Administration of Cardiodoron (R) in Patients with Functional Cardiovascular Disorders and/or Sleep Disorders - Results of a Prospective, Non-Interventional Study

Background: Functional cardiovascular disorders (FCD) can be attributed to around 25-40% of all heart patients, i.e. organic causes are not detectable. Characteristic symptoms are tachycardia, palpitations, cardiac arrhythmia, hyperventilation, vertigo, vasovagal syncopes and sleep disorders, with the latter being a problem of its own. Disturbed vegetative rhythms form the basis of these diseases. The medicinal product Cardiodoron counteracts the dysfunctional vegetative rhythmicity with 3 medicinal plants - Primula veris (common cowslip), Hyoscyamus niger (black henbane) and Onopordum acanthium (cotton thistle). Patients and Methods: By means of a prospective, multicentre, non-interventional study, the development of disease-specific disorders during treatment with Cardiodoron (drops) was supposed to be shown. Between September 2009 and March 2012, 92 physicians documented 501 patients suffering from functional cardiovascular and/or sleep disorders who have been treated with Cardiodoron for 3-6 months. After an initial examination, a final examination after 90 (+/- 10) days and, in case of continuation of therapy, a follow-up examination after 90 (+/- 10) days were carried out. Besides 30 symptoms assessed by the physicians, the patients rated their condition on the basis of the complaints list according to v. Zerssen (B-L and B-L') and the Pittsburgh Sleep Quality Index (PSQI) according to Buysse. Results: The severity of functional cardiovascular disorders as well as sleep disorders was significantly reduced. The same applies for all of the documented 30 disease-specific symptoms. Furthermore, the total score of the complaints list was significantly reduced as well as the PSQI. The largest effect regarding all parameters was detectable after 3 months. Continuation of Cardiodoron therapy stabilised the symptomatology once more and resulted in further improvement. On average, patients reported initial improvement after 13 days of treatment. Tolerability was almost consistently assessed with 'very good/good'. Accordingly, the acceptance of the preparation by the patients was good, which resulted in a very good compliance of 70%. 52% of the patients used additional therapies. Conclusions: Cardiodoron shows positive effects in medical practice; it is a well-tolerated medicinal product for treatment of functional cardiovascular and/or sleep disorders with or without concomitant therapies.