title: The efficacy and safety of a combination of glucosamine hydrochloride, chondroitin sulfate and bio-curcumin with exercise in the treatment of knee osteoarthritis: a randomized, double-blind, placebo-controlled study.
abstract: BACKGROUND
  Knee osteoarthritis (OA) conservative treatment aims to delay cartilage degeneration; chondroprotective agents are a valid approach in this sense. A commercially available dietary supplement, CartiJoint Forte, containing glucosamine hydrochloride (GH), chondroitin sulfate (CS) and Bio-Curcumin BCM-95®, was used in this trial.
  
  
  OBJECTIVE
  The aim of this study was to assess efficacy and safety of CartiJoint Forte combined with physical therapy in treating subjects with knee OA.
  
  
  METHODS
  A multicenter, prospective, randomized, double blind, placebo-controlled clinical trial.
  
  
  METHODS
  Outpatients referred to the Rehabilitation Departments of two University Hospitals.
  
  
  METHODS
  Fifty-three patients were randomly assigned to an experimental group (N=26) or a control group (N.=27). Experimental subjects received two tablets of CartiJoint Forte each day for 8 weeks, while those in the control group were provided with a placebo. Three subjects dropped out during the course of the study.
  
  
  METHODS
  The two groups both received 20 sessions of physical therapy during the course of the trial. Primary outcome was pain intensity, measured both at motion and at rest, using the Visual Analogue Scale (VAS). A secondary outcome was an assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and Lequesne Index, knee ROM, and two inflammation markers (C-reactive protein and erythrocyte sedimentation rate). Each assessment was carried out at baseline (T0), at 8 weeks (T1) and at 12 weeks (T2).
  
  
  RESULTS
  VAS at rest was found to be reduced between T0 and T1, as well as between T0 and T2 (F=13.712; P=0.0001), with no differences between groups (F=1.724; P=0.191). VAS at motion revealed a significant "group × time-check" interaction (F=2.491; P=0.032), with increasing effect of time on VAS reduction (F=17.748; P=0.0001). This was most pronounced in the experimental group at 8 weeks (F=3.437; P=0.045). The Lequesne Index showed reductions at T1 and T2 compared to T0 (F=9.535; P=0.0001), along with group effect, since the experimental group presented a lower score at T2 (F=7.091; P=0.009). No significant changes were found in the knee ROM and inflammation markers.
  
  
  CONCLUSIONS
  CartiJoint Forte, added to physical therapy, may ameliorate pain and help to improve algofunctional score in knee OA patients.
  
  
  CONCLUSIONS
  Treatment of knee OA with curcuminoids plus glycosaminoglycans, added to physical therapy, improves VAS at motion and Lequesne Index scores.
authors.affiliation: Department of Physical and Rehabilitation Medicine, Campus Bio-Medico University, Rome, Italy - m.morrone@unicampus.it.
authors.forename: Silvia
authors.initials: S
authors.lastname: Sterzi
authors.forename: Laura
authors.initials: L
authors.lastname: Giordani
authors.forename: Michelangelo
authors.initials: M
authors.lastname: Morrone
authors.forename: Emanuela
authors.initials: E
authors.lastname: Lena
authors.forename: Giovanni
authors.initials: G
authors.lastname: Magrone
authors.forename: Claudia
authors.initials: C
authors.lastname: Scarpini
authors.forename: Stefano
authors.initials: S
authors.lastname: Milighetti
authors.forename: Leonardo
authors.initials: L
authors.lastname: Pellicciari
authors.forename: Marco
authors.initials: M
authors.lastname: Bravi
authors.forename: Ilaria
authors.initials: I
authors.lastname: Panni
authors.forename: Concetta
authors.initials: C
authors.lastname: Ljoka
authors.forename: Federica
authors.initials: F
authors.lastname: Bressi
authors.forename: Calogero
authors.initials: C
authors.lastname: Foti
mesh_terms: D000368:Aged; D001799:Blood Sedimentation; D002097:C-Reactive Protein / Q000032:analysis; D002809:Chondroitin Sulfates / Q000008:administration & dosage*; D003474:Curcumin / Q000008:administration & dosage*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005944:Glucosamine / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D020370:Osteoarthritis, Knee / Q000628:therapy*; D011446:Prospective Studies; D016059:Range of Motion, Articular; D064232:Visual Analog Scale
chemical_list: D002809:Chondroitin Sulfates; D002097:C-Reactive Protein; D003474:Curcumin; D005944:Glucosamine