Table 4.
Published studies using non-absorbable disaccharides for minimal hepatic encephalopathy treatment
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Ref.
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Study type
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Follow-up (wk)
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MHE diagnosis
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Active treatment (s)
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Objectives
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Patients (n)
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Main results/impact measures
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| No history of OHE1 | |||||||
| Prasad et al[47], 2007 | Randomized2 | 12 | NCT-A/FCT-A, NCT-B/FCT-B, PCT, BDT | Lactulose vs no treatment | Psychometry | 31/30 | ITT analysis: Improvement in 20/31 (64.5%) vs 2/30 (6.7%); NNT:2 |
| Horsmans et al[55], 1997 | Randomized, double-blind | 2 | NCT, RTT. | Lactulose vs lactose as placebo4,5 | Psychometry | 7/7 | Improvement in time on Psychometric test on lactulose group respect to basal values.7 Rate of improvement NCT: 5/7 (71.42%) vs 1/7 (14.28%); NNT:2 |
| Sharma et al[50], 2008 | Randomized2 | 4 | NCT-A/FCT-A, NCT-B/FCT-B, P300ERP | Lactulose, probiotics, and lactulose + probiotics5 | Psychometry, P300ERP6 | 35/35/35 | Normalization in 17/31 (54.8%), 16/31 (51.6%), and 17/30 (56.6%) of MHE patients |
| Morgan et al[60], 1989 | Cross-over, randomized | 83 | EEG, NCT, DST, DCT | Lactulose vs lactitol4 | Psychometry | 14/14 | No differences between treatments in median change in psychometric time or scores |
| Possible history of OHE1 | |||||||
| Dhiman et al[51], 2000 | Randomized2 | 12 | NCT-A/FCT-A, NCT-B /FCT-B, PCT, BDT. | Lactulose vs no lactulose4 | MHE improvement | 14/12 | Improvement in 8/10 (80.0%) vs 0/8 (0.0%), P < 0.001)8 |
| Wang et al[49], 2019 | Randomized2 | 8 | NCT-A, DST | Lactulose vs no lactulose | MHE reversal | 67/31 | ITT analysis: 43/67 (64.2%) vs 7/31 (22.6%); NNT: 3PPS: 41/59 (69.5%) vs 6/28 (21.4%); NNT: 2 |
Studies in which the inclusion criteria comprise patients with clinical history to the overt hepatic encephalopathy events.
Unblinded study.
Washout period of 4-6 wk between treatments.
Compliance to treatment was not measured in one or the different treatment groups.
Diet was not standardized according to the suggested treatment.
Secondary objectives within the study.
Analysis was performed within the same group (before–after treatment) despite the experimental design.
Minimal hepatic encephalopathy reversion not measured. BDT: Block design test; DCT: Digit copying test; DST: Digit symbol test; EEG: Electroencephalogram; FCT-A: Figure connection test A; FCT-B: Figure connection test B; ITT: Intention to treat; MHE: Minimal hepatic encephalopathy; NCT: Number connection test; NCT-A: Number connection test A; NCT-B: Number connection test B; NNT: Number needed to treat; OHE: Overt hepatic encephalopathy; PCT: Picture completion test; PPS: Per protocol analysis set; RTT: Race track test.