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. 2021 Nov 15;2021(11):CD009286. doi: 10.1002/14651858.CD009286.pub4

Pan 2018.

Study characteristics
Methods Study type: interventional (clinical trial)
Primary purpose: treatment
Participants 170 participants
Country: China
Setting: inpatient
At randomisation number allocated: 170, paroxetine (n = 85); usual care (n = 85)
% male: paroxetine (71.8); usual care (unclear)
Age: mean age paroxetine = 65.6 ± 7.56; placebo = unclear
Subtype of stroke: not stated.
Severity of stroke: NIHSS, Median (IQR): paroxetine 8 (6 – 10); usual care (unclear)
Time since stroke onset: within 1 week
Inclusion criteria
  • Age between 50 and 80 years old

  • Diagnostic criteria met (Fourth National Cerebrovascular Disease Conference) and confirmation by MRI

  • Ability to participate in assessments within 1 week of stroke onset

  • FMMS score of < 55 points

  • MoCA score of < 26 points


Exclusion criteria
  • NIHSS score > 20 points

  • Aphasia

  • History of pre‐stroke depression and taken antidepressants or benzodiazepines

  • HAMD score > 7 points

  • Receipt of thrombolytic therapy

  • Complications such as infection, bed sores, or heart failure that might affect rehabilitation


Withdrawal criteria: not stated
Interventions Experimental: orally administrated paroxetine at dosages of 10 mg/day during week 1 and 20 mg/day thereafter, for a total treatment duration of 3 months
Comparator: usual care
Outcomes Outcomes were collected at 15, 90 and 180 days
  • Movement assessed using FMMS

  • Cognitive impairment assessed using the MoCA

  • Depression assessed using HAMD

Funding source No grant funding from any grant funding agency, commercial or not‐for‐profit organisations
Notes There is no study protocol/trial register reference
Baseline sociodemographic and clinical characteristics are provided only for those who completed the study
The authors state that one of the inclusion criteria is MOCA score of < 26 points. In the Results section they state that there were "72 cases of cognitive impairment" (i.e. a MoCA score of < 26 points) in the comparator group and 82 in the experimental group at days 15, 90 and 180. This suggests that either that the inclusion criteria were not strictly adhered to or if 100% of participants had a MoCA score of < 26 points at baseline then 10/82 participants in the comparator group and 3/85 in the experimental group have improved on the MoCA between days 0 and 15
Dates study conducted: participants recruited between January 2012 and June 2014
Declarations of interest: none reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Random number table"
Allocation concealment (selection bias) Unclear risk Insufficient information to judge high or low
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient information to judge high or low
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "All scale evaluators were trained and tested by the main investigator and were blind to the group assignment."
Incomplete outcome data (attrition bias)
All outcomes Low risk All data available for all participants in the experimental group (n = 85/85) and data available for (n = 82/85) participants in the comparison group for the Fugl–Meyer Motor Scale and the HAMD score
For the MoCA (see 'Other bias' below)
< 5% overall loss to follow‐up
Selective reporting (reporting bias) Unclear risk There is no study protocol/trial register reference, so insufficient information to judge high or low
Other bias High risk The authors state that one of the inclusion criteria is Montreal Cognitive Assessment (MoCA) score of < 26 points. In the Results section they state that there were "72 cases of cognitive impairment" (i.e., a MoCA score of < 26 points) in the comparator group and 82 in the experimental group at days 15, 90 and 180. This suggests that either that the inclusion criteria were not strictly adhered to or, if 100% of participants had a MoCA score of < 26 points at baseline then 10/82 participants in the comparator group and 3/85 in the experimental group have improved on the MoCA between days 0 and 15. The results 'Comparison of MoCA scores' and table 3 suggests otherwise