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

X-ray Diffraction Study of iPP/clay and iPP/TiO2 Composites Relating to Micromechanical Properties

Composites of isotactic polypropylene with various contents of white clay or titanium dioxide TiO2 were prepared by extrusion molding. The extruded composites were melt-pressed at two different temperatures, and,thereafter, either slowly cooled, or quenched to room temperatures. It is shown that the structure of all the samples, as revealed by wide-angle X-ray scattering and small-angle X-ray scattering (SAXS), depends on the processing conditions. The lack of SAXS maxima in the composites suggests that the presence of the microadditives hinders the stacking of iPP lamellae. Furthermore, the microindentation hardness H in the slowly cooled composites is influenced by the type and amount of the filler used. However, in the quenched samples H depends only on the amount of the filler used, and not on its type. In case of the quenched iPP/clay composites, the relationship between H and the Young’s modulus E is found to be H/E approx. equal to 0.12, in good agreement with Struik’s theoretical predictions of sigma e approx. equal to E/30, in consonance with results previously obtained for a series of polyethylene samples with different morphology.Peer reviewe

The effect of different clays on the structure, morphology and degradation behavior of poly (lactic acid)

In this work, polylacticacid(PLA) based nanocomposites \ufb01lled with different kinds of clay were prepared and their structure, morphology and degradation behavior were compared. A similar degree of dispersion was achieved in the case of cationic and anionic clays. However, these two types of \ufb01llers had different effects on the structure and morphology. Perkalite, ananionic clay, induced higher crystallinity, a faster crystallization rate and also a modi\ufb01cation of the crystallization mechanism. Moreover, when perkalite was used, the lamellar framework of PLA was preserved. Cationic clays, on the other hand, were detrimental for a regular crystallization of the PLA matrix, producing very disordered lamellar stacks. The effects of anionic and cationic clays were different also on the degradation behavior, with the perkalite-containing nanocomposite degrading much faster than either the matrix or the montmorillonite-reinforced materials. This comparison shows that a rational choice of the chemical nature of the nano\ufb01ller allows to tune both the degradation rate of PLA and its structure