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1.  Can probiotic yogurt prevent diarrhoea in children on antibiotics? A double-blind, randomised, placebo-controlled study 
BMJ Open  2015;5(1):e006474.
Objective
To estimate the efficacy of a probiotic yogurt compared to a pasteurised yogurt for the prevention of antibiotic-associated diarrhoea in children.
Design and setting
This was a multisite, randomised, double-blind, placebo-controlled clinical trial conducted between September 2009 and 2012. The study was conducted through general practices and pharmacies in Launceston, Tasmania, Australia.
Participants and interventions
Children (aged 1–12 years) prescribed antibiotics, were randomised to receive 200 g/day of either yogurt (probiotic) containing Lactobacillus rhamnosus GG (LGG), Bifidobacterium lactis (Bb-12) and Lactobacillus acidophilus (La-5) or a pasteurised yogurt (placebo) for the same duration as their antibiotic treatment.
Outcomes
Stool frequency and consistency were recorded for the duration of treatment plus 1 week. Primary outcome was stool frequency and consistency, classified at different levels of diarrhoea severity. Due to the small number of cases of diarrhoea, comparisons between groups were made using Fisher's exact analysis.
Results
72 children commenced and 70 children (36 placebo and 34 probiotic) completed the trial. There were no incidents of severe diarrhoea (stool consistency ≥6, ≥3 stools/day for ≥2 consecutive days) in the probiotic group and six in the placebo group (Fisher's exact p=0.025). There was also only one episode of minor diarrhoea (stool consistency ≥5, ≥2 stools/day for ≥2 days in the probiotic group compared to 21 in the placebo group (Fisher's exact p<0.001). The probiotic group reported fewer adverse events (1 had abdominal pain, 1 vomited and 1 had headache) than the placebo group (6 had abdominal pain, 4 had loss of appetite and 1 had nausea).
Conclusions
A yogurt combination of LGG, La-5 and Bb-12 is an effective method for reducing the incidence of antibiotic-associated diarrhoea in children.
Trial registration number
Australian New Zealand Clinical Trials Registry ACTRN12609000281291
doi:10.1136/bmjopen-2014-006474
PMCID: PMC4298112  PMID: 25588782
NUTRITION & DIETETICS
2.  The Association between Seasonal Variation in Vitamin D, Postural Sway, and Falls Risk: An Observational Cohort Study 
Journal of Aging Research  2013;2013:751310.
Introduction. Low serum vitamin D levels are associated with increased postural sway. Vitamin D varies seasonally. This study investigates whether postural sway varies seasonally and is associated with serum vitamin D and falls. Methods. In a longitudinal observational study, eighty-eight independently mobile community-dwelling older adults (69.7 ± 7.6 years) were evaluated on five occasions over one year, measuring postural sway (force platform), vitamin D levels, fall incidence, and causes and adverse outcomes. Mixed-methods Poisson regression was used to determine associations between measures. Results. Postural sway did not vary over the year. Vitamin D levels varied seasonally (P < 0.001), peaking in summer. Incidence of falls (P = 0.01) and injurious falls (P = 0.02) were lower in spring, with the highest fall rate at the end of autumn. Postural sway was not related to vitamin D (P = 0.87) or fall rates, but it was associated with fall injuries (IRR 1.59 (CI 1.14 to 2.24, P = 0.007). Conclusions. Postural sway remained stable across the year while vitamin D varied seasonally. Participants with high values for postural sway demonstrated higher rates of injurious falls. This study provides important evidence for clinicians and researchers providing interventions measuring balance outcomes across seasons.
doi:10.1155/2013/751310
PMCID: PMC3816055  PMID: 24223307
3.  Make Vitamin D While the Sun Shines, Take Supplements When It Doesn′t: A Longitudinal, Observational Study of Older Adults in Tasmania, Australia 
PLoS ONE  2013;8(3):e59063.
Low vitamin D status has been associated with a number of chronic conditions, particularly in older adults. The aim of this study was to identify how best to maintain optimum vitamin D status throughout the year in this high-risk population. The main objectives of the study were to assess seasonal vitamin D status; identify the main determinants of vitamin D status; determine if taking part in the study led to alterations in participant behaviour and vitamin D status. A longitudinal design across four consecutive seasons observed ninety-one 60–85 year old community-dwelling adults in Tasmania (41π S) over 13 consecutive months, with a follow-up assessment at next winter's end. Associations between solar UVB exposure, sun protection behaviours, dietary and supplemental vitamin D with serum 25(OH)D concentrations were assessed. Variation in serum 25(OH)D demonstrated an identical pattern to solar UVB, lagging 8–10 weeks. Serum 25(OH)D was positively associated with summer UVB (mean 15.9 nmol/L; 95%CI 11.8–19.9 nmol/L, p<0.001) and vitamin D supplementation (100–600 IU/day: 95%CI 10.2 nmol/L; 0.8–19.6 nmol/L; p = 0.03; 800 IU/day: 21.0 nmol/L; 95%CI 8.1–34.0 nmol/L; p = 0.001). Seasonal variation in serum 25(OH)D was greatly diminished in supplement users. The most common alteration in participant behaviour after the study was ingesting vitamin D supplements. Post-study vitamin D supplementation ℘800 IU/day was seven times more likely than during the study resulting in mean difference in serum 25(OH)D between supplement and non-supplement users of 30.1 nmol/L (95%CI 19.4–40.8 nmol/L; p<0.001). The main limitation was homogeneity of participant ethnicity. Solar exposure in summer and ingestion of vitamin D supplements in other seasons are the most effective ways of achieving and maintaining year-round vitamin D sufficiency in older adults in the Southern hemisphere. Vitamin D supplementation has greatest effect on vitamin D status if ingested during and after winter, i.e. between the autumn and spring equinoxes.
doi:10.1371/journal.pone.0059063
PMCID: PMC3601102  PMID: 23527088
4.  Assessment of whole body MRI and sestamibi technetium-99m bone marrow scan in prediction of multiple myeloma disease progression and outcome: a prospective comparative study 
BMJ Open  2013;3(1):e002025.
Objectives
This study aims primarily to determine whether whole body MRI (WB-MRI) and Sestamibi Technetium-99m-bone marrow (MIBI) scans in the same patients produce the same estimate of disease load and location, and secondly, to study possible association between the bone disease detected by these scans and the effect on disease outcome and survival. Bone disease occurs in about 90% of multiple myeloma (MM) patients. There are no data comparing the new diagnostic modalities with WB-MRI and MIBI in MM.
Design
A prospective comparative study between WB-MRI and MIBI scans in assessing bone disease and outcome of MM.
Participants and methods
Sixty-two consecutive patients with confirmed MM underwent simultaneous WB-MRI (both axial T1 and turbo spin echo short tau inversion recovery (STIR)) and MIBI scans at a single institution from January 2010 to January 2011, and their survival status was determined in January 2012. The median age was 62 years (range 37–88) with a male-to-female ratio of 33 : 29.
Results
In vertebrae and long bones, MRI scan detected more disease compared with MIBI scan (p<0.001) but there was less difference in the skull (p=0.09). In the ribcage, the MIBI scan detected more lytic lesions of the ribs compared with MRI scan (p<0.001). Thirteen of the 62 patients died during the 24-month follow-up. Increased disease detected in all bones by both scans was associated with increased mortality risk (MIBI p=0.001; MRI-STIR p=0.044; but not MRI-T1 p=0.44). In all combined bone groups, the mean MIBI scan results provided a better prediction of mortality than MRI scan over the follow-up period (MRI-T1 vs MIBI p=0.019; MRI-STIR vs MIBI p=0.047).
Conclusions
Although WB-MRI detected more MM bone disease, MIBI scan predicted overall disease outcome and mortality better than MRI scan. Further studies to define optimum use of these imaging techniques are warranted.
Trial registration number
The study was registered prospectively in the Australian and New Zealand Clinical Trials Registry at http://www.ANZCTR.org.au under No: ACTRN12609000761268.
doi:10.1136/bmjopen-2012-002025
PMCID: PMC3549203  PMID: 23315438
Nuclear Medicine; Radiology & Imaging; Qualitative Research
5.  Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy 
BMJ Open  2012;2(5):e000998.
Background
To date, there are no data available concerning the impact of iron therapy on the long-term well-being and health-related quality of life (HRQoL) in pregnancy.
Objective
To assess the long-term effect of iron therapy on HRQoL in pregnancy.
Design
This is a follow-up study conducted between January 2010 and January 2011 of an earlier randomised open-label clinical trial of intravenous and oral iron versus oral iron for pregnancy-related iron deficiency anaemia. We used a modified version of the SF-36 questionnaire together with the original prospective HRQoL data collected during and after pregnancy.
Participants and interventions
Of the original evaluable 183 pregnant Caucasian women randomised to receive oral iron or a single intravenous iron polymaltose infusion followed by oral iron maintenance, 126 women completed the follow-up HRQoL study.
Methods
The participants were followed up 4 weeks after treatment, predelivery and postdelivery for a median period of 32 months (range, 26–42) with a well-being and HRQoL questionnaire using a modified SF-36 QoL-survey and child growth charts as set by the Australasian Paediatric Endocrine Group (APEG).
Results
Patients who received intravenous iron demonstrated significantly higher haemoglobin and serum ferritin levels (p<0.001). There were strong associations between iron status and a number of the HRQoL parameters, with improved general health (p<0.001), improved vitality (physical energy) (p<0.001), less psychological downheartedness (p=0.005), less clinical depression (p=0.003) and overall improved mental health (p<0.001). The duration of breastfeeding was longer (p=0.046) in the intravenous iron group. The babies born in both groups recorded similarly on APEG growth chart assessments.
Conclusions
Our data suggest that HRQoL is improved until after pregnancy in anaemic pregnant women by repletion of their iron stores during pregnancy. About 80% of the intravenous iron group showed a maintained normal ferritin until delivery with long-term benefits. Further studies to confirm these findings are warranted.
doi:10.1136/bmjopen-2012-000998
PMCID: PMC3488743  PMID: 23087011
Qualitative Research
6.  Light at the End of the Tunnel: The Learning Curve Associated with Endoscopic Transsphenoidal Skull Base Surgery 
Skull Base  2010;20(2):69-74.
ABSTRACT
Endoscopic transsphenoidal resection of skull base lesions has been introduced widely as an alternative to microscopic transmucosal approaches. We report the introduction of this technique to our unit, including the learning curve recognized for this procedure, comparing techniques in a concurrent case-control fashion. All patients operated on for sellar, suprasellar, or clival lesions were considered for endoscopic surgery, with 51 patients undergoing endoscopic surgery and 46 having microscopic surgery with the operating method determined by the availability of the ear, nose, and throat surgeon involved with the procedures. Endoscopic surgery compared favorably with microscopic surgery with respect to endocrine control, length of stay, diabetes insipidus, and cerebrospinal fluid leakage. A learning curve was found with a significant fall in complication rates between the first third and most recent third of the cohort. Endoscopic skull base surgery has superior results to microscopic approaches once the initial learning curve is overcome, but this can be done quickly and safely.
doi:10.1055/s-0029-1238214
PMCID: PMC2853078  PMID: 20808530
Endoscopy; transsphenoidal surgery; skull base tumor; learning curve
7.  Comparison of markers of oxidative stress, inflammation and arterial stiffness between incident hemodialysis and peritoneal dialysis patients – an observational study 
BMC Nephrology  2009;10:8.
Background
Patients on peritoneal and hemodialysis have accelerated atherosclerosis associated with an increase in cardiovascular morbidity and mortality. The atherosclerosis is associated with increased arterial stiffness, endothelial dysfunction and elevated oxidative stress and inflammation. The aims of this study are to investigate the effects of peritoneal and hemodialysis on arterial stiffness, vascular function, myocardial structure and function, oxidative stress and inflammation in incident patients with end stage kidney disease.
Methods
This is an observational study. Eighty stage five CKD patients will be enrolled and followed for one-year. Primary outcome measures will be changes in 1) arterial stiffness measured by aortic pulse wave velocity, 2) oxidative stress assessed by plasma F2 isoprostanes and 3) inflammation measured by plasma pentraxin-3. Secondary outcomes will include additional measures of oxidative stress and inflammation, changes in vascular function assessed using the brachial artery reactivity technique, carotid artery intimal medial thickness, augmentation index and trans thoracic echocardiography to assess left ventricular geometry, and systolic and diastolic function. Patients will undergo these measures at baseline (6–8 weeks prior to starting dialysis therapy), then at six and 12 months after starting dialysis.
Discussion
The results of this study may guide the choice of dialysis modality in the first year of treatment. It may also lead to a larger study prospectively assessing the effect of dialysis modality on cardiovascular morbidity and mortality.
Trial Registration
ACTRN12609000049279
doi:10.1186/1471-2369-10-8
PMCID: PMC2666726  PMID: 19284599
8.  Astaxanthin vs placebo on arterial stiffness, oxidative stress and inflammation in renal transplant patients (Xanthin): a randomised controlled trial 
BMC Nephrology  2008;9:17.
Background
There is evidence that renal transplant recipients have accelerated atherosclerosis manifest by increased cardiovascular morbidity and mortality. The high incidence of atherosclerosis is, in part, related to increased arterial stiffness, vascular dysfunction, elevated oxidative stress and inflammation associated with immunosuppressive therapy. The dietary supplement astaxanthin has shown promise as an antioxidant and anti-inflammatory therapeutic agent in cardiovascular disease. The aim of this trial is to investigate the effects of astaxanthin supplementation on arterial stiffness, oxidative stress and inflammation in renal transplant patients.
Method and Design
This is a randomised, placebo controlled clinical trial. A total of 66 renal transplant recipients will be enrolled and allocated to receive either 12 mg/day of astaxanthin or an identical placebo for one-year. Patients will be stratified into four groups according to the type of immunosuppressant therapy they receive: 1) cyclosporine, 2) sirolimus, 3) tacrolimus or 4) prednisolone+/-azathioprine, mycophenolate mofetil or mycophenolate sodium. Primary outcome measures will be changes in 1) arterial stiffness measured by aortic pulse wave velocity (PWV), 2) oxidative stress assessed by plasma isoprostanes and 3) inflammation by plasma pentraxin 3. Secondary outcomes will include changes in vascular function assessed using the brachial artery reactivity (BAR) technique, carotid artery intimal medial thickness (CIMT), augmentation index (AIx), left ventricular afterload and additional measures of oxidative stress and inflammation. Patients will undergo these measures at baseline, six and 12 months.
Discussion
The results of this study will help determine the efficacy of astaxanthin on vascular structure, oxidative stress and inflammation in renal transplant patients. This may lead to a larger intervention trial assessing cardiovascular morbidity and mortality.
Trial Registration
ACTRN12608000159358
doi:10.1186/1471-2369-9-17
PMCID: PMC2666668  PMID: 19091127
9.  The Lipid lowering and Onset of Renal Disease (LORD) Trial: A randomized double blind placebo controlled trial assessing the effect of atorvastatin on the progression of kidney disease 
BMC Nephrology  2008;9:4.
Background
There is evidence that dyslipidemia is associated with chronic kidney disease (CKD). Experimental studies have established that lipids are damaging to the kidney and animal intervention studies show statins attenuate this damage. Small clinical trials, meta-analyses, observational studies and post-hoc analyses of cardiovascular intervention studies all support the concept that statins can reduce kidney damage in humans. Based on this background, a double blind randomized placebo controlled trial was designed to assess the effectiveness of atorvastatin 10 mg on slowing the progression of kidney disease in a population of patients with CKD.
Method/Design
The Lipid lowering and Onset of Renal Disease (LORD) trial is a three-year, single center, multi-site, double blind, randomized, placebo controlled trial. The primary outcome measure is kidney function measured by eGFR calculated by both Modification of Diet in Renal Disease (MDRD) and Cockcroft and Gault equations. Secondary outcome measures include kidney function measured by 24-hour urine creatinine clearance and also 24-hour urinary protein excretion, markers of oxidative stress, inflammation and drug safety and tolerability.
Discussion
The results of this study will help determine the effectiveness and safety of atorvastatin and establish its effects on oxidative stress and inflammation in patients with CKD.
Trial Registration
ANZCTRN012605000693628
doi:10.1186/1471-2369-9-4
PMCID: PMC2276485  PMID: 18366658
10.  Robert Lisle Gadd 
BMJ : British Medical Journal  2005;331(7526):1207.
PMCID: PMC1285113
11.  Meningiomas Involving the Internal Auditory Canal 
Skull base surgery  1999;9(2):87-94.
Meningiomas are the second most common lesion encountered within the cerebello-pontine angle (CPA) and rarely project into or originate from the internal auditory meatus (IAM). It is important to distinguish between meningiomas and acoustic neuromas preoperatively as the choice of surgical approach may differ depending on the tumour type. Fortunately, most lesions can be accurately diagnosed with gadolinium-enhanced magnetic resonunce imaging (MRI). We report six cases of meningioma involving the IAM, often leading to an incorrect preoperative MRI diagnosis. We highlight the challenges these tumors present to radiologists and surgeons.
Images
PMCID: PMC1656800  PMID: 17171123

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