From the Guidelines
Vitamin E (alpha-tocopherol) is the only TGA-approved supplement proven to improve liver histology in non-diabetic adults with biopsy-proven NASH, and it should be considered as a first-line pharmacotherapy for this patient population at a daily dose of 800 IU/day. While there are other supplements like milk thistle (silymarin) marketed for liver health, they lack robust clinical evidence and TGA approval for treating liver conditions 1.
Key Points to Consider
- The use of vitamin E can be considered as biopsy-proven NASH treatment in patients without diabetes mellitus, as it decreases oxidative stress and improves liver inflammation 1.
- However, the long-term use of vitamin E also carries safety concerns, such as an increased risk of prostate cancer or hemorrhagic stroke, and high doses (>400 IU/day) are associated with an increased mortality rate 1.
- A retrospective study of 236 patients with biopsy-proven NASH with bridging fibrosis or compensated cirrhosis found that the use of 800 IU/day of vitamin E for more than 2 years decreased the risk of death, liver transplant, and decompensated cirrhosis in patients both with and without diabetes mellitus 1.
Recommendations for Patients
- For liver health concerns, it's best to consult a healthcare provider who may recommend lifestyle changes such as limiting alcohol consumption, maintaining a healthy weight, eating a balanced diet, and regular exercise.
- In cases of liver disease, medically supervised treatments are necessary, which might include prescription medications depending on the specific condition.
- Supplements should not replace proper medical care for liver problems, as they may interact with medications or even cause liver damage in some cases.
- Any supplement use should be discussed with a healthcare provider, especially for those with existing liver conditions.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
TGA Approved Supplements for Liver Health
- Milk thistle (Silybum marianum) is a herbal supplement used to treat liver and biliary disorders, with its active component silymarin protecting liver and kidney cells from toxic effects of drugs 2.
- Silymarin has been shown to reduce oxidative stress and consequent cytotoxicity, thereby protecting intact liver cells or cells not yet irreversibly damaged 3.
- The Eurosil 85® formulation of silymarin has been used in most clinical research and has been found to be effective in treating patients with alcoholic or non-alcoholic fatty liver disease, including patients with cirrhosis 3.
Mechanism of Action
- Silymarin acts as a free radical scavenger and modulates enzymes associated with the development of cellular damage, fibrosis, and cirrhosis 3.
- It has anti-inflammatory and T cell-modulating effects, and has been found to inhibit cancer cell growth in human prostate, skin, breast, and cervical cells 2.
- Silymarin has been suggested to have multifunctional potential, with antioxidant and anti-inflammatory effects, and acts as a modulator of signaling pathways 4.
Safety and Efficacy
- Silymarin is generally well-tolerated, with a low incidence of adverse events and no treatment-related serious adverse events or deaths reported in clinical trials 3, 5.
- It has been found to be safe in humans at therapeutic doses, with some gastrointestinal discomforts occurring like nausea and diarrhea 5.
- However, caution should be exercised during pregnancy, and more studies are needed especially in humans 5.