[Efficacy and safety of a herbal drug containing hawthorn berries and D-camphor in hypotension and orthostatic circulatory disorders/results of a retrospective epidemiologic cohort study].
OBJECTIVE
Korodin Herz-Kreislauf-Tropfen, a herbal drug containing D-camphor (CAS 76-22-2; 2.5 %) and a liquid extract of fresh hawthorn berries (97.3%), has been used since many years for the treatment of orthostatic hypotension. The combination as well as its constituents were tested in clinical trials against placebo with healthy volunteers and patients using tilt-tests. The objective of this study was to investigate efficacy and safety of the drug under the conditions of medical practice in comparison to other drugs admitted for this indication.


METHODS
The study was performed as an epidemiological retrospective cohort study in 46 medical practices in Germany. In the practices the files were reviewed for patients who were treated between 1st January 2000 and 31st December 2002 for orthostatic hypotension. Included in the study were all patients who were treated either with the test drug or a control drug containing etilefrine, oxilofrine, midodrine, norfenefrine or dihydroergotamine and who met the inclusion criteria. The data of the files were coded, transferred to case report forms and augmented by the physician's statements about symptoms and success. Effect criteria were the improvement of symptoms and change of blood pressure during treatment. The correctness of the data was controlled using anonymous copies of the files. A total of 490 patients (399 in the test-group and 91 in the control group) between 11 and 102 years were included in the study. To correct heterogeneities in baseline conditions, treatment results were adjusted by regression and stratification to equal baseline conditions using the propensity score.


RESULTS
The adjusted odds ratio for improvement was 5.6, the adjusted mean increase of the systolic blood pressure the 2-fold compared to the control group. The difference was highly significant and did not depend on age or initial blood pressure. In the test group two adverse events were observed which had no relation to the medication; in the control group one reversible event with a probable relation to the medication was observed.


CONCLUSIONS
The test drug was proven as effective and safe in the treatment of orthostatic hypotension in medical practice for all age groups and independent of the initial blood pressures.
Hempel
Bernd
B
Robugen GmbH Pharmazeutische Fabrik, Esslingen-Zell
Kroll
Michael
M
Schneider
Berthold
B
D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000502:physiology; D002164:Camphor / Q000627:therapeutic use*; D015331:Cohort Studies; D027825:Crataegus / Q000737:chemistry*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007024:Hypotension, Orthostatic / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D012189:Retrospective Studies; D018667:Tilt-Table Test; D016896:Treatment Outcome
D002164:Camphor