© 2004 by Oxford University Press
© 2004 Oxford University Press
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In Brief
Aspirin Associated With Reduced Risk of Colorectal Adenomas
Regular aspirin use is associated with a reduced risk of colorectal adenomas, according to a new study.
The effect of regular aspirin use on cancer risk has been a subject of much study (see related news story, p. 252). For colorectal cancer, questions linger about the potential dose–response relationship of aspirin and colorectal adenomas and about whether aspirin can reduce the risk of colorectal adenomas in a low-risk population.
By examining data from the Nurses’ Health Study, Andrew T. Chan, M.D., of Massachusetts General Hospital, and colleagues found that regular aspirin use (two or more tablets per week) was associated with a 25% reduction in risk of adenoma compared with nonuse. The risk reduction was greatest—51%—among women who took 14 or more aspirin tablets per week. Results were similar among women who reported taking aspirin for 5 years or less compared with those who reported regular aspirin use for more than 5 years.
Editorialist Robert S. Sandler, M.D., of the University of North Carolina at Chapel Hill, noted that recommendations for taking aspirin should not be made on the basis of this observational study and that there are some possible side effects associated with regular aspirin use. "Until we have different or better information from randomized trials, aspirin use should be limited to persons at higher risk for adenomas ... and persons without a history of ulcer disease or hemorrhagic stroke."
The study was published in the February 3 issue of the Annals of Internal Medicine.
Cancer Patients Do Not Necessarily Fare Better in Clinical Trials, Study Suggests
There are not enough data available to conclude that cancer patients have better outcomes when treated in a clinical trial, a message commonly repeated in the oncology community.
This conclusion came from a recent analysis of 24 published comparisons of patients enrolled and not enrolled in clinical trials. Jeffrey M. Peppercorn, M.D., and Steven Joffe, M.D., of Dana-Farber Cancer Institute in Boston, and colleagues found that most comparisons were incomplete and subject to bias, and they overrepresented children with cancer, patients with hematologic cancers, and patients treated before 1986. Their analysis was published in the January 24 issue of Lancet.
The authors discussed four main areas that may have contributed to bias in the studies: An experimental treatment effect, in which the experimental treatment actually was better than the standard treatment, may have influenced the studies; treatment effect, such as differences in the way treatments were delivered, may have biased the studies; apparent improvements in outcomes may have resulted from differences in baseline characteristics of the patients; and the studies may have been subject to bias because of the way data were gathered.
"We believe that patients, professionals, and third-party payers can recognize the crucial function of clinical trials in advancing treatment, and that de-emphasizing direct benefits to patients need not compromise accrual or coverage," the authors concluded.
Randomization Not Well Understood in Pediatric Trials
In spite of the great success of clinical trials in improving treatments for childhood leukemia, the randomization process is still not well understood by many of the patients’ parents, a new study has found.
Federal regulations require that parents give informed consent for participation in a clinical trial before a child is randomly assigned to receive treatment. Whether the informed consent process leads to an understanding of randomization is not clear.
Eric Kodish, M.D., of Rainbow Babies and Children’s Hospital, Cleveland, and colleagues videotaped the informed consent conference of 137 parent participants in childhood leukemia clinical trials at six U.S. children’s hospitals. They then interviewed the parents after the conference.
The investigators found that randomization was explained by the physicians in 83% of the cases and a consent document was presented by the physicians in 95% of the conferences. Interviews after the conferences revealed that only 50% of the parents understood randomization. An understanding of the process was associated with conferences in which specific clinical trial details were discussed and in which a nurse was present.
The study was published in the January 28 issue of the Journal of the American Medical Association.
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