A phase II randomised double-blind placebo-controlled clinical trial investigating the efficacy and safety of ProstateEZE Max: a herbal medicine preparation for the management of symptoms of benign prostatic hypertrophy.

OBJECTIVE: The aim of the clinical trial was to evaluate the efficacy and safety of ProstateEZE Max, an orally dosed herbal preparation containing Cucurbita pepo, Epilobium parviflorum, lycopene, Pygeum africanum and Serenoa repens in the management of symptoms of medically diagnosed benign prostate hypertrophy (BPH). DESIGN: This was a short-term phase II randomized double-blind placebo controlled clinical trial. SETTING: The trial was conducted on 57 otherwise healthy males aged 40-80 years that presented with medically diagnosed BPH. INTERVENTION: The trial participants were assigned to receive 3 months of treatment (1 capsule per day) with either the herbal preparation (n = 32) or a matched placebo capsule (n = 25). OUTCOME MEASURES: The primary outcome measure was the international prostate specific score (IPSS) measured at baseline, 1, 2 and 3 months. The secondary outcomes were the specific questions of the IPSS and day-time and night-time urinary frequency. RESULTS: There was a significant reduction in IPSS total median score in the active group of 36% as compared to 8% for the placebo group, during the 3-months intervention (p < 0.05). The day-time urinary frequency in the active group also showed a significant reduction over the 3-months intervention (7.0-5.9 times per day, a reduction of 15.6% compared to no significant reduction change for the placebo group (6.2-6.3 times per day) (p < 0.03). The night-time urinary frequency was also significantly reduced in the active group (2.9-1.8, 39.3% compared to placebo (2.8-2.6 times, 7%) (p < 0.004). CONCLUSION: The herbal preparation (ProstateEZE Max) was shown to be well tolerated and have a significant positive effect on physical symptoms of BPH when taken over 3 months, a clinically significant outcome in otherwise healthy men.

The clinical efficacy of a bovine lactoferrin/whey protein Ig-rich fraction (Lf/IgF) for the common cold: a double blind randomized study.

OBJECTIVE: The aim of the study was to determine if a bovine lactoferrin/whey protein Ig-rich fraction (Lf/IgF) combination was effective in reducing the number of colds and in turn improving symptom recovery in a cohort of males and females that reported frequently contracting a cold. DESIGN: A double blind randomized placebo-controlled clinical trial. SETTING: One-hundred and twenty-six participants matched by age, BMI, dietary and physical parameters with self-reported frequent upper respiratory tract symptoms and infections were randomly assigned to receive 600 mg of Lf/IgF or a placebo daily for 90 days. MAIN OUTCOME MEASURES AND RESULTS: A total of 90 participants (47 receiving the active and 43 placebo) completed the 90 day trial and 15 completed 45 days participation (6 in the active and 9 in the placebo group). The total number of colds recorded over the study period was 48 for the treatment group versus 112 for the placebo group (p < 0.001). The significant trend was retained when the data was corrected for medications returned (p < 0.001) and for guessing treatment allocations (p < 0.001). Non-parametric analysis demonstrated that the total number of cold-associated symptoms reported by participants that received Lf/IgF was significantly less than those in the placebo group (p < 0.05). Also, total days sick with a cold and cold severity were reduced over the clinical trial period for Lf/IgF over placebo, but the trend was not significant. CONCLUSIONS: These findings demonstrate that the Lf/IgF combination significantly decreased the incidence of colds and the cumulative number of cold-related symptoms over placebo. This therapeutic combination may be indicated for the prevention of colds and its most common symptoms in the general population when administered as a preventative supplement.

Green-lipped mussel extract (Perna canaliculus) and glucosamine sulphate in patients with knee osteoarthritis: therapeutic efficacy and effects on gastrointestinal microbiota profiles.

OBJECTIVE: To investigate how changes in the gastrointestinal tract (GIT) microbiota profile may influence nutraceutical efficacy in osteoarthritis (OA) and allow the formulation of a hypothesis that explains in part the inconsistent and contentious findings from OA clinical studies with green-lipped mussel (GLM) and glucosamine. METHODS: A non-blinded randomised clinical trial was conducted with 38 subjects diagnosed with knee OA. Each participant received either 3,000 mg/day of a whole GLM extract or 3,000 mg/day of glucosamine sulphate (GS), p.o. for 12 weeks. Faecal microbial analyses were carried out after collecting stools at T (0) and T (12) weeks. Additional pharmacometric measures were obtained from changes in arthritic scores in the Western Ontario McMaster Universities Arthritis Index (WOMAC) and the Lequesne algofunctional indices and the Gastrointestinal Symptom Rating Scale (GSRS). An intention-to-treat analysis was employed and participant data collected at T (0), T (6) and T (12) weeks. RESULTS: There were no statistically significant changes in bacterial growth patterns determined by the Wilcoxon test. In both groups there was a trend towards a decrease in Clostridium and Staphylococcus species and increase in Lactobacillus, Streptococcus and Eubacterium species. In the GLM group Bifidobacterium tended to increase and Enterococcus and yeast species to decrease. The GS-treated group demonstrated a trend towards a decrease in Bacteroides and an increase in yeasts and Coliforms species, most notably Escherichia coli. We further confirm significant improvement (p < 0.05) in all OA outcome measures from T (0) to T (12) weeks for both the GLM and GS groups. The GSRS scores indicated that GIT function significantly improved over the 12 weeks duration with GLM and GS supplementation. CONCLUSION: Both GLM and GS reduced OA symptoms and non-significantly altered the gut microbiota profile from baseline. Changes in the microbiota profiles occurred in both treatment groups; the most notable being a reduction in the Clostridia sp. This study suggests that nutritional supplements such as GLM and GS may regulate some of the metabolic and immunological activities of the GIT microbiota. The decrease in Clostridia, a potent modulator of colonic Th17 and CD4+ regulatory T cells, was consistent with a decrease in inflammation; improved GSRS scores and OA symptoms for these OA participants. The GIT microbiota may be important factor in the first-pass metabolism of these nutraceuticals.

Green-lipped mussel (Perna canaliculus) extract efficacy in knee osteoarthritis and improvement in gastrointestinal dysfunction: a pilot study.

OBJECTIVE: Clinical data demonstrating efficacy for nutraceutical compounds marketed for the symptom relief of osteoarthritis (OA) have been largely contentious. Furthermore, no association has been linked between clinical trial inconsistencies and gastrointestinal (GI) dysfunction. The aim of this study was to primarily investigate the efficacy of a high-dose New Zealand green-lipped mussel (GLM) extract in patients diagnosed with OA of the knee and concurrently assess GLM impact on GI function. METHODS: An open label, single group allocation study was conducted, that administered 3,000 mg/day of GLM extract over 8 weeks to 21 subjects diagnosed with knee OA. Outcome measures were scored using the WOMAC, the Lequesne algofunctional index, and the Gastrointestinal Symptom Rating Scale (GSRS) tools. An intention-to-treat analysis was employed and subject data collected at T0, T4 and T8 weeks. RESULTS: Paired t tests showed significant improvement for the Lequesne, WOMAC (p < 0.001) and GSRS (p = 0.005) scores. A repeated measures ANOVA analysis showed significant improvement in scores for the Lequesne (F = 20.317, p < 0.001), WOMAC (F = 28.383, p < 0.001) and the GSRS (F = 9.221, p = 0.002). CONCLUSION: Green-lipped mussel significantly improved knee joint pain, stiffness and mobility. We report for the first time that the administration of GLM extract also significantly improved GI symptoms by 49% in OA patients. Given that GI dysfunction is linked to analgesic medication use, we further conclude that the therapeutic efficacy of the GLM extract used was possibly correlated to its effects on GI function by improving GSRS scores from baseline. Results from this trial highlight the requisite for further clinical investigations of gastrointestinal tract function in OA patients.

Telephone-supported care coordination in an Australian veterans population: a randomized controlled trial.

An evaluation was undertaken on the effectiveness and efficiency of care coordination in delivering health services to Australian veterans with chronic or complex medical conditions requiring multidisciplinary care and who had moderate to high care needs. The veterans participated in a randomized controlled trial (RCT) supported by the Department of Veterans' Affairs. For evaluation of the RCT, information on cost of care and quality of life (QOL) was collected before the commencement of coordinated care and at follow-up after 12 months. Of 525 veterans who were recruited, 481 were surveyed at baseline (243 in the intervention group and 238 controls). At follow-up, 421 were surveyed (213 intervention and 208 controls). There were no significant differences between the coordinated care and control groups of veterans in costs of care or in QOL measurements using the SF-12 Health Survey and the EuroQol Group EQ-5D. These findings are consistent with those reported in earlier studies which suggest that benefits from care coordination programmes may take some time to emerge.

A randomized controlled trial of telephone-supported care coordination in patients with congestive heart failure.

An evaluation was undertaken on the effectiveness and efficiency of care coordination as a means of delivering health services to Australian veterans with a diagnosis of congestive heart failure. The veterans participated in a randomized controlled trial of care coordination that was supported by the Department of Veterans' Affairs (DVA). Of 490 veterans who were recruited, 409 were surveyed at baseline (214 in the intervention group and 195 controls). At follow-up, 288 were surveyed (155 intervention and 133 controls). Information on cost of care and quality of life (QOL) was collected before the commencement of coordinated care and at follow-up after 12 months. Cost of care data were obtained from DVA records. Information on QOL was obtained from telephone interviews, using the Short Form (SF-12) Health Survey and the EuroQol Group EQ-5D survey. There were no significant differences in costs of care between the intervention (coordinated care) and control groups of veterans. Nor were there significant differences between the intervention and control groups in QOL measurements with either of the evaluation tools that were used. Because evidence of benefit from coordinated care may be slow to emerge in patients with chronic disease, it would be desirable for future work in this area to include long term, good quality comparative studies on selected veteran populations. Such studies should measure QOL and economic outcomes in addition to clinical indicators.

The life control scale: validation with a population cohort of middle-aged Australian women.

BACKGROUND: The concept of perceived control is central to many theories of physical and emotional well-being. However, existing measures are lengthy and generally focus on job control. In epidemiological research, brief measures and those which can be applied across entire populations are needed. Among women in particular, a substantial minority have no paid work, while most also have major unpaid family commitments which may affect well-being through their effect on control. Thus, we evaluated the six-item Life Control Scale (Bobak, Soc Sci Med. 47:269-79, 1998) with a population-based sample of middle-aged women. METHOD: A population-based sample of 11,223 women aged 50 to 55, participating in the Australian Longitudinal Study on Women's Health, completed the Life Control Scale as part of an omnibus survey of health and psychosocial factors. RESULTS: The scale was demonstrated to be unifactorial and internally reliable and to show the expected relationships with several measures of socioeconomic position, physical health, and mental health. CONCLUSION: The Life Control Scale is brief, valid, and broadly applicable in epidemiological research.

Life transitions and mental health in a national cohort of young Australian women.

Young adulthood, a time of major life transitions and risk of poor mental health, may affect emotional well-being throughout adult life. This article uses longitudinal survey data to examine young Australian women's transitions across 4 domains: residential independence, relationships, work and study, and motherhood. Changes over 3 years in health-related quality of life, optimism, depressive symptoms, stress, and life satisfaction, were examined in relation to these transitions among 7,619 young adult participants in the nationally representative Australian Longitudinal Study on Women's Health. Positive changes in mental health occurred for women moving into cohabitation and marriage, whereas reductions were observed among those experiencing marital separation or divorce and those taking on or remaining in traditionally "feminine" roles (out of the workforce, motherhood). The data suggest that women cope well with major life changes at this life stage, but reductions in psychological well-being are associated with some transitions. The findings suggest that preventive interventions to improve women's resilience and coping might target women undergoing these transitions and that social structures may not be providing sufficient support for women making traditional life choices.

Predictors and outcomes of early motherhood in the Australian Longitudinal Study on Women's Health.

Early motherhood is identified as a social problem, and having children at an early age is assumed to lead to psychological distress, welfare dependence and socioeconomic disadvantage. Analysis of responses from 9,689 young participants in the Australian Longitudinal Study on Women's Health was used to examine predictors and outcomes of early motherhood in Australia. Survey 1 (1996, aged 18 - 23) and Survey 2 (2000, aged 22 - 27), were used to categorize women as Childless, Existing Mothers (before Survey 1) and New Mothers (became mothers before Survey 2). Multivariate logistic regressions provided comparisons on sociodemographics, gynaecological variables, psychological wellbeing and health behaviours. Survey 1 data show that Existing Mothers experience socioeconomic disadvantages and unhealthy lifestyles. However, those who will go on to become mothers earlier than their peers already experience similar disadvantages. Further, the Survey 2 data show that, when these pre-existing disadvantages are controlled for, the additional deficits experienced by early mothers are relatively minor. Social disadvantage predisposes women to become mothers early, and to adopt unhealthy behaviours. However, young Australian women cope well with the challenges of early motherhood. In the longer term, unhealthy lifestyles and low education may lead to ill health and disadvantage, but early motherhood is not the initiator of this trajectory.

Predictors and correlates of coping well with early motherhood in the Australian Longitudinal Study on Women's Health.

Women who become mothers at an early age are characterised by socio-economic disadvantage and unhealthy lifestyles; however, some cope extremely well. This paper describes Australian women who become mothers at an early age, in order to identify factors that predict coping. The younger cohort of the Australian Longitudinal Study of Women's Health was used to identify 1064 young women who became mothers between Survey 1 and Survey 2. These women were categorised on the basis of the Mental Health Index of the SF-36 as having High, Normal or Low mental health. Survey 1 data were used to examine predictors, and Survey 2 data to examine correlates, of mental health. Surprisingly, few socio-demographic or health-related variables predict level of coping with early motherhood. Women who would have High mental health as mothers were likely to be in paid work, had few symptoms, and had low levels of stress. They were least likely to have a history of miscarriage and most likely to use contraception. There were no significant effects for other socio-demographic factors, or health-related behaviours. In the longer term, however, all young mothers may suffer an increasing level of disadvantage and distress relative to their peers.

Never-married childless women in Australia: health and social circumstances in older age.

A growing proportion of women reach older age without having married or having children. Assumptions that these older women are lonely, impoverished, and high users of social and health services are based on little evidence. This paper uses data from the Older cohort of the Australian Longitudinal Study on Women's Health to describe self-reported demographics, physical and emotional health, and use of services among 10,108 women aged 73-78, of whom 2.7% are never-married and childless. The most striking characteristic of this group is their high levels of education, which are associated with fewer reported financial difficulties and higher rates of private health insurance. There are few differences in self-reported physical or emotional health or use of health services between these and other groups of older women. Compared with older married women with children, they make higher use of formal services such as home maintenance and meal services, and are also more likely to provide volunteer services and belong to social groups. Overall, there is no evidence to suggest that these women are a "problem" group. Rather, it seems that their life experiences and opportunities prepare them for a successful and productive older age.

Motherhood plans among young Australian women: who wants children these days?

Fertility rates in the developed world have been below replacement level for 25 years, and it is often assumed that this results from deliberate, unconstrained individual choice. Data from 7448 childless women aged 22 to 27, participating in the Australian Longitudinal Study on Women's Health, indicate that 9 per cent aspire to childlessness, with 72 per cent wanting 1 or 2 children and 19 per cent more. Differences in psychological functioning disappear after adjustment for socioeconomic variables. Women wanting 1 or 2 children also want paid work, while those wanting many children generally have traditional aspirations. Policy-makers need to consider strategies that support women to negotiate motherhood and paid work.