Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial

Background: The aim of this study will be to investigate the therapeutic effect and safety of non-steroidal anti-inflammatory drugs (NSAIDs) along with symptomatic slow-acting drugs for the treatment of osteoarthritis (SYSADOA), JOINS tablets, for degenerative knee osteoarthritis (OA) treatment and to determine the analgesic and anti-inflammatory effects of the combination therapy. In addition, we will investigate whether JOINS treatment alone after NSAID and JOINS combination treatment is effective in relieving and maintaining knee OA symptoms. Methods: This study will be a prospective, randomized, double-blind endpoint study design. All patients will be randomly assigned to either intervention (celecoxib+JOINS) or control (celecoxib+placebo) groups. In Part 1, the intervention group will be administered celecoxib once a day and JOINS three times a day for a total of 12 weeks. In the control group, celecoxib will be administered once a day and JOINS placebo three times a day for a total of 12 weeks. In Part 2, JOINS alone and JOINS placebo alone will be administered for an additional 24 weeks in both groups, respectively. The primary endpoint will be the amount of change during the 12 weeks as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index total score compared with baseline. The secondary endpoint will be the amount of change at 1, 4, 12, 24, and 36 weeks from the baseline for pain visual analog scale, Brief Pain Inventory, Short Form Health Survey-36 and biomarkers. Results: The trial was registered with Clinical-Trials.gov (NCT04718649). The clinical trial was also registered on Clinical Research Information Service (CRIS) with the trial registration number KCT0005742. Conclusions: The combination treatment of the most commonly used SYSADOA drug, JOINS, and selective COX-2 inhibitor celecoxib as the representative NSAID for knee OA treatment, can be compared with celecoxib alone treatment to determine the safety or therapeutic effect.

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Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017652 ◽

2017 ◽

Vol 7 (9) ◽

pp. e017652 ◽

Cited By ~ 4

Author(s):

Christelle Nguyen ◽

Isabelle Boutron ◽

Gabriel Baron ◽

Emmanuel Coudeyre ◽

Francis Berenbaum ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Knee Pain ◽

Rating Scale ◽

Controlled Trial ◽

Tertiary Care ◽

Double Blind ◽

Double Blind Placebo ◽

Knee Oa ◽

The Mean ◽

Anti Inflammatory

IntroductionOsteoarthritis (OA) pathophysiology is driven in part by joint inflammation. Resveratrol has in vitro anti-inflammatory properties. We aim to assess the efficacy of oral resveratrol for knee pain at 3 months in people with knee OA.Methods and analysisWe will conduct a randomised double-blind placebo-controlled trial. Overall, 164 individuals with knee OA fulfilling 1986 American College of Rheumatology criteria will be recruited in three tertiary care centres in France and randomised to receive oral resveratrol, 40 mg (two caplets) two times per day for 1 week, then 20 mg (one caplet) two times per day or a matching placebo for a total of 6 months. Randomisation will be centralised and stratified by centre. The allocation ratio of assignments will be 1:1. The primary outcome will be the mean change from baseline in knee pain on a self-administered 11-point pain Numeric Rating Scale at 3 months. Secondary outcomes will be the mean change in knee pain at 6 months, the function subscore of the Western Ontario and McMaster Universities Arthritis Index score, patient global assessment, proportion of responders according to the Osteoarthritis Research Society International–Outcome Measures in Rheumatology criteria at 3 and 6 months, and self-reported number of intra-articular injections of corticosteroids or hyaluronic acid and consumption of analgesics and non-steroidal anti-inflammatory drugs since the last contact. Other interventions will be allowed and self-reported. Adherence will be monitored by capsule counts and a booklet and adverse events recorded at 3 and 6 months. Statisticians, treating physicians and participants will be blinded to the allocated treatment.Ethics and disseminationThe oral resveratrol in knee osteoarthritis (ARTHROL) trial has been authorised by theAgenceNationale de Sécurité du Médicament et des Produits de Santéand ethics were approved by theComité deProtection des Personnes Île-de-FranceIII. The findings of the study will be published in a peer-reviewed journal and disseminated at conferences. The design of ARTHROL will warrant the translation of its findings into clinical practice.Trial registration numberClinicalTrials.gov identifier:NCT02905799. Pre-results. First received: 14 September 2016. Last updated: 16 September 2016. Status: not yet recruiting.

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Evaluating the efficacy of Internet-Based Exercise programme Aimed at Treating knee Osteoarthritis (iBEAT-OA) in the community: a study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-030564 ◽

2019 ◽

Vol 9 (10) ◽

pp. e030564

Author(s):

Sameer Akram Gohir ◽

Paul Greenhaff ◽

Abhishek Abhishek ◽

Ana M. Valdes

Keyword(s):

Randomised Controlled Trial ◽

Knee Osteoarthritis ◽

Rating Scale ◽

Controlled Trial ◽

Maximum Voluntary Contraction ◽

Intervention Group ◽

Exercise Programme ◽

Control Group ◽

Knee Oa ◽

Randomised Controlled

IntroductionKnee osteoarthritis (OA) is the most common joint disease worldwide. As of today, there are no disease-modifying drugs, but there is evidence that muscle strengthening exercises can substantially reduce pain and improve function in this disorder, and one very well tested physiotherapy protocol is the ‘Better Management of Patients with Osteoarthritis’ developed in Sweden. Given the high prevalence of knee OA, a potentially cost-effective, digitally delivered approach to treat knee OA should be trialled. This study aims to explore the benefits of iBEAT-OA (Internet-Based Exercise programme Aimed at Treating knee Osteoarthritis) in modulating pain, function and other health-related outcomes in individuals with knee OA.Methods and analysisA randomised controlled trial was designed to evaluate the efficacy of a web-based exercise programme in a population with knee OA compared with standard community care provided by general practitioners (GPs) in the UK. We anticipate recruiting participants into equal groups. The intervention group (n=67) will exercise for 20–30 min daily for six consecutive weeks, whereas the control group (n=67) will follow GP-recommended routine care. The participants will be assessed using a Numerical Rating Scale, the Western Ontario and McMaster Universities Osteoarthritis Index, the Arthritis Research UK Musculoskeletal Health Questionnaire, the Pittsburgh Sleep Quality Index, 30 s sit to stand test, timed up and go test, quantitative sensory testing, musculoskeletal ultrasound scan, muscle thickness assessment of the vastus lateralis, and quadriceps muscles force generation during an isokinetic maximum voluntary contraction (MVC). Samples of urine, blood, faeces and synovial fluid will be collected to establish biomarkers associated with changes in pain and sleep patterns in individuals affected with knee OA. Standard parametric regression methods will be used for statistical analysis.Ethics and disseminationEthical approval was obtained from the Research Ethics Committee (ref: 18/EM/0154) and the Health Research Authority (protocol no: 18021). The study was registered in June 2018. The results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03545048

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The effectiveness of Kinesio Taping® for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial

Clinical Rehabilitation ◽

10.1177/0269215520916859 ◽

2020 ◽

Vol 34 (7) ◽

pp. 877-889 ◽

Cited By ~ 1

Author(s):

Venta Donec ◽

Raimondas Kubilius

Keyword(s):

Knee Osteoarthritis ◽

Controlled Trial ◽

Intervention Group ◽

Outpatient Rehabilitation ◽

Control Group ◽

Double Blind ◽

Kinesio Taping ◽

Patient Reported ◽

Double Blinded

Objective: To evaluate the effectiveness of the Kinesio Taping® method for mobility and functioning improvement for patients with knee osteoarthritis (KO). Design: Randomized, double-blinded, controlled trial. Setting: Outpatient rehabilitation department. Subjects: A total of 187 subjects with symptomatic I–III grade KO participated; of these, 157 subjects were included in the analyses (intervention group, n = 81 (123 knees); control group, n = 76 (114 knees). Intervention: The intervention group received a specific Kinesio Taping application, and the control group received non-specific knee taping for a month. Main measures: Changes in Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST) were assessed at baseline, after four weeks of taping, and a month post taping intervention. Subjective participants’ experiences and opinions on the effect of knee taping were evaluated. The chosen level of significance was p < 0.05. Results: The mean age of participants was 68.7 ± 9.9 in intervention group and 70.6 ± 8.3 in control group ( p > 0.05). The change from baseline in gait speed in the intervention group after taping month was +0.04 ± 0.1 m/s, at follow-up +0.06 ± 0.1 m/s; in control group +0.07 ± 0.1 m/s, and +0.09 ± 0.1 m/s; the change in time needed to accomplish 5xSST was –2.2 ± 3.2 seconds, at follow-up –2.4 ± 3.1 seconds; in control group –2.8 ± 3.6 seconds, and –2.4 ± 4 seconds. Improved knee flexion and enhancement in functioning assessed by KOOS were noticed in both groups, with lasting improvement to follow up. No difference in the change in the above-mentioned outcomes was found between groups ( p > 0.05). Fewer subjects (6.2% (5) vs. 21.1% (16), χ2 = 7.5, df = 2, p = 0.024) from Kinesio Taping group were unsure if taping alleviated their mobility and more intervention group patients indicated higher subjective satisfaction with the effect of knee taping to symptom and mobility alleviation than control group ( p < 0.005). Conclusion: Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.

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Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-3772-y ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Hailong Zhang ◽

Jiansheng Li ◽

Xueqing Yu ◽

Suyun Li ◽

Haifeng Wang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Chinese Medicine ◽

Short Form ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Randomized Controlled ◽

Patient Reported ◽

Acute Exacerbations

Abstract Background The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high in China. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, rates of hospitalization and readmission, and disease progression. AECOPD have been effectively treated with Chinese medicine for a long time. The aim of this proposed trial is to assess the therapeutic effect of Chinese medicine (CM) on AECOPD. Methods/design This proposed study is a multicenter, double-blind, parallel-group randomized controlled trial (RCT). We will randomly assign 378 participants with AECOPD into two groups in a 1:1 ratio. On the basis of health education and conventional treatment, the intervention group will be treated with CM, and the control group is given CM placebo according to CM syndrome. Patients are randomized to either receive CM or placebo, 10 g/packet, twice daily. The double-blind treatment lasts for 2 weeks and is followed up for 4 weeks. The main outcome is the COPD Assessment Test; secondary outcomes are treatment failure rate, treatment success rate, length of hospital stay, AECOPD readmission rate, intubation rate, mortality, dyspnea, the 36-item Short Form Health Survey, and the COPD patient-reported outcome scale. We will document these outcomes faithfully at the beginning of the study, 2 weeks after treatment, and at the 4 weeks follow-up. Discussion This high-quality RCT with strict methodology and few design deficits will help to prove the effectiveness of CM for AECOPD. We hope this trial will provide useful evidence for developing a therapeutic schedule with CM for patients with AECOPD. Trial registration ClinicalTrials.gov, NCT03428412. Registered on 4 February 2018.

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The Effect of Nanocurcumin in Improvement of Knee Osteoarthritis: A Randomized Clinical Trial

Current Rheumatology Reviews ◽

10.2174/1874471013666191223152658 ◽

2020 ◽

Vol 16 (2) ◽

pp. 158-164

Author(s):

Kamila Hashemzadeh ◽

Najmeh Davoudian ◽

Mahmoud R. Jaafari ◽

Zahra Mirfeizi

Keyword(s):

Placebo Group ◽

Knee Osteoarthritis ◽

Controlled Trial ◽

Intervention Group ◽

Final Analysis ◽

Control Group ◽

P Value ◽

Antiinflammatory Drugs ◽

Double Blind ◽

Womac Questionnaire

Objective: Osteoarthritis is a degenerative disease of the joints. Non-steroidal antiinflammatory drugs (NSAIDs) are being used for the treatment of osteoarthritis. However, their use is limited due to complications, such as gastrointestinal bleeding. Therefore, it is necessary to find alternative treatments for osteoarthritis. Recently, nanomicelle curcumin has been developed to increase the oral bioavailability of curcumin. The aim of this study was to evaluate the effect of nano curcumin on the alleviation of the symptoms of knee osteoarthritis patients. Methods: In this randomized, double-blind controlled trial, the intervention group was administered 40 mg of nanocurcumin capsule every 12 hours over a period of six weeks, and the control group received the placebo (similar components of nanomicelle curcumin capsules yet without curcumin). In the final analysis, 36 patients in the nanocurcumin group and 35 patients in the placebo group were enrolled. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was filled for patients in their first visit and at the end of six weeks. Differences were statistically significant at P-value < 0.05. Results: There were no significant differences between the two groups regarding gender, age, Kellgren score, and the duration of the disease before the intervention. A significant decrease was observed in the overall score, along with the scores of pain, stiffness and physical activity subscales of the WOMAC questionnaire in patients of the nano curcumin group compared with the placebo group. Conclusion: Nanocurcumin significantly improves the symptoms of osteoarthritis patients.

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Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

BMJ Open ◽

10.1136/bmjopen-2018-024065 ◽

2019 ◽

Vol 9 (5) ◽

pp. e024065 ◽

Cited By ~ 1

Author(s):

Henrik Gudbergsen ◽

Marius Henriksen ◽

Eva Ejlersen Wæhrens ◽

Anders Overgaard ◽

Henning Bliddal ◽

...

Keyword(s):

Weight Loss ◽

Body Weight ◽

Knee Osteoarthritis ◽

Controlled Trial ◽

Single Centre ◽

Double Blind ◽

Double Blind Placebo ◽

Knee Oa ◽

Parallel Group ◽

Pain Subscale

IntroductionWith an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.Methods and analysis150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week −8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.Ethics and disseminationThe trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numbers2015-005163-16,NCT02905864, U1111-1171-4970Based on protocol versionV.6; 30 January 2017, 15:30 hours

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Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

European Respiratory Journal ◽

10.1183/13993003.00752-2021 ◽

2021 ◽

pp. 2100752

Author(s):

Pradeesh Sivapalan ◽

Charlotte Suppli Ulrik ◽

Therese Sophie Lapperre ◽

Rasmus Dahlin Bojesen ◽

Josefin Eklöf ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Safety Outcome ◽

Hospitalised Patients ◽

Double Blinded ◽

Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

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Cryotherapy associated with tailored land-based exercises for knee osteoarthritis: a protocol for a double-blind sham-controlled randomised trial

BMJ Open ◽

10.1136/bmjopen-2019-035610 ◽

2020 ◽

Vol 10 (6) ◽

pp. e035610 ◽

Cited By ~ 1

Author(s):

Lucas Ogura Dantas ◽

Ana Elisa Serafim Jorge ◽

Paula Regina Mendes da Silva Serrão ◽

Francisco Aburquerque-Sendín ◽

Tania de Fatima Salvini

Keyword(s):

Knee Osteoarthritis ◽

Short Form ◽

Randomised Trial ◽

Unmet Need ◽

Residual Effects ◽

Control Group ◽

Therapeutic Exercise ◽

Exercise Protocol ◽

Double Blind ◽

Intention To Treat

IntroductionThere is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA). Cryotherapy is widely used in rehabilitation as an adjunct treatment due to its effects on pain and the inflammatory process. However, disagreement between KOA guidelines remains with respect to its recommendation status. The aim of this study is to verify the complementary effects of cryotherapy when associated with a tailored therapeutic exercise protocol for patients with KOA.Methods and analysisThis study is a sham-controlled randomised trial with concealed allocation and intention-to-treat analysis. Assessments will be performed at baseline and immediately following the intervention period. To check for residual effects of the applied interventions, 3-month and 6-month follow-up assessments will be performed. Participants will be community members living with KOA divided into three groups: (1) the experimental group that will receive a tailored therapeutic exercise protocol followed by a cryotherapy session of 20 min; (2) the sham control group that will receive the same regimen as the first group, but with sham packs filled with dry sand and (3) the active treatment control group that will receive only the therapeutic exercise protocol. The primary outcome will be pain intensity according to a Visual Analogue Scale. Secondary outcomes will be the Western Ontario & McMaster Universities Osteoarthritis Index; the Short-Form Health Survey 36; the 30-s Chair Stand Test; the Stair Climb test; and the 40-m fast-paced walk test.Ethics and disseminationThe trial was approved by the Institutional Ethics Committee of Federal University of São Carlos, São Paulo, Brazil. Registration approval number: CAAE: 65966617.9.0000.5504. The results will be published in peer-reviewed journals.Trial registration numberNCT03360500

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Effect of Oral Ingestion of Low-Molecular Collagen Peptides Derived from Skate (Raja Kenojei) Skin on Body Fat in Overweight Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Marine Drugs ◽

10.3390/md17030157 ◽

2019 ◽

Vol 17 (3) ◽

pp. 157 ◽

Cited By ~ 6

Author(s):

Young Tak ◽

Yun Kim ◽

Jeong Lee ◽

Yu-Hyun Yi ◽

Young Cho ◽

...

Keyword(s):

Body Fat ◽

Animal Studies ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Collagen Peptides ◽

Collagen Peptide ◽

Skin Collagen ◽

Overweight Adults

Recent animal studies found the potential of a collagen peptide derived from skate skin to have anti-obesity effects through the suppression of fat accumulation and regulation of lipid metabolism. However, no studies have yet been performed in humans. Here, this very first human randomized, placebo-controlled, and double-blinded study was designed to investigate the efficacy and tolerability of skate skin collagen peptides (SCP) for the reduction of body fat in overweight adults. Ninety healthy volunteers (17 men) aged 41.2 ± 10.4 years with a mean body mass index of 25.6 ± 1.9 kg/m2 were assigned to the intervention group (IG), which received 2000 mg of SCP per day or to the control group (CG) given the placebo for 12 weeks and 81 (90%) participants completed the study. Changes in body fat were evaluated using dual energy X-ray absorptiometry as a primary efficacy endpoint. After 12 weeks of the trial, the percentage of body fat and body fat mass (kg) in IG were found to be significantly better than those of subjects in CG (−1.2% vs. 2.7%, p = 0.024 and −1.2 kg vs. 0.3 kg, p = 0.025). Application of SCP was well tolerated and no notable adverse effect was reported from both groups. These results suggest the beneficial potential of SCP in the reduction of body fat in overweight adults.

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Pharmaceutical-grade Chondroitin sulfate is as effective as celecoxib and superior to placebo in symptomatic knee osteoarthritis: the ChONdroitin versus CElecoxib versus Placebo Trial (CONCEPT)

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2016-210860 ◽

2017 ◽

Vol 76 (9) ◽

pp. 1537-1543 ◽

Cited By ~ 39

Author(s):

Jean-Yves Reginster ◽

Jean Dudler ◽

Tomasz Blicharski ◽

Karel Pavelka

Keyword(s):

Placebo Group ◽

Knee Osteoarthritis ◽

Chondroitin Sulfate ◽

Controlled Trial ◽

European Medicines Agency ◽

Double Blind ◽

Knee Oa ◽

Symptomatic Knee Osteoarthritis ◽

Symptomatic Knee ◽

Secondary Endpoints

ObjectivesChondroitin sulfate 800 mg/day (CS) pharmaceutical-grade in the management of symptomatic knee osteoarthritis consistent with the European Medicines Agency guideline.MethodsA prospective, randomised, 6-month, 3-arm, double-blind, double-dummy, placebo and celecoxib (200 mg/day)-controlled trial assessing changes in pain on a Visual Analogue Scale (VAS) and in the Lequesne Index (LI) as coprimary endpoints. Minimal-Clinically Important Improvement (MCII), Patient-Acceptable Symptoms State (PASS) were used as secondary endpoints.Results604 patients (knee osteoarthritis) diagnosed according to American College of Rheumalogy (ACR) criteria, recruited in five European countries and followed for 182 days. CS and celecoxib showed a greater significant reduction in pain and LI than placebo. In the intention-to-treat (ITT) population, pain reduction in VAS at day 182 in the CS group (−42.6 mm) and in celecoxib group (−39.5 mm) was significantly greater than the placebo group (−33.3 mm) (p=0.001 for CS and p=0.009 for celecoxib), while no difference observed between CS and celecoxib. Similar trend for the LI, as reduction in this metric in the CS group (−4.7) and celecoxib group (−4.6) was significantly greater than the placebo group (−3.7) (p=0.023 for CS and p=0.015 for celecoxib), no difference was observed between CS and celecoxib. Both secondary endpoints (MCII and PASS) at day 182 improved significantly in the CS and celecoxib groups. All treatments demonstrated excellent safety profiles.ConclusionA 800 mg/day pharmaceutical-grade CS is superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in symptomatic knee osteoarthritis (OA) patients. This formulation of CS should be considered a first-line treatment in the medical management of knee OA.

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