Summary of findings for the main comparison. Nortripyline for the prevention of postnatal depression.
Nortripyline for the prevention of postnatal depression | ||||||
Patient or population: women with a history of postnatal depression
Intervention: nortripyline Control: placebo | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Control | Tricyclic antidepressants | |||||
Postnatal depression (17 weeks) | 240 per 10001 | 230 per 1000 (86 to 622) | RR 0.96 (0.36 to 2.59) | 51 (1 study) | ⊕⊝⊝⊝ very low2,3 | |
Adverse effects experienced by mother and/or foetus or nursing baby | 51 (1 study) | ⊕⊝⊝⊝ very low2,3 | 1 woman assigned to nortriptyline developed mania within the first week. Constipation was reported more frequently in the nortriptyline than placebo group (78% among women taking nortriptyline and 22% among women taking placebo; Fischer's exact test P < 0.001). This was the only side effect that was more common among women taking nortriptyline than placebo, but the other side effects assessed and the proportion of women experiencing these side effects was not reported. |
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Acceptability of treatment (17 weeks) | 51 (1 study) | ⊕⊝⊝⊝ very low2,3 | Acceptability of treatment was not assessed directly but 1 woman was lost to follow‐up from the nortriptyline arm (and 1 women in the nortriptyline arm withdrew after developing mania in the first postpartum week) and 3 withdrew from the placebo arm (owing to side effects, personal reasons and pregnancy). 4 participants declined to take the study drug after randomisation. |
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Overall maternal satisfaction (17 weeks) | No data available | |||||
Improvement in the maternal relationship with the baby (17 weeks) | No data available | |||||
Establishment or continuation of breastfeeding (17 weeks) | No data available | |||||
*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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio | ||||||
GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: 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 quality: we are very uncertain about the estimate. |
1Assumed risk calculated as the proportion of women on placebo with the outcome (postnatal depression) multiplied by 1000
2Downgraded due to high risk of bias in 1 domain (incomplete outcome data) 3Downgraded twice due to imprecision (only 1 small study available for this comparison)