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.
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.
Department of Orthopedic Surgery, Chung-Ang University, Seoul 140-757, Korea. jungyb2000@hanmir.com
Young-Bok
YB
Lung
Sang-Cheol
SC
Seong
Myung-Chul
MC
Lee
Yong-Un
YU
Shin
Dong-Han
DH
Kim
Jung-Man
JM
Kim
Yang-Kuk
YK
Jung
Jin-Hwan
JH
Ahn
Jai-Gon
JG
Seo
Youn-Soo
YS
Park
Chong-Suh
CS
Lee
Kwon-Jae
KJ
Roh
Chang-Kyun
CK
Han
Yong-Baik
YB
Cho
Don-Yong
DY
Chang
Wie-Jong
WJ
Kwak
Kui-Oak
KO
Jung
Byung-Joo
BJ
Park
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D003692:Delayed-Action Preparations; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006801:Humans; D007719:Knee Joint / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy* / Q000473:pathology; D017060:Patient Satisfaction; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D004365:Drugs, Chinese Herbal; C460104:SKI 306X; D004008:Diclofenac