Ginkgo biloba for the treatment of vitilgo vulgaris: an open label pilot clinical trial

<p>Abstract</p> <p>Background</p> <p>Vitiligo is a common hypopigmentation disorder with significant psychological impact if occurring before adulthood. A pilot clinical trial to determine the feasibility of an RCT was conducted and is reported here.</p> <p>Methods</p> <p>12 participants 12 to 35 years old were recruited to a prospective open-label pilot trial and treated with 60 mg of standardized <it>G. biloba </it>two times per day for 12 weeks. The criteria for feasibility included successful recruitment, 75% or greater retention, effectiveness and lack of serious adverse reactions. Effectiveness was assessed using the Vitiligo Area Scoring Index (VASI) and the Vitiligo European Task Force (VETF), which are validated outcome measures evaluating the area and intensity of depigmentation of vitiligo lesions. Other outcomes included photographs and adverse reactions. Safety was assessed by serum coagulation factors (platelets, PTT, INR) at baseline and week 12.</p> <p>Results</p> <p>After 2 months of recruitment, the eligible upper age limit was raised from 18 to 35 years of age in order to facilitate recruitment of the required sample size. Eleven participants completed the trial with 85% or greater adherence to the protocol. The total VASI score improved by 0.5 (P = 0.021) from 5.0 to 4.5, range of scale 0 (no depigmentation) to 100 (completely depigmented). The progression of vitiligo stopped in all participants; the total VASI indicated an average repigmentation of vitiligo lesions of 15%. VETF total vitiligo lesion area decreased 0.4% (P = 0.102) from 5.9 to 5.6 from baseline to week 12. VETF staging score improved by 0.7 (P = 0.101) from 6.6 to 5.8, and the VETF spreading score improved by 3.9 (P < 0.001)) from 2.7 to -1.2. There were no statistically significant changes in platelet count, PTT, or INR.</p> <p>Conclusions</p> <p>The criteria for feasibility were met after increasing the maximum age limit of the successful recruitment criterion; participant retention, safety and effectiveness criteria were also met. Ingestion of 60 mg of <it>Ginkgo biloba </it>BID was associated with a significant improvement in total VASI vitiligo measures and VETF spread, and a trend towards improvement on VETF measures of vitiligo lesion area and staging. Larger, randomized double-blind clinical studies are warranted and appear feasible.</p> <p>Trial Registration</p> <p>Clinical trials.gov registration number <a href="http://www.clinicaltrials.gov/ct2/show/NCT00907062">NCT00907062</a></p

Seasonal pattern of peptic ulcer hospitalizations: analysis of the hospital discharge data of the Emilia-Romagna region of Italy

BACKGROUND: Previous studies have reported seasonal variation in peptic ulcer disease (PUD), but few large-scale, population-based studies have been conducted. METHODS: To verify whether a seasonal variation in cases of PUD (either complicated or not complicated) requiring acute hospitalization exists, we assessed the database of hospital admissions of the region Emilia Romagna (RER), Italy, obtained from the Center for Health Statistics, between January 1998 and December 2005. Admissions were categorized by sex, age ( or = 75 yrs), site of PUD lesion (stomach or duodenum), main complication (hemorrhage or perforation), and final outcome (intended as fatal outcome: in-hospital death; nonfatal outcome: patient discharged alive). Temporal patterns in PUD admissions were assessed in two ways, considering a) total counts per single month and season, and b) prevalence proportion, such as the monthly prevalence of PUD admissions divided by the monthly prevalence of total hospital admissions, to assess if the temporal patterns in the raw data might be the consequence of seasonal and annual variations in hospital admissions per se in the region. For statistical analysis, the chi2 test for goodness of fit and inferential chronobiologic method (Cosinor and partial Fourier series) were used. RESULTS: Of the total sample of PUD patients (26,848 [16,795 males, age 65 +/- 16 yrs; 10,053 females, age 72 +/- 15 yrs, p or = 75 yrs of age. There were more cases of duodenal (DU). (89.8%) than gastric ulcer (GU) (3.6%), and there were 1,290 (4.8%) fatal events. Data by season showed a statistically difference with the lowest proportion of PUD hospital admissions in summer (23.3%) (p < 0.001), for total cases and rather all subgroups. Chronobiological analysis identified three major peaks of PUD hospitalizations (September-October, January-February, and April-May) for the whole sample (p = 0.035), and several subgroups, with nadir in July. Finally, analysis of the monthly prevalence proportions yielded a significant (p = 0.025) biphasic pattern with a main peak in August-September-October, and a secondary one in January-February. CONCLUSIONS: A seasonal variation in PUD hospitalization, characterized by three peaks of higher incidence (Autumn, Winter, and Spring) is observed. When data corrected by monthly admission proportions are analyzed, late summer-autumn and winter are confirmed as higher risk periods. The underlying pathophysiologic mechanisms are unknown, and need further studies. In subjects at higher risk, certain periods of the year could deserve an appropriate pharmacological protection to reduce the risk of PUD hospitalization

Fortschritte bei der Beherrschung und Begrenzung der Folgen auslegungsueberschreitender Ereignisse

Die in den deutschen Anlagen implementierten Massnahmen entsprechen - global gesehen - dem internationalen Stand der Technik. Eine Optimierung an bestehenden Massnahmen kann sich nach anlagenspezifischen Analysen zu Schweren Stoerfaellen, speziell auch einer PSA der Stufe 2, ergeben. Die Aufbereitung von Informationen und Darstellungstechniken zur Unterstuetzung des Anlagenbetriebs im Sicherheitsmanagement mit Simulationsprogrammen und spezifischen Prozeduren sind in der Entwicklung. Bei Neuanlagen hat man fortgeschriebenen Genehmigungsanforderungen bezueglich Schwerer Stoerfaelle mit limitierten Freisetzungen aus den Anlagen nachzukommen und analytisch nachzuweisen. Fruehe, grosse Freisetzungen sind auszuschliessen. Eine Rueckhaltung - zumindest temporaer - einer Schmelze im Containment und damit eine Begrenzung von Freisetzungen aus der Anlage sind gefordert. Abhaengig von der Anlagentechnik werden unterschiedliche, aber in allen Faellen aufwendige Konzepte verfolgt. Die Erkenntnisse aus den Forschungsarbeiten zu Schweren Stoerfaellen zeigen erhebliche Fortschritte im phaenomenologischen Verstaendnis und in der Analytik. Die meisten Phaenomene sind grundsaetzlich verstanden. Vielfach bestimmen anlagenspezifische Details den Unfallablauf dominant. Zweifellos ist einer Reihe von Detailfragen nocht vertieft nachzugehen; diese Arbeiten werden im internationalen Verbund weitergefuehrt. In der Diskussion zu diesem Punkt wurde angeregt, die identifizierten offenen Fragestellungen mit EVU, Herstellern, Forschungsinstitutionen und Gutachtern zu diskutieren, um im Konsens die Relevanz zu beurteilen und eine Prioritaetensetzung vorzunehmen. Fuer eine risikoorientierte Bewertung der offenen Punkte empfiehlt es sich, eine PSA Stufe 2 heranzuziehen und die anlagenspezifischen Aspekte herauszuarbeiten. Aus EVU-Sicht wurde angemerkt, dass bei politisch bedingter limitierter Laufzeit der Anlagen die Unterstuetzung der Forschungsarbeiten zu Schweren Stoerfaellen verstaendlicheweise sehr begrenzt ist. (orig.)Viewed globally, the measures that are implemented in the German nuclear power plants correspond to the international state of the art. Existing measures can be optimised after plant specific severe accident analyses, especially when using PSA level 2. Evaluation of information and presentation techniques, using simulation programmes and specific procedures, are under development for support of the plant operation in safety management. For new plants, extended licensing requests for limited releases in severe accidents must be followed and proved analytically. Early large releases must be excluded. Retention of core melt within the containment, at least temporarily, is requested to further reduce releases. Depending on plant design, different but always elaborate concepts are followed. The knowledge gained by extended R and D work in the severe accident area demonstrates significant progress in phenomenological understanding and analytical description. Most of the relevant phenomena are basically understood. In many cases, plant specific details dominate the accident sequence. Undoubtedly, a number of details must still be investigated which is being performed in international cooperation. Concerning this topic it was proposed to discuss the identified open problems with utilities, vendors, research and expert organisations, in order to reach agreement on relevance and priorities. For a risk oriented evaluation of open topics it is recommended to elaborate plant specific aspects on the basis of PSA level 2 studies. It was remarked from utilities point of view that, because of limited plant life time due to political boundary conditions, support for severe accident research is understandably rather limited. (orig.)Available from TIB Hannover: ZA5141(6935) / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekSIGLEDEGerman