Milk thistle (Silybum Marianum) is a therapeutic herb with a 2,000-year history of use. It is a flowering herb related to the Ragweed family and is native to Mediterranean countries.  Some people also call it as holy thistle and Mary thistle. It is sometimes used as a natural treatment for liver problems like jaundice, hepatitis, cirrhosis and gallbladder disorders. It is also believed to be lower cholesterol levels and also helps people with Type2 diabetes.

Milk thistle gets its name from the milky sap that comes out of the leaves when it is broken. It can be taken by mouth and is available in different forms like the pill, powder extract or supplements. Apart from curing liver and kidney problems, it also helps to decrease the side effects of chemotherapy and radiation, obsessive-compulsive disorder, Parkinson’s disease, and Alzheimer’s disease, etc. some people also apply directly to the skin to treat skin toxicity caused by radiation. 

Prescription Name and Overview

There is no alternate prescription name for Milk thistle. This natural herb is an antioxidant most commonly used to detoxify the body. It is loaded with anti-inflammatory antioxidant and is regarded as one of the best natural supplement for patients with liver disorders. It is considered as a ‘Hepatic, galactogogue, demulcent and cholagogue’ herb that promotes healthy digestive function through enzyme formulation and soothes the mucous membranes throughout the body.  

Generic Name and Overview

The generic name is Milk thistle. Its benefits are similar to other healing nutrients like Vitamin C or Vitamin E. It contains a high level of lipophilic extracts that are available in the seeds of the plant. It acts as a bioflavonoid antioxidant that helps to reduce oxidative stress and increases immunity. The working mechanism draws out toxins out of the body and protects the liver from damage. Its potent antioxidant properties have been traditionally used as a natural remedy to healing liver problems. Milk thistle acts as a filter that strains the toxic elements consumed in daily life like pollution, alcohol, dangerous fumes, etc. Also, it is said to heal the side effects caused by antibiotics.

OTC Name and Overview

Milk thistle, the natural herb has been used as an alternative medicine that is probably an effective remedy for treating heartburn, seasonal allergy symptoms apart from liver disorders. Although there is no proven research, it can also cure mushroom poisoning, malaria, etc.  There is an immense need for more research studies to clearly prove the benefits of taking milk thistle to effectively treat any medical condition. Medical use of this product has not been approved by the FDA. It is often sold as an herbal supplement and should not be used in place of medication prescribed for you by your physician. 

Manufacturer

Milk thistle is a plant native to Europe and grows in the wilds in The United States, and South America. The medicinal benefits of this herb have been valued for more than 2,000 years. However, the written records shows in Romans were amongst the first to use it as liver-protecting agents. Throughout the middle age, it was frequently used and in the herbal literature, the medicinal property of these seeds were first noted. Today this ancient herb is available in the form of natural supplements that has multi-dimensional health benefits. These supplements are manufactured by numerous leading brands from all over the world. Some of the names of the supplements and its manufacturers’ are-

• Jarrow Formulas, a Los Angeles based distributor, and its products are manufactured in GMP certified facilities. 
• Gaia Herbs – It is manufactured in their own farm that is 100% organic
• Solary – it is manufactured by an US-based company named Nutraceutical Corporation. It is distributed in all 50 states and 60 countries worldwide.
• Apart from these, there are a few other reliable supplements such as Paradise Herb Milk thistle, BlueBonnet Standardized Milk Thistle, etc. 

Labeled Indications

Its uses are:

 Diabetes-

May lower blood sugar in people who are diagnosed with type2 diabetes.

Dyspepsia (indigestion) – 

When combined with other supplements, it might improve the symptoms of indigestion.

Liver Disease: 

Research studies and some historical evidence show that it canreduces liver problems like hepatitis C and cirrhosis.

Active Ingredients

The active ingredient in Milk thistle is Silymarin. It is both an antioxidant and anti-inflammatory. It is a flavonoid complex that can be extracted from the seeds of milk thistle. Silymarin is usually extracted with 95% ethanol, yielding a bright yellow fluid. Standard extract contains 70% silymarin.

What Is It Used For?

Although used for different reasons; it is possibly effective for-

• Diabetes-

If Milk thistle extract is taken with anti-diabetic drugs, it is believed to decrease the blood sugar levels before meals in diabetic patients. However, it might take at least three months for these products to show the benefits.

• Heartburn:

If consumed for four weeks, it may reduce the severity of stomach pain, acid reflux, vomiting, and nausea

There is insufficient evidence for some of the diseases that are also believed to be brought under control with Milk thistle are-

• Liver disease Caused by excessive alcohol intake
• Seasonal allergies
• Alzheimer’s disease
• Enlarged Prostate 
• Blood disorder called beta-thalassemia
• Hand-foot syndrome
• Kidney damage caused by the chemotherapy drug cisplatin
• Toxicity caused by chemotherapy
• Liver Cirrhosis
• Hepatitis 
• High Cholesterol level
• Infertility
• Menopausal symptoms
• Obsessive Compulsive Disorder
• Parkinson’s disease
• Skin toxicity caused by radiation
• Liver damage caused by chemicals 

How Does it Work?

Milk thistle might have the ability to protect liver cells from toxic drugs and chemicals. It also seems to elements that lower blood sugar levels, reduce damage to the livers caused by free radicals and have anti-inflammatory effects. 

Production Anecdotes / History

Milk thistle is a plant from Asteraceae family, native to southern Europe, parts of North Africa and the Middle East. Naturalized in Southern Australia, North America, and South America, milk thistle needs warm, dry soil to grow. History shows it has been used for over 2,000 years. In ancient Greece, Discorides mentioned his book about Milk thistle tea that was used as a remedy for snakebites. In the 1500s, John Gerard mentioned the advantages of taking Milk thistle in order to fight depression and emotional distress. In later years, famous herbalist and physician named Nicolas Culpeper claimed it could help to cure jaundice and ‘unblock’ the liver. It was a great treatment for women with irregular menstruation.

Precautions

There are some special precautions and warnings that you must consider before taking Milk thistle. Let’s have a look-

Pregnancy and breastfeeding-

There is not enough information about the safety of taking thistle during pregnancy. However, it is better to avoid using it to stay safe.

 Hormone-sensitive conditions –

It  act like estrogen and therefore is not safe to take in conditions like, endometriosis, ovarian cancer, breast cancer uterine fibroid, etc. or other conditions that might get worse with more exposure to estrogen. 

Allergic to Ragweed plants:

If you’re are allergic to ragweed and other related plants, you must avoid taking Milk thistle. 

Long-Term Use Considerations

There are no such reports or research studies reported the long-term usage of Milk thistle. People with liver problems have been taking these medicines since long. It is never a good idea to take Milk thistle extracts or supplements without consulting a doctor.

Drug Interactions

Can Interact with the Following

Cytochrome P450 2C9 (CYP2C) substrates: Milk thistle might affect the drugs and enzymes it processes such as warfarin (Janotoven), diazepam (Valium) and others.

Metronidazole (Flagyl): The effectiveness of this antibiotic might be reduced by Milk thistle. It is better to avoid metronidazole and milk thistle together.

Diabetes medications: It may lower blood sugar levels of people with type 2 diabetes. Taking diabetes drugs with milk thistle might result in addiction. It is necessary to monitor blood sugar if you are taking them together.

 Sirolimus (Rapamune): It is an immunosuppressant and taking Milk thistle with this might change the way your body processes the medication.

 Simeprevir (Olysio):  It is never suggested to take Milk thistle with Hepatitis C medication as this combination might increase drug concentrations in your blood plasma. 

Can’t interact with the Following

There are no reports of the drugs that cannot interact with Milk thistle. Nevertheless, it is necessary to be watchful with the following combination that is reported under minor interactions. They are-

• Medications used for lowering cholesterol (Stanins) 
• Estrogens 

When To Stop Taking

• If you have diabetes, it is better to stop taking the supplement might lower the blood sugar levels.
• If you are diagnosed with breast cancer, endometriosis, ovarian cancer or other hormone-related conditions you must not continue taking milk thistle supplements.
• People who are allergic to plants in the Asteraceae family such as daisies, marigolds, you must stop taking Milk thistle.

Long-Term Side Effects

• Might Cause Abdominal Issues
• Might cause Allergic Reactions
• Might Lower Blood Sugar Level
• Can cause weakness
• Can interact with cholesterol Medication

FDA Warnings (History Of)

The U.S. Food and Drug Association (FDA) have not approved the use of Milk thistle as a treatment for cancer or any other medical conditions.  In the United States, it is available in the form of dietary supplement. Dietary supplements are products that are meant to be added to the diet and in no way meant to prevent, cure or treat any diseases. The company that makes the dietary supplement, in this case, Milk thistle supplement must ensure that they are safe and do not mislead the consumer.  However, FDA has sent warning letters to different Milk thistle supplements producers and manufacturers like American Natural Products in 2013, Nature’s Health in 2015 and Independent nutrition, Inc in 2018.

Other Common Side Effects

There are certain common side effects that you may face, including:

•   Gas
•   Rash
•   Nausea
•   Loss of appetite
•   Diarrhea
•   Allergic Reactions
•   Itching
•   Abdominal Bloating 

Lawsuits

Costco Milk thistle products have served lawsuits as independent lab tests have shown that they don’t contain enough of the active ingredient that is Silymarin that is necessary to support liver health. There are also a few other Milk thistle distributors and manufacturers who have been warned for false advertising about their milk thistle supplements.

Tracy Everhart

Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.