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Understanding Research Intro - Research Methods
Understanding Research
Research Methods
What you need to know about Research Methods before you read research reports on Aloe Vera
The Research Process
A clinical trial is a trial to evaluate the effectiveness and safety of
medications or medical devices by monitoring their effects on large groups of
people.
Clinical research
trials may be conducted by government health agencies such as NIH,
researchers affiliated with a hospital or university medical program,
independent researchers, or private industry.
Usually volunteers are recruited, although in some cases research subjects may
be paid. Subjects are generally divided into two or more groups, including a
control group that does not receive the experimental treatment, receives a placebo
(inactive substance) instead, or receives a tried-and-true therapy for
comparison purposes
The
most reliable form of clinical research trial is the randomized double-blind,
placebo-controlled trial. In this form
of trial some of the participants are given the treatment, others are given a fake
treatment (placebo). It is “randomized” because the choice of participants to
take either the placebo or treatment is done randomly.
“Double-blind” means
that neither the researchers nor the participants know which is which is the
treatment group and which is the placebo group until the study ends.
However, clinical research trials cost money and can be expensive to set up and
administer. Sometimes they will be sponsored by drug companies but sometimes
there will not be enough interest in or money available for the proposed trial.
In such a the absence of a clinical trial into a treatment does not disprove
those who advocate the treatment, but merely leaves the matter “unproven”.
When any research is conducted, its conclusion may still be inaccurate. There
may be flaws in the trial design, or in the reasoning which led to its
conclusions may be wrong. A sample of customers of a health food shop studied
over time may find that they have better health than customers in a nearby fast
food shop. Their better health may be due to their diet and the supplements
they take but it may also be due to other factors that are connected with
being members of a higher socio-economic group, or they may simply have
“normal” health but comparison with those whose health is harmed by the high
fat intake at the fast food store.
In short, the initial research must be accurate but so must the way in which it
is a analysed.
More about double-blind placebo trials.
When the research is complete, the researchers write up an account of it and
publish it in a scientific journal....
The Science Publishing Scene
For scientific knowledge to progress scientists need to share their research
findings
with other scientists. The main way they do this is by publishing their
research in
scientific journals – periodical publications intended to further the
development of
science by reporting new research.
When a researcher, or team of researchers, finishes a stage of work, they
usually write a paper presenting their methods, findings and conclusions. They
then send the paper to a scientific journal to be considered for publication.
If the journal’s editor thinks it is suitable for their journal they send the
paper
to other scientists who research and publish in the same field asking them to comment
on its validity (are the research results credible and are the design and
methodology appropriate?), judge the significance (is it an important
finding?), determine its originality
(are the results new and does the paper refer properly to work done by
others?) and give an opinion as to whether the paper should be published,
improved or rejected. This process is called “peer review”.
A
short guide to reading scientific research from “Sense about Science”
Two common errors in reporting research
1. Irresponsible or inaccurate use of someone else’s research to support a health
claim
Under British law it is illegal to make a health claim for any product unless
it has a medicinal licence from the Department of Health's Medicines Control
Agency (MCA) proving that it can do what it claims to do and is safe in normal
use. People do. In the case of Aloe Vera, where there is so much material to
support the conclusion that its use can bring significant health benefits, this
is not altogether surprising.
Some of those claims irresponsibly or inaccurately use someone else’s research.
Just because a fact about something is supported by a reference to a scientific
journal, it doesn’t mean it is a fact it should be accepted without question.
Here’s an example which can be found on a number of websites selling aloe vera
products to body builders:
Vogler and Ernst (1999) systematically reviewed evidence. The results on skin healing,
including post surgery wound healing (Fulton 1990; Schmidt & Greenspoon
1991), psoriasis (Syed, et al 1996) and radiation injuries (Williams, et a!
1996), were positive, though mechanisms of action are unclear. There is also
evidence that aloe vera may have a role in controlling blood glucose (Yongchaiyudha,
et al 1996; Bunyapraphatsara, et al 1996) and lipid levels (Nassiff, et
a! 1993).
Impressed? You are meant to be.
In fact it completely misreports the findings of some of the researchers
mentioned.
“Schmidt & Greenspoon” are credited with providing positive supportive
evidence that aloe vera is effective in wound healing. There have been many encouraging pieces of
research that indicate that aloe vera has pronounced wound healing effects, but
Schimdt and Greenspoon’s work is definitely not one of them. A notorious
“blip”, it actually reports on a delay in wound healing (in women who had a
ceasarian section) which was so significant that the trial was suspended.
A number of researchers have questioned the Schmidt and Greenspoon research methods
as they seem so contrary to their other findings, some of which are more recent,
but there is no way that any responsible writer can use them to support the use
of Aloe Vera in wound healing.
Furthermore “Vogler and Ernst (1999)” actually drew
attention to th Schmidt and Greenspoon's criticism of Aloe Vera, so to
use them in this manner is irresponsible and totally inaccurate.
2. Inconclusive research reported as
conclusive.
One example of this is the report (Int J Clin Pract. 2006;60(9):1080-1086) of clinical trials
conducted in three south Wales hospitals
into Aloe Vera as a treatment for irritable bowel syndrome (IBS) in 2002/2003.
The research report concludes that “There was no evidence that AV benefits patients with
IBS”.
In fact, the trial was inconclusive.
This was because the hospitals were not able recruit enough volunteers to
begin with. The trial designers recommended 200 recruits but the hospitals
could only find 110. Of these, only 45 completed the full trial, and of those
only 16 people sent in the final questionnaire.
There was certainly was “no evidence that AV benefits patients with
IBS”, but likewise, there was very little evidence that it did not. In the
absence of any further information it is even possible (even if unlikely) that
so many dropped out because their condition improved. The truth will never be
known.
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