Table 2 Patient populations in the included studies

 Alt et al., 2016 [11]

Outpatients with noninfectious CLD of different etiologies (including NASH) who were referred to the outpatient clinic of the University Medical Centre of the Johannes Gutenberg University Mainz (excluded malignant disease, previous LT)

CLD n = 150

 NASH n = 29 (19.3%)

 NAFLD n = 25 (16.7%)

NASH n = 29

 Median age 52 y (range 24–76)

 Males 48.3%

 Cirrhosis, n = 10 (34.5%)

CLD etiology (including NASH) determined clinically and by biopsy

Biopsy n = 81 (54%)

 Chawla et al., 2016 [12]

Adults referred for the evaluation of histology-proven NASH at Mayo Clinic, Rochester (excluded cirrhosis, biliary obstruction)

NASH n = 79

 Mean age 46 y (SE 11)

 Males 35%

Age-and gender-matched US population sample, n = 2474^a

 Mean age 46 y

 Males 39%

Normative data for healthy controls^b

Biopsy

(1) Abnormal serum liver tests for > 3 months; (2) liver histology revealing > 10% steatosis and lobular inflammation with or without fibrosis; (3) exclusion of alternate CLD etiologies; (4) history of alcohol consumption < 40 g/day (men) or < 30 g/day (women); (5) no clinical or biochemical evidence for cirrhosis

 David et al., 2009 [8]

Adults with NAFLD (≥ 5% steatosis) and complete biopsy results, from two NASH CRN^c studies: (1) the NAFLD Database (observational cohort study); and (2) the PIVENS trial

NAFLD n = 713

 Definite NASH n = 436 (61%)

 Borderline NASH n = 141 (20%)

 Definitely not NASH n = 136 (19%)

Definite NASH n = 436

 Mean age 49.3 y (SD 11.9)

 Males 33.0%

 Cirrhosis, n = 49 (11.2%)

Biopsy

 Sayiner et al., 2016 [13]

Patients with an established histological diagnosis of NAFLD with or without cirrhosis. Patients with viral hepatitis, with significant alcohol intake (> 20 g/day for men, > 10 g/day for women), and with other causes of CLD were excluded

NAFLD with cirrhosis n = 30^d

 Mean age 54.1 y (SD 10.8)

 Males 56.7%

NAFLD without cirrhosis n = 59

 Mean age 49.1 y (SD 10.4)

 Males 37.3%

Biopsy

 Tapper and Lai, 2016 [14]

Patients with NAFLD enrolled in a NAFLD registry (Beth Israel Deaconess Medical Center, Boston, MA) (Excluded other CLDs and daily consumption of > 20 g alcohol)

NAFLD n = 151

 NASH n = 67 (44%)

 Advanced fibrosis n = 30 (20%) [Age not reported for NASH patients]

No significant weight loss achieved n = 104

 NASH n = 42 (44%)

 Mean NFS –1.41 (SD 1.80)

 Mean FIB-4 index 1.47 (SD 0.99)

 Advanced fibrosis n = 20 (20%)

Significant weight loss achieved n = 47

 NASH n = 25 (54%)

 Mean NFS –1.95 (SD 1.62)

 Mean FIB-4 index 1.29 (SD 0.80)

 Advanced fibrosis n = 10 (21.7%)

Biopsy (NAS 5–8)

 Chande et al. 2006 [15]

Adults (18–75 y) with NASH and persistently (≥ 3 months) abnormal ALT and/or AST. (Excluded overuse of alcohol [20 g/week]; other CLDs or other hepatic, GI, renal, cardiovascular, neurological, or hematological disorder; receipt of herbal treatments or dietary supplements except multivitamins/minerals)

NASH n = 8

YHK group n = 5

 Mean age 56 y (SD 7)

 Males 20%

Placebo group n = 3

 Mean age 47 y (SD 12)

 Males 67%

Cirrhosis status not stated

Biopsy

 Sanyal et al. 2010 [16]

Adults without DM with NASH. Definite or possible steatohepatitis with an activity score of ≥ 5, or definite steatohepatitis with an activity score of 4. A score of ≥ 1 for hepatocellular ballooning was required. (Excluded cirrhosis, other CLDs, alcohol consumption [> 20 g/day women; > 30 g/day men] for ≥ 3 consecutive months during the previous 5 y; receipt of drugs known to cause steatohepatitis)

NASH n = 247

 Mean age 46.3 y (SD 11.9)

 Males 40%

Pioglitazone n = 80

 Vitamin E n = 84

 Placebo n = 83

(Cirrhosis excluded)

Biopsy

 Palsgrove et al. 2016 [17]

Patients (≥ 18 y) with NASH, recruited through local clinicians and disease support groups

NASH n = 132^e

 Mean age 50.2 y

 Males 47%

Self-reported cirrhosis n = 17 (13%)

Self-reported diagnosis of NASH from a healthcare provider