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. 2023 Mar 31;2023(3):CD011006. doi: 10.1002/14651858.CD011006.pub4

Summary of findings 3. Mirtazapine compared to tricyclic antidepressants (TCA) for people with cancer and depression.

Mirtazapine compared to placebo for people with cancer and depression
Patient or population: adults with cancer and depression
Settings: inpatient and outpatient
Intervention: mirtazapine
Comparison: TCA
Outcomes Illustrative comparative risks* (95% CI) Relative effect
(95% CI) No of participants
(studies) Certainty of the evidence
(GRADE) Comments
Assumed risk Corresponding risk
Mirtazapine TCA
Efficacy as a continuous outcome
Follow‐up: 6–12 weeks The mean efficacy as a continuous outcome (MD) in the intervention groups was 4.80 lower in the intervention group (9.70 lower to 0.10 higher) 25 (1 RCT) ⊕⊝⊝⊝
Very lowa,b
Efficacy as a dichotomous outcome
Follow‐up: 6–12 weeks 77 per 1000 62 per 1000
(46 to 84) RR 0.81 (0.60 to 1.09) 33
(1 RCT) ⊕⊝⊝⊝
Very lowa,b
Dropouts due to any cause (acceptability)
Follow‐up: 4–12 weeks 308 per 1000 200 per 1000
(62 to 662) RR 0.65
(0.20 to 2.15) 33 (1 RCT) ⊕⊝⊝⊝
Very lowb,c
*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; RCT: randomised controlled trial; RR: risk ratio; TCA: tricyclic antidepressant.
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.

a Downgraded two levels as overall risk of bias was high according to the RoB 2 assessment, due to missing outcome data.
b Downgraded two levels as very low number of participants recruited (fewer than 100 individuals in both treatment arms) and 95% CIs included both no effect and appreciable benefit or appreciable harm, which suggests the risk of very serious imprecision of the results and thus low confidence in their reliability.
c Downgraded one level as overall risk of bias was moderate according to the RoB 2 assessment.