Phase II trial on the effects of Silexan in patients with neurasthenia, post-traumatic stress disorder or somatization disorder.

Silexan, a novel lavender oil preparation for oral use, has been authorized in Germany for the treatment of states of restlessness during anxious mood. An open-label, exploratory trial was performed to assess the potential of the medicinal product in the treatment of restlessness caused by anxiety as related to several disorders. Outcome measures included the Symptom Checklist-90-Revised (SCL-90-R), von Zerssen's Depression Scale (D-S), the 36-item Short Form Health Survey Questionnaire (SF-36), and a sleep diary. 50 male and female patients with neurasthenia (ICD-10 F48.0), post-traumatic stress disorder (PSD; F43.1), or somatization disorder (F45.0, F45.1) were included to receive 1 × 80 mg/day Silexan over 6 weeks; 47 could be analyzed for efficacy as full analysis set. At baseline, patients suffered from restlessness (96%), depressed mood (98%), sleep disturbances (92%), or anxiety (72%). Of those, resp. 62%, resp. 57%, resp.51%, resp. 62% showed improvements during treatment (p < 0.001). For all patients, mean D-S score decreased by 32.7% and SCL-90-R Global Severity Index by 36.4% as compared to baseline, (p < 0.001), while the SF-36 Mental Health Score increased by 48.2% (p < 0.001). Waking-up frequency (p = 0.002), Waking-up duration (p < 0.001) and morning tiredness (p = 0.005) were reduced, while efficiency of sleep (p = 0.018) and mood (p = 0.03) improved. Patients suffering from neurasthenia or PSD showed comparable improvements with most outcomes. The results in this trial justify to further investigate Silexan in disorders with accompanying restlessness caused by sub-threshold anxiety. Adverse reactions, predominantly gastrointestinal complaints, were judged as mild or moderate.

Ginkgo biloba extract EGb 761(R), donepezil or both combined in the treatment of Alzheimer's disease with neuropsychiatric features: a randomised, double-blind, exploratory trial.

OBJECTIVE: This randomised, double-blind exploratory trial was undertaken to compare treatment effects and tolerability of EGb 761(R), donepezil and combined treatment in patients with AD and neuropsychiatric features. METHOD: We enrolled 96 outpatients, aged 50 years or above, who met the NINCDS/ADRDA criteria for probable AD, scored below 36 on the TE4D, a screening test for dementia, below 6 on the Clock-Drawing Test (CDT) and between 9 and 23 on the SKT, a cross-culturally validated cognitive test battery. They scored at least five on the 12-item Neuropsychiatric Inventory (NPI). EGb 761(R) (240 mg per day), donepezil (initially 5 mg, after 4 weeks 10 mg per day) or EGb 761(R) and donepezil combined (same doses) were administered for 22 weeks. RESULTS: Changes from baseline to week 22 and response rates were similar for all three treatment groups with respect to all outcome measures (SKT, NPI, total score and activities-of-daily-living sub-score of the Gottfries-Bråne-Steen Scale, Hamilton Rating Scale for Depression, CDT and Verbal Fluency Test). An apparent tendency in favour of combination treatment warrants further scrutiny. Compared to donepezil mono-therapy, the adverse event rate was lower under EGb 761(R) treatment and even under the combination treatment. CONCLUSION: These exploratory findings helped to develop three hypotheses that will have to be proven in further studies: (1) there is no significant difference in the efficiency between EGb 761(R) and donepezil, (2) a combination therapy will be superior to a mono-therapy with one of both substances and (3) there will be less side effects under a combination therapy than under mono-therapy with donepezil.

Urothelial cancer of the bladder in an area of former coal, iron, and steel industries in Germany: a case-control study.

In a case-control study performed in an area of former coal, iron, and steel industries, the professional and lifestyle histories of 412 male urothelial bladder cancer inpatients (cases) and 414 inpatients with benign prostatic hyperplasia (controls) were investigated. Smoking habits were identified as the main confounder for occupational bladder cancer risk. Two hundred and forty (58.3%) of the bladder cancer inpatients and 146 (35.3%) of the inpatients with benign prostatic hyperplasia were smokers. The percentage of ex-smokers in the bladder cancer cases was 10.2%; the percentage of ex-smokers in the controls was 9.7%. Smoking-adjusted Mantel-Haenszel estimates of the odds ratios (OR&infMH;) for bladder cancer were elevated in underground hard-coal miners (OR&infMH; =2. 54, 95% CI =[1.64; 3.93]), chemical workers (OR&infMH; =2.16, 95% CI =[0.87; 5.38]), painters/varnishers (OR&infMH; = 2.42, 95% CI =[1. 05; 5.57]), technicians (OR&infMH; = 1.99, 95% CI =[0.95; 4.16]), and foundry workers (OR&infMH; = 2.22, 95% CI = [0.53; 9.08]). Administrative officers had significantly lower smoking-adjusted odds ratios (OR&infMH; = 0.61, 95% CI = [0.42; 0.88]). Although statistically not significant, the results of the Breslow-Day test of homogeneity of the odds ratios over the strata are compatible with interactions between tobacco smoking and the occupations of underground hard-coal miners (chi(2)&infBD; = 4.91, p=0.07) and chemical workers (chi(2)&infBR; = 3.32, p=0.06).