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Dose escalation of a curcuminoid formulation

BMC Complementary and Alternative Medicine 2006年第1期6卷 1-4页

作者： Lao, Christopher D. Ruffin IV, Mack T. Normolle, Daniel Heath, Dennis D. Murray, Sandra I. Bailey, Joanne M. Boggs, Martha E. Crowell, James Rock, Cheryl L. Brenner, Dean E. Division of Hematology-Oncology Department of Internal Medicine University of Michigan Ann Arbor MI 48109-0930 2150 CCGC United States Department of Family Medicine University of Michigan Ann Arbor MI 48109-0708 1018 Fuller St. United States Department of Biostatistics Core Cancer Center University of Michigan Ann Arbor MI 48109-0473 300 North Ingalls Bldg. United States Cancer Prevention and Control Program University of California San Diego La Jolla CA 92093-0901 9500 Gilman Drive United States Division of Cancer Prevention National Cancer Institute Bethesda MD 20892 9000 Rockville Pike United States Department of Family and Preventive Medicine University of California San Diego La Jolla CA 92093-0901 9500 Gilman Drive United States

Background: Curcumin is the major yellow pigment extracted from turmeric, a commonly-used spice in India and Southeast Asia that has broad anticarcinogenic and cancer chemopreventive potential. However, few systematic studies of curcumin's pharmacology and toxicology in humans have been performed. Methods: A dose escalation study was conducted to determine the maximum tolerated dose and safety of a single dose of standardized powder extract, uniformly milled curcumin (C³ Complex™ Sabinsa Corporation). Healthy volunteers were administered escalating doses from 500 to 12,000 Mg. Results: Seven of twenty-four subjects (30%) experienced only minimal toxicity that did not appear to be dose-related. No curcumin was detected in the serum of subjects administered 500, 1,000, 2,000, 4,000, 6,000 or 8,000 mg. Low levels of curcumin were detected in two subjects administered 10,000 or 12,000 mg. Conclusion: The tolerance of curcumin in high single oral doses appears to be excellent. Given that achieving systemic bioavailability of curcumin or its metabolites may not be essential for colorectal cancer chemoprevention, these findings warrant further investigation for its utility as a long-term chemopreventive agent. © 2006 Lao et al;licensee BioMed Central Ltd.

关键词： Curcumin Minimal Toxicity Poor Bioavailability Common Toxicity Criterion Version Single Dose Oral Administration

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Scale and shape issues in focused cluster power for count data

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International Journal of Health Geographics 2005年第3期4卷 8-8页

作者： Puett, Robin C. Lawson, Andrew B. Clark, Allan B. Aldrich, Tim E. Porter, Dwayne E. Feigley, Charles E. Hebert, James R. Department of Epidemiology and Biostatistics Arnold School of Public Health University of South Carolina Columbia SC United States Department of Environmental Health Sciences Arnold School of Public Health University of South Carolina Columbia SC United States School of Medicine Health Policy and Practice University of East Anglia East Anglia United Kingdom South Carolina Statewide Cancer Prevention and Control Program Hollings Cancer Center Medical University of South Carolina Charleston SC United States

Background: Interest in the development of statistical methods for disease cluster detection has experienced rapid growth in recent years. Evaluations of statistical power provide important information for the selection of an appropriate statistical method in environmentally-related disease cluster investigations. Published power evaluations have not yet addressed the use of models for focused cluster detection and have not fully investigated the issues of disease cluster scale and shape. As meteorological and other factors can impact the dispersion of environmental toxicants, it follows that environmental exposures and associated diseases can be dispersed in a variety of spatial patterns. This study simulates disease clusters in a variety of shapes and scales around a centrally located single pollution source. We evaluate the power of a range of focused cluster tests and generalized linear models to detect these various cluster shapes and scales for count data. Results: In general, the power of hypothesis tests and models to detect focused clusters improved when the test or model included parameters specific to the shape of cluster being examined (i.e. inclusion of a function for direction improved power of models to detect clustering with an angular effect). However, power to detect clusters where the risk peaked and then declined was limited. Conclusion: Findings from this investigation show sizeable changes in power according to the scale and shape of the cluster and the test or model applied. These findings demonstrate the importance of selecting a test or model with functions appropriate to detect the spatial pattern of the disease cluster. © 2005 Puett et al;licensee BioMed Central Ltd.

关键词： Power Evaluation Power Curve Pollution Dispersion Cluster Shape Disease Cluster

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Pilot study of treatment of Buruli ulcer with rifampin and dapsone

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International Journal of Infectious Diseases 2002年第1期6卷 60-65页

作者： Espey, David K. Djomand, Gaston Diomande, Idrissa Dosso, Mireille Saki, Mathieu Z. Kanga, Jean-Marie Spiegel, Richard A. Marston, Barbara J. Gorelkin, Leo Meyers, Wayne M. Portaels, Françoise Deming, Michael S. Horsburgh Jr, C.Robert International Health Program Office Centers for Disease Control and Prevention (CDC) AT United States Projet Retro-CI Abidjan Côte d'Ivoire Brazil Secteur Santé Rurale Daloa Brazil Ministere de la Santé et de la Protection Sociale Abidjan Côte d'Ivoire Brazil Service Dermatologie Centre Hospitalier Universitaire de Treichville Côte d'Ivoire Brazil Division of Bacterial and Mycotic Diseases and Scientific Resources Program National Center for Infectious Diseases AT United States Department of Medicine Emory University AT United States Armed Forces Institute of Pathology WA United States Institute of Tropical Medicine AT Belgium Department of Epidemiology and Biostatistics Boston University School of Public Health Boston MA United States Department of Epidemiology and Biostatistics Boston University MA 02118 715 Albany Street T-3E United States

Objective: Buruli ulcer disease (BU), caused by Mycobacterium ulcerans, is endemic in many regions of Africa and causes substantial physical disability. Surgical resection, currently the mainstay of clinical management of BU, is impractical in many endemic areas. Therefore, the study was undertaken to evaluate an antibiotic regimen for medical management of BU. Methods: A randomized, placebo-controlled pilot study of dapsone plus rifampin versus placebo was conducted. Results: Forty-one participants were recruited in a BU-endemic zone of Côte d'Ivoire. Thirty persons completed the 2-month trial: 15 were treated with placebo and 15 with dapsone and rifampin. On blinded evaluation of photographs of the ulcers, clinicians with experience examining BU judged that 82% of ulcers in the treatment group improved compared with 75% in the placebo group (P=0.51). The median change in ulcer size was a decrease of 14.0 cm² in the treatment group and a decrease of 2.5 cm² in the placebo group (P=0.02), but initial ulcer sizes were larger in the treatment group (median 26.2 cm²) compared with the placebo group (median 4.8 cm²) (P=0.04). Conclusions: Results of this study indicate that larger studies of antimycobacterial therapy of BU are warranted and can be successfully undertaken.

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An adjustment to the 1997 estimate for new prostate cancer cases†

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cancer 2000年第9期80卷 1810-1813页

作者： Phyllis A. Wingo Ph.D., M.S. Sarah Landis M.P.H. Lynn A.G. Ries M.S. Surveillance Research Department of Epidemiology and Surveillance Research American Cancer Society Atlanta Georgia Cancer Control Research Program Division of Cancer Prevention and Control National Cancer Institute Bethesda Maryland

In light of new information, the authors present and discuss a proposed adjustment to the American cancer Society's January 1997 estimate of prostate cancer incidence rates.

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cancer surveillance in the U.S.

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cancer 2000年第7期83卷 1282-1291页

作者： Judith Swan M.H.S. Phyllis Wingo Ph.D. Rosemarie Clive L.P.N. Dee West Ph.D. Daniel Miller M.D. Carol Hutchison C.T.R. Edward J. Sondik Ph.D. Brenda K. Edwards Ph.D. Cancer Surveillance Research Program Division of Cancer Control and Population Sciences National Cancer Institute Bethesda Maryland Department of Epidemiology and Surveillance Research American Cancer Society Atlanta Georgia Commission on Cancer American College of Surgeons Chicago Illinois Northern California Cancer Center Union City California National Program of Cancer Registries National Center for Chronic Disease Prevention and Health Promotion Centers for Disease Control and Prevention Atlanta Georgia Cancer Registry Children's Hospital Columbus Ohio National Center for Health Statistics Centers for Disease Control and Prevention Hyattsville Maryland

cancer-related services are consuming ever-increasing health resources; along with this trend, health care costs are rising. As health care planners, researchers, and policymakers formulate strategies to meet this challenge, they are looking to cancer registries and the health information system built around them as collectors of the most extensive information regarding cancer treatment in the U.S. Currently, there are multiple programs collecting and reporting data regarding cancer incidence, morbidity, mortality, and survival. This report profiles cancer surveillance efforts in the U.S. and describes the National Coordinating Council for cancer Surveillance, which was organized in 1995 to facilitate a collaborative approach among the organizations involved. cancer 1998;83:1282-1291. © 1998 American cancer Society.

关键词： cancer control cancer registry cancer surveillance registrar

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Prognosis among African-American women and white women with lymph node negative breast carcinoma†

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cancer 2000年第1期80卷 80-90页

作者： James J. Dignam Ph.D. Carol K. Redmond Sc.D. Bernard Fisher M.D. Joseph P. Costantino Dr.P.H. Brenda K. Edwards Ph.D. Department of Biostatistics and National Surgical Adjuvant Breast and Bowel Project Graduate School of Public Health University of Pittsburgh Pittsburgh Pennsylvania Department of Biometry and Epidemiology College of Medicine Medical University of South Carolina Charleston South Carolina Department of Surgery and Scientific Director's Office NSABP 914 Scaife Hall University of Pittsburgh Pittsburgh Pennsylvania Cancer Control Research Program Division of Cancer Prevention and Control National Cancer Institute Bethesda Maryland

BACKGROUND A disparity in breast carcinoma survival between African-American and white women has been noted over the past several decades. A major factor implicated in this disparity is stage of disease at diagnosis. In this study, survival and related endpoints were examined among African-American women and white women with lymph node negative breast carcinoma who participated in two randomized clinical trials of the National Surgical Adjuvant Breast and Bowel Project (NSABP). METHODS Patients from two studies, one conducted among patients with estrogen receptor (ER) negative tumors and the other among patients with ER positive tumors, were included. Study goals were to determine whether African-Americans and whites had comparable outcomes, accounting for ER status and differences in patient characteristics at diagnosis, and to determine whether treatment response was similar for African-Americans and whites. RESULTS Five-year survival rates were 83% for African-Americans and 85% for whites among ER negative patients, and 93% for African-Americans and 92% for whites among ER positive patients. Rates of disease free survival (DFS) (i.e., time to disease recurrence, second primary cancer, or death) were 71% for African-Americans and 74% for whites at 5 years among ER negative patients, and 81% for African-Americans and 80% for whites among ER positive patients. African-Americans tended to have less favorable baseline prognostic characteristics. Adjusted relative risk (RR) estimates indicated similar prognosis for African-Americans compared with whites for mortality (African-American/white RR = 1.02 with 95% confidence interval [CI], 0.66-1.56 among ER negative patients; RR = 1.14 with 95% CI, 0.84-1.54 among ER positive patients) and DFS (RR = 0.98 with 95% CI, 0.70-1.37 for ER negative patients; RR = 0.96 with 95% CI, 0.75-1.22 for ER positive patients). Estimated percent reductions in DFS events for patients receiving adjuvant therapy were 32% for ER negative Afric

关键词： Breast breast carcinoma race clinical trials hormone receptors adjuvant therapy

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Treatment options, selection, and satisfaction among african american and white men with prostate carcinoma in north carolina

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cancer 2000年第2期83卷 320-330页

作者： Wendy Demark-Wahnefried Ph.D. Joellen M. Schildkraut Ph.D. Christophe E. Iselin M.D. Elizabeth Conlisk Ph.D. Andrew Kavee M.A. Tim E. Aldrich Ph.D. Eugene J. Lengerich V.M.D., M.S. Philip J. Walther M.D., Ph.D. David F. Paulson M.D. Division of Urology Duke University Medical Center Durham North Carolina Program of Cancer Prevention Detection and Control Research Duke University Medical Center Durham North Carolina Office of Epidemiology North Carolina Division of Health Promotion Raleigh North Carolina Department of Epidemiology University of North Carolina at Chapel Hill Chapel Hill North Carolina Division of Epidemiology and Statistics University of Utah School of Medicine Salt Lake City Utah

BACKGROUND In the U.S., prostate carcinoma mortality is greatest among African Americans. In North Carolina, the state with the fourth largest population of African Americans, the prostate carcinoma mortality rate is 2.5 times greater among African Americans than among whites and is the highest reported rate for any state in the nation. To explore potential reasons for the racial differential in mortality, a study was undertaken to determine whether differences related to treatment existed between African American and white men who were diagnosed with prostate carcinoma during the period 1994-1995. METHODS Cases were selected from 16 institutions within a region comprising 63 contiguous counties where the overall population was >20% African American. A stratified design was employed to accrue subjects into groups of even size according to race and disease stage (n = 231). A telephone survey was conducted, which assessed treatment options discussed by patients with their physicians, treatment(s) received, factors influencing treatment, satisfaction with treatments discussed and options given, and sociodemographic information. RESULTS All measures related to treatment were consistently associated with stage at diagnosis ( P < 0.001) rather than other variables measured (i.e., race, age, income, comorbidity, education, and residential status). Furthermore, most subjects reported that their physicians presented several treatment options (65%), that they were satisfied with the options presented (90%), and that the physician was the most important factor influencing their treatment decision (57%). CONCLUSIONS These data suggest that African American and white men in North Carolina receive comparable treatment for prostate carcinoma. Therefore, efforts to reduce the racial disparity in mortality should be directed toward lessening the high incidence of later stage disease at diagnosis and exploring potential biologic differences that may increase the risk of more aggressi

关键词： Prostate prostatic neoplasms disease management patient satisfaction African Americans whites

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Predictors of mortality from kidney cancer in 332,547 men screened for the Multiple Risk Factor Intervention Trial

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cancer 2000年第11期79卷

作者： Steven S. Coughlin Ph.D. James D. Neaton Ph.D. Bryan Randall M.S. Anjana Sengupta Ph.D. Department of Biostatistics and Epidemiology School of Public Health and Tropical Medicine Tulane University New Orleans Louisiana Epidemiology and Statistics Branch Division of Cancer Prevention and Control Centers for Disease Control and Prevention Atlanta Georgia Division of Biostatistics School of Public Health University of Minnesota Minneapolis Minnesota Clinical Research Section Dartmouth-Hitchcock Medical Center Hanover New Hampshire

BACKGROUND The authors examined predictors of mortality from kidney cancer in 332,547 men who were screened as part of the Multiple Risk Factor Intervention Trial. METHODS The vital status of each member of this cohort was ascertained through 1990. Death certificates were obtained from state health departments and coded by a trained nosologist. Three hundred ninety-eight deaths due to kidney cancer occurred among the cohort of 332,547 men after an average of 16 years of follow-up. The authors used the Cox proportional hazards model to study the joint associations of age, race, income, blood pressure, cigarette smoking, and use of medication for diabetes with risk of death from kidney cancer. RESULTS The authors observed independent associations with age, cigarette smoking status (relative risk[RR] = 2.02; 95% confidence interval [CI], 1.65-2.48), and systolic blood pressure (relative risk [RR] = 1.12 for systolic blood pressure level 10 millimeters of mercury higher; 95% CI, 1.06-1.18).The authors obtained similar results when deaths that occurred during the first 5 years were excluded. CONCLUSIONS These findings add to the increasing body of evidence that cigarette smoking and blood pressure level are modifiable risk factors for kidney cancer in men. cancer 1997; 79:2171-7. © 1997 American cancer Society.

关键词： Kidney blood pressure diabetes kidney cancer smoking

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Mutual concurrent validity of the Child Health Questionnaire and the Health Utilities Index: An exploratory analysis using survivors of childhood cancer

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International Journal of cancer 2000年第S12期83卷

作者： Kathy Nixon Speechley Elizabeth Maunsell Marie Desmeules Dena Schanzer Jeanne M. Landgraf David H. Feeny Maru E. Barrera Departments of Pediatrics and of Epidemiology and Biostatistics University of Western Ontario and the Child Health Research Institute London Canada Department de Medecine Sociale et Preventive Université Laval Quebec Canada Cancer Bureau Laboratory Center for Disease Control Ottawa Canada Health Act Boston MA USA Faculty of Pharmacy and Pharmaceutical Sciences University of Alberta Edmonton Canada Department of Psychology and Hematology-Oncology Program Hospital for Sick Children Toronto Canada

Mutual concurrent validity of 2 generic measures of health-related quality of life (HRQL), the Child Health Questionnaire (CHQ) and the Health Utilities Index Mark 2 (HUI2) and HUI3, was assessed. Data were from 3 centers participating in a Canadian multi-center retrospective cohort study currently in progress to assess psycho-social and physical late effects in children surviving ≥5 years after cancer diagnosis between 1981 and 1990. Exploratory results are from 244 parent reports on HRQL in children <16 years old when studied. Spearman rank-order correlations between sub-scale scores for the CHQ and single-attribute utility scores for the corresponding attribute from the HUI2 and HUI3 were used. As predicted, the correlation between CHQ bodily pain and HUI2 and HUI3 pain was strong, 0.58 and 0.60, respectively, while correlations between CHQ physical functioning and HUI2 mobility and HUI3 ambulation were moderate, both 0.45. Correlations between CHQ mental health and HUI2 and HUI3 emotion were strong, 0.64 and 0.54, respectively, rather than moderate, as predicted. Both the CHQ general health scale and the general health single item were moderately correlated with the HUI2 and HUI3 global utility scores rather than weakly, as predicted (CHQ general health scale and HUI2 and HUI3 global utility were 0.43 and 0.44, respectively; CHQ general health single item and HUI2 and HUI3 global utility were 0.38 and 0.42, respectively). The CHQ and HUI, which are based on different methodologies (summative Likert scaling and utility analysis, respectively), appear to capture similar constructs in childhood cancer survivors. Int. J. cancer Suppl. 12:95–105, 1999. ©1999 Wiley-Liss, Inc.

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Ethnicity and variation in breast cancer incidence

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International Journal of cancer 1998年第3期73卷

作者： Louise A. Brinton Jacques Benichou Marilie D. Gammon Donna R. Brogan Ralph Coates Janet B. Schoenberg Division of Cancer Epidemiology and Genetics National Cancer Institute Bethesda MD USA University of Rouen Medical School Rouen France Division of Epidemiology Columbia University School of Public Health New York NY USA Department of Biostatistics Rollins School of Public Health Emory University Atlanta GA USA Division of Cancer Prevention and Control Centers for Disease Control and Prevention Atlanta GA USA Applied Cancer Epidemiology Program New Jersey Department of Health and Senior Services Trenton NJ USA

A breast cancer case–control study in Atlanta and 5 counties of central New Jersey involving interviews with 960 white and 281 black cases younger than 54 years of age enabled assessment of reasons for the varying incidence rates among these 2 ethnic groups. Of interest was why rates of breast cancer are higher among older white women, a trend that is reversed among very young women (<40 years). Calculation of the prevalence of exposure to classic and speculative risk factors and associated relative risks enabled derivation of population attributable risks (PARs) for the various combinations of age and ethnic groups. A higher PAR was derived for older (40–54 years) white (62%) than black (54%) women, which appeared to account for the observed difference in incidence between the 2 ethnic groups. Most of the difference in PARs between older whites and blacks was accounted for by whites having fewer births, later ages at first birth and slightly higher risks associated with reproductive and menstrual factors. Consideration of only well-established breast cancer risk factors showed a PAR among older whites of 57%, an estimate comparable to those previously published. Slightly higher overall PARs were derived when analyses considered several speculative but modifiable risk factors, including years of use of oral contraceptives, body size and alcohol consumption. Many of the analyses among younger women (20–39 years) were limited by available numbers, but it appeared that very little disease occurrence in young black women was associated with the factors studied. Int. J. cancer 73:349–355, 1997. Published 1997 Wiley-Liss, Inc.

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