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Published in: Clinical Rheumatology 8/2009

Open Access 01-08-2009 | Original Article

Eggshell membrane in the treatment of pain and stiffness from osteoarthritis of the knee: a randomized, multicenter, double-blind, placebo-controlled clinical study

Authors: Kevin J. Ruff, Anne Winkler, Robert W. Jackson, Dale P. DeVore, Barry W. Ritz

Published in: Clinical Rheumatology | Issue 8/2009

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Abstract

Natural Eggshell Membrane (NEM®) 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® 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. Sixty-seven patients were randomly assigned to receive either oral NEM® 500 mg (n = 34) or placebo (n = 33) daily for 8 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 population. 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 trending 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. There were no serious adverse events reported during the study and the treatment was reported to be well tolerated by study participants. 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, and 60 days. The Clinical Trial Registration number for this study is NCT00750477.
Literature
1.
go back to reference Lawrence RC, Felson DT, Helmick CG et al (2008) Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum 58(1):26–35PubMedCrossRef Lawrence RC, Felson DT, Helmick CG et al (2008) Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum 58(1):26–35PubMedCrossRef
2.
go back to reference Case JP, Baliunas AJ, Block JA (2003) Lack of efficacy of acetaminophen in treating symptomatic knee osteoarthritis. Arch Intern Med 163:169–178PubMedCrossRef Case JP, Baliunas AJ, Block JA (2003) Lack of efficacy of acetaminophen in treating symptomatic knee osteoarthritis. Arch Intern Med 163:169–178PubMedCrossRef
3.
go back to reference Towheed TE, Maxwell L, Judd MG, Catton M, Hochberg MC, Wells G (2006) Acetaminophen for osteoarthritis. Cochrane Database of Systematic Reviews, No. 2 Towheed TE, Maxwell L, Judd MG, Catton M, Hochberg MC, Wells G (2006) Acetaminophen for osteoarthritis. Cochrane Database of Systematic Reviews, No. 2
4.
go back to reference Geba GP, Weaver AL, Polis AB, Dixon ME, Schnitzer TJ (2002) Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee. J Am Med Assoc 287(1):64–71CrossRef Geba GP, Weaver AL, Polis AB, Dixon ME, Schnitzer TJ (2002) Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee. J Am Med Assoc 287(1):64–71CrossRef
5.
go back to reference Altman RD (1999) Ibuprofen, acetaminophen and placebo in osteoarthritis of the knee: a six-day double-blind study [abstract]. Arthritis Rheum 42:S403 Altman RD (1999) Ibuprofen, acetaminophen and placebo in osteoarthritis of the knee: a six-day double-blind study [abstract]. Arthritis Rheum 42:S403
6.
go back to reference Bresalier RS, Sandler RS, Quan H et al (2005) Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 352:1092–1102PubMedCrossRef Bresalier RS, Sandler RS, Quan H et al (2005) Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 352:1092–1102PubMedCrossRef
7.
go back to reference Solomon SD, McMurray JJ, Pfeffer MA et al (2005) Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 352:1071–1080PubMedCrossRef Solomon SD, McMurray JJ, Pfeffer MA et al (2005) Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 352:1071–1080PubMedCrossRef
8.
go back to reference Nussmeier NA, Whelton AA, Brown MT et al (2005) Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl J Med 352:1081–1091PubMedCrossRef Nussmeier NA, Whelton AA, Brown MT et al (2005) Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl J Med 352:1081–1091PubMedCrossRef
9.
go back to reference Singh G, Wu O, Langhorne P, Madhok R (2006) Risk of acute myocardial infarction with nonselective non-steroidal anti-inflammatory drugs: a meta-analysis. Arthritis Res Ther 8(5):153–162CrossRef Singh G, Wu O, Langhorne P, Madhok R (2006) Risk of acute myocardial infarction with nonselective non-steroidal anti-inflammatory drugs: a meta-analysis. Arthritis Res Ther 8(5):153–162CrossRef
10.
go back to reference Deeks JD, Smith LA, Bradley MD (2002) Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. Br Med J 325:619–627CrossRef Deeks JD, Smith LA, Bradley MD (2002) Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. Br Med J 325:619–627CrossRef
11.
go back to reference Laine L (1996) Nonsteroidal anti-inflammatory drug gastropathy. Gastrointest Endosc Clin N Am 6(3):489–504PubMed Laine L (1996) Nonsteroidal anti-inflammatory drug gastropathy. Gastrointest Endosc Clin N Am 6(3):489–504PubMed
12.
go back to reference Clegg DO, Reda DJ, Harris CL et al (2006) Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med 354(8):795–808PubMedCrossRef Clegg DO, Reda DJ, Harris CL et al (2006) Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med 354(8):795–808PubMedCrossRef
13.
go back to reference Herrero-Beaumont G, Ivorra JAR, Trabado MC et al (2007) Glucosamine sulfate in the treatment of knee osteoarthritis symptoms. Arthritis Rheum 56(2):555–567PubMedCrossRef Herrero-Beaumont G, Ivorra JAR, Trabado MC et al (2007) Glucosamine sulfate in the treatment of knee osteoarthritis symptoms. Arthritis Rheum 56(2):555–567PubMedCrossRef
14.
go back to reference U.N. Food & Agriculture Organization: FAO Statistical Yearbook—United States of America (2004) U.N. Food & Agriculture Organization: FAO Statistical Yearbook—United States of America (2004)
15.
go back to reference Wong M, Hendrix MJC, von der Mark K et al (1984) Collagen in the egg shell membranes of the hen. Devel Biol 104(1):28–36CrossRef Wong M, Hendrix MJC, von der Mark K et al (1984) Collagen in the egg shell membranes of the hen. Devel Biol 104(1):28–36CrossRef
16.
go back to reference Baker JR, Balch DA (1962) A study of the organic material of hen's-egg shell. Biochem J 82:352–361PubMed Baker JR, Balch DA (1962) A study of the organic material of hen's-egg shell. Biochem J 82:352–361PubMed
17.
go back to reference Picard J, Paul-Gardais A, Vedel M (1973) Sulfated glycoproteins from egg shell membranes and hen oviduct. Isolation and characterization of sulfated glycopeptides. Biochimica et Biophysica Acta 320:427–441PubMed Picard J, Paul-Gardais A, Vedel M (1973) Sulfated glycoproteins from egg shell membranes and hen oviduct. Isolation and characterization of sulfated glycopeptides. Biochimica et Biophysica Acta 320:427–441PubMed
18.
go back to reference Long FD, Adams RG, and DeVore DP (September 20, 2005) Preparation of hyaluronic acid from eggshell membrane. USA Patent #6946551 Long FD, Adams RG, and DeVore DP (September 20, 2005) Preparation of hyaluronic acid from eggshell membrane. USA Patent #6946551
19.
go back to reference Nakano T, Ikawa NI, Ozimek L (2003) Chemical composition of chicken eggshell and shell membranes. Poult Sci 82:510–514PubMed Nakano T, Ikawa NI, Ozimek L (2003) Chemical composition of chicken eggshell and shell membranes. Poult Sci 82:510–514PubMed
20.
go back to reference Starcher BC, King GS (1980) The presence of desmosine and isodesmosine in eggshell membrane protein. Connect Tissue Res 8:53–55PubMedCrossRef Starcher BC, King GS (1980) The presence of desmosine and isodesmosine in eggshell membrane protein. Connect Tissue Res 8:53–55PubMedCrossRef
21.
go back to reference Gautron J, Hincke MT, Panheleux M et al (2001) Ovotransferrin is a matrix protein of the hen eggshell membranes and basal calcified layer. Conn Tissue Res 42:255–267CrossRef Gautron J, Hincke MT, Panheleux M et al (2001) Ovotransferrin is a matrix protein of the hen eggshell membranes and basal calcified layer. Conn Tissue Res 42:255–267CrossRef
22.
go back to reference Akagawa M, Wako Y, Suyama K (1999) The presence of desmosine and isodesmosine in eggshell membrane protein. Biochim Biophys Acta 14:151–160 Akagawa M, Wako Y, Suyama K (1999) The presence of desmosine and isodesmosine in eggshell membrane protein. Biochim Biophys Acta 14:151–160
23.
go back to reference Hincke MT, Gautron J, Panheleux M et al (2000) Identification and localization of lysozyme as a component of eggshell membranes and eggshell matrix. Matrix Biol 19:443–453PubMedCrossRef Hincke MT, Gautron J, Panheleux M et al (2000) Identification and localization of lysozyme as a component of eggshell membranes and eggshell matrix. Matrix Biol 19:443–453PubMedCrossRef
24.
go back to reference Hochberg MC, Chang RW, Dwosh I, Lindsey S, Pincus T, Wolfe F (1992) The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 35:498–502PubMedCrossRef Hochberg MC, Chang RW, Dwosh I, Lindsey S, Pincus T, Wolfe F (1992) The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 35:498–502PubMedCrossRef
25.
go back to reference Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW (1988) Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 15:1833–1840PubMed Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW (1988) Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 15:1833–1840PubMed
26.
go back to reference Pham T, van der Heijde D, Altman RD et al (2004) OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage 12:389–399PubMedCrossRef Pham T, van der Heijde D, Altman RD et al (2004) OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage 12:389–399PubMedCrossRef
28.
go back to reference Tubach F, Ravaud P, Giraudeau B (2005) Managing osteoarthritis of the knee: conclusions about use of NSAIDs are misleading. Br Med J 330:672CrossRef Tubach F, Ravaud P, Giraudeau B (2005) Managing osteoarthritis of the knee: conclusions about use of NSAIDs are misleading. Br Med J 330:672CrossRef
29.
go back to reference McQuay H, Moore A (2007) Utility of clinical trial results for clinical practice. Eur J Pain 11:123–124PubMedCrossRef McQuay H, Moore A (2007) Utility of clinical trial results for clinical practice. Eur J Pain 11:123–124PubMedCrossRef
30.
go back to reference Moore RA, Moore OA, Derry S, McQuay HJ (2008) Numbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores. Arthritis Res Ther 10(2):5CrossRef Moore RA, Moore OA, Derry S, McQuay HJ (2008) Numbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores. Arthritis Res Ther 10(2):5CrossRef
31.
go back to reference Lötsch J, Geisslinger G (2006) Current evidence for a genetic modulation of the response to analgesics. Pain 121:1–5PubMedCrossRef Lötsch J, Geisslinger G (2006) Current evidence for a genetic modulation of the response to analgesics. Pain 121:1–5PubMedCrossRef
32.
go back to reference Saver JL (2004) Number needed to treat estimates incorporating effects over the entire range of clinical outcomes. Arch Neurol 61:1066–1071PubMedCrossRef Saver JL (2004) Number needed to treat estimates incorporating effects over the entire range of clinical outcomes. Arch Neurol 61:1066–1071PubMedCrossRef
33.
go back to reference Wen L, Badgett R, Cornell J (2005) Number needed to treat: a descriptor for weighing therapeutic options. Am J Health Syst Pharm 62(19):2031–2036PubMedCrossRef Wen L, Badgett R, Cornell J (2005) Number needed to treat: a descriptor for weighing therapeutic options. Am J Health Syst Pharm 62(19):2031–2036PubMedCrossRef
34.
go back to reference Kristensen LE, Christensen R, Bliddal H, Geborek P, Danneskiold-Samsøe B, Saxne T (2007) The number needed to treat for adalimumab, etanercept, and infliximab based on ACR50 response in three randomized controlled trials on established rheumatoid arthritis: a systematic literature review. Scand J Rheumatol 36:411–417PubMedCrossRef Kristensen LE, Christensen R, Bliddal H, Geborek P, Danneskiold-Samsøe B, Saxne T (2007) The number needed to treat for adalimumab, etanercept, and infliximab based on ACR50 response in three randomized controlled trials on established rheumatoid arthritis: a systematic literature review. Scand J Rheumatol 36:411–417PubMedCrossRef
Metadata
Title
Eggshell membrane in the treatment of pain and stiffness from osteoarthritis of the knee: a randomized, multicenter, double-blind, placebo-controlled clinical study
Authors
Kevin J. Ruff
Anne Winkler
Robert W. Jackson
Dale P. DeVore
Barry W. Ritz
Publication date
01-08-2009
Publisher
Springer-Verlag
Published in
Clinical Rheumatology / Issue 8/2009
Print ISSN: 0770-3198
Electronic ISSN: 1434-9949
DOI
https://doi.org/10.1007/s10067-009-1173-4

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