Intention to treat | Per protocol | |||||
---|---|---|---|---|---|---|
Low dose | High dose | p Value | Low dose | High dose | p Value | |
N | 56 | 59 | 53 | 45 | ||
Cartilage volume: proportion with a statistically significant change (least significant change) at 2 years† | ||||||
Decrease | 3 (5%) | 8 (14%) | 0.21* | 2 (4%) | 5 (11%) | 0.09* |
No change | 47 (84%) | 42 (71%) | 46 (87%) | 31 (69%) | ||
Increase | 6 (11%) | 9 (15%) | 5 (10%) | 9 (20%) | ||
Bone marrow lesions: proportion with a clinically significant change at 2 years‡ | ||||||
Decrease | 5 (9%) | 7 (13%) | 0.23* | 5 (10%) | 6 (14%) | 0.41* |
No change | 48 (87%) | 42 (76%) | 45 (87%) | 33 (77%) | ||
Increase | 2 (4%) | 6 (11%) | 2 (4%) | 4 (9%) |
*p Values refer to comparisons between fish oil treatment groups.
†Least significant change33 was considered a change of >8% in either direction.
‡Clinically significant was considered a change >140 mm2 in either direction, which corresponds to a one-unit change in Western Ontario and McMaster Universities Arthritis Index score.25