Objective: To show better improvement of sleep quality when treating non-organic insomniacs with extractum Valerianae radix siccum instead of oxazepam.
Design: Randomised, double blind, comparative study.
Setting: Out-patients of 8 general practitioners.
Patients: Non-organic and non-psychiatric insomniacs aged between 18 and 70 years were included into the trial. Persons with known hypersensitivity to valerian or benzodiazepines, other psychotropic drugs and various contraindications/limitations for benzodiazepines were excluded.
Intervention: 75 patients were randomly allocated either to the index group (2 x 300 mg extractum Valerianae radix siccum dragées LI 156) or control group (2 x 5 mg oxazepam dragées). The patients took study medication daily over a period of 28 days 30 min before going to bed.
Outcomes: The factor sleep quality of the SF-B was defined as primary outcome. Secondary outcomes were other sleep characteristics of the SF-B, well-being (Bf-S) and anxiety (HAMA). Controls were performed before treatment as well as after 1, 2 and 4 weeks. Vital and laboratory parameters as well as unexpected events were assessed for safety and tolerability.
Statistics: For all outcomes effect sizes between groups were calculated. For the main outcome criteria significance was tested by repeated-measures ANOVA considering all cases for which data of at least one follow-up existed (n = 70).
Results: Baseline characteristics were well balanced. 70% (54/75) of the patients were females, over 53% (40/75) reported insomnia for more than 1 year. Mean age was 52 +/- 12 years. In both groups sleep quality improved significantly (p <0.001), but no statistically significant difference could be found between groups (p = 0.70). Effect sizes between groups varied between 0.02 and 0.25. Five persons withdrew due to possibly adverse drug reactions (2 ( valerian, 3 ( oxazepam). No serious adverse events happened.
Conclusions: The study showed no differences in the efficacy for valerian and oxazepam. Because of the more favourable adverse effect profile of valerian compared to oxazepam, this hypothesis should be analysed confirmatorily in an equivalence study.