Efficacy and Tolerability of GCSB-5 for Hand Osteoarthritis: A Randomized, Controlled Trial

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• 作者：Jin Kyun Park ; MD¹ ; Kichul Shin ; MD ; PhD² ; Eun-Ha Kang ; MD ; PhD³ ; You-Jung Ha ; MD³ ; Yun Jong Lee ; MD ; PhD³ ; Kyung Hee Lee ; BS¹ ; Eun Young Lee ; MD ; PhD¹ ; Yeong Wook Song ; MD ; PhD¹ ; Yunhee Choi ; PhD⁴ ; Eun Bong Lee ; MD ; PhD¹ ; ^{leb7616@snu.ac.kr" class="auth_mail" title="E-mail the corresponding author}
• 关键词：GCSB-5 ; hand ; osteoarthritis ; randomized clinical trial
• 刊名：Clinical Therapeutics
• 出版年：2016
• 出版时间：August 2016
• 年：2016
• 卷：38
• 期：8
• 页码：1858-1868.e2
• 全文大小：372 K

文摘

The aim of this study was to investigate the efficacy and tolerability of GCSB-5, a mixture of 6 purified herbal extracts, in treating hand osteoarthritis (OA).

Methods

A randomized, double-blind, placebo-controlled trial enrolled 220 patients with hand OA who had baseline a visual analog scale joint pain score of >30 of 100 mm at 3 hospitals between September 2013 and November 2014. After randomization, patients were allocated to receive oral GCSB-5 600 mg or placebo, bid for 12 weeks. The primary end point was the change in the Australian/Canadian OA Hand Index (AUSCAN)-defined pain score at 4 weeks relative to baseline. Secondary end points included the frequency Outcome Measures in Rheumatology–OA Research Society International (OMERACT-OARSI)-defined response at 4, 8, 12, and 16 weeks after randomization.

Findings

The allocated treatment was received by 109 and 106 patients in the GCSB-5 and placebo groups, respectively. At 4 weeks, the median (interquartile range) change in AUSCAN pain score relative to baseline was significantly greater in the GCSB-5 group than in the placebo group (–9.0 [–23.8 to –0.4] vs –2.2 [–16.7 to 6.0]; P = 0.014), with sustained improvement at 8, 12, and 16 weeks (P = 0.039). The GCSB-5 group also had a significantly greater OMERACT-OARSI–defined response rate than did the placebo group at 4 weeks (44.0% vs 30.2%), 8 weeks (51.4% vs 35.9%), 12 weeks (56.9% vs 40.6%), and 16 weeks (50.5% vs 37.7%) (P = 0.0074). The 2 treatments exhibited comparable safety profiles.

Implications

GCSB-5 was associated with improved symptoms of hand OA, with good tolerability, in these patients. GCSB-5 may be a well-tolerated alternative of, or addition to, the treatment of hand OA. ClinicalTrials.gov identifier: NCT01910116.