LaFrance 2014.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Study grouping: parallel group Adequate power (evidence of power calculation): quote: "not being powered for differences between groups," but no data provided. Allocation concealment method: no information provided Blinding of outcome assessors: treatment‐blinded trained raters assessed clinician‐scored outcomes Check of blinding: no information provided Duration of study: September 2008 to February 2012 Randomisation method: computer‐generated block randomisation |
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Participants |
Baseline characteristics Intervention
Control
Overall
Inclusion criteria: aged 18–65 years with a VEEG‐confirmed diagnosis of lone PNES and ≥ 1 event in the month prior. Criteria for the diagnosis of events consisted of stereotypic motor manifestations with or without change in level of consciousness. Exclusion criteria: concurrent mixed epilepsy and PNES or equivocal VEEG findings in discerning between epileptic seizures and PNES; use of monoamine oxidase inhibitor or pimozide within 30 days prior to study entry; current use of sumatriptan succinate or other serotonin‐1 receptor agonist; allergy or sensitivity to sertraline; current enrolment in CBT for PNES; current or past‐year self‐mutilation; frank psychosis; current suicidality with intent to self‐harm; serious illness; active substance or alcohol use or dependence that could interfere with participation; pending litigation and current application for long‐term disability. Pretreatment: no statistically significant differences at baseline between groups. |
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Interventions |
Intervention characteristics Intervention
Control
The study included two other interventions, Sertraline hydrochloride (25‐200 mg/d), and CBT+ Sertraline hydrochloride (25‐200 mg/d) which were not relevant to this review. |
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Outcomes |
Monthly seizure frequency (reduction in %)
Seizure freedom
Level of functioning (GAF)
Mental state (SCL‐90)
Mental state – depression (BDI)
Mental state – anxiety (BAI)
Quality of life (QOLIE31)
Dropout
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomised 1:1:1:1 into 1 of 4 treatment arms using a computer‐generated blocked randomisation." |
Allocation concealment (selection bias) | Unclear risk | Quote: "blocked schedule." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Given the nature of interventions delivery, clinicians in the study were not blinded to the intervention." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Treatment‐blinded trained raters assessed clinician‐scored outcomes after reliability was established. Interrater reliability was established by having raters score a sample of the same patients and having the results reviewed." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No data. |
Selective reporting (reporting bias) | Low risk | Matches study protocol. |
Other bias | Low risk | No other apparent sources of bias. |