Term
| what is the gold standard of study designs? |
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Definition
| the randomized controlled trial (RCT) |
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Term
| what is one study design that has been developed for therapies not easily subject to RCT? |
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Definition
| n-of-1: in which a single patient intermittently receives treatment, has treatment stopped, receives a placebo, and then begins treatment again |
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Term
| what criteria guide choosing which alternative tx should be studied? |
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Definition
| biological plausibility of the tx, some existing evidence of safety/effectiveness, and tx targeted towards prevalent conditions which cause a substantial burden of suffering. |
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Term
| what is the potential problem with the Dietary Supplement Health and Education Act (DSHEA) of 1994? |
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Definition
| this legislation classifies dietary supplements as foods, exempting them from the same safety standards to which prescription drugs and over-the-counter medications must adhere - pts who self-medicate may be ingesting something much different than they expect either in composition or in volume. |
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Term
| what is the pharmacologic activity of black cohosh? indications? stimulatory effects on estrogen-dependent CA? |
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Definition
| estrogenic activity: binds to estrogen receptors. black cohosh will *reduce LH, but not FSH after 8 wks in women. it can be used for management of menopausal hot flashes and is a possible alt to HRT. unlike HRT, it has no effect on the endometrium and therefore does not require opposing therapy w/progesterone. it has no stimulatory effects on pts w/hx of estrogen-dependent CA. additional studies are needed in terms of osteoporosis. |
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Term
| what are ADRs associated with black cohosh? |
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Definition
| n/v, visual disturbances, bradycardia, and sweating. large doses may induce miscarriage (contraindicated in pregnancy - may cause premature birth) |
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Term
| what is the pharmacologic activity of echinacea? what is it claimed to tx? |
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Definition
| increased lymphocytic and granulocytic phagocytic activity (increased immunostimulant activity) - claimed to tx: allergies, infections (GI/UT), inflammatory disorders (arthritis), dermatitis, and prevention of colds/flu. |
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Term
| what is the result of studies performed on the efficacy of echinacea's pharmacologic activity? what is the recommended period of time for its use and why? |
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Definition
| some studies have proved echinacea's immunostimulant activity, while others disproved it. in conclusion: immunostimulant activity may occur in some pts presenting with minimal to moderate depression of immunity, *however suppression of the immune response has been observed w/daily dosing for several months - therefore the recommended limit for daily use is 8 wks.* |
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Term
| who is echinacea contraindicated in? |
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Definition
| pts w/compromised immune systems: AIDS, MS, TB |
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Term
| what ADRs are associated with echinacea? |
|
Definition
possible hepatotoxicity (should not be used with other known hepatoxic
agents). paraenteral: rare - shivering, headache, n/v, and fever. |
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Term
| what is the pharmacologic activity of ephedra/ma huang? |
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Definition
| ephedra is an active alkaloid, which acts as an adrenergic agent - activating the sympathetic nervous system (possible tachycardia, hypertension, bronchodilation). |
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Term
| what are signs of ephedra toxicity? |
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Definition
| headache, insomnia, dizziness, palpitations, skin flushing, vomiting, anxiety, and restlessness - toxic psychosis and death are possible. |
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Term
| which pts would ephedra not be recommended for? |
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Definition
|
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Term
| what are drugs which may interact w/ephedra? |
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Definition
| sympathomimetic meds (e.g., antihypertensives; MAO inhibitors). |
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Term
| why did the FDA ban ephedra sales? |
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Definition
| due to reports of toxic effects/fatalities - ephedra presented an unreasonable risk of illness or injury (under the Dietary Supplement Health and Education Act (DSHEA) of 1994, FDA may remove a dietary supplement from the market if it presents a significant or unreasonable risk of illness or injury when used according to its labeling or under ordinary conditions of use.) "in recent years, dietary supplements containing ephedrine alkaloids had been extensively promoted for aiding weight control and boosting sports performance and energy. the totality of the available data showed little evidence of ephedra's effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. these effects are linked to significant adverse health outcomes, including heart attack and stroke." |
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Term
| what is the pharmacologic activity of feverfew? what do studies show? |
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Definition
| feverfew is an inhibitor of prostaglandin synthesis and serotonin release from platelets/PMN leukocyte granules (like ASA). one study showed a reduction in headaches w/feverfew - but more scientific research is necessary. |
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Term
| what are ADRs associated with feverfew? contraindications? |
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Definition
| possible interaction w/anticoagulants and dermatitis. feverfew toxicity may cause: mouth ulceration, widespread inflammation of oral mucosa/tongue, lip swelling, and loss of taste. feverfew should not be used by pregnant women (potential emmenagogue - stimulant of menstrual flow), lactating women, or children under 12. NSAIDs may reduce its ability to treat migranes. |
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Term
| what diseases is garlic claimed to tx? what are claimed pharmacologic actions of garlic? |
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Definition
| diseases claimed to tx: hyperlipidemia, HTN, and hypercholesterolemia. claimed pharmacologic actions: anti-inflammatory, antihyperlipidemic, antibacterial, antifungal, antithrombotic, and hypotensive activity. |
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Term
| what does the meta-analysis of garlic's effects show? |
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Definition
| garlic *decreases cholesterol and triglycerides levels in patients with elevated levels of these lipids*. garlic is *antithrombotic. garlic appears to have a role in reducing deaths caused by malignant diseases has several potentially important agents that possess *antitumor & *anticarcinogenic properties. garlic has potent inhibition of adenosine deaminase and cyclic AMP phosphodiesterase - may explain antithrombotic, vasodilatory, and anticancer actions |
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Term
| which pts should use caution in terms of their garlic intake? |
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Definition
| DM pts (may increase insulin levels) and pts w/bleeding disorders or on anticoagulant medication. |
|
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Term
| what ADRs are associated w/garlic? |
|
Definition
| gastric upset, local (hand) allergic reactions, increased bleeding time |
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Term
| what pharmacologic activity is associated with ginger? |
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Definition
| ginger is claimed to be an antiemetic and has been shown to have a cholagogic effect and increase saliva secretion/gastric juices. ginger is recommended for prophylaxis/tx of nausea and motion sickness. |
|
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Term
| what have studies on ginger shown? |
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Definition
| there were no clear indications of ginger possessing antiemetic properties, anticoagulant properties (*though this has been proven elsewhere*) or anti-n/v properties in the studies provided by dr. goldstein. |
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Term
| which pts should take ginger w/caution? |
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Definition
| pts w/gallstone problems, bleeding disorders, or on anticoagulant medication |
|
|
Term
| who is ginger contraindicated in? |
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Definition
|
|
Term
| what are the conclusions in terms of ginger's medical properties? |
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Definition
| some documented antiemetic and anticoagulation activity |
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Term
| what pharmacologic activity is associated with ginkgo? |
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Definition
| ginkgo is claimed to vasodilate, inhibit platelet aggregation and scavenge free radicals. |
|
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Term
| have ginkgo's vasodilatory effects been proven? |
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Definition
| a study on himalayan mountain climbers showed ginkgo did reduce vasomotor disorders of the extremities and keep those who took it from developing mountain sickness. (some evidence that it works) |
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Term
| has ginkgo been proven to help w/memory deficit? |
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Definition
| there has been shown as small but significant increase in memory deficit of alzheimer's pts - however some of them did develop bleeding problems (anticoagulant properties). |
|
|
Term
| what pts is ginkgo use cautioned in? |
|
Definition
| pts w/bleeding disorders or on anticoagulant medication |
|
|
Term
| what ADRs are associated w/ginkgo? |
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Definition
| increased bleeding and mild GI problems |
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Term
| what medical properties are claimed about ginseng? have any of these been proven in scientific studies? |
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Definition
| CNS stimulation, endurance enhancement, and potential anti-tumor proliferation activity are all properties claimed about ginseng - though none have been proven in scientific trials. |
|
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Term
| what pts should use ginseng w/caution? |
|
Definition
| those who should not receive estrogen therapy |
|
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Term
| what ADRs are associated with ginseng? |
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Definition
| potentially increased bleeding, sleeplessness w/large doses, drug interaction w/digoxin, and increased blood sugar levels (DM) pts |
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Term
| what medicinal properties are claimed for golden seal? |
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Definition
| antimicrobial, astringent, topical anti-inflammatory, CNS stimulant, and drug test avoidance facilitator. |
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Term
| where the claims drug test avoidance properties of golden seal found to be true? |
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Definition
| yes - it is a diuretic, so urine is dilute enough that drugs do not show up, however the specific gravity is low enough to raise suspicion |
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Term
| what are contraindications for golden seal? |
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Definition
| during pregnancy - due to oxytocic effect |
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Term
| what ADRs are associated with golden seal? |
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Definition
| prolonged use can cause CNS excitation, hallucinations and high doses are associated with nausea, vomiting, and bradycardia. |
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Term
| what medicinal properties are claimed for kava kava? |
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Definition
| kava kava is claimed to be an anxiolytic, CNS depressant, and local anesthetic |
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Term
| what have clinical studies of kava kava shown? |
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Definition
| kava kava does have proven anxiolytic/CNS depressant activity similar to benzodiazepines/TCAs and was found to be a reversible inhibitor of human platelet MAO-B. |
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Term
| what cautions should be taken w/kava kava? |
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Definition
| kava kava will increase the effect of other CNS depressants such as alcohol |
|
|
Term
| who is kava kava contraindicated in? |
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Definition
|
|
Term
| what ADRs have been associated with kava kava? |
|
Definition
| GI and ocular disturbances as well as some skin irritation. |
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Term
| what medicinal property has been associated with st. john's wort? |
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Definition
| antidepressant - due to one of its components, hypericum |
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Term
| what have clinical studies on st. john's wort shown? |
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Definition
| st. john's wort does produce a mild antidepressant effect. further testing on severe depression should be performed. |
|
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Term
| what ADRs are associated w/st. john's wort? |
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Definition
| dizziness, confusion, *increased photosensitivity, synergistic action w/rx antidepressant, and *interaction w/other drugs that require CYP metabolism. |
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Term
| what medicinal properties have been associated with saw palmetto? what have clinical studies shown? |
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Definition
| treatment of BPH, which clinical studies have shown to be effective. an extract of saw palmetto, permixon, has been shown to decrease the uptake of DHT and testosterone in all tissue specimens and increase urinary flow rate/decrease residual urin volume (by half) |
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Term
| what pharmacologic activity is associated with valerian? what is it indicated for? |
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Definition
| possible re-uptake inhibitor of GABA, serotonin, and norepinephrine - indicated for mild sleep disorders and mild anxiety. dosage: 150-300 mg. |
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Term
| what cautions area associated w/valerian? |
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Definition
| not appropriate for acute treatment of insomnia as it can take several weeks to have a therapeutic effect. may potentiate effects of CNS depressants and other reuptake inhibitors. may cause morning drowsiness. side effects of long-term use include headaches, excitability, and uneasiness. caution w/concomitant antidepressant rx use. |
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Definition
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Definition
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