Demographics and primary and secondary outcome measures
| . | Baseline . | End point . | P . | ||
|---|---|---|---|---|---|
| Sativex . | Placebo . | Sativex . | Placebo . | ||
| Age (years) | 58.2 ± 8.8 | 54.4 ± 11.6 | 0.24 | ||
| Sex (female) | 4 | 7 | 0.38 | ||
| BMI (kg/m2) | 31.9 ± 6.3 | 31.6 ± 8.2 | 0.92 | ||
| Cannabis (previous use) | 2 | 0 | 0.60 | ||
| A1C (%) | 8.64 ± 1.7 | 8.39 ± 1.6 | 0.72 | ||
| Diabetes duration (years) | 11.2 ± 8.4 | 13.7 ± 6.0 | 0.37 | ||
| Type of diabetes (type 2) | 13 | 11 | 0.23 | ||
| Study medication amount (ml) | 0.70 ± 0.38 | 0.73 ± 0.38 | 0.84 | ||
| Pain diary scores | |||||
| Superficial pain | 52.3 ± 33.0 | 45.9 ± 24.6 | 37.9 ± 32.1 | 30.2 ± 30.1 | 0.72 |
| Deep pain | 63.1 ± 29.4 | 47.4 ± 21.4 | 44.5 ± 32.7 | 24.9 ± 29.5 | 0.38 |
| Muscular pain | 52.0 ± 34.2 | 41.4 ± 28.3 | 37.9 ± 32.9 | 20.4 ± 29.9 | 0.26 |
| TPS | 55.8 ± 26.7 | 44.9 ± 21.5 | 40.1 ± 28.5 | 25.2 ± 28.8 | 0.40 |
| Neuropathic pain scale | |||||
| Total score | 67.1 ± 19.4 | 63.6 ± 14.0 | 51.6 ± 21.9 | 51.9 ± 24.1 | 0.62 |
| McGill pain questionnaire | |||||
| Sensory scale | 19.2 ± 6.9 | 16.3 ± 6.3 | 14.7 ± 7.2 | 12.5 ± 8.7 | 0.65 |
| Affective scale | 4.6 ± 4.3 | 5.0 ± 3.8 | 3.1 ± 2.3 | 3.6 ± 3.8 | 0.81 |
| VAS | 7.6 ± 1.8 | 6.9 ± 1.7 | 5.1 ± 2.2 | 3.8 ± 2.6 | 0.24 |
| Present pain intensity | 2.5 ± 1.1 | 2.0 ± 1.0 | 2.1 ± 1.1 | 1.4 ± 1.7 | 0.57 |
| EQ-5D questionnaire | |||||
| Health status index | 0.40 ± 0.21 | 0.43 ± 0.21 | 0.54 ± 0.22 | 0.6 ± 0.2 | 0.87 |
| Health status VAS | 46.0 ± 20.4 | 44.6 ± 21.8 | 58.1 ± 20.5 | 56.4 ± 11.7 | 0.92 |
| SF-36 questionnaire | |||||
| Physical functioning | 26.9 ± 15.1 | 30.8 ± 22.7 | 30.5 ± 16.6 | 36.5 ± 27.9 | 0.63 |
| Role physical | 8.9 ± 27.1 | 12.5 ± 23.5 | 12.5 ± 32.1 | 39.3 ± 47.7 | 0.12 |
| Bodily pain | 22.4 ± 15.5 | 25.7 ± 11.3 | 35.6 ± 16.6 | 41.2 ± 24.6 | 0.64 |
| General health | 33.5 ± 18.7 | 28.4 ± 20.8 | 34.1 ± 18.2 | 29.6 ± 19.5 | 0.78 |
| Vitality | 28.3 ± 23.2 | 30.8 ± 19.2 | 33.9 ± 22.4 | 39.6 ± 19.4 | 0.45 |
| Social functioning | 50.8 ± 32.5 | 48.2 ± 24.9 | 55.4 ± 25.3 | 67.0 ± 27.6 | 0.08 |
| Role emotional | 38.1 ± 41.1 | 33.3 ± 40.8 | 54.8 ± 46.4 | 47.6 ± 48.4 | 0.76 |
| Mental health | 57.9 ± 22.6 | 57.1 ± 19.9 | 64.4 ± 20.3 | 59.4 ± 20.6 | 0.76 |
| . | Baseline . | End point . | P . | ||
|---|---|---|---|---|---|
| Sativex . | Placebo . | Sativex . | Placebo . | ||
| Age (years) | 58.2 ± 8.8 | 54.4 ± 11.6 | 0.24 | ||
| Sex (female) | 4 | 7 | 0.38 | ||
| BMI (kg/m2) | 31.9 ± 6.3 | 31.6 ± 8.2 | 0.92 | ||
| Cannabis (previous use) | 2 | 0 | 0.60 | ||
| A1C (%) | 8.64 ± 1.7 | 8.39 ± 1.6 | 0.72 | ||
| Diabetes duration (years) | 11.2 ± 8.4 | 13.7 ± 6.0 | 0.37 | ||
| Type of diabetes (type 2) | 13 | 11 | 0.23 | ||
| Study medication amount (ml) | 0.70 ± 0.38 | 0.73 ± 0.38 | 0.84 | ||
| Pain diary scores | |||||
| Superficial pain | 52.3 ± 33.0 | 45.9 ± 24.6 | 37.9 ± 32.1 | 30.2 ± 30.1 | 0.72 |
| Deep pain | 63.1 ± 29.4 | 47.4 ± 21.4 | 44.5 ± 32.7 | 24.9 ± 29.5 | 0.38 |
| Muscular pain | 52.0 ± 34.2 | 41.4 ± 28.3 | 37.9 ± 32.9 | 20.4 ± 29.9 | 0.26 |
| TPS | 55.8 ± 26.7 | 44.9 ± 21.5 | 40.1 ± 28.5 | 25.2 ± 28.8 | 0.40 |
| Neuropathic pain scale | |||||
| Total score | 67.1 ± 19.4 | 63.6 ± 14.0 | 51.6 ± 21.9 | 51.9 ± 24.1 | 0.62 |
| McGill pain questionnaire | |||||
| Sensory scale | 19.2 ± 6.9 | 16.3 ± 6.3 | 14.7 ± 7.2 | 12.5 ± 8.7 | 0.65 |
| Affective scale | 4.6 ± 4.3 | 5.0 ± 3.8 | 3.1 ± 2.3 | 3.6 ± 3.8 | 0.81 |
| VAS | 7.6 ± 1.8 | 6.9 ± 1.7 | 5.1 ± 2.2 | 3.8 ± 2.6 | 0.24 |
| Present pain intensity | 2.5 ± 1.1 | 2.0 ± 1.0 | 2.1 ± 1.1 | 1.4 ± 1.7 | 0.57 |
| EQ-5D questionnaire | |||||
| Health status index | 0.40 ± 0.21 | 0.43 ± 0.21 | 0.54 ± 0.22 | 0.6 ± 0.2 | 0.87 |
| Health status VAS | 46.0 ± 20.4 | 44.6 ± 21.8 | 58.1 ± 20.5 | 56.4 ± 11.7 | 0.92 |
| SF-36 questionnaire | |||||
| Physical functioning | 26.9 ± 15.1 | 30.8 ± 22.7 | 30.5 ± 16.6 | 36.5 ± 27.9 | 0.63 |
| Role physical | 8.9 ± 27.1 | 12.5 ± 23.5 | 12.5 ± 32.1 | 39.3 ± 47.7 | 0.12 |
| Bodily pain | 22.4 ± 15.5 | 25.7 ± 11.3 | 35.6 ± 16.6 | 41.2 ± 24.6 | 0.64 |
| General health | 33.5 ± 18.7 | 28.4 ± 20.8 | 34.1 ± 18.2 | 29.6 ± 19.5 | 0.78 |
| Vitality | 28.3 ± 23.2 | 30.8 ± 19.2 | 33.9 ± 22.4 | 39.6 ± 19.4 | 0.45 |
| Social functioning | 50.8 ± 32.5 | 48.2 ± 24.9 | 55.4 ± 25.3 | 67.0 ± 27.6 | 0.08 |
| Role emotional | 38.1 ± 41.1 | 33.3 ± 40.8 | 54.8 ± 46.4 | 47.6 ± 48.4 | 0.76 |
| Mental health | 57.9 ± 22.6 | 57.1 ± 19.9 | 64.4 ± 20.3 | 59.4 ± 20.6 | 0.76 |
Data are n or means ± SD unless otherwise indicated. Pain diary scores derived from 100 mm VAS completed daily. TPS derived from average of superficial, deep, and muscular pain scores. EQ-5D, EuroQOL quality-of-life questionnaire.