Chapter 11: Botanicals: A biologically based therapy

Question 1

Biologically based therapies

Answer 1

use a variety of natural techniques to maintain health and/or treat diseases

Question 2

What is a major of biologically based therapies

Answer 2

the use of botanicals

Question 3

orthomolecular medicine

Answer 3

emphasizes supplementing diet with mega doses of vitamins, minerals, enzymes, hormones, and amino acids

Question 4

chelation therapy

Answer 4

use of a drug to bind with and remove excess or toxic amounts of metal or minerals from the blood)

Question 5

Botanical

Answer 5

term for the use of plants or plant parts to create scents or to develop therapeutic medicinal treatments

Question 6

The cosmetic industry uses over ___ botanical additives to add fragrance and enhance the looks of their products

Answer 6

360

Question 7

Herbalist

Answer 7

a practitioner and contributor to the field of herbal medicine

Question 8

German commission E

Answer 8

expert panel composed to determine with “reasonable certainty” the safety and efficacy of each herb being evaluated
-the commission checks herbal data independently of other drugs

Question 9

Food and drug administration (FDA)

Answer 9

evaluates the safety and efficacy of new drugs based on data supplied by the drug manufacturer

Question 10

In 1994 the U.S. Dietary supplement health and education act…

Answer 10

allowed herbal products to be labeled with certain information such as side efffects, potential safety problems and contraindications

Question 11

Herbals are defined by the DSHEA as dietary supplements..they are described as a product that:

Answer 11

-is intended to supplement the diet.
-contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and certain other substances) or their constituents.
-is intended to be taken by mouth in forms such as tablet, capsule, powder, softgel, gelcap, or liquid.
-is labeled as being a dietary supplement.

Question 12

What following steps would be taken if the FDA would accept herbal supplements for the approval process

Answer 12

1. investigational new drug application
   -FDA has 30 days to submit questions after proposal submitted
   2.Clinical studies
2. new drug application
   -NDA is submitted
   -after received FDA starts a 180-day approval period
   -reviewing NDA for approval usually take 2.5 years

Question 13

Clinical study phases

Answer 13

Phase 1: Safety, dosage, and effects on the body are tested on 20–80 healthy volunteers (about 1 year).

Phase 2: Effectiveness and side effects are tested on 100–300 people with the disease to be treated by the drug (about 2 years).

Phase 3: The drug is tested on 1,000–3,000 people with the disease who are in clinics or hospitals. Benefits and long-term side effects are compared. Marketing information, including labels and warnings, are developed (about 3 years).

Question 14

True or false: if the FDA finds a product unsafe, it could take action against the manufacturer and/or issue a warning and or be removed from the market

Answer 14

true

Question 15

What did studies show about pharmacists views regarding selling herbal supplements affects and the pharamacys image

Answer 15

inconsistent, some negative views some positive

Question 16

According to the 2007 National center for health statistics the out of pocket spending for all complementary and alternative medicine was estimated at ???

Answer 16

33.9 billion

Question 17

how much of that was spent on homeopathic medicine

Answer 17

2.9 billion

Question 18

Precautions taken before buying an herb for medicinal use

Answer 18

1.discuss idea with your doctor
2.research the company that is producing the herbal