Flavocoxid is as effective as naproxen for managing the signs and symptoms of osteoarthritis of the knee in humans: a short-term randomized, double-blind pilot study.
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.
Levy
Robert M
RM
Primus Pharmaceuticals, Inc. Scottsdale, AZ 85251, USA. rlevy@primusrx.com
Saikovsky
Roman
R
Shmidt
Evgeniya
E
Khokhlov
Alexander
A
Burnett
Bruce P
BP
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D002392:Catechin / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005419:Flavonoids / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007719:Knee Joint / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects / Q000627:therapeutic use*; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*; D031363:Scutellaria
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D005419:Flavonoids; D010936:Plant Extracts; C544478:flavocoxid; C038044:baicalin; D009288:Naproxen; D002392:Catechin