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Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study

Authors
 Chul-Won Ha  ;  Yong-Beom Park  ;  Hee-Soo Kyung  ;  Chung-Soo Han  ;  Ki-Cheor Bae  ;  Hong-Chul Lim  ;  Sang-Eun Park  ;  Myung Chul Lee  ;  Ye-Yeon Won  ;  Dong-Chul Lee  ;  Sung-Do Cho  ;  Chang-Wan Kim  ;  Jin-Goo Kimm  ;  Joon-Soon Kang  ;  Ju-Hong Lee  ;  Eui-Sung Choi  ;  Jong-Keun Seon  ;  Woo-Suk Lee  ;  Seong-Il Bin 
Citation
 JOURNAL OF ETHNOPHARMACOLOGY, Vol.189 : 310-318, 2016 
Journal Title
 JOURNAL OF ETHNOPHARMACOLOGY 
ISSN
 0378-8741 
Issue Date
2016
MeSH
Aged ; Antirheumatic Agents/adverse effects ; Antirheumatic Agents/therapeutic use* ; Celecoxib/adverse effects ; Celecoxib/therapeutic use* ; Female ; Gastrointestinal Diseases/chemically induced ; Gastrointestinal Diseases/epidemiology ; Humans ; Incidence ; Male ; Middle Aged ; Osteoarthritis, Knee/diagnosis ; Osteoarthritis, Knee/drug therapy* ; Plant Extracts/adverse effects ; Plant Extracts/therapeutic use* ; Republic of Korea/epidemiology ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome
Keywords
GCSB-5 ; GI safety ; Herbal medicine ; Osteoarthritis ; Shinbaro
Abstract
ETHNOPHARMACOLOGY RELEVANCE: A previous study indicated non-inferiority of GCSB-5 to celecoxib regarding efficacy and safety in treating OA; however, the gastrointestinal (GI) safety data was limited to 12 weeks. Accordingly, a longer term study with a larger number of patients was necessary to establish the GI safety of GCSB-5. AIM OF STUDY: The primary goal was to determine the safety and efficacy of 24-week use of GCSB-5. The secondary goal was to compare the GI safety data of GCSB-5 with that of the previously reported Celecoxib Long-term Arthritis Safety Study (CLASS). METHOD: This was a 24-week, multicenter, single-arm phase IV Study for the safety and efficacy of GCSB-5. A total of 761 patients were enrolled and 756 patients received at least one dose of GCSB-5. Among them, 629 patients (82.7%) completed the 24 week follow up. The primary goal was to determine the safety and efficacy of GCSB-5 for 24 weeks. The secondary goal was to compare the GI safety data of GCSB-5 with that of the previously reported Celecoxib Long-term Arthritis Safety Study (CLASS). RESULTS: The incidence of GI disorders of GCSB-5 was 23.7%. The annual rate of perforation, ulcer obstruction, or bleeding (PUB) incidence was 0.0%. The drop-out rate due to GI disorders following GCSB-5 use was 4.8%. Compared to celecoxib data from CLASS, the incidence of GI disorders (23.7% vs. 31.4%, p<0.001), annual rate of PUB and gastroduodenal ulcers (0.0% vs 2.2%, p=0.004), and drop-out rate due to GI disorders following GCSB-5 use were significantly low (4.8% vs 8.7%, p<0.001). Efficacy was proven by significant improvements in Western Ontario McMaster Questionnaire (WOMAC) scale, Korean Knee Score (KKS), 100-mm pain visual analogue scale (VAS), and physician's global assessments of patient's response to therapy (PGART). CONCLUSIONS: The safety and efficacy profile of GCSB-5 are comparable to celecoxib. These results indicate GCSB-5 is safe for a long-term treatment of knee OA patients. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01604239).
Files in This Item:
T201603366.pdf Download
DOI
10.1016/j.jep.2016.05.031
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Woo Suk(이우석) ORCID logo https://orcid.org/0000-0002-0798-1660
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/151971
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