scholarly journals Oral Administration of Polymer Hyaluronic Acid Alleviates Symptoms of Knee Osteoarthritis: A Double-Blind, Placebo-Controlled Study over a 12-Month Period

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Toshiyuki Tashiro ◽  
Satoshi Seino ◽  
Toshihide Sato ◽  
Ryosuke Matsuoka ◽  
Yasunobu Masuda ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Placebo Group ◽  
Oral Administration ◽  
Knee Osteoarthritis ◽  
Knee Joints ◽  
Controlled Study ◽  
Double Blind ◽  
Knee Oa ◽  
Strengthening Exercise ◽  
The One

This study was conducted to investigate the efficacy of oral hyaluronic acid (HA) administration for osteoarthritis (OA) in knee joints. Sixty osteoarthritic subjects (Kellgren-Lawrence grade 2 or 3) were randomly assigned to the HA or placebo group. The subjects in the HA group were given 200 mg of HA once a day everyday for 12 months, while the subjects in the placebo group were given placebo. The subjects in both groups were requested to conduct quadriceps strengthening exercise everyday as part of the treatment. The subjects’ symptoms were evaluated by the Japanese Knee Osteoarthritis Measure (JKOM) score. The symptoms of the subjects as determined by the JKOM score improved with time in both the HA and placebo groups. This improvement tended to be more obvious with the HA group, and this trend was more obvious with the subjects aged 70 years or less. For these relatively younger subjects, the JKOM score was significantly better than the one for the placebo group at the 2nd and 4th months after the initiation of administration. Oral administration of HA may improve the symptoms of knee OA in patients aged 70 years or younger when combined with the quadriceps strengthening exercise.

scholarly journals 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)

2017 ◽  
Vol 76 (9) ◽  
pp. 1537-1543 ◽  
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.

scholarly journals T2 mapping evaluation of changes in cartilage matrix after PRP and HA injection therapy in knee osteoarthritis: a prospective, randomized, double blind, placebo controlled study

2020 ◽  
Author(s):  
Matjaz Vogrin ◽  
Jakob Naranda ◽  
Mario Gorenjak ◽  
Tomaz Bajec ◽  
Domen Mongus ◽  
...  
Keyword(s):  
Placebo Group ◽  
Knee Osteoarthritis ◽  
Pain Score ◽  
T2 Mapping ◽  
Womac Score ◽  
Controlled Study ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Knee Oa

Abstract BackgroundIn this study we focused on evaluating the effect of intra-articular platelet-rich plasma (PRP) and hyaluronic acid (HA) on the qualitative and quantitative properties of the articular cartilage in patients with knee osteoarthritis (OA).MethodsWe evaluated 264 patients undergoing treatment of moderate knee OA. Patients aged between 40 and 70 years were included with articular K-L stage ≤ 2. Patients were randomized into three groups and treated with three doses of intra-articular PRP, HA, or placebo injection. Patients were evaluated clinically and by using T2 mapping.ResultsBoth PRP (619.05 ± 243 ms; p = 2.7 × 10− 5) and HA (637.12 ± 273 ms; p = 1.×10− 4) group showed statistically significant lower post-application T2 relaxation times in comparison to the placebo group (859.80 ± 406 ms).Cartilage thickness increased significantly after PRP (2.41±0.87 vs. 2.58±0.97 mm, p=0.033) and HA (2.28±0.81 vs. 2.80±1.00 mm, p=1.8×10) applications. There was a significant decrease in WOMAC pain score by 30% (p=0,001) and the overall WOMAC score by 27 p=1.9×10-4%) in PRP group. The decrease in WOMAC pain score and the overall WOMAC score in the placebo group was similar to the results observed in the PRP group. In the HA group a significant decrease in WOMAC pain score by 14% (p=0,005) was observed only at the first follow-up, whereas no difference was observed at the second follow-up. ConclusionsT2 mapping of cartilage tissue may aid to monitor its properties after the intra-articular therapies in knee OA. However, there is a discrepancy between clinical findings and the results of T2 mapping, suggesting questionable grounds for applying intra-articular therapy.

scholarly journals Randomised, double-blind comparison of a fixed co-formulation of intra-articular polynucleotides and hyaluronic acid versus hyaluronic acid alone in the treatment of knee osteoarthritis: two-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Cesare Stagni ◽  
Martina Rocchi ◽  
Alessandro Mazzotta ◽  
Nicolandrea Del Piccolo ◽  
Nicola Rani ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Treatment Cycle ◽  
Fixed Combination ◽  
Knee Function ◽  
First Year ◽  
Double Blind ◽  
Knee Oa ◽  
Link Type ◽  
Point Reduction

Abstract Background A first-year interim analysis of this two-year study suggested that intra-articular injections of highly purified, natural-origin polynucleotides and hyaluronic acid (HA) as a fixed combination (PNHA) might improve knee function and joint pain more effectively than HA alone in patients with knee osteoarthritis (OA). The purpose of the second-year analysis herein described was to verify whether the first-year interim outcomes persist over the whole two-year period. Methods Randomised, double-blind, HA-controlled clinical trial in 100 knee OA patients (98 randomised, 79 completing the study) in a high-specialisation tertiary care setting. The hypothesised difference of efficacy between PNHA and HA for the original sample size estimate is 20%. Treatment cycle: three intra-articular knee injections of either PNHA or HA, at baseline and weekly for two weeks. Evaluations: Western Ontario and McMaster Universities (WOMAC) score and Knee Society Score (KSS) as, respectively, primary and secondary endpoints, evaluated at baseline and after 2, 6, 12, and 24 months; synovial fluid levels of mediators (at baseline and the end of the treatment cycle). Adverse effects investigated at each control visit. Statistical analysis: Kruskal-Wallis test for independent samples (nonparametric one-way analysis of variance) after correction of means for age, Body Mass Index and Kellgren-Lawrence grade. If significant, pairwise post-hoc Sidak multiple comparisons. Results KSS total score and KSS pain item: significant improvement in both groups, with significantly more pain improvement in patients treated with PNHA (2-point reduction) than HA (1-point reduction). Both groups experienced significant long-term reductions in WOMAC total scores: significantly stronger in PNHA-treated patients after 24 months with a steady difference of 16% favouring PNHA in WOMAC pain subscore. No clinically significant adverse events in either group. Conclusions The outcomes of the 2-year study confirmed that a short cycle of intra-articular treatment (3 weekly double-blind injections) with polynucleotides (long-acting viscosupplementation properties, chondrocyte activation, pain-relieving properties) in fixed combination with high molecular weight hyaluronic acid is more effective in improving knee function and pain in knee OA patients than HA alone. PNHA may be elective for viscosupplementation in knee OA patients with fastidious and resistant pain and worsening disease. Trial registration NCT02417610. Registration, 15/04/2015. ClinicalTrials.gov database link:

scholarly journals L-Carnitine supplementation ameliorates serum tumor necrosis factor-alpha and matrix metalloproteinase-3 in knee osteoarthritis women

2017 ◽  
Vol 12 (1) ◽  
pp. 28 ◽  
Author(s):  
Reza Mahdavi ◽  
Sousan Kolahi ◽  
Vahideh Ebrahimzadeh Attari ◽  
Aida Malek Mahdavi
Keyword(s):  
Placebo Group ◽  
Knee Osteoarthritis ◽  
Global Assessment ◽  
Intervention Group ◽  
Controlled Study ◽  
Carnitine Supplementation ◽  
Double Blind ◽  
Necrosis Factor Alpha ◽  
Matrix Metalloproteinase 3 ◽  
Significant Difference

<p class="Abstract">Seventy-two females with mild to moderate knee osteoarthritis were included in this randomized double-blind placebo-controlled study. Patients in the intervention group (n=36) received L-carnitine supplement (750 mg/day) for two months. L-Carnitine supplementation led to decrease in serum TNF-α and MMP-3 levels significantly in comparison with the baseline (p&lt;0.001 and p&lt;0.001, respectively) and placebo group (p&lt;0.001 and p=0.03, respectively). In addition, physician’s global assessment of the severity of osteoarthritis decreased significantly in the L-carnitine group (p&lt;0.001) and placebo group (p=0.012) after supplementation. At the end of the study, a significant difference was observed between the two groups for mean physician’s global assessment of the severity of osteoarthritis (p&lt;0.001), adjusted for baseline values and duration of osteoarthritis. L-Carnitine supplementation has beneficial effects in reducing inflammatory biomarkers in knee osteoarthritis patients which subsequently leads to the alleviation of disease symptoms.</p>

scholarly journals COMPARATIVE EFFICACY OF INTRAARTICULAR THERAPY OF GONARTHROSIS WITH HYALURONIC ACID OF DIFFERENT MOLECULAR WEIGHT (A DOUBLE-BLIND RANDOMI7ED STUDY)

2014 ◽  
Vol 17 (2) ◽  
pp. 16-21
Author(s):  
N V Vas’kova ◽  
O M Lesnyak
Keyword(s):  
Molecular Weight ◽  
Hyaluronic Acid ◽  
Weight Bearing ◽  
Controlled Study ◽  
Osteoarthritis Of The Knee ◽  
Comparative Efficacy ◽  
Double Blind ◽  
Knee Oa ◽  
Pain At Rest ◽  
Different Molecular Weight

Objectives. To study the comparative efficacy and safety of intra-articular treatment of knee osteoarthritis (OA) with hyaluronic acid (HA) of different molecular weights (MW). Material and methods. Randomized double-blind controlled study included 50 patients with osteoarthritis of the knee stage II-III, weight-bearing pain more 40 mm on VAS and Lequesne index score > 4 and < 12. 25 patients received HA with MW 3500 kDa (Rusvisk group) and 25 patients were treated with HA with MW 1200-1400 kDa (Ostenil group) injected at 3-weekly intervals. During the 22-week observation period we assessed dynamics of pain on VAS (weightbearing pain, pain at rest), index WOMAC, and recorded the overall assessment of the effectiveness of therapy by patient and physician, OMERACT-OARSI criteria and the need for NSAIDs. Results. One week after the last injection, a significant decrease in weight-bearing pain (in the group Rusvisk by 69% in the group Ostenil 55%) and the total index WOMAC (group Rusvisk by 63% in the group Ostenil 60%), continuing until the end of observation. A significant decrease in pain at rest observed in the group Rusvisk at all visits and in the group Ostenil only at 6 and 10 weeks of therapy. The overall evaluation of effectiveness of therapy by patient and physician yielded the benefits observed in high molecular HA group. A high percentage of responses to therapy using OMERACT-OARSI criteria and reduced need for NSAIDs were observed in both groups. Tolerability was satisfactory and did not differ significantly between the groups. Most common adverse reactions were mild pain at the injection site. Conclusion. Intra-articular therapy with HA of different molecular weight Rusvisk and Ostenil resulted in pain reduction and improved joint function in patients with knee OA with satisfactory tolerability.

scholarly journals Randomised, double-blind comparison of a fixed co-formulation of intra-articular polynucleotides and hyaluronic acid versus hyaluronic acid alone in the treatment of knee osteoarthritis: two-year follow-up

2021 ◽  
Author(s):  
Cesare Stagni ◽  
Martina Rocchi ◽  
Alessandro Mazzotta ◽  
Nicolandrea Del Piccolo ◽  
Nicola Rani ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Treatment Cycle ◽  
Fixed Combination ◽  
Tertiary Care ◽  
Knee Function ◽  
First Year ◽  
Double Blind ◽  
Knee Oa ◽  
Point Reduction

Abstract Background: A first-year interim analysis of this two-year study suggested that intra-articular injections of highly purified, natural-origin polynucleotides and hyaluronic acid (HA) as a fixed combination (PNHA) might improve knee function and joint pain more effectively than HA alone in patients with knee osteoarthritis (OA). Purpose of the second-year analysis herein described was verifying whether the first-year interim outcomes persist over the whole two-year period. Methods: Randomised, double-blind, HA-controlled clinical trial in 100 knee OA patients (98 randomised, 69 completing the study) in a high-specialisation tertiary care setting. The hypothesised difference of efficacy between PNHA and HA for the original sample size estimate is 20%. Treatment cycle: 3 weekly intra-articular knee injections of either PNHA or HA. Evaluations: Western Ontario and McMaster Universities (WOMAC) score and Knee Society Score (KSS) as, respectively, primary and secondary endpoints, evaluated at baseline and after 2, 6, 12, and 24 months; synovial fluid levels of proinflammatory mediators (biochemical and immunoenzymatic assays at baseline and the end of the treatment cycle). Adverse effects investigated at each control visit. Statistical analysis: Kruskal-Wallis test for independent samples (nonparametric one-way analysis of variance) after correction of means for age, Body Mass Index and Kellgren-Lawrence grade. If significant, pairwise post-hoc Sidak multiple comparisons. Results: KSS total score and KSS pain item: significant improvement in both groups, with significantly more pain improvement in patients treated with PNHA (2-point reduction) than HA (1-point reduction). Both groups experienced significant long-term reductions in WOMAC total scores: significantly stronger in PNHA-treated patients after 24 months with a steady difference of 16% favouring PNHA in WOMAC pain subscore. No clinically significant adverse events in either group. Conclusions: The outcomes of the 2-year study confirmed that a short cycle of intra-articular treatment (3 weekly double-blind injections) with polynucleotides (long-acting viscosupplementation properties, pro-trophic activity on chondrocytes, pain-relieving properties) in fixed combination with high molecular weight hyaluronic acid is more effective in improving knee function and pain in knee OA patients than HA alone. PNHA may be elective for viscosupplementation in knee OA patients with fastidious and resistant pain, signs of inflammation or worsening disease.

Effects of Consumption of Probiotic Powder Containing Lactobacillus Plantarum Dad-13 on Fecal Bacterial Population in School-Age Children in Indonesia

2019 ◽  
Vol 14 (1) ◽  
pp. 1-8 ◽  
Author(s):  
Banin Maghfirotin Marta ◽  
Utami Tyas ◽  
Cahyanto Muhammad Nur ◽  
Widada Jaka ◽  
Rahayu Endang Sutriswati
Keyword(s):  
Placebo Group ◽  
Gut Microbiota ◽  
Lactobacillus Plantarum ◽  
Coliform Bacteria ◽  
School Age Children ◽  
Controlled Study ◽  
School Age ◽  
Double Blind ◽  
Probiotic Group ◽  
E Coli

Consumption of probiotics is known to influence the gut microbiota. The aim of this study was to assess the effect of probiotic powder containing Lactobacillus plantarum Dad-13 on bacterial composition in the gut by examining fecal samples of school-age children in Yogyakarta, Indonesia. This is a randomized, double-blind, placebo-controlled study. A total of 40 healthy subjects were recruited for this study and were divided into two groups: placebo group and probiotic group. The placebo group consumed skim milk and the probiotic group consumed probiotic powder containing L. plantarum Dad-13 (2 × 109 CFU/g) for 65 days. The results showed that placebo intake had no significant effect on gut microbiota; however, probiotic caused a significant increase in L. plantarum and Lactobacillus population, while decreasing the population of E. coli and non-E. coli coliform bacteria by 55% and 75%, respectively and Bifidobacteria count did not change significantly. The study concluded that consumption of probiotic powder L. plantarum Dad-13 could increase propionic acid thereby decreasing the gut pH which has an effect on the microbial population.

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