Table 3.
Days 1–7 | Weeks 2–4 | |||||||
Naproxen | Colchicine | OR (95% CI) (p value) | Naproxen | Colchicine | OR (95% CI) (p value) | |||
N (%)* | N (%)* | Complete case* | Imputed† | N (%)* | N (%)* | Complete case* | Imputed† | |
Paracetamol | 20 (13.4) | 34 (23.6) | 2.09 (1.11 to 3.93) (p=0.022) |
1.91 (1.05 to 3.51) (p=0.035) |
10 (7.5) | 11 (7.1) | 1.12 (0.45 to 2.82) (p=0.81) |
0.98 (0.40 to 2.37) (p=0.96) |
Ibuprofen | 16 (10.7) | 20 (13.9) | 1.54 (0.72 to 3.29) (p=0.27) |
1.58 (0.80 to 3.12) (p=0.19) |
12 (9.0) | 27 (17.5) | 2.34 (1.11 to 4.94) (p=0.026) |
1.93 (0.90 to 4.14) (p=0.089) |
Diclofenac | 2 (1.3) | 4 (2.8) | – | – | 4 (3.0) | 6 (3.9) | – | – |
Indomethacin | 1 (0.7) | 0 (0.0) | – | – | 2 (1.5) | 5 (3.2) | – | – |
Tramadol | 1 (0.7) | 0 (0.0) | – | – | 1 (0.7) | 2 (1.3) | – | – |
Codeine | 7 (4.7) | 21 (14.6) | 3.62 (1.47 to 8.93) (p=0.005) |
3.20 (1.35 to 7.57) (p=0.008) |
12 (9.0) | 8 (5.2) | 0.60 (0.22 to 1.65) (p=0.32) |
0.59 (0.23 to 1.50) (p=0.27) |
Prednisolone | 3 (2.0) | 2 (1.4) | – | – | 2 (1.5) | 1 (0.6) | – | – |
Any analgesic or non-naproxen NSAID‡ | 37 (24.8) | 61 (42.4) | 2.23 (1.35 to 3.66) (p=0.001) |
1.89 (1.24 to 2.88) (p=0.003) |
37 (27.6) | 52 (33.8) | 1.34 (0.81 to 2.21) (p=0.26) |
0.95 (0.63 to 1.43) (p=0.81) |
OR for colchicine relative to naproxen (adjusted for age, gender and baseline pain score). *Analysis of complete case data (days 1–7: n=288; five cases excluded due to missing baseline pain scores; week 4: n=283; five cases excluded due to missing baseline pain scores). †Analysis of imputed data (n=399). n/a: analysis not applicable (as it is an evaluation of compliance with allocated treatment). –, ORs not estimated due to small frequency counts.
*Complete response to medication questions: diary days 1–7—149 in naproxen group and 144 in colchicine group; week 4—134 in naproxen group and 154 in colchicine group.
†Imputed data set: 200 in naproxen group; 199 in colchicine group (full ITT analysis).
‡Paracetamol or codeine or tramadol or ibuprofen or diclofenac or indomethacin.
ITT, intention-to-treat; NSAID, non-steroidal anti-inflammatory drug.