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This study evaluates efficacy of Phosphatidylcholine in addition to life style modification and patient health education by clinical Pharmacist in the Management of Non Alcoholic Fatty Liver NAFLD. All participants with NAFLD will receive life style intervention and half of them will receive additionally Phosphatidylcholine.
As a result of increasing rates of obesity Non Alcoholic Fatty Liver (NAFLD) is the most common liver disorder affecting 17-46% of adults and parallels the prevalence of Metabolic Syndrome (MetS) and its components which also increases the risk of more advanced disease both in adults and in children.
Its pathogenesis is complex and multifactorial, mainly involving genetic, environmental and metabolic factors. New concepts are constantly appearing in the literature, promising new diagnostic and therapeutic tools. Further studies are needed to better characterize not only NAFLD development but overall NAFLD progression, in order to better identify NAFLD patients at higher risk of metabolic, cardiovascular and neoplastic complications. Pharmacological treatments aimed primarily at improving liver disease should generally be limited to those with biopsy-proven Nonalcoholic steatohepatitis (NASH) and liver fibrosis. Not much therapeutic options for NAFLD are accepted until today besides correction of obesity with hypocaloric diets and physical exercise and controlling hyperglycemia with diet, insulin, or oral hypoglycemic agents. Weight loss generally reduces hepatic steatosis.Essential phospholipid (EPL) as a nutritional supplement is one of the drugs under discussion with significant positive effects as antioxidative, antifibrotic effects and high biocompatibility on NAFLD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 50 Participants with NAFLD that receive lifestyle modification by Clinical Pharmacist plus Phosphatidylcholine two soft capsules 3 times daily(2.1 g per day) for 6 month |
|
| Control Group | Active Comparator | 50 Participants with NAFLD that receive only lifestyle modification by Clinical Pharmacist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phosphatidyl Choline | Dietary Supplement | 2.1 g Phosphatidylcholine daily in addition to lifestyle modification |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline Body Mass Index (BMI) at 3 and 6 month | person's weight in kilograms divided by the square of the person's height in metres (kg/m2). | baseline, at 3 and 6 month |
| change from baseline liver stiffness at 3 and 6 month | Liver Stiffness and fibrosis score measured by Transient elastography (Fibroscan) F0 = no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3 = numerous septa without cirrhosis F4 = cirrhosis | baseline , at 3 and 6 month |
| change from baseline Lipid Profile | Total cholesterol ,Triglyceride ,Low Density Lipoprotein ,High Density Lipoprotein | baseline , at 3 and 6 month |
| change from baseline Oxidative stress markers | malonaldehyde (MDA) as an index of lipid peroxidation by colorimetric assay | baseline , at 3 and 6 month |
| change from baseline NAFLD score at 3 and 6 month | NAFLD Fibrosis Score is based on six readily available variables (age, BMI, hyperglycemia, albumin, platelet count, AST/ALT ratio) and it is calculated using published formula (http: //naflds- core.com) . A low cutpoint (score < -1.455) signified the absence of advanced fibrosis, whereas a high cutpoint (score> 0.676) identified advanced fibrosis. | baseline , at 3 and 6 month |
| change from baseline homeostasis model assessment Insulin resistance HOMA IR scores at 3 and 6 month | HOMA IR scores <3 normal HOMA IR scores >5 severe insulin resistance 3 to 5 moderate insulin resistance |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline Complete Blood Picture at 3 and 6 month | platelet count | baseline , at 3 and 6 month |
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Patients were included in the study when the following criteria to were fulfilled :
Inclusion Criteria:
Patients were excluded from the study if showing evidence :
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12485966 | Background | National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available. | |
| 27062661 |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010713 | Phosphatidylcholines |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D005994 | Glycerophosphates |
| D010743 | Phospholipids |
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Shams University Hospitals and Ain Shams Specialized Hospital outpatient Gastroenterology Clinics.
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| Lifestyle modification | Behavioral | Lifestyle modification and health education by Clinical Pharmacist |
|
|
| baseline , at 3 and 6 month |
| Background |
| European Association for the Study of the Liver (EASL); 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. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available. |
| 23297154 | Background | Chalasani N; Writing Group for American Association for Study of Liver Diseases; American College of Gastroenterology; American Gastroenterology Association practice guideline on Diagnosis and Management of Nonalcoholic Fatty Liver Disease. Reply: To PMID 22488764. Hepatology. 2013 Feb;57(2):853-4. doi: 10.1002/hep.26199. Epub 2013 Jan 7. No abstract available. |
| 29118867 | Background | Ahmed MH, Noor SK, Bushara SO, Husain NE, Elmadhoun WM, Ginawi IA, Osman MM, Mahmoud AO, Almobarak AO. Non-Alcoholic Fatty Liver Disease in Africa and Middle East: An Attempt to Predict the Present and Future Implications on the Healthcare System. Gastroenterology Res. 2017 Oct;10(5):271-279. doi: 10.14740/gr913w. Epub 2017 Oct 26. |
| 27217791 | Result | Gundermann KJ, Gundermann S, Drozdzik M, Mohan Prasad VG. Essential phospholipids in fatty liver: a scientific update. Clin Exp Gastroenterol. 2016 May 5;9:105-17. doi: 10.2147/CEG.S96362. eCollection 2016. |
| 28714183 | Result | Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available. |
| D008563 |
| Membrane Lipids |
| D008055 | Lipids |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |