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Diclofenac sodium gel in patients with primary hand osteoarthritis: a randomized, double-blind, placebo-controlled trial
Journal of Rheumatology, 09/09/09
Altman RD et al. – Topical diclofenac sodium gel was generally well tolerated and effective in primary hand OA.
Methods- In a randomized, double–blind, placebo–controlled trial, men and women aged >= 40 years diagnosed with primary OA in the dominant hand were randomly assigned to self–apply topical 1% diclofenac sodium gel (Voltaren® Gel) (n = 198) or vehicle (n = 187) to both hands 4 times daily for 8 weeks
- Diclofenac sodium gel decreased pain intensity scores by 42%–45%, total AUSCAN scores by 35%–40%, and global rating of disease by 36%–40%
- Significant differences favoring diclofenac sodium gel over vehicle were observed at week 4 for pain intensity and AUSCAN, with a trend for global rating of disease activity
- At week 6, diclofenac sodium gel treatment significantly improved each primary outcome measure compared with vehicle. Secondary outcomes generally supported the primary outcomes
- The most common treatment–related adverse event (AE) was application–site paresthesia; most AE were mild; no cardiac events, gastrointestinal bleeding, or ulcers were reported
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