CLINICAL TRIALS: TESTING MEDICAL PRODUCTS IN PEOPLE WHAT ARE

CLINICAL TRIALS?

Clinical trials, also known as clinical studies, test potential treatments in human volunteers to

see whether they should be approved for wider use in the general population . A treatment

could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene

therapy. Potential treat-ments, however, must be studied in laboratory animals first to

determine potential toxicity before they can be tried in people. Treatments having acceptable

safety profiles and showing the most promise are then moved into clinical trials.

Although “new” may imply “better”, it is not known whether the potential medical treatment

offers benefit to patients until clinical research on the treatment is complete. Clinical trials are

an integral part of new product discovery and development and are required before a new

product can be brought to the market.

Every clinical trial is carefully designed to answer certain research questions. A trial plan

called protocol maps out what study procedures will be done, by whom, and why. Products

are often tested to see how they compare to standard treatments or to no treatment.

Clinical trial teams include doctors and nurses, as well as other health care professionals.

These teams check the health of participants at the beginning of the trial and assess whether

those persons are eligible to participate. Those found eligible - and who agree to participate -

are given specific instructions, and then monitored and carefully assessed during the trial and

after it is completed.

Done at hospitals and research centers, clinical trials are conducted in phases

Phase 1 trials, primarily concerned with safety, try to determine dosing, document how a

drug is metabolized and excreted, and identify acute side effects. This phase usually only

involves small numbers of participants (between 20 and 80), and are usually undertaken in
healthy volunteers. Increasing doses of the drugs are administrated during the studies, and

blood samples collected.

Phase 2 trials include more participants (usually 100 - 300) who have the disease or

condition that the product potentially could treat. In Phase 2 trials, researchers seek to gather

further safety data and preliminary evidence of the drug’s efficacy, and they develop and

refine research methods for future trials. If the Phase 2 trials indicate that the drug may be

effective and the risks are considered acceptable, given the observed efficacy and the severity

of the disease, the drug moves to Phase 3.

In Phase 3 trials, the drug is studied in a larger number of people with the disease

(approximately 1,000 - 3,000 but up to 20,000). This phase further tests the product’s

effectiveness, monitors side effects and, in some cases, compares new treatments with the

existing one to demonstrate long term safety and tolerance. As more and more participants are

tested over longer periods of time, the less common side effects are more likely to be

revealed.

Phase 4 trials are generally performed after a product is already approved on the market to

find out more about the treatment's long-term risks, benefits, and optimal use, or to test the

product in different populations of people, such as children or elderly.

Phase 2 and Phase 3 clinical trials generally involve a "standard procedure of control”. In

many studies one group of volunteers is given a "test” drug or treatment (test group) while the

other group (control group) is given either a standard treatment for the illness or an inactive

substance that has no treatment value (placebo).

The treatments that trial participants receive are often decided by a process called

randomization. This process can be compared to a coin toss that is done by computer. During

clinical trials randomization assures that treatment selection will be free of any bias.
In conjunction with randomization, a feature known as binding helps ensure that bias doesn't

affect the trial or the interpretation of its results. Single-blinding means participants do not

know whether they are receiving the experimental drug or a placebo. A double-blinded trial

means that neither the research team nor the participants know who is receiving the

experimental drug. The keys that allow the identification of the treatment used are made

available only at the end of the study.

(A special report from FDA Consumer Magazine, adapted from)

Decide which statements are True (T) or False (F)

1. Clinical trials are required before a new drug is on sale

2. Phase 1 trials generally involve healthy volunteers

3. Drug trials with human subjects are carried out after tests on laboratory animals

4. Once accepted into a study, clinical trial participants should be randomly assigned to

treatments

5. In single blind studies patients do not know whether they are in the treatment or not.

6 A double blind study is when the test is carried out with only two patients

7. Phase 3 is basically about long-term risks

8. Phase 4 trials are generally carried out on drugs which have been refused by the market

9. The “standard procedure of control" is generally carried out in phases 2 and 3.

10. Blind trials are helpful in trying not to affect the interpretation of results.

Filling the blanks with the words from the box

 Designed - drug - health - involves - treat - long-term - randomization - researchers -

tolerance – treatment – participants – concerned - determine – disease - effectiveness - risks

- research - develop - side - effective - trial

1. Every clinical trial carefully ____________ to answer certain questions.

2. These teams check the ____________ of participants at the beginning of the

____________.

3. Phase 1 trials, primarily ____________ with safety, try to ____________ dosing and

document how a ____________ is metabolized

4. This phase usually only _____________ small numbers of participants.

5. This trial includes participants who have the _____________ or condition that the product

potentially could _____________

6. They ____________ and research methods for future trials

7. This indicates that the drug may be ____________ and the ____________ are considered

acceptable.

8. Phase 3 tests the product's ____________ and monitors ____________

9. ____________ compare new treatments with the existing one to demonstrate

____________ safety and _____________

10. The ____________ that trial ____________ receive is often decided by a process called

____________

Read this new passage about clinical trials and kill in the blanks with the words from the box

(Pay attention! The given words are more than what you need.)

safely – diseases - volunteer - whether - health authorities – side effects – testing – for sale

– phases – market – safety – effectiveness – larger – small - potentially – drug - patients –

treatment – health – lungs - efficacy

Clinical trials are research ştudies which try to answer scientific questions and find better

ways to treat or prevent (1) _______________. A clinical ttrial is conducted to determine (2)

_______________ a new drug or treatment is both safe and effective in people. These

research studies rely on patients who volunteer to participate and try a new (3)

_______________ drug or treatment. Some of these drugs have not yet been approved by

international (4) _______________. Sometimes the drugs are currently available (5)

_______________ but are being tested for a new disease or additional information

Most clinical trials that involve the (6) _______________ of a new drug follow a series of

steps called (7) _______________. This process allows researchers to ask and answer

questions in a way that result in reliable information about the drug and protects the (8)

_______________. Clinical trials are usualy classified into one of four phases:

- In Phase I trials, researchers test a new drug or treatment in a (9) _______________ group

of people (20 – 80) for the first time to evaluate its safety, determine a safe dosage range,

an identity (10) _______________

- In Phase Il trials, the study drug or treatment is given to a (11) _______________ group of

people (100 - 300) to see it is effective and to further evaluate its (12) _____________.

- In Phase III trials, the study drug or treatment is given to a large group of people (1,000 -

3,000) to confirm its (13) _______________, monitor side effects, compare it to

commonly used treatments, and collect information that will allow the drug or treatment to

be used (14) _______________

- In Phase IV trials, post marketing studies delineate additional information including the

drug's (15) _______________, benefits, and optimal use.

The success of clinical trials depends upon the participation of patients who volunteer.

Participants in clinical trials can play a more active role in their own (16) _______________

care, gain access to new research (17) ________________ before they are widely available,

and help others by contributing to medical (18) _______________

PLACEBOS

Placebos are substances that are made to resemble drugs but do not contain an active

compound. A placebo is made to look exactly like a real drug but is made of an inactive

substance such as starch or sugar.

Placebos are usually used in research studies. Placebos can result in or be coincidentally

associated with many changes, both desiderable and undesiderable. This phenomenon, called

the "placebo effect", appears to have two components: anticipation of results, usually

optimistic, from taking a drug (sometimes called suggestibility) and spontaneous change.

Sometimes people improve spontaneously, without treatment. If spontaneous change -

whether positive or negative - occurs after a placebo is taken, the placebo may incorrectly be

credited or blamed for the result.

Some people seem more susceptible to the placebo effect than others. People who have a

positive opinion of drugs, doctors, nurses and hospitals are more likely to respond favourably

to placebos than are people who have a negative opinion. Some people who are particularly

susceptible to placebos tend to become compulsive about using the drug; they tend to increase

the dose, and they develop withdrawal symptoms when they are deprived of the placebo.

Read the passage and answer the questions.

Why participate in a Clinical Trial?

People volunteer to participate in clinical trials for different reasons. Some volunteer because

they to help advance medical knowledge. Others have tried all available treatments for their

condition without success. In a 2000 Harris Poll of cancer clinical trial participants, 76

percent of the respondents said they participated because they believed that the trial offered
the best quality of care for their disease. Helping other people and receiving more and better

attention for their own specific disease were other reasons cited.

People should not, however, be tempted to enroll in a clinical trial simply because a potential

treatment is being offered free during a study, or because of the promise of money, says

David Banks, an FDA pharmacist.

People attracted by compensation may overlook the known risks, or they may fail to

adequately appreciate the potential for discovery of serious new side effects during clinical

testing of a new treatment. Clinical trials are generally not a means for patients to receive

long-term treatment for their chronic disease still clinical trials often represent an option to be

seriously taken into consideration.

What are the risks? Some treatments being studied can have unpleasant, or even serious,

side effects. Often these are temporary and end when the treatment is stopped. Others,

however, can be permanent. Some side effects appear during treatment, and others may not

show up until after study is over. The risks depend on the treatment being studied and the

health of the people participating in the trial. All known risks must be fully explained by the

researchers before the trial begins. If new risk information becomes available during the trial,

participants must be informed.

(A Special Report from FDA Consumer Magazine)

TRUE – FALSE – NOT GIVEN STATEMENTS

1. People volunteer to participate in clinical trials for 04 reasons: help
advance medical knowledge, being offered the best quality of care for
private disease, helping other people and receiving better and more
attention for their own specific disease.
2. In a Haris Poll of cancer clinical trial participants, less than three-fourths
percent of the respondents believed that the trial offered the best quality
of care for private disease.
 3. In a Haris Poll of cancer clinical trial participants, 02 other reasons why
people take part in a clinical trial are: helping other people as well as
receiving better and more attention for their own specific disease.
4. In a Haris Poll of cancer clinical trial participants, a small portion of
people take part in clinical trials because of the promise of money.
5. David Banks, an FDA pharmacist, advises people to take part in a clinical
trial due to the benefically potential treatment.
6. Those participants attracted by compensation tend to ignore the known
risks or other potential serious side effects.
7. One clinical trial means one way for patients to receive long-term
treatment for their chronic diseases.
8. A side effect is classified as unpleasant and serious or temporary and
permanent.
9. 02 factors (the treatment being studied and the health of the people
participating in the trial) decide the potential risks related to one clinical
trial.
10.Any participant must be informed regarding any known risk in case that
one new risk information becomes available during the trial.

Read the teext below and decide which answers best fit each gap

FDA's Role in Assuring Safe and Effective Drugs

[A] ______ the authority of the Federal Food, Drug, and Cosmetic Act and other laws, the

Food and Drug Administration (FDA) [B] ______ safe and effective and supported [C]

______ rigorous scientific research. This typically [D] ______ pharmaceutical companies to

conduct extensive pre-clinical and clinical testing spanning 12 to 15 years and costing

upwards of $800 million for [E] ______ new drug. The FDA-approved drug label distills this

mountain of data into a clear set of instructions that permits physicians [F] ______ the drug

product safely and effectively.

Pre-clinical Testing

Before a new drug can be tested in human volunteers (clinical testing), it [G] ______ be

shown to be reasonably safe in pre-clinical tests. Pre-clinical testing - [H] ______ involves

testing the drug product in animals - [I] _______ an early warning regarding possible safety

risks of a drug product. The FDA reviews the pre-clinical testing of a new drug and examines

the company's proposed research plan before [L] ______ trials in human to begin.

Clinical Studies

Clinical studies - which involve testing a drug product in human volunteers - [M] ______ and

must follow the pre-set research plan approved by the FDA. Also, the FDA requires an

Investigational Review Board (IRB) composed of community health care practitioners to

review and approve all studies [N] ______ human subjects. IRBs ensure that the risks to

patients are minimized, that patients’ rights are protected, and that informed consent and

privacy are obtained. Once the clinical studies [0] ______, information gathered from the

study is regularly submitted to the FDA for ongoing review. Controlled clinical studies are the

only legal basis for the FDA to conclude that a new drug is safe and effective for use.

Drug Approval

After all clinical studies [P] ______, the FDA reviews the data and decides whether the drug

can be placed on the market. To be considered for approval, the following information

[Q]______ to FDA

- documentation of the clinical test results;

- the drug's components;

- results of animal studies;

- how the drug [R] ______ manufactured, processed, and packaged;

- drug samples;
- the proposed drug label with complete prescribing information.

Before [S] ______ a drug, the FDA makes on-site visits to the investigators responsible for

the clinical studies. The FDA approves the drug if the results of controlled clinical studies

show effectiveness of the drug and that the product is safe (T) ______ labeling. Once a drug is

approved, the FDA continues to monitor the safety and quality of the drug by, [U] _____

other things, requiring drug manufacturers to comply with FDA's good manufacturing-

practices requirements. The FDA also oversees the promotion and advertising of prescription

drugs. Companies continue their responsibility [V] ______ for safety and promptly reporting

serious side effects of the drug to the FDA.

[A] 1. under 2. on 3. to ensure

[B] 1. ensures 2. ensuring 3. to ensure

[C] 1. from 2. by 3. over

[D] 1. requires 2. required 3. has required

[E] 1. all 2. several 3. each

[F] 1. use 2. using 3. to use

[G] 1. shall 2. has 3. must

[H] 1. whose 2. who 3. which

[I] 1. providing 2. provides 3. to provide

[L] 1. allowing 2. to allow 3. allowed

[M] 1. control 2. controlling 3. are controlled

[N] 1. to involve 2. involving 3. involved

[O] 1. are started 2. start 3. have started

[P] 1. have completed 2. are completed 3. have been completed

[Q] 1. must submit 2. have submitted 3. must be submitted

[R] 1. has 2. is 3. are

[S] 1. approving 2. to approve 3. have approved

[T] 1. above 2. by 3. under

[U] 1. between 2. within 3. among

[V] 1. to monitor 2. by monitoring 3. from monitoring

NATURAL REMEDIES

HERBAL MEDICINE

Herbal medicine, also called botanical medicine or phytomedicine, refers to the use of any

plant: seeds, berries, roots, leaves, bark, or flowers for medicinal purposes. Long practiced

outside of conventional medicine, herbalism is becoming more common as up-dated

researches showed its value in the treatment and prevention of disease.

What is the History of Herbal Medicine?

Plants had been used for medicinal purposes long before recorded history. For example,

ancient African and Native American used herbs in their healing rituals, while others

developed traditional medical systems (e.g., Ayurveda and Traditional Chinese Medicine) in

which herbal therapies were used systematically. Scientists found that people in different parts

of the globe tended to use the same or similar plants for the same purposes.

In the early 19th century, when methods of chemical analysis first became available, scientists

began extracting and modifying the active ingredients from plants. Later, chemists began

making their own version of plant compounds, beginning the transition from raw herbs to

synthetic pharmaceuticals. Over time, the use of herbal medicines declined in favor of

pharmaceuticals. Recently, the World Health Organization estimated that 80% of people
worldwide rely on herbal medicines for some aspect of their primary healthcare. In the last

twenty years in the United States, increasing public dissatisfaction with the cost is a system of

traditional medicine native to the Indian Subcontinent and practiced in other parts of the

world as a form of alternative medicine.

HERBAL MEDICINE herbal medicine, also called botanical medictor mes conventionies,

roots, leaves, bark, or lowers for me common as value in the treatment and prevention of

disease. Plans had been used Yor medicinal purposes long before recorded history

devexample, ancient African and Natived For me discinepos in their healing rituals, while

others developed tradition. • al medical systems (ee. Curveda and Traditional Chinese

Medicines in thich herbal therapies the same or similar plants for the same purposes. In the

carly 19th centur, when methods of chemicl analysis firs became avalable, scientss began

plant compounds, beginning the transition from raw herbs cine native to the Indian

Subcontinent and to synthetic pharmaceuticals. Over time, the use of herball practiced in other

parts of the world as a medicines declined in favor of pharmaceuticals. Recently, their

primary healthcare. In the last twenty years in the a form of complementary and alternative

United States, increasing public dissatisfaction with the cost medicine (CAM) within the

western world, of prescription medications, combined with an interest in where several of its

methods, such as the returning to natural or organic remedies, has led to an use of herbs,

massage, and Yoga as exer-increase in the use of herbal medicines, In Germany, rough- cise

or alternative medicine, are applied on ly 600 to 700 plant-based medicines are available and

are their own as a form of CAM treatment. prescribed by approximately 70% of German

physicians. How Do Herbs Work? For most herbs, the specific ingredient that causes a

therapeutic effect is not known. Whole herbs contain many ingredients (phytocomplex), and it

is likely that they work together to produce the desired medicinal effect. Many factors affect

how effective an herb will be. For example, the type of environment (climate, bugs, soil
quality) in which a plant grew will affect its components, as will how and when it was

harvested and processed

How Are Herbs Used? For the reasons described in the previous section, herbalists prefer

using whole plants rather than extracting single components from them. Whole plant extracts

have many components. These components work together to produce therapeutic effects and

also to lessen the chances of side effects from any one component. Several herbs are often

used together to enhance effectiveness and synergistic actions and to reduce toxicity.

Herbalists must take many things into account when prescribing herbs. For example, the

species and variety of the plant, the plant's habitat, how it was stored and processed, and

whether or not there are contaminants. What Happens during a Visit to an Herbalist? When

you visit an herbalist, the treatment goals are often more broad than stopping a single com-

plaint. Herbalists aim to correct imbalances, resolve patterns of dysfunction, and treat the

underlying cause of your complaint. Specific symptoms may also be treated if necessary. A

session with an herbalist typically lasts one hour. You may be physically examined and asked

about your medical history and your general well-being (that is, how well you sleep, what you

eat, if you have a good appetite, good digestion and elimination, how often you exercise, and

what you do to relax). The herbalist might recommend one or more herbs, dietary changes,

and lifestyle modifications. Because herbal medicines are slower acting than pharmaceuticals,

you might be asked to return for a follow-up in two to four weeks.

and tou. Tou may be physically examined and asked abou have a good appetite, good

digestion and dieng at 5, not weevercise, and what you if you have a good appetite, good

digestion and elimination, how often you exercise, and what you do to relax). The herbalist

might recommend one or more herbs, dietary changes, and lifestyle modifications. Because

herbal medicines are slower acting than pharmaceuticals, you might be asked to return for a

follow-up in two to four weeks. Who Is Using Herbal Medicine? Nearly one-third of

Americans use herbs and it is estimated that in 1998 alone $4 billion was spent on herbal
products in this country. Unfortunately, a recent study in the New England Journal of

Medicine indicated that nearly 70% of individuals taking herbal medicines (the majority of

which were well educated and had a higher-than-average income) were reluctant to reveal

their use of complementary and alternative medicine to their doctors. Because herbal

medicines contain a combination of chemicals, each with a specific action, many are capable

of eliciting complex physiological responses - some of which may create unwanted or

unexpected results when combined with conventional drugs. Be sure to consult your doctor

before trying any herbal products. How Is Herbal Medicine Sold in Stores? The herbs

available in most stores come in several different forms: teas, syrups, oils, liquid extracts,

tinctures, and dry extracts (pills or capsules). Teas are simply dried herbs left to soak for a few

minutes in boiling water. Syrups, made from concentrated extracts and added to sweet-tasting

prepara-tions, are frequently used for sore throats and coughs. Oils are extracted from plants

and often used as rubs for massage, either alone or as part of an ointment or cream. Tinctures

and liquid extracts are solvents (usually water, alcohol, or glycerol) that contain the active

ingredients of the herbs. Tinctures are typically a 1:5 or 1:10 concentration, meaning that one

part of the herbal material is prepared with five to ten parts (by weight) of the liquid. Liquid

extracts are more concentrated than tinctures and are typically a 1:1 concentration. A dry

extract form is the most concentrated form of an herbal product (typically 2:1 to 8:1) and is

sold as a tablet, capsule, or lozenge. Currently, no organization or government body regulates

the manufacture or certifies the labeling of herbal preparations. This means you can't be sure

that the amount of the herb contained in the bot-tle, or even from dose to dose, is the same as

what is stated on the label. Some herbal preparations NATURAL REMEDIES

ufacturers of these herbal products may begin to implement more quality control processes,

like microscopic, chemical, and biological analyses, Again, it is important to consult your

doc- tor or an expert in herbal medicine for the recommended doses of any herbal products

you are considering. Are there Experts in Herbal Medicine? Herbalists, chiropractors,
naturopathic physicians, and prac- titioners of Traditional Chinese Medicine all use herbs to

treat illness. Naturopathic physicians believe that the body is continually striving for balance

and that natural therapies can be used tr support this process. They are trained in four-year,

postgraduate institutions that combine courses in conventional medical science (such as

pathology, microbiology, pharmacology, and surgery) with clinical training in herbal

medicine, homeopathy, nutrition, and lifestyle counseling. What is the Future of Herbal

Medicine? Although a renaissance is occurring in herbal medicine in the United States, the

FDA still classifies herbs as dietary supplements and forbids manufacturers to claim that their

products are able to treat or prevent specific diseases. In some countries in Europe, however,

herbs are classified a drugs and are regulated. The German Commission E, an expert medical

panel, actively researches their safety and effectiveness.

are standardized, meaning that the preparation is guaranteed to contain a specific amount of

one active ingredient of the herb. However, it is still important to ask companies that are

making standardized herbal products the basis for their product's guar-antee. If consumers

insist on an answer to this question, manufacturers of these herbal products may begin to

implement more quality control processes, like microscopic, chemical, and biological

analyses. Again, it is important to consult your doctor or an expert in herbal medicine for the

recommended doses of any herbal products you are considering Are there Experts in Herbal

Medicine? Herbalists, chiropractors, naturopathic physicians, and prac- titioners of

Traditional Chinese Medicine all use herbs to treat illness. Naturopathic physicians believe

that the body is continually striving for balance and that natural therapies can be used tr

support this process. They are trained in four-year, postgraduate institutions that combine

courses in conventional medical science (such as pathology, microbiology, pharmacology,

and surgery) with clinical training in herbal medicine, homeopathy, nutrition, and lifestyle

counseling.
Exercise 5 Decide which statement better fits. Herbal Medicine, [A] 2 referred to B1 as

Herbalism or Botanical Medicine, is the use of herbs for their therapeutic or medicinal value.

An herb is a plant or plant part [C] 2 for its medicinal, aromatic or savory qualities. Herb

plants produce and contain a variety of chemical substances that act (D] 3 the body. Herbal

medicine is the (E) 2 form of healthcare [F] 2: to mankind. Herbs had been [6) 3 by all

cultures throughout history. It was an integral part of the [H] 1 of modern civilization.

Primitive man observed and appreciated the great diversity of plants (1) 1_ to him. The plants

(L] (M) 3. of the medicinal use of plants seems to have been developed INJ 2 observations of

wild animals, and by trial and error. As time went on, [0] 3 3 tribe added the medicinal power

of herbs in their area to its knowledgebase. They methodically collected information [P] -

herbs and developed well-defined herbal pharmacopoeias. Indeed, well into the 20th century

much of the pharmacopoeia of scientific medicine (Q] 1 from the herbal lore of native

peoples. [R] 3 drugs commonly used today are of herbal origin. Indeed, about 25 percent of

the prescription drugs dispensed in the United States contain at [S) 2 one active ingredient

derived from plant material. Some T] . from plant extracts; others are synthesized to mimic a

natural plant compound. The World Health Organization (WHO) [U] 2 that 4 billion people,

80 percent of the world popu-lation, presently use herbal medicine for V 4 aspect of primary

health care. WHO notes that of 119 plant-derived pharmaceutical medicines, [2] 2. 74 percent

are used in modern medicine in ways that correlated directly with their traditional uses as

plant medicines [X] 3 native cultures. Major pharmaceutical companies Y extensive research

on plant materials gathered from the rain forests and other places for their potential medicinal

value.
Aloe vera's use can be traced back 6.000 years to early Egyptian civilization where the plant

was depicted on stone carvings. Known as the "plant of immor-tality," aloe was presented as a

burial gift to deceased pharaohs. Common Names: aloe vera, aloe, burn plant, lily of the

desert, elephant's gall. Latin Names: Aloe vera, Aloe barbadensis.

Traditionally, aloe was used topically to heal wounds and for various skin con- ditions, and

orally as a laxative. Today, in addition to traditional uses, people take aloe orally te treat a

variety of conditions, including diabetes, asthma, epilepsy, and osteoarthritis. People use aloe

topically for osteoarthritis, burns, and sunburns. Aloe vera gel can be found in hundreds of

skin products, including lotions and sunblocks. The Food and Drug Administration (FDA) has

approved aloe vera as a natural food flavoring. Aloe leaves contain a clear gel that is often

used as a topical ointment. The green part of the leaf that surrounds the gel can be used to

produce a juice or a dried sub stance (called latex) that is taken by mouth. What the Science

Says Aloe latex contains strong laxative compounds. Products made with various components

of aloe (aloin aloe-emodin, and barbaloin) were at one time regulated by the FDA as oral

over-the-counter (OTC) lax-atives. In 2002, the FDA required that all OTC aloe laxative

products be removed from the US market or reformulated because the companies that

manufactured them did not provide the necessary safety data. Early studies show that topical

aloe gel may help heal burns and abrasions. One study, however. showed that aloe gel inhibits

healing of deep surgical wounds. Aloe gel does not prevent burns from radiation therapy.

There is not enough scientific evidence to support aloe vera for any of its other uses. Side

Effects and Cautions Use of topical aloe vera is not associated with significant side effects. -

Abdominal cramps and diarrhea have been reported with oral use of aloe vera. - Diarrhea,

caused by the laxative effect of oral aloe vera, can decrease the absorption of many drugs. -

People with diabetes who use glucose-lowering medication should be cautious if also taking

aloe by mouth because preliminary studies suggest aloe may lower blood glucose levels.
What It Is Used For Blberry has been used for nearly 1,000 years in traditional European

medicine. Historically bilberry fruit was used to treat diarrhea, scurvy, and other conditions.

Today, the fruit is used to treat diarrhea, menstrual cramps, eye problems, varicose veins,

venous insulficiency (poor blood low to the heart, and other circulatory problems. Bilberry

leaf is used for entirely different conditions, including diabetes. How It Is Used The fruit of

the bilberry plant can be eaten or made into extracts. Similarly, the leaves of the bilberry plant

can be made into extracts or used to make teas. What the Science Says Some claim that

bilberry fruit improves night vision, but clinical studies have not shown this to be true. There

is not enough scientific evidence to support the use of bilberry fruit or leaf for any other

health conditions. NCCAM has not yet funded any research on bilberry. Side Effects and

Cautions Bilberry fruit is considered safe. However, high doses of bilberry leaf or leaf extract

are considered unsafe; animal studies have shown high doses to be toxic.

Bilberry is a relative of the blueberry, and its fruit is commonly used to make pies and jams.

Bilberry grows in North America, Europe, and northern Asia. Common Names: European

blueberry, whortleberry, huckleberry. Latin Names: Vaccinium myrtillus.

Asian ginseng is native to China and Korea and has been used in various systems of medicine

for many centuries. Asian ginseng is one of several types of true ginseng (another is American

ginseng, Panax quinquefolius). An herb called Siberian ginseng or eleuthero (Eleutherococcus

senticosus) is not a true ginseng. Common Names: Asian ginseng, ginseng, Chinese ginseng,

Korean ginseng, Asiatic ginseng. Latin Name: Panax ginseng.

What It Is Used For Treatment claims for Asian ginseng are numerous and include the use of

the herb to support overall health and boost the immune system. Traditional and modern uses

of ginseng include: - Improving the health of people recovering from illness; - Increasing a

sense of well-being and stamina, and improving both mental and physical perform- - Treating

erectile dysfunction, hepatitis C, and symptoms related to menopause; - Lowering blood

glucose and controlling blood pressure.

The root of Asian ginseng contains active chemical components called ginsenosides (or

panaxosides that are thought to be responsible for the herbs medicinal properties. The root is

dried and used i make tablets or capsules, extracts, and teas, as well as creams or other

preparations for external use. What the Science Says Some studies have shown that Asian

ginseng may lower blood glucose. Other studies indicate pos.. sible beneficial effects on

immune function. To date, research results on Asian ginseng are not conclusive enough to

prove health claims associated with the herb. Only a handful of large clinical trials on Asian

ginseng have been conducted Most studies have been small or have had flaws in design and

reporting. Some claims for healt benefits have been based only on studies conducted in

animals. NCCAM is supporting research studies to better understand the use of Asian

ginseng. NCCAM i studying how Asian ginseng interacts with other herbs and drugs and

exploring its potential tc treat chronic lung infection, impaired glucose tolerance, and

Alzheimer's disease. Side Effects and Cautions When taken by mouth, ginseng is usually well

tolerated. Some sources suggest that its use be limited to 3 months because of concerns about

the development of side effects. The most common side effects are headaches and sleep and

gastrointestinal problems. Ginseng can cause allergic reactions.

The most common side effects are headaches and sleep and gastrointestinal problems.

Ginseng can cause allergic reactions. There have been reports of breast tenderness, menstrual

irregularities, and high blood pressure associated with ginseng products, but these products'

components were not analyzed, so effects may have been due to another herb or drug in the

product. Ginseng may lower levels of blood sugar; this effect may be seen more in people

with dia- betes. Therefore, people with diabetes should use extra caution with Asian ginseng,

especially if they are using medicines to lower blood sugar or taking other herbs, such as

bitter melon and fenu-greek, that are also thought to lower blood sugar. www.nccam.nih.gov?

The gel contained by the leaves of aloe is the only part of the plant which is used. 5. Asian

ginseng can have beneficial effects in boosting the immune system. 6. The leaves of Asian
ginseng are dried and then used to make extracts. 7. Bilberry fruit is commonly used in

cooking and tea making. 8. Deep surgical wounds can receive healing from aloe. 9. Burns

from radiation therapy can be prevented thanks to aloe treatments. 10. Bilberry fruit is useful

in improving night vision. 11. Exhaustive studies have been carried out on Asian ginseng

proving its potential in treating chronic lung infections and Alzheimer's disease. 12. Ginseng

can help in controlling blood pressure. 13. Patients with diabetes can lower the levels of blood

sugar taking ginseng. 14. There are concerns about possible side effects caused by ginseng

which suggest a use limited to 3 months.