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1
Q

Original definition of unconventional therapies

A

Lack of inclusion in medical schools or availability in US hospitals

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2
Q

What is the purpose of National Center for Complementary and Integrative Health (NCCIH)

A

Oversees and funds research in the area of unconventional medicine

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3
Q

Is alternative common or rare in the US?

A

Very rare

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4
Q

What is alternative medicine?

A

The use of unconventional therapies as a substitute for conventional medical treatments

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5
Q

Why do many people use unconventional treatments?

A

They are a way to reject, and challenge, the mainstream medical establishment

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6
Q

What is complementary medicine?

A

The use of unconventional therapies in conjunction with conventional medical treatments

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7
Q

What is integrative medicine?

A

Comprehensive, often interdisciplinary approach to treatment, prevention and health promotion that brings together both CAM and conventional therapies in a coordinated way to ensure positive clinical outcomes

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8
Q

What are self-administered unconventional therapies?

A

Dietary supplements

Aroma therapy

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9
Q

What are practitioner based therapies?

A

Chiropractic
Acupuncture
Hypnotherapy
Massage therapy

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10
Q

What is the largest, most regulated, and best recognized of the health care professions that functions outside of mainstream medicine?

A

Chirpractic

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11
Q

What is the most used CAM product in the US?

A

Natural products

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12
Q

What are natural products?

A

All of the supplements except for vitamins and minerals

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13
Q

Which CAM therapy is the most widely disseminated indigenous US system of healing?

A

Chiropractic

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14
Q

Are Chiropractors licensed or regulated?

A

Yes, both

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15
Q

What is the core clinical procedure of chirpractic health care?

A

Spinal manipulation

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16
Q

Is chiropractic care conventional or unconventional?

A

Unconventional

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17
Q

What is the most common reason to see a chiropractor?

A

Musculoskeletal problems

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18
Q

What premise is chiropractic care based on?

A

Neurologic dysfunction caused by impinged nerves at the spinal level is the cause of most diseases and that spinal manipulation removes the interference

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19
Q

What is a subluxation?

A

A form of joint strain or sprain with clinically associated hypomobility, malalignment, local and referred pain, inflammation, and muscle tension

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20
Q

What advice do chiropractors give to patients?

A 
Nutrition
Vitamins
Weight loss
Smoking cessation
Relaxation techniques
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21
Q

What are other treatments and services chiropractors preform?

A

Physical therapies

Therapeutic and general fitness exercises and other forms of CAM

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22
Q

What are nonserious adverse effects of spinal manipulation?

A

Localized discomfort
HA
Fatigue

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23
Q

What are serious complications of spinal manipulation?

A

Cauda equina syndrome (paralysis)
Cerebrovascular artery dissection
Death

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24
Q

What is the basic principle of hemopathy?

A

Treating the cause of the disease
Like cures like
Inverse Dose-response relationship

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25
What are other names for herbal medicine?
Botanical medicine Phytomedicine Phytotherapy Herbalism
26
What type of energy in homeopathy based on?
Innate healing energy
27
Homeopaths believe that sickness occurs when...
The innate healing energy and the body are not in harmoney
28
What is the innate healing energy known as?
Vital force
29
Are homeopathic remedies high or low dose?
Low dose to assity the attenuated Vital force in promoting self-healing
30
What are botanicals?
plants (woody or non-woody stems) or crude substances derived from plants
31
What are herbs?
Only plants with non-woods stems that die in winter
32
What is the botanical/herb relationship
Herbs are botanicals, but not all botanicals are herbs
33
What are the two different types of herbal modalities?
Paraherbalism | Rational herbalism
34
What is paraherbalism?
Irrational, non-scientific practice of herbal medicine. Have mystical/magical properties that cannot harm humans
35
What is rational herbalism?
Scientific and sensible use for the treatment/prevention of disease Evidence based
36
What is the gold standard for public health and safety?
Placebo-controlled, randomized human clinical trials with adequate sample size
37
What is the gold standard for assessing value of therapies?
PCRCT
38
What is arnica indicated for?
Bruising and swelling
39
What are the AEs for topical arnica?
``` Itching Rash Petechiae Dry skin At high doses: skin vesicles/necrosis ```
40
What are the AEs for oral arnica?
``` Stomach irritaton Dry mouth HA Drowsiness Sore tongue Lethargy ```
41
What are the DDIs for arnica?
Enhances effects of anticoagus and antiplatelets with increased risk of bleeding Potentially decrease the efficacy of antihypertensives
42
What are CIs for arnica?
External use on broken or damaged skin | Allergy to any herb in the asteraceae family
43
What are cautions for arnica?
Those on NSAID, anticoag, oral corticosteroids, use of other homeopathic remedies, bleeding/bruising disorders, pregnancy, lactation, severe liver or kidney disease, malignancy, infection, immunodeficiency and metabolic syndrome
44
What is the active ingredient in arnica?
Arnica lactones
45
What is the MOA of arnica?
Directly inhibit nuclear factor kappa B which reduces synthesis of proinflammatory cytokines, cox2 and NO synthesis, which results in a diminished inflammation response
46
What is Butterbur indication?
Migraine prevention
47
What are the AEs of butterbur?
``` GI effects (belching) Dermal sx Dizziness HA Drowsiness Fatigue N/V/D Stomach pain Flatulence Allergic conjunctivitis Eye and skin discoloration Sneezing Mild elevations in liver enzymes ```
48
What are butterbur's DDIs?
Don't use with any other herb/supplement containing pyrrolizidine alkaloids Don't use with 3A4 inducts (St John's wort, carbamazepine, phenytoin, rifampin, phenobarbitol) Don't use with meds that are anticholinergic
49
What are the CIs for butterbur?
Those with hypersensitivity or are allergic to plants in the Asteraceae family Don't take if pregnant/breastfeeding
50
What is the active ingredient in butterbur?
Iso-petasin for anti-inflammatory and petasin for the antispasmodic and smooth muscle relaxation
51
What is the MOA of butterbur?
Anti-inflammatory properties Inhibits the lipooxygenase pathway and leukotriene synthesis Also has antispasmodic properties that cause smooth muscle and vascular wall relaxation Petasins have a high affinity for cerebral blood vessels
52
What is fenugreek used for?
DM
53
What are the ADRs of FenuGreek?
``` Diarrhea Dyspepsia Ab distention Flatulence May cause hypoglycemia In healthy males, decreased serum potassium, dizziness, hunger, and increase frequency of urination ```
54
What are the DDIs for FenuGreek?
May impair absorption of other PO meds and concomitant administration should be avoided May enhance the hypoprothrombinemic effects of anticoagulants
55
What are the contraindications for FenuGreek?
Should not be consumed during pregnancy Avoid in pts with allergy/hypersensitivity to fenugreek or plants in the Fabaceae family Avoid in pts with allergy to peanuts, chickpeas, and coriander d/t cross reactivity
56
What is the active ingredient in FenuGreek?
4-hydroxyisoleucine
57
What is the MOA of FenuGreek?
Stimulate insulin secretion and improve glucose tolerance by direct stimulation of pancreatic beta cells On cellular levels, its actions are very similar to that of insulin
58
What is guggul indicated for?
Hypercholesterolemia
59
What are the AEs for guggul?
``` Rhabdomyolysis Rash Ab pain Diarrhea HA Restlessness Hiccups ```
60
What are the DDIs for guggul?
Decreased bioavailability of propranolol or diltiazem used concurrently Increased risk of bleeding in patients taking anticoagulants or antiplatelet medications
61
What are the CIs for guggul?
Avoid in patients with thyroid disorder | Pregnant patients should avoid guggul since it stimulates menstrual flow
62
What is the active ingredient in guggul?
Guggulsterones E and Z
63
What is the MOA of guggul?
May decrease hepatic steroid production, ultimately increasing the catabolism of plasma LDL cholesterol Active components may increase hepatic binding sites for LDL cholesterol thus increasing LDL clearance
64
What is the indication for melatonin?
Managing sleep disorders in children with autism spectrum disorder
65
What are the AEs of melatonin?
``` Morning drowsiness Increased enuresis HA Dizziness Diarrhea Rash Hypothermia ```
66
What are the DDIs of melatonin?
Inhibitors of 1A2 (TCAs, fluvoxamine, cimetidine) may increase melatonin concentratoin. Patients who take BP or DM drugs should be monitored since melatonin may decreased BP or serum glucose
67
What are the MOAs of melatonin?
Production stimulated by darkness | Biosynthesized from tryptophan which is converted to serotonin and ultimately to melatonin
68
Pycnogenol is used for what?
Chronic venous insufficiency
69
What are the AEs of pycnogenol?
``` GI upset (use w/ or after meals) Dizziness HA N/D Acne in women Dysfunction of uterine bleeding in women ```
70
What are the DDIs of Pycnogenol?
Potential to interfere with immunosuppressant therapy | Avoided in patients with MS, SLE, RA, or autoimmune disorders
71
What is the CI for pycnogenol?
Pregnant/lactating pts | Children <6yo
72
What are precautions for pycnogenol?
Pts on meds for CV disorders, DM, bone/joint disorders, and confirmed or suspected h/o thrombosis
73
What is the active ingredient in pycnogenol?
Procyanidins
74
What is the MOA of pycnogenol?
Enhance vascular endothelial function, reduce capillary permeability, and improve microcirculation
75
What are the criteria for dietary supplements
Contain vitamin, mineral, herb, amino acid, dietary substance, concentrate, metabolite, constituent, extract or combination Intended for ingestion Labeled as dietary supplement Cannot be represented for use as conventional food
76
What are nutraceuticals?
Dietary supplements that deliver a concentrated form of a bioactive agent from a food in dosages that exceed those that could be obtained from normal foods
77
Examples of nutraceuticals
L-tryptophan | Genistein (soybean)
78
What are functional foods?
Similar in appearance to conventional foods and are consumed as part of a normal diet Have high levels of one or more bioactive ingredients
79
Examples of functional foods
Cholesterol-reducing margarines (Benecol) Cereal fortified with folic acid/psyllium Soy products prepared from genetically-altered soybeans Pasta enriched in fiber, antioxidants and vitamin E
80
When was the dietary supplements health and education act (DSHEA) created?
1994
81
Who controlled supplements before the DSHEA?
FDA
82
What kind of claims dose DSHEA allow companies to market on their supplements?
Structure/Function claims: | Health claims or claims describing their effect on the structure/function of the human body
83
What disclaimer must be on the bottle if the product makes an SFC?
This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease
84
What responsibilities does the FDA still have?
Overseeing safety of supplements Establishing/enforcing good manufacturing practices (GMPs) Ensuring that product information is truthful
85
When is the FDA able to take action?
If it determines that a product is unsafe or mislabeled
86
Who regulates the advertising of dietary supplements?
FTC
87
When does a manufacturer not require evidence before distribution?
if the ingredient is on the Generally Recognized as Safe List
88
Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, what are manufacturers require to document?
All adverse events reported - these must be submitted to the FDA
89
What is required on the label to report ADRs?
Full domestic mailing address or phone number
90
What are health claims regulated under?
Nutritional Labeling and Education Act
91
Who approves health claims?
FDA
92
What are examples of SFCs?
``` Helps maintain CV health Builds strong bones Helps maintain a healthy cholesterol level Helps promote urinary tract health Promotes relaxation ```
93
What type of product is allowed for disease/drug claims?
Drugs
94
What do all supplement labels require per the FDA?
``` Statement of identity Name of each ingredient Total quantity of all dietary ingredients Words dietary supplement If standardized must be labeled such Directions for use "Supplement facts" ```
95
What are supplement facts?
``` Net quantity of ingredients Active ingredients Other ingredients Serving size Quantity and percent daily value Amount per serving Warnings Storage Lot number/exp Name and place of business of the manufacturer, packager, and/or distributor ```
96
When can the term high potency be used?
When products contain 100% or more of the established RDI for a vitamin or mineral
97
Who has the authority to establish and enforce GMPs that are specific for dietary supplements?
FDA
98
What do GMPs govern?
Preparation Packaging Labeling Storing
99
What is GBE indicated for?
Cerebrovascular disease | Preventing Cognitive decline
100
What is the MOA of GBE in cerebrovascular disease?
Blocks platelet activation and inactivates free radicals
101
ADRs of GBE
GI symptoms HA N/V
102
What is GBE CI with?
Bleeding disorders
103
What are DDIs of GBE?
Anticoags ASA NSAIDs
104
What are the active ingredients of GBE/
Flavone glycosides | Terpenoids
105
What is the aim of standardization?
To ensure high quality, safety and effectiveness of botanical dietary supplements
106
Do all manufacturers standardize their products?
No
107
What is a standardized product?
Produced using a standard protocol Ingredients are identical, both qualitatively and quantitatively, from one batch to the next Should perform the same way each time
108
When is a marker compound used?
When the active ingredient is not known
109
What is the standardization protocol currently used?
Acquisition of high quality herbal/botanical material Perform quality and quantity control procedures Extraction and sterilization Preparation of extract followed by quality controls Standardization of the extract Addition of auxiliary agents Performing quality control procedures in the finished product
110
What complications are there with standardization?
Activity of most botanicals is not d/t a single chemical Components in a botanical extract may enhance/detract from the therapeutic utility of the active principles Most botanical products are standardized based on one marker Assumption that if the single marker is in the right quantity, the other components will be too
111
What is phytoequivalency?
The only practical way to ensure uniformity of therapeutic action
112
When is phytoequivalency particularly important?
When we do now know the exact MOA and/or the identity of all of its active ingredients
113
Why do manufacturers not use phytoequivalency?
Expensive
114
Who do the manufacturers/packers/distributors report serious AEs or toxicities to?
FDA
115
How do botanial dietary supplements affect surgery patients?
Prolong clotting time and increase risk of bleeding OR Adversely affect BP/HR
116
What are two was to report AEs?
MedWatch | Department of Health and Human Services' Safety Reporting Portal
117
Who does MedWatch belong to?
FDA
118
When an AE or product problem is reported, what can the FDA do?
Label changing Boxed warnings Product recalls and Withdrawals Medical and safety alerts
119
What should a pharmacist report?
``` Product contamination Defective components Poor packaging or product mix up Questionable stability Labeling concerns AEs Interactions ```
120
What are the common botanicals that are known to be toxic?
``` Comfrey Sassafras Colts foot Pennyroyal oil Germander Chaparral Bayberry Ephedra Licorice Wormwood ```
121
What is the toxic ingredient and toxicity of comfrey?
Pyrrolizidine alkaloids | Hepatotoxicity & carcinogenicity
122
What is the toxic ingredient and toxicity of sassafras
Safrole | Carcinogenic
123
What is the toxic ingredient and toxicity of coltsfoot
Pyrrolidizine alkaloids | Hepatotoxicity & carcinogenic
124
What is the toxic ingredient and toxicity of Pennyroyal oil?
Pulegone | Hepatotoxicity
125
What is the toxic ingredient and toxicity of germander?
Furanoditerpenes | Hepatotoxicity
126
What is the toxic ingredient and toxicity of bayberry
Tannins | Carcinogenic
127
What is the toxic ingredient and toxicity of ephedra
Ephedrine | CV
128
What is the toxic ingredient and toxicity of chaparral
Nordihydro-guaiaretic acid | Hepatotoxicity & nephrotoxocity
129
What is the toxic ingredient and toxicity of licorice?
Glycyrrhizic acid HTN Na and water retention HF
130
What is the toxic ingredient and toxicity of wormwood
Thujone Convulsions Psychotic effects

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