Table 4.

Randomized controlled trials for hepatic encephalopathy

Ref.	Year	Sample size (treatment/placebo)	Treatment regimens	Duration	Favorable effects
¹ ²Loguercio et al[69]	1987	40 (20/20)	Enterococcus Lactic Acid bacteria strain SF68 vs lactulose	10 d	NH₃ ↓
¹ ²Loguercio et al[69]	1987	40 (20/20)		10 d	Performance status: improved
²Loguercio et al[70]	1995	40 (21/19)	Enterococcus Lactic Acid bacteria strain SF68 vs lactulose	3 x 4 wk	NH₃ ↓
²Loguercio et al[70]	1995	40 (21/19)		3 x 4 wk	Psychometric test: improved
¹ ²Liu et al[71]	2004	55 (20/35)	Pediacoccus pentoseceus, Leuconostoc mesenteroides, Lactobacillus paracasei, and Lactobacillus plantarum with fermentable fibers vs fermentable fibers only or non-fermentable fiber	30 d	Endotoxemia ↓Child-Turcotte-Pugh classification: improved
²Malaguarnera et al[72]	2007	60 (30/30)	Bifidobacterium (subtype not available) with fructo-oligosaccharide (FOS) vs mix of vitamins	90 d	NH₃ ↓
²Malaguarnera et al[72]	2007	60 (30/30)		90 d	Psychometric test: improved
¹ ²Bajaj et al[73]	2008	25 (17/8)	Streptococcus thermophilus, Lactobacillus bulgaricus, Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacteria vs none	60 d	Psychometric test: improved
¹ ²Sharma et al[74]	2008	105 (70/35)	Streptococcus faecalis, Clostridium butyricum, Bacillus mesentricus, and Lactic acid bacillus with lactulose vs lactulose	30 d	NH₃ ↓
¹ ²Sharma et al[74]	2008	105 (70/35)		30 d	Psychometric test: improved
¹ ²Mittal et al[75]	2011 (2009)	160 (120/40)	VSL#3 (containing Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus) vs lactulose or placebo	3 mo	NH₃ (arterial) ↓
¹Malaguarnera et al[76]	2010	125 (63/62)	Bifidobacterium (subtype not available) and FOS vs lactulose	60 d	NH₃ ↓
¹Malaguarnera et al[76]	2010	125 (63/62)		60 d	Psychometric test: improved
¹Pereg et al[77]	2011	40 (20/20)	Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium bifidum, and Streptococcus thermophiles (Bio-plus, Supherb, Israel) vs placebo	6 mo	NH₃ ↓
Agrawal et al[80]	2012	235 (157/78)	VSL#3 vs lactulose or none	> 3 mo	NH₃ (arterial) ↓
					Psychometric test: improved
					Secondary prophylaxis of HE
Lunia et al[81]	2014	160 (86/74)	VSL#3 vs placebo	> 6 mo	NH₃ (arterial) ↓
Lunia et al[81]	2014	160 (86/74)	VSL#3 vs placebo	> 6 mo	Prevention of HE

RCTs included in meta-analysis by McGee et al[78];

RCTs included in meta-analysis by Holte et al[79].