Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 1997; 2: 199
Fixed combinations of Valeriana officinalis and Passiflora incarnata are characterised by sedative and spasmolytic properties. They improve the sleep latency and quality.
503 patients suffering from sleep disorders were treated with Domo-Sem® syrup (DS) (100g syrup = 25g passiflora fluid extract (1:1), 12.5g valerian root extract (1:1)). The mean dose taken at bedtime was 11.8 ml., the mean day time dose (21% of the patients) was 11.8 ml. Duration of treatment 7 days (median). The mean age was 51.6 years (m/f 36%/64%). About one third of the patients have received a pre-treatment with other sedative drugs. The data were analysed using descriptive statistical methods.
The overall sleep disturbance and psycho-vegetative symptoms improved by about 55%. The disorders of inhibiting sleep and sleeping through improved by 58% and 54%, nervousness by 51%. Compared to the initial situation 29% of the patients evaluated the sleep quality as considerably better, 57% as rather better, 13.1% as unchanged and 0.8% as rather worse. The overall vigilance during the day was improved. The global efficacy was evaluated as excellent in 31% of the cases, good in 52%, moderate in 9%, minimal in 4%, with no effect in the remaining 4%. In 51% the global tolerance was excellent, in 45% it was good, in 3% moderate, in 1% minimal and 1% bad. Seven mild adverse reactions have been reported (2.4%).
DS can be considered as a safe and effective herbal drug combination. In mild sleep disorders and psycho-vegetative dysfunctions it can be an alternative to benzodiazepines. A major advantage of DS seems to be the unimpaired vigilance.
