الفهرس 
Review of Literature 3Only 14 pages are availabe for public view
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Abstract
Nonalcoholic fatty liver Disease is considered the most common
hepatic disorder affecting 20-30% of adults worldwide and is a condition
defined by significant lipid accumulation (5–10%) in hepatic tissue in the
absence of significant chronic alcohol consumption.
The natural history of NAFLD is fairly dichotomous– NAFL is
generally benign whereas nonalcoholic steatohepatitis (NASH) can
progress to cirrhosis, liver failure, and hepatocellular carcinoma (HCC)
increasing liver related mortality. NAFLD tends to be the most common
indication for liver transplantation with high rates of complications due to
prevalent comorbidities including diabetes and obesity. NASH is also
associated with an increased mortality due to cardiovascular and chronic
kidney diseases.
Nonalcoholic fatty liver Disease pathogenesis is multifactorial as
genetic factors cooperate with metabolic and environmental factors to
promote the accumulation of fat in hepatocytes and successively cause
inflammation, cellular death and fibrosis. NAFLD is a considerable health
problem affecting the Egyptian community it was recorded in 65.3% of
children and in 62.7% of adults.
There is no licensed pharmacotherapy for NAFLD; the cornerstone
of management is lifestyle dietary and exercise interventions and bariatric
surgery or liver transplantation for some cases.
Management must focus on treatment of the ―metabolic syndrome‖
rather than NAFLD as an individual entity. This entails an important
challenge in educating clinicians in the recognition of this disease.
Antidiabetics, antioxidants, prebiotics, drugs acting on bile, lipid
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lowering therapies, and weight loss medications have been tested in
NAFLD therapy with conflicting results.
Given the well-recognized problems of adherence to lifestyle
interventions, achieving sustainable weight loss, and side-effects with
pharmacological agents adjuvant essential phospholipid (EPL) is one of the
medications currently under investigation. EPL key component is 1,2-
dilinoleoylphosphatidylcholine (DLPC) and is relating to potential positive
effects on NAFLD and NASH because of its membrane repairing,
antioxidative, and antifibrotic effects and high biocompatibility. They are
also effective in reducing serum and hepatic cholesterol and triglycerides
(Adinolfi et al.,2017) and increasing high density lipoproteins cholesterol
(HDL-C) and apolipoprotein A-I (apo A-I) levels.
The objectives of the current study were to evaluate the efficacy of
Phosphatidylcholine in addition to patient health education and intensive
lifestyle intervention and also to evaluate the impact of the clinical
pharmacist led education, counseling and follow up in the management of
Egyptian NAFLD patients with metabolic co-morbidities. .
The current study was conducted in Ain Shams Specialized
outpatient gastroenterology clinics in Cairo-Egypt. Patients diagnosed as
any types of NAFLD including non-alcoholic fatty liver, non-alcoholic
steatohepatitis were recruited to the study according to the predetermined
inclusion and exclusion criteria. Hundred eligible patients with NAFLD
were included in the study after signing an informed consent were
randomized into two study groups (each n=50) at the beginning of the
study for investigating the efficacy and safety of phosphatidylcholine as
adjuvant treatment of NAFLD patients with metabolic co-morbidities as
follows:
Summary and Conclusion
109
group I (Control group; CG) who received only lifestyle interventions
through receiving health education by the clinical pharmacist for life style
modification for achieving sustainable weight loss, involving diet and
exercise for 6 months.
group II (Intervention Group, IG) who received lifestyle therapy
through health education by the clinical pharmacist plus treatment with
2100 mg/day Phosphatidylcholine for 6 months (two Essentiale® soft
capsules three times daily).
All patients underwent clinical, biochemical, and radiological
measurements of NAFLD and metabolic co-morbidities at the beginning
of the study (baseline), after 3 month (midpoint) and after 6 month at the
(endpoint). Adverse events of therapy were also recorded.
All Patients received Health education by clinical pharmacist every
two weeks in a scheduled interview for 6 months on NAFLD and
accompanying diseases such as diabetes, obesity, and metabolic
syndrome, life style modification for achieving sustainable weight loss,
involving diet and exercise.
Regrouping for investigating the impact of a clinical pharmacist
education, counseling and follow up in the management of NAFLD
patients with metabolic co-morbidities was done at the end of the study
duration based on patients compliance to scheduled follow up and
education sessions into; compliant group, those who attended all 12
sessions (n=60); and non-compliant group, those who attended more than
8 sessions but did not complete all 12 sessions (n=40). No participants
attended less than 8 sessions.
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The Results showed that:
Intervention group showed significantly (p<0.05) higher number with
normalized; ALT, total cholesterol and LDL at midpoint and endpoint,
AST at midpoint and HDLs and MDA at endpoint.
Intervention group showed a significantly higher participants‘ number
who shifted to more favorable category of NAFLD-fibrosis score
(p=0.02), radiological fibrosis stage (p=0.015) at endpoint,
radiological steatosis grades and HOMA-IR score at midpoint and
endpoint (p<0.05).
Additionally, significant number of participants in intervention group
(34%) lost MetS components compared to (10%) in control group at
endpoint (p=0.004).
Only one patient in intervention group suffered from diarrhea,
managed with anti-diarrhea and didn‘t need to interrupt treatment.
The compliant group showed a more significant decrease in weight
(p=0.003), LDL (p=0.009), and VLDL (p<0.001), and a more
significant increase in HDL (p=0.010) compared with the noncompliant
group.
Moreover, the compliant group showed a statistically significant
higher number of patients achieving normalization of total cholesterol
(p=0.002), HDL (p=0.004), waist circumference (p=0.004),
improvement of BMI category (p=0.008), liver steatosis grade
(p=0.009), liver fibrosis grade (p<0.001), and absence of dyspeptic
symptoms (p=0.0010) and hepatomegaly (p= 0.027) compared with
the non-compliant group.
Fasting blood glucose (p=0.209), fasting insulin (p=0.179), and
HOMAIR score (p=0.193) showed non-significant difference between
both groups at endpoint.
Summary and Conclusion
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Study conclusions:
EPLs had significant favorable effects on Mets attributes including
w/h ratio, TG, TC, VLDL, LDL, HDL, and HOMA-IR score at
endpoint of the study (p<0.05).
The present study proved that adding EPL to life style modifications
and health education has significantly improved the clinical,
laboratory and radiological outcomes in Egyptian NAFLD patients
with metabolic comorbidities decreasing technical and economic
burden of needed liver transplant
current study clearly demonstrated that administration of EPL may
provide a valuable treatment for patients with NAFLD
The current study has also provided significant evidence of the benefit
of incorporating a clinical pharmacist in NAFLD patient counseling,
education and follow up. This significantly facilitates reaching desired
therapeutic goals of NAFLD and metabolic co-morbidities.
Thus, the current study indicates that clinical pharmacists could be
viable health care providers for such a patient population especially in
the face of shortage of primary care provider time in developing
countries.