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.

A cohort study on the association between psychotropics and hip fracture in Korean elderly women.

To test the hypothesis that the intake of psychotropics may increase the risk of hip fracture, a cohort study was conducted upon elderly Korean women. The Korean Elderly Pharmacoepidemiology Cohort was constructed from members of the Korea Medical Insurance Corporation over 65 yr of age who were living in Busan Metropolitan City in 1993. Study participants (n=6,043) were female respondents to a self-administered question survey. Information on the intake of psychotropics was obtained from the drug prescription database, which contained all psychotropic prescriptions during any hospital admission over the two-year period between January 1, 1993 and December 31, 1994. The cohort follow-up has been conducted with information on hip fracture being collected from the Korea Medical Insurance Corporation medical treatment claims database over the four year period between January 1, 1993 and December 31, 1996. Three hundred and three subjects had received 745 psychotropics prescriptions and 56 cases of hip fracture were found. After adjusting for age, body mass index, and drinking history, it was found that the intake of psychotropics significantly increased the risk of hip fracture (adjusted odds ratio, 4.24; 95% confidence interval, 1.89-9.52). This study suggests that the intake of psychotropics might be an important risk factor for hip fracture in elderly Korean women.