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Efficacy and safety of combination of curcuminoid complex and diclofenac versus diclofenac in knee osteoarthritis: A randomized trial.
Shep, D, Khanwelkar, C, Gade, P, Karad, S
Medicine. 2020;(16):e19723
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Abstract
BACKGROUND To compare the efficacy and safety of combination of curcuminoid complex and diclofenac vs diclofenac alone in the treatment of knee osteoarthritis (OA). METHODS In this randomized trial, 140 patients of knee OA received either curcuminoid complex 500 mg (BCM-95) with diclofenac 50 mg 2 times daily or diclofenac 50 mg alone 2 times daily for 28 days. Patients were assessed at baseline, day 14 and day 28. Primary efficacy measures were Knee injury and OA outcome score (KOOS) subscale at day 14 and day 28. Anti-ulcer effect and patient-physician's global assessment of therapy at day 28 were included as secondary endpoints. Safety after treatment was evaluated by recording adverse events and laboratory investigations. RESULTS Both treatment groups showed improvement in primary endpoints at each evaluation visit. Patients receiving curcuminoid complex plus diclofenac showed significantly superior improvement in KOOS subscales, viz. pain and quality of life at each study visit (P < .001) when compared to diclofenac. Less number of patients required rescue analgesics in curcuminoid complex plus diclofenac group (3%) compared to diclofenac group (17%). The number of patients who required histamine 2 (H2) blockers was significantly less in curcuminoid complex plus diclofenac group compared to diclofenac group (6% vs 28%, respectively; P < .001). Adverse effects were significantly less in curcuminoid complex plus diclofenac group (13% vs 38% in diclofenac group; P < .001). Patient's and physician's global assessment of therapy favored curcuminoid complex plus diclofenac than diclofenac. CONCLUSION Combination of curcuminoid complex and diclofenac showed a greater improvement in pain and functional capacity with better tolerability and could be a better alternative treatment option in symptomatic management of knee OA. TRIAL REGISTRATION ISRCTN, ISRCTN10074826.
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Needle knife therapy plus sodium hyaluronate injection for knee osteoarthritis: A protocol for a systematic review and meta-analysis.
Xie, K, Pan, X, Huang, F, Ma, Y, Qi, Y, Wu, J, Ma, Z, Li, X, Liang, H, Wang, S, et al
Medicine. 2020;(46):e23242
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BACKGROUND Knee osteoarthritis (KOA) is a worldwide disease and more and more people are suffered from it. With the increasing number of patients, it brings a huge burden on social economy and security system. There are varieties of methods to cure KOA, such as Traditional Chinese Medicine and surgery. Needle knife therapy plus Sodium hyaluronate Injection is one of the prevalent treatments for KOA. Therefore, we perform a systematic review and meta-analysis to evaluate the evidence for the treatment of needle knife therapy plus sodium hyaluronate Injection. METHODS Randomized controlled trials will be used to compare the effect of needle knife therapy plus sodium hyaluronate injection with needle knife alone for KOA patients. Six studies will be included in this meta-analysis, and the relative risk and weight mean difference with 95% CI for the Lysholm knee score, visual analogue scale, and effective rate will be evaluated by using RevMan 5.3 software. Besides, the bias assessment of the included studies will be evaluated using the Cochrane risk of bias tool, and the Grading of Recommendations, Assessment Development, and Evaluation system will be applied to assess the overall quality of the evidence. RESULTS From the study we will assess the effectiveness, safety of needle knife therapy plus sodium hyaluronate injection on joint pain relief and functional improvement in patients with KOA. CONCLUSION The study will provide a new evidence to confirm the effect of needle knife therapy plus sodium hyaluronate injection on KOA, which can further guide the selection of therapy. PROSPERO REGISTRATION NUMBER CRD42020169602.
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Herbal formulation "turmeric extract, black pepper, and ginger" versus Naproxen for chronic knee osteoarthritis: A randomized, double-blind, controlled clinical trial.
Heidari-Beni, M, Moravejolahkami, AR, Gorgian, P, Askari, G, Tarrahi, MJ, Bahreini-Esfahani, N
Phytotherapy research : PTR. 2020;(8):2067-2073
Abstract
Osteoarthritis is the most common articular disease that can lead to chronic pain and severe disability. Curcumin-an effective ingredient in turmeric with anti inflammatory property-plays an important role in protecting the joints against destructive factors. Gingerols and piperine, are the effective ingredients of ginger and black pepper, which may potentially enhance and sustain the effect of curcumin in this direction. To determine the effect of cosupplementation with turmeric extract, black pepper, and ginger on prostaglandin E2 (PGE2 ) in patients with chronic knee osteoarthritis, compared with Naproxen. Sixty patients with two different levels of knee osteoarthritis (Grade 2 and 3) were studied. Individuals were randomly assigned to receive daily turmeric extract, ginger, and black pepper together or Naproxen capsule for 4 weeks. PGE2 was evaluated by ELISA method. 24-hr recall was also assessed. All of participants completed the study. PGE2 decreased significantly in both groups (p < .001), but there was no significant differences between groups. The results of this study indicated that intake of the selected herbs twice a day for 4 weeks may improve the PGE2 levels in patients with chronic knee osteoarthritis similar to Naproxen drug.
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Effect of an oral preparation containing hyaluronic acid, chondroitin sulfate, hydrolyzed collagen type II and hydrolyzed keratin on synovial fluid features and clinical indices in knee osteoarthritis. A pilot study.
Oliviero, F, Ramonda, R, Hoxha, A, Scanu, A, Galozzi, P, Favero, M, Frallonardo, P, Punzi, L
Reumatismo. 2020;(3):125-130
Abstract
The aim of this study was to evaluate the effect of an oral preparation containing a naturally occurring matrix of hydrolyzed collagen type II, chondroitin sulfate (CS), and hyaluronic acid (HA), and bioactive oligopeptides of natural hydrolyzed keratin (K) in patients affected by knee OA through the evaluation of synovial fluid (SF) and clinical changes before and after treatment. Thirty patients with knee OA and swollen joint were included in the study and submitted to arthrocentesis. Patients were randomized in two groups: 1) the treatment group (N.15) took a dietary supplement containing 120 mg HA, 240 mg CS and 300 mg K once a day for 4 weeks; 2) the control group (N.15) was only submitted to arthrocentesis. Patient symptoms were evaluated at the beginning and at the end of the study by the WOMAC self-assessment questionnaire, the Lequesne algofunctional index, and the VAS forms. SF changes were evaluated by measuring local inflammatory indices, cytokines IL-1β, IL-8, IL-6, IL-10 and GM-CSF. The group of patients treated with the oral supplement showed an improvement in the clinical indices WOMAC (p<0.01), Lequesne (p=0.014) and VAS pain (p<0.01). On the contrary, no significant changes were found in the control group. The SF collected from the treated group showed a reduction of IL-8 (p=0.015), IL-6 and IL-10 levels, while no changes in cytokines were observed in the control group. This pilot study suggests that an oral administration of a preparation containing a combination of HA, CS and K can improve some clinical parameters and affect cytokine concentrations in SF in patients with knee OA.
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Low-dose strength training in addition to neuromuscular exercise and education in patients with knee osteoarthritis in secondary care - a randomized controlled trial.
Holm, PM, Schrøder, HM, Wernbom, M, Skou, ST
Osteoarthritis and cartilage. 2020;(6):744-754
Abstract
OBJECTIVES To investigate the effects of lower limb strength training in addition to neuromuscular exercise and education (ST + NEMEX-EDU) compared to neuromuscular exercise and education alone (NEMEX-EDU) on self-reported physical function in patients with knee osteoarthritis (KOA). DESIGN Patient-blinded, parallel-group randomized controlled trial (RCT). METHODS The trial included 90 patients in secondary care with radiographic and symptomatic KOA, ineligible for knee replacement. Both groups exercised twice weekly for 12 weeks. Additional strength training consisted of a single, fatiguing knee extension set (30-60RM) before four sets of leg-press (8-12RM). Primary outcome was the between-group difference on the subscale activities of daily living from the Knee Injury and Osteoarthritis Outcome Score (KOOSADL) at 12 weeks. Secondary outcomes included KOOS symptoms, pain, function in sport and recreation, and quality of life, 40 m walk, stair climb, leg extension power, EuroQol-5D-5L, pain medication usage, and adverse events. RESULTS There was no statistically significant between-group difference in KOOSADL at 12-weeks; adjusted mean difference -1.15 (-6.78 to 4.48). Except for the stair climb test, which demonstrated an adjusted mean difference of 1.15 (0.09-2.21) in favor of ST + NEMEX-EDU, all other outcomes showed no statistically significant between-group differences. Neither group improved leg extension power. CONCLUSION The addition of lower-limb strength training, using a low-dose approach, to neuromuscular exercise and education carried no additional benefits on self-reported physical function or on most secondary outcomes. Both groups displayed similar improvements at 12-week follow-up. Hence, the current low-dose strength training approach provided no additional clinical value in this group of KOA patients. Trial identifier (ClinicalTrials.gov): NCT03215602.
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The efficacy of topical red clover oil on knee osteoarthritis: A pilot prospective randomized triple-blind placebo-controlled clinical trial.
Mokhtari, M, Yousefi, M, Bazaz, MM, Rakhshandeh, H, Vahid, H, Ariamanesh, AS
Phytotherapy research : PTR. 2020;(7):1687-1695
Abstract
A triple-blind placebo-controlled clinical trial was performed to evaluate the efficacy of topical red clover oil (containing standardized red clover extract in olive oil) on knee osteoarthritis (OA). A total of 80 patients, 50-80 years old, with primary knee OA were randomly allocated to two groups. The study group used topical red clover oil and the control group used olive oil for 4 weeks (20 drops twice a day). Both groups adhered to nonpharmacological American College of Rheumatology recommendations and took meloxicam tablets during the study (0-8 weeks), and were followed up from Week 4 to 8. Efficacy measures were evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale and Visual Analogue Scale (VAS). At baseline, both groups were homogeneous regarding demographic characteristics. In addition, they were asked about the side effects during the intervention. The results showed that the WOMAC score and its subscales of pain and stiffness and function scores and VAS significantly increased over time in both groups (p < .001). The study group showed a significant increase regarding pain (p = .001), function (p = .010), VAS (p < .001), and the WOMAC total score (p = .018). No serious drug side effects were observed. Red clover oil may have positive effects on symptoms of knee OA and can be considered as a complementary treatment.
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Mineral rich algae with pine bark improved pain, physical function and analgesic use in mild-knee joint osteoarthritis, compared to Glucosamine: A randomized controlled pilot trial.
Heffernan, SM, McCarthy, C, Eustace, S, FitzPatrick, RE, Delahunt, E, De Vito, G
Complementary therapies in medicine. 2020;:102349
Abstract
INTRODUCTION Osteoarthritis (OA) is characterised by synovial joint pain, functional disability and affects ∼13 % of people worldwide, of which ∼16-27 % report Knee-OA (KOA). Glucosamine (Glu) is the most widely used nutraceutical treatment for OA despite a lack of scientific consensus, therefore alternative nutraceutical treatments are required. The aim of this study was to investigate the effect of Lithothamnion species, seawater-derived magnesium and pine bark (Aq+) on pain, symptoms and improve physical function in symptomatic (sKOA), compared to Glu. METHODS 358 participants were screened. In a double-blinded crossover pilot-trial, sKOA participant (n = 30) were randomly assigned to either the Glu group (2000 mg day-1) or Aq+ (3056 mg day-1) for 12 weeks (clinicaltrials.gov:NCT03106584). The Knee Injury and Osteoarthritis Outcome Score was used to assess subjective pain and symptoms. Timed-up-and-Go (TuG) and Six minute walking distance were used to assess functional change and analgesic use was recorded. RESULTS Aq+ improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06). Only Aq+ improved pain (P < 0.05) for males (d' = 0.91, 95 %CI 0.162-1.667) and females (d' = 0.55, 95 %CI 0.210-1.299). In females, Aq+ improved TuG by -7.02 % (d' = 0.92, 95 %CI 1.699-0.141) while Glu worsened performance by 4.18 % (P = 0.04). Aq+ reduced analgesia by 71.6 %, compared to Glu (P = 0.02; d' = 0.82, 95 %CI 1.524-0.123). Aq+ was superior to Glu at improving pain, KOOS subscales, physical function and analgesia use in mild-sKOA. Given these data, Aq+ should be considered as a supplementary treatment for early-stage-KOA and may have the potential to reduce use of pain medication, although larger replication studies are required.
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Alternative and complementary therapies in osteoarthritis and cartilage repair.
Fuggle, NR, Cooper, C, Oreffo, ROC, Price, AJ, Kaux, JF, Maheu, E, Cutolo, M, Honvo, G, Conaghan, PG, Berenbaum, F, et al
Aging clinical and experimental research. 2020;(4):547-560
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Osteoarthritis (OA) is the most common joint condition and, with a burgeoning ageing population, is due to increase in prevalence. Beyond conventional medical and surgical interventions, there are an increasing number of 'alternative' therapies. These alternative therapies may have a limited evidence base and, for this reason, are often only afforded brief reference (or completely excluded) from current OA guidelines. Thus, the aim of this review was to synthesize the current evidence regarding autologous chondrocyte implantation (ACI), mesenchymal stem cell (MSC) therapy, platelet-rich plasma (PRP), vitamin D and other alternative therapies. The majority of studies were in knee OA or chondral defects. Matrix-assisted ACI has demonstrated exceedingly limited, symptomatic improvements in the treatment of cartilage defects of the knee and is not supported for the treatment of knee OA. There is some evidence to suggest symptomatic improvement with MSC injection in knee OA, with the suggestion of minimal structural improvement demonstrated on MRI and there are positive signals that PRP may also lead to symptomatic improvement, though variation in preparation makes inter-study comparison difficult. There is variability in findings with vitamin D supplementation in OA, and the only recommendation which can be made, at this time, is for replacement when vitamin D is deplete. Other alternative therapies reviewed have some evidence (though from small, poor-quality studies) to support improvement in symptoms and again there is often a wide variation in dosage and regimens. For all these therapeutic modalities, although controlled studies have been undertaken to evaluate effectiveness in OA, these have often been of small size, limited statistical power, uncertain blindness and using various methodologies. These deficiencies must leave the question as to whether they have been validated as effective therapies in OA (or chondral defects). The conclusions of this review are that all alternative interventions definitely require clinical trials with robust methodology, to assess their efficacy and safety in the treatment of OA beyond contextual and placebo effects.
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Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial.
Zhuang, Q, Tao, L, Lin, J, Jin, J, Qian, W, Bian, Y, Li, Y, Dong, Y, Peng, H, Li, Y, et al
BMJ open. 2020;(1):e030501
Abstract
OBJECTIVES To evaluate the morphine-sparing effects of the sequential treatment versus placebo in subjects undergoing total knee arthroplasty (TKA), the effects on pain relief, inflammation control and functional rehabilitation after TKA and safety. DESIGN Double-blind, pragmatic, randomised, placebo-controlled trial. SETTING Four tertiary hospitals in China. PARTICIPANTS 246 consecutive patients who underwent elective unilateral TKA because of osteoarthritis (OA). INTERVENTIONS Patients were randomised 1:1 to the parecoxib/celecoxib group or the control group. The patients in the parecoxib/celecoxib group were supplied sequential treatment with intravenous parecoxib 40 mg (every 12 hours) for the first 3 days after surgery, followed by oral celecoxib 200 mg (every 12 hours) for up to 6 weeks. The patients in the control group were supplied with the corresponding placebo under the same instructions. PRIMARY AND SECONDARY OUTCOME MEASURES The primary endpoint was the cumulative opioid consumption at 2 weeks post operation (intention-to-treat analysis). Secondary endpoints included the Knee Society Score, patient-reported outcomes and the cumulative opioid consumption. RESULTS The cumulative opioid consumption at 2 weeks was significantly smaller in the parecoxib/celecoxib group than in the control group (median difference, 57.31 (95% CI 34.66 to 110.33)). The parecoxib/celecoxib group achieving superior Knee Society Scores and EQ-5D scores and greater Visual Analogue Scale score reduction during 6 weeks. Interleukin 6, erythrocyte sedation rate and C-reactive protein levels were reduced at 72 hours, 2 weeks and 4 weeks and prostaglandin E2 levels were reduced at 48 hours and 72 hours in the parecoxib/celecoxib group compared with the placebo group. The occurrence of adverse events (AEs) was significantly lower in the parecoxib/celecoxib group. CONCLUSIONS The sequential intravenous parecoxib followed by oral celecoxib regimen reduces morphine consumption, achieves better pain control and functional recovery and leads to less AEs than placebo after TKA for OA. TRIAL REGISTRATION NUMBER ClinicalTrials.gov (ID: NCT02198924).
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Patient-specific reference values for objective physical function tests: data from the Osteoarthritis Initiative.
Harkey, MS, Price, LL, Reid, KF, Lo, GH, Liu, SH, Lapane, KL, Dantas, LO, McAlindon, TE, Driban, JB
Clinical rheumatology. 2020;(6):1961-1970
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INTRODUCTION/OBJECTIVE We aimed to establish sex-specific reference values of objective physical function tests among individuals with or at risk for knee osteoarthritis (KOA) across subsets of age, radiographic KOA severity, and body mass index (BMI). METHOD We included Osteoarthritis Initiative participants with data for objective physical function tests, sex, age, BMI, and radiographic KOA severity (Kellgren-Lawrence [KL] grade) at baseline. Objective physical function was quantified with 20-m walk speed, chair-stand speed, 400-m walk time, and knee extension and flexion strength. We created participant characteristic subsets for sex, age, KL grade, and BMI. Reference values were created as percentiles from minimum to maximum in 10% increments for each combination of participant characteristic subsets. Previously established clinically important differences for 20-m walk speed and knee extension strength were used to highlight clinically relevant differences. RESULTS Objective physical function reference values tables and an interactive reference value table were created across all combinations of sex, age, KL grade, and BMI among 3860 individuals with or at risk for KOA. Clinically relevant differences exist for 20-m walk speed and knee extension strength between males and females across age groups, KL grades, and BMI categories. CONCLUSIONS Establishing an individual's relative level of objective physical function by comparing their performance to individuals with similar sex, age, KL grade, or BMI may help improve interpretation of physical function performance. The interactive reference value table will provide clinicians and researchers a clinically accessible avenue to use these reference values.Key Points• Since greater age, radiographic knee osteoarthritis severity, and body mass index are all associated with worse objective physical function, reference values should consider the complex inter-play among these patient characteristics.• This study provides objective physical function reference values among subsets of individuals across the spectrum of sex, age groups, radiographic knee osteoarthritis severity, and body mass index categories.• These reference values offer a more patient-centered approach for interpreting an individual's relative level of objective physical function by comparing them to a more homogeneous group of individuals with similar participant characteristics.• We have provided a clinically accessible interactive table that will enable clinicians and researchers to input their patient's data to quickly and efficiently determine a patient's relative objective physical function compared to individual's with similar characteristics.