Chondroitin Sulfate

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section

Note: The archived version of this monograph has been temporarily removed. For an electronic copy of this archived version, please contact the Natural Health Products Directorate (NHPD) at NHPD_DPSN@hc-sc.gc.ca.

---

monograph has been temporarily removed. For an electronic copy of this archived version, please contact the Natural Health Products Directorate (NHPD) at NHPD_DPSN@hc-sc.gc.ca.

Date: July 17, 2008

Proper name: Chondroitin sulfate (O'Neil et al. 2006)

Common name: Chondroitin sulfate (O'Neil et al. 2006)

Source material(s): Chondroitin sulfate sodium obtained from bovine (Bovidae), porcine (Suidae), and/or avian (Phasianidae) cartilage.

Note: Cartilage must be derived from healthy and domestic animals used for food by humans (USP 31).

Route(s) of administration: Oral

Dosage form(s): Those pharmaceutical dosage forms suited to oral administration, including but not limited to chewables (eg. gummies, tablets), caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons, or tablespoons are acceptable.

This monograph is not intended to include food-like dosage forms such as beverages, bars or chewing gums.

Use(s) or Purpose(s): Statement(s) to the effect of:

• Helps to relieve joint pain associated with osteoarthritis (Mazières et al. 2007; Uebelhart et al. 2004; Mazières et al. 2001; Bourgeois et al. 1998; Bucsi and Poor 1998; Uebelhart et al. 1998).
• Helps to relieve pain associated with osteoarthritis of the knee (Mazières et al. 2007; Uebelhart et al. 2004; Mazières et al. 2001; Bourgeois et al. 1998; Bucsi and Poor 1998; Uebelhart et al. 1998).

Dose(s): 800-1,200 mg, per day (Mazières et al. 2007; Hathcock and Shao 2006; Uebelhart et al. 2004; Mazières et al. 2001; Bourgeois et al. 1998; Bucsi and Poor 1998; Uebelhart et al. 1998)

Duration of use: Use for a minimum of 3 months to see beneficial effects (Bjordal et al. 2007).

Risk information: Statement(s) to the effect of:

Caution(s) and warning(s):

• Consult a health care practitioner if symptoms worsen.
• Consult a health care practitioner prior to use if you are pregnant or breastfeeding.

Contraindication(s): No statement required.

Known adverse reaction(s): No statement required.

Non-medicinal ingredients: Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Specifications:

• The finished product must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.
• The medicinal ingredient must either:
  1. Comply with the specifications outlined in the Chondroitin Sulfate Sodium Monographs published in the British or European Pharmacopoeiae, or the United States Pharmacopoeia or,
     
  2. Be cited in an approved NHP Master File, authorized by a letter of access issued to the applicant by the NHP Master File's registered owner.
• In order to minimize the risk of Transmissible Spongiform Encephalopathies (TSEs) from products sourced from bovine tissues, product licence applicants must have a veterinary certificate on file and must ensure that the following criteria has been met (EP 2008):
  1. Source animal is fit for human consumption;
  2. Source material can be traced back to the herd or animal;
  3. Avoidance of cross-contamination with high-infectivity tissues is ensured during sourcing;
  4. Manufacturing procedures that are known to reduce infectivity are implemented (e.g. procedures that are in accordance with those outlined in Chapter 5.2.8 of the European Pharmacopoeia).
     Note: This information is not to be submitted with the compendial Product Licence Application, although it may be requested at the NHPD's discretion.

References cited:

Bjordal JM, Klovning A, Ljunggren AE, Slørdal L. 2007. Short-term efficacy of pharmacotherapeutic interventions in osteoarthritic knee pain: A meta-analysis of randomised placebo-controlled trials. European Journal of Pain 11(2):125-138.

Bourgeois P, Chales G, Dehais J, Delcambre B, Kuntz JL, Rosenberg S. 1998. Efficacy and tolerability of chondroitin sulfate 1200 mg/day vs chondroitin sulfate 3 x 400 mg/day vs placebo. Osteoarthritis Cartilage 6(Suppl A):25-30.

Bucsi L, Poor G. 1998. Efficacy and tolerability of oral chondroitin sulfate as a symptomatic slow acting drug for osteoarthritis (SYSADOA) in the treatment of knee osteoarthritis. Osteoarthritis Cartilage 6(Suppl A):31-36.

EP 2008: European Pharmacopoeia, 6th edition, Volume 1. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).

Hathcock JN, Shao A. 2006. Risk assessment for glucosamine and chondroitin sulphate. Regulatory Toxicology and Pharmacology 47(1):78-83.

Mazières B, Combe B, Phan Van A, Tondut J, Grynfeltt M. 2001. Chondroitin sulphate in osteoarthritis of the knee ; a prospective, double-blind, placebo-controlled multicenter clinical study. Journal of Rheumatology 28:173-181.

Mazières B, Hucher M, Zaïm M, Garnero P. 2007. Effect of chondroitin sulphate in symptomatic knee osteoarthritis: a multicentre, randomised, double-blind, placebo-controlled study. Annals if the Rheumatic Diseases 66(5):639-645.

NIH 2008: National Institutes of Health. The NCBI Entrez Taxonomy Homepage. [online]. Bethesda (MD): Specialized Information Services, National Library of Medicine, National Institutes of Health, US Department of Health & Human Services. Available from:
http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=search&db=taxonomy [Accessed 17 July 2008].

O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. 2006. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th edition. Whitehouse Station (NJ): Merck & Co., Inc.

Uebelhart D, Malaise M, Marcolongo R, de Vathaire F, Piperno M, Mailleux E, Fioravanti A, Matoso L, Vignon E. 2004. Intermittent treatment of knee osteoarthritis with oral chondroitin sulphate: a one-year, randomized, double-blind, multicenter study versus placebo. Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society 12(4):269-276.

Uebelhart D, Thonar EJ, Delmas PD, Chant Raine A, Vignon E. 1998. Effects of oral chondroitin sulfate on the progression of knee osteoarthritis: a pilot study. Osteoarthritis Cartilage 6(Suppl A):39-46.

USP 31: The United States Pharmacopeia and the National Formulary (USP 31/NF 26). 2008. Rockville (MD): United States Pharmacopeial Convention, Inc.

References reviewed:

Bana G, Jamard B, Mazières B. 2006. Chondroitin sulphate in the management of hip and knee osteoarthritis: an overview. Advances in Pharmacology 53:507-522.

Boon H. Chondroitin sulfate. In: Chandler F, editor. 2000. Herbs: Everyday Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association.

Clegg DO, Reda DJ, Harris CL, Klein MA, O'Dell JR, Hooper MM, Bradley JD, Bingham CO 3rd, Weisman MH, Jackson CG, Lane NE, Cush JJ, Moreland LW, Schumacher HR Jr, Oddis CV, Wolfe F, Molitor JA, Yocum DE, Schnitzer TJ, Furst DE, Sawitzke AD, Shi H, Brandt KD, Moskowitz RW, Williams HJ. 2006. Glucosamine, chondroitin sulphate, and the two in combination for painful knee osteoarthritis. The New England Journal of Medicine 354(8):795-808.

Conrozier T. 1998. [Anti-arthrosis treatments: efficacy and tolerance of chondroitin sulfates (CS 4&6)]. Presse Médicale 27(36):1862-1865 (in French).

Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M. 2003. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Annals of the Rheumatic Disease 62(12):1145-1155.

Luo XM, Fosmire GJ, Leach RM Jr. 2002. Chicken keel cartilage as a source of chondroitin sulfate. Poultry Science 81(7):1086-9.

Malavaki CJ, Asimakopoulou AP, Lamari FN, Theocharis AD, Tzanakakis GN, Karamanos NK. 2008. Capillary electrophoresis for the quality control of chondroitin sulfates in raw materials and formulations. Analytical Biochemistry 374(1):213-220.

Mazières B, Loyau G, Menkès CJ, Valat JP, Dreiser RL, Charlot J, Masounabe-Puyanne A. 1992. [Chondroitin sulfate in the treatment of gonarthrosis and coxarthrosis. 5-months result of a multicenter double-blind controlled prospective study using placebo]. Revue du Rhumatisme et des Maladies Ostéo-articulaires 59(7-8):466-472 (in French).

Michel BA, Stucki G, Frey D, De Vathaire F, Vignon E, Bruehlmann P, Uebelhart D. 2005. Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: a randomized, controlled trial. Arthritis and Rheumatism 52(3):779-786.

Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L. 1996. Comparison of the anti-inflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. The Journal of Rheumatology 23(8):1385-1391.

Murray MT. 1996. Encyclopedia of Nutritional Supplements: The Essential Guide for Improving your Health Naturally. Rocklin (CA): Prima Publishing.

NIH 2007a: National Institutes of Health. ChemIDplus advanced [online database]. Chondroitin, hydrogen sulfate, sodium salt; RN: 9082-07-9. Specialized Information Services, National Library of Medicine, National Institutes of Health, US Department of Health & Human Services, Bethesda (MD). Available from: http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp [Accessed 17 July 2008].

NIH 2007b: National Institutes of Health. ChemIDplus advanced [online database]. Chondroitin sulfates; RN: 9007-28-7. Specialized Information Services, National Library of Medicine, National Institutes of Health, US Department of Health & Human Services, Bethesda (MD). Available from: http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp [Accessed 17 July 2008].

Pisenti, ME Delany, RL Taylor, Jr., UK Abbott, H. Abplanalp, JA Arthur, MR Bakst, C Baxter-Jones, JJ Bitgood, FA Bradley, KM Cheng, RR Dietert, JB Dodgson, AM Donoghue, AB Emsley, RJ Etches, RR Frahm, RJ Gerrits, PF Goetinck, AA Grunder, DE Harry, SJ Lamont, GR Martin, PE McGuire, GP Moberg, LJ Pierro, CO Qualset, MA Qureshi, FT Shultz, BW Wilson. 1999. Chapter 2: Avian genetic diversity: Domesticated species. In: Avian Genetic Resources at Risk: An Assessment and Proposal for Conservation of Genetic Stocks in the USA and Canada. Report No. 20. Davis (CA): University of California Division of Agriculture and Natural Resources, Genetic Resources Conservation Program.

Reichenbach S, Sterchi R, Scherer M, Trelle S, Bürgi E, Bürgi U, Dieppe PA, Jüni P. 2007. Meta-analysis: chondroitin for osteoarthritis of the knee or hip. Annals of Internal Medicine 146(8):580-590.

Richy F, Bruyere O, Ethgen O, Cucherat M, Henrotin Y, Reginster JY. 2003. Structural and symptomatic efficacy of glucosamine and chondroitin in knee osteoarthritis: a comprehensive meta-analysis. Archives of Internal Medicine 163(13):1514-1522.

Rovetta G. 1991. Galactosaminoglycuronoglycan sulfate (matrix) in therapy of tibiofibular osteoarthritis of the knee. Drugs under Experimental and Clinical Research 17(1):53-57.

Shankland WE. 1998. The effects of glucosamine and chondroitin sulphate on osteoarthritis of the TMJ: a preliminary report of 50 patients. Cranio: the journal of craniomandibular practice 16(4):230-235.

Verbruggen G, Goemaere S, Veys E. 2002. Systems to assess the progression of finger joint osteoarthritis and the effects of disease modifying osteoarthritis drugs. Clinical Rheumatology 21(3):231-243.

Verbruggen G, Goemaere S, Veys E. 1998. Chondroitin sulfate: S/MOAD (structure/disease modifying anti-osteoarthritis drug) in the treatment of finger joint OA. Osteoarthritis and Cartilage 6(suppl A):37-38.

Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. 2008. OARSI recommendations for the management of hip and knee osteoarthritis part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis and Cartilage 16(2):137-162.