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).
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).