CLEVELAND, Feb. 23 /PRNewswire/ -- In the wake of a large study challenging the effectiveness of two popular arthritis pain relievers, Ganeden Biotech today announced the results of two clinical trials showing that its drug-free arthritis treatment, Arthritis Advantage(TM), improved mobility and provided a statistically significant reduction in pain in both osteoarthritis (OA) and rheumatoid arthritis (RA) patients. The treatment also reduced a blood protein called C-reactive Protein (CRP), a telltale marker for inflammation associated with diseases such as arthritis.
In the last two years, arthritis sufferers have been running out of options to help them treat the pain associated with this disease. Two COX-2 inhibitors, a common medication used to treat arthritis pain, were pulled off the market due to safety concerns in 2004 and 2005. Now, a study published today in the New England Journal of Medicine raises new questions about the effectiveness of two popular supplements for treating arthritis pain -- glucosamine and chondroitin sulfate.
Conversely, data from two initial trials demonstrate that Ganeden Biotech's drug-free treatment for arthritis, Arthritis Advantage(TM), provides statistically significant reduction in pain and improvement in mobility. Based on this success, planning is underway for further studies. The complete results are being prepared for submission to a peer-reviewed medical journal. Below are some highlights from these trials.
Patients in the Arthritis Advantage(TM) RA trial reported a 29 percent decrease in pain after taking the daily drug-free over-the-counter tablet for 60 days. Treated patients achieved statistically significant benefits in pain reduction and in function and mobility, including lifting a 5-pound weight, and bending over.
"For a typical RA sufferer 40 years of age or over, this is a dramatic improvement in pain reduction and mobility," said David Mandel, M.D., a rheumatologist and the primary investigator of the RA study. "This means the difference between staying home, in pain all day, and being active. The results seen with Arthritis Advantage(TM) are similar to those reported in clinical trials with COX-2 inhibitors and non-selective NSAIDs (non-steroidal anti-inflammatory drugs) like naproxen and ibuprofen, but with none of the risks."
Study Design
In the double-blind placebo controlled trial, 44 RA patients were randomized into two equal populations: the control group received a daily placebo and the treated group received Arthritis Advantage(TM). Patients took one capsule a day for 60 days.
Prior to the test, patients were assessed using the American College of Rheumatology criteria, which includes both a self assessment and an assessment based on a physical exam by a physician. Patients were assessed at day 30 and 60. No significant side effects were seen in either population.
One of the most impressive results from the RA trial was a significant decrease in blood levels of C-reactive Protein (CRP) in patients treated with Arthritis Advantage(TM). CRP is used to monitor and measure flare-ups of acute inflammation. As a group, RA patients treated with Arthritis Advantage(TM) saw a 46 percent decrease in CRP blood levels, while the placebo group experienced a 4.8 percent increase in CRP blood levels.
In a separate double-blind study, 18 patients with OA in the knee were randomized into two groups: 10 received placebo and eight received Arthritis Advantage(TM). These patients were assessed prior to the beginning of the trial using the Knee Injury and Osteoarthritis Outcome Score (KOOS), the most widely accepted criterion to evaluate the functional limitations from inflammatory joint disease in the knee.
The treated patients were given a single daily dose of Arthritis Advantage(TM) for 60 days and were reassessed at 30 days and again at the end of the study. As measured by the KOOS scale, patients who took Arthritis Advantage(TM) experienced statistically significant benefits in pain reduction when bending their knees.
The patients taking Arthritis Advantage(TM) experienced a decrease in pain while twisting and pivoting on their knees, and while bending and fully straightening their legs. These patients experienced a marked increase in functionality, and achieved statistically significant reductions in the physical limitations the disease causes related to rising from bed and in taking off their socks, according to the KOOS scale. These are two of the most difficult activities patients with arthritic knees face on a daily basis. It was easier for treated patients to both climb and descend stairs by the end of the trial, than it was at the beginning. Overall, they reported improved mobility and much less difficulty performing daily tasks, such as household chores.
In the second half of the Arthritis Advantage(TM) double-blind, placebo controlled OA study: eight patients with OA of the back were treated with the product for 60 days, while seven additional patients were given a placebo. Patients were assessed prior to the study, at day 30, and at the end of the trial. The validation scale used for the OA trial was the Oswestry Disability Index (ODI), which is the principal outcome measure used to gauge the severity of spinal disorders.
According to the ODI assessment, the treated patients experienced statistically significant reductions in back pain over the course of the 60- day trial. They also demonstrated an increased ability to lift heavy objects, could walk farther with less back pain than they could before the trial, and could sit longer with less pain. Half of the treated patients had improved pain index scores, while the placebo patients reported no improvement in pain index scores.
The main side effects in both the RA and OA patients treated with Arthritis Advantage(TM) were mild gas and bloating. The placebo patients experienced more severe side effects.
"We are delighted by these results," said Andy Lefkowitz, CEO of Ganeden Biotech. "These trials prove that Arthritis Advantage(TM) is a safe and drug- free product that every arthritis sufferer should have in his or her arsenal."
About Arthritis Advantage
Classified as a medical food, Arthritis Advantage(TM) contains a strain of bacteria found in many common foods and is defined by the U.S. Food & Drug Administration (FDA) as "Generally Recognized as Safe" (GRAS).
The benefits of good bacteria treatments for Irritable Bowel Syndrome (IBS), Crohn's Disease, and other inflammatory conditions of the intestine are well-known and documented. However, two years ago, a team of researchers in Israel hypothesized that the same benefit could be achieved for non-digestive inflammatory diseases. They were able to ameliorate arthritis in rats using a strain of good bacteria known to reduce inflammation.(1) The recent RA and OA trials sponsored by Ganeden Biotech prove that humans can experience the same benefits.
Many good bacteria products sold today are labeled as "probiotics"; however, very few of the bacterial cells survive production, storage, and the human stomach's own acidity. Furthermore, probiotics taken as supplements do not colonize the gastrointestinal tract, so to derive any benefits, patients must continue to consume new bacteria.
In sharp contrast, Arthritis Advantage(TM) is produced in a process that captures these bacteria in the spore phase. They are protected by the shell of the spore, enabling significantly more therapeutic bacteria to reach their target.
"Research continues into the exact mechanism of action of bacteria and inflammatory disorders," said Dr. David Keller, Vice President of Scientific Operations, Ganeden Biotech. "However, we know that the epithelial cells of the intestine serve as a first line of defense against food-borne pathogens. These cells send signals to the rest of the body when they encounter pathogens."
One of the leading chemical messengers that mediates inflammation is tumor necrosis factor alpha (TNF-a). Ganeden's OTC products enhance the mucosal barrier of the intestine, which in turn helps to down regulate the release of TNF-a. This helps to modulate the immune response triggered at the intestine.
There are several RA prescription drugs on the market that block TNF-a, such as Remicade and Humira. However, these treatments are expensive and can have severe side effects.
"The appeal of Arthritis Advantage(TM) is that not all patients need or want to take these prescription therapies," Dr. Mandel said. "This treatment offers an absolutely safe alternative which can be used, instead of or in conjunction with, these traditional treatments depending upon the severity of the disease."
A one-month supply of Arthritis Advantage(TM) has a suggested retail cost of $18.95 and is available at most large drug store chains. To find a retailer near you or where it can be purchased online, visit Ganeden's Web site at http://www.ArthritisAdvantage.com .
(1). Baharav E, Mor F, Halpern M, Weinberger A., Lactobacillus GC bacteria ameliorate arthritis in Lewis rats. J. Nutr. 2004 Aug; 134(8): 1964-9
About RA and OA
RA is an inflammatory disorder marked by an extreme inflammation in the joints. OA is characterized by excessive inflammation resulting from wear and tear on the joints. Inflammation is normal and healthy and is the body's way to fight infection and heal wounds. However, in inflammatory diseases, such as RA and other autoimmune diseases like multiple sclerosis, the immune response is excessive, causing painful inflammation, and tissue damage.
Ganeden BiotechCONTACT: Molly Johnson for Ganeden Biotech, +1-216-928-3475 office,+1-216-410-5218 cell
Web site: http://www.ArthritisAdvantage.com/
