OBJECTIVE: To assess the ability of avocado-soybean unsaponifiable-Expanscience (ASU-E) to slow radiographic progression in symptomatic hip osteoarthritis (OA).
METHODS: Prospective, randomised, double blind, parallel group, placebo controlled 3 year trial. Patients with symptomatic (painful ≥1 year, Lequesne Index between 3 and 10) hip OA (American College of Rheumatology criteria) and a minimum joint space width (JSW) of the target hip between 1 and 4 mm on a pelvic radiograph were randomly assigned to 300 mg/day ASU-E or placebo. Standing pelvis, target hip anteroposterior (AP) and oblique views were taken annually. The primary outcome was JSW change at year 3, measured at the narrowest point on pelvic or target hip AP view (manual measure using a 0.1 mm graduated magnifying glass). The full analysis dataset (FAS) included all patients having at least two successive radiographs. An analysis of covariance Mixed Model for Repeated Measurements with Missing at Random (for missing data) was performed to compare adjusted 3 year JSW changes (primary outcome) and the percentages of 'progressors' (JSW loss≥0.5 mm) between groups.
RESULTS: 399 patients were randomised (345 kept in the FAS), aged 62 (35-84) years, 54% women, mean body mass index 27 (SD 4) kg/m(2), mean symptom duration 4 (SD 5) years, 0-100 normalised Lequesne Index 30 (SD 9) and global pain visual analogue scale 37 (SD 23) mm. Mean baseline JSW was 2.8 (0.9) mm. There was no significant difference on mean JSW loss (-0.638 mm vs -0.672 mm, p=0.72, in the ASU-E and placebo groups, respectively) but there were 20% less progressors in the ASU-E than in the placebo group (40% vs 50%, respectively, p=0.040). No difference was observed on clinical outcomes. Safety was excellent.
CONCLUSIONS: 3 year treatment with ASU-E reduces the percentage of JSW progressors, indicating a potential structure modifying effect in hip OA to be confirmed, and the clinical relevance requires further assessment.
OBJETIVO: demostrar la equivalencia clínica entre dos formulaciones estandarizadas Ayurveda (India) (SGCG y SGC), glucosamina y celecoxib (AINE).
MÉTODOS: fórmulas ayurvédicas (extractos de tinospora cordifolia, Zingiber officinale, Emblica officinalis, Boswellia serrata), sulfato de glucosamina (2 g al día) y celecoxib (200 mg al día) fueron evaluados en una, paralelos y eficacia aleatorizado, doble ciego, de cuatro brazo, multicéntrico ensayo de la droga equivalencia de 24 semanas de duración. Un total de 440 pacientes elegibles que sufren de artrosis sintomática de rodilla se inscribieron y monitoreada según el protocolo. Las variables de eficacia primaria fueron dolor activa el cuerpo de soporte de peso (escala analógica visual) y el dolor WOMAC modificado y la puntuación de Likert dificultad funcional (por la rodilla y la cadera); los correspondientes a priori rangos de equivalencia eran ± 1,5 cm, ± 2.5 y ± 8.5.
RESULTADOS: Las diferencias entre los grupos de intervención para la media de los cambios en las variables de eficacia primaria estaban dentro del rango de equivalencia por intención de tratar y análisis por protocolo. Veintiséis pacientes mostraron una mayor transaminasa glutámico pirúvico en suero asintomática (SGPT) con la función del hígado por lo demás normal; siete pacientes (intervención ayurvédica) se retiraron y SGPT normalizaron después de suspender el medicamento. Otros eventos adversos fueron leves y no se diferencian por la intervención. En general, el 28% de los pacientes se retiraron del estudio.
Conclusión: En este estudio controlado de 6 meses de la OA de la rodilla, las formulaciones de Ayurveda (especialmente SGCG) redujo significativamente el dolor de rodilla y la función mejorada de la rodilla y fue equivalente a la glucosamina y celecoxib. El aumento de SGPT inesperada requiere una mayor evaluación de la seguridad.
Prueba de registro: Drogas Registro de Ensayos Clínicos y la India, www.ctri.nic.in, CTRI / 2008/091 / 000.063.
OBJECTIVES: The objectives of this study were to determine the efficacy and safety of Derris scandens Benth extracts in pain reduction and functional improvement in patients with knee osteoarthritis (OA).
DESIGN: This was a prospective, randomized, controlled trial, single-blinded (assessor).
SETTINGS: The study was conducted at the Rehabilitation Medicine Department, Siriraj Hospital.
SUBJECTS: One hundred and seven (107) patients with primary OA knee who had pain score of ≥ 5 were recruited.
INTERVENTIONS: Patients were randomized to receive naproxen 500 mg/day or Derris 800 mg/day for 4 weeks.
OUTCOME MEASUREMENTS: Western Ontario McMaster Osteoarthritis Index (WOMAC) scores and 6-minute walking distance were the outcome measurements.
RESULTS: Fifty-five (55) and 52 patients were randomized to Derris and naproxen groups, respectively. The mean differences of all WOMAC scores between 2 groups at week 4 adjusted by week 0 were within ± 1 point. The mean scores of the aforementioned outcomes at weeks 0, 2, and 4 were significantly improved compared to the baseline values. There was no difference of WOMAC scores between groups. The gastrointestinal irritation and dyspepsia were observed more often in the naproxen than in the Derris group.
CONCLUSIONS: Derris scandens Benth extracts were efficacious and safe for the treatment of knee OA.
Objective: To test Antarth, a polyherbal phytomedicine, for its efficacy and safety in patients with osteoarthritis (OA) and compared with placebo. Material and Methods: A total of 90 male or female adult patients who were diagnosed clinically and radiologically with OA were recruited in the study. Antarth or placebo was given 2 capsules b.i.d. for 3 months and the patients were assessed every month for its efficacy. Diclofenac sodium was allowed to be taken as rescue medication. Results: After 3 months of treatment, the reduction in severity of pain on Visual Analog Scale (VAS) was more in Antarth group compared to placebo but the difference between the two groups was not significant. However, pain during functioning of disabled joints while walking distance, squatting, sitting cross-legged and climbing steps were significantly reduced in Antarth group compared to placebo (P < 0.05). Reduction in consumption of rescue medication, diclofenac sodium, was more in Antarth than in placebo group. Conclusions: In Patients' Global Assessment, patients treated with Antarth were more satisfied than the ones treated with placebo. Observations were similar in Physicians' Global Assessment too. There were no adverse events in both the groups.
El Proyecto de la artritis multidisciplinar "Iniciativa de Liderazgo en Tecnología de la India nuevo milenio" se llevó a cabo para validar la medicina ayurvédica. Las formulaciones a base de hierbas en uso popular fueron seleccionados por consenso de expertos y se estandarizaron utilizando herramientas modernas. Nuestra estrategia clínica evolucionó a partir de simples evaluaciones exploratorias a los ensayos de medicamentos diseñados estadísticamente mejor alimentados. Los resultados del primer ensayo de la droga se presentan aquí. Cinco formulaciones orales (codificado A, B, C, D y E), con una base común de Zingiber officinale y Tinospora cordifolia, con un máximo de cuatro extractos de plantas, se evaluaron; con placebo y la glucosamina como controles. 245 pacientes que sufren de rodillas OA sintomática fueron distribuidos aleatoriamente en siete brazos (35 pacientes por grupo) de un estudio doble ciego, de eficacia en paralelo, el juicio multicéntrico de la duración de dieciséis semanas. Los grupos emparejados bien al inicio del estudio. No hubo diferencias para los retiros de los pacientes (17,5%) o eventos adversos (EA) de carácter leve. Intención de tratar el análisis de eficacia, demostró que no había diferencias significativas (P <0,05) para el dolor (que soporta el peso) y el cuestionario de WOMAC (función de la rodilla); respuesta al placebo fue alta. Sobre la base de un mejor alivio del dolor, significativa (P <0,05) menos el consumo de analgésicos y un mejor estado de la rodilla, la formulación "C" fue seleccionado para un mayor desarrollo. ensayos de medicamentos de exploración controlados con múltiples brazos de tratamiento se pueden usar para evaluar económicamente formulaciones estandarizadas varios candidatos.
Aflapin(®) is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is more efficacious as an anti-inflammatory agent compared to the existing Boswellia products, 5-Loxin(®) and traditional 65% Boswellia extract. A 30-day, double-blind, randomized, placebo-controlled study was conducted to validate the efficacy of Aflapin(®) in the management of clinical symptoms of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN69643551). Sixty eligible OA subjects selected through screening were included in the study. The subjects received either 100 mg (n=30) of Aflapin(®) or placebo (n=30) daily for 30 days. Each subject was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 5, 15 and 30. A series of biochemical tests in serum, urine and hematological parameters established the safety of Aflapin. The observations suggest that Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Aflapin provided significant improvements in pain score and functional ability in as early as 5 days of treatment. In conclusion, our observations suggest that Aflapin is a safe, fast acting and effective alternative intervention in the management of OA.
Aflapin(®) is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is significantly better as an anti-inflammatory agent compared to the Boswellia extracts presently available in the market. A 90-day, double-blind, randomized, placebo-controlled study was conducted to evaluate the comparative efficacy and tolerability of 5-Loxin(®) and Aflapin(®) in the treatment of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN80793440). Sixty OA subjects were included in the study. The subjects received either 100 mg (n=20) of 5-Loxin(®) or 100 mg (n=20) of Aflapin(®) or a placebo (n=20) daily for 90 days. Each patient was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 7, 30, 60 and 90. A battery of biochemical parameters in serum, urine and hematological parameters in citrated whole blood were performed to assess the safety of 5-Loxin(®) and Aflapin(®) in OA subjects. Fifty seven subjects completed the study. At the end of the study, both 5-Loxin(®) and Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Interestingly, significant improvements in pain score and functional ability were recorded as early as 7 days after initiation of the study in the treatment group supplemented with 100 mg Aflapin. Corroborating the improvements in pain scores in treatment groups, our in vitro studies provide evidences that Aflapin(®) is capable of inhibiting cartilage degrading enzyme MMP-3 and has the potential to regulate the inflammatory response by inhibiting ICAM-1. Aflapin(®) and 5-Loxin(®) reduce pain and improve physical functions significantly in OA subjects. Aflapin exhibited better efficacy compared to 5-Loxin(®). In comparison with placebo, the safety parameters were almost unchanged in the treatment groups. Hence both 5-Loxin(®) and Aflapin(®) are safe for human consumption.
Para investigar que un tratamiento de 6 meses con aguacate soja insaponificable (Piasclédine 300 mg) una vez al día es tan efectivo como con sulfato de condroitina 400 mg tres veces al día en gonartrosis femorotibial, y también el efecto de arrastre de dos meses más es comparable. Los pacientes fueron aleatorizados (1: 1) para los grupos de tratamiento. Ellos recibieron durante 6 meses 3 cápsulas por día sulfato de condroitina o una cápsula de aguacate soja insaponificable (ASU) en una técnica de doble simulación. Un período de post-tratamiento de 2 meses seguido para determinar el efecto de arrastre. Criterio principal de eficacia fue el cambio del índice WOMAC de estudio comienzan a terminar el tratamiento. Criterios secundarios fueron los cambios en el índice de Lequesne-, dolor en el movimiento activo y en reposo, la evaluación global de la eficacia. Trescientos sesenta y cuatro pacientes han sido recogidas en el ensayo. Trescientos sesenta y un pacientes fueron elegibles para su evaluación. Ciento ochenta y tres recibieron ASU 300 mg una vez al día, ciento setenta y ocho de sulfato de condroitina tres veces al día. El WOMAC-índice disminuyó en ambos grupos durante aprox. 50% hasta el final de la terapia. Durante la observación post-tratamiento se produjo una ligera mejora adicional. No hubo diferencia estadística significativa entre los grupos de tratamiento durante toda la observación. Todos los demás parámetros observados mostraron el mismo patrón. La ingesta diaria de medicación de rescate se redujo continuamente. Eficacia general ha sido calificado excelente y buena en más del 80% de los pacientes en ambos grupos. Ambos fármacos fueron seguras y bien toleradas. La primera comparación directa entre soja aguacate insaponificable 300 mg una vez al día y sulfato de condroitina tres veces al día reveiled ninguna diferencia en los aspectos de eficacia o seguridad entre 1 cápsula ASU 300 mg por día y 3 cápsulas de sulfato de condroitina por día. Se puede suponer que la ingesta de una vez al día de ASU conducirá a un mejor cumplimiento en la terapia de rutina.
To assess the ability of avocado-soybean unsaponifiable-Expanscience (ASU-E) to slow radiographic progression in symptomatic hip osteoarthritis (OA).
METHODS:
Prospective, randomised, double blind, parallel group, placebo controlled 3 year trial. Patients with symptomatic (painful ≥1 year, Lequesne Index between 3 and 10) hip OA (American College of Rheumatology criteria) and a minimum joint space width (JSW) of the target hip between 1 and 4 mm on a pelvic radiograph were randomly assigned to 300 mg/day ASU-E or placebo. Standing pelvis, target hip anteroposterior (AP) and oblique views were taken annually. The primary outcome was JSW change at year 3, measured at the narrowest point on pelvic or target hip AP view (manual measure using a 0.1 mm graduated magnifying glass). The full analysis dataset (FAS) included all patients having at least two successive radiographs. An analysis of covariance Mixed Model for Repeated Measurements with Missing at Random (for missing data) was performed to compare adjusted 3 year JSW changes (primary outcome) and the percentages of 'progressors' (JSW loss≥0.5 mm) between groups.
RESULTS:
399 patients were randomised (345 kept in the FAS), aged 62 (35-84) years, 54% women, mean body mass index 27 (SD 4) kg/m(2), mean symptom duration 4 (SD 5) years, 0-100 normalised Lequesne Index 30 (SD 9) and global pain visual analogue scale 37 (SD 23) mm. Mean baseline JSW was 2.8 (0.9) mm. There was no significant difference on mean JSW loss (-0.638 mm vs -0.672 mm, p=0.72, in the ASU-E and placebo groups, respectively) but there were 20% less progressors in the ASU-E than in the placebo group (40% vs 50%, respectively, p=0.040). No difference was observed on clinical outcomes. Safety was excellent.
CONCLUSIONS:
3 year treatment with ASU-E reduces the percentage of JSW progressors, indicating a potential structure modifying effect in hip OA to be confirmed, and the clinical relevance requires further assessment.
