Summary of findings 1. Antidepressants versus placebo for postnatal depression.
| Antidepressants versus placebo for postnatal depression | ||||||
|
Patient or population: women of any age, with PND up to 12 months Settings: any Intervention: antidepressant (SSRI) Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of women (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with antidepressant | |||||
|
Depression response (acute, 5 ≤ 12 weeks) |
427 per 1000 | 543 per 1000 (414 to 719) |
RR 1.27 (0.97 to 1.66) |
205 (4 RCTs) | ⊕⊕⊝⊝a,b,c Low |
Three studies defined response as ≥ 50% reduction in EPDS or HAM‐D score from baseline. One study defined response as CGI‐I score of 1 or 2. |
|
Depression remission (acute, 5 ≤ 12 weeks) |
272 per 1000 | 419 per 1000 (269 to 655) |
RR 1.54 (0.99 to 2.41) |
205 (4 RCTs) | ⊕⊕⊝⊝a,b,c Low |
All studies defined remission as a score of ≤ 7 or ≤ 8 on EPDS or HAM‐D scales |
| Adverse events | Yonkers 2008 reported that some side effects appeared more common in the antidepressant group, no significant differences were found. Hantsoo 2013 reported side effects in 3/17 women from the sertraline group and 1/19 in the placebo group. No women dropped out due to side effects. Bloch 2012 showed no significant difference between treatment groups at week 8 (P = 0.46) or at week 12 (P = 0.94) in UKU Side Effect Rating scores, although the overall proportion of women experiencing side effects in each group was not given, neither were the details of types of side effects experienced. Appleby 1997 reported that 1 woman dropped out of the fluoxetine group and 3 women dropped out of the placebo group due to side effects, but the nature of these side effects was not reported. Side effects were only reported among women who dropped out of the study. Wisner 2015 used the Asberg rating scale for side effects. Comparing items rating moderate intensity, the only significant difference was for headaches, which were more common in the placebo (75%) group than the sertraline (43%) group (P = 0.03). For items rated 3 (severe), no significant differences between treatment groups were observed. 5 women (4/30 from sertraline group and 1/29 from placebo group) were withdrawn from the study as 4 developed hypomania (3 sertraline, 1 placebo) and 1 developed psychosis (sertraline). OHara 2019 reported that serious adverse events occurred in 10 women treated with sertraline and 7 women treated with placebo. |
⊕⊕⊝⊝d Low |
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|
Depression severity ‐ overall (acute, 5 ≤ 12 weeks) |
The mean depression severity score was between 7 and 13 | SMD 0.30lower (0.55 lower to 0.05 lower) |
‐ | 251 (4 RCTs) | ⊕⊕⊝⊝a,c Low |
Measured with HAM‐D or EPDS. Lower mean score = less severe depression. SMD 0.30 represents a small effect in favour of SSRI. This reflects a reduction of 1.68 on the EPDS scale or a reduction of 2.08 on the HAMD scale. |
|
Depression severity ‐ EPDS (acute, 5 ≤ 12 weeks) |
The mean EPDS score (acute phase) was between 8 and 14 | MD 3.51 lower (6.24 lower to 0.78 lower) | ‐ | 122 (2 RCTs) |
⊕⊕⊝⊝c,e Low |
Lower mean score = less severe depression |
| Treatment acceptability ‐ dropouts | 271 per 1000 |
298 per 1000 (201 to 445) |
RR 1.10 (0.74 to 1.64) |
233 (4 RCTs) |
⊕⊕⊝⊝a,b,c Low |
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| Child‐related outcomes | See comment | ‐ | ‐ | ‐ | No study reported this outcome | |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. 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). CI: confidence interval; CGI: Clinical Global Impressions; EPDS: Edinburgh Postnatal Depression Scale; HAM‐D: Hamilton Rating Scale for Depression; MD: mean difference; PND: postnatal depression; RR: risk ratio; SMD: standardised mean difference; SSRI: selective serotonin reuptake inhibitors | ||||||
| GRADE Working Group grades of evidence High 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. | ||||||
aDowngraded one level for high risk of attrition and reporting bias in one study, unclear risk of selection, detection, reporting and other bias in three other studies. bDowngraded one level for imprecision as the confidence interval includes no effect and appreciable harm. cDowngraded one level for imprecision as the number of participants is less than 400. dDowngraded two levels for high risk of attrition bias in one study and unclear risk of attrition bias in the remaining three studies, high risk of reporting bias in one study and unclear risk of reporting bias in the remaining three studies, unclear risk of selection bias in three studies, unclear risk of performance bias in one study and unclear risk of other bias in all four studies. eDowngraded one level for unclear risk of selection bias, attrition bias, reporting bias and other bias in two studies.