Table 17.
Summary of findings table for treatment with galcanezumab 120 mg compared with no treatment for prevention of chronic migraine
| Outcomes | Anticipated absolute effects*(95% CI) | Relative effect(95% CI) | № of participants (studies) | Certainty of the evidence(GRADE) | Comments | |
|---|---|---|---|---|---|---|
| Risk with placebo | Risk with galcanezumab | |||||
| Reduction of monthly migraine days follow up: 3 months | The mean reduction of monthly headache days was −2.7 days | The mean reduction of monthly headache days in the intervention group was 2.1 days lower (2.9 lower to 1.3 lower) | – | 836(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with Galcanezumab 120 mg reduces monthly migraine days slightly compared to placebo. |
| Reduction of monthly acute treatment days follow up: 3 months | The mean reduction of monthly headache days was −2.2 days | The mean reduction of monthly acute treatment days in the intervention group was 2.5 days lower (3.3 lower to 1.8 lower)b | – | 836(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with Galcanezumab 120 mg reduces monthly acute treatment days slightly compared to placebo. |
| Improvement in functional MIDAS score follow up: 3 months | The mean improvement in functional MIDAS score was −11.5 points | The mean improvement in functional MIDAS score in the intervention group was 8.7 points lower (16.4 lower to 1.1 lower) | – | 836(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with Galcanezumab 120 mg improves functional MIDAS score compared to placebo. |
| At least 50% reduction of monthly migraine days follow up: 3 months | 149 per 1000 | 284 per 1000(215 to 375) | RR 1.9112(1.4477 to 2.5232) | 836(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with Galcanezumab 120 mg mg results in at least 50% reduction of monthly headache days compared to placebo. |
| Serious adverse events follow up: 3 months | 7 per 1000 | 4 per 1000(0 to 34) | RR 0.5288(0.0594 to 4.7092) | 836(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with Galcanezumab 120 mg mg results in a possibly unimportant effect on serious adverse event occurrence compared to placebo. |
| Mortalityfollow up: 3 months | 0 per 1000 | 0 per 1000(0 to 0) | not estimable | 836(1 RCT) | No deaths were observed with treatment with Galcanezumab 120 mg or placebo | |
CI: Confidence interval; RR: Risk ratio; RCT: randomized controlled trial; aDowngraded once due to inconsistency; bnominall significance, non-significant after multiplicity adjustments
GRADE Working Group grades of evidenceHigh certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect