Table 2.
Trial | Treatment arm vs placebo | Overall | On clobazam | ||||
---|---|---|---|---|---|---|---|
Interaction p‐value | Treatment/odds ratio a (95% CI) | p‐value | Interaction p‐value | Treatment/odds ratio a (95% CI) | p‐value | ||
Reduction in drop seizure frequency | |||||||
GWPCARE3 | CBD10 | 0.71 (0.56‐0.89) | 0.0032 | 0.9727 | 0.70 (0.51‐0.98) | 0.0355 | |
CBD20 | 0.66 (0.53‐0.83) | 0.0005 | 0.0067 | 0.46 (0.33‐0.64) | <0.0001 | ||
GWPCARE4 | CBD20 | 0.73 (0.59‐0.90) | 0.0036 | 0.0123 | 0.54 (0.40‐0.73) | <0.0001 | |
Meta‐analysis | CBD10 + CBD20 | 0.8244 | 0.70 (0.62‐0.80) | <0.0001 | 0.1948 | 0.56 (0.47‐0.67) | <0.0001 |
CBD20 | 0.5363 | 0.70 (0.60‐0.82) | <0.0001 | 0.4734 | 0.51 (0.41‐0.63) | <0.0001 | |
≥50% responder rate | |||||||
GWPCARE3 | CBD10 | 3.30 (1.48‐7.35) | 0.0035 | 0.5021 | 2.72 (0.96‐7.67) | 0.0584 | |
CBD20 | 3.87 (1.76‐8.53) | 0.0008 | 0.7015 | 5.12 (1.81‐14.54) | 0.0021 | ||
GWPCARE4 | CBD20 | 2.61 (1.35‐5.06) | 0.0044 | 0.6190 | 3.14 (1.26‐7.81) | 0.0140 | |
Meta‐analysis | CBD10 + CBD20 | 0.7482 | 3.14 (2.04‐4.81) | <0.0001 | 0.6720 | 3.48 (1.96‐6.17) | <0.0001 |
CBD20 | 0.4545 | 3.07 (1.85‐5.10) | <0.0001 | 0.4879 | 3.88 (1.95‐7.71) | <0.0001 |
Results are based on a fixed‐effects meta‐analysis. The interaction p‐value tested the null hypothesis of homogeneity of the treatment effect across trials/dose comparisons.
Abbreviations: CBD10, cannabidiol 10 mg/kg/day; CBD20, cannabidiol 20 mg/kg/day; CI, confidence interval; LGS, Lennox–Gastaut syndrome.
Reductions in drop seizure frequency are displayed using treatment ratios; ≥50% responder rates are displayed using odds ratios.