Eggshell membrane: A possible new natural therapeutic for joint and connective tissue disorders. Results from two open-label human clinical studies

Abstract

Background

Natural Eggshell Membrane (NEM^®) is a novel dietary supplement 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: Supplementation 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: Supplementation 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 remainder 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 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. Supplementation 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, demonstrating that significant proportions of treated patients may be helped considerably from NEM^® supplementation. The Clinical Trial Registration numbers for these trials are: NCT0750230 and NCT0750854.

Keywords:

• arthritis
• pain
• stiffness
• eggshell membrane
• joint
• connective tissue
• complimentary
• alternative

Disclosure

KJR is currently employed by the sponsor of both studies. DPD has served as a paid consultant for the sponsor of the studies. MDL and MAR have no competing interests. KJR carried out the statistical analysis of the data and drafted the manuscript. DPD participated in the design of both studies, assisted in the statistical analysis of the data, and assisted in drafting the manuscript. MDL was the clinical investigator for the Double-Arm Trial and assisted in drafting the manuscript. MAR was the clinical investigator for the Single-Arm Trial and assisted in drafting the manuscript. All authors read and approved the final manuscript. The authors would like to acknowledge Dr Barry W. Ritz, Drexel University, Department of Bioscience and Biotechnology, USA, for his assistance with the preparation of this manuscript. Both studies were sponsored by ESM Technologies, LLC.