| Methods |
Double‐blind parallel randomised trial versus placebo: pre‐treatment period of 14 days; no run‐in period; treatment period of 28 days. |
| Participants |
134 adult participants with narcolepsy (50 women and 84 men).
Mean age: 40.9 years (SD 14.2) in the placebo group; 43.2 years (SD 12.5) in the Ritanserin 5 mg group; 43.2 years (SD 15.0) in the Ritanserin 10 mg group.
Place of the study: Belgium, France, Germany, Italy, Norway, Sweden, the Netherlands (not specified ethnic composition of participants).
Inclusion criteria: 1990 International Classification of Sleep Disorders.
Exclusion criteria: shift work, irregular sleep/wake habits, hepatic, cardiac, renal, mental disorders, substance or drug abuse, anti‐arrhythmic medication, potassium loss‐inducing diuretics, pregnancy or probability of pregnancy.
Recruitment procedures: not reported.
At baseline the main complaints were "sleep attacks" (40%), EDS (37%), cataplexy (12%).
Pre‐trial treatment: 21 participants with no medication; 76 participants with psychostimulants; 66 participants with antidepressants (38 clomipramine and 8 viloxazine); 7 participants with benzodiazepines; 6 participants with GHB. "Medication intake between groups did not differ". |
| Interventions |
46 participants allocated to ritanserin, dosage 5 mg once daily.
45 participants allocated to ritanserin, dosage 10 mg once daily.
43 participants allocated to placebo. |
| Outcomes |
Considered in the review and present in the study:
(1) Reduction of cataplexy measured by mean values of subjective ordinal scales at the short‐term follow up.
(2) Adverse events by treatment groups.
(3) 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 |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Unclear |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Blinding?
All outcomes |
Unclear risk |
Unclear |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Twelve out of 134 participants dropped out before trial completion: six from the ritanserin 5 mg group and six from the ritanserin 10 mg group; eight due to adverse events. All randomised participants were included in the analysis on an intention‐to‐treat basis. |
| Free of other bias? |
Low risk |
Diagnosis was made according to the 1990 International Classification of Sleep Disorders. |
