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

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• 作者：Chul-Won Ha^a ; ¹ ; ^{chulwon.ha@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Yong-Beom Park^b ; ¹ ; ^{whybe1122@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Hee-Soo Kyung^c ; ^{hskyung@knu.ac.kr" class="auth_mail" title="E-mail the corresponding author} ; Chung-Soo Han^d ; ^{chungsoohan29@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Ki-Cheor Bae^e ; ^{bkc@dsmc.or.kr" class="auth_mail" title="E-mail the corresponding author} ; Hong-Chul Lim^f ; ^{lhc2455@daum.net" class="auth_mail" title="E-mail the corresponding author} ; Sang-Eun Park^g ; ^{pse0518@hotmail.com" class="auth_mail" title="E-mail the corresponding author} ; Myung Chul Lee^h ; ^{leemc@snu.ac.kr" class="auth_mail" title="E-mail the corresponding author} ; Ye-Yeon Wonⁱ ; ^{thrtkr@ajou.ac.kr" class="auth_mail" title="E-mail the corresponding author} ; Dong-Chul Lee^j ; ^{osdclee@naver.com" class="auth_mail" title="E-mail the corresponding author} ; Sung-Do Cho^k ; ^{sdcho@uuh.ulsan.kr" class="auth_mail" title="E-mail the corresponding author} ; Chang-Wan Kim^l ; ^{doctor-bluesea@hanmail.net" class="auth_mail" title="E-mail the corresponding author} ; Jin-Goo Kim^m ; ^{boram107@hanmail.net" class="auth_mail" title="E-mail the corresponding author} ; Joon-Soon Kangⁿ ; ^{kangjoon@inha.ac.kr" class="auth_mail" title="E-mail the corresponding author} ; Ju-Hong Lee^° ; o ; ^{Jhlee55@jbnu.ac.kr" class="auth_mail" title="E-mail the corresponding author} ; Eui-Sung Choi^p ; ^{oseschoi@chungbuk.ac.kr" class="auth_mail" title="E-mail the corresponding author} ; Jong-Keun Seon^q ; ^{seonbell@jnu.ac.kr" class="auth_mail" title="E-mail the corresponding author} ; Woo-Suk Lee^r ; ^{wsleeos@yuhs.ac" class="auth_mail" title="E-mail the corresponding author} ; Seong-Il Bin^s ; ^{sibin@amc.seoul.kr" class="auth_mail" title="E-mail the corresponding author}
• 关键词：GCSB-5 ; Shinbaro ; Osteoarthritis ; GI safety ; Herbal medicine
• 刊名：Journal of Ethnopharmacology
• 出版年：2016
• 出版时间：2 August 2016
• 年：2016
• 卷：189
• 期：Complete
• 页码：310-318
• 全文大小：889 K

文摘

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).