The significance of "nonsignificance" in randomized controlled studies: a discussion inspired by a double-blinded study on St. John's Wort (Hypericum perforatum L.) for premenstrual symptoms

Objectives: This study aimed to investigate the efficacy of St. John's wort extract (SJW) as a treatment for premenstrual symptoms. Design: The study was a randomized, double-blinded, placebo-controlled trial, with two parallel treatment groups. After a no-treatment baseline cycle, volunteers were randomized to either SJW or placebo for a further two menstrual cycles. Settings/location: A postal trial conducted from The University of Reading, Berkshire, England. Subjects: One hundred and sixty-nine (169) normally menstruating women who experienced recurrent premenstrual symptoms were recruited onto the study. One hundred and twenty-five (125) completed the protocol and were included in the analysis. Interventions: Six hundred milligrams (600) mg of SJW (standardized to contain 1800 mug of hypericin) or placebo (containing lactose and cellulose). Outcome measure: A menstrual diary was used to assess changes in premenstrual symptoms. The anxiety-related subgroup of symptoms of this instrument was used as the primary outcome measure. Results: After averaging the effects of treatment over both treatment cycles it was found that there was a trend for SJW to be superior to placebo. However, this finding was not statistically significant. Conclusion: The possibility that this nonsignificant finding resulted from insufficient statistical power in the study, rather than a lack of efficacy of SJW, is discussed. Following this discussion the recommendation is made that, in future, similar studies should be powered to detect a minimum clinically relevant difference between treatments.

Children of the golden minster: St. Oswald's Priory and the impact of industrialisation on child health.

This study explores the disease experience of children buried within the cemetery of St. Oswald’s Priory, Gloucester from AD1153 to 1857. Evidence for ages-at-death, infant mortality, and the prevalence of stress indicators, trauma, and pathology were compared between the early and postmedieval periods. The skeletal remains of these children provide evidence for child health spanning the economic expansion of Gloucester at St. Oswald’s, from a mostly rural parish to a graveyard catering for families from the poorer northern part of the town and the workhouse. Results showed that the children from the postmedieval period in Gloucester suffered higher rates of dental caries (38%) and congenital conditions (17.3%) than their counterparts from the early and later medieval period. This paper serves to highlight the value of nonadult skeletal material in the interpretation of past human health in transitional societies and illustrates the wide variety of pathological conditions that can be observed in nonadult skeletons.

Two sources of Michael Polanyi`s prototypal notion of incommensurability: Evans-Pritchard on Azande witchcraft and St Augustine on conversion

Michael Polanyi argues in Personal Knowledge (1958) that conceptual frameworks involved in major scientific controversies are separated by a `logical gap'. Such frameworks, according to Polanyi (1958: 151), are logically disconnected: their protagonists think differently, use different languages and occupy different worlds. Relinquishing one framework and adopting another, Polanyi's scientist undergoes a `conversion' to a new `faith'. Polanyi, in other words, presaged Kuhn and Feyerabend's concept of incommensurability. To what influences was Polanyi subject as he developed his concept of the logical gap? The answer, as unfolded in this article, is twofold: Evans-Pritchard's Witchcraft, Oracles and Magic among the Azande and the Confessions of St Augustine.

Asynchronous patterns of reproduction for the sympatric scallops Chlamys bifrons and Chlamys asperrima (Bivalvia : Pectinidae) in South Australia

Patterns of spawning activity were assessed by monitoring gonad states over 2.5 years for Chlamys asperrima and Chlamys bifrons at two sites in Gulf St Vincent, South Australia. Chlamys asperrima appeared to have a minor spawning in June, followed by a major spawning starting in late August. In contrast, the gonads of C. bifrons were regressed only during winter and it appeared that C. bifrons spawned for a long period, from late spring (September) until early autumn (March). At one site where sampling was frequent, there was evidence of three series of C. bifrons spawning events during the summer of 1994/95 and at least two series of events during 1995/96. Build-up and decrease in gonad weight was quick, but there was strong evidence of serial spawning for both species. Subsequently, we once observed C. asperrima spawning in situ at Edithburgh Jetty, at a time when gonad weights had been decreasing in previous years, but also long after the time when peak gonad weights had usually occurred. Only patches within the population were seen spawning, with scallops not spawning observed less than 100 m away from those that were. Indirect sampling of gonad condition also suggested that spawning in C. bifrons at Largs Bay was not always synchronous among patches of scallops within a population, nor always between sexes within patches.

A mechanistic study on altered pharmacokinetics of irinotecan by St. Johns wort

Irinotecan (CPT-11) is an important anticancer drug in management of advanced colon cancer. A marked protective effect on CPT-11-induced blood and gastrointestinal toxicity is obtained by combination of St. John's wort (SJW) in recent clinical and rat studies. However, the mechanism is unclear. This study aimed to explore the effects of SJW on the pharmacokinetics of CPT-11 and its major metabolites (SN-38 and SN-38 glucuronide) in rats and the underlying mechanisms using several in vitro models. Short-term (3 days) and long-term (14 days) pretreatment with SJW were conducted in rats to examine the effects of co-administered SJW on the plasma pharmacokinetics of CPT-11, SN-38 and SN- 38 glucuronide. Rat liver microsomes and a rat hepatoma cell line, H4-II-E cells, were utilized to study the effects of aqueous and ethanolic extracts (AE and EE) and major active components (hyperforin, hypericin and quercetin) of SJW on CPT-11 and SN-38 metabolism and intracellular accumulation. Co-administered SJW for consecutive 14 days significantly decreased the initial plasma concentration (C0) of CPT-11, the area under the concentration-time curve (AUC0-10hr) and maximum plasma concentration (Cmax) of SN-38. The ethanolic extracts (EE) of SJW at 5 μ g/ml significantly decreased SN-38 glucuronidation by 45% (P < 0.05) in rat hepatic microsomes. Pre-incubation of aqueous SJW extracts (AE) at 10 g/ml, SJW EE at 5 μg/ml, and quercetin at 10μ M significantly increased the glucuronidation of SN-38 in H4- II-E cells. A 2-hr pre-incubation of quercetin (100μ M) significantly increased the intracellular accumulation of CPT-11 (P < 0.05). However, pre-incubation of hypericin (20 nM and 200 nM) and hyperforin (1μ M) significantly decreased the intracellular accumulation of CPT-11. In addition, pre-incubation of hypericin, SJW EE and quercetin significantly increased the intracellular accumulation of SN-38. Aqueous and ethanolic SJW extracts and its major active components did not alter the plasma protein binding of CPT-11 and SN-38. These results indicated that the aqueous and ethanolic extracts of SJW and its major active components could markedly alter glucuronidation of SN-38 and intracellular accumulation of CPT-11 and SN-38, which probably provides partial explanation for the altered plasma pharmacokinetics of CPT-11 and SN-38 and the antagonizing effects on the toxicities of CPT-11. Further studies are needed to explore the role of both pharmacokinetic and pharmacodynamic components in the protective effect of SJW against the toxicities of CPT-11.

Checks and cheques : implementing a population health and recall system to improve coverage of patients with diabetes in a rural general practice

Identification of all diabetic patients in the population is essential if diabetic care is to be effective in achieving the targets of the St Vincent Declaration.¹ The challenge therefore is to establish population based monitoring and control systems by means of state of the art technology in order to achieve quality assurance in the provision of care for patients with diabetes. ^2,3 Disease management receives extensive international support as the most appropriate approach to organising and delivering healthcare for chronic conditions like diabetes.⁴ This approach is achieved through a combination of guidelines for practice, patient education, consultations and follow up using a planned team approach and a strong focus on continuous quality improvement using information technology. ^5,6 The current software (Medical Director) could not easily meet these requirements which led us to adopt a trial of Ferret. In designing this project we used change management⁷ and the plan, do, study, act cycle⁸ illustrated in Diagram 1.

Prioritization of psychological well-being in the care of diabetes: moving beyond excuses, bringing solutions

Jones and colleagues recently made a plea for the prioritization of psychological well-being in diabetes care [1]. Such calls to action began over 20 years ago with the 'St Vincent Declaration' guidelines [2]. A 'plea' two decades later emphasizes that this paradigm shift is a long, slow burn. In the 21st century, people with diabetes are now adding their powerful voices via social media, advocating for better psychological support, as active consumers (and constructive critics) of health care [3]. We can learn considerably from organizations such as Cancer Voices (www.cancervoicesaustralia.org) - they demonstrate how consumer representation and involvement in research agendas, policy and service provision play an integral part in shaping holistic health care. This article is protected by copyright. All rights reserved.

The bizarre male of Spalangia dozieri (Hymenoptera: Pteromalidae): adaptations for male phoresy or the result of sexual selection?

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Economic profiles of Caribbean countries

Includes bibliography

Economic Survey of the Caribbean 2011-2012: positive growth amidst lingering downside risks

Includes bibliography

Needs assessment of economic planning units in gender analysis in selected Caribbean countries

Includes bibliography

Report on the implementation of the ECLAC work programme subregional activities for the Caribbean 2006-2007 biennium [Covering the period 1 Janurary 2006- 31 December 2007]

The focus of the activities of the Economic Commission for Latin America and the Caribbean/Caribbean Development and Cooperation Committee (ECLAC/CDCC) secretariat during the 2006-2007 biennium continued to be on assistance to member governments of the subregion with policy-making and development strategies, especially on issues relevant to the promotion of the economic, social, and environmental dimensions of development in the Caribbean. The Subregional Headquarters for the Caribbean worked closely with member countries of the CDCC in an effort to ensure the relevance of outputs which would inform policy options. This involved the strengthening of partnerships with both regional and subregional institutions and relevant agencies of the United Nations system working in the Caribbean. A major decision was taken to refocus the operational aspects of the secretariat to ensure that they were relevant to the development goals of its members. This involved the introduction of a thematic approach to the work of the office. One of the changes resulting from this was the restructuring and renaming of the Caribbean Documentation Centre. The Caribbean Knowledge Management Centre (CKMC), as it is now known, has changed its emphasis from organizing and disseminating documents, and is now a more proactive partner in the research undertaken by staff and other users of the service. The CKMC manages the ECLAC website, the public face of the organization. Newsletters and all other documents, including Information and Communications Technology (ICT) profiles of selected countries, prepared by the secretariat, are now available online at the ECLAC/CDCC website www.eclacpos.org . The Caribbean Knowledge Management Portal was launched at a meeting of information specialists in St. Vincent and the Grenadines in 2007. In addition to reaching a wider public, this measure was introduced as a means of reducing the cost of printing or disseminating publications. In spite of the unusually high vacancy rate, at both the international and local levels, during the biennium, the subregional headquarters accomplished 98 per cent of the 119 outputs earmarked for the period. Using vacant positions to carry out the assignments was not an easy task, given the complexity in recruiting qualified and experienced persons for short periods. Nevertheless, consultancy services and short-term replacement staff greatly aided the delivery of these outputs. All the same, 35 work months remained unused during the biennium, leaving 301 work months to complete the outputs. In addition to the unoccupied positions, the work of the subprogramme was severely affected by the rising cost of regional and subregional travel which limited the ability of staff to network and interact with colleagues of member countries. This also hampered the outreach programme carried out mainly through ad hoc expert group meetings. In spite of these shortcomings, the period proved to be successful for the subprogramme as it engaged the attention of member countries in its work either through direct or indirect participation. Staff members completed 36 technical papers plus the reports of the meetings and workshops. A total of 523 persons, representing member countries, participated in the 18 intergovernmental and expert meetings convened by the secretariat in the 24-month period. In its effort to build technical capacity, the subprogramme convened 15 workshops/seminars which offered training for 446 persons.

An assessment of social vulnerability and resilience in poverty reduction strategy papers (PRSPS/I-PRSPS) of selected Caribbean SIDS

The study undertakes a review of the Poverty Reduction Strategy Papers (PRSPs), and Interim Poverty Reduction Strategy Papers (I-PRSPs) of four selected Caribbean SIDS from the Eastern Caribbean. The countries had participated in the Poverty Reduction Strategy initiative formulated by the World Bank. The country papers reviewed were the Commonwealth of Dominica, Grenada, Saint Lucia and St. Vincent and the Grenadines. The review assesses and provides a comparative analysis of the general awareness of the notions of vulnerability and the inclusion and use of strategies that address the reduction of vulnerability and the strengthening of resilience by the countries reviewed. It also explores how vulnerability reduction strategies were applied to differing groups, as elaborated through the PRSPs.

Isotope geochemistry of Ninetyeast Ridge basalts

The Ninetyeast Ridge lavas have Sr and Nd isotopic ratios intermediate between those of Indian Ocean MORBs and those of the very enriched Kerguelen hot spot. In an Nd-Sr isotope diagram, they also plot close to the fields of St. Paul Island lavas and of the early magmatism on Kerguelen Archipelago. The Ninetyeast Ridge lavas were generated by mixing among at least three components: a depleted, MORB-type component, such as the one erupted today on the Southeast Indian Ridge; a very enriched, high- Sr/ Sr, low-epsilon-Nd, OIB-type component (the Kerguelen hot spot); and an OIB-type component comparable to that sampled from the St. Paul (and Amsterdam) lavas. The Ninetyeast Ridge lavas show a typical Dupal anomaly signature and Pb, Sr, and Nd isotopic systematics indicate that the Kerguelen hot spot was involved in the ridge's formation as the Indian plate moved northward. The different sites cored during ODP Leg 121 show a trend in their isotopic compositions, from less radiogenic Pb/ Pb ratios and intermediate 87Sr/86Sr and 143Nd/**Nd ratios in the oldest lavas (Site 758) toward more radiogenic 206Pb/204Pb, higher epsilon-Nd, and lower 87Sr/86Sr values in the youngest lavas (Site 756). The lavas from Site 757 have 206Pb/204Pb ratios intermediate between those of the lavas from Sites 756 and 758 and higher 87Sr/86Sr and lower epsilon-Nd values. The relative proportions of the hot spot(s) and MORB component have evolved with time, reflecting differences of tectonic setting: the relative proportion of the Kerguelen hot spot component appears lower in the younger Site 756 lavas than in the older lavas from Sites 757 and 758. Site 756 coincides with the beginning of rifting at the Southeast Indian Ridge, about 43 Ma ago. The formation of the early Kerguelen Archipelago lavas may have drained most of the plume-derived material toward the Antarctic plate. Alternatively, the proximity of the spreading-ridge axis may account for the isotopic similarity of the Site 756 lavas to young lavas erupted on the Southeast Indian Ridge, from 33? to 37?S. The older lavas of Ninetyeast Ridge may have formed when the hot spot and ridge axis did not exactly coincide. The involvement of the third component, a St. Paul hot spot, in the genesis of the Ninetyeast Ridge lavas, especially for the Site 756 lavas, is clearly indicated by Sr, Pb, and Nd isotope systematics and also by trace element ratios. These data, together with those from the Kerguelen Plateau, indicate that the Kerguelen hot spot has been active more or less continuously in the South Indian Ocean for at least 115 Ma. This could indicate that the plume, and by inference the Dupal anomaly, is deep seated in origin.