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

Kevin J Ruff, Dale P DeVore, Michael D Leu, Mark A Robinson, Kevin J Ruff, Dale P DeVore, Michael D Leu, Mark A Robinson

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: NCT00750230 and NCT00750854.

Keywords: alternative; arthritis; complimentary; connective tissue; eggshell membrane; joint; pain; stiffness.

References

    1. Helmick CG, et al. Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions in the United States. Part I. Arthritis Rheum. 2008;58(1):15–25.
    1. Lawrence RC, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008;58(1):26–35.
    1. Altman RD. Ibuprofen, acetaminophen and placebo in osteoarthritis of the knee: a six-day double-blind study [abstract] Arthritis Rheum. 1999;42:S403.
    1. Case JP. Lack of efficacy of acetaminophen in treating symptomatic knee osteoarthritis: A randomized, double-blind, placebo-controlled comparison trial with diclofenac sodium. Arch Intern Med. 2003;163:169–178.
    1. Geba GP. Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee: a randomized trial. JAMA. 2002;287(1):64–71.
    1. Towheed TE. Acetaminophen for osteoarthritis. Cochrane Database Syst Rev. 2006;(1):CD004257.
    1. Singh G. Risk of acute myocardial infarction with nonselective non-steroidal anti-inflammatory drugs: a meta-analysis. Arthritis Res Ther. 2006;8(5):153–162.
    1. Solomon SD, et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med. 2005;352:1071–1080.
    1. Deeks JD. Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. Brit Med J. 2002;325:619–627.
    1. Laine L. Nonsteroidal anti-inflammatory drug gastropathy. Gastrointest Endosc Clin N Am. 1996;6(3):489–504.
    1. Porter J. Addiction rate in patients treated with narcotics. N Engl J Med. 1980;320:123–126.
    1. Weaver M. Addiction issues in prescribing opioids for chronic nonmalignant pain. J Addict Med. 2007;1(1):2–10.
    1. Clegg DO, et al. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med. 2006;354(8):795–808.
    1. Herrero-Beaumont G, et al. Glucosamine sulfate in the treatment of knee osteoarthritis symptoms. Arthritis Rheum. 2007;56(2):555–567.
    1. Wong M. Collagen in the egg shell membranes of the hen. Dev Biol. 1984;104(1):28–36.
    1. Baker JR. A study of the organic material of hen’s-egg shell. Biochem J. 1962;82:352–361.
    1. Picard J. Sulfated glycoproteins from egg shell membranes and hen oviduct. Isolation and characterization of sulfated glycopeptides. Biochim Biophys Acta. 1973;320:427–441.
    1. Long FD.Preparation of hyaluronic acid from eggshell membraneUS Patent #6946551,September202005
    1. Nakano T. Chemical composition of chicken eggshell and shell membranes. Poult Sci. 2003;82:510–514.
    1. Starcher BC. The presence of desmosine and isodesmosine in eggshell membrane protein. Connect Tissue Res. 1980;8(1):53–55.
    1. Gautron J, et al. Ovotransferrin is a matrix protein of the hen eggshell membranes and basal calcified layer. Conn Tissue Res. 2001;42:255–267.
    1. Akagawa M. Lysyl oxidase coupled with catalase in egg shell membrane. Biochim Biophys Acta. 1999;1434(1):151–160.
    1. Hincke MT, et al. Identification and localization of lysozyme as a component of eggshell membranes and eggshell matrix. Matrix Biol. 2000;19:443–453.
    1. Ahlborn GJ. Identification of eggshell membrane proteins and purification of ovotransferrin and β-NAGase from hen egg white. Protein J. 2006;25(1):71–81.
    1. Systat Software, Inc. San Jose, CA. 2007Accessed May 10, 2007. Available from: .

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