BACKGROUND: Knee osteoarthritis (OA) conservative treatment aims to delay cartilage degeneration; chondroprotectives represent one approach. A commercially available dietary supplement, CartiJoint Forte, based on glucosamine hydrochloride (GH), chondroitin sulfate (CS) and Bio-Curcumin BCM-95®, was used in this trial.AIM: To assess efficacy and safety of CartiJoint Forte combined with physical therapy in treating subjects with knee OA.DESIGN: A multicenter, prospective, randomized, double blind, placebo-controlled clinical trial.SETTING: Outpatients referred to the Rehabilitation Departments of two University Hospitals.POPULATION: 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 'on moving' 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=.0001), with no differences between groups (F=1.724; p=.191). VAS 'on moving' revealed a significant 'group x time-check' interaction (F=2.491; p=.032), with increasing effect of 'time' on VAS reduction (F=17.748; p=.0001). This was most pronounced in the experimental group at 8 weeks (F=3.437; p=.045). The Lequesne Index showed reductions at T1 and T2 compared to T0 (F=9.535; p=.0001), along with group effect, since the experimental group presented a lower score at T2 (F=7.091; p=.009). No significant changes were found in the knee ROM and inflammation markers.CONCLUSION: CartiJoint Forte, added to physical therapy, may ameliorate pain and help to improve algofunctional score in knee OA patients.CLINICAL REHABILITATION IMPACT: Treatment of knee OA with Curcuminoids plus glycosaminoglycans, added to physical therapy, improves 'on moving' VAS and Lequesne Index scores.
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
Sterzi S;Morrone M;Bravi M;Bressi F;
2016-01-01
Abstract
BACKGROUND: Knee osteoarthritis (OA) conservative treatment aims to delay cartilage degeneration; chondroprotectives represent one approach. A commercially available dietary supplement, CartiJoint Forte, based on glucosamine hydrochloride (GH), chondroitin sulfate (CS) and Bio-Curcumin BCM-95®, was used in this trial.AIM: To assess efficacy and safety of CartiJoint Forte combined with physical therapy in treating subjects with knee OA.DESIGN: A multicenter, prospective, randomized, double blind, placebo-controlled clinical trial.SETTING: Outpatients referred to the Rehabilitation Departments of two University Hospitals.POPULATION: 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 'on moving' 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=.0001), with no differences between groups (F=1.724; p=.191). VAS 'on moving' revealed a significant 'group x time-check' interaction (F=2.491; p=.032), with increasing effect of 'time' on VAS reduction (F=17.748; p=.0001). This was most pronounced in the experimental group at 8 weeks (F=3.437; p=.045). The Lequesne Index showed reductions at T1 and T2 compared to T0 (F=9.535; p=.0001), along with group effect, since the experimental group presented a lower score at T2 (F=7.091; p=.009). No significant changes were found in the knee ROM and inflammation markers.CONCLUSION: CartiJoint Forte, added to physical therapy, may ameliorate pain and help to improve algofunctional score in knee OA patients.CLINICAL REHABILITATION IMPACT: Treatment of knee OA with Curcuminoids plus glycosaminoglycans, added to physical therapy, improves 'on moving' VAS and Lequesne Index scores.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
