Anti-inflammatory activity of 1.8-cineol (eucalyptol) in bronchial asthma: a double-blind placebo-controlled trial.

Airway hypersecretion is mediated by increased release of inflammatory mediators and can be improved by inhibition of mediator production. We have recently reported that 1.8-cineol (eucalyptol) which is known as the major monoterpene of eucalyptus oil suppressed arachidonic acid metabolism and cytokine production in human monocytes. Therefore, the aim of this study was to evaluate the anti-inflammatory efficacy of 1.8-cineol by determining its prednisolone equivalent potency in patients with severe asthma. Thirty-two patients with steroid-dependent bronchial asthma were enrolled in a double-blind, placebo-controlled trial. After determining the effective oral steroid dosage during a 2 month run-in phase, subjects were randomly allocated to receive either 200 mg 1.8-cineol t. i.d. or placebo in small gut soluble capsules for 12 weeks. Oral glucocorticosteroids were reduced by 2.5 mg increments every 3 weeks. The primary end point of this investigation was to establish the oral glucocorticosteroid-sparing capacity of 1.8-cineol in severe asthma. Reductions in daily prednisolone dosage of 36% with active treatment (range 2.5-10 mg, mean: 3.75 mg) vs. a decrease of only 7% (2.5-5 mg, mean: 0.91 mg) in the placebo group (P = 0.006) were tolerated. Twelve of 16 cineol vs. four out of 16 placebo patients achieved a reduction of oral steroids (P = 0.012). Long-term systemic therapy with 1.8-cineol has asignificant steroid-saving effect in steroid-depending asthma. This is the first evidence suggesting an anti-inflammatory activity of the monoterpene 1.8-cineol in asthma and a new rational for its use as mucolytic agent in upper and lower airway diseases.

[Therapy of active Crohn disease with Boswellia serrata extract H 15]. / Therapie des aktiven Morbus Crohn mit dem Boswellia-serrata-Extrakt H 15.

BACKGROUND: The purpose of this clinical trial was to compare efficacy and safety of the Boswellia serrata extract H15 with mesalazine for the treatment of active Crohn's disease. PATIENTS AND METHODS: Randomised, double-blind, verum-controlled, parallel group comparison for which 102 Patients were randomised. The per protocol population included 44 patients treated with H15 and 39 patients treated with mesalazine. As primary outcome measure the change of the Crohn Disease Activity Index (CDAI) between the status of enrolment and end of therapy was chosen. H 15 was tested on non-inferiority compared to standard treatment with mesalazine. RESULTS: The CDAI between the status of enrolment and end of therapy after treatment with H15 was reduced by 90 and after therapy with mesalazine by 53 scores in the mean. In this non-inferiority-trial the test hypothesis was confirmed by the statistical analysis. The difference between both treatments could not be proven to be statistically significant in favor to H15 for the primary outcome measure. The secondary efficacy endpoints confirm the assessment of the comparison of H15 and mesalazine. The proven tolerability of H15 completes the results of the shown clinical efficacy. CONCLUSIONS: The study confirms that therapy with H15 is not inferior to mesalazine. This can be interpreted as evidence for the efficacy of H15 according to the state of art in the treatment of active Crohn's disease with Boswellia serrata extract, since the efficacy of mesalazine for this indication has been approved by the health authorities. Considering both safety and efficacy of Boswellia serrata extract H15 it appears to be superior over mesalazine in terms of a benefit-risk-evaluation.

Lessons learned from co-operative terminology work in the medical domain.

High-quality terminologies are crucial for communication, documentation, and information retrieval. The creation, adoption, and maintenance of such terminologies is a complex task that requires human co-operation. We have developed a terminology server that supports remote, asynchronous co-operation and allows data inconsistencies that can later be resolved through human discussion. We have employed the terminology server in two projects and report on the lessons learned, which have led us to extend our approach.

A comparison of similarity measures for digital subtraction radiography.

Subtraction is useful in detecting small changes in sequentially acquired radiographs. Even if the imaging geometry is constant, radiographs must be registered after their digitization. To compare different algorithms for image registration and to register digital X-rays themselves, various similarity measures have been proposed. This study compares eight mathematical similarity standards using 172 radiographs acquired in different, but exactly known projection. Whenever the computation time is a critical factor, e.g. registering images using methods similar to correlation techniques, the entropy of the subtraction image's histogram function (EHDI) is found to be the best similarity standard. If not, e.g. comparative assessing different image registration techniques, the cross covariance coefficient (CCC) is appropriate.

Treatment of premenstrual tension syndrome with Vitex agnus castus controlled, double-blind study versus pyridoxine.

The objective of the present study was to determine the efficacy and tolerability of a new solid formulation (capsules) of Agnolyt®(*)) in a randomized, controlled trial versus pyridoxine in women with PMTS over a period of three treatment cycles (Vitex agnus castus (VAC): 1 capsule + 1 placebo capsule/day, n = 90; pyridoxine (B6): 2 capsules day, n = 85). The therapeutic response was assessed using the premenstrual tension syndrome scale (PMTS scale), the recording of six characteristic complaints of the syndrome, and the clinical global impression scale (CGI scale). Upon completion of the trial, efficacy of the treatment was assessed by the physician as well as by the patient. On the PMTS scale, treatment with VAC and B6 produced a reduction in score points from 15.2 to 5.1 (-47,4%) and from 11.9 to 5.1 (-48%)(*), respectively. In comparison with pyridoxine, VAC caused a considerably more marked alleviation of typical PMTS complaints, such as breast tenderness, edema, inner tension, headache, constipation, and depression. Analogous results were obtained with the CGI scale. In both treatment groups, efficacy was rated as at least adequate by more than 80% of the investigators; however, VAC treatment was rated as excellent by 24.5% and pyridoxine treatment by 12.1% of the investigators. According to the patients' assessment, 36.1% of the cases in the VAC group and 21.3% in the pyridoxine group were free from complaints. Adverse events (gastrointestinal and lower abdominal complaints, skin manifestations and transitory headache) occurred in 5 patients under B6 and in 12 patients under VAC. Serious adverse events were not observed. The results of the present study confirm the efficacy and safety of Agnolyt® capsules in the treatment of PMTS.

Rapid diagnostic DNA cytometry with an automatic microscope and a TV image-analysis system.

A TV-based image-analysis system (Leitz TAS plus) combined with a Leitz automatic microscope was used for rapid DNA cytometry for diagnostic purposes. Malignant or suspicious cells found by the cytopathologists in conventionally stained smears were automatically relocated and measured. A program for automatic detection and measurement of nuclear DNA content was developed. DNA data are processed by an algorithm for the diagnosis and grading of malignancy. This diagnostic procedure is performed in real time and yields highly reproducible results. With this equipment, diagnostic DNA cytometry may be introduced in the routine cytology laboratory. Our mode of application does not replace the cytopathologist, but assists him or her in cases of doubtful diagnosis and in the grading of malignant tumors.

Flow distribution in closed networks: minimal sets of measuring sites.

In microvascular research it is of great importance to know how the flow of blood is distributed to all the vessels in a capillary network. However, it is generally impossible to obtain simultaneous measurements of the flow values in all branches of a network. A method of selecting minimal subsets of branches is presented, by which the flow measurements in these branches can be used to compute the flow values in all other branches. It is sufficient to measure between half and one-third of the branch flows. The experimenter can also specify a subset of the branches as inaccessible to measurement; nevertheless the method allows him to decide whether determination of all flows is possible from the remaining branches, and in which branches the measuring devices should then be optimally placed.

[Electronic data processing in medical microbiology--a guide and some critical thoughts]. / Elektronische Datenverarbeitung in der Medizinischen Mikrobiologie--Leitlinien und kritische Gedanken

Applications of electron data processing in all fields of medicine and especially in medical microbiology are increasing rapidly. It seems important to discuss a guide for using such complicated electronical systems, because, on the one hand, computer applications in medicine are desirable for scientific reasons, but on the other hand few very costly and sophisticated projects had to be cancelled, after a shorter or longer time of implementation by reason of lack of co-operation of medical collaborators. This paper puts on discussion such a guide for using electronic data processing in medical microbiology. It is proposed to put through the following tasks before introducing a computer system into a microbiological institution: a system analysis of the status quo, an objective determination of the set state, a system design and a cost-benefit analysis. Those tasks are described in detail and are illustrated to some extent by graphics and tables from own research for preparing a data processing system for medical microbiology. It is emphasized that beside hard- and software criteria of the desired computer system one has to pay attention to the problems of man-machine engineering. The paper finishes with concrete propositions of proceeding when the computer system is implemented and shows possibilities of scientific data evaluation of a microbiological data base.