Therapeutic equivalence study of two formulations (innovator v. generic) of beclomethasone dipropionate in adult asthmatic patients

Objective. To study the therapeutic equivalence of two formulations (innovator v. generic) of beclomethasone dipropionate (BDP) 400 pg twice daily administered per metered dose inhaler (MDO, in adults with moderate to severe asthma.Methods. A double-blind randomised parallel-group trial was performed with a 2-week run-in and an 8-week treatment period. Thirty-six symptomatic adult asthmatics on a mean daily dose of 750 μg inhaled corticosteroids during run-in, a mean forced expiratory volume in 1 second (FEV1) of 70% predicted normal and a mean histamine concentration provoking a 20% reduction in FEV1 (histamine PC20 of 0.11 mg/l were randomised to one of the two treatment groups. Primary variables were morning peak expiratory flow (mPEF), FEV1 and histamine PC20- Secondary variables were β2-agonist use, symptom score and nocturnal awakening. The Schuirmann two one-sided tests procedure was used for the statistical analysis. Ninety-five per cent confidence intervals (CIs) were calculated for the differences in means.Results. The mean differences end of treatment to baseline for the two formulations (Becotide and Beclate) respectively were: mPEF 5.61/min (0 -16.4- 27.6) and -22.31/min (0 -35.6 - -9); FEV 1 -2.90/0 (0 -11 - 5.2) and 0.2% (0 -4.8 -5.2); Histamine PC20-0.04 mg/ml (0 -0.15- 0.06) and 0.02 mg/ mi (0 -0.37 - 0.4). Changes in clinical variables were not conclusive. The mean differences with CIs for Primary variables were contained within the limits set for equivalence. The sample size was sufficient to differentiate the groups for mPEF, but this was not of clinical significance.Conclusion. After 8 weeks of treatment the two formulations of BDP, delivered by MDI through a large-volume spacer, were therapeutically equivalent in moderate-to-severe asthmatic adults

The unknown underworld : understanding soil health in South Africa

CITATION: Louw, S. et al. 2014. The unknown underworld: understanding soil health in South Africa. South African Journal of Science, 110(5/6): 1-4, doi:10.1590/sajs.2014/a0064.The original publication is available at http://www.sajs.co.zaThe need to provide food security to a growing human population in the face of global threats such as climate change, land transformation, invasive species and pollution is placing increasing pressure on South African soils. South Africa is losing an estimated 300–400 million tonnes of soil annually, while soil degradation is a major threat to agricultural sustainability. In spite of these problems, treatment of soil health in biodiversity assessment and planning in South Africa has been rudimentary to date.http://www.sajs.co.za/unknown-underworld-understanding-soil-health-south-africa/schalk-v-d-m-louw-john-r-u-wilson-charlene-janion-ruan-veldtman-sarah-j-davies-matthew-addisonPublisher's versio

Soil biota in a megadiverse country: Current knowledge and future research directions in South Africa

Soils are integral to agricultural productivity, biodiversity, and the maintenance of ecosystem services. However, soil ecosystem research depends on foundational biological knowledge that is often missing. In this review, we present a comprehensive, cross-taxa overview of the soil biota of South Africa. We discuss the literature and sampling methods used to assess soil biota, the available taxonomic expertise and main collections within South Africa, the availability of identification guides and online resources, and the status and distribution of described species. We include species lists for all South African soil biota and, for groups with sufficient distribution records, species richness maps. Despite South Africa being only 0.8% of the earth’s terrestrial area, it contains nearly 1.8% of the world’s described soil species (mean per taxon 3.64%, range 0.17–15%; n = 36 groups), with nematodes and earthworms showing a remarkable (6.4 and 7.7%) proportion of globally described diversity. Endemism is high for most groups, ranging from 33–92%. However, major knowledge gaps exist for most soil biota groups. While sampling has been relatively comprehensive in some areas for a few groups (particularly those with direct socioeconomic impacts), the Nama-Karoo, Northern Cape and Eastern Cape are poorly sampled. Natural soils in biodiversity hotspots, such as the Fynbos Biome, are also understudied. We argue that a more integrative approach to acquiring foundational knowledge in soil biodiversity is needed if applied soil research is to be effective in ensuring sustainable soil health. Considerable investment will be required to bring our understanding of the soil biodiversity in this megadiverse region to a level where the Millennium Development Goals can be reached