Supplementary data
Supp Table 1:Comparison of baseline SIP scores (HRQOL) between LOLA and placebo groups Mean ±SD Total (N= 150) LOLA group (n=75) Placebo group (n=75) P value
SR 22.12±8.22 22.88±8.10 21.90±8.45 0.81
EB 25.12±8.10 26.07±8.82 24.80±7.53 0.82
BCM 6.13±3.11 6.92±3.21 5.63±2.98 0.75
HM 14.94±6.14 14.99±6.42 14.90±5.58 0.91
M 12.42±6.12 12.71±5.71 12.05±6.20 0.84
SI 10.92±6.13 11.60±4.75 10.32±4.67 0.78
A 10.84±4.42 10.56±5.84 11.54±3.82 0.61
AB 14.24±6.21 13.94±6.59 15.12±5.36 0.64
C 5.53±5.10 5.71±5.51 4.85±5.60 0.51
W 20.12±11.81 20.09±10.60 20.19±14.60 0.84
RP 19.30±6.34 19.69±5.48 18.91±7.33 0.61
E 5.08±4.82 5.19±5.36 4.98±4.69 0.75
Psychosocial 14.42±5.12 14.78±5.22 13.90±4.36 0.68
Physical 9.46±4.63 9.84±4.90 9.16 ±4.76 0.81
Total SIP 19.30± 7.48 19.54 ± 7.44 19.05 ± 7.57 0.69
Sickness impact profile subscores: A, alertness; AB, ambulation; BCM, body care and
movements; C, communication; E, eating; EB, emotional behavior; HM, home management; M, mobility; RP, recreation and pastime; SI, social interaction; SR, sleep and rest; W, work
Ambulation, mobility, body care and movement constitute the Physical score and rest of them form the Psychosocial score.
Supplementary Table 2: Delta change in parameters at 3 months and 6 months follow up between LOLA group and placebo group
∆ Change
LOLA Placebo P value
∆ PHES 3 1.28±1.67 0.30±1.97 <0.001
∆ PHES 6 2.53± 2.18 -0.01 ± 1.92 <0.001
∆ CFF 3 3.28± 3.65 0.39± 3.59 <0.001
∆ CFF 6 5.85 ±4.82 0.59± 4.53 <0.001
∆ NH3 3 (μmol/L) -12.92±9.04 -0.66 ± 10.72 <0.001
∆ NH3 6 (μmol/L) -23.58 ± 14.8 1.41 ±13.34 <0.001
∆ SIP 3 -4.56 ± 3.27 -0.74 ± 3.21 <0.001
∆ SIP 6 -7.89 ± 5.52 -0.95 v 4.25 <0.001
Abbreviations: CTP- Child Turcotte Pugh score, MELD- Model for end stage liver disease, PHES- Pychometric hepatic encephalopathy scores, CFF- Critical flicker frequency
∆= Delta= Change in value of parameters from baseline; 3 is at 3 months and 6 is at 6 months follow up; - value denotes decrease from the baseline and + value denotes increase from baseline.
Supplementary table 3: Comparison of change in SIP subscores at 6 months follow up between the LOLA and placebo groups
Mean ±SD Group A (LOLA) Group B (Placebo) P value
ΔSR 10.37±6.87 1.04±8.85 <0.001
ΔEB 10.16±7.68 2.81±8.94 <0.001
ΔBCM 2.83±3.07 1.15±2.93 0.01
ΔHM 7.06±5.28 -0.01±6.10 <0.001
ΔM 6.47±3.98 0.81±5.32 <0.001
ΔSI 3.86±4.17 0.62±5.51 0.001
ΔA 3.94±4.24 1.09±4.14 0.0006
ΔAB 5.08±5.44 1.85±5.27 0.02
ΔC 1.91±3.79 0.64±4.71 0.07
ΔW 6.36±7.94 2.87±11.37 0.05
ΔRP 6.50±5.53 1.73±8.79 0.001
ΔE 2.42±4.46 0.41±4.95 0.02
Δ Psychosocial 9.04±3.57 1.35±4.35 <0.001
Δ Physical 3.45±2.51 1.11±3.66 <0.001
Δ Total SIP 7.89 ± 3.92 1.26 ± 4.39 <0.001
Sickness impact profile sub scores: A, alertness; AB, ambulation; BCM, body care and
movements; C, communication; E, eating; EB, emotional behavior; HM, home management; M, mobility; RP, recreation and pastime; SI, social interaction; SR, sleep and rest; W, work
Ambulation, mobility, body care and movement constitute the Physical score and rest of them form the Psychosocial score.
ABBREVIATIONS:
CFF: critical flicker frequency, CI: confidence interval, CLD: chronic liver disease,
CTP :Child turcotte pugh score, DST: digit symbol test, FCT: figure connection test, HE:
hepatic encephalopathy, HRS: hepato-renal syndrome, HRQOL: health related quality of life, INR: international normalized ratio, LOLA: L-ornithine L-aspartate, MELD: Model for end
stage liver disease, MHE: minimal hepatic encephalopathy, NCT: number connection test, NH3 :ammonia, PHES: Psychometric hepatic encephalopathy score, PT: prothrombin time, SBP:
spontaneous bacterial peritonitis, SIP: sickness impact profile, UGIE: upper gastrointestinal endoscopy, UTI: urinary tract infection.