Efficacy and tolerability of a red-vine-leaf extract in patients suffering from chronic venous insufficiency--results of a double-blind placebo-controlled study.

OBJECTIVES: The aim of this study was to investigate the effect of a red-vine-leaf extract (AS195, Antistax(®), Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany) on the volume of the leg and clinical symptoms in patients with chronic venous insufficiency (CVI). DESIGN, MATERIALS AND METHODS: A multicentre, randomised, double-blind and placebo-controlled study was carried out with 720 mg AS195 per day over 12 weeks in CVI patients (CEAP Grades 3-4a) and moderate-to-severe clinical symptoms. Efficacy endpoints were changes in limb volume determined by water displacement volumetry, clinical CVI symptoms assessed on a 10-cm visual analogue scale and global efficacy evaluations. RESULTS: The full-analysis set included 248 patients (placebo: n = 122; AS195: n = 126). After 12 weeks, AS195 significantly reduced lower limb volume by a mean of 19.9 standard error (SE) 8.9 ml over placebo (95% confidence interval (CI): -37.5, -2.3; p = 0.0268; analysis of covariance, ANCOVA). The standardised effect size of 0.28 for volume reduction indicates a clinically relevant effect. On Day 84, the symptom of 'pain in the legs' assessed by visual analogue scale decreased in the AS195 group compared with the placebo group: mean difference -6.6 SD 3.3 mm (95% CI: -13.1,-0.1; p = 0.047). Other symptoms showed no significant change. The tolerability of AS195 was similar to that of placebo. CONCLUSIONS: AS195 treatment for 84 days resulted in an approximately 20 ml reduction of limb volume in the active treatment group compared with the placebo group. Patients reported subjective improvement following treatment with AS195 compared with placebo. However, patients' overall rating of efficacy did not correlate well with measured reductions in limb volume. TRIAL REGISTRATION: ClinicalTrials.gov NCT00855179.

Antimicrobial efficacy of chloroxylenol and chlorhexidine in the treatment of infected root canals.

PURPOSE: To investigate the antimicrobial efficacy of a chlorhexidine gluconate (2.0%) and of an ethanolic chloroxylenol solution (10%) as a temporary root canal dressing against selected test microorganisms (Staphylococcus aureus, Streptococcus faecium, Escherichia coli, Candida albicans). MATERIALS AND METHODS: Extracted single-rooted human teeth were instrumented up to size 40. After removal of the smear layer suspensions of the test microorganisms were inserted into the root canals. After incubation for 48 hrs each suspension of the test organisms was removed and the root canals were filled with one of the two different disinfectants. The teeth were then incubated for 48 hrs. Twelve teeth and three controls were used for each of the four test organisms and each of the two regimens. After incubation, each root canal was instrumented and the removed canal wall dentin was examined microbiologically. RESULTS: With a contact time of 48 hrs between the two disinfectants and the four bacterial suspensions the medications led to a total killing of microorganisms in 82% of a total of 96 contaminated teeth. In the dentin layer situated 50 microm from the root canal, both medications achieved bacterial killing in a range from 99.9% to 99.99%, depending on the test organism. There were no significant differences (P> 0.1) between the relative antimicrobial activity of the two root canal dressings.

The response regulator ARR2: a pollen-specific transcription factor involved in the expression of nuclear genes for components of mitochondrial complex I in Arabidopsis.

Two-component signal systems regulate a variety of cellular activities. They involve at least two common signalling molecules: a signal-sensing kinase and a response regulator that mediates the output response. Multistep systems also require proteins containing phosphotransfer domains. Here we report that the response regulator ARR2 from Arabidopsis is predominantly expressed in pollen and is localized in the nuclear compartment of the plant cell. Furthermore, ARR2 is transcriptionally active in yeast and binds to the promoters of nuclear genes for several components of mitochondrial respiratory chain complex I (nCI) from Arabidopsis. The nuclear nCI genes are up-regulated in pollen during spermatogenesis. The transcription factor functions of ARR2 are mediated by its C-terminal output domain. Our data identify ARR2 as the first eukaryotic response regulator which functions as a transcription factor at a known promoter sequence. Yeast two-hybrid analysis and in vitro interaction studies suggest that ARR2 very probably forms part of a multistep two-component signalling mechanism that includes HPt proteins like AHP1 or AHP2. These findings point to an as yet unidentified signal transduction system that may regulate aspects of floral and mitochondrial gene expression.

pH changes in root dentin after root canal dressing with gutta-percha points containing calcium hydroxide.

Alkalinizing action on root dentin was investigated by treating the enlarged root canals of a total of 120 extracted teeth for 24 h, 3 days, or 7 days with either gutta-percha points (size 40) containing calcium hydroxide or an equivalent quantity of aqueous calcium hydroxide suspension. After splitting the teeth longitudinally the pH of the dentin was determined using a pH microelectrode in small cavities at each of four set measuring points. The gutta-percha points were unable to alkalinize the root dentin over a period of 7 days. Clear, rapid, and prolonged alkalinization of the dentin extending through to the root surface was achieved, however, with the aqueous calcium hydroxide suspension.

Effect of transcutaneous electrical nerve stimulation on pain perception threshold of human teeth: a double-blind, placebo-controlled study.

In this double-blind, placebo-controlled study, we studied the effect of three different transcutaneous electrical nerve stimulation (TENS) devices with extra- and intraoral electrodes on the pain perception thresholds of 234 unrestored, caries-free human teeth of 66 healthy individuals subjected to stimulation with an electric pulp tester. A placebo control collective of 64 healthy subjects received no electrical stimulation, since an inactive TENS device was used. In all tooth types tested (maxillary and mandibular incisors and premolars), the use of the active TENS devices resulted in an increase of 16.3-32.5% versus baseline in the pain perception threshold. The differences between active TENS and baseline were statistically significant for both TENS devices using extraoral electrodes (P < 0.05). No statistically significant differences were found between the different devices tested (P > 0.05). In the placebo collective, the increase in the pain perception threshold ranged between 6.4% and 10.3% versus baseline. There were no significant differences between placebo TENS and baseline on the one hand and between placebo TENS and the active TENS devices on the other hand (P > 0.05). The findings suggest that, as an alternative to local anesthetics, TENS seems not to be useful in the case of painful dental interventions, since it offered only minor advantages over a placebo.

Promoter elements of the mustard CHS1 gene are sufficient for light regulation in transgenic plants.

The expression of chalcone synthase (CHS) genes, which encode the first enzyme of the flavonoid pathway, is under developmental control as well as affected by external stimuli such as light. Varying fragments of the 1 kb upstream region of the CHS1 gene from white mustard (Sinapis alba L.) were fused to the GUS-coding region, and the light-regulated expression of these constructs was analysed in transgenic Arabidopsis and tobacco plants. Studies performed with Arabidopsis seedlings indicate the presence of two elements within the CHS1 promoter mediating light responses via different photoreceptors. One element, located about 150 bp upstream of the transcription start site, is homologous to Unit 1 of the parsley CHS gene, the second, far more upstream element carries sequences similar to Unit 2 of the same gene. Detailed studies on Unit 1-driven expression indicate that this element transfers the expression characteristics of the original gene to both Arabidopsis and tobacco. Although the expression characteristics of Unit 1 are indistinguishable from those of the full-length promoter within the same species, we observed differences in mustard CHS promoter regulation between Arabidopsis and tobacco plants transgenic for the identical construct. The difference in photoreceptor usage by the same promoter element in different transgenic species (Unit 1 from mustard in Arabidopsis vs. tobacco) was also observed for different but homologous promoter elements in the same transgenic species (Unit 1 from mustard and parsley in tobacco). We therefore conclude that the same promoter and even the same promoter element (Unit 1) can mediate different spatial patterns of expression and modes of light regulation in different transgenic species.

Two Tcp-1-related but highly divergent gene families exist in oat encoding proteins of assumed chaperone function.

Tcp-1-related sequences have been isolated from a cDNA library of etiolated 6-day-old oat (Avena sativa) seedlings. This attempt was made to obtain cDNAs of a recently published 60 kDa plant chaperone that re-folds denatured phytochrome and which was biochemically characterised as a Tcp-1-related protein [(1993) Nature 363, 644-647]. The translation of the putative coding sequence from one full-length cDNA clone displays no specific homologies to amino acid sequences known from peptide sequencing of the oat 60 kDa chaperone. Antibodies raised against the 60 kDa chaperone and over-expressed protein from one full-length coding sequence for Tcp-1 from oat show no cross-reactivity, whereas a monoclonal antibody raised against mouse Tcp-1 protein recognizes both the 60 kDa protein purified from plant extracts and over-expressed protein from Tcp-1-related cDNA sequences.

The 23 KDa polypeptide of the photosynthetic oxygen-evolving complex from mustard seedlings (Sinapis alba L.). Nucleotide sequence of cDNA and evidence for phytochrome control of its mRNA abundance.

The nucleotide sequence of a cDNA from mustard shows 78% homology in deduced amino acid sequence for the mature protein compared to the sequence for the 23 kDa protein of the oxygen-evolving complex from spinach [(1987) FEBS Lett. 216, 234-240]. There is also a high degree of homology between the premature protein sequences concerning the hydrophobic domain and its distance from the suggested processing site. The accumulation of mRNA for the 23 kDa protein in mustard was stimulated by continuous far-red light and reversal experiments by means of red/far-red light pulse treatment show the involvement of phytochrome in controlling the mRNA abundance for the 23 kDa polypeptide in mustard. The accumulation of the mRNA can be inhibited in white light if the seedlings are treated with the herbicide Norflurazon.

Effects of dietary vitamin E on serum and pulmonary fatty acids and prostaglandins in rats fed excess linoleic acid.

The interrelationships of dietary vitamin E and essential fatty acids and their effects on serum and pulmonary prostaglandin (PG) synthesis and fatty acid precursors were examined. In a preexperimental period, male weanling rats were depleted of essential fatty acids (EFA) by feeding on a hydrogenated coconut oil diet. At the end of 45 days, average serum triene:tetraene ratio for the EFA-deficient rats was 0.76. After a refeeding period with a 20% safflower oil diet and 0, 1 or 50 mg of dl-alpha-tocopheryl acetate daily, serum and pulmonary fatty acid profiles and PG synthesis were determined. A trend to growth depression on the high vitamin E diet was observed. Vitamin E supplementation seemed to have no significant effect on fatty acid composition or synthesis of PGE1, PGE2, PGF2 alpha or PGI2 in lung. This may be due to the small lipid content and presumed inability of lung to accumulate excess vitamin E. Lung may, therefore, be resistant to such dietary manipulations. Serum PG synthesis was not affected by vitamin E dose, although the C20:4 omega 6/C18:2 omega 6 ratio in serum was significantly lowered on the high vitamin E diet.

Vitamin-mineral supplement fails to improve IQ of mentally retarded young adults.

Twenty mentally retarded persons participated in a study to determine the effect of large doses of vitamin-mineral supplements on IQ, educability, electrophysiological responsiveness, and pyridoxine metabolism. Using a double-blind matched group experimental design, we administered supplements and placebos for 6 months. Pre- and postmeasurements showed no significant effects on any of the measured variables.

Early auditory evoked potentials (EAEP) in vertebral basilar insufficiency.

Stimulation with a short tone pip elicits an acoustic nerve compound action potential (I) and different waves (II--VII) in the inital 10 ms. Seven waves have been studied in 40 control subjects and five waves in 12 patients with vertebral-basilar insufficiency. Abnormalities of the different waves were observed at levels such as cochlea and/or acoustic nerve, medulla, caudal pons, rostral pons, and midbrain. The recording of early auditory evoked potentials (EAEP) is a noninvasive method of confirming impairment of the auditory pathway caused by a reduced vascular supply of vertebral and basilar arteries.