TABLE 2.
Overview of adverse events and effectiveness reported in accordance with different oral cannabinoid regimens at first follow‐up consultation (N = 529)
| THC N = 284 | CBD N = 198 | THC/CBD N = 47 | p‐value | Total N = 529 | |
|---|---|---|---|---|---|
| (A) Adverse events, n (%) | |||||
| One or more adverse reactions | 145 (51) | 59 (30) | 19 (40) | <0.0001 | 223 (42) |
| Gastrointestinal disorders | 64 (23) | 19 (10) | 8 (17) | 0.0011 | 91 (17) |
| Nervous system disorders | 58 (21) | 13 (7) | 5 (11) | <0.0001 | 76 (14) |
| General disorders and administration site conditions | 49 (17) | 17 (9) | 7 (15) | 0.0245 | 73 (14) |
| Psychiatric disorder | 17 (6) a | 7 (4) | 0 | 0.1307 | 24 (5) |
| Vascular disorders | 5 (2) | 0 | 1 (2) | NA | 6 (1) |
| Musculoskeletal disorders | 1 (<1) | 4 (2) | 1 (2) | NA | 6 (1) |
| Skin and subcutaneous tissue disorders | 1 (<1) | 2 (1) | 0 | NA | 3 (1) |
| Eye disorders | 1 (<1) | 1 (1) | 0 | NA | 2 (<1) |
| Respiratory disorders | 0 | 1 (1) | 0 | NA | 1 (<1) |
| Cardiac disorders | 0 | 1 (1) | 0 | NA | 1 (<1) |
| Sensory disorders | 0 | 0 | 1 (2) | NA | 1 (<1) |
| Other disorders | 6 (2) | 2 (1) | 2 (4) | NA | 10 (2) |
| Missing, n | 1 | 0 | 0 | 1 | |
| (B) NRS, collectively mean of means ± SD | |||||
| Baseline consultation | 7.3 ± 1.6 | 6.8 ± 1.6 | 6.7 ± 1.9 | 0.0052 | 7.0 ± 1.7 |
| Follow‐up consultation | 5.8 ± 2.3 | 5.6 ± 2.4 | 4.6 ± 2.5 | 0.0200 | 5.6 ± 2.4 |
| p‐value | <0.0001 | <0.0001 | <0.0001 | — | <0.0001 |
| Mean reduction NRS from baseline to follow‐up | 1.5 ± 2.1 | 1.2 ± 2.2 | 1.9 ± 2.5 | 0.0662 | 1.4 ± 2.2 |
| Missing, n | 59 | 32 | 7 | 98 | |
| (C) Percentage change in paired mean NRS, n (%) | |||||
| Increase NRS | 34 (15) | 34 (21) | 5 (13) | 0.2759 | 73 (17) |
| No change NRS | 37 (16) | 30 (18) | 6 (15) | 0.8618 | 73 (17) |
| Reduction NRS >0–<30% | 86 (38) | 50 (30) | 9 (23) | 0.0720 | 145 (34) |
| Reduction NRS ≥30%–<50% | 27 (12) | 26 (16) | 10 (25) | 0.0891 | 63 (15) |
| Reduction NRS ≥50% | 41 (18) | 26 (16) | 10 (25) | 0.3761 | 77 (18) |
| Missing, n | 59 | 32 | 7 | 98 | |
| (D) Patient‐reported quality outcomes | |||||
| Quality of sleep | |||||
| Improved | 133 (53) | 98 (55) | 26 (63) | 0.4579 | 257 (55) |
| No change | 115 (46) | 71 (40) | 14 (34) | 0.2471 | 200 (43) |
| Worsened | 3 (1) | 9 (5) | 1 (2) | 0.0553 | 13 (3) |
| Missing, n | 33 | 20 | 6 | 59 | |
| Quality of life | |||||
| Improved | 132 (56) | 88 (53) | 29 (78) | 0.0175 | 249 (57) |
| No change | 95 (40) | 76 (46) | 8 (22) | 0.0248 | 179 (41) |
| Worsened | 10 (4) | 2 (1) | 0 | 0.1066 | 12 (3) |
| Missing, n | 47 | 32 | 10 | 89 | |
Note: Statistics: Chi2 (Adverse events, Percentage change in NRS, Patient‐reported quality outcomes), One‐way ANOVA (NRS difference between CBM regimens), Paired t‐test (NRS difference between baseline and follow‐up).
Abbreviations: CBD, Cannabidiol; NRS, Numeric rating scale; SD, Standard deviation; THC, Tetrahydrocannabinol.
a
One patient (0.2%) developed hallucinations following intake of THC. The patient did not comply with the recommended dosage guideline.