A Comparative Study to Evaluate the Effectiveness of Obeticholic Acid vs Ursodeoxycholic Acid in Patients With Non-alcoholic Fatty Liver Disease (Grade I & II)

A Comparative Study to Evaluate the Effectiveness of Obeticholic Acid vs Ursodeoxycholic Acid in Patients With Non-alcoholic Fatty Liver Disease (Grade I & II) | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A Comparative Study to Evaluate the Effectiveness of Obeticholic Acid vs Ursodeoxycholic Acid in Patients With Non-alcoholic Fatty Liver Disease (Grade I & II) Sara Shreen, Afrah Ahmed, Fatima Anjum Siddiqui, Mohammed Abdul Aziz, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6600753/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract BACKGROUND NAFLD, a common liver disorder where fat builds up in the liver without excessive alcohol intake, can be effectively managed with pharmacological interventions. Two such treatments, OCA and UDCA, have shown promising outcomes in improving NAFLD parameters. However, a comparative evaluation of their effectiveness, particularly in individuals with Grade I and II NAFLD, is required. METHODS The research took place at a tertiary care hospital within the Gastroenterology Department and involved 80 individuals diagnosed with Grade I and II NAFLD. The participants were randomly allocated to receive either OCA or UDCA treatment for a duration of 6 months. Data was collected from various sources, such as patient records, case files, and laboratory test results. In addition, patient contact information was obtained to gather supplementary details and enable follow-up procedures. RESULTS The data obtained from the study was analyzed using SPSS 25 (SPSS, Inc., 2020), a statistical software program. Descriptive statistics were utilized to summarize the demographic and clinical characteristics of the patients. Changes in liver size, liver function tests (LFTs), lipid profiles, and comorbidities were assessed before and after the treatment period. Statistical procedures, such as paired t-tests and independent t-tests, were employed to compare the outcomes between the two treatment groups. Both the OCA and UDCA groups demonstrated notable enhancements in LFTs, lipid profiles, liver size, and comorbidities. The UDCA group exhibited significant improvements in LFTs and lipid profiles, while the OCA group showed significant improvements in LFTs and lipid profiles, excluding triglyceride levels. Additionally, both treatment groups experienced a significant decrease in liver size. CONCLUSION The results of this study suggest that both OCA and UDCA have positive impacts on LFTs, lipid profiles, liver size, and comorbidities in patients diagnosed with Grade I and II NAFLD. However, UDCA appears to be more effective than OCA in improving NAFLD parameters and promoting liver health. To further validate these findings, it is essential to conduct long-term studies and randomized controlled trials that can evaluate the sustained effectiveness and safety profiles of these medications. Healthcare professionals should carefully consider individual patient characteristics, disease stage, and weigh the potential risks and benefits of each medication when making treatment decisions for NAFLD. Non-alcoholic fatty liver disease Obeticholic acid Ursodeoxycholic acid Grade I and II NAFLD Comparative study Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 BACKGROUND Non-alcoholic fatty liver disease (NAFLD) is a clinical condition characterized by the accumulation of excessive fat in the liver, typically in individuals who consume little to no alcohol [ 1 ]. It encompasses a range of liver disorders, from simple fatty liver to more severe conditions like steatohepatitis, fibrosis, and cirrhosis [ 1 ]. NAFLD poses a significant public health challenge due to its increasing prevalence and potential for severe liver-related complications [ 1 ]. This discussion aims to explore the epidemiology, causes, underlying mechanisms, diagnosis, and management strategies for NAFLD. The global prevalence of NAFLD is rapidly rising, making it the second most common reason for liver transplant waiting lists [ 2 ]. Western countries have particularly high rates of NAFLD, affecting around 70–75% of individuals with diabetes and obesity and approximately 33.3% of the general population [ 3 ]. Prevalence estimates vary across regions, ranging from 13% in Africa to 30% in the United States [ 3 ]. If the NAFLD epidemic continues unchecked, projections suggest that the burden of end-stage liver disease will double by 2030 [ 2 ]. Various factors contribute to the development and risk of NAFLD, including obesity, insulin resistance, type 2 diabetes, polycystic ovarian syndrome, obstructive sleep apnea, menopause, malnutrition, genetic variations, dietary and lifestyle factors, as well as ethnicity [ 4 ][ 5 ]. These factors interact with hormonal, dietary, and genetic influences, ultimately influencing the underlying mechanisms of NAFLD [ 6 ]. The pathophysiology of NAFLD involves a complex interaction of factors such as hormonal dysregulation, nutrition, intestinal dysbiosis, insulin resistance, lipotoxicity, hepatic inflammation, and genetic influences [ 6 ]. Factors like obesity, excessive calorie intake, and high-fructose diets contribute to the accumulation of liver fat [ 6 ]. Insulin resistance and hyperinsulinemia further promote lipogenesis and oxidative stress, leading to liver cell damage and inflammation [ 6 ]. Genetic variations, including those in the PNPLA3 gene, also play a role in hepatic fat levels and susceptibility to NAFLD [ 7 ]. Accurate diagnosis of NAFLD requires the exclusion of other causes of liver fat accumulation and distinguishing between its subtypes, namely NAFL and NASH [ 8 ]. Diagnosis often involves non-invasive tests such as serologic testing, ultrasonography, transient elastography, and magnetic resonance imaging, with liver biopsy reserved for cases where non-invasive assessments are inconclusive or advanced disease is suspected [ 9 ][ 10 ][ 11 ]. The management of NAFLD involves a combination of pharmacological and non-pharmacological approaches [ 12 ]. Lifestyle modifications, including weight loss, adopting healthy dietary patterns, regular exercise, and smoking cessation, are fundamental to treatment [ 12 ]. Pharmacological interventions may include medications such as pioglitazone, vitamin E, GLP-1 analogues, statins, obeticholic acid, and emerging therapies [ 12 ]. In specific cases, bariatric surgery and liver transplantation may be considered [ 13 ]. NAFLD is associated with various extrahepatic complications, including cardiovascular disease, diabetes mellitus, chronic kidney disease, extrahepatic neoplasms, and endocrinopathies [ 14 ][ 15 ][ 16 ][ 17 ][ 18 ]. These complications arise due to systemic inflammation, insulin resistance, and shared risk factors between NAFLD and these conditions [ 19 ]. Regular screening, comprehensive management, and targeted treatments are essential to address and mitigate these complications [ 20 ]. The increasing prevalence of NAFLD and its potential for liver-related complications highlight the need to prioritize its recognition as a global health issue [ 1 ]. It is essential to enhance understanding of the risk factors, diagnostic criteria, and management approaches for NAFLD [ 3 ]. A holistic approach encompassing lifestyle adjustments, early detection, and suitable interventions is indispensable for effectively tackling this complex disease and its related complications [ 20 ]. METHODS This study was designed as a comparative prospective observational study conducted over a period of 6 months. The aim was to assess the effectiveness of two drugs, Obeticholic acid (OCA) and Ursodeoxycholic acid (UDCA), in the treatment of non-alcoholic fatty liver disease (NAFLD) at Grade I and II. The study took place at a tertiary care hospital in Hyderabad, specifically within the Department of Gastroenterology, which provided medical care to both outpatients and inpatients. To gather data for the study, information was collected from patient case sheets and laboratory investigation reports. The drugs administered in the study were Obeticholic acid at a dosage of 5 mg and Ursodeoxycholic acid at a dosage of 300 mg. The inclusion criteria for participants included individuals aged between 18 to 70 years, both male and female, from both the inpatient and outpatient departments. These individuals had to have a confirmed diagnosis of NAFLD based on abdominal ultrasound (USG), either with or without any accompanying comorbidities. On the other hand, certain individuals were excluded from the study. This included paediatric patients, those with incomplete laboratory data, pregnant and lactating women, patients with viral hepatitis, autoimmune hepatitis, hereditary or drug-induced liver diseases (DILDs), individuals with a history of alcohol consumption, and patients taking hepatotoxic drugs or dyslipidemic medications. By employing these inclusion and exclusion criteria, the study aimed to examine the effects of OCA and UDCA in treating NAFLD at Grade I and II. The comparative analysis of these two drugs would provide insights into their efficacy and potential differences in outcomes. RESULTS The survey data collected for this study underwent statistical analysis using the SPSS 25 software. To begin with, descriptive analysis was conducted to provide a summary of the variables. The hypotheses formulated for the study were then tested using appropriate statistical tools, focusing on the dependent and independent variables. The results obtained were presented and discussed within the theoretical framework of the study. Reliability testing was performed to assess internal consistency, and the normality of the data was evaluated. Since the data was found to follow a normal distribution, parametric tests such as paired sample t-tests and independent t-tests were employed for further analysis. A significance level of p < 0.05 was considered to indicate statistical significance, with an alpha (α) error set at 5% and a beta (β) error set at 20%, providing a study power of 80%. In the tables, statistically significant differences were denoted by "*", highly significant differences by "**", and non-significant differences by "#". Table No.1: Descriptive Statistics (UDCA) : Descriptive statistics were calculated for various parameters in the UDCA and OCA groups, including total cholesterol (T.C.), triglycerides (T.G.), high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and USG. The mean, minimum, maximum, variance, and standard error values were reported for each parameter, indicating significant treatment effects. Mean differences between the pre- and post-treatment measurements were calculated for each parameter in the UDCA and OCA groups. The results demonstrated that both UDCA and OCA treatments had positive effects on reducing total cholesterol, triglyceride, LDL, VLDL, AST, ALT levels, and total bilirubin. Additionally, both treatments had a positive impact on increasing HDL levels. It was observed that the mean differences were generally smaller in the UDCA group compared to the OCA group, indicating a slightly greater effect of UDCA treatment. UDCA DISTRIBUTION Parameter N Min Max Mean Std. Deviation Variance Statistic Statistic Statistic Statistic Std. Error Statistic Statistic T.C. Before 40 117 198 191.0225 7.723595 48.8483 2386.157 After 40 110 195 173.4675 7.010283 44.33692 1965.763 T.G. Before 40 31 252 156.9 7.736842 48.93208 2394.349 After 40 54 244 147.7225 6.947381 43.9391 1930.644 HDL Before 40 29 69.6 44.5025 1.294196 8.185211 66.99769 After 40 32.8 68 52.0975 1.181549 7.472771 55.8423 LDL Before 40 55 182 110.8775 5.317338 33.6298 1130.963 After 40 51 164 94.84 4.029564 25.4852 649.4953 VLDL Before 40 11.6 45 30.5575 1.179797 7.461693 55.67687 After 40 12 44 27.025 1.308134 8.273366 68.44859 AST Before 40 12 164 52.15 5.777005 36.53699 1334.951 After 40 11 109 42.33 3.41669 21.60905 466.9509 ALT Before 40 19 188 66.2125 5.615366 35.51469 1261.293 After 40 15 132 40.0575 3.144464 19.88734 395.5061 TOTAL BILIRUBIN Before 40 0.3 31.6 0.79 0.071054 0.449387 0.201949 After 40 0.2 1.3 0.58 0.045461 0.287518 0.082667 USG Before 40 128 209 160.575 3.576434 22.61936 511.6353 After 40 115 198 140.975 2.968961 18.77736 352.5891 In summary, the study findings indicated significant improvements in lipid profiles, liver function tests, liver size and USG grades for both UDCA and OCA treatments. However, the UDCA group displayed greater effectiveness in improving the measured parameters. These results emphasize the potential benefits of UDCA in managing non-alcoholic fatty liver disease (NAFLD) compared to OCA. DISCUSSION The study findings regarding the effects of UDCA (ursodeoxycholic acid) and OCA (obeticholic acid) treatments on lipid profiles, liver function tests, and liver size in patients with non-alcoholic fatty liver disease (NAFLD). The results demonstrate significant improvements in these parameters for both treatment groups, with UDCA showing greater effectiveness compared to OCA. The improvements in lipid profiles, including reductions in total cholesterol, triglycerides, LDL, and VLDL levels, as well as an increase in HDL levels, align with previous research on UDCA and OCA treatments for NAFLD (Ratziu et al., 2018; Younossi et al., 2019). These lipid changes indicate a positive impact on dyslipidemia, a common feature of NAFLD, and suggest the potential of both treatments in managing lipid abnormalities associated with the disease. The improvements in liver function tests, specifically reductions in AST and ALT levels, reflect the improvement of hepatocellular injury and inflammation. These findings are consistent with previous studies demonstrating the hepatoprotective effects of UDCA and OCA in NAFLD (Ratziu et al., 2018; Younossi et al., 2019). The significant reduction in liver size observed through ultrasonography further suggests a favorable response to both treatments, indicating a reduction in liver steatosis and inflammation (Younossi et al., 2019). The comparison between the UDCA and OCA groups indicates a slightly greater effectiveness of UDCA in improving the measured parameters. This finding is consistent with previous studies reporting the favorable effects of UDCA in NAFLD management (Li et al., 2019; Sumida et al., 2020). UDCA exerts its hepatoprotective effects through various mechanisms, including modulation of bile acid metabolism, reduction of oxidative stress, and inhibition of apoptosis (Li et al., 2019). These mechanisms may contribute to the observed improvements in lipid profiles, liver function, and liver size in the UDCA group. However, OCA, a selective farnesoid X receptor agonist, has shown promising results in the treatment of NAFLD and non-alcoholic steatohepatitis (NASH) in clinical trials (Ratziu et al., 2018). Nevertheless, the present study suggests that UDCA might be more effective in improving the studied lipid and liver-related parameters. Further research and larger clinical trials are needed to better understand the comparative effectiveness of UDCA and OCA in NAFLD treatment. It is important to note that both UDCA and OCA treatments demonstrated statistically significant improvements in lipid profiles, liver function tests, and liver size compared to baseline. These findings highlight the potential of both treatments in managing NAFLD and support the notion that pharmacological interventions can positively impact disease progression. However, the choice of treatment should be based on individual patient characteristics, comorbidities, and potential side effects, which need to be carefully considered in clinical practice. While this study contributes valuable insights into the effects of UDCA and OCA on NAFLD, there are limitations to consider. The sample size was relatively small, and the study duration was limited to a 6-month period. Long-term follow-up studies with larger sample sizes are warranted to assess the sustainability of the observed improvements and to evaluate the safety profiles of these treatments. CONCLUSION The study findings demonstrate the considerable impact of UDCA and OCA treatments on lipid profiles, liver function tests, and liver size in patients diagnosed with NAFLD. The results suggest that UDCA exhibits superior efficacy in improving the measured parameters compared to OCA. However, further inquiries are necessary to establish a comprehensive comprehension of the relative efficacy and long-term ramifications of these therapeutic approaches. Overall, these findings contribute to the expanding body of evidence supporting the utilization of pharmacological interventions for the effective management of NAFLD. Declarations This study was conducted with the agreement of IRB Approval of the Deccan College of Medical Sciences, Hyderabad, Telangana, India. References Younossi ZM, Koenig AB, Abdelatif D et al (2016) Global epidemiology of nonalcoholic fatty liver disease—meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology 64(1):73–84 Estes C, Razavi H, Loomba R et al (2018) Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology 67(1):123–133 Estes C, Anstee QM, Arias-Loste MT et al (2018) Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016–2030. J Hepatol 69(4):896–904 Chalasani N, Younossi Z, Lavine JE et al (2018) The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology 67(1):328–357 Rinella ME (2015) Nonalcoholic fatty liver disease: A systematic review. JAMA 313(22):2263–2273 Byrne CD, Targher G (2015) NAFLD: A multisystem disease. J Hepatol 62(1 Suppl):S47–S64 Tilg H, Moschen AR, Roden M (2017) NAFLD and diabetes mellitus. Nat Rev Gastroenterol Hepatol 14(1):32–42 Romeo S, Kozlitina J, Xing C et al (2008) Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease. Nat Genet 40(12):1461–1465 Tapper EB, Sengupta N, Hunink MG et al (2016) Cost-effectiveness analysis: Risk stratification of nonalcoholic fatty liver disease (NAFLD) by the primary care physician using the NAFLD fibrosis score. PLoS ONE 11(2):e0147237 European Association for the Study of the Liver (EASL) (2016) European Association for the Study of Diabetes (EASD), European Association for the Study of Obesity (EASO). EASL-EASD-EASO clinical practice guidelines for the management of non-alcoholic fatty liver disease. J Hepatol 64(6):1388–1402 Castera L, Friedrich-Rust M, Loomba R (2019) Noninvasive assessment of liver disease in patients with nonalcoholic fatty liver disease. Gastroenterology 156(5):1264–1281 Chalasani N, Younossi Z, Lavine JE et al (2018) The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology 67(1):328–357 Singh S, Allen AM, Wang Z, Prokop LJ, Murad MH, Loomba R (2015) Fibrosis progression in nonalcoholic fatty liver vs nonalcoholic steatohepatitis: A systematic review and meta-analysis of paired-biopsy studies. Clin Gastroenterol Hepatol 13(4):643–654 Targher G, Byrne CD, Tilg H (2020) NAFLD and increased risk of cardiovascular disease: Clinical associations, pathophysiological mechanisms and pharmacological implications. Gut 69(9):1691–1705 Mantovani A, Byrne CD, Bonora E, Targher G (2018) Nonalcoholic fatty liver disease and risk of incident type 2 diabetes: A meta-analysis. Diabetes Care 41(2):372–382 Targher G, Chonchol M, Byrne CD (2014) CKD and nonalcoholic fatty liver disease. Am J Kidney Dis 64(4):638–652 Loomba R, Lim JK, Patton H et al (2020) AGA clinical practice update on screening and surveillance for hepatocellular carcinoma in patients with nonalcoholic fatty liver disease: Expert review. Gastroenterology 158(6):1822–1830e6 Kotronen A, Yki-Järvinen H (2008) Fatty liver: A novel component of the metabolic syndrome. Arterioscler Thromb Vasc Biol 28(1):27–38 Younossi Z, Anstee QM, Marietti M et al (2018) Global burden of NAFLD and NASH: Trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol 15(1):11–20 Lonardo A, Mantovani A, Lugari S, Targher G (2019) NAFLD in some common endocrine diseases: Prevalence, pathophysiology, and principles of diagnosis and management. Int J Mol Sci 20(11):2841 Additional Declarations The authors declare no competing interests. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6600753","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":452518648,"identity":"6cca255a-e8a7-45d6-b5a8-497f70944540","order_by":0,"name":"Sara Shreen","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA30lEQVRIiWNgGAWjYLACxgYQyXwASFgwMPAQr4UtgYEhQYIkLTwGxGmRbz/78OPPHffk+KV7Pj7m/SEhx89zgPHDxxzcWgzOpBtL854pNpacc3azMU+ChLFkbwOz5MxteLQwpDFIM7YlJG64kbtNGqglccN5BjZmXjxa5PufMf/82ZZQv/9GzjPitDDcSGOT4G1LSDCQyGGDaDnbgF+LwY1nbNZALYYzbqQZG85JA/ql52AzXr/I96cx3wQ6TJ5/RvLDB29sbIAhlnzww0d8DsMCINE0CkbBKBgFo4ACAADth0r19ReuMgAAAABJRU5ErkJggg==","orcid":"","institution":"","correspondingAuthor":true,"prefix":"","firstName":"Sara","middleName":"","lastName":"Shreen","suffix":""},{"id":452521636,"identity":"de462d67-9d56-407c-9ebb-813f444b16cf","order_by":1,"name":"Afrah Ahmed","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Afrah","middleName":"","lastName":"Ahmed","suffix":""},{"id":452521637,"identity":"202b36d3-75ab-49a2-839c-971f5d70c403","order_by":2,"name":"Fatima Anjum 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08:36:00","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-6600753/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6600753/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":82167443,"identity":"8d7bc47c-2380-448e-9af3-e7295c7898e9","added_by":"auto","created_at":"2025-05-07 09:21:59","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":40884,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cu\u003e\u003cem\u003e\u003cstrong\u003eGender Distribution: \u003c/strong\u003e\u003c/em\u003e\u003c/u\u003eIn terms of gender distribution, it was observed that 45% of the UDCA group and 57.5% of the OCA group consisted of males, while the remaining percentages represented females.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6600753/v1/2c4baf7bcc8ae39135274a79.png"},{"id":82167450,"identity":"ee39795e-35e5-4092-b19e-2d2107acc5b7","added_by":"auto","created_at":"2025-05-07 09:21:59","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":54851,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cu\u003e\u003cem\u003e\u003cstrong\u003eAge Distribution: \u003c/strong\u003e\u003c/em\u003e\u003c/u\u003eRegarding age distribution, a small proportion of respondents (5% in UDCA and 7.5% in OCA) belonged to the 18-30 age group, the majority of patients (32.5% in UDCA and 37.5% in OCA) fell into the 31-45 age group, and the rest were above 45 years old.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-6600753/v1/25acea887b250c0b1083d179.png"},{"id":82168821,"identity":"5d0f897f-0d10-47b3-b0ab-58e8dad912f8","added_by":"auto","created_at":"2025-05-07 09:37:59","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":38774,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cu\u003e\u003cem\u003e\u003cstrong\u003eComorbidities Distribution: \u003c/strong\u003e\u003c/em\u003e\u003c/u\u003eThe above graph shows Comorbidities distribution in both UDCA and OCA Group. ACID PEPTIC DISEASE and HTN are high frequent comorbidities and PERIPHERAL NEUROPATHY is less frequent comorbidities.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-6600753/v1/1151789b19641774cb282388.png"},{"id":82168499,"identity":"ebcb2619-10d3-47f4-9a26-6e25ae1e0422","added_by":"auto","created_at":"2025-05-07 09:29:59","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":12781,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cu\u003e\u003cem\u003e\u003cstrong\u003eMMAS Scoring: \u003c/strong\u003e\u003c/em\u003e\u003c/u\u003eIn the above graph, MMAS Scoring distribution of the both the UDCA and OCA group is given. After the trial of UDCA, there are 85% patients are of High [\u0026gt;8], 10% patients are of Moderate [6-8], 5% patients are of Low [\u0026lt;6]. Also, After the trial of OCA, there are 77.5% patients are of High [\u0026gt;8],15% patients are of Moderate [6-8], 7.5% patients are of Low [\u0026lt;6]. The proportion of Score 8 patients is high in UDCA group\u003cu\u003e\u003cstrong\u003e.\u003c/strong\u003e\u003c/u\u003e\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-6600753/v1/6f698f8ac7dc4c7c4720ae27.png"},{"id":82167447,"identity":"69ac9216-bed6-46d0-918c-a3abcd33af27","added_by":"auto","created_at":"2025-05-07 09:21:59","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":32696,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cu\u003e\u003cem\u003e\u003cstrong\u003eFigure 4: Prescribed Medications:\u003c/strong\u003e\u003c/em\u003e\u003c/u\u003e\u003cstrong\u003e \u003c/strong\u003eThe distribution of medications in both the UDCA and OCA groups included commonly used medications such as Tab Ornio, Nexpro HP kit, Inj Zofer, and Tab. Glimepride. When considering comorbidities, acid peptic disease and hypertension were found to be the most prevalent, while peripheral neuropathy was less commonly observed\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-6600753/v1/dd1bd14ddcaca613629e83d2.png"},{"id":82167445,"identity":"e912145c-2a64-4539-bd0e-71041d3db146","added_by":"auto","created_at":"2025-05-07 09:21:59","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":22792,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cu\u003e\u003cem\u003e\u003cstrong\u003eLipid Profile: \u003c/strong\u003e\u003c/em\u003e\u003c/u\u003eAnalysis of lipid profiles revealed changes in lipid measures for both the UDCA and OCA groups, with the UDCA group showing greater improvements compared to the OCA group. Similarly, liver function tests (LFT) demonstrated significant changes in both groups, with the UDCA group exhibiting greater improvements. Ultrasonography (USG) measurements, specifically liver size, indicated a decrease for both groups, with the UDCA. group showing a slightly greater reduction. The distribution of USG grades also indicated a higher proportion of patients in the UDCA group transitioning to lower grades compared to the OCA group.\u003c/p\u003e","description":"","filename":"6.png","url":"https://assets-eu.researchsquare.com/files/rs-6600753/v1/d505d87053f4308bf2b0cfb8.png"},{"id":82168822,"identity":"a4cd4ef8-5a80-45e6-bf59-4d859bf951ef","added_by":"auto","created_at":"2025-05-07 09:38:03","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":649482,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6600753/v1/1e1a7179-0c15-425b-a3e1-0c8550bbc2b1.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003eA Comparative Study to Evaluate the Effectiveness of Obeticholic Acid vs Ursodeoxycholic Acid in Patients With Non-alcoholic Fatty Liver Disease (Grade I \u0026amp; II)\u003c/p\u003e","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003eNon-alcoholic fatty liver disease (NAFLD) is a clinical condition characterized by the accumulation of excessive fat in the liver, typically in individuals who consume little to no alcohol [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. It encompasses a range of liver disorders, from simple fatty liver to more severe conditions like steatohepatitis, fibrosis, and cirrhosis [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. NAFLD poses a significant public health challenge due to its increasing prevalence and potential for severe liver-related complications [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. This discussion aims to explore the epidemiology, causes, underlying mechanisms, diagnosis, and management strategies for NAFLD. The global prevalence of NAFLD is rapidly rising, making it the second most common reason for liver transplant waiting lists [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Western countries have particularly high rates of NAFLD, affecting around 70\u0026ndash;75% of individuals with diabetes and obesity and approximately 33.3% of the general population [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Prevalence estimates vary across regions, ranging from 13% in Africa to 30% in the United States [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. If the NAFLD epidemic continues unchecked, projections suggest that the burden of end-stage liver disease will double by 2030 [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Various factors contribute to the development and risk of NAFLD, including obesity, insulin resistance, type 2 diabetes, polycystic ovarian syndrome, obstructive sleep apnea, menopause, malnutrition, genetic variations, dietary and lifestyle factors, as well as ethnicity [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e][\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. These factors interact with hormonal, dietary, and genetic influences, ultimately influencing the underlying mechanisms of NAFLD [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe pathophysiology of NAFLD involves a complex interaction of factors such as hormonal dysregulation, nutrition, intestinal dysbiosis, insulin resistance, lipotoxicity, hepatic inflammation, and genetic influences [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Factors like obesity, excessive calorie intake, and high-fructose diets contribute to the accumulation of liver fat [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Insulin resistance and hyperinsulinemia further promote lipogenesis and oxidative stress, leading to liver cell damage and inflammation [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Genetic variations, including those in the PNPLA3 gene, also play a role in hepatic fat levels and susceptibility to NAFLD [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Accurate diagnosis of NAFLD requires the exclusion of other causes of liver fat accumulation and distinguishing between its subtypes, namely NAFL and NASH [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Diagnosis often involves non-invasive tests such as serologic testing, ultrasonography, transient elastography, and magnetic resonance imaging, with liver biopsy reserved for cases where non-invasive assessments are inconclusive or advanced disease is suspected [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e][\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e][\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe management of NAFLD involves a combination of pharmacological and non-pharmacological approaches [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Lifestyle modifications, including weight loss, adopting healthy dietary patterns, regular exercise, and smoking cessation, are fundamental to treatment [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Pharmacological interventions may include medications such as pioglitazone, vitamin E, GLP-1 analogues, statins, obeticholic acid, and emerging therapies [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. In specific cases, bariatric surgery and liver transplantation may be considered [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. NAFLD is associated with various extrahepatic complications, including cardiovascular disease, diabetes mellitus, chronic kidney disease, extrahepatic neoplasms, and endocrinopathies [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e][\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e][\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e][\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e][\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. These complications arise due to systemic inflammation, insulin resistance, and shared risk factors between NAFLD and these conditions [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Regular screening, comprehensive management, and targeted treatments are essential to address and mitigate these complications [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe increasing prevalence of NAFLD and its potential for liver-related complications highlight the need to prioritize its recognition as a global health issue [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. It is essential to enhance understanding of the risk factors, diagnostic criteria, and management approaches for NAFLD [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. A holistic approach encompassing lifestyle adjustments, early detection, and suitable interventions is indispensable for effectively tackling this complex disease and its related complications [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003eThis study was designed as a comparative prospective observational study conducted over a period of 6 months. The aim was to assess the effectiveness of two drugs, Obeticholic acid (OCA) and Ursodeoxycholic acid (UDCA), in the treatment of non-alcoholic fatty liver disease (NAFLD) at Grade I and II. The study took place at a tertiary care hospital in Hyderabad, specifically within the Department of Gastroenterology, which provided medical care to both outpatients and inpatients. To gather data for the study, information was collected from patient case sheets and laboratory investigation reports. The drugs administered in the study were Obeticholic acid at a dosage of 5 mg and Ursodeoxycholic acid at a dosage of 300 mg. The inclusion criteria for participants included individuals aged between 18 to 70 years, both male and female, from both the inpatient and outpatient departments. These individuals had to have a confirmed diagnosis of NAFLD based on abdominal ultrasound (USG), either with or without any accompanying comorbidities. On the other hand, certain individuals were excluded from the study. This included paediatric patients, those with incomplete laboratory data, pregnant and lactating women, patients with viral hepatitis, autoimmune hepatitis, hereditary or drug-induced liver diseases (DILDs), individuals with a history of alcohol consumption, and patients taking hepatotoxic drugs or dyslipidemic medications. By employing these inclusion and exclusion criteria, the study aimed to examine the effects of OCA and UDCA in treating NAFLD at Grade I and II. The comparative analysis of these two drugs would provide insights into their efficacy and potential differences in outcomes.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eThe survey data collected for this study underwent statistical analysis using the SPSS 25 software. To begin with, descriptive analysis was conducted to provide a summary of the variables. The hypotheses formulated for the study were then tested using appropriate statistical tools, focusing on the dependent and independent variables. The results obtained were presented and discussed within the theoretical framework of the study.\u003c/p\u003e\n\u003cp\u003eReliability testing was performed to assess internal consistency, and the normality of the data was evaluated. Since the data was found to follow a normal distribution, parametric tests such as paired sample t-tests and independent t-tests were employed for further analysis. A significance level of p\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered to indicate statistical significance, with an alpha (\u0026alpha;) error set at 5% and a beta (\u0026beta;) error set at 20%, providing a study power of 80%. In the tables, statistically significant differences were denoted by \u0026quot;*\u0026quot;, highly significant differences by \u0026quot;**\u0026quot;, and non-significant differences by \u0026quot;#\u0026quot;.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n \u003cdiv align=\"left\" class=\"colspec\"\u003e\u003cspan type=\"BoldUnderline\" name=\"Emphasis\"\u003eTable No.1: Descriptive Statistics (UDCA)\u003c/span\u003e: Descriptive statistics were calculated for various parameters in the UDCA and OCA groups, including total cholesterol (T.C.), triglycerides (T.G.), high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and USG. The mean, minimum, maximum, variance, and standard error values were reported for each parameter, indicating significant treatment effects. Mean differences between the pre- and post-treatment measurements were calculated for each parameter in the UDCA and OCA groups. The results demonstrated that both UDCA and OCA treatments had positive effects on reducing total cholesterol, triglyceride, LDL, VLDL, AST, ALT levels, and total bilirubin. Additionally, both treatments had a positive impact on increasing HDL levels. It was observed that the mean differences were generally smaller in the UDCA group compared to the OCA group, indicating a slightly greater effect of UDCA treatment.\u003c/div\u003e\n \u003cdiv align=\"left\" class=\"colspec\"\u003e\u003cbr\u003e\u003c/div\u003e\u0026nbsp;\u003ctable id=\"Taba\" border=\"1\"\u003e\n \u003ccolgroup cols=\"9\"\u003e\u003c/colgroup\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" colspan=\"9\"\u003e\n \u003cp\u003eUDCA DISTRIBUTION\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eParameter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMin\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMax\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003eMean\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStd. 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\u003cp\u003e8.185211\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e66.99769\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAfter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e32.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e68\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e52.0975\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.181549\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7.472771\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e55.8423\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eLDL\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBefore\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e55\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e182\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e110.8775\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.317338\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e33.6298\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1130.963\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAfter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e51\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e164\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e94.84\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.029564\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e25.4852\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e649.4953\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eVLDL\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBefore\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e11.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e45\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e30.5575\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.179797\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7.461693\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e55.67687\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAfter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e27.025\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.308134\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e8.273366\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e68.44859\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eAST\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBefore\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e164\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e52.15\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.777005\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36.53699\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1334.951\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAfter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e109\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e42.33\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3.41669\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e21.60905\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e466.9509\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eALT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBefore\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e19\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e188\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e66.2125\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.615366\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e35.51469\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1261.293\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAfter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e15\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e132\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40.0575\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3.144464\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e19.88734\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e395.5061\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eTOTAL BILIRUBIN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBefore\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e31.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.79\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.071054\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.449387\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.201949\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAfter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.58\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.045461\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.287518\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.082667\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eUSG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBefore\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e128\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e209\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e160.575\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3.576434\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e22.61936\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e511.6353\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAfter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e115\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e198\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e140.975\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2.968961\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e18.77736\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e352.5891\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003eIn summary, the study findings indicated significant improvements in lipid profiles, liver function tests, liver size and USG grades for both UDCA and OCA treatments. However, the UDCA group displayed greater effectiveness in improving the measured parameters. These results emphasize the potential benefits of UDCA in managing non-alcoholic fatty liver disease (NAFLD) compared to OCA.\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThe study findings regarding the effects of UDCA (ursodeoxycholic acid) and OCA (obeticholic acid) treatments on lipid profiles, liver function tests, and liver size in patients with non-alcoholic fatty liver disease (NAFLD). The results demonstrate significant improvements in these parameters for both treatment groups, with UDCA showing greater effectiveness compared to OCA.\u003c/p\u003e \u003cp\u003eThe improvements in lipid profiles, including reductions in total cholesterol, triglycerides, LDL, and VLDL levels, as well as an increase in HDL levels, align with previous research on UDCA and OCA treatments for NAFLD (Ratziu et al., 2018; Younossi et al., 2019). These lipid changes indicate a positive impact on dyslipidemia, a common feature of NAFLD, and suggest the potential of both treatments in managing lipid abnormalities associated with the disease.\u003c/p\u003e \u003cp\u003eThe improvements in liver function tests, specifically reductions in AST and ALT levels, reflect the improvement of hepatocellular injury and inflammation. These findings are consistent with previous studies demonstrating the hepatoprotective effects of UDCA and OCA in NAFLD (Ratziu et al., 2018; Younossi et al., 2019). The significant reduction in liver size observed through ultrasonography further suggests a favorable response to both treatments, indicating a reduction in liver steatosis and inflammation (Younossi et al., 2019).\u003c/p\u003e \u003cp\u003eThe comparison between the UDCA and OCA groups indicates a slightly greater effectiveness of UDCA in improving the measured parameters. This finding is consistent with previous studies reporting the favorable effects of UDCA in NAFLD management (Li et al., 2019; Sumida et al., 2020). UDCA exerts its hepatoprotective effects through various mechanisms, including modulation of bile acid metabolism, reduction of oxidative stress, and inhibition of apoptosis (Li et al., 2019). These mechanisms may contribute to the observed improvements in lipid profiles, liver function, and liver size in the UDCA group.\u003c/p\u003e \u003cp\u003eHowever, OCA, a selective farnesoid X receptor agonist, has shown promising results in the treatment of NAFLD and non-alcoholic steatohepatitis (NASH) in clinical trials (Ratziu et al., 2018). Nevertheless, the present study suggests that UDCA might be more effective in improving the studied lipid and liver-related parameters. Further research and larger clinical trials are needed to better understand the comparative effectiveness of UDCA and OCA in NAFLD treatment.\u003c/p\u003e \u003cp\u003eIt is important to note that both UDCA and OCA treatments demonstrated statistically significant improvements in lipid profiles, liver function tests, and liver size compared to baseline. These findings highlight the potential of both treatments in managing NAFLD and support the notion that pharmacological interventions can positively impact disease progression. However, the choice of treatment should be based on individual patient characteristics, comorbidities, and potential side effects, which need to be carefully considered in clinical practice.\u003c/p\u003e \u003cp\u003eWhile this study contributes valuable insights into the effects of UDCA and OCA on NAFLD, there are limitations to consider. The sample size was relatively small, and the study duration was limited to a 6-month period. Long-term follow-up studies with larger sample sizes are warranted to assess the sustainability of the observed improvements and to evaluate the safety profiles of these treatments.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThe study findings demonstrate the considerable impact of UDCA and OCA treatments on lipid profiles, liver function tests, and liver size in patients diagnosed with NAFLD. The results suggest that UDCA exhibits superior efficacy in improving the measured parameters compared to OCA. However, further inquiries are necessary to establish a comprehensive comprehension of the relative efficacy and long-term ramifications of these therapeutic approaches. Overall, these findings contribute to the expanding body of evidence supporting the utilization of pharmacological interventions for the effective management of NAFLD.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eThis study was conducted with the agreement of IRB Approval of the Deccan College of Medical Sciences, Hyderabad, Telangana, India.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eYounossi ZM, Koenig AB, Abdelatif D et al (2016) Global epidemiology of nonalcoholic fatty liver disease\u0026mdash;meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology 64(1):73\u0026ndash;84\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEstes C, Razavi H, Loomba R et al (2018) Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology 67(1):123\u0026ndash;133\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEstes C, Anstee QM, Arias-Loste MT et al (2018) Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016\u0026ndash;2030. J Hepatol 69(4):896\u0026ndash;904\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChalasani N, Younossi Z, Lavine JE et al (2018) The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology 67(1):328\u0026ndash;357\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRinella ME (2015) Nonalcoholic fatty liver disease: A systematic review. JAMA 313(22):2263\u0026ndash;2273\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eByrne CD, Targher G (2015) NAFLD: A multisystem disease. J Hepatol 62(1 Suppl):S47\u0026ndash;S64\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTilg H, Moschen AR, Roden M (2017) NAFLD and diabetes mellitus. Nat Rev Gastroenterol Hepatol 14(1):32\u0026ndash;42\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRomeo S, Kozlitina J, Xing C et al (2008) Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease. Nat Genet 40(12):1461\u0026ndash;1465\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTapper EB, Sengupta N, Hunink MG et al (2016) Cost-effectiveness analysis: Risk stratification of nonalcoholic fatty liver disease (NAFLD) by the primary care physician using the NAFLD fibrosis score. PLoS ONE 11(2):e0147237\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Association for the Study of the Liver (EASL) (2016) European Association for the Study of Diabetes (EASD), European Association for the Study of Obesity (EASO). EASL-EASD-EASO clinical practice guidelines for the management of non-alcoholic fatty liver disease. J Hepatol 64(6):1388\u0026ndash;1402\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCastera L, Friedrich-Rust M, Loomba R (2019) Noninvasive assessment of liver disease in patients with nonalcoholic fatty liver disease. Gastroenterology 156(5):1264\u0026ndash;1281\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChalasani N, Younossi Z, Lavine JE et al (2018) The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology 67(1):328\u0026ndash;357\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSingh S, Allen AM, Wang Z, Prokop LJ, Murad MH, Loomba R (2015) Fibrosis progression in nonalcoholic fatty liver vs nonalcoholic steatohepatitis: A systematic review and meta-analysis of paired-biopsy studies. 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Gastroenterology 158(6):1822\u0026ndash;1830e6\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKotronen A, Yki-J\u0026auml;rvinen H (2008) Fatty liver: A novel component of the metabolic syndrome. Arterioscler Thromb Vasc Biol 28(1):27\u0026ndash;38\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYounossi Z, Anstee QM, Marietti M et al (2018) Global burden of NAFLD and NASH: Trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol 15(1):11\u0026ndash;20\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLonardo A, Mantovani A, Lugari S, Targher G (2019) NAFLD in some common endocrine diseases: Prevalence, pathophysiology, and principles of diagnosis and management. Int J Mol Sci 20(11):2841\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Non-alcoholic fatty liver disease, Obeticholic acid, Ursodeoxycholic acid, Grade I and II NAFLD, Comparative study","lastPublishedDoi":"10.21203/rs.3.rs-6600753/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6600753/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBACKGROUND\u003c/h2\u003e \u003cp\u003eNAFLD, a common liver disorder where fat builds up in the liver without excessive alcohol intake, can be effectively managed with pharmacological interventions. Two such treatments, OCA and UDCA, have shown promising outcomes in improving NAFLD parameters. However, a comparative evaluation of their effectiveness, particularly in individuals with Grade I and II NAFLD, is required.\u003c/p\u003e\u003ch2\u003eMETHODS\u003c/h2\u003e \u003cp\u003e The research took place at a tertiary care hospital within the Gastroenterology Department and involved 80 individuals diagnosed with Grade I and II NAFLD. The participants were randomly allocated to receive either OCA or UDCA treatment for a duration of 6 months. Data was collected from various sources, such as patient records, case files, and laboratory test results. In addition, patient contact information was obtained to gather supplementary details and enable follow-up procedures.\u003c/p\u003e\u003ch2\u003eRESULTS\u003c/h2\u003e \u003cp\u003eThe data obtained from the study was analyzed using SPSS 25 (SPSS, Inc., 2020), a statistical software program. Descriptive statistics were utilized to summarize the demographic and clinical characteristics of the patients. Changes in liver size, liver function tests (LFTs), lipid profiles, and comorbidities were assessed before and after the treatment period. Statistical procedures, such as paired t-tests and independent t-tests, were employed to compare the outcomes between the two treatment groups. Both the OCA and UDCA groups demonstrated notable enhancements in LFTs, lipid profiles, liver size, and comorbidities. The UDCA group exhibited significant improvements in LFTs and lipid profiles, while the OCA group showed significant improvements in LFTs and lipid profiles, excluding triglyceride levels. Additionally, both treatment groups experienced a significant decrease in liver size.\u003c/p\u003e\u003ch2\u003eCONCLUSION\u003c/h2\u003e \u003cp\u003eThe results of this study suggest that both OCA and UDCA have positive impacts on LFTs, lipid profiles, liver size, and comorbidities in patients diagnosed with Grade I and II NAFLD. However, UDCA appears to be more effective than OCA in improving NAFLD parameters and promoting liver health. To further validate these findings, it is essential to conduct long-term studies and randomized controlled trials that can evaluate the sustained effectiveness and safety profiles of these medications. Healthcare professionals should carefully consider individual patient characteristics, disease stage, and weigh the potential risks and benefits of each medication when making treatment decisions for NAFLD.\u003c/p\u003e","manuscriptTitle":"A Comparative Study to Evaluate the Effectiveness of Obeticholic Acid vs Ursodeoxycholic Acid in Patients With Non-alcoholic Fatty Liver Disease (Grade I \u0026amp; II)","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-07 09:21:54","doi":"10.21203/rs.3.rs-6600753/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ea9bfb1b-6137-45bc-847a-72a3c3a63200","owner":[],"postedDate":"May 7th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-05-07T09:21:54+00:00","versionOfRecord":[],"versionCreatedAt":"2025-05-07 09:21:54","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6600753","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6600753","identity":"rs-6600753","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}