Osteoinductive Protein Complex for Moderate to Severe Osteoarthritis

Abstract / Osteoarthritis, also known as degenerative joint disease, is one the most common forms of joint disorder in the United States and affects over 20 million people. Current treatments for its management involve the use of analgesics such as acetaminophen and nonsteroidal, anti-inflammatory drugs (NSAIDs). These treatments, however, have shown limited effectiveness, and in some cases, have produced severe side effects, including GI conditions, internal bleeding, and kidney damage. The following study explores the value of an osteoinductive protein complex for moderate to severe osteoarthritis. Published in Integrative Medicine, a Clinician’s Journal, written by Richard Garian, DC, MS; Arlene Donar, ND; Donald DeFabio, DC; Nancy Gahles, DC; James J. Scaffidi, BS.

Objective: The study intended to demonstrate the clinical effects of a novel protein complex, Cyplexinol, in combination with glucosamine and chondroitin, in the regenerative stimulation of bone and cartilage to reduce pain and increase joint flexibility in healthy individuals with degenerative joint disease due to osteoarthritis.

Design: The research team conducted an open-labeled, randomized, prospective, multicenter trial.

Setting: The offices of the four licensed health-care professionals were the four centers in which the trial took place.

Participants: Participants were patients at the four health-care centers—18 women and 10 men with a mean age of 61 years.
Intervention(s): In this trial, the 28 randomized partici- pants in the intervention group received a combination of Cyplexinol, a bone morphogenetic protein (BMP) complex, plus glucosamine and chondroitin, three times a day. The total daily dose was 150 mg of Cyplexinol, 1500 mg of glucosamine sulfate, and 1200 mg of chondroitin sulfate for a period of 4 weeks.

Outcome Measure(s): The research team evaluated pain and joint flexibility using a visual analog scale (VAS). Participants completed the questionnaire at baseline and weekly thereafter to allow the research team to assess the effectiveness of the product.

Results: Based on the comparison of mean values reported at baseline, the research team noted a significant reduction at the end of the trial in overall pain (54.7%) as well as frequency of pain (58.8%) in the affected joints. Similarly, a significant reduction in pain and stiffness was reported during recreation/activity as participants moved the affected joints. This reduction in pain translated into an increase in the strength of the affected joints and an increase in overall activity for participants.

Conclusions: The results of this trial suggest that the combination of Cyplexinol, which contains BMPs and growth factors, plus glucosamine and chondroitin, reduced joint pain and stiffness effectively in individuals with reduced joint function associated with osteoarthritis.

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