Estudios primarios incluidos en esta revisión sistemática

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Estudio primario

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Revista Clinical interventions in aging
Año 2014
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OBJECTIVE: To determine the efficacy and safety of Curcuma domestica extracts in pain reduction and functional improvement. METHODS: 367 primary knee osteoarthritis patients with a pain score of 5 or higher were randomized to receive ibuprofen 1,200 mg/day or C. domestica extracts 1,500 mg/day for 4 weeks. The main outcomes were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total, WOMAC pain, WOMAC stiffness, and WOMAC function scores. Adverse events (AEs) were also recorded. RESULTS: 185 and 182 patients were randomly assigned into C. domestica extracts and ibuprofen groups, respectively. The baseline characteristics were no different between groups. The mean of all WOMAC scores at weeks 0, 2, and 4 showed significant improvement when compared with the baseline in both groups. After using the noninferiority test, the mean difference (95% confidence interval) of WOMAC total, WOMAC pain, and WOMAC function scores at week 4 adjusted by values at week 0 of C. domestica extracts were noninferior to those for the ibuprofen group (P=0.010, P=0.018, and P=0.010, respectively), except for the WOMAC stiffness subscale, which showed a trend toward significance (P=0.060). The number of patients who developed AEs was no different between groups. However, the number of events of abdominal pain/discomfort was significantly higher in the ibuprofen group than that in the C. domestica extracts group (P=0.046). Most subjects (96%-97%) were satisfied with the treatment, and two-thirds rated themselves as improved in a global assessment. CONCLUSION: C. domestica extracts are as effective as ibuprofen for the treatment of knee osteoarthritis. The side effect profile was similar but with fewer gastrointestinal AE reports in the C. domestica extracts group.

Estudio primario

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Autores Madhu K , Chanda K , Saji MJ
Revista Inflammopharmacology
Año 2013
Curcuma longa Linn. is widely used for the treatment of disorders associated with inflammation and was evaluated for its safety and efficacy in the treatment of painful knee osteoarthritis (OA). This was a randomized, single blind, placebo-controlled trial. Total of 120 patients (37 males and 83 females) with primary knee OA received either placebo (400 mg twice daily) or NR-INF-02 (500 mg twice daily) or glucosamine sulphate (GS) (750 mg twice daily) alone or combination of NR-INF-02 and GS for 42 days. The efficacy was assessed during treatment period, on day 21 and day 42. The decrease in severity of pain symptom and function of affected knee as primary efficacy outcome measure was assessed by Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale, respectively. The clinical examination of affected joint was measured by an orthopaedic specialist and using a Clinician Global Impression Change (CGIC) scale. The analysis of post-treatment scores following administration of NR-INF-02 using VAS, WOMAC, and CGIC at each clinical visit showed significant decrease (p < 0.05) compared to placebo. NR-INF-02 treated group showed a significant (p < 0.01) decrease in use of rescue medication, along with clinical and subjective improvement compared to placebo. The tolerability and acceptability profile of NR-INF-02 was better during the trial period. The study demonstrates safety and efficacy of NR-INF-02 as a useful treatment option for patients with primary painful knee OA.

Estudio primario

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Autores Paramdeep G
Revista Indian J Physiol Pharmacol
Año 2013
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Estudio primario

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Revista J Med Plant Res
Año 2011
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Estudio primario

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Revista Journal of alternative and complementary medicine (New York, N.Y.)
Año 2009
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OBJECTIVE: The objective of this study was to determine the efficacy and safety of Curcuma domestica extracts in pain reduction and functional improvement in patients with knee osteoarthritis. STUDY DESIGN AND SETTING: The design and setting were a randomized controlled study at a university hospital in Bangkok, Thailand. METHODS: One-hundred and seven (107) patients with primary knee osteoarthritis (OA) with pain score of &gt; or =5 were randomized to receive ibuprofen 800 mg per day or C. domestica extracts 2 g per day for 6 weeks. The main outcomes were improvement in pain on level walking, pain on stairs, and functions of knee assessed by time spent during 100-m walk and going up and down a flight of stairs. The adverse events were also recorded. RESULTS: Fifty-two (52) and 55 patients were randomized to C. domestica extracts and ibuprofen groups, respectively. Baseline characteristics of the patients in both groups were not different. The mean scores of the aforementioned outcomes at weeks 0, 2, 4, and 6 were significantly improved when compared with the baseline values in both groups. There was no difference in those parameters between the patients receiving ibuprofen and C. domestica extracts, except pain on stairs (p = 0.016). No significant difference of adverse events between both groups was found (33.3% versus 44.2%, p = 0.36 in C. domestica extracts and ibuprofen groups, respectively). CONCLUSIONS: C. domestica extracts seem to be similarly efficacious and safe as ibuprofen for the treatment of knee OA.

Estudio primario

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Revista Indian Journal of Pharmacology
Año 2007
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Objective: To compare the efficacy, safety and tolerability of Boswellia serrata extract (BSE) in osteoarthritis (OA) knee with valdecoxib, a selective COX-2 inhibitor. Materials and Methods: In a randomized, prospective, open-label, comparative study the efficacy, safety and tolerability of BSE was compared with valdecoxib in 66 patients of OA of knee for six months. The patients were assessed by WOMAC scale at baseline and thereafter at monthly interval till 1 month after drug discontinuation. Antero-posterior radiographs of affected knee joint were taken at baseline and after 6 months. Results: In BSE group the pain, stiffness, difficulty in performing daily activities showed statistically significant improvement with two months of therapy which even lasted till one month after stopping the intervention. In valdecoxib group the statistically significant improvement in all parameters was reported after one month of therapy but the effect persisted only as long as drug therapy continued. Three patients from BSE group and two from valdecoxib group complained of acidity. One patient from BSE group complained of diarrhea and abdominal cramps. Conclusion: BSE showed a slower onset of action but the effect persisted even after stopping therapy while the action of valdecoxib became evident faster but waned rapidly after stopping the treatment.

Estudio primario

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Revista Archives of Iranian Medicine
Año 2005
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ABSTRACT: BACKGROUND: Ginger (Zingiber officinale) extract supplementation has been shown to improve the severity of symptoms and decrease the nonsteroidal antiinflammatory drug (NSAID) requirements in patients with osteoarthritis (OA). OBJECTIVE: To assess the effects of ginger extract as an alternative to NSAIDs and as a supplement drug in the symptomatic treatment of OA. METHODS: Between April and October 2002, 120 outpatients with OA of moderate to severe pain, requiring only the use of NSAIDs, were enrolled into a double-blind, randomized, placebo- controlled clinical trial. These patients were randomized into three groups of 40, including the placebo (PL), ginger extract (GE), and ibuprofen (IBP) groups. After a washout period of one week (week 0), patients received either 30 mg ginger extract in two 500 mg capsules, placebo, or three 400 mg ibuprofen tablets daily for one month. Acetaminophen tablet was prescribed as a rescue analgesic during the study. The clinical assessments included a visual analog scale (VAS) for pain, gelling pain, joint swelling measurement, and joint motion slope measurement. Joint motion slope was measured by goniometry (normal = 130°, limited = 120°, and very limited = 110°). RESULTS: The improvement of symptoms (defined as reduction in the mean change) was superior in the ginger extract and ibuprofen groups than the placebo group. VAS scores and gelling or regressive pain after rising the scores were significantly higher in the PL group than both the GE and IBP groups, a month after the treatment (P < 0.0001). However, there was no significant difference in VAS and gelling pain scores between the ginger extract and the ibuprofen groups. CONCLUSION: Ginger extract and ibuprofen were significantly more effective than the placebo in the symptomatic treatment of OA, while there was no significant difference between the ginger extract and ibuprofen groups in a test for multiple comparison.

Estudio primario

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Revista ZeitschriftfurPhytotherapie
Año 2004
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Estudio primario

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Revista The Journal of rheumatology
Año 2004
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OBJETIVO: Investigar la eficacia y seguridad de un extracto de corteza de sauce estandarizado en pacientes con osteoartritis (OA) y artritis reumatoide (AR). MÉTODOS: Se estudiaron 127 pacientes ambulatorios con artrosis de cadera o de rodilla y una puntuación de dolor WOMAC de al menos 30 mm y 26 pacientes ambulatorios con artritis reumatoide activa en 2 aleatorizados, controlados, doble ciego, con seguimiento durante 6 semanas. Juicio OA: Los pacientes fueron aleatorizados para recibir el extracto de corteza de sauce, que corresponde a 240 mg de salicina / día, diclofenaco 100 mg / día, o placebo (n = 43, 43 y 41, respectivamente). Medida de resultado principal fue la puntuación de dolor de la artrosis índice WOMAC. RA de prueba: Los pacientes fueron aleatorizados para recibir el extracto de corteza de sauce, que corresponde a 240 mg de salicina / día (n = 13) o placebo (n = 13). Medida de resultado principal fue la evaluación del paciente del dolor evaluado en una de 100 mm escala analógica visual (VAS). RESULTADOS: La prueba OA: WOMAC dolor se redujo en 8 mm (17%) en el grupo de la corteza del sauce, y en 23 mm (47%) en el grupo de diclofenaco, en comparación con 5 mm (10%) en el grupo placebo. La diferencia entre el extracto de corteza de sauce y el placebo no fue estadísticamente significativa (-2,8 mm; IC 95%: -12,1 a 6,4 mm, p = 0,55, ANCOVA), pero la diferencia entre el diclofenac y el placebo fue altamente significativa (-18,0 mm; 95% IC -27,2 a -8,8 mm, p = 0,0002, ANCOVA). RA de prueba: La reducción media del dolor en la EVA fue de -8 mm (15%) en el grupo de corteza de sauce en comparación con -2 mm (4%) en el grupo placebo. La diferencia no fue estadísticamente significativa (diferencia estimada -0,8 mm; IC 95%: -20,9 a 19,3 mm, p = 0,93, ANCOVA). CONCLUSIÓN: El estudio de la OA sugirió que el extracto de corteza de sauce no mostró eficacia relevante en pacientes con artrosis. Del mismo modo, el juicio RA no indican la eficacia de este extracto en pacientes con AR.

Estudio primario

No clasificado

Autores Wigler I , Grotto I , Caspi D , Yaron M
Revista Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society
Año 2003
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OBJECTIVE: Evaluation of the effect of a ginger extract (Zintona EC) on patients suffering from gonarthritis. MATERIAL AND METHODS: Twenty-nine patients (6 men and 23 women) with symptomatic gonarthritis (ACR criteria), in the age range 42-85 years, were included after randomization in a double blind, placebo controlled, crossover study of 6 months' duration. The treatment group was given a ginger extract (250 mg of Zingiberis Rhizoma per capsule, qid), while the placebo group received the same number of identical looking capsules per day. The crossover occurred after 3 months of therapy. Results were evaluated by a 100mm visual analog scale (VAS) of pain on movement and of handicap. RESULTS: Eight patients dropped out because of inefficacy, three from group 1 (ginger extract first) and five from group 2 (placebo first). One patient from group 1 and one from group 2 dropped out because of heartburn (while they were on ginger extract). Twenty patients completed the study period of 24 weeks and 19 that of 48 weeks follow-up. By the end of 24 weeks there was a highly statistically significant difference between the VAS of pain and handicap of the two groups (P<0.001). However, at crossover both groups showed a statistically significant decrease in VAS of pain on movement and of handicap, but the differences between the groups did not reach statistical significance. CONCLUSIONS: Zintona EC was as effective as placebo during the first 3 months of the study, but at the end of 6 months, 3 months after crossover, the ginger extract group showed a significant superiority over the placebo group.