Title

Improvement in nonalcoholic steatohepatitis: a comparison of various treatment modalities offered to patients attending a teaching, tertiary care hospital, in Karachi, Pakistan

Date of Award

2007

Document Type

Thesis

Degree Name

Master of Science in Epidemiology & Biostatistics (MSc Epidemiology & Biostats)

Department

Community Health Sciences

Abstract

Background Non-alcoholic steatohepatitis (NASH) has become an important disease entity owing to its p otential to progress to cinhosis and hepatic failure. It is associated with metabolic syndrome, diabetes mellitus, hypertension, obesity, and drugs like amiodarone, diltiazem, nifedipine, corticosteroids. Due to increasing prevalence of the above mentioned pathological conditions in the developing countries, the prevalence of NASH can be anticipated to be quite high. Evi Bence based data that support any treatment options for NASH is currently lacking. conducted a retrospective cohort study to compare various treatment options ided to patients with NASH, visiting the Aga Khan University Hospital (AKUH), Karachi, and assessed for improvement in liver status, via reduction in serum alanine aminotransferase (ALT) levels as a surrogate biomarker. Pati ents & Methods Patients of age between 20-70 years, with sonological evidence of fatty liver and raised serum ALT (ALT > 55 IU/1 for males; ALT > 33 Mil for females) were included, having at least one follow up, after a baseline visit. The patients had variable number of follow ups, a maximum of 3 follow ups were considered. They attended the outpatient clinics at AKUH from April 2000 — April 2007. Subjects with only one visit were excluded. Records of patients were reviewed to collect data on age, sex, body mass index (BMI), Abstract past medical and family history of diabetes mellitus, hypertension, dyslipidemia, and laboratory investigations, such as liver function tests, total lipid profile, and serum glucose levels. The treatment options were categorized as (1) diet and exercise only, (2) diet, exercise and statins, and (3) diet, exercise and other medications. Serum ALT levels, a non-invasive surrogate marker to assess steato hepatitis, was the main outcome, measured in 1U/1. Repeated-measures ANOVA, using a linear mixed model approach, with treatment options as the between subject factor, and follow up times as the within subject factor was performed. P-value < 0.05 was considered significant. Results A total of 69 subjects, aged between 20-70 years were selected. Of these, 50 (72%) were males and the remaining were females. The mean age was 40 ± 12 years. Sixty-five patients (94%) were overweight, 9 (13%) were hypertensive, 44 (64%) were diabetic, and 48 (70%) dyslipidemic. Thirty-one (45%) received the option of diet and exercise only, and experienced a 72% reduction in serum ALT levels, over the mean follow up time of 9 ± 3 months. Twelve (17%) received statins along with counseling for dietary restriction and weight reduction. The serum ALT levels among this group decreased by 56% over the mean follow up time of 11 ± 7 months. Twenty-six (38%) received other medications along with diet and exercise and experienced a 73% reduction in serum ALT levels over the mean follow up time of 10 ± 4 months. Mixed model analysis demonstrated that the mean ALT declined at follow up times, irrespective of the prescribed treatment modality. It also showed that the decline in serum ALT levels at the various follow ups is different for males and females (p-value 0.045). Conclusions Serum ALT levels among patients with NASH decreased with time, regardless of theprovided treatment, and this decrease was different for males and females. There is aneed for further studies on this subject, in similar circumstances, to better assess improvement of fatty liver status in NASH with respect to treatment and time.

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