Table 6.
Placebo comparator: Patient profile comparison.
| Characteristics of patients at inclusion | Chevalier et al8 | Strand et al7* | Hangody et al10 | Pooled placebo† | Arthrum 2.5%‡ | Matching the groups§ |
|
|---|---|---|---|---|---|---|---|
| Difference | Statistics | ||||||
| Population, n | 129 | 128 | 69 | 326 | 218 | ||
| Age, y | |||||||
| Mean (SD) | 62.5 (9.2) | 60.3 (10.0) | 58.0 (9.0) | 60.7 (9.5) | 62.9 (12.6) | –2.2 (10.8) | P = 0.019 |
| Sex, n (%) | |||||||
| Men | 41 (32) | 51 (40) | 18 (26) | 110 (34) | 95 (44) | –10% | |
| Women | 88 (68) | 77 (60) | 51 (74) | 216 (66) | 123 (56) | 10% | |
| KL radiologic grade of knee osteoarthritis, n (%) | |||||||
| Grade I-II | 51 (39) | 65 (51) | 55 (80) | 171 (52) | 118 (54) | –2% | χ2 = 0.86 |
| Grade III | 78 (60) | 63 (49) | 14 (20) | 155 (48) | 99 (46) | 2% | |
| Grade IV | 1 (1) | 0 | 0 | 1 (0) | 0 | 0% | P = 0.65 |
| Body mass index | |||||||
| Mean (SD) | 29.8 (5.7) | 28.7 (3.8) | 29.1 (4.5) | 29.2 (4.8) | 27.2 (4.3) | 2.0 (4.6) | p < 0.001|| |
| Anteriority of knee osteoarthritis, y | |||||||
| Mean (SD) | 5.8 (5.4) | – | – | 5.8 (5.4) | 4.1 (5.4) | 1.7 | |
KL= Kellgren-Lawrence.
⁎
Strand was only effective for the Western Ontario and McMaster Universities Osteoarthritis Index pain subscore A, from day 30 to day 90. With Chevalier and Hangody alone (N = 198), there was no incidence on the Kellgren-Lawrence (radiologic osteoarthritis scale profile matching (χ2 = 1.12; P = 0.57) and the age criteria passed (P = 0.070).
‡
LCA Pharmaceutical (Product group studied), Chartres, France.
§
Matching the pooled placebo group with the Arthrum 2.5% group.
||
The body mass index difference (2.0 more for placebo) was accepted as both groups were in the same body mass index category (overweight).