suri, Vishal Sharma","doi":"10.1007/s12664-024-01688-x","DOIUrl":"10.1007/s12664-024-01688-x","url":null,"abstract":"","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"407-408"},"PeriodicalIF":2.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142286175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comment on \"Eating behaviors and mental health among celiac patients, case-control study\".","authors":"Ahmed Faizan, Hubaib Iqbal Cheema","doi":"10.1007/s12664-025-01762-y","DOIUrl":"10.1007/s12664-025-01762-y","url":null,"abstract":"","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"411-412"},"PeriodicalIF":2.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ernesto Calderon Martinez, Gabriela D Briceño Silva, Camila Sanchez Cruz, Nathnael Abera Woldehana, Yash Shah, Dushyant Singh Dahiya, Manesh Kumar Gangwani, Saurabh Chandan, Fides Myles C Caliwag, Rodrigo Sebastian Maldonado, Rubeliz Bolivar-Barrios, Ada Motino, Rashmi Advani
{"title":"Tranexamic acid as treatment for acute gastrointestinal bleeding: A comprehensive systematic review and meta-analysis.","authors":"Ernesto Calderon Martinez, Gabriela D Briceño Silva, Camila Sanchez Cruz, Nathnael Abera Woldehana, Yash Shah, Dushyant Singh Dahiya, Manesh Kumar Gangwani, Saurabh Chandan, Fides Myles C Caliwag, Rodrigo Sebastian Maldonado, Rubeliz Bolivar-Barrios, Ada Motino, Rashmi Advani","doi":"10.1007/s12664-025-01749-9","DOIUrl":"10.1007/s12664-025-01749-9","url":null,"abstract":"<p><strong>Introduction: </strong>Gastrointestinal (GI) bleeding is a common and potentially life-threatening medical emergency. Despite advancements in therapy, mortality rates associated with GI bleeding remain high (2.4% to 11%). Tranexamic acid (TXA) has been proposed as a treatment. However, the HALT-IT trial questioned its efficacy and safety, showing no significant reduction in death and potential thrombotic complications. This meta-analysis aims to evaluate the effectiveness and safety of TXA in treating acute GI bleeding.</p><p><strong>Methods: </strong>This systematic review and meta-analysis followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. In October 2024 a comprehensive literature search was conducted using relevant MeSh terms and keywords in 11 databases. We included patients with acute GI bleeding treated with TXA and compared it with either a placebo or standard treatment. Outcomes such as mortality, need for blood transfusion, surgery and thrombotic events were studied.</p><p><strong>Results: </strong>The search identified 6810 articles. After screening, 23 studies were included, encompassing 2,061,231 participants. Our meta-analysis demonstrated that TXA significantly reduced rebleeding rates overall (RR: 0.81, 95% CI: 0.87-0.97). This effect was even more pronounced in studies with a lower risk of bias. Additionally, TXA use was associated with a mortality reduction when administered through both oral and intravenous routes (RR: 0.56, 95% CI: 0.35-0.89) and in cases of upper GI bleeding (RR: 0.72, 95% CI: 0.59-0.87). However, TXA was linked to a significant increase in mortality in patients with lower GI bleeding (RR: 1.67, 95% CI: 1.44-1.93) and overall reduction when only randomized controlled trials (RCTs) were included (RR:0.83, 95% CI; 0.70 to 0,97, I2=0%). Other variables, such as the overall need for blood transfusions (RR: 1.03, 95% CI: 0.80-1.32), thrombotic events (RR: 1.30, 95% CI: 0.75-2.23) and the need for surgical intervention (RR: 0.78, 95% CI: 0.57-1.09), did not reach statistical significance. However, when considering only low risk of bias studies the need for surgical interventions was significantly reduced (RR: 0.85, 95% CI: 0.75 to 0.97, I2=0%).</p><p><strong>Conclusions: </strong>Our findings suggest that TXA significantly reduces rebleeding in patients, particularly in upper gastrointestinal bleeding (UGIB) and reduces need for surgical intervention when excluding high risk of bias studies. The findings also demonstrated a significant reduction in mortality, particularly in certain sub-groups. There was no definitive evidence that its use is associated with thromboembolictic events. These results highlight the potential benefit of TXA without dismissing the need for cautious interpretation and individualized patient management when considering TXA for GI bleeding.</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"311-329"},"PeriodicalIF":2.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143541902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}