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.
abstract: BACKGROUND
  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.
  
  
  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.
authors: Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors: Yong-Geun
authors: YG
authors: Park
authors: Chul-Won
authors: CW
authors: Ha
authors: Chang-Dong
authors: CD
authors: Han
authors: Seong-Il
authors: SI
authors: Bin
authors: Hee-Chun
authors: HC
authors: Kim
authors: Young-Bok
authors: YB
authors: Jung
authors: Hong-Chul
authors: HC
authors: Lim
mesh_terms: D000068579:Celecoxib; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010147:Pain Measurement; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D016138:Walking
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D010936:Plant Extracts; D011720:Pyrazoles; D013449:Sulfonamides; C571726:shinbaro; D000068579:Celecoxib
keywords: 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