Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial

Background. Gumiganghwal-tang (GMGHT) is a traditional herbal medicine consisting of nine different herbs. GMGHT inhibits the mRNA expression and production of inflammatory cytokines tumor necrosis factor-α (TNF- α), interleukin-6 (IL-6), and TNF- β on lipopolysaccharide- (LPS-) stimulated peritoneal macrophages in a dose-dependent manner. It is empirically used for the treatment of inflammatory disease, but there are few reports of clinical trials that investigate its efficacy and safety. The current study aimed to investigate the clinical efficacy and safety of GMGHT in patients with knee osteoarthritis (OA). Methods. This was a multicenter, two-armed, double-blinded, randomized, placebo controlled study of GMGHT over 6 weeks. Eligible patients who fulfilled the American College of Rheumatology criteria for OA were randomized to receive either GMGHT or the placebo. Clinical assessments included measurement of knee pain and function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), patient global assessment (PGA), and knee pain scores every 2 weeks. Results. A total of 128 patients were enrolled (91.4% female; mean age, 58.7 ± 8.1 years). At baseline, pain visual analogue score (VAS) was 67.2 ± 1.4, resp. 71.3 ± 1.6 (treatment, resp. placebo group, p=0.84), and total WOMAC score was 55.2 ± 1.6, resp. 55.6 ± 1.5 (p = 0.84). After 6 weeks, the pain VAS was 43.0 ± 2.5, resp. 61.6 ± 2.5 (p < 0.01) and the total WOMAC score was 34.1 ± 2.4, resp. 46.9 ± 1.8 (p < 0.01). No patients withdrew because of treatment emergent adverse events. Expected adverse events including dyspepsia, liver function abnormality, and lower extremity edema were comparable between both groups. Conclusions. Treatment with GMGHT resulted in significant improvement in pain, function, and global assessment, and it was generally safe and well tolerated in patients with OA.

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Der Effekt von hochintensivem Kräftigungstraining auf Knieschmerzen und im Kniegelenk auftretende Kräfte bei Erwachsenen mit Kniearthrose

B&G Bewegungstherapie und Gesundheitssport ◽

10.1055/a-1588-1842 ◽

2021 ◽

Vol 37 (05) ◽

pp. 241-241

Author(s):

Janik Scheer

Keyword(s):

Clinical Trial ◽

Knee Joint ◽

Knee Osteoarthritis ◽

Strength Training ◽

Randomized Clinical Trial ◽

Knee Pain ◽

High Intensity

OriginalpublikationMessier SP, Mihalko SL, Beavers DP et al. Effect of High-Intensity Strength Training on Knee Pain and Knee Joint Compressive Forces Among Adults With Knee Osteoarthritis. The START Randomized Clinical Trial 2021; 325: 646–657

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A Multicenter, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of a Cell and Gene Therapy in Knee Osteoarthritis Patients

Human Gene Therapy Clinical Development ◽

10.1089/humc.2017.249 ◽

2018 ◽

Vol 29 (1) ◽

pp. 48-59 ◽

Cited By ~ 21

Author(s):

Myung-Ku Kim ◽

Chul-Won Ha ◽

Yong In ◽

Sung-Do Cho ◽

Eui-Sung Choi ◽

...

Keyword(s):

Clinical Trial ◽

Gene Therapy ◽

Knee Osteoarthritis ◽

Phase Iii ◽

Efficacy And Safety ◽

Double Blind ◽

Phase Iii Clinical Trial ◽

A Cell ◽

Cell And Gene Therapy

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Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial

PLoS ONE ◽

10.1371/journal.pone.0238024 ◽

2020 ◽

Vol 15 (9) ◽

pp. e0238024

Author(s):

Joung Youp Shin ◽

Moon Jong Chang ◽

Myung Ku Kim ◽

Seung-Baik Kang ◽

Kang-Il Kim ◽

...

Keyword(s):

Clinical Trial ◽

Knee Osteoarthritis ◽

Active Drug ◽

Efficacy And Safety ◽

Short Term ◽

Parallel Group ◽

Symptomatic Knee Osteoarthritis ◽

Symptomatic Knee ◽

Double Blinded ◽

Phase Iv

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Efficacy and safety of a single intra-articular injection of 6 ml Hylan G-F 20 compared to placebo in Chinese patients with symptomatic knee osteoarthritis

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04252-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Yan Ke ◽

Wenxue Jiang ◽

Yongsheng Xu ◽

Yajun Chen ◽

Qingsong Zhang ◽

...

Keyword(s):

Clinical Trial ◽

Knee Osteoarthritis ◽

Clinical Efficacy ◽

Post Injection ◽

Efficacy And Safety ◽

Treatment Groups ◽

Knee Oa ◽

Link Type ◽

Symptomatic Knee Osteoarthritis ◽

The Mean

Abstract Background Single 6 ml Hylan G-F 20 injection, is indicated for knee osteoarthritis patients who have failed to respond to non-pharmacologic therapy and/or simple analgesics. To obtain more thorough understanding of the clinical efficacy and safety, a randomized clinical trial was conducted comparing intra-articular (IA) administration of single 6 ml Hylan G-F 20 injection versus placebo in knee OA patients of Chinese ethnicity. Methods This was a randomized, multi-center, double-blind, placebo-controlled clinical trial conducted in 21 centers across China. Four hundred forty adults with knee OA received a single 6 ml Hylan G-F 20 or placebo injection and were evaluated for clinical efficacy and safety outcomes over 26 weeks. Western Ontario and McMaster Universities OA (WOMAC) A1 index, treatment-emergent adverse events (TEAEs) and standard safety parameters were measured at pre-injection, and at weeks 1, 4, 8, 12, 16, 20 and 26 post-injection. Results Four hundred forty patients (male: 98 [22.3%]; female: 342 [77.7%]) were randomized. The mean age [standard deviation (SD)] was 61.5 (7.9) years. All patients were of East Asian ethnicity. Mean WOMAC A1 score at baseline was 5.3 (1.2) and 5.2 (1.3) in single 6 ml Hylan G-F 20 injection and placebo groups, respectively. Significant reductions of WOMAC A1 score were observed in both treatment groups when compared to baseline at 26 weeks post-injection, with the mean reduction of [standard error (SE)/percentage] -2.146 (0.108)/− 40.5% and − 2.271 (0.110) /− 43.7% in the single 6 ml Hylan G-F 20 injection and the placebo groups, respectively. Additionally, clinically important reductions in pain at 26 weeks was reported in 67.0 and 68.2% in single 6 ml Hylan G-F 20 injection and placebo groups (p = 0.36). Regarding safety, TEAEs were similar between the two treatment groups (hylan G-F 20 single: 61.5%; placebo: 64.5%). Conclusions While the magnitude of the effect of a single 6 ml Hylan G-F 20 injection in this study is consistent with previously published literature with respect to the efficacy and safety of the drug, the current study shows a strong IA placebo effect and did not established superiority of single 6 ml Hylan G-F 20 injection over IA placebo in Chinese knee OA patients. Trial registration Prospectively registered Jun 16, 2017 at www.clinicaltrials.gov (NCT03190369).

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