Trial reportClinical drug investigation2011
Oral L-ornithine-L-aspartate improves health-related quality of life in cirrhotic patients with hepatic encephalopathy: an open-label, prospective, multicentre observational study.
Trial report in Clinical drug investigation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Efficacy and Safety of Rifaximin in the Prevention of Recurrent Episodes of Hepatic Encephalopathy: A Systematic Review and Meta-analysis.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2023Pooled it
- KASL clinical practice guidelines for liver cirrhosis: Varices, hepatic encephalopathy, and related complications.Clinical and molecular hepatology · 2020Guideline
- L-ornithine L-aspartate for prevention and treatment of hepatic encephalopathy in people with cirrhosis.The Cochrane database of systematic reviews · 2018Pooled it
- SHORT-TERM EFFECT OF WHEY PROTEIN SUPPLEMENTATION ON THE QUALITY OF LIFE OF PATIENTS WAITING FOR LIVER TRANSPLANTATION: A DOUBLE BLINDED RANDOMIZED CLINICAL TRIAL.Arquivos brasileiros de cirurgia digestiva : ABCD = Brazilian archives of digestive surgery · 2021Trial
- Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding.Canadian journal of gastroenterology & hepatology · 2018Trial
- Factors influencing and enhancing health-related quality of life in sarcopenia patients with liver cirrhosis: A comprehensive review.Journal of family medicine and primary care · 2025Review
- Analysis and mining of L-ornithine L-aspartate adverse events based on FAERS database.Scientific reports · 2025Article
- Novel Agents in the Management of Hepatic Encephalopathy: A Review.Journal of clinical and translational hepatology · 2021Review
- Development and predictive validity of the cirrhosis-associated ascites symptom scale: A cohort study of 103 patients.World journal of gastroenterology · 2018Observational
- Sleep disturbances in patients with liver cirrhosis: prevalence, impact, and management challenges.Nature and science of sleep · 2018Review
- A randomized, double-masked, placebo-controlled crossover trial on the effects of L-ornithine on salivary cortisol and feelings of fatigue of flushers the morning after alcohol consumption.BioPsychoSocial medicine · 2013Article
- Quality of life in cirrhosis.Current gastroenterology reports · 2013Review
- Indications of antibiotic prophylaxis in dental practice- review.Asian Pacific journal of tropical biomedicine · 2012Review
- Novel Drugs for the Management of Hepatic Encephalopathy: Still a Long Journey to Travel.Journal of clinical and experimental hepatologyReview
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveHepatic encephalopathy (HE) is a serious complication of cirrhosis. Clinical trials have consistently shown that L-ornithine-L-aspartate significantly improves HE symptoms. Health-related quality of life (HR-QOL) is impaired in HE patients and represents an important outcome measure for therapeutic intervention. The present study aimed to assess the impact of L-ornithine-L-aspartate on HR-QOL and safety in patients with HE in a clinical practice setting.
methodsThis was an open-label, prospective, multicentre observational study in clinical practice (general practitioners in Germany) that included 191 cirrhotic patients with HE. Patients were administered three sachets daily of L-ornithine-L-aspartate 6 g (Hepa-Merz®, Merz Pharmaceuticals GmbH, Frankfurt/Main, Germany) dissolved in water taken during or after meals. L-ornithine-L-aspartate was administered over a period of 8 weeks. The main outcome variable was the mean change in HR-QOL over the observation period as assessed by the patients using the German-validated version of the Chronic Liver Disease Questionnaire (CLDQ-D). Further assessments included mean changes in the severity of cirrhosis/HE-related symptoms, changes in disease severity (measured on the modified Clinical Global Impression-Severity [CGI-S] scale), and changes in disease status (measured on the modified CGI-Improvement [CGI-I] scale).
resultsTreatment with L-ornithine-L-aspartate for 8 weeks markedly improved all HR-QOL domains, in particular fatigue (67.5% improvement), resulting in a mean±SD CLDQ-D sum score improvement from 3.53±1.03 at baseline to 5.04±0.93 at the end of treatment. Symptom severity also improved, with particular benefits seen in fatigue, sleep quality and concentration deficits. Patient self-assessment correlated well with the physicians' clinical evaluation. Physicians rated 70.0% of the patients very much or much improved at the end of treatment. Very good or good tolerability was observed in 97.8% of patients. No drug-related adverse events were reported.
conclusionTreatment of HE with oral L-ornithine-L-aspartate in cirrhotic patients markedly improved HR-QOL and was well tolerated by 97.8% of patients.
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