Herbal Presentation

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Does it Really Work?

Goodrich Pharmacy Presentation

Linh Nguyen, PharmD Candidate, 2008

Introduction

Have you encountered patients that have asked about products they’ve heard about from friends or T.V ads?

Many patients approach community pharmacies about products that have not been well studied. Herbal and “fad” products are hitting the market faster than ever! It is our job to help patients determine what is safe and effective.

Objectives

  • Become familiar with common herbal and “fad” products

    • Herbal Menopause Medications
    • Cranberry Juice
    • Pomegranate Juice
    • Mangosteen Juice
    • Red Wine
    • Dark Chocolate
    • Green Tea
    • Airborne
    • Head-On

  • Determine which products are safe and effective based on literature

Herbal Menopause Medications

  • Menopause symptoms:

    • Vasomotor (hot flashes, night sweats)
    • Vaginal dryness
    • Urinary incontinence
    • Insomnia
    • Sexual dysfunction
    • Depression
    • Anxiety
    • Labile mood
    • Memory loss
    • Fatigue
    • Headache
    • Joint pain
    • Weight gain

Herbal Menopause Medications

  • Phytoestrogens: plant estrogens used for vasomotor symptoms

  • Not structurally related to estrogen but contains a phenolic ring that binds to estrogen receptors

  • Avoid if history of breast cancer

  • Isoflavones, lignans, coumestans

Herbal Menopause Medications

  • Lignans

    • Flaxseed
    • Lentils
    • Whole grains
    • Beans
    • Fruit
    • Vegetables

  • Coumestans

    • Red clover
    • Sunflower seeds
    • Sprouts

  • Isoflavones

    • Most potent
    • Legumes – soy
    • Chickpeas
    • Garbanzo beans
    • Red clover
    • Lentils
    • Beans

Herbal Menopause Medications

  • Soy Isoflavones: most well studied and used

    • 20-60 mg/day modestly decreases frequency and severity of hot flashes
    • 50 mg/day tablet form found beneficial in ~30% of postmenopausal women
    • Not really effective for women with hot flashes related to breast cancer
    • Caution in patients taking warfarin – soy can decrease INR

Herbal Menopause Medications

  • Black Cohosh

    • Does not seem to affect estrogen receptors
    • Does not seem to affect breast or endometrial tissue
    • Seems safe and well-tolerated
    • May help with hot flashes, sleep disorders, and depression
    • Possible side effects include upset stomach and low blood pressure

Herbal Menopause Medications

  • Flaxseed

    • Rich source of lignans,omega-3 fatty acids, alpha-linoleic acid, and fiber
    • Modest benefit for mild menopausal symptoms
    • 40 g contains 6 g of fat and lots of calories

  • Red Clover

    • Not well studied – perhaps modest improvement
    • Contains coumarins – possible anticoagulation effects

Herbal Menopause Medications

  • Evening Primrose Oil

    • North American wildflower
    • No evidence that it works

  • Chasteberry

    • Thought to reduce vaginal dryness and depression at menopause
    • No conclusive evidence that it works

Herbal Menopause Medications

  • Ginseng

    • Thought to increase a woman’s desire to have sex
    • No evidence that it works

  • Valerian Root

    • Mostly used to treat sleep problems
    • May cause muscle spasms or eye problems
    • Do not recommend

  • Wild Yam

    • Used topically as a cream for menopausal symptoms
    • No estrogenic effects have been identified

Herbal Menopause Medications

  • Dong Quai

    • Root of a plant that is commonly prescribed to regulate menstrual cycles
    • Thought to help with vaginal dryness and hot flashes
    • Can cause increased sun sensitivity, clotting time, and may be carcinogenic

  • St. John’s Wort

    • Used in patients with depression
    • No evidence to help in menopausal women
    • Many drug interactions

Herbal Menopause Medications

  • Which ones to recommend?

    • Based on the Natural Medicines Database, soy and black cohosh are the most studied and can be recommended to menopausal women.
    • Other herbals are lacking sufficient evidence and may cause adverse side effects.

Cranberry Juice

  • People Use it for:

    • Prevention of urinary tract infections (UTIs)
    • Urinary odor
    • Neurogenic bladder
    • Prevention of urinary catheter blockage
    • Type 2 diabetes
    • Chronic fatigue syndrome
    • Scurvy, diuretic, antiseptic,
    • antipyretic, cancer

Cranberry Juice

  • Possibly effective for:

    • Urinary odor in patients with urinary incontinence
    • UTI Prevention
      • Daily consumption of 10 oz (300 ml) in young and elderly women
      • Does not seem to prevent UTIs in adults or children with neurogenic bladder
      • Reliable evidence lacking for use of capsule form

  • Possibly ineffective for diabetes

    • Have patients avoid products sweetened with sugar

Cranberry Juice

  • Mechanism

    • Once thought to have antibiotic properties from benzoic acid and quinic acid metabolizing to hippuric acid
      • Would have to drink over six 8 oz glasses per day
    • Proanthocyanidins (PACs) have unique microbial antiadhesion properties
    • PACs block uropathogenic bacteria from adhering to epithelium and proliferating
    • Does not acidify the urine
    • Does not release bacteria already adhered to the urinary tract epithelial cells

Cranberry Juice

  • A study showed consuming 300 ml (10 fl. oz) of low-calorie cranberry juice cocktail (approx. 33% juice) per day showed a decrease in bacteria in the urine after one month compared to placebo

  • Adverse Reactions

    • Usually well tolerated
    • Large doses (3-4 L/day) can cause gastrointestinal upset and diarrhea
    • More than 1 L/day for long periods of time can increase risk of uric acid kidney stone formation

  • Interactions

    • Contradictory evidence about effect on CYP2C9 enzymes and warfarin (can possibly increase INR)

Cranberry Juice

  • Cranberry juice contains significant amounts of salicylic acid

    • Contains 7 mg salicylic acid per liter
    • Caution patients taking warfarin
    • Large amounts can trigger allergic reaction in people with an aspirin allergy or asthma

Pomegranate Juice

  • Native to a region ranging from Iran to the Himalaya. It now grows in most of the United states.

  • Greece: fruit of the dead

  • Hebrew: adorned vestments of the high priests

  • Ancient Persians: believed the seeds made warriors invincible

  • China: symbolized longevity

  • Mythology of Ancient Babylonia: agent of resurrection

http://news.nationalgeographic.com/news/...

Pomegranate Juice

  • Used for

    • Hypertension
    • Congestive heart failure (CHF)
    • Atherosclerosis
    • Hypertension
    • Hyperlipidemia
    • Myocardial ischemia
    • Acidosis
    • Hemorrhage
    • Tapeworm
    • Obesity/Weight loss
    • Astringent
    • Diarrhea/Dysentary
    • Abortifacent
    • COPD
    • Influenza
    • Periodontal disease
    • Erectile dysfunction
    • Diabetes
    • Preventing prostate cancer
    • Cancer

Pomegranate Juice

Insufficient reliable evidence to rate:

  • Atherosclerosis

    • 50 ml/day reduced thickness of the carotid artery by up to one 35% after one year

  • Coronary Heart Disease

    • 8 oz/day improved myocardial perfusion by ~17% compared to a worsening of 18% in patients treated with placebo

  • Hyperlipidemia

    • 40 g/day (concentrated pomegranate juice) can reduce total cholesterol and lower LDL in patients with hyperlipidemia and type 2 diabetes
    • No effect seen in triglycerides or HDL

Pomegranate Juice

  • Hypertension

    • 50 ml/day for up to one year may reduce systolic blood pressure by 5-21%, but does not seem to affect diastolic pressure

  • Prostate Cancer

    • Length of time to doubling of prostate specific antigen was significantly longer in men who drank 8 oz/day for up to 2 years after surgery or radiation for prostate cancer

  • Possibly ineffective for COPD

    • Drinking 400 ml daily for 5 weeks did not improve respiratory function

Pomegranate Juice

  • Mechanism of action

    • Contains 0.2-1% polyphenols (more than red wine, blueberry, cranberry, green tea, or orange juice)
    • Polyphenols have antioxidant activity
    • Bark of root and stem contain alkaloids with muscle relaxant properties
    • Flower extract may have alpha-glucosidase inhibiting activity and is used to treat diabetes in Eastern traditional medicine

Pomegranate Juice

  • Adverse reactions

    • Generally well tolerated
    • Angioedema rarely occurs even in people who have eaten pomegranate for years

  • Interactions

    • May have antihypertensive affects – taking with other medications decreasing blood pressure may increase risk of hypotension
    • Thought to have ACE inhibitor-like effects – monitor blood pressure and potassium levels
    • May inhibit CYP2D6
    • May inhibit CYP3A4 (similar to grapefruit juice)

Pomegranate Juice

  • Doses used

    • Hypertension: 50 ml/day
    • Hyperlipidemia: 40 g/day (concentrated pomegranate juice)
    • Atherosclerosis: 50 ml/day
    • Myocardial ischemia: 240 ml (8 oz)/day
    • Prostate cancer: 240 ml (8 oz)/day

Pomegranate Juice

  • Antioxidant effects may contribute to decrease macrophage activity and reduced lipid peroxidation of LDLs

  • Leaf extract thought to inhibit pancreatic lipase causing antihyperlipidemic and antiobesity effects

  • Possibly increases nitric oxide synthetase activity in the blood vessel endothelium

  • Fruit extracts have found to inhibit cell growth and induces apoptosis of aggressive prostate cancer cells in vitro

Mangosteen Juice

  • Tropical fruit that is “sourly sweet”

  • Was thought to be Queen Victoria’s favorite fruit

  • Thought to treat

    • Diarrhea
    • Menstrual problems
    • Urinary tract infections
    • Tuberculosis

  • No reliable evidence to support these claims

Mangosteen Juice

Possible mechanisms of action:

  • Contains tannins

    • Astringent effect on mucosal tissue may reduce secretions
    • May reduce diarrhea

  • Contains xanthones

    • Antioxidant effects
    • In vitro activity against Mycobacterium tuberculosis
    • May also have serotonin and histamine blocking effects

Red Wine

  • Used for

    • Reducing risk of cardiovascular disease (coronary heart disease, atherosclerosis, and myocardial infarction)
    • Reduce risk of ischemic stroke and type 2 diabetes
    • Prevent Alzheimer’s disease
    • Anxiety, appetite stimulant

Red Wine

  • Likely effective for

    • Reducing risk of cardiovascular disease by ~30-50% compared to non-drinkers

  • Possibly effective for

    • Elderly men to maintain general cognitive function
    • CHF
    • Diabetes
    • H. pylori infections

Red Wine

  • Insufficient reliable evidence to rate

    • Alzheimer’s disease
    • Anxiety
    • Cancer
    • Post-menopausal osteoporosis

Red Wine

  • Mechanism of action

    • Polyphenols found in wine (phenolic acids, resveratrol, flavanols, procyanidins, and anthocyanins)
    • Antioxidant properties
    • Resveratrol reduces LDL oxidation and reduces platelet aggregation in vitro
    • White wines have very low polyphenol concentration
    • Moderate alcohol intake may protect against type 2 diabetes due to increase insulin sensitivity
    • “French Paradox”
      • Red wine versus diet low in animal fat

Red Wine

  • How much to drink?

    • Reduce cardiovascular disease, ischemic stroke, and all cause mortality
      • 1-2 glasses/day (120-240 ml)
    • Lessen cognitive decline in older mend
      • 1 glass/day
    • Reduce type 2 diabetes risk
      • 1 glass/day

Dark Chocolate

  • Also called “bittersweet” or “semisweet” chocolate

  • Has a high percentage of cocoa solids (70%)

  • Qualities wanted in dark chocolate:

    • 70% cocoa or more
    • Made from cocoa butter instead of fats (palm oil, coconut oils)
    • Made without “hydrogenated” or “partially hydrogenated” oils
    • Darker is better since they contain more flavonoids (more flavonoids=darker color)

Dark Chocolate

  • Contains flavonoids

    • Antioxidant properties
    • Decreases LDL oxidation
    • Decreases platelet aggregation
    • Decrease blood pressure
      • Improve nitric oxide availability (epicatechin and catechin)
    • May improve mood and pleasure by increasing serotonin and endorphin levels in the brain

Dark Chocolate

  • Milk binds to antioxidants in chocolates

  • Milk chocolate is not an antioxidant source and is higher in fat

  • Avoid drinking milk with dark chocolate

  • Dosage

    • 30 to 90 g/day
    • 3-4 bars (1.5 oz) per week if can afford the caloric intake

Dark Chocolate

  • Health Concerns

    • Contains caffeine
    • Headaches, anxiety, palpitations, insomnia
    • Diuretic effect
    • Increases stomach acid causing stomach irritation

  • Kidney stones

    • Contains oxalates

  • Migraine headaches

    • Contains tyramines

Green Tea

  • Likely effective for

    • Genital warts (ointment)
      • Completely cleared external genital and perianal warts in 24-60% of patients after 10-16 weeks of treatment
      • Veregen (by Bradley Pharmaceuticals) is applied 3 times daily for up to 16 weeks
    • Mental alertness

  • Possibly effective for

    • Bladder, esophageal, and pancreatic cancer
    • Cervical dysplasia
    • Hyperlipidemia
      • 325 mg daily for 12 weeks reduced LDL levels

Green Tea

  • Hypotension

    • Increased BP in elderly with postprandial hypotension

  • Ovarian cancer

  • Parkinson’s disease

    • Men consuming 5-33 cups of tea daily had greatest reduction risk
    • Risk reduction still seen from 1-3 cups per day
    • Effect in women does not seem dose related
    • Prevent adenosine’s inhibition of dopaminergic transmission

Green Tea

  • Mechanism

    • Contains polyphenols which are responsible for many of green tea’s proposed benefits
    • Contains phytoestrogens
    • Catechins may have anti-inflammatory activity
    • Caffeine stimulates the CNS, heart, muscles, and possibly the pressor centers controlling BP
      • Block adenosine receptors, increasing dopamine
      • Diuretic effect, decreases airway resistance

Green Tea

  • Adverse reactions

    • Nausea, vomiting, diarrhea, dizziness, insomnia, fatigue in high doses (5-6 L/day)
    • Hepatotoxicity
    • Large doses can cause catecholamine release leading to sinus tachycardia, metabolic acidosis, hyperglycemia

Green Tea

  • Dose

    • Vary significantly, but usually range between 1-10 cups/day
    • Average amount consumed in Asian countries is about 3 cups per day and provides 240-320 mg of polyphenols
    • A typical dose of 250 mg per day is used for headache or restoring mental alertness

Airborne

  • Marketed to prevent colds

  • Created by a former second-grade school teacher, Victoria Knight-McDowell

  • Each tablet contains: Vitamin A (100% acetate) 5000 IU • Vitamin C 1000 mg • Vitamin E 30 IU • Magnesium (sulfate) 40 mg • Zinc (sulfate) 8 mg • Selenium (sodium selinite) 15 mcg • Manganese (gluconate) 3 mg • Potassium (bicarbonate) 75 mg • Organic Herbal Extracts 350 mg: Lonicera, Forsythia, Schizonepeta, Ginger, Chinese Vitex, Isatis root, Echinacea • Amino Acids 50 mg: Glutamine, Lysine. Other Ingredients: Citric Acid, Sodium Bicarbonate, Polyethylene Glycol, Canola, Sorbitol, Natural Orange Flavor, Mineral Oil, Sucralose, Acesulfame Potassium.

  • $6.99 for 10 tablets

http://www.airbornehealth.com/about_inde...

Airborne

Airborne settles lawsuit for $23.3 million

The herbal supplement firm will settle class action lawsuit that alleges false advertising; money will be refunded to consumers, non-profit advocacy group says.

"There's no credible evidence that what's in Airborne can prevent colds or protect you from a germy environment," said CSPI Senior nutritionist David Schardt. "Airborne is basically on overpriced, run-of-the-mill vitamin pill that's been cleverly, but deceptively, marketed."


http://money.cnn.com/2008/03/04/news/com...

Airborne

  • Airborne said that a double-blind, placebo-controlled study was conducted with "care and professionalism" by a company specializing in clinical trial management, GNG Pharmaceutical Services. GNG is actually a two-man operation started up just to do the Airborne study.

  • Before, the box said that Knight-McDowell had created it because she was "sick of catching colds." Now, it says she created Airborne because she "needed help supporting her immune system." The word "cold" no longer appears on the new package or in the advertising.


http://abcnews.go.com/GMA/OnCall/Story?i...

HeadOn

  • Marketed to relieve headaches

  • "Some people say they get tingling, or a sense of coldness when you put it over your forehead. You'd be better off wrapping a towel around a bag of frozen vegetables, putting that on your forehead and then sensing tingling."

  • The company says it works homeopathically

    • Bryonia Alba (White Bryony) 12X H.P.U.S.
    • Iris Versicolor (Blue Flag) 12X H.P.U.S.
    • Kali Bichromicum (Potassium Bichromate) 6X H.P.U.S.
    • Hydrastis Canadensis (Golden Seal) 30X H.P.U.S.

  • Menthol listed as an inactive ingredient

  • $7.99 for 0.2 oz tube


http://www.cbsnews.com/stories/2006/08/0...

Questions?

References