Relief of symptoms in female patients with a hypotensive symptom complex treated with Cardiodoron® – results of a randomized double-blind controlled study

Aims: To test the efficacy and safety of Cardiodoron® (consisting of extracts from Primula officinalis, Onopordon acanthium, and Hyoscyamus
niger) in the treatment of a hypotensive symptom complex in female patients. Methods: Sixty women (14–45 years) with hypotensive autonomic dysregulation symptoms including immediate or late orthostatic intolerance, blurred vision, physical weakness, fatigue, or cold limbs took part in this joint study of Joanneum Research and the Medical Universities of Vienna and Graz, Austria. They were recruited at three doctors practices and the clinical Department of Occupational Medicine Vienna. Patients were treated double blind with either Cardiodoron ® or a Placebo orally in a dose of 20 drops 3 times a day for 8 weeks. General medical advice, e.g. regarding fluid and salt intake, was allowed in both groups. A questionnaire of symptoms (von Zerssen's symptom list) was filled out weekly throughout the study. Heart rate variability (HRV) was assessed by six 24h-Holter-ECG recordings, sleep quality by questionnaires: 2 times before treatment, during the third and sixth week of treatment, and 1 and 4 weeks after treatment.
Results: Data of 57 patients were analyzed. The symptom score before treatment showed a value of 23.2 (Cardiodoron group) vs 22.5 (Placebo
group) compared to the reference value of 15.5 in a german population of healthy females, and improved in both groups. The improvement was significantly higher in the Cardiodoron group (47%, to a score of 12.2 post medication) than in the control group (24%, to 17.0 post placebo).
Besides the reduction of typical symptoms, back pain and sleep related problems improved. Despite of randomization, HRV was better in the Cardiodoron group right from the beginning, yet there were small additional improvements in nightly HRV parameters during the treatment phase. Conclusions: Cardiodoron® was more effective in treating the hypotensive symptom complex than placebo, and the effects remained at least four weeks after treatment. We do not suppose an unidirectional but a normalizing effect on autonomic regulation which will be further explored based on the collected data.