Trial reportClinical and molecular hepatology2013
Efficacy and safety of entecavir plus carnitine complex (GODEX®) compared to entecavir monotherapy in patient with ALT elevated chronic hepatitis B: randomized, multicenter open-label trials. The GOAL study.
Trial report in Clinical and molecular hepatology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 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
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.
- Does L-carnitine supplementation affect serum levels of enzymes mainly produced by liver? A systematic review and meta-analysis of randomized controlled clinical trials.European journal of nutrition · 2020Pooled it
- Effects of carnitine supplementation on liver aminotransferase enzymes: A systematic review and meta-analysis of randomized controlled clinical trials.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2019Pooled it
- Effect of L-carnitine on quality of life in covert hepatic encephalopathy: a randomized, double-blind, placebo-controlled study.The Korean journal of internal medicine · 2022Trial
- Superior Efficacy of Besifovir in Reducing Hepatocellular Carcinoma Risk Compared to Tenofovir in Chronic Hepatitis B Patients: A Nationwide Cohort Study.Journal of Korean medical science · 2026Article
- A Real-World Retrospective Cohort Study on the Clinical Effect of Silymarin (Legalon) on Liver Damage and Diseases Using a Domestic Multicenter Common Data Model.Gut and liver · 2026Article
- Prolonged Use of Carnitine-Orotate Complex (GodexJournal of personalized medicine · 2022Article
- Therapeutic mechanisms and beneficial effects of non-antidiabetic drugs in chronic liver diseases.Clinical and molecular hepatology · 2022Review
- Impact of l-Carnitine Supplementation on Liver Enzyme Normalization in Patients with Chronic Liver Disease: A Meta-Analysis of Randomized Trials.Journal of personalized medicine · 2022Review
- Carnitine Orotate Complex Ameliorates Insulin Resistance and Hepatic Steatosis Through Carnitine Acetyltransferase Pathway.Diabetes & metabolism journal · 2021Article
- Role of Carnitine in Non-alcoholic Fatty Liver Disease and Other Related Diseases: An Update.Frontiers in medicine · 2021Review
- High L-Carnitine Levels Impede Viral Control in Chronic Hepatitis B Virus Infection.Frontiers in immunology · 2021Observational
- Influence of Besifovir Dipivoxil Maleate Combined with L-Carnitine on Hepatic Steatosis in Patients with Chronic Hepatitis B.Journal of Korean medical science · 2020Article
- Levocarnitine for asparaginase-induced hepatic injury: a multi-institutional case series and review of the literature.Leukemia & lymphoma · 2018Review
- L-Carnitine Suppresses Loss of Skeletal Muscle Mass in Patients With Liver Cirrhosis.Hepatology communications · 2018Article
- Effect of L-Carnitine in Patients With Liver Cirrhosis on Energy Metabolism Using Indirect Calorimetry: A Pilot Study.Journal of clinical medicine research · 2016Article
- Quantitative NTCP pharmacophore and lack of association between DILI and NTCP Inhibition.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2015Article
Corrections and comments
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Authors and funding
28 authors at 13 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
aimsCarnitine and vitamin complex (Godex®) is widely used in patients with chronic liver disease who show elevated liver enzyme in South Korea. The purpose of this study is to identify the efficacy and safety of carnitine from entecavir combination therapy in Alanine aminotransferase (ALT) elevated Chronic Hepatitis B (CHB) patients.
methods130 treatment-naïve patients with CHB were enrolled from 13 sites. The patients were randomly selected to the entecavir and the complex of entecavir and carnitine. The primary endpoint of the study is ALT normalization level after 12 months.
resultsAmong the 130 patients, 119 patients completed the study treatment. The ALT normalization at 3 months was 58.9% for the monotherapy and 95.2% for the combination therapy (P<0.0001). ALT normalization rate at 12 months was 85.7% for the monotherapy and 100% for the combination group (P=0.0019). The rate of less than HBV DNA 300 copies/mL at 12 months was not statistically significant (P=0.5318) 75.9% for the monotherapy, 70.7% for the combination and it was. Quantification of HBsAg level was not different from the monotherapy to combination at 12 months. Changes of ELISPOT value to evaluate the INF-γ secretion by HBsAg showed the increasing trend of combination therapy compare to mono-treatment.
conclusionsALT normalization rate was higher in carnitine complex combination group than entecavir group in CHB. Combination group was faster than entecavir mono-treatment group on ALT normalization rate. HBV DNA normalization rate and the serum HBV-DNA level were not changed by carnitine complex treatment.
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