Flavocoxid (
Limbrel), a proprietary mixture of
flavonoid molecules (
baicalin and
catechin), was tested against a traditional nonsteroidal anti-inflammatory
drug,
naproxen, for the management of the signs and symptoms of moderate
osteoarthritis (OA) in humans. Discomfort and global disease activity were used as the primary end points, and safety assessments were also taken for both treatments as a secondary endpoint. In this double-blind study, 103 subjects were randomly assigned to receive either
flavocoxid [500 mg twice daily (BID)] or
naproxen (500 mg BID) in a 1-month onset of action trial. Outcome measures included the short Western Ontario and McMaster University
Osteoarthritis Index, subject Visual Analogue Scale for discomfort and global response, and investigator Visual Analogue Scale for global response and fecal occult blood. Both
flavocoxid and
naproxen showed significant reduction in the signs and symptoms of knee OA (P < or = .001). There were no statistically detectable differences between the
flavocoxid and
naproxen groups with respect to any of the outcome variables. Similarly, there were no statistically detectable differences between the groups with respect to any adverse event, although there was a trend toward a higher incidence of
edema and nonspecific musculoskeletal discomfort in the
naproxen group. In this short-term pilot study,
flavocoxid was as effective as
naproxen in controlling the signs and symptoms of OA of the knee and would present a safe and effective option for those individuals on traditional nonsteroidal anti-inflammatory drugs or
cyclooxygenase-2 inhibitors. A low incidence of adverse events was reported for both groups.