RAINS Study FAQ's
Q - What
is the purpose of the RAINS Study?
A - The RAINS Study will examine
the influence of scientifically-formulated, pharmaceutical-quality, synergistically
blended, nutritional supplements on asthma symptoms.
Q - How was the “Retrospective Survey” conducted?
A - Asthmatics, using the same
scientifically-formulated supplements used in the RAINS Study protocols, were asked to
respond to 35 questions regarding their experience.
Q - What type of tests and
treatments does the RAINS Study involve?
A - The data collected will be
by way of Asthma Quality of Life Questionnaires. They record perceived changes in asthma
symptoms and are recognized as being equivalent to measured changes in FEV and/or
PEF.
Prior to beginning a protocol,
participants will answer a background survey questionnaire to establish baseline symptoms.
Seven different nutritional protocols will be tested. (link to
protocols)
Q - Has anyone ever conducted a
complementary, multi-faceted, dose-dependent, nutritional approach to asthma symptoms?
A - To our knowledge, the RAINS
Study is the first, international, study of it’s kind.
Q - Why hasn’t a study like
this been conducted before?
A - Drug manufacturers spend
millions of dollars to develop, test and study new drugs. They recoup their investment
with patents that allow them to profit from their research. With the exception of some
combinations of ingredients, nutritional supplements cannot be patented. Therefore, any
research showing the efficacy of nutrients, becomes in essence “public domain”,
with no returns available to the researchers.
The RAINS Study is unique, in that all
development and research time has been donated by researchers, with participants paying
for their own nutrients. To conduct a study of this kind could cost millions of dollars,
with no promise of return. It is the
study’s hope that if the protocols prove to be effective, they can be followed by
double-blind studies through which a complementary drug-free strategy to asthma may be
developed.
Q - What kind of a Study is this
- a Clinical Pilot Study, Phase I, Phase II, etc.?
A - In many ways, this is
comparable to a Phase IV Clinical Study. All protocol nutrients have already been approved
for safe use and distribution, in their respective countries, and have been in use for a
number of years.
The safety of the protocol nutrients
are not being tested, but rather, the protocol combinations and concentrations are being
investigated for their influence on symptoms in a population of asthmatics.
Q - Some of the protocol
nutrient levels are in excess of the Recommended Dietary Allowances (RDA). Are the
protocol quantities safe?
A - Yes. The Food and Nutrition
Board of the National Research Council began setting guidelines for RDA’s for
vitamins and minerals in 1941. The purpose was to reduce the rates of severe nutritional
deficiency diseases such as pellagra, scurvy and beriberi. The RDA’s were established
to serve as the basis for evaluating the adequacy of diets of groups of people, not
individuals. Individuals vary too widely in their nutritional requirements to assume that
RDA’s are identical for all people. As stated by the Food and Nutrition Board,
“Individuals with special nutritional needs are not covered by the RDA’s.”
There is a great deal of medical evidence to suggest asthmatics have deficiencies in a
number of nutrients.145
It must be kept in mind that the
RDA’s were never meant to indicate maximum safe levels of nutrients (the levels above
which toxicity could occur), but rather, the bare minimum levels for the average person.
The quantities of nutrients used in the
RAINS Study protocols have been used safely for over seven years with no serious reported
side effects. This is in sharp contrast to many approved prescription drugs, which have
been estimated by the American Medical Asssociation to be associated with up to 150,000
deaths a year. This figure includes thousands of deaths from common aspirin.
Q - Why is beta carotene rather
that vitamin A used in the protocol nutrients?
A - Vitamin A has been shown in
some studies to be toxic at 10,000 to 20,000 IU per day. However, beta-carotene, a
precursor to vitamin A is converted to vitamin A only when needed, at safe, effective
levels. Enzymes begin to convert beta-carotene as the levels of vitamin A in the body
drop. This allows the safe consumption of levels of beta-carotene in the 15-20,000 IU
range/day, without the corresponding toxicity concerns of vitamin A.
Q - Will these protocols
interfere with my asthma medications?
A - In general, dietary
supplements will not interfere with asthma medications, just as eating a healthy diet
would not interfere.
However, there are some circumstances,
due to other existing medical conditions, which may
warrant special advice or contraindication.
We require each participant to agree to
work with their physician. If your physician cites a contraindication, have him/her give
you the references for the contraindication.
It is not uncommon for practicing
physicians to know very little about nutritional science, as it is a very specialized
field, and only a very few medical schools have courses in it.
If your physician has any questions, we
recommend referring them to the referenced studies indicating the nutritional influences
on asthma. Many of the more common protocol nutrients are already widely recommended by
physicians for their asthma patients (calcium, magnesium, vitamin D, etc.)
Q - A bioflavonoid complex is
used in all protocols. Why?
A - Studies show that the
flavonoids contained in the bioflavonoid complex exhibit strong antioxidant,
antiinflammatory and antihistamine effects.
In addition, the bioflavonoid complex
has the ability to “saturate” the body, at dose-dependant levels, which remain
in the body up to 72 hours. (link to detailed
explanation)
This means that individual specific
levels can be reached and maintained 24 hours a day, allowing for maximum antioxidant,
anti-inflammatory and antihistamine effects.
The CAPI Retrospective Survey of asthmatics
on similar protocols gives further support to the medical literature.
Q - Will I experience any side
effects from the protocol nutrients?
A - While a small percentage of
people beginning nutritional supplements sometimes experience temporary diarrhea, or
loosening of the stool, it is usually due to increased doses of vitamin C, magnesium or
grapeseed extract in the diet.
To reduce these side effects, our
protocol guidelines recommend that participants start the protocols on a graduated basis,
slowly increasing the amounts over the first three weeks to allow for the body to adapt to
changes in it’s absorption of nutrients.
On that basis the majority of people
don’t experience any side effects, while those who do, find they can eliminate any
problems by cutting back on nutrients for a few days to allow the body to adjust to the
increases.
Q - Should I stop or reduce my
asthma medications while I’m on the protocols?
A - Do not change any of your
current medications unless your physician agrees that your symptoms have improved to the
point where they believe it is safe to do so. If you feel an improvement, discuss it with
your physician. They are there to help you
gain control of your asthma.
Q. - I see that it is
recommended I take grapefruit juice with my nutrients. Why?
A. - Grapefruit juice
contains enzymes that help transport chemicals across the mucosal lining of the intestine,
increasing the bioavailability of beneficial nutrients to your cells. Studies have shown
that orally taken medication levels can be increased up to 7 times the anticipated level
in the bloodstream. It is not uncommon to see physicians contraindicating grapefruit juice
in patients taking oral medications.
We
recommend that if you are going to drink grapefruit juice, while you are taking
medications, to check with your physician first to see if it is contraindicated.
