Radiotherapy-induced xerostomia: a randomised, double-blind, controlled trial of Visco-ease™ oral spray compared with placebo in patients with cancer of the head and neck.

Radiotherapy-induced xerostomia (RIX) is a common and untreatable side effect of radiotherapy to the head and neck. Visco-ease™ mouth spray (Lamellar Biomedical Ltd), a new product that is made from lamellar body mimetics, reduces the viscosity of saliva ex vivo. The purpose of this study was to evaluate its safety and effectiveness in the treatment of RIX in 43 patients with cancer of the head and neck. They were randomised into the Visco-ease™ or placebo groups, and asked to complete the Groningen radiotherapy-induced xerostomia (GRIX) questionnaire each week. The primary endpoint was a change in GRIX score from baseline to end of treatment. There was no difference in scores between the two groups, and none of the patients had device-related serious adverse events. Visco-ease™ oral spray was safe and tolerable but no better than placebo in reducing RIX in this group of patients.

An Urgent Need to Incorporate Evidence-Based Nutrition and Lifestyle Medicine Into Medical Training.

It is well established that evidence based clinical nutrition and lifestyle practices play a pivotal role in the prevention, treatment and potential reversal of various common chronic diseases. However, this area of science is under appreciated at all levels of medical education and training. Most medical schools and residency programs do not offer any organized training in nutrition and lifestyle medicine. Given recent data on the rising cost and loss of quality of life secondary to preventable causes, there is an absolute need for a drastic reform of the US medical education system.

A portable miniaturized laser heterodyne radiometer (mini­LHR) for remote measurements of column CH4 and CO2.

We present the design of a portable version of our miniaturized laser heterodyne radiometer (mini-LHR) that simultaneously measures methane (CH4) and carbon dioxide (CO2) in the atmospheric column. The mini-LHR fits on a backpack frame, operates autonomously, and requires no infrastructure because it is powered by batteries charged by a folding 30 W solar panel. Similar to our earlier instruments, the mini-LHR is a passive laser heterodyne radiometer that operates by collecting sunlight that has undergone absorption by CH4 and CO2. Within the mini-LHR, sunlight is mixed with light from a distributive feedback (DFB) laser centered at approximately 1.64 µm where both gases have absorption features. The laser scans across these absorption features roughly every minute and the resulting beat signal is collected in the radio frequency (RF). Scans are averaged into half hour and hour data products and analyzed using the Planetary Spectrum Generator (PSG) retrieval to extract column mole fractions. Instrument performance is demonstrated through two deployments at significantly different sites in interior Alaska and Hawaii. The resolving power (λ/∆λ) is greater than 500,000 at 1.64 µm with precisions of better than 20 ppb and 1 ppm for CH4 and CO2, respectively. Because mini-LHR instruments are portable and can be co-located, they can be used to characterize bias between larger, stationary, column observing instruments. In addition, mini-LHRs can be deployed quickly to respond to transient events such as methane leaks or can be used for field studies targeting geographical regions.

Appropriateness for testis-sparing surgery based on the testicular tumor size in a pediatric and adolescent population.

INTRODUCTION: In children, most small testicular tumors are benign, and testicular-sparing surgery (TSS) is a viable treatment option. OBJECTIVE: The objective of this study is to assess for correlation between the tumor size and final pathologic diagnoses appropriate for TSS for pediatric and adolescent patients with an intratesticular mass and negative serum tumor markers (STMs). MATERIALS AND METHODS: A retrospective review of 24 patients (aged 0-18 years) who underwent radical or partial orchiectomy between 2003 and 2015. Patients with unifocal, unilateral intratesticular tumors and negative STMs were included. Tumors with benign and non-germ cell histology were considered appropriate for TSS, and active germ cell tumor elements on final histology were categorized as inappropriate for TSS. Baseline characteristics, tumor size, and frozen section results were evaluated for association, for the entire cohort and then for a subset of pubertal and postpubertal patients (defined as ≥10 years old). RESULTS: Patients with testicular tumor pathology inappropriate for TSS were significantly older (median age 17.1 years, P = 0.03). A 2-cm size cutoff did not accurately predict pathology for the entire cohort, or for just pubertal and postpubertal patients (P = 0.132, P = 0.154, respectively). Frozen section and final pathology demonstrated good agreement (κ = 0.826, P < 0.001) as did pre-operative and final pathologic size measurement (κ = 0.703, P < 0.001). Frozen section analysis did not miss a TSS inappropriate pathology. DISCUSSION: The present data refute the finding in adults that a 2-cm cutoff accurately predicts pathology in pediatric patients with an intratesticular mass and normal STMs. These data suggest that TSS should still be offered, regardless of the tumor size alone, but frozen section appears to more accurately predict pathology than the tumor size, and its use should, thus, be emphasized. There are several limitations of this study to mention. First, this is a retrospective review of a small cohort of patients with a rare clinical scenario, which necessitated the combination of pediatric and adolescent patients. The study did not evaluate oncologic outcomes. CONCLUSIONS: In children with an intratesticular tumor and normal STMs, a tumor size cutoff of 2 cm does not appear to accurately predict the final pathology. However, the data presented support the continued use intra-operative frozen section analysis in both children and adolescents undergoing TSS.

A Clinician's Guide for Trending Cardiovascular Nutrition Controversies: Part II.

The potential cardiovascular (CV) benefits of many trending foods and dietary patterns are still incompletely understood, and scientific inquiry continues to evolve. In the meantime, however, a number of controversial dietary patterns, foods, and nutrients have received significant media attention and are mired by "hype." This second review addresses some of the more recent popular foods and dietary patterns that are recommended for CV health to provide clinicians with current information for patient discussions in the clinical setting. Specifically, this paper delves into dairy products, added sugars, legumes, coffee, tea, alcoholic beverages, energy drinks, mushrooms, fermented foods, seaweed, plant and marine-derived omega-3-fatty acids, and vitamin B12.

Prospective study of enhanced recovery after surgery protocol in children undergoing reconstructive operations.

BACKGROUND: Enhanced recovery after surgery (ERAS) protocol is a set of peri-operative strategies to increase speed of recovery. ERAS is well established in adults but has not been well studied in children. OBJECTIVE: The purpose of the current study was to establish the safety and efficacy of an ERAS protocol in pediatric urology patients undergoing reconstructive operations. It was hypothesized that ERAS would reduce length of stay and decrease complications when compared with historical controls. STUDY DESIGN: Institutional Review Board approval was obtained to prospectively enroll patients aged <18 years if they had undergone urologic reconstruction that included a bowel anastomosis. ERAS included: no bowel preparation, administration of pre-operative oral carbohydrate liquid, avoidance of opioids, regional anesthesia, laparoscopy when feasible, no postoperative nasogastric tube, early feeding, and early removal of intravenous fluids (IVF). Recent (2009-2014) historical controls were propensity matched in a 2:1 ratio on age, sex, ventriculoperitoneal shunt status and whether the patient was undergoing bladder augmentation. Outcomes were protocol adherence, length of stay (LOS), emergency department (ED) visits, re-admission within 30 days, re-operations and adverse events occurring within 90 days of surgery. RESULTS: A total of 26 historical and 13 ERAS patients were included. Median ages were 10.4 (IQR 8.0-12.4) and 9.9 years (IQR 9.1-11), respectively (P = 0.94) (see Summary Table). There were no significant between-group differences in prior abdominal surgery (38% vs 62%), rate of augmentation (88% vs 92%) or primary diagnosis of spina bifida (both 62%). ERAS significantly improved use of pre-operative liquid load (P < 0.001), avoidance of opioids (P = 0.046), early discontinuation of IVF (P < 0.001), and early feeding (P < 0.001). Protocol adherence improved from 8/16 (IQR 4-9) historically to 12/16 (IQR 11-12) after implementation of ERAS. LOS decreased from 8 days to 5.7 days (P = 0.520). Complications of any grade per patient decreased from 2.1 to 1.3 (OR 0.71, 95% CI 0.51-0.97). There were fewer complications per patient across all grades with ERAS. No differences were seen in emergency department (ED) visits, re-admissions and re-operations. DISCUSSION: Implementation improved consistency of care delivered. Tenets of ERAS that appeared to drive improvements included maintenance of euvolemia through avoidance of excess fluids, multimodal analgesia, and early feeding. CONCLUSION: ERAS decreased length of stay and 90-day complications after pediatric reconstructive surgery without increased re-admissions, re-operations or ED visits. A multicenter study will be required to confirm the potential benefits of adopting ERAS.

Evaluating feasibility of an automated 3-dimensional scanner using Raman spectroscopy for intraoperative breast margin assessment.

Breast conserving surgery is the preferred treatment for women diagnosed with early stage invasive breast cancer. To ensure successful breast conserving surgeries, efficient tumour margin resection is required for minimizing tumour recurrence. Currently surgeons rely on touch preparation cytology or frozen section analysis to assess tumour margin status intraoperatively. These techniques have suboptimal accuracy and are time-consuming. Tumour margin status is eventually confirmed using postoperative histopathology that takes several days. Thus, there is a need for a real-time, accurate, automated guidance tool that can be used during tumour resection intraoperatively to assure complete tumour removal in a single procedure. In this paper, we evaluate feasibility of a 3-dimensional scanner that relies on Raman Spectroscopy to assess the entire margins of a resected specimen within clinically feasible time. We initially tested this device on a phantom sample that simulated positive tumour margins. This device first scans the margins of the sample and then depicts the margin status in relation to an automatically reconstructed image of the phantom sample. The device was further investigated on breast tissues excised from prophylactic mastectomy specimens. Our findings demonstrate immense potential of this device for automated breast tumour margin assessment to minimise repeat invasive surgeries.

A Deficiency of Nutrition Education and Practice in Cardiology.

BACKGROUND: Nutrition is one of the foundations of cardiovascular guidelines for risk reduction and treatment. However, little is known about whether cardiologists, cardiology fellows-in-training, and cardiovascular team members have the nutrition education and knowledge necessary to implement these guidelines. The aim of this study was to describe the educational experiences, attitudes, and practices relating to nutrition among cardiovascular professionals. METHODS: Surveys completed by cardiologists, fellows-in-training, and cardiovascular team members inquired about their personal dietary habits, history of nutrition education, and attitudes regarding nutrition interventions. RESULTS: A total of 930 surveys were completed. Among cardiologists, 90% reported receiving no or minimal nutrition education during fellowship training, 59% reported no nutrition education during internal medicine training, and 31% reported receiving no nutrition education in medical school. Among cardiologists, 8% described themselves as having "expert" nutrition knowledge. Nevertheless, fully 95% of cardiologists believe that their role includes personally providing patients with at least basic nutrition information. The percentage of respondents who ate ≥5 servings of vegetables and fruits per day was: 20% (cardiologists), 21% (fellows-in-training), and 26% (cardiovascular team members). CONCLUSIONS: A large proportion of cardiovascular specialists have received minimal medical education and training in nutrition, and current trainees continue to experience significant education and training gaps.

Trending Cardiovascular Nutrition Controversies.

The potential cardiovascular benefits of several trending foods and dietary patterns are still incompletely understood, and nutritional science continues to evolve. However, in the meantime, a number of controversial dietary patterns, foods, and nutrients have received significant media exposure and are mired by hype. This review addresses some of the more popular foods and dietary patterns that are promoted for cardiovascular health to provide clinicians with accurate information for patient discussions in the clinical setting.

Research awareness, attitudes and barriers among clinical staff in a regional cancer centre. Part 1: a quantitative analysis.

Research is of key importance in delivering high-quality patient care through evidence-based practice. Attitude towards research and barriers to research can have an impact on research activity. A survey was conducted to establish the levels of research awareness and attitudes among clinical staff groups in this regional cancer centre and identify any barriers to participation in research. The survey consisted of 26 questions and was distributed electronically and completed online. The response rate was 22.3% (n = 123). All participants felt that clinical research will help the regional cancer centre develop and progress treatments in the future. A positive attitude towards research was evident and consistent across professional groups. The main identified barriers to research included lacking the required knowledge, skills and training, lacking support from managers, and lack of opportunity or time to be involved in research, in particular for allied health professionals. However, there appears to be the foundation of a healthy research culture for nurses supported by management. The results of the survey support the implementation of an action plan based on the recommendations of this journal article.

Study of clitoral hood anatomy in the pediatric population.

INTRODUCTION AND AIMS: Pediatric female genitalia size and morphology have not previously been well described. The aims of this study were to create a standard reference for the anterior vulval structures, and examine the relationship between the clitoral hood and labia minora. METHOD: Female patients between 0 and 16 years of age, and with normal external genitalia had the following measurements taken: length of clitoral hood, length of sides of clitoral hood, clitoral diameter, apex of clitoral hood to base of pubic symphysis, apex of clitoral hood to urethral orifice, distance of clitoral hood to labia majora, and length and depth of labia minora. Qualitative descriptors of the clitoral hood and labia were recorded. Patients were grouped into age ranges for analysis: 0-3 years, 4-8 years, 9-12 years, and 13-16 years. RESULTS: Fifty-eight girls were examined. There was a linear relationship between age and genital structure size. In the majority of patients, the labia minora converged under the clitoral glans, separate to the clitoral hood. Four shapes of clitoral hood were observed: horseshoe, trumpet, coffee bean, and tent. DISCUSSION: This study observed great variation in size and morphology of pediatric female genitalia, which is in keeping with other studies. The study was limited by ability to recruit older patients to the study (girls aged 11-16 years) and, therefore, there were lower numbers in this age category. However, the trends that were observed were present in both younger and older girls. CONCLUSION: External genitalia size and morphology are varied in the pediatric female population. The clitoral hood and labia minora were observed to be distinctly separate structures. This study provides a reference for surgeons undertaking genital reconstruction procedures. The study demonstrated that the clitoral hood and labia minora are anatomically distinct structures.

Defining an Overdue Requiem for Palliative Cardiovascular Medicine.

During the past 40 years, we have witnessed significant advances in the pharmaceutical and interventional treatment of cardiovascular disease (CVD), which have helped achieve a decrease in morbidity and mortality for this illness. Nevertheless, CVD remains the number 1 killer of women and men in Western civilizations. This fact is in stark contrast to the scenario in multiple whole food, plant-based nutrition (WFPBN) cultures, where CVD is virtually nonexistent. The utility of plant-based nutrition to halt and prevent CVD has been demonstrated epidemiologically, during wartime deprivation, in large cohort and population transitioning studies, and through prospective randomized and nonrandomized investigations. A basic scientific study confirms that omnivores have intestinal bacteria capable of converting animal food to trimethylamine oxide (TMAO), which injures blood vessels, whereas those eating plants only do not have intestinal bacteria capable of producing TMAO. Despite this overwhelming evidence for the safety, simplicity, and efficacy of plant nutrition to halt and prevent coronary artery disease, the cardiovascular medicine community has failed to embrace this option of therapy and persists in palliative treatments associated with high morbidity, mortality, and expense. It is long overdue to question why.

Radiotherapy-induced xerostomia, pre-clinical promise of LMS-611.

PURPOSE: Radiotherapy-induced xerostomia (RIX) is the most common permanent side effect of radiotherapy (RT) to the head and neck (H&N). There is no effective topical treatment. LMS-611 is a mimetic of a natural lamellar body which prevents thick secretions like saliva from congesting organs. The primary objective of this study was to assess saliva properties before and during RT to the H&N. The secondary objectives were to re-assess saliva properties with the addition of LMS-611, measure inter-patient variability, correlate patient-reported symptoms with laboratory measurements and design subsequent first-in-human clinical trial of LMS-611. METHODS: Patients with H&N cancer receiving RT as primary treatment were recruited. Patients completed the Groningen RIX (GRIX) questionnaire and provided saliva samples at baseline and weeks 2, 4 and 6 of RT. Saliva adhesiveness and viscosity were tested by measuring time taken to travel 5 cm down an inclined plane. RESULTS: Thirty patients were enrolled. The inclined plane test (IPT) results (s) were as follows: baseline 31.3, week 2 49.7, week 4 51.1 and week 6 55.7. Wide inter-patient variability was seen at baseline. GRIX scores increased as RT progressed. Spearman rank correlation coefficient of inclined plane tests with GRIX scores was -0.06 at baseline, 0.25 at week 2, 0.12 at week 4 and 0.08 at week 6. LMS-611 concentrations of 10 and 20 mg/ml significantly reduced IPT times on saliva samples. CONCLUSIONS: Saliva becomes more visco-adhesive and RIX worsens as RT progresses. There is little correlation between objective and subjective measures of RIX. The addition of LMS-611 to thick, sticky saliva restores its fluidity ex vivo. This warrants in vivo analysis of the effect of LMS-611 upon RIX.

A way to reverse CAD?

PURPOSE: Plant-based nutrition achieved coronary artery disease (CAD) arrest and reversal in a small study. However, there was skepticism that this approach could succeed in a larger group of patients. The purpose of our follow-up study was to define the degree of adherence and outcomes of 198 consecutive patient volunteers who received counseling to convert from a usual diet to plant-based nutrition. METHODS: We followed 198 consecutive patients counseled in plant-based nutrition. These patients with established cardiovascular disease (CVD) were interested in transitioning to plant-based nutrition as an adjunct to usual cardiovascular care. We considered participants adherent if they eliminated dairy, fish, and meat, and added oil. RESULTS: Of the 198 patients with CVD, 177 (89%) were adherent. Major cardiac events judged to be recurrent disease totaled one stroke in the adherent cardiovascular participants­a recurrent event rate of .6%, significantly less than reported by other studies of plant-based nutrition therapy. Thirteen of 21 (62%) nonadherent participants experienced adverse events. CONCLUSION: Most of the volunteer patients with CVD responded to intensive counseling, and those who sustained plant-based nutrition for a mean of 3.7 years experienced a low rate of subsequent cardiac events. This dietary approach to treatment deserves a wider test to see if adherence can be sustained in broader populations. Plant-based nutrition has the potential for a large effect on the CVD epidemic.

Randomised double-blind, placebo-controlled trial of the effects of the 'party pills' BZP/TFMPP alone and in combination with alcohol.

The objective of this study was to determine the clinical effects of party pills containing benzylpiperazine (BZP) and trifluoromethylphenylpiperazine (TFMPP) when taken alone and in combination with alcohol. The study was a randomised, double-blind, placebo-controlled trial conducted in a hospital-based clinic in Wellington, New Zealand. Thirty-five volunteers who had previously used party pills containing BZP were included in this trial. Participants received one of the following four treatments: 300 mg/74 mg BZP/TFMPP and placebo, 300 mg/74 mg BZP/TFMPP and 57.6 g (6 units) alcohol, placebo and 57.6 g (6 units) alcohol and double placebo. The primary outcome variable was a measure of driving performance, the standard deviation of lateral position (SDLP) measured at 6.5 h. Secondary measures included adverse events, cardiovascular effects, psychological function and delayed effects on sleep. The study was stopped early, after 35 of the planned 64 subjects had undertaken testing, because of severe adverse events that occurred in four of 10 BZP/TFMPP-only subjects, three of seven combined BZP/TFMPP and alcohol subjects, none of the 6 placebo subjects, and none of the 12 alcohol-only subjects. The overall rate of severe adverse events (defined as causing considerable interference with usual activity and/or rated by subject as severe) in those receiving BZP/TFMPP was seven of 17 (41.2%, 95% CI 18.4-67.1). The severe events included agitation, anxiety, hallucinations, vomiting, insomnia and migraine. BZP/TFMPP significantly improved the driving performance, decreasing SDLP at -4.2 cm (95% CI -6.8 to -1.6, P = 0.002). The effect of alcohol was to increase SDLP: 2.3 cm (95% CI -0.3 to 4.9, P = 0.08). BZP/TFMPP also resulted in increased heart rate and blood pressure and in difficulty in getting to sleep. BZP/TFMPP alone or with alcohol carries a significant risk of severe adverse events when taken in similar doses to those recommended by manufacturers.

Early mobilisation after conventional knee replacement may reduce the risk of postoperative venous thromboembolism.

We carried out an audit on the result of achieving early walking in total knee replacement after instituting a new rehabilitation protocol, and assessed its influence on the development of deep-vein thrombosis as determined by Doppler ultrasound scanning on the fifth post-operative day. Early mobilisation was defined as beginning to walk less than 24 hours after knee replacement. Between April 1997 and July 2002, 98 patients underwent a total of 125 total knee replacements. They began walking on the second post-operative day unless there was a medical contraindication. They formed a retrospective control group. A protocol which allowed patients to start walking at less than 24 hours after surgery was instituted in August 2002. Between August 2002 and November 2004, 97 patients underwent a total of 122 total knee replacements. They formed the early mobilisation group, in which data were prospectively gathered. The two groups were of similar age, gender and had similar medical comorbidities. The surgical technique and tourniquet times were similar and the same instrumentation was used in nearly all cases. All the patients received low-molecular-weight heparin thromboprophylaxis and wore compression stockings post-operatively. In the early mobilisation group 90 patients (92.8%) began walking successfully within 24 hours of their operation. The incidence of deep-vein thrombosis fell from 27.6% in the control group to 1.0% in the early mobilisation group (chi-squared test, p < 0.001). There was a difference in the incidence of risk factors for deep-vein thrombosis between the two groups. However, multiple logistic regression analysis showed that the institution of an early mobilisation protocol resulted in a 30-fold reduction in the risk of post-operative deep-vein thrombosis when we adjusted for other risk factors.