Table 1.
Author | Study design | Target Population | Treatment duration | n | Study groups | Age, years | Female (n, %) | BMI, (kg/m2) | Total cholesterol (mg/dl) | LDL cholesterol (mg/dl) | HDL cholesterol (mg/dl) | Triglycerides (mg/dl) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Balan et al. (1994) [18] | Randomized, double-blind, placebo-controlled | Primary biliary cirrhosis | 2 years | 89 | Placebo | 52 ± 9.4 | 77 (87) | ND | 277.5 ± 106.0 | ND | 60.9 ± 20.3 | 117.2 ± 70.7 |
88 | UDCA 13–15 mg/kg/day | 54 ± 9.3 | 80 (91) | ND | 288.3 ± 121.7 | ND | 63.1 ± 23.6 | 102.0 ± 50.4 | ||||
Battezzati et al. (1993) [21] | Randomized, double-blind, placebo-controlled | Primary biliary cirrhosis | 6 months | 44 | UDCA 500 mg/day | 54 ± 2 | 37 (84) | ND | 263 ± 12 | ND | 78 ± 6 | ND |
44 | Placebo | 55 ± 2 | 41 (93) | ND | 266 ± 13 | ND | 61 ± 5 | ND | ||||
Braga et al. (2009) [22] | Randomized, double-blind, placebo-controlled | Primary hypercholeste-rolemia | 6 months | 57 | UDCA 13–15 mg/kg/day | ND | ND | ND | 241.1 ± 30 | 160.2 ± 23 | 47.7 ± 12 | 166.0 ± 70 |
68 | Placebo | ND | ND | ND | 244.7 ± 29 | 160.6 ± 19 | 48.0 ± 12 | 180.8 ± 96 | ||||
Carulli et al. (1981) [32] | Randomized, double-blind, placebo-controlled | Hypertriglyce-ridemia | 1 month | 8 | UDCA 600 mg/day | 40.4a | 1 (12) | ND | 266a | ND | 38a | 405a |
8 | Placebo | 40.2a | 2 (25) | ND | 254a | ND | 39a | 249a | ||||
Fromm et al. (1983) [23] | Randomized, double-blind, placebo-controlled | Patients with gallstones | 2 years | 12 | Placebo | 55 ± 10.3 | 10 (82) | ND | 201 ± 7.6 | ND | ND | 162 ± 30.8 |
12 | UDCA 400 mg/day | 56 ± 16.9 | 8 (67) | ND | 227 ± 16.5 | ND | ND | 162 ± 20.6 | ||||
12 | UDCA 800 mg/day | 55 ± 16.9 | 6 (50) | ND | 248 ± 17.7 | ND | ND | 180 ± 32.4 | ||||
Gianturco et al. (2013) [39] | Randomized, double-blind, placebo-controlled | NAFLD | 1 year | 53 | ALA 400 mg/day + UDCA 300 mg/day | 65 ± 5 | 23 (43) | 30 ± 2.1 | 203 ± 8 | 133 ± 9 | 45 ± 5 | 123 ± 11 |
54 | ALA 400 mg/day | 60 ± 4 | 25 (46) | 29.5 ± 2 | 208 ± 9 | 133 ± 10 | 49 ± 6 | 128 ± 15 | ||||
46 | UDCA 300 mg/day | 62 ± 6 | 21 (45) | 29.7 ± 1.6 | 209 ± 10 | 136 ± 11 | 47 ± 7 | 127 ± 11 | ||||
47 | Placebo | 61 ± 4 | 23 (48) | 29.3 ± 1.3 | 207 ± 7 | 138 ± 12 | 43 ± 8 | 129 ± 9 | ||||
Leuschner et al. (2010) [40] | Randomized, double-blind, placebo-controlled | NASH | 18 months | 95 | UDCA 23–28 mg/kg/day | 41.4 (18–71)a | 32 (33) | ND | 148 ± 102 | ND | ND | 208 ± 111 |
91 | Placebo | 45.0 (18–73)a | 28 (30) | ND | 162 ± 94 | ND | ND | 202 ± 111 | ||||
Lindenthal et al. (2002) [33] | Randomized, placebo-controlled, cross-over | Healthy volunteers | 1 month | 20 | Overall | 19–38b | 5 (25) | ND | ||||
20 | UDCA 750 mg/day | 186 ± 24 | ND | ND | ND | |||||||
20 | Placebo | 186 ± 19 | ND | ND | ND | |||||||
Méndez-Sánchez et al. (2004) [19] | Randomized, double-blind, placebo-controlled | NAFLD | 6 weeks | 14 | UDCA 1200 mg/day | 39.7 ± 8 | 14 (100) | 34.2 ± 4.2 | 196.1 ± 36.7 | ND | ND | ND |
13 | Placebo | 37.8 ± 8 | 13 (100) | 33.3 ± 1.6 | 177.7 ± 29.3 | ND | ND | ND | ||||
Miettinen et al. (1995) [20] | Randomized, double-blind, placebo-controlled | Primary biliary cirrhosis | 2 years | 23 | UDCA 12–15 mg/kg/day | 50 ± 9 | 18 (78) | 24.1 ± 2.8 | 250 ± 122 | 138 ± 39 | 65 ± 19 | ND |
22 | Placebo | 57 ± 14 | 21 (95) | 24.8 ± 3.7 | 226 ± 76 | 131 ± 21 | 51 ± 26 | ND | ||||
Nakagawa et al. (1977) [37] | Randomized, double-blind, placebo-controlled | Patients with gallstones | 6 months | 13 | Placebo | ND | ND | ND | 196 ± 30 | ND | ND | 120 ± 33 |
16 | UDCA 150 mg/day | ND | ND | ND | 192 ± 41 | ND | ND | 110 ± 37 | ||||
15 | UDCA 600 mg/day | ND | ND | ND | 193 ± 29 | ND | ND | 143 ± 59 | ||||
Parés et al. (2000) [34] | Randomized, double-blind, placebo-controlled | Primary biliary cirrhosis | 2 years | 99 | UDCA 14–16 mg/kg/day | 57.4 ± 8.9 | 92 (92) | ND | 276 ± 89 | ND | ND | ND |
93 | Placebo | 53.5 ± 9.6 | 87 (93) | ND | 276 ± 86 | ND | ND | ND | ||||
Poupon et al. (1990) [35] | Randomized, double-blind, placebo-controlled | Primary biliary cirrhosis | 6 months | 70 | UDCA 13–15 mg/kg/day | 55 ± 11 | 66 (94) | ND | 282 ± 73 | ND | ND | ND |
68 | Placebo | 58 ± 9 | 60 (89) | ND | 266 ± 65 | ND | ND | ND | ||||
Poupon et al. (1993) [38] | Randomized, double-blind, placebo-controlled | Primary biliary cirrhosis | 2 years | 17 | UDCA 13–15 mg/kg/day | 55 ± 12 | ND | ND | 289 ± 66 | 155 ± 52 | 44 ± 17 | 93 ± 32 |
16 | Placebo | 58 ± 8 | ND | ND | 273 ± 36 | 134 ± 38 | 41 ± 14 | 102 ± 49 | ||||
Vuoristo et al. (1995) [36] | Randomized, double-blind, placebo-controlled | Primary biliary cirrhosis | 2 years | 31 | Placebo | 57a | 27 (87) | 24a | 278 ± 105 | 189 ± 84 | 61 ± 21 | 106 ± 48 |
30 | UDCA 12–15 mg/kg/day | 52a | 22 (73) | 24a | 251 ± 86 | 158 ± 64 | 58 ± 42 | 115 ± 49 |
Values are expressed as mean ± SD
Abbreviations: ND no data, BMI body mass index, IQR interquartile range
aMean only
bRange