[Efficacy and tolerability of Baldrian versus oxazepam in non-organic and non-psychiatric insomniacs: a randomised, double-blind, clinical, comparative study].
OBJECTIVE
To show better improvement of sleep quality when treating non-organic insomniacs with extractum Valerianae radix siccum instead of oxazepam.


METHODS
Randomised, double blind, comparative study.


METHODS
Out-patients of 8 general practitioners.


METHODS
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.


METHODS
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.


RESULTS
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.


METHODS
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.
Dorn
M
M
Wissenschaftliche Beratung Pharma, Elz, Deutschland.
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010076:Oxazepam / Q000627:therapeutic use*; D010936:Plant Extracts / Q000627:therapeutic use*; D010946:Plants, Medicinal; D012890:Sleep / Q000187:drug effects / Q000502:physiology; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D014632:Valerian
D006993:Hypnotics and Sedatives; D010936:Plant Extracts; D010076:Oxazepam