Changes in biochemical and histologic parameters related to nonalcoholic steatohepatitis (NASH) in placebo-treated patients may provide an insight into the natural history of nonalcoholic steatohepatitis.
This may help in defining treatment end points in nonalcoholic steatohepatitis.
Dr Rohit Loomba and colleagues from Maryland, USA assessed the biochemical and histologic changes seen in the placebo arm of the randomized, placebo-controlled trials in adult patients with nonalcoholic steatohepatitis.
The team searched Medline for studies published in the English language.
|A 1-point improvement in steatosis scores was seen in 31%|
|Clinical Gastroenterology & Hepatology|
Randomized, placebo-controlled trials of at least 6 months' duration in patients with nonalcoholic steatohepatitis that provided biochemical and/or histologic data of the placebo arm were included.
One investigator performed the literature search and data extraction.
There were 2 investigators that independently confirmed that the studies met prespecified criteria.
Pooled estimates of biochemical and histologic parameters associated with nonalcoholic steatohepatitis were calculated.
The researchers identified 5 randomized controlled trials that met the predefined criteria involving 162 placebo-treated, and 189 active-treatment patients.
The mean serum alanine and aspartate aminotransferase levels decreased on placebo.
A 1-point improvement in steatosis, ballooning degeneration, and lobular inflammation
Scores was seen in 31%, 15%, and 33% of patients, respectively.
A 1-point improvement in nonalcoholic steatohepatitis fibrosis, and combined inflammation scores was seen in 22%, and 32% of patients, respectively.
A 2-point improvement in nonalcoholic steatohepatitis histologic scores is rarely seen.
Dr Loomba’s team concluded, “Serum alanine aminotransferase levels may decrease on placebo, and is not a reliable measure of treatment response.”
“Although a 1-point improvement is seen in a third of patients, a 2-point improvement in histologic parameters is rarely seen in the placebo arm and may be more reliable in assessing treatment response.”
“These data may have important implications in designing future clinical trials in nonalcoholic steatohepatitis.”