title: Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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).
  
  
  METHODS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT01604239).
authors.affiliation: Department of Orthopedic Surgery, Stem Cell & Regenerative Medicine Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: chulwon.ha@gmail.com.
authors.forename: Chul-Won
authors.initials: CW
authors.lastname: Ha
authors.affiliation: Department of Orthopedic Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, South Korea. Electronic address: whybe1122@gmail.com.
authors.forename: Yong-Beom
authors.initials: YB
authors.lastname: Park
authors.affiliation: Department of Orthopedic Surgery, School of Medicine, Kyungpook National University, Daegu, South Korea. Electronic address: hskyung@knu.ac.kr.
authors.forename: Hee-Soo
authors.initials: HS
authors.lastname: Kyung
authors.affiliation: Department of Orthopedic Surgery, Kyung Hee University Hospital, Seoul, South Korea. Electronic address: chungsoohan29@gmail.com.
authors.forename: Chung-Soo
authors.initials: CS
authors.lastname: Han
authors.affiliation: Department of Orthopedic Surgery, Keimyung University Dongsan Medical Center, Daegu, South Korea. Electronic address: bkc@dsmc.or.kr.
authors.forename: Ki-Cheor
authors.initials: KC
authors.lastname: Bae
authors.affiliation: Department of Orthopedic Surgery, Korea University Guro Hospital, Seoul, South Korea. Electronic address: lhc2455@daum.net.
authors.forename: Hong-Chul
authors.initials: HC
authors.lastname: Lim
authors.affiliation: Department of Orthopedic Surgery, Dongguk University International Hospital, Seoul, South Korea. Electronic address: pse0518@hotmail.com.
authors.forename: Sang-Eun
authors.initials: SE
authors.lastname: Park
authors.affiliation: Department of Orthopedic Surgery, Seoul National University Hospital, Seoul, South Korea. Electronic address: leemc@snu.ac.kr.
authors.forename: Myung Chul
authors.initials: MC
authors.lastname: Lee
authors.affiliation: Department of Orthopedic Surgery, Ajou University Hospital, Suwon, South Korea. Electronic address: thrtkr@ajou.ac.kr.
authors.forename: Ye-Yeon
authors.initials: YY
authors.lastname: Won
authors.affiliation: Department of Orthopedic Surgery, BoGang Hospital, Daegu, South Korea. Electronic address: osdclee@naver.com.
authors.forename: Dong-Chul
authors.initials: DC
authors.lastname: Lee
authors.affiliation: Department of Orthopedic Surgery, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea. Electronic address: sdcho@uuh.ulsan.kr.
authors.forename: Sung-Do
authors.initials: SD
authors.lastname: Cho
authors.affiliation: Department of Orthopedic Surgery, Busan Paik Hospital, Inje University, Busan, South Korea. Electronic address: doctor-bluesea@hanmail.net.
authors.forename: Chang-Wan
authors.initials: CW
authors.lastname: Kim
authors.affiliation: Department of Orthopedic Surgery, Konkuk University Medical Center, Seoul, South Korea. Electronic address: boram107@hanmail.net.
authors.forename: Jin-Goo
authors.initials: JG
authors.lastname: Kim
authors.affiliation: Department of Orthopedic Surgery, Inha University Hospital, Incheon, South Korea. Electronic address: kangjoon@inha.ac.kr.
authors.forename: Joon-Soon
authors.initials: JS
authors.lastname: Kang
authors.affiliation: Department of Orthopedic Surgery, Jeonbuk National University Medical School, Jeonju, South Korea. Electronic address: Jhlee55@jbnu.ac.kr.
authors.forename: Ju-Hong
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Orthopedic Surgery, Chungbuk National University Hospital, Cheongju, South Korea. Electronic address: oseschoi@chungbuk.ac.kr.
authors.forename: Eui-Sung
authors.initials: ES
authors.lastname: Choi
authors.affiliation: Department of Orthopedic Surgery, Chonnam National University Hwasun Hospital, Hwasun, South Korea. Electronic address: seonbell@jnu.ac.kr.
authors.forename: Jong-Keun
authors.initials: JK
authors.lastname: Seon
authors.affiliation: Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul, South Korea. Electronic address: wsleeos@yuhs.ac.
authors.forename: Woo-Suk
authors.initials: WS
authors.lastname: Lee
authors.affiliation: Department of Orthopedic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address: sibin@amc.seoul.kr.
authors.forename: Seong-Il
authors.initials: SI
authors.lastname: Bin
mesh_terms: D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068579:Celecoxib / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy*; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D056910:Republic of Korea / Q000453:epidemiology; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D010936:Plant Extracts; C571726:shinbaro; D000068579:Celecoxib
keywords: GCSB-5; GI safety; Herbal medicine; Osteoarthritis; Shinbaro