Double blind placebo controlled study confirms rapid 10-day results seen in previous human trials

Introduction NEM® brand eggshell membrane is a new novel dietary supplement that contains naturally occurring glycosaminoglycans and proteins essential for maintaining healthy articular cartilage and the surrounding synovium.  The randomized, multicenter, double blind, placebo controlled Osteoarthritis Pain Treatment IncorpOrating NEM® (OPTION) clinical study was conducted to evaluate the efficacy and safety of NEM® as a treatment for pain and stiffness associated with osteoarthritis of the knee.

Methods  Sixty-seven patients were randomly assigned to receive either oral NEM® 500 mg (n = 34) or placebo (n = 33) daily for eight weeks.  The primary endpoint was the change in overall Western Ontario and McMasters Universities (WOMAC) Osteoarthritis Index, as well as pain, stiffness, and function WOMAC subscales measured at 10, 30, and 60 days.  The clinical assessment was performed on the intent to treat (ITT) population.

NEM treated patients experiencing >50% Improvement

Results  Supplementation with NEM® produced an absolute rate of response that was statistically significant (up to 26.6%) versus placebo at all time points for both pain and stiffness, but was not significantly improved for function and overall WOMAC scores although trended toward improvement.  Rapid responses were seen for mean pain subscores (15.9% reduction, P = 0.036) and mean stiffness subscores (12.8% reduction, P = 0.024) occurring after only 10 days of supplementation.  At 60 days, pain response was maintained (15.4%, P = 0.038), while stiffness had improved further to 26.6% reduction (P = 0.005).  Mean function subscores showed a 15.5% (P = 0.084) absolute improvement versus placebo at 10 days, which fell slightly to 13.5% (P = 0.076) by day 60.  Overall mean WOMAC scores resulted in a 15.2% (P = 0.059) absolute improvement versus placebo at 10 days, which was maintained at 60 days (15.1%, P = 0.052).  There were no serious adverse events reported during the study and the treatment was reported to be well tolerated by study participants.Changes in Pain & Stiffness WOMAC Scores

Conclusions  Natural Eggshell Membrane (NEM®) is an effective and safe option for the treatment of pain and stiffness associated with knee osteoarthritis.  Supplementation with NEM®, 500 mg taken once daily, significantly reduced both joint pain and stiffness compared to placebo at 10, 30 & 60 days.  Subjects taking NEM® didnot report any gastric or cardiac side effects which are associated with long-term use of other OA treatments such as NSAIDs.  The Clinical Trial Registration number for this study is NCT00750477.

Double Blind Trial Chart

 

Supplementation with NEM® produced an absolute rate of response that was statistically significant (up to 26.6%) versus placebo at all time points for both pain and stiffness WOMAC scores.

 

Rapid responses were seen for mean pain subscores (15.9% reduction, P = 0.036) and mean stiffness subscores (12.8% reduction, P = 0.024) occurring after only 10 days of supplementation.

NEM® is almost 5X more clinically effective than Glucosamine & Chondroitin. (alone or in combination)*

Number Needed to Treat (NNT): the number of patients needed to treat to see a clinically significant treatment effect versus placebo.

*NNT for glucosamine & chondroitin calculated from the GAIT Study. (N Engl J Med 2006, 354(8):795-808.)

*This information has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure or prevent any disease.

 

Ruff, K.J., Winkler, A., Jackson, R.W., DeVore, D.P., and Ritz, B.W.  Eggshell Membrane in the Treatment of Pain and Stiffness from Osteoarthritis of the Knee: A Randomized, Multicenter, Double Blind, Placebo Controlled Clinical Study. Clin Rheumatol, (2009) 28:907-914. >>
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*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

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