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

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

doi:10.1016/j.jep.2016.05.031

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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).