Acupuncture Reduces Severity of Hot Flashes in Breast Cancer: A Randomized Single-Blind Trial.

This study evaluated the effectiveness of traditional Chinese medicine-based therapeutic acupuncture (TA) in reducing the severity of hot flashes (HFs) in breast cancer patients and compared the effectiveness of TA to "sham" placebo acupuncture (SA). Subjects experiencing more than 10 episodes of HF/week were randomly assigned to TA or SA. The response was assessed by the Menopause-specific Quality of Life (MenQoL) scale, scoring the subject's perception of the severity of HFs. HFs were scored at baseline, after treatment, and 1-month follow-up. A total of 54 subjects enrolled (28 TA and 26 SA). Seven women withdrew from the study. A hot flash diary documented the number of HFs a subject experienced. Analysis included 47 subjects (27 TA and 20 SA). A statistically significant response in HF scores was noted in the TA group compared with the SA group (P = .0064.) On average HF scores dropped by 1.89 with TA, and only 0.16 with SA. At follow-up, TA subjects had a sustained response. TA is effective in reducing the intensity and severity of HF. With SA, no relative response/change in HF scores was noted. Larger studies and longer follow-up to assess durability of response to TA are needed.

Prospective impacts of oil spills on floodplain vegetation: Both crude oil and diluted bitumen increase foliar temperatures, senescence and abscission in three cottonwood (Populus) species.

Oil pipelines are vulnerable at river crossings since floods can expose and rupture pipes, releasing oil that floats and coats floodplain vegetation. This study investigated the consequences of oil coatings on leaves of cottonwoods (riparian poplars), the predominant trees in floodplain woodlands around the Northern Hemisphere. The study compared conventional crude oil (CO) versus diluted bitumen (dilbit, DB), heavy oil originating from the Alberta oil sands; with petroleum jelly (PJ) as a reference. The treatments increased leaf surface temperatures (Tleaf) in narrowleaf and plains cottonwoods (Populus angustifolia, P. deltoides) and balsam poplars (P. balsamifera) (Control = 21.8°C, PJ = 23.7°C; CO = 26.2°C; DB = 28.1°C; Tair = 25°C). The leaf warming followed stomatal occlusion from the foliar coating, which would reduce transpiration and evaporative cooling, combined with increased solar warming with the darker oils. Tleaf varied across the three cottonwood species, with cooler, narrow, narrowleaf cottonwood leaves; intermediate plains cottonwood leaves; and warmer, darker, balsam poplar leaves (average Tleaf: narrowleaf = 23.8°C, plains = 24.3°C, and balsam = 26.7°C), with similar warming in each species following the different treatments. Across species and treatments, Tleaf was tightly correlated with foliar condition, which assessed turgor versus wilting of leaf blades and petioles, along with leaf necrosis and senescence (r2 = 0.980, narrowleaf; 0.998, plains; 0.852, balsam). This tight association indicates validity of both Tleaf and foliar condition as diagnostic measures. Crude oil and dilbit had similar foliar impacts, and for both, leaf abscission occurred within 2 to 3 weeks. Consequently, following an oil spill, remediation should commence quickly but extending vegetation removal beyond a few weeks would have limited benefit since the contaminated leaves would have abscised.

Call to action: A new path for improving diabetes care for Indigenous peoples, a global review.

Diabetes has reached epidemic proportions in Indigenous populations around the globe, and there is an urgent need to improve the health and health equity of Indigenous peoples with diabetes through timely and appropriate diabetes prevention and management strategies. This review describes the evolution of the diabetes epidemic in Indigenous populations and associated risk factors, highlighting gestational diabetes and intergenerational risk, lifestyle risk factors and social determinants as having particular importance and impact on Indigenous peoples. This review further describes the impact of chronic disease and diabetes on Indigenous peoples and communities, specifically diabetes-related comorbidities and complications. This review provides continued evidence that dramatic changes are necessary to reduce diabetes-related inequities in Indigenous populations, with a call to action to support programmatic primary healthcare transformation capable of empowering Indigenous peoples and communities and improving chronic disease prevention and management. Promising strategies for transforming health services and care for Indigenous peoples include quality improvement initiatives, facilitating diabetes and chronic disease registry and surveillance systems to identify care gaps, and prioritizing evaluation to build the evidence-base necessary to guide future health policy and planning locally and on a global scale.

Developing community-driven quality improvement initiatives to enhance chronic disease care in Indigenous communities in Canada: the FORGE AHEAD program protocol.

BACKGROUND: Given the dramatic rise and impact of chronic diseases and gaps in care in Indigenous peoples in Canada, a shift from the dominant episodic and responsive healthcare model most common in First Nations communities to one that places emphasis on proactive prevention and chronic disease management is urgently needed. METHODS: The Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD) Program partners with 11 First Nations communities across six provinces in Canada to develop and evaluate community-driven quality improvement (QI) initiatives to enhance chronic disease care. FORGE AHEAD is a 5-year research program (2013-2017) that utilizes a pre-post mixed-methods observational design rooted in participatory research principles to work with communities in developing culturally relevant innovations and improved access to available services. This intensive program incorporates a series of 10 inter-related and progressive program activities designed to foster community-driven initiatives with type 2 diabetes mellitus as the action disease. Preparatory activities include a national community profile survey, best practice and policy literature review, and readiness tool development. Community-level intervention activities include community and clinical readiness consultations, development of a diabetes registry and surveillance system, and QI activities. With a focus on capacity building, all community-level activities are driven by trained community members who champion QI initiatives in their community. Program wrap-up activities include readiness tool validation, cost-analysis and process evaluation. In collaboration with Health Canada and the Aboriginal Diabetes Initiative, scale-up toolkits will be developed in order to build on lessons-learned, tools and methods, and to fuel sustainability and spread of successful innovations. DISCUSSION: The outcomes of this research program, its related cost and the subsequent policy recommendations, will have the potential to significantly affect future policy decisions pertaining to chronic disease care in First Nations communities in Canada. TRIAL REGISTRATION: Current ClinicalTrial.gov protocol ID NCT02234973 . Date of Registration: July 30, 2014.

Elemental fingerprinting of Hypericum perforatum (St John's Wort) herb and preparations using ICP-OES and chemometrics.

St. John's wort (SJW) (Hypericum perforatum) is a herbal remedy commonly used to treat mild depression. The elemental profiles of 54 samples (i.e., dry herbs, tablets and capsules) were evaluated by monitoring 25 elements using Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES). The major elemental constituents in the SJW samples were Ca (300-199,000µg/g), Mg (410-3,530µg/g), Al (4.4-900µg/g), Fe (1.154-760µg/g), Mn (2.4-261µg/g), Sr (0.88-83.6µg/g), and Zn (7-64µg/g). For the sixteen elements that could be reliably quantified, principal component analysis (PCA) was used to investigate underlying patterns in the data. PCA models identified 7 key elements (i.e., Ba, Ca, Cd, Mg, Mo, Ni and Y), which described 85% of the variance in the dataset in the first three principal components. The PCA approach resulted in a general delineation between the three different formulations and provides a basis for monitoring product quality in this manner.

Traditional foods and 25(OH)D concentrations in a subarctic First Nations community.

BACKGROUND: Sub-optimal vitamin D status is common worldwide and the condition may be associated with increased risk for various chronic diseases. In particular, low vitamin D status is highly prevalent in indigenous communities in Canada, although limited data are available on the determinants of serum 25-hydroxyvitamin D (25(OH)D) concentrations in this population. The relationship between traditional food consumption and vitamin D status has not been well documented. OBJECTIVE: To investigate the determinants of serum 25(OH)D status in a First Nations community in Ontario, Canada, with a focus on the role of traditional food consumption and activities. METHODS: A cross-sectional analysis was conducted within the Sandy Lake Health and Diabetes Project (2003-2005). A total of 445 participants (>12 years of age) were assessed for serum 25(OH)D status, anthropometric and lifestyle variables, including traditional and non-traditional dietary practices and activities. Diet patterns were identified using factor analysis, and multivariate linear regression analysis was used to analyse the determinants of 25(OH)D concentrations. RESULTS: Mean serum 25(OH)D concentrations were 22.1 nmol/L (16.9, 29.9 nmol/L) in men and 20.5 nmol/L (16.0, 27.3 nmol/L) in women. Multivariate determinants of higher serum 25(OH)D included higher consumption of traditional and healthier market foods, higher wild fish consumption, male gender, spring/summer season of blood collection and more frequent physical activity. Significant negative determinants included hours of TV/day, higher BMI and higher consumption of unhealthy market foods. CONCLUSIONS: Traditional food consumption contributed independently to higher 25(OH)D concentrations in a First Nations community with a high prevalence of sub-optimal vitamin D status.

Prospective association of 25(OH)D with metabolic syndrome.

CONTEXT: Vitamin D may play a role in the aetiology of the metabolic syndrome (MetS), yet the majority of previous studies have been cross-sectional, and the limited number of prospective studies has yielded inconsistent results. OBJECTIVE: To examine the prospective association of vitamin D [25-hydroxyvitamin D, 25(OH)D] with MetS in a multi-ethnic cohort of adults in Ontario, Canada. DESIGN: Nondiabetic individuals with pre-existing MetS risk factors were recruited for participation in the PROspective Metabolism and ISlet cell Evaluation (PROMISE) cohort study, a longitudinal study of the determinants of insulin resistance and MetS. METHODS: Of the 654 participants enrolled at baseline, 489 attended a 3-year follow-up visit. There were 301 participants eligible for the analysis of 25(OH)D with incident MetS (age 49·2 ± 9·3 years old, 75·4% female), after excluding 188 (38·5%) prevalent MetS cases at baseline. Longitudinal change in MetS components was assessed in the entire follow-up cohort. RESULTS: There were 76 (15·5%) participants who developed MetS over the 3-years of follow-up. Multivariate logistic regression analyses indicated a decreased risk of MetS at follow-up per standard deviation increase in baseline 25(OH)D after adjustment for sociodemographics, season, baseline and change in supplement use and physical activity and insulin resistance (OR = 0·63, 95% CI 0·44-0·90). Multivariate linear regression analyses revealed a significant inverse association of baseline 25(OH)D with fasting glucose at follow-up (ß = -0·0005, P = 0·025). CONCLUSIONS: There was a significant inverse association of baseline 25(OH)D with incident MetS, which may be partly driven by its association with glucose homoeostasis.

Doing supplements to improve performance in club cycling: a life-course analysis.

Using qualitative life-course and pathway analysis, this article explores the beliefs that serious club cyclists have about performance improvement, and what they think are appropriate and inappropriate ways of achieving it. We interviewed 11 cyclists from suburban clubs in Melbourne, Australia, and invited them to discuss their approach to training, racing, and supplementation. We found that each of the 11 cyclists were not only committed to the sport, but also paid a keen interest in bike technology and training regimes. In addition, they believed that supplement use was integral to meeting the physical and mental demands of their sport, even at club level. They also understood that supplement use, like training regimes, followed a sequential pathway where the accumulation of capacity, know-know, and knowledge, allowed progression to the next level of performance. And, like similar studies of club cycling in Europe, this cohort of cyclists balked at using banned substances, but also believed that in order to effectively transition to the elite - that is, professional - level, some additional supplement and drug-use was essential.

Outcomes of guided imagery in patients receiving radiation therapy for breast cancer.

Guided imagery is an established intervention in integrative oncology. This study was initiated to evaluate the impact of guided imagery on patients undergoing radiation therapy for breast cancer. Eligible patients receiving guided imagery sessions were monitored via biofeedback before and after each session. Monitored measures included blood pressure, respiration rate, pulse rate, and skin temperature. In addition, the EuroQoL Group's EQ-5D questionnaire was used for subjective assessment and patient feedback was collected at the end of radiation therapy through a satisfaction survey. Measured parameters revealed statistically significant improvement from baseline, with decreases noted in respiration rate and pulse rate as well as systolic and diastolic blood pressure. Skin temperature increased, indicating more peripheral capillary flow secondary to a decrease in the sympathetic response. Overall, 86% of participants described the guided imagery sessions as helpful, and 100% said they would recommend the intervention to others. The results of this study illustrate the positive impact of guided imagery as measured through subjective and objective parameters. Improving the overall care for patients with breast cancer supports the value of incorporating practices of integrative oncology into standard practice.

Repetitive magnetic stimulation of the phrenic nerves for diaphragm conditioning: a normative study of feasibility and optimal settings.

Electrical stimulation can enhance muscle function. We applied repetitive cervical magnetic phrenic stimulation (rCMS) to induce diaphragm contractions in 7 healthy subjects (800 ms trains; transdiaphragmatic pressure (Pdi) measurements; tolerance ratings). Each rCMS train produced a sustained diaphragm contraction. Sixty-five percent of the maximal available output at 15 Hz proved the best compromise between Pdi and discomfort with nonfatiguing contractions. rCMS appears feasible and should be investigated for diaphragm conditioning in appropriate clinical populations.

Prospective associations of vitamin D with ß-cell function and glycemia: the PROspective Metabolism and ISlet cell Evaluation (PROMISE) cohort study.

OBJECTIVE: To examine the prospective associations of baseline vitamin D [25-hydroxyvitamin D; 25(OH)D] with insulin resistance (IR), ß-cell function, and glucose homeostasis in subjects at risk for type 2 diabetes. RESEARCH DESIGN AND METHODS: We followed 489 subjects, aged 50 ± 10 years, for 3 years. At baseline and follow-up, 75-g oral glucose tolerance tests (OGTTs) were administered. IR was measured using the Matsuda index (IS(OGTT)) and the homeostasis model assessment of IR (HOMA-IR), ß-cell function was determined using both the insulinogenic index divided by HOMA-IR (IGI/IR) and the insulin secretion sensitivity index-2 (ISSI-2), and glycemia was assessed using the area under the glucose curve (AUC(glucose)). Regression models were adjusted for age, sex, ethnicity, season, and baseline value of the outcome variable, as well as baseline and change in physical activity, vitamin D supplement use, and BMI. RESULTS: Multivariate linear regression analyses indicated no significant association of baseline 25(OH)D with follow-up IS(OGTT) or HOMA-IR. There were, however, significant positive associations of baseline 25(OH)D with follow-up IGI/IR (ß = 0.005, P = 0.015) and ISSI-2 (ß = 0.002, P = 0.023) and a significant inverse association of baseline 25(OH)D with follow-up AUC(glucose) (ß = -0.001, P = 0.007). Progression to dysglycemia (impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes) occurred in 116 subjects. Logistic regression analyses indicated a significant reduced risk of progression with higher baseline 25(OH)D (adjusted odds ratio 0.69 [95% CI 0.53-0.89]), but this association was not significant after additional adjustment for baseline and change in BMI (0.78 [0.59-1.02]). CONCLUSIONS: Higher baseline 25(OH)D independently predicted better ß-cell function and lower AUC(glucose) at follow-up, supporting a potential role for vitamin D in type 2 diabetes etiology.

Impact of the Urban Zen Initiative on patients' experience of admission to an inpatient oncology floor: a mixed-methods analysis.

PURPOSE: The purpose of this study was to evaluate the impact of the Urban Zen Initiative, an "optimal healing environment" intervention, at Beth Israel Medical Center on both quantitative and qualitative measures of the experience of patients admitted for inpatient oncology care. MATERIALS AND METHODS: A quasi-experimental design was used comparing a baseline sample of patients admitted to the oncology floor before the intervention to a similar group admitted during the intervention. Data collected included the Profile of Mood States, the EuroQol-5D (EQ-5D), and, on a subset of patients, a semistructured qualitative interview. RESULTS: Patients in the intervention group experienced significantly less emotional distress during their stay when compared to patients in the baseline group. There were also significantly greater improvements in pain and discomfort during the stay in the treatment group as compared to controls. The qualitative analysis described a number of possible explanations for this change including increased sense of connection and control as well as specific techniques for symptom relief. CONCLUSIONS: It is possible to improve the experience of patients admitted for inpatient cancer care with a "healing environment" intervention. Further studies are needed that incorporate randomized design and the ability to examine specific components of the intervention independently as well as the impact of the intervention as a whole.

Association of 25(OH)D and PTH with metabolic syndrome and its traditional and nontraditional components.

CONTEXT: Emerging evidence suggests that 25-hydroxy vitamin D [25(OH)D] and PTH may play a role in the etiology of the metabolic syndrome (MetS). However, evidence to date is limited and inconsistent, and few studies have examined associations with nontraditional MetS components. OBJECTIVE: The objective of the study was to examine the association of vitamin D and PTH with MetS and its traditional and nontraditional components in a large multiethnic sample. DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional study, we examined 654 participants from London and Toronto, Ontario, Canada, aged 30 yr and older with risk factors for type 2 diabetes. MAIN OUTCOME MEASURES: Presence of MetS and its traditional and nontraditional components was measured. RESULTS: Approximately 43% of the study participants were classified as having MetS. Higher 25(OH)D was significantly associated with a reduced presence of MetS after adjustment for age, sex, season, ethnicity, supplement use, physical activity, and PTH (odds ratio 0.76, 95% confidence interval 0.62-0.93). PTH was not associated with the presence of MetS after multivariate adjustment. Multivariate linear regression analyses indicated significant adjusted inverse associations of 25(OH)D with waist circumference, triglyceride level, fasting insulin, and alanine transaminase (P < 0.041). Elevated PTH was positively associated with waist circumference and high-density lipoprotein cholesterol (P < 0.04). Other associations between PTH and MetS components were attenuated after adjustment for adiposity. CONCLUSIONS: Serum 25(OH)D, but not PTH, was significantly associated with MetS as well as a number of MetS components after multivariate adjustment. These results suggest that low 25(OH)D may play a role in the etiology of the MetS.

Association of vitamin D with insulin resistance and beta-cell dysfunction in subjects at risk for type 2 diabetes.

OBJECTIVE: To examine cross-sectional associations of serum vitamin D [25-hydroxyvitamin D, 25(OH)D] concentration with insulin resistance (IR) and beta-cell dysfunction in 712 subjects at risk for type 2 diabetes. RESEARCH DESIGN AND METHODS: Serum 25(OH)D was determined using a chemiluminescence immunoassay. Insulin sensitivity/resistance were measured using the Matsuda insulin sensitivity index for oral glucose tolerance tests (IS(OGTT)) and homeostasis model assessment of insulin resistance HOMA-IR. beta-Cell function was determined using both the insulinogenic index (IGI) divided by HOMA-IR (IGI/IR) and the insulin secretion sensitivity index-2 (ISSI-2). RESULTS Linear regression analyses indicated independent associations of 25(OH)D with IS(OGTT) and HOMA-IR (beta = 0.004, P = 0.0003, and beta = -0.003, P = 0.0072, respectively) and with IGI/IR and ISSI-2 (beta = 0.004, P = 0.0286, and beta = 0.003, P = 0.0011, respectively) after adjusting for sociodemographics, physical activity, supplement use, parathyroid hormone, and BMI. CONCLUSIONS: Vitamin D may play a role in the pathogenesis of type 2 diabetes, as 25(OH)D concentration was independently associated with both insulin sensitivity and beta-cell function among individuals at risk of type 2 diabetes.

Cultivar effect on Moringa oleifera glucosinolate content and taste: a pilot study.

Leaves of the tropical tree Moringa oleifera are widely promoted in areas of chronic malnutrition as nutritional supplements for weaning infants and nursing mothers. Adoption, in these circumstances may hinge upon taste, which can vary greatly amongst cultivars. It is widely assumed that this taste variation is primarily germplasm-dependent, and results from the breakdown of glucosinolates to isothiocyanates. Leaves of 30 accessions, grown at a single field plot, were sampled 3 times over the course of a year. Taste, assessed in a masked protocol, was not related to glucosinolate content of the leaves.

An integrated multi-institutional diabetes prevention program improves knowledge and healthy food acquisition in northwestern Ontario First Nations.

This article presents the impact results of a feasibility study in Canada for prevention of risk factors for diabetes in seven northwestern Ontario First Nations. Baseline and follow-up data were collected before and after the 9-month intervention program in schools, stores, and communities that aimed to improve diet and increase physical activity among adults. Regression analyses indicate a significant change in knowledge among respondents in intervention communities (p < .019). There was also a significant increase in frequency of healthy food acquisition among respondents in the intervention communities (p < .003). There were no significant changes in physical activity or body mass index in either intervention or comparison groups. The multi-institutional approach demonstrated promising results in modifying selected risk factors for diabetes First Nations communities.

Clinical trial to compare tinnitus masking and tinnitus retraining therapy.

CONCLUSION: Both tinnitus masking (TM) and tinnitus retraining therapy (TRT) can be effective therapies for amelioration of tinnitus. TM may be more effective for patients in the short term, but with continued treatment TRT may produce the greatest effects. OBJECTIVES: Although TM and TRT have been used for many years, research has not documented definitively the efficacy of these methods. The present study was a controlled clinical trial to prospectively evaluate the clinical efficacy of these two methods for US military veterans with severe tinnitus. SUBJECTS AND METHODS: Over 800 veterans were screened to ensure that enrolled patients had tinnitus of sufficient severity to justify 18 months of individualized treatment. Qualifying patients (n=123) were placed quasi-randomly (alternating placement) into treatment with either TM or TRT. Treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated primarily using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index). RESULTS: Findings are presented from the three written questionnaires with respect to three categories of patients: describing tinnitus as a 'moderate,' 'big,' and 'very big' problem at baseline. Based on effect sizes, both groups showed considerable improvement overall. In general, TM effects remained fairly constant over time while TRT effects improved incrementally. For the patients with a 'moderate' and 'big' problem, TM provided the greatest benefit at 3 and 6 months; benefit to these TRT patients was slightly greater at 12 months, and much greater at 18 months. For patients with a 'very big' problem, TM provided the greatest benefit at 3 months. For these latter patients, results were about the same between groups at 6 months, and improvement for TRT was much greater at 12 months, with further gains at 18 months.

The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinical study on children in the United States of America.

PURPOSE: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 5-17 yr-old children from the Central and South areas of Florida and from the Lares area of Puerto Rico. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. Two calibrated examiners performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. RESULTS: Two thousand five hundred six (2,506) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 2.29 for the Test Dentifrice group, and 2.47 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 0.69 for the Test Dentifrice group and 0.81 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 1.25 for the Test Dentifrice group, and 1.46 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 14.38% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.

The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinical study on children in Brazil.

PURPOSE: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 6-10 yr-old children from the metropolitan area of Maceio, Alagoas, Brazil. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. One calibrated examiner performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. RESULTS: Two thousand four hundred thirty-two (2,432) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 3.84 for the Test Dentifrice group, and 4.06 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 2.02 for the Test Dentifrice group and 2.12 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 4.30 for the Test Dentifrice group, and 4.83 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 10.97% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.

Intralesional injection of herpes simplex virus 1716 in metastatic melanoma.

We have previously shown that avirulent but replication-competent herpes simplex virus (HSV) 1716 causes cell death in human melanoma cell lines in vitro and selectively replicates in melanoma tissue in nude mice. We now present a pilot study of intratumoral injection of HSV1716 into subcutaneous nodules of metastatic melanoma in five patients with stage 4 melanoma. Two patients each received one injection, two received two injections, and one received four injections of 10(3) plaque-forming units HSV1716. In one patient, flattening of previously palpable tumour nodules was seen 21 days after two direct injections of HSV1716, and in injected nodules from all three patients who received two or more injections there was microscopic evidence of tumour necrosis. Immunohistochemical staining of injected nodules revealed evidence of virus replication confined to tumour cells. These findings suggest that HSV1716 is non-toxic and could be of therapeutic benefit in patients with metastatic melanoma.