A comparison of the efficacy and safety of olanzapine versus haloperidol during transition from intramuscular to oral therapy

Background: Acutely agitated patients with schizophrenia who receive intramuscular (IM) medications typically are switched to oral (PO) antipsychotic maintenance therapy Objective: The goal of this study was to assess the efficacy and safety of olanzapine versus those of haloperidol during transition from IM to PO therapy We used additional data from a previously reported trial to test the hypothesis that the reduction in agitation achieved by IM olanzapine 10 mg or IM haloperidol 7.5 mg would be maintained following transition to 4 days of PO olanzapine or PO haloperidol (5-20 mg/d for both). We also hypothesized that olanzapine would maintain its more favorable extrapyramidal symptom (EPS) safety profile. Methods: This was a multinational (hospitals in 13 countries), double-blind, randomized, controlled trial. Acutely agitated inpatients with schizophrenia were treated with 1 to 3 IM injections of olanzapine 10 mg or haloperidol 7.5 mg over 24 hours and were entered into a 4-day PO treatment period with the same medication (5-20 mg/d for both). The primary efficacy measurement was reduction in agitation, as measured by the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score. Adverse events and scores on EPS rating scales were assessed. Results: A total of 311 patients (204 men, 107 women; mean [SD] age, 38.2 [11.6] years) were enrolled (131, 126, and 54 patients in the olanzapine, haloperidol, and placebo groups, respectively). In all, 93.1% (122/131) of olanzapine-treated patients and 92.1% (116/126) of haloperidol-treated patients completed the IM period and entered the PO period; 85.5% (112/131) of olanzapine-treated patients and 84.1% (106/126) of haloperidol-treated patients completed the PO period. IM olanzapine and IM haloperidol effectively reduced agitation over 24 hours (mean [SD] PANSS-EC change, -7.1 [4.8] vs -6.7 [4.3], respectively). Reductions in agitation were sustained throughout the PO period with both study drugs (mean [SD] change from PO period baseline, -0.6 [4.8] vs -1.3 [4.4], respectively). During PO treatment, haloperidol-treated patients spontaneously reported significantly more acute dystonia than olanzapine-treated patients (4.3% [5/116] vs 0% [0/122], respectively; P = 0.026) and akathisia (5.2% [6/116] vs 0% [0/122], respectively; P = 0.013). Significantly more haloperidol-treated patients than olanzapine-treated patients met categorical criteria for treatment-emergent akathisia (18.5% [17/92] vs 6.5% [7/107], respectively; P = 0.015). Conclusions: In the acutely agitated patients with schizophrenia in this study, both IM olanzapine 10 mg and IM haloperidol 7.5 mg effectively reduced agitation over 24 hours. This alleviation of agitation was sustained following transition from IM therapy to 4 days of PO treatment (5-20 mg/d for both). During the 4 days of PO treatment, olanzapine-treated patients did not spontaneously report any incidences of acute dystonia, and olanzapine had a superior EPS safety profile to that of haloperidol. The combination of IM and PO olanzapine may help improve the treatment of acutely agitated patients with schizophrenia. Copyright (C) 2003 Excerpta Medica, Inc.

The other side of the coin: safety of complementary and alternative medicine

Most consumers consider complementary and alternative medicine (CAM) products inherently safe. The growing simultaneous use of CAM products and pharmaceutical drugs by Australian consumers increases the risk of CAM-drug interactions. The Therapeutic Goods Administration (TGA) has a two-tier, risk-based regulatory system for therapeutic goods - CAM products are regulated as low risk products and are assessed for quality and safety; and sponsors of products must hold the evidence for any claim of efficacy made about them. Adverse reactions to CAM products can be classified as intrinsic (innate to the product), or extrinsic (where the risk is not related to the product itself, but results from the failure of good manufacturing practice). Adverse reactions to CAM practices can be classified as risks of commission (which includes removal of medical therapy) and risks of omission (which includes failure to refer when appropriate). While few systematic studies of adverse events with CAM exist, and under-reporting is likely, most CAM products and practices do not appear to present a high risk; their safety needs to be put into the perspective of wider safety issues. A priority for research is to rigorously define the risks associated with both CAM products and practices so that their potential impact on public health can be assessed.

Electronic patient records: Achieving best practice in information transfer between hospital and community providers - an integration success story

Effective healthcare integration is underpinned by clinical information transfer that is timely, legible and relevant. The aim of this study was to describe and evaluate a method for best practice information exchange. This was achieved based on the generic Mater integration methodology. Using this model the Mater Health Services have increased effective community fax discharge from 34% in 1999 to 86% in 2002. These results were predicated on applied information technology excellence involving the development of the Mater Electronic Health Referral Summary and effective change management methodology, which included addressing issues around patient consent, engaging clinicians, provision of timely and appropriate education and training, executive leadership and commitment and adequate resourcing. The challenge in achieving best practice information transfer is not solely in the technology but also in implementing the change process and engaging clinicians. General practitioners valued the intervention highly. Hospital and community providers now have an inexpensive, effective product for critical information exchange in a timely and relevant manner, enhancing the quality and safety of patient care.

Effectiveness and safety of repeat courses of hylan G-F 20 in patients with knee osteoarthritis

Objective: To compare the effectiveness and safety of repeat treatment with hylan G-F 20 based on data from a randomized, controlled trial [Raynauld JP, Torrance GW, Band PA, Goldsmith CH, Tugwell P, Walker V, et al. A prospective, randomized, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F 20 into the treatment paradigm for patients with knee osteoarthritis (Part 1 of 2): clinical results. Osteoarthritis Cartilage 2002;10:506-17]. The hypotheses tested were whether the single-course and repeat-course subgroups would be superior to appropriate care and not different from each other. Method: A total of 255 patients with knee osteoarthritis were randomized to appropriate care with hylan G-F 20 or appropriate care without hylan G-F 20. The hylan G-F 20 group was partitioned into two subgroups: (1) patients who received a single course of hylan G-F 20; and (2) patients who received two or more courses of hylan G-F 20. Results: For the primary effectiveness measure, change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score as a percent of baseline, the single-course subgroup improved by 41%, the repeat-course subgroup by 35%, and the appropriate care group by 14%. Both subgroups improved significantly more than the appropriate care group (P < 0.05), and were not statistically significantly different from each other (70% power to detect a 20% difference). Secondary effectiveness measures showed similar results. In the repeat-course subgroup, no statistically significant differences were found in the number of local adverse events, the number of patients with local adverse events, or arthrocentesis rates between the first and repeat courses of treatment. Conclusions: Although the study was neither designed nor powered to examine repeat treatment, this a posteriori analysis provides support for a favorable effectiveness and safety profile of hylan G-F 20 in repeat course patients. (C) 2004 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Milling quality and protein properties of autumn-sown Chinese wheats evaluated through multi-location trials

Eight milling quality and protein properties of autumn-sown Chinese wheats were investigated using 59 cultivars and advanced lines grown in 14 locations in China from 1995 to 1998. Wide ranges of variability for all traits were observed across genotypes and locations. Genotype, location, year, and their interactions all significantly influenced most of the quality parameters. Kernel hardness, Zeleny sedimentation value, and mixograph development time were predominantly influenced by the effects of genotype. Genotype, location and genotype x location interaction were all important sources of variation for thousand kernel weight, test weight, protein content, and falling number, whereas genotype x location interaction had the largest effect on flour yield. Most of the genotypes were characterized by weak gluten strength with Zeleny sedimentation values less than 40 ml and mixograph development time shorter than 3 min. Eight groups of genotypes were recognized based on the average quality performance, grain hardness and gluten strength were the two parameters that determined the grouping, with contributions from protein content. Genotypes such as Zhongyou 16 and Annong 8903 displayed good milling quality, high grain hardness, protein content and strong gluten strength with high sedimentation value and long mixograph development time. Genotypes such as Lumai 15 and Yumai 18 were characterized by low grain hardness, protein content and weak gluten strength. Genotypes such as Yannong 15 and Chuanmai 24 were characterized by strong gluten strength with high sedimentation value and long mixograph development time, but low grain hardness and protein content lower than 12.3%. Genotypes such as Jingdong 6 and Xi'an 8 had weak gluten strength, but with high grain hardness and protein content higher than 12.2%. Five groups of locations were identified, and protein content and gluten strength were the two parameters that determined the grouping. Beijing, Shijiazhuang, Nanyang, Zhumadian and Nanjing produced wheats with medium to strong gluten strength and medium protein content, although there was still a large variation for most of the traits investigated between the locations. Wheat produced in Yantai was characterized by strong gluten strength, but with low protein content. Jinan, Anyang and Linfen locations produced wheats with medium to weak gluten strength and medium to high protein content. Wheats produced in Yangling, Zhenzhou, and Chengdu were characterized by weak gluten strength with medium to low protein content, whereas wheats produced in Xuzhou and Wuhan were characterized by weak gluten strength with low protein content. Industrial grain quality could be substantially improved through integrating knowledge of geographic genotype distribution with key location variables that affected end-use quality.

Mapping water quality and substrate cover in optically complex coastal and reef waters: an integrated approach

Sustainable management of coastal and coral reef environments requires regular collection of accurate information on recognized ecosystem health indicators. Satellite image data and derived maps of water column and substrate biophysical properties provide an opportunity to develop baseline mapping and monitoring programs for coastal and coral reef ecosystem health indicators. A significant challenge for satellite image data in coastal and coral reef water bodies is the mixture of both clear and turbid waters. A new approach is presented in this paper to enable production of water quality and substrate cover type maps, linked to a field based coastal ecosystem health indicator monitoring program, for use in turbid to clear coastal and coral reef waters. An optimized optical domain method was applied to map selected water quality (Secchi depth, Kd PAR, tripton, CDOM) and substrate cover type (seagrass, algae, sand) parameters. The approach is demonstrated using commercially available Landsat 7 Enhanced Thematic Mapper image data over a coastal embayment exhibiting the range of substrate cover types and water quality conditions commonly found in sub-tropical and tropical coastal environments. Spatially extensive and quantitative maps of selected water quality and substrate cover parameters were produced for the study site. These map products were refined by interactions with management agencies to suit the information requirements of their monitoring and management programs. (c) 2004 Elsevier Ltd. All rights reserved.

Aphasia websites: An examination of their quality and communicative accessibility

Background: Studies have examined Internet use as a source of information by various populations, however no study has examined the quality and accessibility of websites for people with aphasia, or their use of such sites. Aims: This study aimed to describe the quality, communicative accessibility, and readability of a sample of aphasia websites and to determine whether sites preferred by people with aphasia were those rated highly on measures of accessibility and quality. The perceptions of people with aphasia regarding the accessibility of the sites were compared with those of speech pathologists. The relationship between the quality and communicative accessibility of websites was analysed. Factors that may influence use of the Internet by people with aphasia and speech pathologists were explored. Methods & Procedures: Tools for measuring quality and communicative accessibility were developed and a sample of five websites was selected. Two participant groups (18 speech pathologists and 6 people with aphasia) assessed aphasia websites in terms of communicative accessibility. Speech pathologists also rated website quality. Spearman's rho was used to determine levels of agreement between variables. Outcomes & Results: People with aphasia and speech pathologists showed minimal agreement on their perceptions of communicative accessibility. However, when the preferences of websites (Aphasia Help and Speakability) were of a very high standard. There was a weak relationship between quality and communicative accessibility, however it was not statistically significant. Conclusions: Accessible websites are not necessarily of high quality, and quality websites are not guaranteed to be easily accessible. People with aphasia did not agree with speech pathologists as to what makes a good aphasia website. Therefore, people with aphasia should be involved in the design of aphasia websites since they are often the intended users. If Internet use by people with aphasia increases in line with other health populations, speech pathologist need to have the skills and confidence to recommend appropriate sites to their clients.

Between-tree variation in fruit quality and fruit mineral concentrations of Hass avocados

Inconsistent internal fruit quality in Hass avocados affects consumer confidence. To determine the influence of individual trees on fruit quality, Hass avocado fruit were harvested from adjacent trees of similar external appearance in 3 commercial orchards in 1998 and 1 orchard in 1999. The trees in each orchard were grown with similar commercial practices and in similar soil types. Within each location, there were significant (P < 0.05) differences in the mean ripe fruit quality between trees with respect to fruit body rot severity ( mainly anthracnose) with and without cold storage, internal disorders severity due to diffuse discolouration and vascular browning ( after cold storage), days to ripen, percentage dry matter, and the percentage of the skin area with purple-black colour when ripe. These effects were also noted in the same orchard in 1999. There were significant (P < 0.05) differences in fruit flesh calcium, magnesium, potassium, boron and zinc concentrations between trees. Significant (P < 0.05) correlations were observed between average fruit mineral concentrations in each tree ( particularly calcium, magnesium and potassium) and body rot severity, percentage dry matter and fruit mass. There was little conclusive evidence that characteristics such as the growth of the non-suberised roots or the degree of scion under- or overgrowth was involved in these tree effects; however, differences between trees with respect to other rootstock characteristics may be involved. The inconsistency of the correlations across sites and years suggested that other factors apart from tree influences could also affect the relationship between fruit minerals and fruit quality.

Therapeutic efficacy and safety of chaperonin 10 in patients with rheumatoid arthritis: A double-blind randomised trial

Background Chaperonin 10 (heat shock protein 10, XToll(TM)) has anti-inflammatory properties related to the inhibition of Toll-like receptor signalling pathways. Our aim was to establish whether chaperonin 10 is safe and effective in the treatment of rheumatoid arthritis. Methods in this randomised, double-blind, multicentre study, 23 patients with moderate to severe active rheumatoid arthritis receiving disease-modifying antirheumatic drugs were randomly allocated to three treatment groups receiving intravenous chaperonin 10 twice weekly for 12 weeks at doses of 5 mg (n=8), 7.5 mg (8), or 10 mg (7). The primary outcomes were change in disease activity score (DAS28) and improvement of core disease measures (American College of Rheumatology response score) from baseline to week 12. All analyses were done by intention to treat. This study is registered with the Australian Clinical Trials Registry, number ACTRNO12606000041550. Findings Primary endpoint measures improved from day 14 in all groups and continued to improve to day 84. By end of study, a 20% improvement of core disease measures was seen in six (86%, 95% Cl 43-100), a 50% improvement in four (57%, 14-86), and a 70% improvement in two (29%, 0-57) patients given the highest dose of chaperonin 10. Clinical remission (as defined by a DAS28

The continuing use of complementary and alternative medicine in South Australia: costs and beliefs in 2004

Objective: To survey the use, cost, beliefs and quality of life of users of complementary and alternative medicine (CAM). Design: A representative population survey conducted in 2004 with longitudinal comparison to similar 1993 and 2000 surveys. Participants: 3015 South Australian respondents over the age of 15 years (71.7% participation). Results: In 2004, CAMs were used by 52.2% of the population. Greatest use was in women aged 25-34 years, with higher income and education levels. CAM therapists had been visited by 26.5% of the population. In those with children, 29.9% administered CAMs to them and 17.5% of the children had visited CAM therapists. The total extrapolated cost in Australia of CAMs and CAM therapists in 2004 was AUD$1.8 billion, which was a decrease from AUD$2.3 billion in 2000. CAMs were used mostly to maintain general health. The users of CAM had lower quality-of-life scores than non-users. Among CAM users, 49.7% used conventional medicines on the same day and 57.2% did not report the use of CAMs to their doctor. About half of the respondents assumed that CAMs were independently tested by a government agency; of these, 74.8% believed they were tested for quality and safety, 21.8% for what they claimed, and 17.9% for efficacy. Conclusions: Australians continue to use high levels of CAMs and CAM therapists. The public is often unaware that CAMs are not tested by the Therapeutic Goods Administration for efficacy or safety.