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Biomedical subjects

J S Jacobson

Publications and source records attributed to J S Jacobson.

At least 19 recordsLinked to original sources

Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer.

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.

Antineoplastic Agents, Hormonal↗

Complementary and alternative medicine in prostate cancer.

Prostate cancer patients, like other cancer patients as well as the general population, are increasingly exploring the use of complementary and alternative medicine (CAM). This paper describes the use of CAM in this patient population and the evidence regarding some CAM treatments in the setting of prostate cancer. Some herbal agents and micronutrients have demonstrated biologic activity that may benefit patients with prostate cancer. The clinical effects of these and others and the potential interactions among CAM treatments and with conventional treatment remain an appropriate target for further investigation.

Complementary Therapies↗

Research on complementary/alternative medicine for patients with breast cancer: a review of the biomedical literature.

PURPOSE: This article reviews English-language articles published in the biomedical literature from 1980 to 1997 that reported results of clinical research on complementary and alternative medical treatments (CAM) of interest to patients with breast cancer. METHODS: We searched 12 electronic databases and the bibliographies of the retrieved papers, review articles, and books on CAM and breast cancer. The retrieved articles were grouped by end point: breast cancer (eg, tumor size, survival), disease-related symptoms, side effects of treatment, and immune function. Within each end point, we organized the articles by modality and assessed study design, findings, and qualitative aspects. RESULTS: Of the more than 1,000 citations retrieved, 51 fit our criteria for review. Of the articles reviewed, 17 were randomized clinical trials; three of these were trials of cancer-directed interventions, two of which involved the same treatment (melatonin). Seven articles described observational studies, and the remainder were reports of phase I or II trials. Relatively few CAM modalities reportedly used by many breast cancer patients were mentioned in articles retrieved by this process. Most articles had shortcomings. CONCLUSION: Although many studies had encouraging results, none showed definitively that a CAM treatment altered disease progression in patients with breast cancer. Several modalities seemed to improve other outcomes (eg, acupuncture for nausea, pressure treatments for lymphedema). If CAM studies are well-founded, well-designed, and meticulously conducted, and their hypotheses, methods, and results are reported clearly and candidly, research in this controversial area should acquire credibility both in the scientific community and among advocates of unconventional medicine.

Breast Neoplasms↗

Effects of a 6-month vitamin intervention on DNA damage in heavy smokers.

Because their formation is associated with tumor development in specific tissues, DNA adducts have potential usefulness as intermediate end points in chemoprevention studies. To determine the efficacy of a combination of antioxidant vitamins (vitamins C and E and beta-carotene), a randomized clinical trial was conducted among heavy smokers using DNA damage as the end point. Immunological methods were used to measure polycyclic aromatic hydrocarbon-DNA adducts and oxidative DNA damage (8-oxo or hydroxydeoxyguanosine) in mononuclear and oral cells. A total of 121 subjects were randomized to the 6-month intervention and received either vitamins or placebo. Dropout rates were higher in the placebo than in the vitamin group; 65% of subjects in the vitamin group, but only 47% in the placebo group, provided specimens at 6 months. Plasma levels of all three antioxidants rose significantly in the vitamin group but not in the placebo group. All four measures of DNA damage decreased in both groups; the between-group differences were not statistically significant. These data do not provide clear evidence that antioxidant vitamin intake prevents DNA damage. However, the study demonstrates that DNA damage is a useful end point in chemoprevention trials.

8-Hydroxy-2'-Deoxyguanosine↗

Benefits and costs of screening Ashkenazi Jewish women for BRCA1 and BRCA2.

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.

Adult↗

Research on complementary and alternative therapies for cancer: issues and methodological considerations.

Recent evidence suggests that at least one cancer patient in three uses some form of complementary and alternative medicine (CAM). We conducted a review of the published research on the efficacy of these treatments for breast cancer, which resulted in some observations about the current state of research and guidelines for future research. Although many of the papers reported encouraging results, the preponderance of phase I and II trials and other limitations precluded definitive conclusions about the efficacy of the treatments reported in these studies. A growing institutional base in this country has begun to facilitate improved research on CAM for cancer, yet many gaps remain. For example, there are no published reports of clinical trials or observational studies with survival endpoints for treatment agents used by many cancer patients. Clinical trials of a few CAM treatments are now in progress, but the results will not be available for several years. More complex and customized treatments may require innovative study designs and practitioner-investigator collaborations. Given the mounting evidence that CAM treatments are biologically active as well as widely used, CAM research may affect cancer outcomes.

Breast Neoplasms↗

Safety and costs of treating neutropenic fever in an outpatient setting.

PURPOSE: The purpose of this study is to analyze the safety of outpatient treatment for cancer patients with chemotherapy-induced neutropenic fever in a community hospital setting and to compare the costs of outpatient treatment with those of inpatient treatment for such patients. PATIENTS AND METHODS: We reviewed charts and charges for 32 consecutive patients initially treated for neutropenic fever with broad-spectrum antibiotics in the offices of Hematology/Oncology Associates (HOA) at the Bennett Cancer Center in the Stamford Hospital January 1997-June 1998. We also reviewed charts and charges for eight consecutive HOA patients with neutropenic fever who met the criteria for outpatient treatment but were initially hospitalized for other reasons during this period. We compared these two groups with respect to mean nadir absolute neutrophil count (ANC), mean number of days when ANC < 1,000 cells cu mm, and mean number of days of intravenous antibiotic treatment. We compared costs for ambulatory and hospital care of the two groups using Health Care Financing Administration (HCFA) payments in 1998 as a proxy for costs. RESULTS: Of 32 patients with neutropenic fever initially treated in the outpatient setting, only four required hospitalization. No patients in either group died in connection with neutropenic fever. Although outpatients received an average of 3.6 days and inpatients only 2.5 days of antibiotic treatment, outpatient treatment was significantly less costly than inpatient treatment. CONCLUSION: In a community hospital setting most cancer patients with neutropenic fever who meet certain criteria can be safely, effectively, and inexpensively treated as outpatients.

Ambulatory Care↗

Family history of colorectal adenomatous polyps and increased risk for colorectal cancer.

BACKGROUND: The risk for colorectal cancer among family members of patients with colorectal cancer is well established, but the risk among family members of patients with colorectal adenomas is less well established. OBJECTIVE: To examine the risk for colorectal cancer among first-degree relatives of patients with adenoma compared with that among first-degree relatives of controls without adenoma. DESIGN: Reconstructed cohort study. SETTING: Three university-based colonoscopy practices in New York City. PATIENTS: 1554 first-degree relatives of 244 patients with newly diagnosed adenomas and 2173 first-degree relatives of 362 endoscopically normal controls. MEASUREMENTS: Structured interviews were used to obtain family history. Adjusted relative risks (RR) were estimated from Cox proportional hazards regression models. RESULTS: The risk for colorectal cancer was elevated (RR, 1.74 [95% CI, 1.24 to 2.45]) among first-degree relatives of patients with newly diagnosed adenomas compared with the risk among first-degree relatives of controls. This increased risk was the same for parents (RR, 1.58 [CI, 1.07 to 2.34]) and siblings (RR, 1.58 [CI, 0.81 to 3.08]). First-degree relatives of patients with adenomas did not have elevated risk for other cancers. The risk for colorectal cancer among family members increased with decreasing age at diagnosis of adenoma in probands. Among first-degree relatives of patients who were 50 years of age or younger when the adenoma was diagnosed, the risk was more than four times greater (RR, 4.36 [CI, 2.24 to 8.51]) than that among first-degree relatives of patients who were older than 60 years of age when the adenoma was diagnosed. CONCLUSIONS: First-degree relatives of patients with newly diagnosed adenomas, particularly of patients who are 50 years of age or younger at diagnosis, are at increased risk for colorectal cancer and should undergo screening similar to that recommended for relatives of patients with colorectal cancer.

Adenomatous Polyposis Coli↗

The epidemiology of cancer of the small bowel.

Despite its anatomical location between two regions of high cancer risk, the small bowel rarely develops a malignant tumor. However, in recent years, small bowel cancer incidence rates have begun to rise. The purpose of this review is to explore the descriptive and analytic epidemiology of small bowel cancer for those factors that protect this organ and those factors associated with loss of this protection. Within the small intestine, the sites at the highest risk are the duodenum, for adenocarcinomas, and the ileum, for carcinoids and lymphomas. In industrialized countries, small bowel cancers are predominantly adenocarcinomas; in developing countries, lymphomas are much more common. The incidence of small bowel cancer rises with age and has generally been higher among males than among females. The risk factors for small bowel cancer include dietary factors similar to those implicated in large bowel cancer, cigarette smoking, alcohol intake, and other medical conditions, including Crohn's disease, familial adenomatous polyposis, cholecystectomy, peptic ulcer disease, and cystic fibrosis. The protective factors may include rapid cell turnover, a general absence of bacteria, an alkaline environment, and low levels of activating enzymes of precarcinogens. Adenocarcinomas of the small and large bowel are similar in risk factors and geographic distribution but not in recent time trends; colorectal cancer incidence rates in the United States have been falling since the mid-1980s. Small bowel lymphoma may be associated with infectious agents, such as HIV. Given the differences in anatomic and geographic location among histological subtypes, much may be learned from well-designed, histology-specific epidemiological and genetic studies of cancer of the small bowel.

Adenocarcinoma↗

Association between coronary heart disease and cancers of the breast, prostate, and colon.

Coronary heart disease (CHD) and cancers of the breast, prostate, and colon are more common in industrialized countries than in the developing world, and to some degree, these conditions appear to share risk factors. To investigate whether there is an association between these cancers and a prior history of CHD, a hospital-based case-control study was conducted at Columbia-Presbyterian Medical Center in New York. The study was based on 252 breast cancer cases, 256 colorectal cancer cases, and 322 benign surgical controls, all of whom underwent biopsy or surgery between January 1989 and December 1992, and on 319 prostate cancer cases and 189 benign prostatic hypertrophy controls diagnosed between January 1984 and December 1986 (prior to widespread use of prostate-specific antigen screening). Medical records were reviewed on each, focusing on the preoperative anesthesia and surgical clearances. No association was found between a history of CHD and breast or colorectal cancer, but an elevated risk was found for prostate cancer (odds ratio, 2.00; 95% confidence interval, 1.18-3.39), using unconditional logistic regression with adjustment for appropriate confounders. No association was found between cigarette smoking and any of the three cancers. Aspirin use was protective for colorectal cancer (odds ratio, 0.35; 95% confidence interval, 0.17-0.73) but had no association with breast or prostate cancer. The study suggests that individuals with CHD are at elevated risk for prostate cancer but not breast or colorectal cancer. Etiological risk factors associated with CHD should be investigated with regard to prostate cancer. Patients with CHD may represent a high-risk group for prostate cancer and potential future targets for prostate cancer screening interventions.

Aged↗

Prevalence and incidence of colorectal adenomas and cancer in asymptomatic persons.

The prevalence of colorectal adenomatous polyps varies widely from country to country and is highly correlated with colorectal cancer incidence rates in each country. The prevalence of adenomas reported in older studies was based on autopsy findings and is higher than that in more recent studies based on endoscopy findings. Among asymptomatic, average-risk patients, adenoma prevalence averages approximately 10% in sigmoidoscopy studies and more than 25% in colonoscopy studies, whereas the prevalence of colorectal cancer among these patients is less than 1%. The cumulative incidence of new adenomas within 3 years after normal endoscopy averages about 7% by flexible sigmoidoscopy and 27% by colonoscopy.

Adenoma↗

Recurrent adenomatous polyps and body mass index.

Interest in risk factors for the recurrence of adenomatous polyps derives from the use of recurrent adenomas as surrogate end points in longitudinal studies of invasive colorectal cancer. In this case-control study, the effect of increased body mass index (BMI) on the risk of recurrent adenomas was investigated. Subjects consisted of patients seen at three colonoscopy practices in New York City, all of whom had a previous history of adenomas. On index colonoscopy, recurrent cases had an adenoma, whereas controls were normal. Men and women were analyzed separately, with different logistic models developed using backward elimination from a full model containing the covariates age at diagnosis, age-at-highest-weight, pack-years of smoking, activity level, energy intake, and fat and fiber intake. Men in the upper quartiles of BMI were found to be at greater risk of recurrent adenomas. In a model which controlled for age at diagnosis, age-at-highest-weight, activity level, pack-years of smoking and kilocalories, the estimated odds ratios were 2.2, 1.9 and 1.9 respectively for the second, third and fourth quartiles compared to the first quartile. Only the estimate for the second quartile was found to be statistically significant. No effect was observed for women, even in a model which controlled for age at diagnosis, age-at-highest-weight, pack-years and total fat. Obesity may play a role in adenoma recurrence. Confirmation of this finding would have important implications for possible prevention strategies in the future.

Adenomatous Polyps↗

Epidemiology of gastrointestinal polyps.

Associations between polyps and cancer of the gastrointestinal tract have been fully documented for adenomatous polyps and cancer of the large bowel. The geographic, gender, and age distribution of colorectal adenomas parallels that of colorectal cancer incidence, and individuals with a history of adenomas are at increased risk for metachronous adenomas and cancer. Observational studies of risk factors for incident adenomas have found elevated risk associated with dietary variables including: high fat, low fiber, and low vegetable intake; family history; obesity; smoking; and other exposures, some of which also are associated with cancer. Dietary intervention trials with adenoma recurrence as an endpoint, however, have had little success. Screening with polypectomy has proved effective in reducing cancer incidence and may change the epidemiology of colorectal cancer.

Humans↗

Reproductive risk factors for colorectal adenomatous polyps (New York City, NY, United States).

Events of reproductive life, such as parity and age at menarche, have been found in some but not all studies to be associated with risk for colorectal cancer in females. Because adenomatous polyps (adenomas) are precursors of colorectal cancer, we investigated whether reproductive variables were associated with colorectal adenomas. We conducted a case-control study among patients examined in three colonoscopy practices in New York City (NY, United States) from 1986 to 1988. Adenoma cases (n = 128) were defined as women who had an adenoma detected at the index colonoscopy with no history of inflammatory bowel disease, adenomas, or cancer. Controls (n = 283) were women with a normal index colonoscopy and no history of inflammatory bowel disease, adenomas, or cancer. The adjusted odds ratio (OR) for the association of early menarche (age less than 13 years) with adenomas was 0.6 (95 percent confidence interval = 0.4-0.9). Parity, history of spontaneous or induced abortion, infertility, type of menopause, age at menopause, use of oral contraceptives, and use of menopausal hormone replacement therapy were not associated statistically significantly with adenoma risk, although some possible trends were observed. Our findings do not implicate reproductive events, nulliparity, or overexposure to estrogens or to menstrual cycles as mechanisms of increased risk for colorectal neoplasia.

Abortion, Spontaneous↗