5- Study Guide for Complementary and Alternative Herbal Therapies

Introduction to Complementary and Alternative Medicine (CAM)

  • Definition and Utilization

    • Complementary and alternative medicine (CAM) is utilized by approximately 40%40\% of adults to either augment or replace traditional medical therapies.

    • Traditional medical therapies are often referred to as conventional medicine.

    • CAM practices encompass a wide range of products and practices, including but not limited to botanicals, nutritional products, and herbal supplements.

  • Botanicals and Phytomedicine

    • Botanicals: These are additive substances derived from plants.

    • Herb: Defined as any plant used for culinary or medicinal purposes.

    • Phytomedicine: The therapeutic value of plants, which serves as the basis for many modern and ancient drugs.

  • Historical and Modern Plant-Derived Drugs

    • Foxglove: Source of digitalis.

    • Snakeroot: Source of reserpine.

    • Willow Bark: Source of aspirin.

    • Pacific Yew Tree: Source of paclitaxel.

  • Market Dynamics and Education

    • Sales of herbal products in the United States have exceeded the 6 billion6 \text{ billion} dollar mark and continue to grow, fueled by marketing on television, in magazines, and on the internet.

    • While few pharmacy schools in the U.S. offer dedicated courses in botanical remedies, the professional literature increasingly addresses herbal therapy regarding effectiveness, toxicity, and drug interactions.

Regulatory Framework: DSHEA 1994 and CGMPs

  • Dietary Supplement Health and Education Act (DSHEA) of 1994

    • Enacted by the U.S. Congress to define and regulate dietary supplements.

    • Definition of a Dietary Supplement:

      • Intended to supplement the diet.

      • Contains one or more dietary ingredients (vitamins, minerals, herbs, botanicals, amino acids).

      • Intended for oral ingestion (tablets, capsules, powders, softgels, gelcaps, or liquids).

      • Is explicitly labeled as a dietary supplement.

    • FDA Oversight: Oversight is more limited than for prescription drugs. Manufacturers must ensure safety and truthful labeling but are not required to demonstrate safety before the product is sold.

    • Mandatory Disclaimer: Labels must state: "This statement has not been evaluated by the US Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease."

  • Standardized Labeling Requirements

    1. Name of the supplement.

    2. Amount of the supplement (net quantity).

    3. Nutrition labeling.

    4. Ingredient list.

    5. Name and place of the manufacturer, packer, or distributor.

  • Permitted Claims by Manufacturers

    • Health Claims: Regarding the relationship between a nutrient and a disease.

    • Structure and Function Claims: (e.g., "helps increase blood flow to the heart" is allowed; "prevents heart disease" is NOT allowed).

    • Nutrient Content Claims: Regarding the amount of a nutrient in the product.

    • Regulatory Body: The Federal Trade Commission (FTC) regulates truth in advertising for supplements.

  • Current Good Manufacturing Practices (CGMPs)

    • Proposed in 2003, these standards require labels to disclose the quality and strength of all contents and ensure products are free of contaminants and impurities.

    • Quality Seals: Organizations like the U.S. Pharmacopeial Convention (USP), ConsumerLab.com, National Products Association, and NSF International provide seals of approval for identity, potency, dissolution, and purity. A seal does not guarantee safety or efficacy.

    • Botanical Safety Consortium (2019): Established by the FDA, NIEHS, and HESI to provide a scientific basis for evaluating the safety of botanical supplements.

Definitions of Herbal Preparations

  • Decoction: A tea made by boiling plant material (bark, rhizomes, roots) in water.

  • Infusion: A tea made by pouring water (usually boiling) over plant material (flowers, fruit, leaves) and steeping it.

  • Tincture: An extract made by soaking herbs in glycerin, alcohol, or vinegar for 22 to 66 weeks; the liquid is then strained.

  • Liniment: A plant extract added to alcohol or vinegar and applied topically.

  • Poultice: A topical application of a soft, moist mass of plant material, usually wrapped in cloth.

  • Essential Oils: Aromatic volatile oils extracted from plant parts; usually highly concentrated and require dilution.

  • Herb-infused Oils: Volatile oils extracted by soaking plants in a carrier oil for approximately 22 weeks.

  • Percolation: Extracting soluble constituents by allowing a liquid (menstruum) to flow through packed plant material using gravity.

Profile of Commonly Used Herbal Remedies (A–G)

  • Asian Ginseng (Panax ginseng)

    • Uses: Increases resistance to stress, improves stamina, concentration, memory, and stimulates immune function.

    • Side Effects: Insomnia is most common. Also reports of breast tenderness, menstrual irregularities, and high blood pressure.

    • Interactions: Caution in diabetes due to risk of hypoglycemia. Interacts with calcium channel blockers, antihypertensives, statins, antidepressants, and warfarin.

  • Chamomile (Matricaria recutita)

    • Uses: Sleeplessness, anxiety, and GI conditions (upset stomach, gas, diarrhea).

    • Side Effects: Nausea, dizziness, and allergic reactions (up to anaphylaxis). Cross-sensitivity with ragweed or the daisy family.

  • Echinacea (Echinacea purpurea)

    • Uses: Colds and upper respiratory infections; thought to stimulate the immune system.

    • Side Effects: Nausea, stomach pain, and rashes.

  • Garlic (Allium sativum)

    • Uses: Lowering cholesterol and blood pressure; heart health.

    • Side Effects: Heartburn, upset stomach, body odor, and reduced blood clotting.

    • Interactions: Bleeding disorders, surgery/dental work, and the drug saquinavir (HIV protease inhibitor), as garlic reduces its effectiveness.

  • Ginger (Zingiber officinale)

    • Uses: Nausea (postoperative, pregnancy, chemotherapy, motion sickness) and arthritis pain/swelling.

    • Side Effects: Gas, bloating, heartburn, and nausea.

  • Ginkgo (Ginkgo biloba)

    • Uses: Anxiety, dementia (conflicting evidence), eye problems, peripheral artery disease, and tinnitus.

    • Side Effects: Headache, stomach upset, dizziness, palpitations, constipation.

    • Interactions: Interacts with anticoagulants; increases bleeding risk.

Profile of Commonly Used Herbal Remedies (H–Z)

  • Lavender (Lavandula angustifolia)

    • Uses: Anxiety, depression, and digestive symptoms.

    • Side Effects: Topical use may cause allergic skin reactions.

  • Saw Palmetto (Serenoa repens)

    • Uses: Urinary symptoms related to BPH (benign prostatic hypertrophy), pelvic pain, and hair loss.

    • Note: Research suggests it is no more effective than a placebo for BPH.

  • St. John’s Wort (Hypericum perforatum)

    • Uses: Depression (mild), menopausal symptoms, ADHD, and topical wound healing.

    • Interactions (Critical): Dangerous interactions with antidepressants (serotonin syndrome), birth control pills, cyclosporine, digoxin, indinavir, irinotecan, seizure meds, and anticoagulants. It is a potent inducer of CYP−450CYP-450 enzymes and intestinal p-glycoprotein.

    • Side Effects: Photosensitivity, anxiety, dry mouth, dizziness, GI problems, fatigue, headache, sexual dysfunction.

  • Turmeric (Curcuma longa)

    • Uses: Arthritis, respiratory infections, allergies, and depression.

    • Note: Active curcuminoids have low oral bioavailability.

Potential Hazards and Clinical Safety

  • COVID-19 Warning: Herbs and dietary supplements have not been proven effective for the prevention or treatment of COVID-19.

  • Drug-Herb Interactions

    • Asian Ginseng: Induces CYP3ACYP3A; monitor drugs with a narrow therapeutic index.

    • Goldenseal: Potent inhibitor of both CYP3A4CYP3A4 and CYP2D6CYP2D6.

    • St. John’s Wort: Potent inducer of CYP−450CYP-450 enzymes.

  • Interference with Laboratory Tests

    • Danshen and Chan Su: Can interfere with digoxin level tests. Patients on digoxin must avoid these.

  • Specific Hazards by Route

    • Comfrey: Safe for external use (swelling/sprains) but internal use is discouraged due to fatal hepatic damage risk.

  • Surgical Considerations

    • Herbs can interfere with anesthetics and anticoagulants.

    • The American Society of Anesthesiologists suggests discontinuing herbal therapy 22 to 33 weeks before surgery.

  • Anticoagulant Interference List

    • The following herbs may interfere with anticoagulants: Bilberry, Cat's claw, German Chamomile, Dong Quai, Feverfew, Garlic, Ginseng, Ginger, Ginkgo, Licorice, and St. John's Wort.

Patient and Healthcare Provider Responsibilities

  • Patient Responsibilities

    1. Consult healthcare providers before starting herbal preparations.

    2. Report all herbal use to all providers.

    3. Inform providers of any herbal allergies.

    4. Use caution if pregnant or lactating.

    5. Do not exceed recommended doses.

  • Tips for Prudent Use

    • "Natural" does not equal "safe."

    • Avoid giving herbs to infants or young children.

    • Do not use herbs if attempting to become pregnant, or if currently pregnant or nursing.

    • What is on the label may not match what is in the bottle due to lack of standardization.

Clinical Judgment and Nursing Interventions

  • Key Concepts

    • Culture: Assessing patient beliefs and generational practices.

    • Safety: Protecting patients from harm.

    • Health, Wellness, and Illness: Maintaining a holistic view within nursing care.

  • Assessment (Recognize Cues)

    • Use culturally sensitive, nonjudgmental questions.

    • Inquire about the name of the herb, duration of use, reason for use, who recommended it, and dosage/frequency.

    • Assess for drug-herb and drug-supplement interactions.

  • Nursing Interventions (Take Action)

    • Advise patients to stick to the same brand of herbal therapy due to manufacturing inconsistencies.

    • Consult with dietitians as needed.

    • Teach patients about food-herb interactions.

    • Counsel patients on symptoms requiring prompt medical reporting.

Clinical Case Study and Review

  • Case Study: Cinnamon for Diabetes

    • Scenario: A 5555-year-old with type 2 diabetes replaces prescribed metformin with a heaping spoonful of baking cinnamon in tea, based on a neighbor's advice and a Google search.

    • Nurse Requirements: The nurse needs to assess the patient's rationale for avoiding metformin and educate the patient on the lack of clinical standardization for "baking cinnamon" compared to pharmacological doses, as well as potential risks of unmanaged blood sugar.

  • Review Question Key Points

    • DSHEA (1994) reclassified herbs as dietary supplements and allowed marketing with suggested dosages.

    • When a patient starts multiple herbal products, the first priority is to have them inform their healthcare provider.

    • Appropriate labeling for an herbal product includes structure/function claims like "helps increase blood flow."

    • Garlic, ginger, and ginkgo are notable for interfering with anticoagulants.

    • Garlic is not an effective treatment for preventing depression or curing impotence.