Palomaki 2003.

Methods	Randomised, double‐blind, controlled trial
Participants	Insomnia diagnosis criteria (method of diagnosis): insomnia was not diagnosed, but just rated on 3 items of the HAM‐D Other diagnoses: acute ischaemic stroke Number of participants randomised: n = 100 Mianserin: n = 51 Placebo: n = 49 Number of participants: n = 81 Mianserin: n = 42 Placebo: n = 39 Age, mean (SD) years: Mianserin: 55.7 (11.1) Placebo: 54.7 (10.1) Gender (M/F): Mianserin: 36/15 Placebo: 32/17 Race/ethnicity: not reported Country: Finland Setting: inpatients Department of Neurology, University of Helsinki Included: acute ischaemic stroke inpatients aged < 71 years admitted to Department of Neurology Excluded: older people because of a reported risk of mianserin‐related leukopenia and agranulocytosis in elderly people. People were not eligible for the study if stroke had occurred more than 30 days earlier, if CT or MRI examinations were not compatible with acute ischaemic stroke, or if informed consent was not obtained from the patient or a carer. Excluded were also those with other severe diseases than ischaemic stroke, such as severe cardiovascular, renal or liver disease, psychosis, alcoholism or dementia Withdrawals: n = 19 Mianserin: n = 9 (lack of efficacy n = 1, lack of compliance n = 1, adverse effects n = 6, death n = 1) Placebo: n = 10 (lack of efficacy n = 3, lack of compliance n = 3, adverse effects n = 3, death n = 1) Baseline imbalances: (Table 1) participants in the mianserin group had more heart disease (n = 17) than participants in the placebo group (n = 10)
Interventions	Intervention: mianserin 30 mg for up to 10 days then increased to 60 mg/night for 12 months followed by withdrawal over 4 weeks Comparator: placebo/presumably 1 or 2 tablets/might for 12 months followed by withdrawal over 4 weeks
Outcomes	Primary outcome Composite score from 3 HAM‐D sleep items Secondary outcome Needing for sleep‐promoting medication
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details given
Allocation concealment (selection bias)	Unclear risk	No details given
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No details given
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details given
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Ten patients on placebo and 9 on mianserin discontinued the treatment prematurely" (Pg 60).
Selective reporting (reporting bias)	Low risk	All outcome measures were reported briefly (Pg 58‐60).
Other bias	Unclear risk	No mention or disclosure of funding