Ginseng - Drug Monograph

Introduction

Ginseng refers to several species of the genus Panax (true ginseng) and other plants that are sometimes referred to as ginseng. The most commonly used and studied varieties are Panax ginseng (Asian/Korean ginseng) and Panax quinquefolius (American ginseng). Ginseng has been used for centuries in traditional medicine systems, particularly in East Asia, and is classified as an adaptogen—a substance that purportedly helps the body adapt to stress and exerts a normalizing effect on physiological processes.

Mechanism of Action

The pharmacological activity of ginseng is attributed to its active compounds, primarily ginsenosides (also called panaxosides), which are steroid-like saponins. These compounds demonstrate multiple mechanisms including:

• Modulation of the hypothalamic-pituitary-adrenal axis
• Antioxidant properties through free radical scavenging
• Anti-inflammatory effects via inhibition of NF-κB and COX-2 pathways
• Enhancement of nitric oxide production leading to vasodilation
• Modulation of neurotransmitter systems (particularly GABA and glutamate)
• Improvement of insulin sensitivity and glucose metabolism
• Potential immunomodulatory effects through cytokine regulation

Indications

Common traditional and evidence-supported uses include:

• Physical and mental fatigue
• Cognitive enhancement and memory support
• Immune system support
• Diabetes mellitus adjunct therapy (modest glucose-lowering effects)
• Erectile dysfunction
• Quality of life improvement during cancer treatment
• Stress adaptation support

Dosage and Administration

Standardized preparations typically contain 2-3% total ginsenosides.

• Dried root: 0.5-2 g daily
• Standardized extract: 100-400 mg daily
• Tincture (1:5): 5-10 mL daily

• Typically administered orally
• Often taken in divided doses with meals
• Cyclical administration (3-4 weeks on, 1-2 weeks off) is commonly recommended to prevent potential tolerance

• Elderly: Start with lower doses
• Hepatic/renal impairment: No specific guidelines; use caution
• Pregnancy/lactation: Not recommended due to insufficient safety data

Pharmacokinetics

Contraindications

• Known hypersensitivity to ginseng or plants in the Araliaceae family
• Pregnancy and breastfeeding (due to insufficient safety data)
• Uncontrolled hypertension
• Acute illness with fever
• Mania or bipolar disorder (may exacerbate symptoms)
• Hormone-sensitive conditions (breast cancer, endometriosis, uterine fibroids)

Warnings and Precautions

• May cause insomnia, especially if taken later in the day
• Use caution in patients with cardiovascular disease due to potential effects on blood pressure and heart rate
• May affect blood glucose levels—monitor closely in diabetics
• Potential for bleeding risk—use caution in patients with bleeding disorders or taking anticoagulants
• May interact with immunosuppressants in transplant patients
• Quality control issues: Products may vary significantly in ginsenoside content and may be adulterated

Drug Interactions

• Warfarin: May decrease INR (increased risk of thrombosis)
• MAO inhibitors: Risk of headache, tremors, and manic episodes
• Immunosuppressants: May decrease efficacy

• Antidiabetic medications: Enhanced hypoglycemic effects
• Antihypertensives: Potential interference with blood pressure control
• Stimulants: Additive CNS stimulation
• Alcohol: May increase alcohol clearance

• May inhibit CYP3A4, CYP2D6, and CYP2C9
• Potential interactions with substrates of these enzymes

Adverse Effects

• Insomnia
• Headache
• Gastrointestinal discomfort
• Agitation/nervousness

• Hypertension or hypotension
• Tachycardia
• Allergic reactions
• Breast tenderness
• Vaginal bleeding
• Hypoglycemia

• Stevens-Johnson syndrome (case reports)
• Manic episodes in susceptible individuals
• Severe allergic reactions

Monitoring Parameters

• Blood pressure (baseline and periodically)
• Blood glucose levels in diabetics
• INR in patients taking warfarin
• Mood and sleep patterns
• Signs of allergic reactions
• Medication efficacy for intended use

Patient Education

• Ginseng is a supplement, not an FDA-approved medication
• Choose products from reputable manufacturers that standardize ginsenoside content
• Inform all healthcare providers about ginseng use
• Be aware of potential interactions with prescription medications
• Monitor for changes in sleep patterns, mood, or energy levels
• Report any unusual bleeding, allergic reactions, or persistent side effects
• Consider cyclical use (3-4 weeks on, 1-2 weeks off) to maintain effectiveness
• Discontinue use at least 2 weeks before scheduled surgery

References

1. Kim JH, Yi YS, Kim MY, Cho JY. Role of ginsenosides, the main active components of Panax ginseng, in inflammatory responses and diseases. J Ginseng Res. 2017;41(4):435-443.

2. Lee NH, Yoo SR, Kim HG, Cho JH, Son CG. Safety and tolerability of Panax ginseng root extract: a randomized, placebo-controlled, clinical trial. PLoS One. 2015;10(4):e0123472.

3. Shergis JL, Zhang AL, Zhou W, Xue CC. Panax ginseng in randomised controlled trials: a systematic review. Phytother Res. 2013;27(7):949-965.

4. Natural Medicines Comprehensive Database. Ginseng Professional Monograph. Therapeutic Research Center. 2023.

5. World Health Organization. WHO Monographs on Selected Medicinal Plants - Volume 1. Geneva: World Health Organization; 1999.

6. Qi LW, Wang CZ, Yuan CS. Ginsenosides from American ginseng: chemical and pharmacological diversity. Phytochemistry. 2011;72(8):689-699.

7. Kiefer D, Pantuso T. Panax ginseng. Am Fam Physician. 2003;68(8):1539-1542.

8. European Medicines Agency. Assessment report on Panax ginseng C.A. Meyer, radix. EMA/HMPC/321232/2012. 2014.