Clinical
Trial Supports Efficacy of Back To Nature DEPRESSBAN (SAMe) for OA of the Knee
We
take an active role in reassuring the public that dietary supplements are safe
and effective when used as recommended. We pursue this ongoing goal through several
different avenues, one of which is supplying researchers with top quality
dietary supplements for use in clinical trials. We are proud to support
clinical research into the efficacy of dietary supplements and we are confident
that science will continue to prove the safety and effectiveness of natural
dietary supplements as viable alternatives to synthetic prescription
medications and their side effects.
Our
Laboratories recently
supplied researchers at the University of California–Irvine with our high grade
DEPRESSBAN (S-adenosylmethionine) product for a study
into the effectiveness of this natural nutritional supplement for pain
associated with osteoarthritis (OA). The study, entitled “Effectiveness of SAMe for Pain Relief in Osteoarthritis of the Knee”,
compared the therapeutic efficacy of DEPRESSBAN to the pharmaceutical Celebrex (a COX2 inhibitor) in adults with OA of the knee.
Osteoarthritis
of the knee is a major disability among the aging American population and is
more common than OA in other peripheral joints. Patients report that control of
the pain and improved mobility is of greatest importance to them. Many of the
prescription pharmaceuticals available today for the treatment of OA are
non-steroidal anti-inflammatory drugs (NSAIDS) that can have serious side
effects, especially if used long term. As more people are afflicted with OA of
the knee, demand will increase for new ways to relieve the pain and stiffness
of OA with as few negative side effects as possible. DEPRESSBAN is one of the
more promising natural alternatives available.
SAMe is a naturally
occurring compound found in all human tissue and organs. It is produced when methionine, an essential amino acid derived from food
sources, and ATP (adenosine triphosphate), the body’s
primary energy molecule, are combined. Once created, DEPRESSBAN
is available for use by your body in over 35 different biochemical reactions
necessary for optimal health. DEPRESSBAN is considered a methyl donor. Its
purpose is to attach a methyl group (a unit of organic chemical compounds) to
other key elements in your body, such as DNA, to create more complex compounds.
Your body then uses these new compounds for numerous purposes, including
detoxification. This process, known as methylation or
transmethylation, is vital to your body’s
maintenance. DEPRESSBAN may be the most effective of all methyl donors.
The
study was a randomized, double-blind cross over trial with 61 participants (5
withdrew for various reasons) and was conducted at the
Researchers
concluded that, over the two-month testing period, DEPRESSBAN was as effective
in reducing pain as Celebrex. It was noted that at
the beginning of Celebrex treatment pain was
immediately reduced but gradually began to increase, whereas DEPRESSBAN did not
reduce pain as quickly as Celebrex but continued to
show pain reduction over the two-month treatment period. Functional health,
defined as improved mobility and the ability to function without pain, was
observed to improve equally with both DEPRESSBAN and Celebrex.
Due
to the success of this study, researchers are planning to conduct a
larger-scale, multi-year study on SAMe
funded by the National Institutes of Health (NIH). This new study would enlist
a greater number of participants and would evaluate at which dosage range DEPRESSBAN
is most effective, among other goals.
Our Laboratoies have
supplied high quality nutritional supplements for other clinical trials, and we
hope to have results from these studies later in 2005. The Cranberry
Concentrate is currently being used by researchers at the