[Treatment of chronic bronchitis with ivy leaf special extract--multicenter post-marketing surveillance study in 1,350 patients]. / Behandlung chronischer Bronchitis mit einem Spezialextrakt aus Efeublättern - multizentrische Anwendungsbeobachtung mit 1350 Patienten.

BACKGROUND AND OBJECTIVES: The changes of clinical symptoms and the tolerability of Prospan((R)) acute Effervescent Cough Tablets were investigated in a multicenter, prospective post-marketing surveillance (PMS) study focusing on patients with chronic bronchitis. PATIENTS AND METHODS: The study included 1,350 male and female patients aged 4 years and above who were treated in one of 135 participating medical practices and who suffered from chronic bronchitis (with or without airway obstruction). During a scheduled observational period of 4 weeks, the patients had to take 1(1/2) or 2 tablets per day (depending on their age), according to the manufacturer's dosing recommendations, corresponding to 97.5 or 130 mg of dried ivy leaf extract (about 585- 780 mg of drug). Treatment success was assessed by observing the changes in the direct symptoms of chronic bronchitis between the baseline examination and the end of treatment. Safety was evaluated by analyzing adverse events. RESULTS: In comparison to baseline, the following percentages of patients showed improved symptoms or were cured at treatment end: cough 92.2%; expectoration 94.2%; dyspnea 83.1%; respiratory pain 86.9%. In each of the four symptoms at least 38% of the initially affected patients were completely free of complaints. Three patients (0.2%) experienced adverse events in which a causal relationship to the drug under investigation could not be excluded (2x eructation, 1x nausea). CONCLUSIONS: Considering the favorable changes in all investigated clinical symptoms as well as the excellent tolerability in children and adults, the ivy leaf extract preparation Prospan acute Effervescent Cough Tablets can be considered as a therapeutic option in alleviating the symptoms of chronic bronchitis.

Study of the long-term action of a Ginkgo biloba extract on vigilance and mental performance as determined by means of quantitative pharmaco-EEG and psychometric measurements.

The action of a Ginkgo biloba extract (rökan, Tanakan, G.B.E.) in promoting blood flow has been demonstrated in several animal and human pharmacological studies. The aim of this present study was to estimate the action of the substance on the central nervous system in order to be able to assess its potential use as a therapeutic agent in geriatric patients with cerebral insufficiency. Quantitative pharmaco-EEG is the method of choice for studying the vigilance-promoting effects of a drug. It is incomparable for confirming the findings of behavioural and psychometric studies. 60 volunteers of either sex participated in the double-blind trial. They were aged 57-77 years and showed mental deterioration corresponding to their age. They were randomly divided into three experimental groups: 20 subjects received 3 X 40 mg/day G.B.E., 20 received 5 mg nicergoline and 20 received a placebo of similar appearance. The subjects underwent an extensive series of examinations before and 4, 8 and 12 weeks after the start of medication. Analysis of the EEG results for the whole group revealed no significant advantage of G.B.E. over the two reference substances with regard to vigilance. However, a subclassification of the subjects showed that the vigilance of those persons with a more unfavourable initial situation measured in the resting EEG could be clearly improved by chronic G.B.E. medication. This increase in vigilance was reflected at the behavioural level by an improvement of reaction times in the G.B.E. group by comparison with the reference substances.(ABSTRACT TRUNCATED AT 250 WORDS)