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Publications and source records attributed to A I Neugut.
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PURPOSE: Most breast cancer survivors experience hot flashes; many use complementary or alternative remedies for these symptoms. We undertook a randomized clinical trial of black cohosh, a widely used herbal remedy for menopausal symptoms, among breast cancer patients. PATIENTS AND METHODS: Patients diagnosed with breast cancer who had completed their primary treatment were randomly assigned to black cohosh or placebo, stratified on tamoxifen use. At enrollment, patients completed a questionnaire about demographic factors and menopausal symptoms. Before starting to take the pills and at 30 and 60 days, they completed a 4-day hot flash diary. At the final visit, they completed another menopausal symptom questionnaire. Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels were measured in a subset of patients at the first and final visits. RESULTS: Of 85 patients (59 on tamoxifen, 26 not on tamoxifen) enrolled in the study, 42 were assigned to treatment and 43 were assigned to placebo; 69 completed all three hot flash diaries. Both treatment and placebo groups reported declines in number and intensity of hot flashes; the differences between the groups were not statistically significant. Both groups also reported improvements in menopausal symptoms that were, for the most part, not significantly different. Changes in blood levels of FSH and LH also did not differ in the two groups. CONCLUSION: Black cohosh was not significantly more efficacious than placebo against most menopausal symptoms, including number and intensity of hot flashes. Our study illustrates the feasibility and value of standard clinical trial methodology in assessing the efficacy and safety of herbal agents.
BACKGROUND: Although adenomatous polyps have been established clearly as precursor lesions for most cases of colorectal cancer, the role, if any, of hyperplastic polyps remains uncertain. The aim of the current study was to determine whether a patient with an index finding of hyperplastic polyp on colonoscopy is at increased risk for adenomatous polyps. METHODS: We conducted a retrospective cohort study using the records of a single surgeon's colonoscopic experience over a 20-year period (June 1973 to December 1994). Patients found to have hyperplastic lesions on index colonoscopy were compared with those who had "clean" index colonoscopies. The two groups were compared for the subsequent diagnosis of adenomatous polyps on follow-up colonoscopies. Those with cancer or adenomas at index colonoscopy or in their history were excluded. We used Cox proportional hazard modeling with subsequent adenoma or cancer diagnosis at follow-up colonoscopy as the outcome, controlling for age and gender. RESULTS: We identified 42 patients for whom hyperplastic polyps were the only colorectal neoplasms found on the index examination, in contrast to 362 control patients who had a "clean" index examination. In this cohort study, patients found to have only hyperplastic polyps on initial examination had a rate of subsequent adenoma diagnoses (42%) twice that of patients with a clean initial colonoscopy (21%). Mean follow-up time was 4.3 years. The relative rate ratio was 2.0 (95% confidence interval, 1.2-3.4). CONCLUSIONS: This study suggests that patients found to have hyperplastic polyps on initial colonoscopic examination may have twice the risk of adenomas on follow-up colonoscopy, as compared with those who have clean initial examinations. If this finding is borne out in larger prospective studies, surveillance strategies may need to be modified accordingly.
BACKGROUND: The authors used propensity score adjustment to investigate the impact of intensive screening on stage of breast carcinoma at diagnosis in women who were at elevated risk for breast carcinoma. METHODS: The authors compared 58 women participating in a surveillance program at the Columbia Presbyterian Medical Center of New York Presbyterian Hospital who developed breast carcinoma with 3022 nonparticipating breast carcinoma patients. A propensity score was constructed for each woman by using important background covariates, and multivariable regression modeling was used to estimate the association of program membership with disease stage after adjusting for the propensity score. RESULTS: Before propensity score adjustment, nine baseline covariates significantly differed between the two groups (number of pregnancies, number of births, age at first delivery, race, how the tumor was discovered, history of prior breast disease, breast carcinoma in mother, breast carcinoma in maternal aunt, and breast carcinoma in sister), and there was a significant difference in stage at diagnosis. After adjustment, no significant differences remained. Program participants were more likely to have lower stage tumors at diagnosis than nonparticipants, but this association did not reach statistical significance (odds ratio, 1.52; 95% confidence interval, 0.94--2.46). CONCLUSIONS: Propensity score methods can remove bias in treatment comparisons in observational studies. An intensive surveillance program at a major cancer center may have had some effect on improving stage at diagnosis, but this effect was not statistically significant.
BACKGROUND: Anaphylaxis is a severe, life-threatening allergic reaction that affects both children and adults in the United States. However, data regarding the incidence and prevalence of anaphylaxis and the number of deaths caused by it are limited. OBJECTIVE: To provide a better understanding of the magnitude of the problem of anaphylaxis in the United States. METHODS: A thorough review of the current medical literature was conducted to obtain prevalence estimates on each of the 4 major subtypes of anaphylaxis (food, drugs, latex, and insect stings). We calculated an overall estimate of the risk of anaphylaxis by using only estimates that are specifically derived from epidemiologic studies measuring anaphylaxis in the general population. RESULTS: Known rates or cases of anaphylaxis were 0.0004% for food, 0.7% to 10% for penicillin, 0. 22% to 1% for radiocontrast media, and 0.5% to 5% after insect stings. There were 220 cases after latex exposure. Considering the 1999 US population of 272 million, the population at risk for anaphylaxis from food is 1099, from penicillin is 1.9 million to 27. 2 million, from radiocontrast media is 22 000 to 100 000, from latex is 220, and from insect stings is 1.36 million to 13.6 million. These calculations yield a total of 3.29 million to 40.9 million individuals at risk of anaphylaxis. CONCLUSION: The occurrence of anaphylaxis in the US is not as rare as is generally believed. On the basis of our figures, the problem of anaphylaxis may, in fact, affect 1.21% to 15.04% of the US population.
A sample of 115 urban, working-class, predominantly minority men and women was interviewed by telephone to assess knowledge, beliefs, and barriers relevant to colorectal cancer (CRC) and CRC screening. More than half (53.9%) were unable to name a CRC screening test. Misconceptions were common. Dispelling inaccurate beliefs, establishing an individual's preference for fecal occult blood tests or flexible sigmoidoscopy, and helping individuals take a proactive role in the receipt of CRC screening are important goals for health education efforts aimed at increasing rates of CRC screening. Participants' willingness to engage in detailed telephone conversations about CRC and CRC screening was encouraging.
OBJECTIVE: The clinical spectrum of adults with celiac disease in the United States, where the disease is considered rare, is not known. We sought this information by distributing a survey. METHODS: A questionnaire was distributed by way of a celiac newsletter, directly to celiac support groups, and through the Internet. RESULTS: Respondents (1,612) were from all United States except one. Seventy-five percent (1,138) were biopsy proven. Women predominated (2.9:1). The majority of respondents were diagnosed in their fourth to sixth decades. Symptoms were present a mean of 11 yr before diagnosis. Diarrhea was present in 85%. Diagnosis was considered prompt by only 52% and 31% had consulted two or more gastroenterologists. Improved quality of life after diagnosis was reported by 77%. Those diagnosed at age > or = 60 yr also reported improved quality of life. Five respondents had small intestinal malignancies (carcinoma 2, lymphoma 3) accounting for a relative risk of 300 (60-876) for the development of lymphoma and 67 (7-240) for adenocarcinoma. CONCLUSIONS: Patients with celiac disease in the United States have a long duration of symptoms and consider their diagnosis delayed. Improved quality of life after diagnosis is common. An increased risk of developing small intestine malignancies is present.
Rates of lung cancer in American men have greatly exceeded those in Japanese men for several decades despite the higher smoking prevalence in Japanese men. It is not known whether the relative risk of lung cancer associated with cigarette smoking is lower in Japanese men than American men and whether these risks vary by the amount and duration of smoking. To estimate smoking-specific relative risks for lung cancer in men, a multicentric case-control study was carried out in New York City, Washington, DC, and Nagoya, Japan from 1992 to 1998. A total of 371 cases and 373 age-matched controls were interviewed in United States hospitals and 410 cases and 252 hospital controls in Japanese hospitals; 411 Japanese age-matched healthy controls were also randomly selected from electoral rolls. The odds ratio (OR) for lung cancer in current United States smokers relative to nonsmokers was 40.4 [95% confidence interval (CI) = 21.8-79.6], which was >10 times higher than the OR of 3.5 for current smokers in Japanese relative to hospital controls (95% CI = 1.6-7.5) and six times higher than in Japanese relative to community controls (OR = 6.3; 95% CI = 3.7-10.9). There were no substantial differences in the mean number of years of smoking or average daily number of cigarettes smoked between United States and Japanese cases or between United States and Japanese controls, but American cases began smoking on average 2.5 years earlier than Japanese cases. The risk of lung cancer associated with cigarette smoking was substantially higher in United States than in Japanese males, consistent with population-based statistics on smoking prevalence and lung cancer incidence. Possible explanations for this difference in risk include a more toxic cigarette formulation of American manufactured cigarettes as evidenced by higher concentrations of tobacco-specific nitrosamines in both tobacco and mainstream smoke, the much wider use of activated charcoal in the filters of Japanese than in American cigarettes, as well as documented differences in genetic susceptibility and lifestyle factors other than smoking.
CONTEXT: A relative paucity of data exist on the possible health effects of using cellular telephones. OBJECTIVE: To test the hypothesis that using handheld cellular telephones is related to the risk of primary brain cancer. DESIGN AND SETTING: Case-control study conducted in 5 US academic medical centers between 1994 and 1998 using a structured questionnaire. PATIENTS: A total of 469 men and women aged 18 to 80 years with primary brain cancer and 422 matched controls without brain cancer. MAIN OUTCOME MEASURE: Risk of brain cancer compared by use of handheld cellular telephones, in hours per month and years of use. RESULTS: The median monthly hours of use were 2.5 for cases and 2.2 for controls. Compared with patients who never used handheld cellular telephones, the multivariate odds ratio (OR) associated with regular past or current use was 0.85 (95% confidence interval [CI], 0.6-1.2). The OR for infrequent users (<0. 72 h/mo) was 1.0 (95% CI, 0.5-2.0) and for frequent users (>10.1 h/mo) was 0.7 (95% CI, 0.3-1.4). The mean duration of use was 2.8 years for cases and 2.7 years for controls; no association with brain cancer was observed according to duration of use (P =.54). In cases, cerebral tumors occurred more frequently on the same side of the head where cellular telephones had been used (26 vs 15 cases; P =.06), but in the cases with temporal lobe cancer a greater proportion of tumors occurred in the contralateral than ipsilateral side (9 vs 5 cases; P =.33). The OR was less than 1.0 for all histologic categories of brain cancer except for uncommon neuroepitheliomatous cancers (OR, 2.1; 95% CI, 0.9-4.7). CONCLUSIONS: Our data suggest that use of handheld cellular telephones is not associated with risk of brain cancer, but further studies are needed to account for longer induction periods, especially for slow-growing tumors with neuronal features.
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When a risk factor influences the intermediary but not progression to the endpoint, it has been shown that the relative risk estimate for the causal intermediate is identical to that for the endpoint under a single pathway framework. When there are multiple pathways, the relative risk estimate for the endpoint is reduced. The authors examine how the reduction of the effect size from a risk factor's association with the causal intermediate to that with the endpoint relates to the proportion of endpoint cases arising through other pathways, and the measure of effect used. For multiple pathways, all measures of effect are reduced and the reduction increases as the proportion of endpoint cases arising through other pathways increases. For single pathways, the relative rate ratio and odds ratios are reduced. In particular, the reduction in the odds ratio may be dramatic because of the commonness of causal intermediates relative to the endpoint. Comparisons of causal intermediate studies with those for the endpoint should consider the influences of multiple pathways, the prevalence of the causal intermediate, the measure of effect used, and the multiple effects a risk factor may have along the pathway when interpreting the differences observed across the causal chain.
INTRODUCTION: Effective preventive services are needed most in underserved, inner-city settings that suffer disproportionately from morbidity and mortality. Primary care physicians can play an important role in the provision of efficacious cancer prevention and screening services to patients in these communities. METHOD: We surveyed 122 primary care physicians about their cancer prevention and screening knowledge, attitudes, and practices. RESULTS: Relative to the findings from national and local surveys, sample physicians were not as knowledgeable about national guidelines for preventive care, were less likely to counsel on smoking cessation, and were less likely to advise diet modification. Although physician practices reflected national cancer prevention and screening guidelines in general, a significant proportion of physicians suggested lung and prostate cancer screening tests that were inconsistent with national recommendations. CONCLUSIONS: Systematic efforts are needed to increase the knowledge and practices of inner-city physicians concerning cancer prevention and screening.
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INTRODUCTION: Although some have suggested that certain vitamins or calcium supplements may reduce adenoma recurrence, our own prior retrospective study found no such effects. The purpose of this case-control study was to further investigate whether regular vitamin or calcium supplement intake influenced the incidence of recurrent adenomatous polyps in patients with previous neoplasia who were undergoing follow-up colonoscopy. METHODS: This study enrolled 1,162 patients who underwent colonoscopy by one of three surgeons at Columbia-Presbyterian Medical Center in New York City between March 1993 and February 1997. Of these patients 448 (250 males) had a previous diagnosis of colorectal neoplasia (cancer, adenomas, or dysplasia). Of these, 183 (40.8 percent) had an adenoma at the index colonoscopy. Information was collected on personal and family history of colonic diseases, cigarette smoking, medication, and vitamin and micronutrient supplement usage on a questionnaire that was completed by the patients before the colonoscopy. Odds ratios were obtained by unconditional logistic regression analysis, adjusting for age and gender, and used adenoma recurrence at index colonoscopy as the outcome. RESULTS: The mean interval between colonoscopic examinations was 37 months for the recurrent adenoma group and 38 months for the nonrecurrent group of patients (P = not significant). In this case-control study we found a protective effect for the use of vitamin supplements in general (any vitamin) on the recurrence of adenomas (odds ratio, 0.41; 95 percent confidence interval, 0.27-0.61). Specifically, this protective effect was observed for the use of multivitamins (odds ratio, 0.47; 95 percent confidence interval, 0.31-0.72), vitamin E (odds ratio, 0.62; 95 percent confidence interval, 0.39-0.98), and for calcium supplementation (odds ratio, 0.51; 95 percent confidence interval, 0.27-0.96). Nonsignificant protective effects were noted for carotene/vitamin A, vitamin D, and vitamin C. CONCLUSIONS: The use of multivitamins, vitamin E, and calcium supplements were found to be associated with a lower incidence of recurrent adenomas in a population of patients with history of previous colonic neoplasia. Prospective, randomized trials are needed to better assess the impact of these agents and to determine whether the use of these supplements is associated with a protective effect against recurrent adenomas.
OBJECTIVE: Little is known regarding risk factors for biliary tract cancer, i.e., gallbladder carcinoma and extrahepatic bile duct carcinoma. This is the first case-control study conducted in the U.S. regarding risk factors for these cancers. METHODS: In this hospital-based case-control study, we reviewed the medical records of 69 patients with primary biliary tract cancer who were admitted to Columbia-Presbyterian Medical Center for surgery between January 1, 1980, and April 4, 1994, and of 138 controls, consisting of patients admitted for surgery for benign conditions. RESULTS: We found a significant association between cholelithiasis and biliary tract cancers (odds ratio, 19.5; 95% confidence interval, 6.4-59.4). Risk factors associated with gallbladder cancer included female gender, age, cigarette smoking, and postmenopausal status in women. Risk factors associated with extrahepatic bile duct cancer included history of cholecystectomy and hysterectomy in women. CONCLUSION: The risk factors for biliary tract cancers that have been identified in our study delineate a high-risk population, which in the future may be targeted for preventive measures.
OBJECTIVE: Cancers of the biliary tract, including cancers of the gallbladder and bile duct, generally carry a very poor prognosis. Little is known about their etiology. The pattern of co-occurrence of two cancers may give clues to shared etiological risk factors. We therefore investigated the association of biliary tract cancer with other cancers, especially with estrogen- and tobacco-related cancers. METHODS: We used data from the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute. Associations between biliary tract cancer and other cancers were evaluated using the standardized incidence ratio as an estimate of the relative risk of a second primary malignancy. RESULTS: Estrogen-related cancers of the breast and uterine corpus and smoking-related upper aerodigestive tract cancers were not associated with biliary tract cancer. The risk of gallbladder cancer was inversely related to the risk of prostate cancer in men, but positively related to the risk of cervical cancer in women. CONCLUSIONS: This study suggests that smoking and estrogen exposure have minimal roles in the pathogenesis of biliary tract cancer. Our finding of an inverse relationship between prostate cancer and gallbladder cancer requires confirmation by further studies.
PURPOSE: To determine the survival benefit and cost-effectiveness of screening Ashkenazi Jewish women for three specific BRCA1/2 gene mutations. METHODS: We used a Markov model and Monte Carlo analysis to estimate the survival benefit and cost-effectiveness of screening for three specific mutations in a population in which their prevalence is 2.5% and the associated cancer risks are 56% for breast cancer and 16% for ovarian cancer. We assumed that the sensitivity and specificity of the test were 98% and 99%, respectively, that bilateral prophylactic oophorectomy would reduce ovarian cancer risk by 45%, and that bilateral prophylactic mastectomy would reduce breast cancer risk by 90%. We used Medicare payment data for treatment costs and Surveillance, Epidemiology, and End Results data for cancer survival. RESULTS: Our model suggests that genetic screening of this population could prolong average nondiscounted survival by 38 days (95% probability interval, 22 to 57 days) for combined surgery, 33 days (95% probability interval, 18 to 43 days) for mastectomy, 11 days (95% probability interval, 4 to 25 days) for oophorectomy, and 6 days (95% probability interval, 3 to 8 days) for surveillance. The respective cost-effectiveness ratios per life-year saved, with a discount rate of 3%, are $20,717, $29,970, $72,780, and $134,273. CONCLUSION: In this Ashkenazi Jewish population, with a high prevalence of BRCA1/2 mutations, genetic screening may significantly increase average survival and, depending on costs and screening/treatment strategies, may be cost-effective by the standards of accepted cancer screening tests. According to our model, screening is cost-effective only if all women who test positive undergo prophylactic surgery. These estimates require confirmation through prospective observational studies and clinical trials.