title: Efficacy and tolerance of enzymatic hydrolysed collagen (EHC) vs. glucosamine sulphate (GS) in the treatment of knee osteoarthritis (KOA).
abstract: This was a 13-week, multicentre, randomised, parallel, double-blind study. One hundred men and women volunteers aged ≥ 40 years with knee osteoarthritis (KOA) were randomised to once daily enzymatic hydrolysed collagen (EHC) 10 g or glucosamine sulphate (GS) 1.5 g for 90 consecutive days. Follow-up took place after two weeks and after one, two and three months. Primary [visual analogue scale (VAS), Western Ontario and McMaster Universities (WOMAC Index)] and secondary outcomes variables, assessed at weeks two, four, eight and 12, were KOA pain intensity measured by quadruple visual analogue scales in the target knee, the WOMAC total score index, patient's and investigator's global assessments of disease activity, joint assessment, use of rescue medication (ibuprofen 400 mg tablets) and assessment of Quality of Life index (SF-36 Questionnaire). Safety and tolerability were also evaluated. Clear improvement was observed in both joint pain and symptoms in patients with KOA treated with EHC (Colatech®) and significant differences were observed. Mean reductions from baseline for EHC 10 g daily and GS 1.5 g, respectively, were KOA pain intensity reduction in the target knee for Colatech® (p < 0.05): WOMAC index decrease ≤ 15 points at the last visit (day 90) for Colatech® in 16 patients (34.04%) (p < 0.05) and for glucosamine in six patients (13.04%); total score index for painful joints: Colatech® 1.6 (p < 0.05) and glucosamine 1.8; total score index for swollen joints: Colatech® 0.5 (p < 0.05) and glucosamine 0.7; patient's global assessment of efficacy as the sum of improvement good + ideal: 80.8% for Colatech® and 46.6% for glucosamine (p < 0.05). EHC (Colatech®) showed superior improvement over GS in the SF-36 Questionnaire in the Physical Health Index (42.0 for Colatech and 40.0 for glucosamine). The incidence of adverse events was similar in both groups. Both EHC and GS were well tolerated.
authors.affiliation: Orthopaedic Clinic, 2nd Medical School, Charles University, Prague, Czech Republic. tomas.trc@lfmotol.cuni.cz
authors.forename: Tomáš
authors.initials: T
authors.lastname: Trč
authors.forename: Jana
authors.initials: J
authors.lastname: Bohmová
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D003094:Collagen / Q000378:metabolism / Q000627:therapeutic use*; D017364:Collagenases / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D005944:Glucosamine / Q000627:therapeutic use*; D006304:Health Status; D006801:Humans; D006868:Hydrolysis; D007719:Knee Joint / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000503:physiopathology; D010146:Pain / Q000188:drug therapy / Q000503:physiopathology; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D003094:Collagen; D017364:Collagenases; D005944:Glucosamine
references.citation: Lancet. 2001 Jan 27;357(9252):251-6
references.pmid: 11214126
references.citation: Arthritis Rheum. 2007 Dec;56(12):4055-64
references.pmid: 18050202
references.citation: Science. 1993 Sep 24;261(5129):1727-30
references.pmid: 8378772
references.citation: J Nutr. 1999 Oct;129(10):1891-5
references.pmid: 10498764
references.citation: J Rheumatol. 1988 Dec;15(12):1833-40
references.pmid: 3068365
references.citation: J Rheumatol. 1992 Mar;19(3):444-50
references.pmid: 1578461
references.citation: Rheumatology (Oxford). 2002 Mar;41(3):279-84
references.pmid: 11934964
references.citation: Acta Chir Orthop Traumatol Cech. 2002;69(5):302-7
references.pmid: 12557601
references.citation: West J Med. 2000 Feb;172(2):91-4
references.pmid: 10693368
references.citation: J Rheumatol. 1992 Mar;19(3):451-7
references.pmid: 1578462
references.citation: Ann Rheum Dis. 1989 Apr;48(4):271-80
references.pmid: 2712610
references.citation: Curr Rheumatol Rep. 2000 Dec;2(6):472-7
references.pmid: 11123100
references.citation: Acta Chir Orthop Traumatol Cech. 1997;64(2):95-8
references.pmid: 20470605
references.citation: J Rheumatol Suppl. 1991 Mar;28:2-5
references.pmid: 2038013
references.citation: Lancet. 2001 Jan 27;357(9252):247-8
references.pmid: 11214122
references.citation: Osteoarthritis Cartilage. 1994 Mar;2(1):51-9
references.pmid: 11548224
references.citation: Lancet. 1985 Jul 6;2(8445):11-4
references.pmid: 2861455