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A prospective, randomized, double-blind, multicenter comparative study on the safety and efficacy of Celecoxib and GCSB-5, dried extracts of six herbs, for the treatment of osteoarthritis of knee joint

 Yong-Geun Park  ;  Chul-Won Ha  ;  Chang-Dong Han  ;  Seong-Il Bin  ;  Hee-Chun Kim  ;  Young-Bok Jung  ;  Hong-Chul Lim 
 JOURNAL OF ETHNOPHARMACOLOGY, Vol.149(3) : 816-824, 2013 
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Issue Date
Celecoxib ; Cyclooxygenase 2 Inhibitors/administration & dosage ; Cyclooxygenase 2 Inhibitors/adverse effects ; Cyclooxygenase 2 Inhibitors/therapeutic use* ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Osteoarthritis, Knee/drug therapy* ; Pain Measurement ; Plant Extracts/administration & dosage ; Plant Extracts/adverse effects ; Plant Extracts/therapeutic use* ; Prospective Studies ; Pyrazoles/administration & dosage ; Pyrazoles/adverse effects ; Pyrazoles/therapeutic use* ; Severity of Illness Index ; Sulfonamides/administration & dosage ; Sulfonamides/adverse effects ; Sulfonamides/therapeutic use* ; Surveys and Questionnaires ; Treatment Outcome ; Walking
ADR ; AE ; COX-1 ; COX-2 inhibitor ; Celecoxib ; Efficacy ; FDA ; Food and Drug Administration ; GCSB-5 ; GEE ; IL-1beta ; ITT ; K/L ; Kellgren and Lawrence ; Knee ; LOCF ; MCID ; NSAIDs ; OA ; Osteoarthritis ; PGART ; PGI2 ; PP ; SD ; TNF-α ; TXA2 ; VAS ; WOMAC ; Western Ontario and McMaster Universities Arthritis Index ; adverse drug reaction ; adverse events ; cyclooxygenase-1 ; cyclooxygenase-2 inhibitor ; generalized estimating equation ; inteleukin-1β ; intention to Treat ; last observation carried forward ; minimum clinically important differences ; non-steroidal anti-inflammatory drugs ; osteoarthritis ; per protocol ; prostaglandin I2 ; standard deviation ; the physician's global assessment of response to therapy ; thromboxane A2 ; tissue necrotic factor alpha ; visual analogue scale
ETHNOPHARMACOLOGICAL RELEVANCE: This prospective, randomized, double-blind, multicenter study compared the efficacy and safety of Celecoxib and GCSB-5, a new product from extracts of six herbs, for the treatment of knee osteoarthritis. MATERIALS AND METHODS: A total of 198 eligible patients were randomly assigned to the Celecoxib group (n=99 patients) or the GCSB-5 group (n=99 patients) for the 12-week study. The amount of change and percentage of the change in Western Ontario and McMaster Universities (WOMAC) Arthritis Index from the baseline, the change in pain on walking by visual analogue scale (VAS), physician's global assessment on response to therapy (PGART) by five point Likert scale, and the amount of rescue medicine taken were used as parameters for efficacy. Adverse drug reactions (ADRs) were carefully investigated. RESULTS: The WOMAC score improved in both the Celecoxib group and GCSB-5 group by 20.5 and 21.3 (P=0.79). The percentage of the change in WOMAC score were -42.0% and -38.9% (P=0.54). The pain VAS score decreased by 29.9 and 27.9 (P=0.58). The responders by PGART were 95.3% and 93.8% (P= 0.66), and the median amount of rescue medicine taken were 2.0 and 6.5 tablets (P=0.06). The incidence of ADRs were 31.3% and 21.2% (P=0.11). The most common ADRs were gastrointestinal system related; 17.2% in GCSB-5 group and 22.2% in Celecoxib group. Any severe ADR was not observed in either group. CONCLUSIONS: The result of this study supports that GCSB-5 is comparable to Celecoxib in terms of the efficacy and safety for the treatment of osteoarthritis of knee joint.
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1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
Yonsei Authors
Han, Chang Dong(한창동)
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