BACKGROUND: Intra-articular injections of sodium hyaluronate (Na-HA) and corticosteroid (CS) are often used for the treatment of osteoarthritis (OA), and the clinical usefulness of such treatment has been reported. Some studies have discussed the effectiveness of intra-articular drug injection therapy in terms of the clinical results, but no cohort studies have performed evaluations of effectiveness based on changes in joint biomarkers. This prospective randomized study compared the efficacy of Na-HA and CS injections based on clinical scores and levels of biochemical markers for osteoarthritis.
METHODS: A total of 51 patients with knee osteoarthritis received intra-articular injections of either Na-HA or CS and were followed for 6 months after treatment. Pain and inflammatory scores were evaluated at the baseline, at 5 weeks, and at 6 months. We also measured joint fluid levels of hyaluronan (HA), chondroitin 6-sulfate, chondroitin 4-sulfate, matrix metalloproteinase (MMP)-9, and tissue inhibitor of MMP (TIMP)-1 at the baseline and at 5 weeks.
RESULTS: In both groups, injection therapy significantly improved pain/inflammation scores and visual analog scale scores with time (P < 0.01). HA levels were significantly increased after injection only in the Na-HA group (P < 0.05); and the MMP-9 level decreased significantly after injection only in the Na-HA group (P < 0.01). Other marker levels did not differ significantly between groups.
CONCLUSIONS: The results of this prospective randomized study suggest that the clinical effects of Na-HA and CS as local therapies for OA are comparable and that both drugs are useful. Considering the results of the measurement of biomarkers, compared with CS injection therapy Na-HA injection therapy may have protective effects on the articular cartilage by increasing the HA concentration in synovial fluid, as well as inhibitory effects on the catabolism of articular cartilage by reducing the MMP-9 concentration.
Evaluation of gait performance and muscle activity patterns as well as clinical efficacy and safety after intraarticular injections with hyaluronan (Ostenil) compared with triamcinolone (Volon A10) injections in patients with knee osteoarthritis. This was a prospective, randomised, double-blind clinical trial evaluating the influence of five injections of hyaluronan or triamcinolone on gait pattern and muscle activity. For the clinical evaluation visual analogue scale, Lequesne index, and Knee Society Score were used. Quality of life was estimated with the SF-36. The definitive analysis was performed on the population who received all five injections and were examined in the two follow-up visits. Fifteen patients were treated with triamcinolone and 20 with hyaluronan. Significant improvement could be demonstrated for pain scale and clinical scores in both groups. Gait patterns showed significant differences only for Knee Abduction Moment (p=0.007) in the hyaluronan group and for Maximum Vertical Force 1 and 2 between the both groups in the follow up visit (p=0.018) (p=0.019). In both groups there was no significant difference regarding to muscle activity. Quality of life showed no changes in all visits between the groups. Hyaluronan was not superior to triamcinolone. The results suggest that treatment with hyaluronan can reduce pain and improve knee function. A significant short term improvement in gait and muscle activity patterns, however, was not observed, in either hyaluronan or triamcinolone.
ABSTRACT: OBJECTIVE: To assess prospectively the efficacy and tolerability of hylan G-F 20 (HG-F 20; Synvisc) and intraarticular triamcinolone hexacetonide (TH; Aristospan) for treatment of osteoarthritis (OA) knee pain in a 26 week, randomized, multicenter, evaluator-blind study. METHODS: Patients with OA were treated with typical regimens of HG-F 20 (n = 113) and TH (n = 102). Primary assessments were the WOMAC question A1 (pain walking on a flat surface), and a 100 mm visual analog scale (VAS) for patient and investigator overall assessments. Total WOMAC and WOMAC domain C (function) scores were also assessed. The intent-to-treat population was analyzed using a last-observation carried forward approach. RESULTS: Maximum pain relief occurred at 1-2 weeks for TH and at Week 12 for HG-F 20. At Weeks 12 and 26, HG-F 20 was significantly better than TH for the WOMAC question A1 responses (p = 0.0071 and p = 0.0129, respectively), and patient VAS (p < 0.0001 and p < 0.0001) and investigator VAS (p < 0.0300 and p = 0.0004) assessments. Similar significant (p < 0.01) results were observed at Weeks 12 and 26 for total WOMAC and domain C scores. While 15 TH-treated patients discontinued the study due to lack of efficacy, none did so with HG-F 20 treatment (p < 0.01). Both agents were well tolerated with similar adverse event profiles. CONCLUSION: Viscosupplementation with HG-F 20 resulted in a longer duration of effect than TH with a comparable tolerability profile. These data support the preferential use of HG-F 20 over TH for treatment of chronic OA knee pain.
To assess the efficacy of intra-articular hyaluronic acid in patients with knee osteoarthritis, sixty female patients with knee osteoarthritis were randomised to three weekly intra-articular injections of 30 mg sodium hyaluronate (Na HA) with a high molecular weight (1.0 to 2.9 million Da) or 40 mg 6-methylprednisolone acetate (6-MPA). The clinical assessments included pain at rest, at weight-bearing and on walking, Lequesne Index and active range of knee flexion. Assessments were done at baseline, at week 4, and at months 3 and 6. A significant decrease in VAS scores for pain at rest, at weight-bearing and pain on walking, and in Lequesne index was found in both groups at week 4 when compared to baseline and there was no significant differences between the two groups. However, at 3(rd) month improvement in all pain scores and Lequesne index was found in favour of hyaluronic acid. At 6(th), no significant difference was found between the treatment groups. Improvement in pain was accompanied by an increase in joint flexion at week 4 and at month 3 in both groups. Both treatments were well-tolerated. The results showed that both intra-articular hyaluronic acid and 6-MPA treatments provide clinically significant improvement and demonstrated that Na HA has a long-term beneficial effect in patients with knee osteoarthritis.
Los corticosteroides han representado durante mucho tiempo los fármacos de elección para el tratamiento intra-articular de la osteoartritis (OA), pero su uso tiene desventajas, lo que indica la necesidad de alternativas carentes de estos efectos. Este estudio comparativo examinado la eficacia clínica y los efectos estructurales de las inyecciones intraarticulares de hialuronato sódico (HA) de peso molecular (MW) 500 a 730 kDa (una inyección semanal durante 5 semanas) versus acetato de metilprednisolona (MP) (una inyección semanal durante 3 semanas) en el tratamiento de la OA de rodilla. Se estudiaron 99 pacientes con OA de la rodilla, primaria o secundaria a un evento traumático, clasificados de acuerdo con los criterios del Colegio Americano de Reumatología. Las evaluaciones del dolor por EVA y exámenes artroscópicos de la membrana sinovial y el cartílago se realizaron al inicio y 180 días después del inicio del tratamiento. Características artroscópica fueron evaluados bajo condiciones ciegas. Inicialmente, MP mostraron una más inmediato efecto clínico beneficioso en la reducción del dolor que la HA, pero después de 180 días el efecto sintomático de HA fue más duradera que la de MP. Hallazgos artroscópicos en día 180, en comparación con las condiciones de referencia, mostró que ambos fármacos se redujo la inflamación sinovial pero HA fue superior a la MP en la reducción del grado y extensión del daño del cartílago. HA de 500-730 kDa representa una alternativa válida a los corticosteroides en el tratamiento intra-articular de la OA con un efecto beneficioso sobre las alteraciones estructurales. Este estudio apoya los datos anteriores en un potencial modificador de la estructura de la actividad de HA en la OA de la rodilla.
El objetivo de este estudio fue determinar la eficacia comparativa y la seguridad del comercio intra-articular (I / A) de triamcinolona. hexacetonida (TH) y I / A de ácido hialurónico (AH) en la osteoartritis de rodilla inflamatoria. Un estudio aleatorizado doble ciego comparativo de ruta se llevó a cabo en el departamento ambulatorio de reumatología. Hubo 63 pacientes (24 varones, 39 mujeres, edad promedio 70,5 años) con osteoartritis sintomática de rodilla bilateral con derrame. Cada uno recibió cinco inyecciones de AH a intervalos semanales, o 20 de mg, seguida de cuatro placebo (solución salina) inyecciones. Los pacientes fueron examinados semanalmente durante el período de tratamiento y luego a intervalos mensuales durante 6 meses más. La evaluación incluyó el registro de: las puntuaciones visuales analógicas (EVA) para el dolor, la duración de la rigidez, rango de movimiento, derrame articular, calor local; engrosamiento de la sinovial, sensibilidad articular-line y periarticular. La medida de resultado principal fue el dolor en una actividad auto-seleccionada evalúa Vas. Los dos grupos eran comparables al inicio y no hubo diferencias significativas entre los grupos desarrollados en cualquier momento durante el período de tratamiento. Sin embargo, hubo una alta tasa de deserción escolar y la intención de tratar el análisis no demostró diferencias estadísticamente significativas entre los grupos. En pacientes que permanecieron en el estudio, fue significativamente menos dolor experimentado por el grupo HA durante los 6 meses de seguimiento. Otros parámetros mostraron una tendencia similar a favor de la experimentada por el grupo HA durante los 6 meses de seguimiento. Otros parámetros mostraron una tendencia similar a favor de la HA. No podíamos, sin embargo, demuestran diferencias significativas entre el placebo y los tratamientos activos. HA por lo tanto, puede ser una terapia adicional útil para la osteoartritis sintomática de rodilla y puede tener una larga duración de acción.
Intra-articular injections of sodium hyaluronate (Na-HA) and corticosteroid (CS) are often used for the treatment of osteoarthritis (OA), and the clinical usefulness of such treatment has been reported. Some studies have discussed the effectiveness of intra-articular drug injection therapy in terms of the clinical results, but no cohort studies have performed evaluations of effectiveness based on changes in joint biomarkers. This prospective randomized study compared the efficacy of Na-HA and CS injections based on clinical scores and levels of biochemical markers for osteoarthritis.
METHODS:
A total of 51 patients with knee osteoarthritis received intra-articular injections of either Na-HA or CS and were followed for 6 months after treatment. Pain and inflammatory scores were evaluated at the baseline, at 5 weeks, and at 6 months. We also measured joint fluid levels of hyaluronan (HA), chondroitin 6-sulfate, chondroitin 4-sulfate, matrix metalloproteinase (MMP)-9, and tissue inhibitor of MMP (TIMP)-1 at the baseline and at 5 weeks.
RESULTS:
In both groups, injection therapy significantly improved pain/inflammation scores and visual analog scale scores with time (P < 0.01). HA levels were significantly increased after injection only in the Na-HA group (P < 0.05); and the MMP-9 level decreased significantly after injection only in the Na-HA group (P < 0.01). Other marker levels did not differ significantly between groups.
CONCLUSIONS:
The results of this prospective randomized study suggest that the clinical effects of Na-HA and CS as local therapies for OA are comparable and that both drugs are useful. Considering the results of the measurement of biomarkers, compared with CS injection therapy Na-HA injection therapy may have protective effects on the articular cartilage by increasing the HA concentration in synovial fluid, as well as inhibitory effects on the catabolism of articular cartilage by reducing the MMP-9 concentration.
