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A four-week, randomized, double-blind trial of the efficacy and safety of SKI306X: A herbal anti-arthritic agent versus diclofenac in osteoarthritis of the knee

Title
A four-week, randomized, double-blind trial of the efficacy and safety of SKI306X: A herbal anti-arthritic agent versus diclofenac in osteoarthritis of the knee
Authors
Jung Y.-B.Seong S.-C.Lee M.-C.Shin Y.-U.Kim D.-H.Kim J.-M.Jung Y.-K.Ahn J.-H.Seo J.-G.Park Y.-S.Lee C.-S.Roh K.-J.Han C.-K.Cho Y.-B.Chang D.-Y.Kwak W.-J.Jung K.-O.Park B.-J.
Ewha Authors
노권재
SCOPUS Author ID
노권재scopus
Issue Date
2004
Journal Title
American Journal of Chinese Medicine
ISSN
0192-415XJCR Link
Citation
vol. 32, no. 2, pp. 291 - 301
Indexed
SCIE; SCOPUS WOS scopus
Abstract
The efficacy and safety of SKI306X, an herbal anti-arthritic agent, was compared with that of diclofenac sodium for the treatment of osteoarthritis of the knee. In a randomized, double-blind, active comparator-controlled trial, a total of 249 patients were randomly assigned to receive either 200 mg of SKI306X three times daily or 100 mg of diclofenac sustained release (SR) once daily. Clinical efficacy variables (visual analog scale, Lesquesne index and global satisfaction score) and adverse events were monitored at baseline and 2nd and 4th weeks of treatment. SKI306X demonstrated efficacy statistically comparable to that of diclofenac, as assessed by the VAS and patients' and investigators' global satisfaction score. Both treatments were well tolerated, however, the SKI306X treatment group experienced less heartburn (4.0% versus 13.7%, p = 0.015, chi-square test). In this four-week trial, SKI306X was well tolerated and demonstrated clinical efficacy comparable to that of diclofenac SR. © 2004 World Scientific Publishing Company.
DOI
10.1142/S0192415X04001941
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의학전문대학원 > 의학과 > Journal papers
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