RESUMO
Background: Hepatic encephalopathy (HE) in acute-on-chronic liver failure (ACLF) is associated with significant morbidity and mortality. We conducted a prospective, randomized controlled clinical trial to study the efficacy of intravenous branched chain amino acids (IV-BCAA) with lactulose versus lactulose alone for improvement in HE at 24 h, day 3, and day 7. The primary outcome was an improvement in encephalopathy by ≥ 1 grade at 72 h. Patients and methods: European association for study of liver (EASL) defined ACLF patients with overt HE were assessed and randomized into the experimental arm (IV-BCAA - 500 mL/day for 3 days + Lactulose; n = 39) and the comparator arm (Lactulose alone; n = 37). Six patients developed COVID-19 after randomization and were excluded (4-experimental arm and 2-comparator arm). Results: Of 222 screened patients, 70 (35 in each arm) were included in the analysis. Baseline characteristics, including HE grade (2.9 ± 0.7 vs 2.8 ± 0.7; P = 0.86) and (chronic liver failure) CLIF-C ACLF score (54.2 ± 5.6 vs 54.8 ± 5.7; P = 0.65), were similar. Overall survival was 40% at 28 days (48.5% vs 31.4%; P = 0.14). Improvement in hepatic encephalopathy scoring algorithm (HESA) by ≥ 1 grade at 24 h occurred in 14 patients (40%) in the BCAA arm and 6 patients (17.1%) in the control group (P = 0.03) which translated to a shorter intensive care unit (ICU) stay. The median change in HESA at 24 h was greater in the BCAA arm than the control arm (P = 0.006), which was not sustained at days 3 or 7. Ammonia levels did not correlate with the grade of HE (Spearman's correlation coefficient (ρ) = - 0.0843; P = 0.29). Conclusion: Intravenous BCAA does not lead to a sustained improvement in HE grade in ACLF. Trial registration no: NCT04238416 (clinicaltrials.gov).
RESUMO
Introduction: To understand neuromyelitis optica spectrum disorders (NMOSDs) better we need to study them in different populations. This prospective study was conducted to characterize clinical, serological, radiological, and therapeutic profile of NMOSDs in a North Indian population. Materials and Methods: This study included 81 patients with NMOSDs. All patients underwent detailed history and examinations and were followed at 3 monthly intervals. They were evaluated using standard investigations including gadolinium-enhanced magnetic resonance imaging (MRI) of the brain and spine with thin section optic nerve cuts and treated as per the standard guidelines. Data were recorded meticulously. Results: The mean age was 33.7 ± 13.4 years. The mean age at disease onset was 31.2 ± 13.5 years. Female-to-male ratio was 1.9:1. About 32.1% of patients presented with optic neuritis (ON), 56.8% with transverse myelitis (TM), and 11.1% with both ON and TM. The mean time from disease onset to diagnosis was 16.17 ± 23.09 months. Muscle atrophy, Lhermitte symptom, and tonic spasms were common. Foster-Kennedy syndrome-like presentation was seen in 8.6%. NMO antibodies were positive in 41 patients. MRI revealed involvement of <4 vertebral segments in 16.4% of patients with TM. Patients were managed as per standard guidelines. The mean follow-up duration was 15.3 ± 6 months. Approximately 88.9% had good functional outcome. Conclusion: NMOSDs are a common cause of demyelinating illnesses in Northern India. The response to treatment is excellent and most patients recover without residual disability.
