Entwicklung eines Plans für eine Pilotstudie zur Evaluierung der Beeinflussung der Herzfrequenz, des Blutdruckes und der Verkürzungsfraktion bei Herzinsuffizienz der Isachc Klassen 1a und 1b bis Klasse 2 infolge einer Mitralisendokardose beim Hund durch Crataegus-Extrakt.
Dissertation, Vet. Med. Univ. Wien, pp. 107.
In this doctor thesis a study design is presented for a pilot study for the investigation of the clinical efficacy of Crataegus extract in treating canine cardiac insufficiency, as the first of its kind in the field of veterinary medicine. This is a placebo-controlled, randomised, double-blind and multicentric clinical study of parallel group design, in which 80 dogs with mitral endocardosis of the ISACHC classes 1a, 1b and in transition to class 2 are examined and treated over a period of 12 weeks. In this framework both objective clinical symptoms and the subjective quality of life of patients in connection with this disease are given consideration. This paper includes recommendations for the organisation, execution, collection, documentation and verification of data such a clinical trial. This comprises the derivation of the hypothesis, choice of trial type, patient material, compound, dosage, trial duration, outcome variable and evaluation of collected data as well as the development of standardised forms for data collection. The findings of the clinical-cardiologic examination as well as the special cardiologic examination methods such as electrocardiography and echocardiography are described. The various treatment methods for cardiac insufficiency are listed, whereby both chemical-synthetic and phytotherapeutic medications are included. In particular, herbal medicinal products based on Crataegus sp. are presented - their effects, uses, pharmacological active substances, and mechanism of action. 15 published clinical studies are discussed in which the efficacy of Crataegus extract in the treatment of cardiac insufficiency in humans has been proven. This paper points out the need for a systematic aproach towards the development of a study design, in order to ensure credibility as well as scientific and technical quality of the study. It aims to be a guide line for the correct planning of future larger clinical trials with Crataegus in veterinary medicine.
phytotherapy / Crataegus sp. / chronic cardiac insufficiency / dog / study design