By John Gever,
Published: May 16, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, N
* Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.
PRAGUE -- Adding the nutritional supplement alpha-lipoic acid to ursodeoxycholic acid (UDCA, ursodiol) reduced the major symptoms of non-alcoholic steatohepatitis (NASH) in a small controlled trial, it was reported here.
Measures of fibrosis, liver transaminase levels, and overall disease severity were all improved significantly relative to diet-based treatment in a six-month, 20-patient study, according to Vincenzo Gianturco, MD, of the University of Rome "La Sapienza" in Italy.
UDCA is already an FDA-approved treatment for NASH, one of the major complications of diabetes and obesity, but many patients fail to show substantial improvement on the treatment.
Gianturco, speaking here at the World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension, said about 2% to 3% of the population in Western countries suffers from NASH, an advanced stage of non-alcoholic fatty liver disease.
Both conditions are most common in middle-age, obese women with diabetes. However, according to Gianturco, NASH may be seen in individuals of any age or gender.
Alpha-lipoic acid is an antioxidant compound found naturally in human cells and in many foods -- and, in capsule form, in health food stores. It is used in complementary medicine to treat various diabetic complications and some neurologic conditions, on the theory that it has cytoprotective effects.
UDCA also appears to have cytoprotective effects, by a different mechanism; hence the idea to combine the two agents as a one-two punch against NASH.
Gianturco and colleagues randomly assigned 10 patients to receive ALAURSO -- 400 mg of alpha-lipoic acid plus 300 mg UDCA -- daily for six months. Ten other patients were randomized to a placebo group that was treated only with a low-calorie diet plan.
Patients with hepatitis B or C virus infection, alcohol drinkers, and those with gallbladder stones were excluded. Patients underwent liver biopsy at baseline, confirming the diagnosis, and again at the end of treatment.
Essentially no change in mean liver enzyme levels were seen in the control group, whereas the ALAURSO group showed substantial and statistically significant reductions (P=0.001) relative to controls, even with the small number of patients involved:
In the control group, none of the liver enzymes changed by more than 1 mg/dL with treatment.
Fibrosis scores increased in the control group, from 1.4 at baseline to 1.52, whereas scores declined significantly in the ALAURSO group, from 1.2 at baseline to 1.01 (P=0.04), Gianturco said.
Both compliance and tolerability were good, he told attendees here.
However, he cautioned that detailed histological analyses had not been performed. The small number of patients and the relatively short follow-up were also limitations, Gianturco said.
Session moderator Robert Niecestro, PhD, of the drug development firm Accelapharm in New York City, commented that alpha-lipoic acid is a chiral molecule, with both R- and S- enantiomers contained in commercially sold versions.
He said the R- enantiomer is responsible for the compound's beneficial effects, whereas the S- version tends to offset them somewhat.
Niecestro suggested that using only the R- form might further boost the effectiveness of the ALAURSO combination.
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