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. 2017 Feb 27;177(5):633–640. doi: 10.1001/jamainternmed.2016.9607

Table. Randomized Clinical Trials (RCTs) With Posttreatment Histological Features of the Liver Assessing Thiazolidinedione Therapy in Nonalcoholic Steatohepatitis (NASH) Included in the Meta-analysis.

Source No. of Patients Mean Age, y Male, % Mean BMI Diabetes, % Agent (Daily Dosage) Trial Duration, mo Comparator BMI Change From Baseline, % Quality Scorea
Ratziu et al,15 2008 63 54 59 31 31 Rosiglitazone maleate (8 mg) 12 Placebo +1 7 (H)
Sanyal et al,16 2004 20 46 50 32 0 Pioglitazone hydrochloride (30 mg) 6 Vitamin E 0 7 (E)
Belfort et al,17 2006 55 51 45 34 48 Pioglitazone hydrochloride (45 mg) 6 Placebo +2.7 7 (E)
Aithal et al,18 2008 74 54 61 31 0 Pioglitazone hydrochloride (30 mg) 12 Placebo +3 7 (E)
Idilman et al,19 2008 74 47 59 32 0 Rosiglitazone maleate (8 mg) 12 Metformin hydrochloride, placebo −2.6 4 (B, C, D, E)
Omer et al,20 2010 64 49 55 31 70 Rosiglitazone maleate (4 mg) 12 Metformin hydrochloride, metformin hydrochloride plus rosiglitazone maleate 0 4 (B, C, D, E)
Sanyal et al,21 2010 247 46 40 34 0 Pioglitazone hydrochloride (30 mg) 24 Vitamin E, placebo +4.8 8
Cusi et al,12 2016 101 51 70 34 51 Pioglitazone hydrochloride (45 mg) 18 Placebo +1 8

Abbreviation: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared).

a

The Cochrane Risk of Bias Tool (score range, 0-8) score for RCTs is reported, with failing items in parentheses. Quality items of RCTs according to the Cochrane Risk of Bias Tool are as follows: A (adequate method of sequence generation), B (masking of participants performed), C (masking of personnel performed), D (masking of assessors performed), E (randomization concealment adequate), F (adequate assessment of each outcome), G (selective outcome reporting avoided), and H (intent-to-treat analysis of the results).