03.01.10
Nutraceutical: Glucosamine and omega 3 fatty acids
Indication: Osteoarthritis (OA)
Source: Advances in Therapy, September 2009;(26)9:858-871.
Research: A total of 177 patients with moderate-to-severe hip or knee osteoarthritis (OA) were tested during 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 EPA and DHA (group A), showed equivalence (noninferiority) or superiority as opposed to glucosamine sulfate alone (group B). 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 ≥20% was required (primary target criterion) and the quantitative difference in the WOMAC subscores pain, stiffness and function were analyzed (secondary target criteria).
Results: When a minimal pain reduction of ≥80% was chosen (in the WOMAC pain score) results indicated 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%). OA symptoms (morning stiffness, pain in hips and knees) were reduced at the end of the study by 48.5–56% in group A and by 42–55% 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 were found to be very safe in long-term treatment over 26 weeks.
Indication: Osteoarthritis (OA)
Source: Advances in Therapy, September 2009;(26)9:858-871.
Research: A total of 177 patients with moderate-to-severe hip or knee osteoarthritis (OA) were tested during 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 EPA and DHA (group A), showed equivalence (noninferiority) or superiority as opposed to glucosamine sulfate alone (group B). 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 ≥20% was required (primary target criterion) and the quantitative difference in the WOMAC subscores pain, stiffness and function were analyzed (secondary target criteria).
Results: When a minimal pain reduction of ≥80% was chosen (in the WOMAC pain score) results indicated 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%). OA symptoms (morning stiffness, pain in hips and knees) were reduced at the end of the study by 48.5–56% in group A and by 42–55% 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 were found to be very safe in long-term treatment over 26 weeks.
