EBM

CRITICAL APPRAISAL

“Daily Consumption of an Aqueous Green Tea Extract Supplement Does Not Impair Liver Function or Alter Cardiovascular

Disease Risk Biomarkers in Healthy Men”

Disusun oleh :

Nama : R.M. Ridho Hidayatulloh

NIM : 1102011215

Dosen Pembimbing :

dr. Taufik Nashrulloh, S.Si

FAKULTAS KEDOKTERAN UNIVERSITAS YARSI

MARET 2014

EBM

Nama : R.M. Ridho Hidayatulloh

NIM : 1102011215

TUGAS EVIDENCE BASED MEDICINE

Skenario

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Pertanyaan (foreground question)

Apakah teh hijau yang dikonsumsi setiap hari oleh laki-laki dewasa dapat merusak fungsi hati?

PICO

• Population : Pria Dewasa

• Intervention : Mengkonsumsi the hijau setiap hari

• Comparison : Tidak mengkonsumsi the hijau

• Outcomes : Tidak merusak fungsi hati

Pencarian bukti ilmiah

Alamat website : http://www.bmj.comKata kunci : “men” AND “green tea” AND “liver function”

Limitasi : Januari 2003 – Desember 2013

Hasil Pencarian : 67 artikel

Dipilih artikel berjudul :

Daily Consumption of an Aqueous Green Tea Extract Supplement Does Not Impair Liver Function or Alter Cardiovascular Disease Risk Biomarkers in Healthy Men

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REVIEW JURNAL

Pendahuluan

The limited data on hepatotoxicity induced by dietary GTP in humans are based on case reports of abnormally high concentrations of liver injury markers. In these patients, cessation of green tea consumption normalized liver function and resumption of green tea drinking again elevated these biomarkers . Impaired liver function was observed in participants regularly consuming as little as 6 cups (;900-1200 mL) per day of green tea or 720 mg/d GTE (2). On the other hand, GTP were also suggested to protect from hepatic injury. For example, ingestion of 1 or 2% GTE in the diet for 6 wk reduced ALT and aspartate transaminase (AST) serum activities in obese but not in lean mice compared with control animals.Metoda

The trial was designed as a double-blind, placebocontrolled parallel study. The 35 eligible volunteers were randomized (stratified for age and BMI) into 1 of 2 treatment groups [GTP (n =18) or placebo (n = 17)] with similar BMI (GTP, 26.0 ± 3.0 kg/m2; placebo, 25.1 ± 3.0 kg/m2; mean ± SD) and age (GTP, 41.0 ± 9.5 y; placebo, 40.8 ± 9.5 y). Participants took a total of 6 capsules per day, 2 capsules, together with a glass of water, before each principal meal, for 3 wk and were instructed to limit their daily tea and coffee consumption to ≤3cups (~200 mL each) but to otherwise maintain their normal diet and exercise patterns.Hasil

Urinary excretion over 24 h of epicatechin and its 3’-O- and 4’-O-methylated metabolites did not differ between groups at baseline and was not altered by intake of placebo capsules for 3 wk, but was increased by GTP supplementation postintervention (P ˂ 0.0001; Wilcoxon’s matched-pairs Signed Rank test). Catechin, its 3’-O- and 4’-O-methylated metabolites, and epigallocatechin were not detectable in urine. Cumulative urinary excretion of the α- and γ-tocopherol metabolites α-CEHC and γ-CEHC, respectively, and the kidney function biomarker creatinine were not affected by dietary intervention. The plasma concentrations of AST, ALT, GGT, bilirubin, urea, uric acid, and albumin were within the physiological ranges (13–19) for all participants at all time points and remained unaltered by GTP intake. Concentrations of total cholesterol, HDL cholesterol, NEFA, TAG, α- and γ-tocopherol, and glucose in plasma obtained from fasting participants were not affected by the treatments. Time (P ˂ 0.04) and the time 3 treatment interaction (P ˂ 0.03) affected the ratio of total:HDL cholesterol. Systolic and diastolic blood pressure, plasma ADMA concentrations, and endothelium-dependent and –independent vascular relaxation did not differ between treatments at baseline and postintervention (data not shown).Kesimpulan

In conclusion, supplementation of healthy men for 3 wk with a high daily dose of 714 mg GTP did not cause adverse effects or impair liver and kidney function and did not improve CVD risk biomarkers other than the ratio of total:HDL cholesterol. Therefore, despite isolated reports of acute liver failure, a high intake of green tea for 3 wk appears to be safe for healthy men.

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APAKAH HASIL PENELITIAN TERSEBUT VALID?

A. Petunjuk Primer

1. Apakah terdapat sampel yang representatif, terdefinisi jelas, dan berada pada kondisi yang

sama dalam perjalanan penyakitnya?

2. Apakah follow-up cukup lama dan lengkap?

B. Petunjuk sekunder

1. Apakah kriteria outcome yang digunakan obyektif dan tanpa bias?

2. Bila ditemukan subgrup dengan prognosis yang beda, apakah dilakukan adjustment untuk

faktor-faktor prognostik yang penting?

3. Apakah dilakukan validasi pada suatu kelompok independen (test-set)?

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APA HASILNYA?

1. Bagaimana gambaran outcome menurut waktu?

2. Seberapa tepat perkiraan prognosis?

4

APAKAH HASIL PENELITIAN INI DAPAT DIAPLIKASIKAN?

1. Apakah pasien dalam penelitian tersebut serupa dengan pasien saya?

2. Apakah hasil tersebut membantu memilih atau menghindari terapi tertentu?

3. Apakah hasilnya membantu dalam memberikan konseling kepada pasien saya?

.

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