Summary of findings 4. Sertraline compared to cognitive behavioural therapy for people with epilepsy and depression.
| Sertraline compared to cognitive behavioural therapy for people with epilepsy and depression | ||||||
| Patient or population: people with epilepsy and depression Settings: outpatients Intervention: sertraline Comparison: cognitive behavioural therapy (CBT) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| CBT | sertraline | |||||
|
> 50% reduction in depressive symptoms Follow‐up: NA |
‐ | ‐ | ‐ | 0 (0 studies) |
‐ | |
|
Mean depression scores (BDI scores; lower = better) Follow‐up: 16 weeks |
NA | The mean BDI depression score in the intervention group was 0.50 lower (4.47 lower to 3.47 higher) | NA | 117 (1 RCT) | ⊕⊕⊕⊝ moderatea |
At 8 weeks: MD ‐2.50 (95% CI ‐6.28 to 1.28; 104 participants) |
|
Seizure frequency Follow‐up: 16 weeks |
NA | The mean frequency of GTCS per month in the intervention group was 0 lower (‐0.10 lower to 0.10 higher) The mean frequency of focal seizures with impaired awareness per month in the intervention group was 3.00 lower (7.81 lower to 1.81 higher) |
NA | 96 with GTCS plus 75 with focal seizures (1 RCT) |
⊕⊕⊝⊝ lowb |
At 8 weeks: GTCS per month: MD ‐0.10 (95% CI ‐0.26 to 0.06; 86 participants) focal seizures with impaired awareness per month: MD ‐2.60 (95% CI ‐6.52 to 1.32; 75 participants) |
|
Withdrawals Follow‐up: 16 weeks |
176 per 1000 |
222 per 1000 (113 to 434 per 1000) |
RR 1.26 (0.64 to 2.46) | 140 (1 RCT) | ⊕⊕⊕⊝ moderatea |
CBT: 6 withdrew, 6 lost to follow‐up sertraline: 7 withdrew, 9 lost to follow‐up |
|
Cognitive functioning Follow‐up: NA |
‐ | ‐ | ‐ | 0 (0 studies) |
‐ | |
|
Quality of life (QOLIE‐89 scale; lower = better) Follow‐up: 16 weeks |
NA | The mean QOLIE‐89 score in the intervention group was 3.10 higher (3.41 lower to 9.61 higher) | NA | 118 (1 RCT) |
⊕⊕⊕⊝ moderatea |
at 8 weeks: MD 6.10 (95% CI ‐0.28 to 12.48; 104 participants) |
|
Adverse effects Follow‐up: 16 weeks |
NA | The mean adverse event profile score in the intervention group was 2.10 lower (6.21 lower to 2.01 higher) | NA | 118 (1 RCT) |
⊕⊕⊕⊝ lowa,c |
Sertraline resulted in more cases of tiredness than CBT (RR 3.54, 99% CI 1.40 to 8.96; 140 participants) Sertraline did not result in more cases of any other adverse effects than CBT. |
| *The basis for the assumed risk is the event rate in the CBT group. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BDI: Beck Depression Inventory; CBT: cognitive behavioural therapy; CI: confidence interval; MD: mean difference; NA: not applicable; QOLIE: Quality of life in Epilepsy; RCT: randomised controlled trial; RR: risk ratio; GTCS: generalised tonic‐clonic seizures | ||||||
| GRADE Working Group grades of evidence High certainty. Further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty, Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty. Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty. We are very uncertain about the estimate. | ||||||
aCertainty of the evidence downgraded once due to risk of bias: participants and personnel not blinded, and lack of blinding may have influenced outcome bCertainty of the evidence downgraded twice due to risk of bias and imprecision: risk of recall bias as seizure frequency data at baseline was collected retrospectively, and data not available for all participants
cCertainty of the evidence downgraded once due to imprecision: adverse event data not available for all participants who received an intervention