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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.
Eur J Phys Rehabil Med 2016; 52(3):321-30EJ

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.

AIM

The aim of this study was 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 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.

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 VAS at motion and Lequesne Index scores.

Authors+Show Affiliations

Department of Physical and Rehabilitation Medicine, Campus Bio-Medico University, Rome, Italy - m.morrone@unicampus.it.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26937646

Citation

Sterzi, Silvia, et al. "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." European Journal of Physical and Rehabilitation Medicine, vol. 52, no. 3, 2016, pp. 321-30.
Sterzi S, Giordani L, Morrone M, et al. 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. Eur J Phys Rehabil Med. 2016;52(3):321-30.
Sterzi, S., Giordani, L., Morrone, M., Lena, E., Magrone, G., Scarpini, C., ... Foti, C. (2016). 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. European Journal of Physical and Rehabilitation Medicine, 52(3), pp. 321-30.
Sterzi S, et al. 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. Eur J Phys Rehabil Med. 2016;52(3):321-30. PubMed PMID: 26937646.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Sterzi,Silvia, AU - Giordani,Laura, AU - Morrone,Michelangelo, AU - Lena,Emanuela, AU - Magrone,Giovanni, AU - Scarpini,Claudia, AU - Milighetti,Stefano, AU - Pellicciari,Leonardo, AU - Bravi,Marco, AU - Panni,Ilaria, AU - Ljoka,Concetta, AU - Bressi,Federica, AU - Foti,Calogero, Y1 - 2016/03/03/ PY - 2016/3/4/entrez PY - 2016/3/5/pubmed PY - 2017/6/6/medline SP - 321 EP - 30 JF - European journal of physical and rehabilitation medicine JO - Eur J Phys Rehabil Med VL - 52 IS - 3 N2 - 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. AIM: The aim of this study was 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 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. 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 VAS at motion and Lequesne Index scores. SN - 1973-9095 UR - https://www.unboundmedicine.com/medline/citation/26937646/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_ L2 - http://www.minervamedica.it/index2.t?show=R33Y2016N03A0321 DB - PRIME DP - Unbound Medicine ER -