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Pitfalls and prospects in clinical research on antianxiety drugs: benzodiazepines and placebo--a research review.

The research methodology of 78 double-blind studies comparing benzodiazepines and placebo in treating neurotic anxiety is critically reviewed. Many faults are noted in areas of subject selection, assessment of clinical response, study design and data analysis. Although 56.4% of the studies reviewed had results demonstrating a significant difference in clinical response between benzodiazepines and placebo, the frequent methodologic difficulties and inconsistent results from study to study lead the authors to question the efficacy of these drugs as a treatment for anxiety. A need for better designed studies is discussed and some research methodologies proposed.

Anti-Anxiety Agents

Development and application of basic research techniques in bladder cancer research.

The growth of transitional epithelial cells with different growth media and growth supports was examined. Sephadex G-10, Bio-Gel P-20, Bio-Glas-1000, DEAE-Sephadex A-50, DEAE-cellulose, CM-Sephadex C-50, acid-soluble collagen, and immobilized collagen fibers were used to enhance plating efficiency. Acid-soluble collagen layers optimally increased the plating efficiency of primary cultures of bladder carcinoma. Media alterations with serial combinations of fetal calf, newborn calf, calf, bovine, and bull serum with minimum essential medium, Roswell Park Memorial Institute Tissue Culture Medium 1640, Connaught Medical Research Laboratories Medium 1066, Medium 199, Grand Island Biological, National Cancer Tissue Culture 135, 1415, McCoy's 5A, and National Cancer Institute medium were established. No promotion of cell division was noted with any one of these basic medium formulations.

Animals

Plasma lipid distributions in selected North American populations: the Lipid Research Clinics Program Prevalence Study. The Lipid Research Clinics Program Epidemiology Committee.

Cross-sectional age- and sex-specific plasma lipid distributions (means, medians and selected percentiles) are given for 48,431 white participants in visit 1 of the Lipid Research Clinics (LRC) Prevalence Study. This study consisted of two visits in which 10 LRCs screened participants selected from well-defined North American target populations that included a broad range of sociodemographic subgroups. These data confirm findings from earlier studies in developed countries, showing age-related differences in plasma lipid levels. However, for overall distributions, the LRC data showed slightly lower cholesterol and markedly higher triglyceride values than those previously reported for North America. Some variation in plasma lipid values was evident among the clinic populations. The large number of participants within most subgroups permitted a variety of analytic and comparative studies. For example, data from the large pediatric population revealed a drop in plasma cholesterol levels in adolescent males and females. Males aged 20--50 years had higher cholesterol levels than females in the same age group, and higher triglyceride levels between ages 20--70 years. Numbers were also sufficient for meaningful comparisons between lipid distributions of females who were taking sex hormones and those who were not: In females taking sex hormones, cholesterol and triglyceride levels were higher for subjects younger than 45 years, but slightly lower after age 45, than lipid levels in females not taking hormones.

Adolescent

Research in leprosy. A report of a committee set up by the medical research council to study future prospects.

Recommendations for future research in leprosy include (i) cultivation of M. leprae in vitro; (ii) genetic control of susceptibility, including twin studies and HLA typing; (iii) precise antigenic analysis of M. leprae; (iv) mechanisms involved in the macrophage response to mycobacterial infections; (v) more use of experimental models such as normal mice infected with M. lepraemurium; (vi) reassessment of the protection afforded by BCG; (vii) assessment of protection afforded by killed (armadillo) M. leprae vaccine; (viii) pathogenesis of erythema nodosum leprosum including a study of the effect of thalidomide; and (ix) development of in vitro systems for drug sensitivity testing.

Animals

Epidemiology of tumours in the Oncological Research Programme of the Research Institute of Clinical and Experimental Oncology.

The author submits the results of initial epidemiological investigations, conducted at the department for the epidemiology of tumours in the Research Institute of Clinical and Experimental Oncology, which have the character of statistical epidemiological surveys. He compares the incidence of tumours in the CSSR, CSR and South Moravian region. He draws special attention to the different incidence of tumours among women in the South Moravian region, as compared with the incidence in the CSR.

Czechoslovakia