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Estudio primario

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Combined Treatment With Chondroitin Sulfate and Glucosamine Sulfate Shows No Superiority Over Placebo for Reduction of Joint Pain and Functional Impairment in Patients With Knee Osteoarthritis: A Six-Month Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Revista Arthritis & rheumatology (Hoboken, N.J.)
Año 2017
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OBJECTIVE: To assess the efficacy and safety of combination therapy with chondroitin sulfate (CS) and glucosamine sulfate (GS) compared to placebo in patients with symptomatic knee osteoarthritis (OA). METHODS: A multicenter, randomized, double-blind, placebo-controlled study was performed in 164 patients with Kellgren/Lawrence grade 2 or grade 3 radiographic knee OA and moderate-to-severe knee pain (mean ± SD global pain score 62.1 ± 11.3 mm on a 100-mm visual analog scale [VAS]). Patients were randomized to receive either combined treatment with CS (1,200 mg) plus GS (1,500 mg) or placebo in a single oral daily dose for 6 months. The mean change from baseline in the VAS global pain score was set as the primary end point. Secondary outcomes included the mean change in the investigator's global assessment of disease activity, total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), pain and function subscale scores on the WOMAC, responder rates based on the Outcome Measures in Rheumatology (OMERACT)-Osteoarthritis Research Society International (OARSI) 2004 response criteria, and rescue medication use. Adverse events were also recorded. A Data and Safety Monitoring Board was instituted to ensure patient safety and data accuracy. RESULTS: Intriguingly, in the modified intent-to-treat (mITT) population, CS/GS combination therapy was inferior to placebo in the reduction of joint pain (mean ± SD change in VAS global pain score over 6 months -11.8 ± 2.4 mm [19% reduction] in patients receiving CS plus GS versus -20.5 ± 2.4 mm [33% reduction] in patients receiving placebo; peak between-group difference in global pain score at 6 months 8.7 mm [14.2%], P < 0.03), but no between-group differences were seen in the per-protocol completers. Both placebo treatment and CS/GS combination treatment improved to a similar extent the total WOMAC score as well as the pain and function WOMAC subscale scores, both in the mITT population and in the per-protocol completers. Neither the OMERACT-OARSI responder rate nor the frequency of rescue medication use differed between the treatment groups. Severe adverse events were uncommon and equally distributed. CONCLUSION: The results of this trial demonstrate a lack of superiority of CS/GS combination therapy over placebo in terms of reducing joint pain and functional impairment in patients with symptomatic knee OA over 6 months. Further research might fully elucidate the suitability of CS/GS combination therapy in patients with OA.

Estudio primario

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Comparison of Glucosamine-Chondroitin Sulfate with and without Methylsulfonylmethane in Grade I-II Knee Osteoarthritis: A Double Blind Randomized Controlled Trial.

Revista Acta medica Indonesiana
Año 2017
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BACKGROUND: Glucosamine, chondroitinsulfate are frequently used to prevent further joint degeneration in osteoarthritis (OA). Methylsulfonylmethane (MSM) is a supplement containing organic sulphur and also reported to slow anatomical joint progressivity in the knee OA. The MSM is often combined with glucosamine and chondroitin sulfate. However, there are controversies whether glucosamine-chondroitin sulfate or their combination with methylsulfonylmethane could effectively reduce pain in OA. This study is aimed to compare clinical outcome of glucosamine-chondroitin sulfate (GC), glucosamine-chondroitin sulfate-methylsulfonylmethane (GCM), and placeboin patients with knee osteoarthritis (OA) Kellgren-Lawrence grade I-II. METHODS: a double blind, randomized controlled clinical trial was conducted on 147 patients with knee OA Kellgren-Lawrence grade I-II. Patients were allocated by permuted block randomization into three groups: GC (n=49), GCM (n=50), or placebo (n=48) groups. GC group received 1500 mg of glucosamine + 1200 mg of chondroitin sulfate + 500 mg of saccharumlactis; GCM group received 1500 mg of glucosamine + 1200 mg of chondroitin sulfate + 500 mg of MSM; while placebo group received three matching capsules of saccharumlactis. The drugs were administered once daily for 3 consecutive months VAS and WOMAC scores were measured before treatment, then at 4th, 8th and 12th week after treatment. RESULTS: on statistical analysis it was found that at the 12th week, there are significant difference between three treatment groups on the WOMAC score (p=0.03) and on the VAS score (p=0.004). When analyzed between weeks, GCM treatment group was found statistically significant on WOMAC score (p=0.01) and VAS score (p<0.001). Comparing the score difference between weeks, WOMAC score analysis showed significant difference between GC, GCM, and placebo in week 4 (p=0.049) and week 12 (p=0.01). In addition, VAS score also showed significant difference between groups in week 8 (p=0.006) and week 12 (p<0.001). CONCLUSION: combination of glucosamine-chondroitinsulfate-methylsulfonylmethane showed clinical benefit for patients with knee OAK ellgren-Lawrence grade I-II compared with GC and placebo. GC did not make clinical improvement in overall groups of patients with knee OA Kellgren Lawrence grade I-II.

Estudio primario

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Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study.

Autores Lugo JP , Saiyed ZM , Lane NE
Revista Nutrition journal
Año 2016
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 3 Revisiones sistemáticas Revisiones sistemáticas (3 referencias)

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BACKGROUND: Undenatured type II collagen (UC-II) is a nutritional supplement derived from chicken sternum cartilage. The purpose of this study was to evaluate the efficacy and tolerability of UC-II for knee osteoarthritis (OA) pain and associated symptoms compared to placebo and to glucosamine hydrochloride plus chondroitin sulfate (GC). METHODS: One hundred ninety one volunteers were randomized into three groups receiving a daily dose of UC-II (40 mg), GC (1500 mg G & 1200 mg C), or placebo for a 180-day period. The primary endpoint was the change in total Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) from baseline through day 180 for the UC-II group versus placebo and GC. Secondary endpoints included the Lequesne Functional Index (LFI), the Visual Analog Scale (VAS) for pain and the WOMAC subscales. Modified intent-to-treat analysis were performed for all endpoints using analysis of covariance and mixed model repeated measures, while incremental area under the curve was calculated by the intent-to-treat method. RESULTS: At day 180, the UC-II group demonstrated a significant reduction in overall WOMAC score compared to placebo (p = 0.002) and GC (p = 0.04). Supplementation with UC-II also resulted in significant changes for all three WOMAC subscales: pain (p = 0.0003 vs. placebo; p = 0.016 vs. GC); stiffness (p = 0.004 vs. placebo; p = 0.044 vs. GC); physical function (p = 0.007 vs. placebo). Safety outcomes did not differ among the groups. CONCLUSION: UC-II improved knee joint symptoms in knee OA subjects and was well-tolerated. Additional studies that elucidate the mechanism for this supplement's actions are warranted. TRIAL REGISTRATION: CTRI/2013/05/003663 ; CTRI/2013/02/003348 .

Estudio primario

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Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis: a multicentre, randomised, double-blind, non-inferiority trial versus celecoxib.

Revista Annals of the rheumatic diseases
Año 2016
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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OBJECTIVES: To compare the efficacy and safety of chondroitin sulfate plus glucosamine hydrochloride (CS+GH) versus celecoxib in patients with knee osteoarthritis and severe pain. METHODS: Double-blind Multicentre Osteoarthritis interVEntion trial with SYSADOA (MOVES) conducted in France, Germany, Poland and Spain evaluating treatment with CS+GH versus celecoxib in 606 patients with Kellgren and Lawrence grades 2-3 knee osteoarthritis and moderate-to-severe pain (Western Ontario and McMaster osteoarthritis index (WOMAC) score ≥301; 0-500 scale). Patients were randomised to receive 400 mg CS plus 500 mg GH three times a day or 200 mg celecoxib every day for 6 months. The primary outcome was the mean decrease in WOMAC pain from baseline to 6 months. Secondary outcomes included WOMAC function and stiffness, visual analogue scale for pain, presence of joint swelling/effusion, rescue medication consumption, Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria and EuroQoL-5D. RESULTS: The adjusted mean change (95% CI) in WOMAC pain was -185.7 (-200.3 to -171.1) (50.1% decrease) with CS+GH and -186.8 (-201.7 to -171.9) (50.2% decrease) with celecoxib, meeting the non-inferiority margin of -40: -1.11 (-22.0 to 19.8; p=0.92). All sensitivity analyses were consistent with that result. At 6 months, 79.7% of patients in the combination group and 79.2% in the celecoxib group fulfilled OMERACT-OARSI criteria. Both groups elicited a reduction >50% in the presence of joint swelling; a similar reduction was seen for effusion. No differences were observed for the other secondary outcomes. Adverse events were low and similarly distributed between groups. CONCLUSIONS: CS+GH has comparable efficacy to celecoxib in reducing pain, stiffness, functional limitation and joint swelling/effusion after 6 months in patients with painful knee osteoarthritis, with a good safety profile. TRIAL REGISTRATION NUMBER: NCT01425853.

Estudio primario

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Efficacy and safety of nonsteroidal anti-inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo-controlled study.

Autores Essex MN , O'Connell MA , Behar R , Bao W
Revista International journal of rheumatic diseases
Año 2016
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 8 Revisiones sistemáticas Revisiones sistemáticas (8 referencias)

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AIM: To compare the efficacy, tolerability and safety of celecoxib, naproxen and placebo in Asian patients with osteoarthritis (OA) of the knee. METHOD: Patients of Asian descent with knee OA, aged ≥ 45 years, in a flare state with a functional capacity classification of I-III, received celecoxib 200 mg once daily, naproxen 500 mg twice daily or placebo, for 6 weeks. The change in Patient's Assessment of Arthritis Pain (week 6 vs. baseline) was the primary endpoint. Secondary endpoints, including Patient's and Physician's Global Assessments of Arthritis, Western Ontario and McMaster Universities OA Index (WOMAC), use of complementary and alternative medicines, incidence of treatment-emergent adverse events (TEAEs) and measurements of upper gastrointestinal tolerability, were also assessed. RESULTS: Three hundred and sixty-seven patients were randomized: 145 to celecoxib, 144 to naproxen and 78 to placebo. Celecoxib was as effective as naproxen in reducing OA pain (least squares mean change from baseline in visual analogue scale score [standard error] -37.1 [2.0] for celecoxib and -37.5 [2.0] for naproxen). Patient's and Physician's Global Assessment of Arthritis, WOMAC scores, Pain Satisfaction Scale and Patient Health Questionnaire-9 showed statistically significant improvement in active treatment groups versus placebo, with the exception of naproxen WOMAC scores. Treatment-related TEAEs occurred in 19 (13%), 34 (24%) and six (8%) patients in the celecoxib, naproxen and placebo groups, respectively. CONCLUSION: Celecoxib and naproxen were comparable in their effects to reduce the signs and symptoms of knee OA in Asian patients. Celecoxib was shown to be safe and well tolerated in this patient population.

Estudio primario

No clasificado

Glucosamine and chondroitin for knee osteoarthritis: A double-blind randomised placebo-controlled clinical trial evaluating single and combination regimens

Revista Annals of the rheumatic diseases
Año 2015
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Este artículo está incluido en 10 Revisiones sistemáticas Revisiones sistemáticas (10 referencias)

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Objective: To determine if the dietary supplements, glucosamine and/or chondroitin, result in reduced joint space narrowing (JSN) and pain among people with symptomatic knee osteoarthritis. Methods: A double-blind randomised placebo-controlled clinical trial with 2-year follow-up. 605 participants, aged 45-75 years, reporting chronic knee pain and with evidence of medial tibio-femoral compartment narrowing (but retaining >2 mm medial joint space width) were randomised to once daily: glucosamine sulfate 1500 mg (n=152), chondroitin sulfate 800 mg (n=151), both dietary supplements (n=151) or matching placebo capsules (n=151). JSN (mm) over 2 years was measured from digitised knee radiographs. Maximum knee pain (0-10) was self-reported in a participant diary for 7 days every 2 months over 1 year. Results: After adjusting for factors associated with structural disease progression (gender, body mass index (BMI), baseline structural disease severity and Heberden's nodes), allocation to the dietary supplement combination (glucosamine-chondroitin) resulted in a statistically significant (p=0.046) reduction of 2-year JSN compared to placebo: mean difference 0.10 mm (95% CI 0.002 mm to 0.20 mm); no significant structural effect for the single treatment allocations was detected. All four allocation groups demonstrated reduced knee pain over the first year, but no significant between-group differences (p=0.93) were detected. 34 (6%) participants reported possibly-related adverse medical events over the 2-year follow-up period. Conclusions: Allocation to the glucosamine-chondroitin combination resulted in a statistically significant reduction in JSN at 2 years. While all allocation groups demonstrated reduced knee pain over the study period, none of the treatment allocation groups demonstrated significant symptomatic benefit above placebo. © 2014 BMJ Publishing Group Ltd & European League Against Rheumatism.

Estudio primario

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Onset and durability of pain relief in knee osteoarthritis: Pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib.

Autores Holt RJ , Fort JG , Grahn AY , Kent JD , Bello AE
Revista The Physician and sportsmedicine
Año 2015
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Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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OBJECTIVE: To further characterize time-to-first pain relief, effect size, correlations between various outcome measures and durability of relief for single-tablet naproxen 500 mg/esomeprazole 20 mg (NAP/ESO) given twice daily and celecoxib (CEL) (200 mg) given once daily versus placebo in knee osteoarthritis (OA). METHODS: Unpublished data from two double-blind, double-dummy, placebo-controlled trials in which patients aged ≥ 50 years with knee OA were randomized to NAP/ESO (n = 487), CEL (n = 486) or placebo (n = 246) were pooled (NCT00664560 and NCT00665431). Acute response endpoints: 1) Time to first significant pain response, 2) Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale and 3) American Pain Society Patient Outcome Questionnaire (APS-POQ) scores. Sustainability endpoints: 1) Routine Assessment of Patient Index Data (RAPID3) and 2) WOMAC Stiffness, Pain and Total scores; and Patient Global Assessment (PGA) at 6 and 12 weeks. Effect sizes for all measures were calculated. Rescue pain medication use also was analyzed, as was the correlation of WOMAC to RAPID3. RESULTS: NAP/ESO produced statistically significant decreases in WOMAC Pain on Days 2-7 and at Weeks 6 and 12 (all p < 0.05); most APS-POQ pain assessments with NAP/ESO were significantly improved on Days 2-7 compared with placebo (all p < 0.05). A good or excellent response occurred in a median of 6 days. RAPID3 and WOMAC total/stiffness/function/PGA scores decreased significantly at Weeks 6 and 12 (all p < 0.05). Placebo-adjusted WOMAC pain effect sizes were 0.44, 0.34 and 0.25 at Day 7, week 6 and week 12, respectively. RAPID3 to WOMAC total and WOMAC pain to RAPID3: Pain scores were highly correlated at 6 and 12 weeks (correlation coefficients >0.80). No significant differences in overall responses were found between CEL and NAP/ESO. CONCLUSION: Naproxen/esomeprazole produced a significant absolute moderate early pain response, which was maintained for 12 weeks. RAPID3 was found to be highly correlated with the typical OA measure (WOMAC) and might be a useful clinical tool for measuring NSAID response. NCT00664560: https://clinicaltrials.gov/ct2/show/NCT00664560, NCT00665431: https://www.clinicaltrials.gov/ct2/show/NCT00665431.

Estudio primario

No clasificado

Efficacy and tolerability of celecoxib and naproxen versus placebo in Hispanic patients with knee osteoarthritis.

Revista International journal of general medicine
Año 2014
Enlaces Pubmed DOI PubMed Central

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BACKGROUND: Celecoxib is an effective treatment for osteoarthritis (OA). However, information on its efficacy and safety profile in different racial/ethnic groups is limited. Noticeable differences among racial groups are found in other disease states, but a thorough investigation of OA is lacking. The objective of this study was to determine if celecoxib 200 mg once daily is as effective as naproxen 500 mg twice daily in the treatment of OA of the knee in Hispanic patients. METHODS: Hispanic patients aged ≥45 years with knee OA were randomized to receive celecoxib 200 mg once daily, naproxen 500 mg twice daily, or placebo for 6 weeks. The primary efficacy variable was the change in Patient's Assessment of Arthritis Pain at 6 weeks compared with baseline. Secondary variables were change in Patient's and Physician's Global Assessments of Arthritis from baseline to week 6/early termination, change in Western Ontario and McMaster Universities OA Index (WOMAC) from baseline to week 6/early termination, change in American Pain Society pain score, Pain Satisfaction Scale, Patient Health Questionnaire (PHQ-9), and measurements of upper gastrointestinal tolerability. RESULTS: In total, 239 patients completed the trial (96 celecoxib, 96 naproxen, 47 placebo). Celecoxib was as effective as naproxen in reducing OA pain (least squares mean change from baseline [standard error] -39.7 [2.7] for celecoxib and -36.9 [2.6] for naproxen). Patient's and Physician's Global Assessments of Arthritis, WOMAC scores, upper gastrointestinal tolerability, Pain Satisfaction Scale, and PHQ-9 showed no statistically significant differences between the celecoxib and naproxen groups. The incidence of adverse events and treatment-related adverse events were similar among the treatment groups. CONCLUSION: Celecoxib 200 mg once daily was as effective as naproxen 500 mg twice daily in the treatment of signs and symptoms of knee OA in Hispanic patients. Celecoxib was shown to be safe and well tolerated in this patient population.

Estudio primario

No clasificado

Efecto de la glucosamina oral sobre la estructura de las articulaciones en personas con dolor crónico de rodilla: un ensayo clínico aleatorizado y controlado con placebo.

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Revista Arthritis & rheumatology (Hoboken, N.J.)
Año 2014
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OBJETIVO: Determinar la eficacia a corto plazo de los suplementos de glucosamina por vía oral mediante la evaluación de las lesiones estructurales en las articulaciones de la rodilla, tal como se evaluó utilizando 3T imágenes por resonancia magnética (MRI). MÉTODOS: Este estudio fue diseñado como un estudio doble ciego, aleatorizado, controlado con placebo. La contratación se realiza a través de correos masivos y un registro de la artritis en el suroeste de Pennsylvania. En total, 201 participantes con dolor de leve a moderado en una o ambas rodillas, tal como se definen por un Western Ontario y McMaster Universidades osteoartritis Index (WOMAC) y la puntuación del dolor ≥25 ≤100, se inscribieron. De estos sujetos, el 69,2% tenían un grado de Kellgren / Lawrence ≥2 en al menos 1 de rodilla. Los participantes recibieron 24 semanas de tratamiento con hidrocloruro de glucosamina 1500 mg en forma de bebida o una bebida placebo. El resultado primario se redujo el empeoramiento del daño del cartílago en la RM 3T de ambas rodillas, evaluó de acuerdo con un sistema de puntuación validado, el Todo-RM Organ Score (lombrices). Los resultados secundarios incluyeron el cambio en la lesión de la médula ósea (BML) las puntuaciones en todas las rodillas y el cambio en la excreción urinaria de telopéptido C-terminal de reticulación del colágeno tipo II (CTX-II). RESULTADOS: La odds ratio (OR) ajustadas para la probabilidad de disminución de daños en el cartílago de más de 24 semanas en cualquier subregión GUSANOS anotadas de la rodilla en el grupo de tratamiento con glucosamina en comparación con el grupo control fue de 0,938 (intervalo de confianza del 95% [IC 95%] 0.528, 1.666). En comparación con los pacientes tratados con glucosamina, los sujetos de control mostraron una mayor mejoría en BMLS (OR ajustada 0,537; IC del 95% 0,291, 0,990) pero no hubo diferencias en el empeoramiento BMLS (OR ajustada IC 0,691, 95% 0.410, 1.166) durante 24 semanas. No había indicios de que el tratamiento con glucosamina disminuye la excreción urinaria de CTX-II (β = -0,10, IC del 95% -0.21, 0.002). Conclusión: Los resultados de este estudio a corto plazo no proporcionan evidencia de los beneficios estructurales (es decir, las mejoras en las características morfológicas de resonancia magnética o la excreción urinaria de CTX-II) de la administración de suplementos de glucosamina en personas con dolor crónico de rodilla.

Estudio primario

No clasificado

A, doble ciego, ensayo de 12 semanas controlado con placebo, aleatorizado de acetaminofeno de liberación prolongada para el tratamiento de los signos y síntomas de la osteoartritis.

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Revista Current medical research and opinion
Año 2014
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Este artículo está incluido en 6 Revisiones sistemáticas Revisiones sistemáticas (6 referencias)

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OBJETIVO: determinar la eficacia y la seguridad de acetaminofeno de liberación prolongada (ER) 1300 mg dado tres veces al día en comparación con el placebo para el alivio de los signos y síntomas de la cadera o de la osteoartritis de rodilla. Material y métodos: Sesenta investigadores en 58 sitios privados, ambulatorios, atención primaria en los EE.UU. reclutaron 542 pacientes ambulatorios adultos ≥ 40 años de edad, con moderado a severo dolor de la osteoartritis idiopática en un ensayo aleatorizado, controlado con placebo, doble ciego 12 semanas clínica. Los pacientes fueron asignados aleatoriamente a tratamiento dado tres veces al día de paracetamol 1300 mg (n = 267) o placebo (n = 275). RESULTADOS: Los tres principales criterios de valoración medidos hasta la semana 12 ER acetaminofeno favorecida de la siguiente manera: mínimos cuadrados (LS) el cambio medio desde la línea de base para la función física WOMAC subescala fue significativamente mayor para ER acetaminofeno que para el placebo (p = 0,011); LS significan evaluación global del paciente de la respuesta al tratamiento fue significativamente mayor para ER acetaminofeno que para el placebo (p = 0,010); LS y el cambio medio desde la línea base para la puntuación de dolor WOMAC subescala fue ligeramente mayor para las ER acetaminofeno que para el placebo (P = 0,054). LS cambio medio desde la línea de base para los objetivos secundarios hasta la semana 12 también favorecida ER paracetamol en comparación con el placebo: de manera significativa para WOMAC puntuación de rigidez subescala (P = 0,004), de manera significativa para la puntuación del índice total de WOMAC (p = 0,013), y marginalmente de Salud de Nottingham energía Perfil subescala (P = 0,057). El porcentaje de pacientes con eventos adversos fue similar en ambos grupos de tratamiento. transaminasas hepáticas superaron 3 x LSN en siete pacientes ER paracetamol y un paciente con placebo. Las elevaciones se atribuyeron a las condiciones de salud en tres de los siete pacientes ER acetaminofeno; elevaciones en los cuatro pacientes restantes volvieron a o hacia normal. CONCLUSIONES: El acetaminofeno ER 1300 mg, un medicamento de venta libre, dado tres veces al día, pueden proporcionar un alivio eficaz de los signos y síntomas de la artrosis de cadera o de rodilla y fue bien tolerado. ClinicalTrials.gov número de registro: NCT00240799.