Table 1.
Randomised trial | Preference study | ||||
---|---|---|---|---|---|
Oral | Topical | Oral | Topical | ||
No of participants | 144 | 138 | 79 | 224 | |
Demographic data | |||||
No (%) of men | 63 (44) | 68 (49) | 31 (39) | 95 (42) | |
Mean age at randomisation (median, IQR) | 63 (60, 56-69) | 63 (60, 56-68) | 64 (64, 57-72) | 66 (66, 60-72) | |
No (%) with occupational codes 1-330 * | 54 (38) | 39 (28) | 24 (30) | 53 (24) | |
No (%) who met clinical criteria for osteoarthritis13 | 140 (98) | 134 (97) | 79 (100) | 217 (97) | |
Mean BMI (median, IQR) | 31 (29, 26-34) | 30 (29, 26-32) | 30 (29, 27-33) | 29 (28, 26-32) | |
Pain/wellbeing | |||||
WOMAC (each scale range 0-100†): | |||||
No of participants with data | 144 | 135 | 76 | 216 | |
Pain score | 39 (21.5) | 39 (19.3) | 39 (19.3) | 41 (20.1) | |
Stiffness | 47 (25.7) | 50 (24.6) | 50 (22.4) | 49 (24.9) | |
Difficulty | 38 (23.1) | 37 (18.3) | 41 (20.2) | 40 (20.4) | |
Global | 39 (22.0) | 38 (17.6) | 41 (18.7) | 41 (19.4) | |
EQ-5D utility score: | |||||
No of participants with data | 140 | 138 | 78 | 219 | |
Score | 0.65 (0.22) | 0.67 (0.19) | 0.63 (0.23) | 0.66 (0.19) | |
Chronic pain grade: | |||||
No of participants with data | 141 | 136 | 78 | 219 | |
Pain intensity | 52.6 (19.9) | 52.0 (18.2) | 54.9 (18.3) | 51.9 (18.4) | |
Disability | 38.5 (27.3) | 34.5 (23.4) | 37.6 (23.3) | 35.3 (25.7) | |
No (%) with grade III or IV | 50 (35) | 35 (26) | 26 (33) | 68 (31) | |
SF-36 (SD): | |||||
No of participants with data | 138 | 136 | 74 | 209 | |
Physical component score | 39.0 (9.7) | 39.2 (8.9) | 37.7 (7.8) | 38.5 (9.4) | |
Mental component score | 52.0 (10.2) | 53.7 (9.6) | 51.7 (10.4) | 52.0 (10.0) | |
No (%) with very/extremely troublesome knee pain14 | 45/144 (31) | 45/138 (33) | 26/79 (33) | 66/224 (29) | |
No (%) with indigestion in past 3 months: | |||||
No of participants with data | 144 | 138 | 78 | 224‡ | |
None | 86 (60) | 78 (57) | 47 (59) | 106 (47) | |
A few days or occasionally | 50 (35) | 54 (39) | 28 (35) | 106 (47) | |
Over occasional-less than 50% of time | 8 (6) | 6 (4) | 3 (4) | 11 (5) | |
No (%) who used NSAIDs in past year: | |||||
No of participants with data | 141 | 138 | 78 | 223 | |
Used neither oral nor topical | 34 (24) | 20 (14) | 8 (10) | 64 (29) | |
Used oral only | 59 (41) | 81 (59) | 49 (62) | 82 (37) | |
Used topical only | 9 (6) | 8 (6) | 1 (1) | 40 (18) | |
Used both topical and oral | 39 (27) | 28 (20) | 21 (27) | 37 (17) | |
No (%) with other pain: | |||||
No of participants with data | 143 | 138 | 79 | 221 | |
At least one more area of at least moderately troublesome pain14 | 101 (71) | 97 (71) | 66 (84)§ | 160 (73)§ | |
Expectation (%): | |||||
How helpful do you think tablets will be? (very, helpful, not helpful) | 30, 63, 7 (n=144) | 28, 64, 8 (n=136) | 44, 54, 1 (n=79) | 11, 59, 30 (n=222) | |
How helpful do you think ointment will be? (very, helpful, not helpful) | 30, 59, 10 (n=138) | 16, 67, 17 (n=135) | 7, 48, 45 (n=71) | 30, 69, 1 (n=216) | |
Blood pressure (average of three readings before study entry¶) | |||||
No of participants with data | 142 | 138 | 76 | 222 | |
Systolic (mm Hg) | 134 (15) | 131 (15) | 135 (15) | 132 (15) | |
Diastolic (mm Hg) | 74 (10) | 75 (10) | 73 (9) | 71 (8) | |
Lung function (best of three readings at study entry assessment) and blood results | |||||
No of participants with data | 143 | 135 | 78 | 223 | |
PEF (l/min) | 380 (126) | 388 (125) | 365 (105) | 345 (114) | |
FEVl (l) | 2.36 (0.69) | 2.42 (0.72) | 2.40 (0.71) | 2.24 (0.65) | |
Hb (g/l) | 141 (11) | 141 (11) | 139 (10) | 139 (13) | |
Creatinine (µmol/l) | 86 (15) | 88 (16) | 88 (17) | 88 (15) | |
Ferritin (μg/l) | 120 (94) | 127 (106) | 117 (92) | 106 (92) | |
loge (ferritin (μg/l) | 4.5 (0.8) | 4.5 (0.8) | 4.5 (0.8) | 4.4 (0.8) |
BMI=body mass index; IQR=interquartile range, PEF=peak expiratory flow, FEV1=forced expiratory volume in one second.
*Managers and senior officials, professionals, and associate professional and technical, better of self or partner.30
†0=no symptoms, 100=maximum symptoms.
‡One person included in error with pain > half the days.
§95% CI for difference −1% to −21%.
¶Excluding seven participants with higher than eligible mean BP recorded.