Effect of glucosamine sulfate with or without omega-3 fatty acids in patients with osteoarthritis.
BACKGROUND
A total of 177 patients with moderate-to-severe hip or knee osteoarthritis (OA) were tested over a period of 26 weeks in a two-center, two-armed, randomized, double-blind, comparison study. The aim was to see if a combination of glucosamine sulfate (1500 mg/day) and the omega-3 polyunsaturated fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (group A), showed equivalence (noninferiority) or superiority as opposed to glucosamine sulfate alone (group B).


METHODS
The primary therapy evaluation was performed using the Western Ontario and McMaster Universities Arthrosis index (WOMAC) score. At the end of the study, a reduction in the pain score of > or =20% was required (primary target criterion) and the quantitative difference in the WOMAC subscores pain, stiffness, and function were analyzed (secondary target criteria).


CONCLUSIONS
When a minimal pain reduction of > or =20% was chosen, there was no statistically significant difference in the number of responders between the two groups (92.2% group A, 94.3% group B). A higher responder criterion (> or =80% reduction in the WOMAC pain score) was chosen. Therefore, the frequency of responders showed a therapeutic and statistical superiority for the combination product of glucosamine sulfate and the omega-3 polyunsaturated fatty acids in patients who complied with the study protocol (group A 44%, group B 32%; P=0.044). OA symptoms (morning stiffness, pain in hips and knees) were reduced at the end of the study: by 48.5%-55.6% in group A and by 41.7%-55.3% in group B. The reduction was greater in group A than in group B. There was a tendency toward superiority shown in the secondary target criteria and concurrent variables. In the global safety evaluation, both products have been demonstrated to be very safe in long-term treatment over 26 weeks. To our knowledge, this is the first clinical trial in which glucosamine was given in combination with omega-3 fatty acids to patients with OA.
Gruenwald
Joerg
J
Analyze & Realize AG, Berlin, Germany. jgruenwald@analyze-realize.com
Petzold
Ellen
E
Busch
Regina
R
Petzold
Heinz-Peter
HP
Graubaum
Hans-Joachim
HJ
D000328:Adult; D000368:Aged; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015118:Eicosapentaenoic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005944:Glucosamine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000188:drug therapy*; D020370:Osteoarthritis, Knee / Q000188:drug therapy*
D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; D005944:Glucosamine