Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents)

This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs). Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

Frequency of Fanconi anemia in Brazil and efficacy of screening for the FANCA 3788-3790del mutation

Fanconi anemia (FA) is an autosomal recessive genetic disease characterized by progressive bone marrow failure, susceptibility to cancer and multiple congenital anomalies. There is important clinical variability among patients and the knowledge of factors which might predict outcome would greatly help the decision making regarding the choices of treatment and the appropriate time to start it. Future studies of the possible correlation between specific mutations with specific clinical presentations will provide the answer to one of these factors. At our Center we standardized a rapid and precise screening test using a mismatch PCR assay for a specific mutation (3788-3790del in exon 38 of gene FANCA) in Brazilian FA patients. We present the results obtained after screening 80 non-consanguineous FA patients referred from all regions of Brazil with a clinical diagnosis of FA supported by cellular hypersensitivity to diepoxybutane. We were able to detect the 3788-3790del allele in 24 of the 80 (30%) FA patients studied. Thirteen of the 80 (16.25%) were homozygotes and 11 of the 80 (13.75%) were compound heterozygotes, thus confirming the high frequency of the FANCA 3788-3790del mutation in Brazilian FA patients. The identification of patients with specific mutations in the FA genes may lead to a better clinical description of this condition, also providing data for genotype-phenotype correlations, to a better understanding of the interaction of this specific mutation with other mutations in compound heterozygote patients, and ultimately to the right choices of treatment for each patient with improvement of the prognosis on future studies.

Effect of adding flours from marolo fruit (Annona crassiflora Mart) and jerivá fruit (Syagrus romanzoffiana Cham Glassm) on the physicals and sensory characteristics of food bars

Abstract The marolo (Annona crassiflora Mart.) and jerivá (Syagrus romanzoffiana Cham Glassm) fruits grow in the Cerrado biome, and have important sensory and nutritional characteristics. These fruits are eaten fresh or processed and embedded in ice cream, candy, juices, and liquors. However, their use is very limited and is localized exclusively to their native region. The aim of this study was to evaluate the use of these fruits in food consumer products to improve the nutritional patterns of consumers and extend knowledge thereof. To do this, different levels (0%, 5%, 10%, 15%, and 20%) of flour derived from the marolo and jerivá fruits were incorporated into food bars, which were then characterized in terms of their physical of the texture (TPA), porosity, color and sensorial properties. The food bars enriched with marolo and jerivá flours had an intense yellow color and increased hardness relative to the control bars; the porosity of the bars progressively decreased as the amount of flour added increased. The sensorial analysis in the snack bars developed added with the fruits flour no was influence by incorporation this component, showed good averages for the scores evaluated.

AN ANTI-MANAGEMENT STATEMENT IN DIALOGUE WITH CRITICAL BRAZILIAN AUTHORS

The expressions Management and Organization Studies and Management and Organization Knowledge are expressions of an Anglo-Saxon construct. The association of Organization Studies (OS) with Management (M) produces the subordination of the former to the latter. In a different direction, a critical approach elaborated in Brazilian OS provides an original body of knowledge that expresses an anti-management (A-M) attitude. As the Brazilian A-M authors point out, the distinction between North/South M is irrelevant; what is relevant is a coherent pluriversal A-M attitude. In this paper, we honor and disseminate the Brazilian original body of knowledge on OS and introduce an OS agenda that is liberated from M.

Worldwide molecular epidemiology of HIV

Human immunodeficiency virus (HIV) is the worldwide disseminated causative agent of acquired immunodeficiency syndrome (AIDS). HIV is a member of the Lentivirus genus of Retroviridae family and is grouped in two types named HIV-1 and HIV-2. These viruses have a notable ability to mutate and adapt to the new conditions of human environment. A large incidence of errors at the transcriptional level results in changes on the genetic bases during the reproductive cycle. The elevated genomic variability of HIV has carried important implications for the diagnosis, treatment and prevention as well as epidemiologic investigations. The present review describes important definitions and geographical distribution of subtypes, circulating recombinant forms and other genomic variations of HIV. The present study aimed at leading students of Biomedical Sciences and public health laboratory staff guidance to general and specific knowledge about the genomic variability of the HIV.