[Acute sedative effect of a herbal relaxation tablet as compared to that of bromazepam]

The relaxing effect and the systemic tolerance of a single oral dose of Valverde relaxation dragées have been examined double-blinded against 3 mg of bromazepam and placebo in groups of 20 healthy male volunteers each treatment. The systemic tolerance was assessed at the end of the examination, relying on spontaneous remarks or comments made on side effects upon questioning. As the four plants from which Valverde has been extracted (valerian, balm, passion-flower, and pestilence wort) have a reputation of being tranquilizing agents with spasmolytic effect, not only this effect needs to be demonstrated, but also sedative side effects and impairment of vigilance must be assessed to explore the risk for accident proneness. We expected that the relaxing-tranquilizing effect of bromazepam as well as of Valverde relaxation dragées compared with placebo is perceived subjectively. A potentially existing impairment of performance due to Valverde was assumed to be milder than impairment due to bromazepam. The study, however, inspite of a sophisticated test battery with extended testing, could not detect any effect for either of the two drugs; nor could it detect a side effect. The sedation and reduction of vigilance observed in a pre-study without placebo controls (Gerhard and Hobi, unpublished) was explained by natural fatigue which appeared in the course of the morning also under placebo. Therefore, sedative side effects, leading to an impairment in performance, can be excluded for both drugs at the studied dose level.