Impact of ursodeoxycholic acid on circulating lipid concentrations: a systematic review and meta-analysis of randomized placebo-controlled trials

Simental-Mendía, Luis E.; Simental-Mendía, Mario; Sánchez-García, Adriana; Banach, Maciej; Serban, Maria-Corina; Cicero, Arrigo F. G.; Sahebkar, Amirhossein

doi:10.1186/s12944-019-1041-4

Lipids in Health and Disease

Table 1 Demographic characteristics of the included studies

From: Impact of ursodeoxycholic acid on circulating lipid concentrations: a systematic review and meta-analysis of randomized placebo-controlled trials

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
Balan et al. (1994) [18]	Randomized, double-blind, placebo-controlled	Primary biliary cirrhosis	2 years	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
Battezzati et al. (1993) [21]	Randomized, double-blind, placebo-controlled	Primary biliary cirrhosis	6 months	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
Braga et al. (2009) [22]	Randomized, double-blind, placebo-controlled	Primary hypercholeste-rolemia	6 months	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	40.4^a	1 (12)	ND	266^a	ND	38^a	405^a
Carulli et al. (1981) [32]	Randomized, double-blind, placebo-controlled	Hypertriglyce-ridemia	1 month	8	Placebo	40.2^a	2 (25)	ND	254^a	ND	39^a	249^a
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
Leuschner et al. (2010) [40]	Randomized, double-blind, placebo-controlled	NASH	18 months	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	19–38^b	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
Méndez-Sánchez et al. (2004) [19]	Randomized, double-blind, placebo-controlled	NAFLD	6 weeks	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
Miettinen et al. (1995) [20]	Randomized, double-blind, placebo-controlled	Primary biliary cirrhosis	2 years	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
Parés et al. (2000) [34]	Randomized, double-blind, placebo-controlled	Primary biliary cirrhosis	2 years	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
Poupon et al. (1990) [35]	Randomized, double-blind, placebo-controlled	Primary biliary cirrhosis	6 months	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
Poupon et al. (1993) [38]	Randomized, double-blind, placebo-controlled	Primary biliary cirrhosis	2 years	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	57^a	27 (87)	24^a	278 ± 105	189 ± 84	61 ± 21	106 ± 48
Vuoristo et al. (1995) [36]	Randomized, double-blind, placebo-controlled	Primary biliary cirrhosis	2 years	30	UDCA 12–15 mg/kg/day	52^a	22 (73)	24^a	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

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