Efficacy of artichoke leaf extract in the treatment of patients with functional dyspepsia: a six-week placebo-controlled, double-blind, multicentre trial.

BACKGROUND: This study aimed to assess the efficacy of artichoke leaf extract (ALE) in the treatment of patients with functional dyspepsia (FD). METHODS: In a double-blind, randomized controlled trial (RCT), 247 patients with functional dyspepsia were recruited and treated with either a commercial ALE preparation (2 x 320 mg plant extract t.d.s.) or a placebo. The primary efficacy variable was the sum score of the patient's weekly rating of the overall change in dyspeptic symptoms (four-point scale). Secondary variables were the scores of each dyspeptic symptom and the quality of life (QOL) as assessed by the Nepean Dyspepsia Index (NDI). RESULTS: Two hundred and forty-seven patients were enrolled, and data from 244 patients (129 active treatment, 115 placebo) were suitable for inclusion in the statistical analysis (intention-to-treat). The overall symptom improvement over the 6 weeks of treatment was significantly greater with ALE than with the placebo (8.3 +/- 4.6, vs. 6.7 +/- 4.8, P < 0.01). Similarly, patients treated with ALE showed significantly greater improvement in the global quality-of-life scores (NDI) compared with the placebo-treated patients (- 41.1 +/- 47.6 vs. - 24.8 +/- 35.6, P < 0.01). CONCLUSION: The ALE preparation tested was significantly better than the placebo in alleviating symptoms and improving the disease-specific quality of life in patients with functional dyspepsia.

Efficacy and tolerability of valerian extract LI 156 compared with oxazepam in the treatment of non-organic insomnia--a randomized, double-blind, comparative clinical study.

Patients aged 18 to 73 years and diagnosed with non-organic insomnia according to ICD-10 (F 51.0) were treated in a multicentre, double-blind, randomised parallel group comparison with either 600 mg/die valerian extract LI 156 (Sedonium) or 10 mg/die oxazepam taken for 6 weeks. A total of 202 outpatients with a mean duration of insomnia of 3.5 months at baseline were included at 24 study centres (general practices) in Germany. - Sleep quality (SQ) after 6 weeks measured by the Sleep Questionnaire B (SF-B; CIPS 1996) showed that 600 mg/die valerian extract LI 156 was at least as efficacious as a treatment with 10 mg/die oxazepam. Both treatments markedly increased sleep quality compared with baseline (p <0.01). The other SF-B subscales, i.e. feeling of refreshment after sleep (GES), psychic stability in the evening (PSYA), psychic exhaustion in the evening (PSYE), psychosomatic symptoms in the sleep phase (PSS), dream recall (TRME), and duration of sleep confirmed similar effects of both treatments. Clinical Global Impressions scale (CGI) and Global Assessment of Efficacy by investigator and patient, again, showed similar effects of both treatments. Adverse events occurred in 29 patients (28.4%) receiving valerian extract LI 156 and 36 patients (36.0%) under oxazepam, and were all rated mild to moderate. No serious adverse drug reactions were reported in either group. Most patients assessed their respective treatment as very good (82.8% in the valerian group, 73.4% in the oxazepam group). During the 6 week treatment phase Valerian extract LI 156 (Sedonium) 600 mg/die showed a comparable efficacy to 10 mg/die oxazepam in the therapy of non-organic insomnia.

Ethinylestradiol 20 versus 30 micrograms combined with 150 micrograms desogestrel: a large comparative study of the effects of two low-dose oral contraceptives on the hemostatic system.

In a 6-month, randomized, double-blind study the effects of two combined oral contraceptives containing 150 micrograms desogestrel and either 20 or 30 micrograms ethinylestradiol on hemostatic parameters were investigated in 1633 healthy women. Compared with baseline, the 30 micrograms ethinylestradiol formulation increased prothrombin fragment 1 + 2 (+72.2%), D-dimer (+42.4%) and protein C activity (+6.1%), whereas antithrombin-III activity (-6.3%) and protein S activity (-19.7%) were decreased. The use of the 20 micrograms ethinylestradiol formulation was associated with the same pattern of changes, but with lower magnitude (F1+2 + 61.1%, D-dimer +36.0%, antithrombin III -5.3%, protein C +4.6% and protein S-16.0%). The changes from baseline were significantly smaller in the 20 micrograms ethinylestradiol group for D-dimer, antithrombin III and protein S than in the 30 micrograms ethinylestradiol group (p = 0.019, p = 0.038 and p = 0.001, respectively). One woman with a combined deficiency of proteins C and S developed deep venous thrombosis while using the 20 micrograms ethinylestradiol formulation. Use of both formulations was associated with a shift of the coagulation-fibrinolysis balance to an enhanced fibrin-generating and fibrin-degradating activity. The less-pronounced effect on hemostasis with the 20 micrograms ethinylestradiol preparation is reassuring with regard to thromboembolic risk in general. However, women with coagulation inhibitor deficiency should be advised not to use oral contraceptives.

Routine screening for coagulation inhibitors prior to prescribing the pill: prevalence data from a large cohort of German pill starters.

A total of 2674 women were recruited to participate in a multicenter oral contraceptive (OC) study on hemostasis. At baseline, protein S activity less than 60% of normal values was found in two volunteers (0.75 per 1000) and the antithrombin III activity was less than 60% of normal values in three volunteers (1.1 per 1000). All measurements were confirmed by a second assessment. In contrast, of the 28 women presenting with protein C levels less than 60% of normal values, only six were confirmed (2.3 per 1000). Of these, one was also protein S-deficient. Seven women could not be studied twice and 15 were false-low according to their normal control values. These data suggest that routine screening of the hemostatic system may reveal findings suggestive of inhibitor deficiencies in as many as 3.75 per 1000 of apparently healthy candidates for OCs. However, our data also demonstrate that unselected screening is compromised by a considerable rate of false-positive results and cannot generally be recommended. However, screening of coagulation inhibitors is feasible in women with a family history of thromboembolic disease.

Modulation of lead-induced performance deficit in children by varying signal rate in a serial choice reaction task.

Evidence is presented showing that serial choice reaction performance is disrupted at low blood lead levels (PbB), and that parametric variation of task characteristics modulates the degree of disruption. This evidence is based on two independent studies in 6- to 9-year-old children living in two lead smelter areas in the cities of Nordenham (N = 114) and Stolberg (N = 109) in West Germany. Average PbB was 8.2 micrograms/100 ml (4.4-23.8 micrograms/100 ml) in the Nordenham sample and 7.4 micrograms/100 ml (4.2-18.0 micrograms/100 ml) in the Stolberg sample. Serial choice reaction performance was assessed by means of the Vienna reaction device in which a random sequence of light and tone signals has to be answered by pressing appropriate response buttons. Correct (hits) and false responses (errors) were evaluated as performance measures, and signal rate was varied in order to achieve easy and difficult task conditions. Exposure-related performance deficit was more pronounced for errors than for hits, more clearcut for high than for low signal rates, and proved significant in both studies after correction for confounding using confounder models of different complexities. Some features of the observed deficit resemble clinical observations in children presenting with attention deficit disorder.

Doubts on the adequacy of the principal component varimax analysis for the identification of event-related brain potential components: a commentary on Glaser and Ruchkin, and Donchin and Heffley.

Glaser and Ruchkin (1976) as well as Donchin and Heffley (1978) have proposed principal component varimax analysis (PCVA) for identification of event-related potential (ERP) components. In the present commentary, the assumptions on the ERP data structure of this procedure are considered. They are formalized and compared with a simpler and more restrictive hypothesized ERP data structure containing autoregressive properties. Referring to the principle of parsimony, the comparison of the two models shows the superiority of the hypothesized autoregressive structure: to fit a set of ERP data equally well, the autoregressive structure does so with considerably more parsimonious assumptions, i.e. with fewer parameters to be estimated, than the structure induced by PCVA. It is concluded that an appropriate model for the ERP data structure should take the autocorrelated nature of the ERP into account.

The effects of lead in laboratory animals and environmentally-exposed children.

Consistent association has been found in 4 independent studies between disruption of visual-motor integration and reaction performance and markers of lead exposure (blood, teeth) in children, but not for intelligence deficit; blood-lead levels were typically below 30 micrograms/dl in these children. In order to demonstrate the persistent nature of Pb-induced neurobehavioral deficit experimentally rats were studied after cessation of dietary Pb-exposure in a variety of behavioral tasks. Persistent retention-deficit was found for visual discrimination-learning and for radical arm-maze performance.

Exposure to lead and cadmium of children living in different areas of north-west Germany: results of biological monitoring studies 1982-1986.

Between 1982 and 1986 several surveys were carried out to determine the levels of lead and cadmium in blood, urine, and shed deciduous teeth (incisors only) of children living in rural, suburban, urban, and industrial areas of North-West Germany. Blood lead (PbB) and blood cadmium (CdB) were measured in about 4000 children. In rural, suburban and urban areas the median PbB levels vary between 5.5 and 7 micrograms/dl, with 98th percentiles varying between 10 and 13 micrograms/dl. The median CdB levels are between 0.1 and 0.2 microgram/dl, with 95th percentiles between 0.3 and 0.4 microgram/l. Children from urban areas have significantly higher PbB levels than children from rural and suburban areas. Regarding CdB no differences could be detected. Children living in areas around lead and zinc smelters, particularly those living very close to the smelters, have substantially increased PbB and CdB levels. Children from lead worker families also have substantially increased PbB and CdB levels. The lead levels in shed milk teeth (PbT) were determined in about 3000 children. In rural, suburban and urban areas the median PbT levels are between 2 and 3 micrograms/g, with 95th percentiles between 4 and 7 micrograms/g. Children from urban areas have significantly higher PbT levels than children from rural and suburban areas. The highest PbT levels (on a group basis) are in children from nonferrous smelter areas. The median levels of lead in urine (PbU) are between 6 and 10 micrograms/g creatinine, with 95th percentiles between 20 and 30 micrograms/g creatinine. Children from polluted areas have higher PbU levels than children from less polluted areas. The median levels of cadmium in urine (CdU) are in the order of 0.1 microgram/g creatinine, with 95th percentiles being in the range of 0.5 and 1.0 microgram/g creatinine. Girls have higher CdU levels than boys. There are no differences between groups of children from different areas. Children from lead worker families have higher PbU and CdU levels than otherwise comparable children. The results of the present studies indicate a further decrease of PbB in children from North-West Germany since the CEC blood lead campaigns carried out in 1979 and 1981. The decrease of lead exposure also seems to be reflected by a decrease of tooth lead levels.