L-Carnitine Supplementation to Diet: A New Tool in Treatment of Nonalcoholic Steatohepatitis—A Randomized and Controlled Clinical Trial

Mariano Malaguarnera AP; Maria Pia Gargante MD; Cristina Russo MD; Tijana Antic MD; Marco Vacante MD; Michele Malaguarnera MD; Teresio Avitabile; Giovanni Li Volti AP; Fabio Galvano AP

Disclosures

Am J Gastroenterol 

In This Article

Results

The patients were enrolled between January 2001 and March 2003. Eighty patients suspected of having NASH were evaluated and 74 patients were enrolled in the study. Reasons for exclusion included patient's unwillingness to undergo liver biopsy (n=4) and normalization of aminotransferase levels during the prerandomization phase (n=2) (Figure 1).

Biochemical Responses

Effects of L-carnitine on Liver Enzymes At the end of the evaluation (24 weeks), subjects treated with L-carnitine plus diet compared with placebo plus diet group showed significant differences in aspartate aminotransferase (P=0.000), ALT (P=0.000), γ-GT (P=0.007) ( Table 2 ).

Effects of L-carnitine on Lipid Profile At 24 weeks, L-carnitine plus diet-treated patients compared with placebo plus diet group showed significant difference in total cholesterol (P=0.000) and LDL cholesterol (P=0.000) ( Table 2 ).

Effects of L-carnitine on Glycometabolic Profile At the end of the study period, we observed that L-carnitine plus diet compared with placebo plus diet showed a significant decrease in plasma glucose level (P=0.000) and HOMA-IR (P=0.000) ( Table 2 ).

Effects of L-carnitine on Inflammation Factors At the end of 24 weeks, L-carnitine plus diet compared with placebo plus diet group showed significant decreases in CRP (P=0.004) and TNF-α (P=0.000) ( Table 2 ).

Histological Responses

Repeat liver biopsies were available on all 36 patients treated with L-carnitine. Each of the component features of the NASH-activity index (steatosis, parenchymal inflammation, and hepatocellular injury) improved significantly, as did fibrosis and Mallory bodies. Thirty-one patients (86%) had improvement in fibrosis scores (17 patients had one level reduction, 12 had two levels reduction, and 2 had three levels reduction of fibrosis score). Fibrosis scores were unchanged in five patients (14%).

Overall, the mean NASH-activity score decreased from 9.42 (range, 8–11) at baseline to 3.19 (range, 1–8) at 24 weeks. The NASH-activity score decreased by at least two points in all patients. A histological response was defined as a reduction in the NASH-activity index by three points or more with improvements of at least one point each in steatosis, parenchymal inflammation, and hepatocellular injury. Using this strict definition, 35 patients (97%) had a histological response ( Table 3 ).

Tolerability Both L-carnitine and placebo were well tolerated in 100% of patients. In the group treated with L-carnitine, one patient reported nausea, two moderate headache, and two abdominal pain. In the placebo group, two patients reported diarrhea, one moderate headache, and two fatigue. Patients were evaluated at baseline, after 1 month, and for next 6 months every 4 weeks.

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