[Improvement of Stress Resistance and Quality of Life of Adults with Nervous Restlessness after Treatment with a Passion Flower Dry Extract].

BACKGROUND: The passion flower dried ethanolic extract investigated in this non-interventional study has well-documented calmative effects and good tolerability. We investigated the effects of this extract on the stress resistance (resilience) and quality of life (QoL) of patients suffering from nervous restlessness. The addiction potential of the drug and the course of symptoms were also evaluated. METHODS: Adult patients aged ≤ 95 years with the diagnosis 'nervous restlessness' were treated for 12 weeks with a dried ethanolic extract of passion flower (Passiflora incarnata L.). Standardized questionnaires were used to evaluate the resilience (RS-13), QoL (EQ-5D including EQ-VAS), and the addiction potential (BDEPQ). RESULTS: After 12 weeks of treatment, significant (p < 0.001) improvements were measured in the patients' resilience (RS-13: from 52.1 to 67.7 points) and QoL (EQ-VAS: from 47.9 to 75.0 points). Also, the mean BDEPQ score was significantly (p < 0.001) reduced (from 23.0 to 19.3 points). The mean values of all accompanying symptoms (inner restlessness, sleep disturbance, exhaustion, fear, lack of concentration, transpiration, nausea, trembling, and palpitation) improved significantly (p < 0.001). Tolerability of treatment was rated as 'very good' or 'good' by the majority of the patients. Three cases of mild adverse events (tiredness) were reported. CONCLUSION: The passion flower extract investigated in the present study appears to be effective in improving resilience and QoL in patients suffering from nervous restlessness and is well tolerated.

[Treatment costs of otogenic vertigo]. / Die Kosten der Behandlung des otogenen Schwindels. Therapie mit einem Kombinationspräparat (Cinnarizin 20 mg und Dimenhydrinat 40 mg) im Vergleich zur Therapie mit Betahistin (12 mg).

PURPOSE: In this decision-tree analysis, the costs of otogenic vertigo treatment were investigated from the third-party payer's perspective. Either the combination preparation, with cinnarizine 20 mg and dimenhydrinate 40 mg as active substances, or betahistine (12 mg betahistinedimesilate) was administered. METHODS: A core model, based on clinical studies, was developed and a cost-effectiveness analysis was conducted. Both differences in effectiveness of the alternative treatments and adverse reactions and side effects were included. The number of cases, in which no more symptoms of dizziness were detected after 4 weeks of therapy, served as the effectiveness parameter. RESULTS: The effectiveness-adjusted costs amounted to 130.11 Euros for patients treated with the combination preparation and 629.28 Euros for treatment with betahistine. CONCLUSION: From the third-party payer's perspective, therapy of otogenic vertigo with the combination preparation is more cost-effective than a treatment with betahistine. From the patient's perspective, the higher effectiveness and the superior profile of side effects militate in favor of a therapy with the combination preparation.