Double Blind Placebo Controlled Study Confirms Rapid 10-Day Results Seen in Previous Human Trials
Introduction: Natural Eggshell Membrane (NEM®) is a new novel dietary supplement that contains naturally occurring glycosaminoglycans and proteins essential for maintaining healthy joint and connective tissues. Two single center, open label pilot clinical studies were conducted to evaluate the efficacy and safety of NEM® as a treatment for pain and inflexibility associated with joint and connective tissue disorders. The follow-up 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: Patients received oral NEM® 500 mg once daily for four weeks (open label) or eight weeks (placebo controlled). The primary outcome measure for the open label trials was to evaluate the change in general pain associated with the treatment joints/areas at 7 and 30 days. In the Single-Arm Pilot Trial, range of motion (ROM) and related ROM-associated pain was also evaluated. The primary endpoint for the OPTION trial 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.
Results: Single-Arm Pilot Trial: Supplementation with NEM® produced a significant treatment response at 7 days for flexibility (27.8% increase, P = 0.038) and at 30 days for general pain (72.5% reduction, P = 0.007), flexibility (43.7% increase, P = 0.006), and ROM-associated pain (75.9% reduction, P = 0.021). Double-Arm Pilot Trial: Supplementation with NEM® produced a significant treatment response for pain at 7 days for both treatment arms (X: 18.4% reduction, P = 0.021, Y: 31.3% reduction, P = 0.014). There was no clinically meaningful difference between treatment arms at 7 days, so the Y arm crossed over to the X formulation for the remainder of the study. The significant treatment response continued through 30 days for pain (30.2% reduction, P = 0.0001). Placebo Controlled OPTION Trial: 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, and trended toward improvement for function and overall 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. 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 any of the studies and the treatment was reported to be extremely well tolerated by study participants.
Conclusions: Natural Eggshell Membrane (NEM®) is a possible new effective and safe therapeutic option for the treatment of pain and inflexibility associated with joint and connective tissue (JCT) disorders, particularly osteoarthritis (OA). Supplementation with NEM®, 500 mg taken once daily, significantly reduced pain and stiffness, both rapidly (7-10 days) and continuously (60 days). It also showed clinically meaningful results from a brief responder analysis, demonstrating that significant proportions of treated patients will be helped considerably with NEM® supplementation. Subjects taking NEM® did not report any gastric or cardiac side effects associated with long-term use of other JCT or OA treatments, such as NSAIDs. The Clinical Trial Registration numbers for these trials are: NCT00750230, NCT00750854, and NCT00750477.
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