Effects of a ginger extract on knee pain in patients with osteoarthritis.
OBJECTIVE
To evaluate the efficacy and safety of a standardized and highly concentrated extract of 2 ginger species, Zingiber officinale and Alpinia galanga (EV.EXT 77), in patients with osteoarthritis (OA) of the knee.


METHODS
Two hundred sixty-one patients with OA of the knee and moderate-to-severe pain were enrolled in a randomized, double-blind, placebo-controlled, multicenter, parallel-group, 6-week study. After washout, patients received ginger extract or placebo twice daily, with acetaminophen allowed as rescue medication. The primary efficacy variable was the proportion of responders experiencing a reduction in "knee pain on standing," using an intent-to-treat analysis. A responder was defined by a reduction in pain of > or = 15 mm on a visual analog scale.


RESULTS
In the 247 evaluable patients, the percentage of responders experiencing a reduction in knee pain on standing was superior in the ginger extract group compared with the control group (63% versus 50%; P = 0.048). Analysis of the secondary efficacy variables revealed a consistently greater response in the ginger extract group compared with the control group, when analyzing mean values: reduction in knee pain on standing (24.5 mm versus 16.4 mm; P = 0.005), reduction in knee pain after walking 50 feet (15.1 mm versus 8.7 mm; P = 0.016), and reduction in the Western Ontario and McMaster Universities osteoarthritis composite index (12.9 mm versus 9.0 mm; P = 0.087). Change in global status and reduction in intake of rescue medication were numerically greater in the ginger extract group. Change in quality of life was equal in the 2 groups. Patients receiving ginger extract experienced more gastrointestinal (GI) adverse events than did the placebo group (59 patients versus 21 patients). GI adverse events were mostly mild.


CONCLUSIONS
A highly purified and standardized ginger extract had a statistically significant effect on reducing symptoms of OA of the knee. This effect was moderate. There was a good safety profile, with mostly mild GI adverse events in the ginger extract group.
Altman
R D
RD
Miami Veterans Affairs Medical Center and University of Miami, Florida, USA.
Marcussen
K C
KC
D000368:Aged; D004066:Digestive System Diseases / Q000139:chemically induced / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D020939:Zingiber officinale / Q000737:chemistry; D006801:Humans; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000503:physiopathology; D010146:Pain / Q000188:drug therapy* / Q000503:physiopathology; D010936:Plant Extracts / Q000627:therapeutic use*; D010946:Plants, Medicinal; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D010936:Plant Extracts