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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

Title
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
Authors
Yong-Geun Park;Chul-Won Ha;Hong-Chul Lim;Young-Bok Jung;Hee-Chun Kim;Seong-Il Bin;Chang-Dong Han
Issue Date
2013
Journal Title
Journal of Ethnopharmacology
ISSN
0378-8741
Citation
Journal of Ethnopharmacology , Vol.149(3) : 816~824, 2013
Abstract
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.
URI
http://www.sciencedirect.com/science/article/pii/S0378874113005503

http://ir.ymlib.yonsei.ac.kr/handle/22282913/87948
DOI
10.1016/j.jep.2013.08.008
Appears in Collections:
1. 연구논문 > 1. College of Medicine > Dept. of Orthopedic Surgery
Yonsei Authors
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