| Methods |
Double‐blind cross‐over versus placebo: pre‐treatment period, without any drugs, of 7 days; no run‐in period; first treatment period of 21 days; wash‐out of 7 days; second treatment period of 21 days. |
| Participants |
18 adult participants with narcolepsy (7 women and 11 men).
Mean age 48.8 years (range 31‐68).
Place of the study: London, UK (not specified ethnic composition of participants).
Inclusion criteria: "EDS + cataplexy".
Exclusion criteria: not reported.
Recruitment procedures: not reported.
Mild cataplexy: 5 participants; moderate: 6; severe: 7.
Mild "narcolepsy": 2 participants; moderate: 8; severe: 8.
Pre‐trial treatment:
15 participants clomipramine (mean dosage 49 mg; of them: 4 only clomipramine, 5 also with maxindol, 5 also with dextro‐amphetamine, 1 also with efedrine);
2 participants with maxindol (4 and 6 mg in die);
1 participant with no therapy. |
| Interventions |
Fluvoxamine: serotonin selective re‐uptake inhibitors class (N06AB); dosage between 25 and 200 mg (average 76 mg).
Clomipramine: tricyclics class (N06AA); dosage between 25 and 200 mg (average 60 mg). |
| Outcomes |
Considered in the review and present in the study:
(1) Elimination of cataplexy according to simple subjective report, at the short‐term follow up.
(2) Reduction of cataplexy by more than 50% with respect to baseline according to simple subjective report, at the short‐term follow up.
(3) Adverse events by treatment groups.
(4) Drop‐outs by treatment groups.
Not considered in the review (as picked‐up with not validated tools): elimination or reduction of EDS according to subjective report. |
| Notes |
The authors inappropriately treat the trial design as a parallel study. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Unclear |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Blinding?
All outcomes |
High risk |
Procedures to make recipients unaware of the assigned therapy: inadequate.
Procedures to make those providing care unaware of the assigned therapy: unclear.
Procedures of blinding (unawareness of the assigned therapy in the group of those measuring outcomes): unclear. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
6 participants did not complete the fluvoxamine treatment period because of side effects.
One more participant data on cataplexy outcomes were missing. |
| Free of other bias? |
Low risk |
Each treatment period was of 21 days duration with a seven day wash‐out period. |
