TABLE 3.
Overview of adverse events and effectiveness reported in accordance with different oral cannabinoid regimens at second follow‐up consultation (N = 214)
| THC N = 110 | CBD N = 82 | THC/CBD N = 22 | p‐value | Total N = 214 | |
|---|---|---|---|---|---|
| A. Adverse events, n (%) | |||||
| One or more adverse reactions | 41 (37) | 22 (27) | 9 (41) | 0.2021 | 72 (34) |
| Gastrointestinal disorders | 16 (15) | 9 (11) | 2 (9) | 0.5564 | 27 (13) |
| Nervous system disorders | 16 (15) | 4 (5) | 3 (14) | 0.0912 | 23 (11) |
| General disorders and administration site conditions | 14 (13) | 4 (5) | 2 (8) | 0.1810 | 20 (9) |
| Psychiatric disorder | 4 (4) | 2 (2) | 0 | 0.8842 | 6 (3) |
| Vascular disorders | 2 (2) | 0 | 0 | NA | 2 (1) |
| Musculoskeletal disorders | 1 (1) | 4 (5) | 0 | NA | 5 (2) |
| Skin and subcutaneous tissue disorders | 0 | 1 (1) | 0 | NA | 1 (<1) |
| Eye disorders | 0 | 0 | 1 (5) | NA | 1 (<1) |
| Respiratory disorders | 1 (1) | 1 (1) | 1 (5) | NA | 3 (1) |
| Cardiac disorders | 1 (1) | 0 | 0 | NA | 1 (<1) |
| Sensory disorders | 0 | 0 | 0 | NA | 0 |
| Other disorders | 1 (1) | 0 | 1 (4) | NA | 2 (1) |
| Missing, n | 0 | 1 | 0 | 2 | |
| B. NRS, collectively mean of means ± SD | |||||
| Baseline consultation | 7.2 ± 1.8 | 6.8 ± 1.7 | 6.8 ± 2.0 | 0.4211 | 7.0 ± 1.8 |
| Follow‐up consultation | 5.4 ± 2.4 | 5.0 ± 2.8 | 4.6 ± 2.4 | 0.3860 | 5.1 ± 2.5 |
| p‐value | <0.0001 | <0.0001 | 0.0006 | — | <0.0001 |
| Mean reduction NRS from baseline to follow‐up | 1.8 ± 2.3 | 1.8 ± 2.6 | 2.4 ± 2.4 | 0.5839 | 1.8 ± 2.4 |
| Missing, n | 18 | 17 | 4 | 39 | |
| C. Percentage change in paired mean NRS, n (%) | |||||
| Increase NRS | 12 (13) | 13 (20) | 2 (11) | 0.4276 | 27 (15) |
| No change NRS | 11 (12) | 9 (14) | 1 (6) | 0.6320 | 21 (12) |
| Reduction NRS >0 ‐ <30% | 31 (34) | 15 (23) | 2 (11) | 0.0889 | 48 (27) |
| Reduction NRS ≥30%‐ < 50% | 20 (22) | 9 (14) | 6 (33) | 0.1563 | 35 (20) |
| Reduction NRS ≥50% | 18 (20) | 19 (29) | 7 (39) | 0.1419 | 44 (25) |
| Missing, n | 18 | 17 | 4 | 39 | |
| D. Patient‐reported quality outcomes, n (%) | |||||
| Quality of sleep | |||||
| Improved | 50 (49) | 31 (44) | 13 (77) | 0.0511 | 94 (49) |
| No change | 45 (44) | 37 (52) | 3 (18) | 0.0359 | 85 (45) |
| Worsened | 8 (8) | 3 (4) | 1 (6) | 0.6375 | 12 (6) |
| Missing, n | 7 | 11 | 5 | 23 | |
| Quality of life | |||||
| Improved | 48 (51) | 35 (60) | 10 (71) | 0.2558 | 93 (56) |
| No change | 38 (40) | 21 (36) | 2 (14) | 0.1659 | 61 (37) |
| Worsened | 8 (9) | 2 (4) | 2 (14) | 0.2856 | 12 (7) |
| Missing, n | 16 | 24 | 8 | 48 | |
Note: Statistics: Chi2 (Adverse events, Percentage change in NRS, Patient‐reported quality outcomes), One‐way ANOVA (NRS difference between oral cannabinoid regimens), Paired t‐test (NRS difference between baseline and follow‐up).
Abbreviations: CBD, Cannabidiol; NRS, Numeric rating scale; SD, Standard deviation; THC, Tetrahydrocannabinol.