“Most of the currently available data supporting a potential hepatoprotective [liver protecting] effect of P. mume have been obtained using in vitro testing, in vivo animal models, or non-controled human trials,” the researchers wrote in the study published in Phythotherapy Research.
Hence, the current study was the first that looked into the effects of two doses of a P. mune extract supplement on liver enzymes through a randomized, placebo-controlled, double-blind study.
From the 44 subjects who participated throughout the 3-month long study, researchers found a “beneficial and statistically significant effect versus placebo of P. mune extract on liver function.”
Study design
Participants were at least 18 years, and needed to have transaminase levels between 20 and 40 UI/L to qualify for the study. A healthy liver (which means no viral hepatitis, alcoholic hepatitis, hepatic steatosis, diabetes, etc.) was also a requirement to participate.
There were three different groups subjects were assigned to: one that received one oral capsule of placebo and one P. mune extract (low dose group), one group received two oral placebo capsules (placebo group), and another one received two oral capsules containing the active ingredient (high dose group).
All capsules were provided by the study’s sponsor, Stragen Pharma SA. The active capsules contained 150 mg of a standardized extract of P. mune each, ”which is defined by a dry plant/dry extract ratio and by a titration of specific triterpenoid content,” the researchers wrote.
Low dose of extract lowers toxic liver enzymes
On weeks 4, 8, and 12, participants went to the clinic (San Raffaele Hospital in Milan, Italy) to measure their liver lipid profiles.
Researchers found that, over the course of the study, participants supplemented with the low dose of Prunus mume experienced significant decreases in their high aspartate aminotransferase, alanine aminotransferase, and gamma-glutamyl transpeptidase liver enzymes, all of which induce hepatotoxicity, whereas the high dose group did not experience significant changes in their liver enzymes.
“This was most likely because of the fact that randomization resulted in baseline levels for all three enzymes that were only slightly elevated in the high dose group,” they wrote. “In contrast the low dose group baseline levels were much higher, resulting in a significant difference among groups at baseline.”
Another benefit they found among high and low dose group compared to the placebo was improvements in several metabolic function parameters and oxidative stress parameters, including a beneficial decrease in glycemia, as well as positive modification in the lipid profile such as increase in HDL cholesterol and a decrease in LDL/HDL ratio and triglycerides.
However, the researchers note that the baseline levels of liver enzymes in the high dose group were only slightly elevated, “resulting in significant differences in baseline levels of these enzymes among treatment groups.” Future studies should also be odne in seeing the efficacy of the product in pattients suffering from hepatic disorders.
Source: Phytotherapy Research
Published online: doi: 10.1002/ptr.5597
Efficacy of a Standardized Extract of Prunus mume in Live Protection and Redox Homeostasis: A Randomized, Double-Blind Placebo-Controlled Study
Authors: Alberto Beretta, Roberto Accinni, Cinzia Dellanoce, Annamaria Tonini, Jean-Michel Cardot, and Anthony Bussière