|Research & Discoveries|
Eggshell membrane: A possible new natural therapeutic for joint and connective tissue disorders. Results from two open-label human clinical studies
Kevin J Ruff1 Dale P DeVore2 Michael D Leu3 Mark A Robinson4
"Background: Natural Eggshell Mspan style="font-style:italic;"brane (NEM®) is a novel dietary supplspan style="font-style:italic;"ent that contains naturally occurring glycosaminoglycans and proteins essential for maintaining healthy joint and connective tissues. Two single center, open-label human 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.
Methods: Eleven (single-arm trial) and 28 (double-arm trial) patients received oral NEM® 500 mg once daily for four weeks. The primary outcome measure was to evaluate the change in general pain associated with the treatment joints/areas (both studies). In the single-arm trial, range of motion (ROM) and related ROM-associated pain was also evaluated. The primary treatment response endpoints were at seven and 30 days. Both clinical assessments were performed on the intent-to-treat (ITT) population within each study.
Results: Single-arm trial: Supplspan style="font-style:italic;"entation with NEM® produced a significant treatment response at seven 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 trial: Supplspan style="font-style:italic;"entation with NEM® produced a significant treatment response for pain at seven 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 seven days, so the Y arm crossed over to the X formulation for the rspan style="font-style:italic;"ainder of the study. The significant treatment response continued through 30 days for pain (30.2% reduction; P = 0.0001). There were no adverse events reported during either study and the treatment was reported to be well tolerated by study participants.
Conclusions: Natural Eggshell Mspan style="font-style:italic;"brane (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. Supplspan style="font-style:italic;"entation with NEM®, 500 mg taken once daily, significantly reduced pain, both rapidly (seven days) and continuously (30 days). It also showed clinically meaningful results from a brief responder analysis, dspan style="font-style:italic;"onstrating that significant proportions of treated patients may be helped considerably from NEM® supplspan style="font-style:italic;"entation. The Clinical Trial Registration numbers for these trials are: NCT00750230 and NCT00750854."