Short-term acetylsalicylic acid (aspirin) use for pain, fever, or colds - Gastrointestinal adverse effects: A meta-analysis of randomized clinical trials

Background and Aim: Acetylsalicylic acid (ASA [aspirin]) is a commonly used over-the-counter drug for the treatment of pain, fever, or colds, but data on the safety of this use are very limited. The aim of this study was to provide data on the safety of this treatment pattern, which is of interest to clinicians, regulators, and the public. Methods: A meta-analysis of individual patient data from 67 studies sponsored by Bayer HealthCare was completed. The primary endpoints were patient-reported gastrointestinal (GI) adverse events (AEs); the secondary endpoints were the incidence of patient-reported non-GI AEs. Event incidence and odds ratios (ORs) based on Cochran-Mantel-Haenszel estimates are reported. In total, 6181 patients were treated with ASA, 3515 with placebo, 1145 with acetaminophen (paracetamol), and 754 with ibuprofen. Exposure to ASA was short term (82.5% of patients had a single dose). Results: GI AEs were more frequent with ASA (9.9%) than with placebo (9.0%) [OR 1.3; 95% CI 1.1, 1.5]. Dyspeptic symptoms were infrequent (4.6% in placebo subjects). The ORs for ASA were 1.3 (95% CI 1.1, 1.6) versus placebo; 1.55 (95% CI 0.7, 3.3) versus ibuprofen; and 1.04 (95% CI 0.8, 1.4) versus acetaminophen. There were very few serious GI AEs (one ASA case; three placebo cases). No differences were found for non-GI AEs and no cases of cerebral hemorrhage were reported. Conclusion: Short-term, mostly single-dose exposure to ASA for the treatment of pain, fever, or colds was associated with a small but significant increase in the risk of dyspepsia relative to placebo.No serious GI complications were reported

Design of an epidemiologic study of drinking water arsenic exposure and skin and bladder cancer risk in a U.S. population

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/155818/1/Karagas_et_al_1998_Design_of_an_epidemiologic.pd

Gastrointestinal adverse effects of short-term aspirin use: A meta-analysis of published randomized controlled trials

Background and Objectives: Aspirin is widely used for short-term treatment of pain, fever or colds, but there are only limited data regarding the safety of this use. To summarize the available data on this topic, we conducted a meta-analysis of the published clinical trial literature regarding the gastrointestinal adverse effects of short-term use of aspirin in comparison with placebo and other medications commonly used for the same purpose. Data Sources and Methods: An extensive literature search identified 119,310 articles regarding possible adverse effects of aspirin, among which 23,131 appeared to possibly include relevant data. An automated text-mining procedure was used to score the references for potential relevance for the meta-analysis. The 3,983 highest-scoring articles were reviewed individually to identify those with data that could be included in this analysis. Ultimately, 78 relevant articles were identified that contained gastrointestinal adverse event data from clinical trials of aspirin versus placebo or an active comparator. Odds ratios (ORs) computed using a Mantel–Haenszel estimator were used to summarize the comparative effects on dyspepsia, nausea/vomiting, and abdominal pain, considered separately and also aggregated as ‘minor gastrointestinal events’. Gastrointestinal bleeds, ulcers, and perforations were also investigated. Results: Data were obtained regarding 19,829 subjects (34 % treated with aspirin, 17 % placebo, and 49 % an active comparator). About half of the aspirin subjects took a single dose. Aspirin was associated with a higher risk of minor gastrointestinal events than placebo or active comparators: the summary ORs were 1.46 (95 % confidence interval [CI] 1.15–1.86) and 1.81 (95 % CI 1.61–2.04), respectively. Ulcers, perforation, and serious bleeding were not seen after use of aspirin or any of the other interventions. Conclusions: During short-term use, aspirin is associated with a higher frequency of gastrointestinal complaints than other medications commonly used for treatment of pain, colds, and fever. Serious adverse events were not observed with aspirin or any of the comparators. Electronic supplementary material: The online version of this article (doi:10.1007/s40268-013-0011-y) contains supplementary material, which is available to authorized users

An integrated electronic health record-based workflow to improve management of colonoscopy-generated pathology results

Purpose: Managing and communicating colonoscopy-generated pathology results and appropriate follow-up recommendations can be challenging. To improve this process, we developed and implemented a standardized electronic health record-based intervention with built-in decision support. Methods: Fourteen attending endoscopists performed enough colonoscopies to qualify for the study. For each, we randomly sampled and abstracted data from 35 colonoscopies that met prespecified inclusion criteria during both the pre-intervention and also post-intervention periods. Follow-up recommendations were compared to guidelines. We used the Wilcoxon Signed Rank Test to assess the change in the proportion of cases with guideline-concordant results, the proportion with a documented follow-up result letter, and the median time to letter completion. A brief survey assessed endoscopists’ satisfaction with the intervention. Results: In total, 1,947 colonoscopies were extracted, of which 968 met inclusion criteria. The proportion of follow-up recommendations that were guideline concordant increased from a median of 82.9% pre-intervention to 85.7% post-intervention (P=0.72). The proportion of observations with a documented follow-up result letter increased from a median of 88.9% pre-intervention to 97.1% post-intervention (P=0.07). The number of calendar days between the date of the colonoscopy and the date the letter was sent decreased from a median of 7.7 days pre-intervention to 6.8 days post-intervention (P=0.79). Eighty-six percentage of endoscopists were either “very satisfied” or “satisfied” with the overall process. Conclusion: The intervention was not associated with a statistically significant increase in guideline-concordant recommendations or efficiency measures, perhaps due to high baseline performance. The intervention was well received by endoscopists and captured data necessary for important downstream processes

Racial Disparities in Incidence of Young-Onset Colorectal Cancer and Patient Survival

Background & Aims: Increasing rates of young-onset colorectal cancer (CRC) have attracted substantial research and media attention, but we know little about racial disparities among younger adults with CRC. We examined racial disparities in young-onset CRC by comparing CRC incidence and relative survival among younger (<50-year-old) adults in 2 time periods. Methods: Using data from the Surveillance, Epidemiology, and End Results program of cancer registries, we estimated CRC incidence rates (per 100,000 persons 20–49 years old) from 1992 through 2014 for different periods (1992–1996 vs 2010–2014) and races (white vs black). Relative survival was calculated as the ratio of observed survival to expected survival in a comparable cancer-free population. Results: From 1992–1996 to 2010–2014, CRC incidence increased from 7.5 to 11.0 per 100,000 in white individuals and from 11.7 to 12.7 per 100,000 in black individuals. The increase in rectal cancer was larger in whites (from 2.7 to 4.5 per 100,000) than in blacks (from 3.4 to 4.0 per 100,000); in the 2010–2014 period, blacks and whites had similar rates of rectal cancer. Compared with whites, blacks had smaller increases in relative survival with proximal colon cancer but larger increases in survival with rectal cancer (from 55.3% to 70.8%). Conclusion: In an analysis of the Surveillance, Epidemiology, and End Results database, we found racial disparities in incidence of young-onset CRC and patient survival for cancer of the colon but minimal difference for rectal cancer. Well-documented and recent increases in young-onset CRC have largely been due to increases in rectal cancer, especially in whites

Cigarette smoking and estrogen-related cancer

Cigarette smoking is a known cause of many cancers, yet epidemiologic studies have found protective associations with the risk of four “estrogen-related” malignancies: endometrial cancer, endometrioid and clear cell ovarian cancers, and thyroid cancer. This review considers epidemiologic and biological aspects of these associations, focusing particularly on estrogen signaling, and contrasts them with those for breast cancer, another estrogen-related malignancy. The observational findings regarding the inverse associations are consistent and remain after adjustment for possible confounding factors. In general, women who smoke do not have lower circulating estrogen levels than nonsmokers, eliminating one possible explanation for reduced risks of these malignancies. For endometrial and endometrioid ovarian cancer, the negative associations could plausibly be explained by interference with signaling through the estrogen receptor α. However, this is unlikely to explain the lower risks of thyroid and clear cell ovarian cancers. For thyroid cancer, an anti-inflammatory effect of nicotine and reduced TSH levels from smoking have been proposed explanations for the inverse association, but both lack convincing evidence. While the overall impact of cigarette smoking is overwhelmingly negative, protective associations such as those discussed here can provide potential clues to disease etiology, treatment, and prevention

Moving from immune phenotyping of colorectal cancer to mechanistic insights on aspirin use

Colorectal cancer is the third most common cancer in men and women in the US, with over 95,000 new cases expected in 2016. Many preclinical, epidemiological, and clinical studies have shown that regular aspirin (acetylsalicylic acid) use, even in low-doses, prevents the development of colorectal neoplasia. In 2015, the US Preventative Services Task Force acknowledged the value of low-dose aspirin in primary prevention of colorectal cancer in adults aged 50–59 years. Despite this wealth of evidence, how aspirin reduces colorectal cancer risk is not fully understood. Many mechanisms have been proposed, but the most commonly cited is aspirin’s inhibition of PTGS2 (COX-2), a known mediator of inflammation and immunosuppression that is overexpressed in many colorectal neoplasms

Decrease in Incidence of Young-Onset Colorectal Cancer Before Recent Increase

The increasing incidence of colorectal cancer in younger adults (aged <50 years) has been widely reported. Using data from the Surveillance, Epidemiology, and End Results Program, we found young-onset colorectal cancer incidence rates decreased from 1975 through about 1990. Decreases were more prominent in the colon, a contrast with more recent increases in rectal cancer. Incidence rates subsequently increased, differing by time period and 5-year age group. This inflection point is consistent with a birth cohort effect and points to early life exposures—accumulated throughout the life course—that may increase cancer risk. Studying early life exposures among persons born after 1960 may advance our understanding of colorectal cancer in younger adults

Unitarized Chiral Perturbation Theory in a finite volume: scalar meson sector

We develop a scheme for the extraction of the properties of the scalar mesons f0(600), f0(980), and a0(980) from lattice QCD data. This scheme is based on a two-channel chiral unitary approach with fully relativistic propagators in a finite volume. In order to discuss the feasibility of finding the mass and width of the scalar resonances, we analyze synthetic lattice data with a fixed error assigned, and show that the framework can be indeed used for an accurate determination of resonance pole positions in the multi-channel scattering.Comment: 15 pages, 17 figure

How subgroup analyses can miss the trees for the forest plots: A simulation study

Objectives: Subgroup analyses of clinical trial data can be an important tool for understanding when treatment effects differ across populations. That said, even effect estimates from prespecified subgroups in well-conducted trials may not apply to corresponding subgroups in the source population. While this divergence may simply reflect statistical imprecision, there has been less discussion of systematic or structural sources of misleading subgroup estimates. Study Design and Setting: We use directed acyclic graphs to show how selection bias caused by associations between effect measure modifiers and trial selection, whether explicit (e.g., eligibility criteria) or implicit (e.g., self-selection based on race), can result in subgroup estimates that do not correspond to subgroup effects in the source population. To demonstrate this point, we provide a hypothetical example illustrating the sorts of erroneous conclusions that can result, as well as their potential consequences. We also provide a tool for readers to explore additional cases. Conclusion: Treating subgroups within a trial essentially as random samples of the corresponding subgroups in the wider population can be misleading, even when analyses are conducted rigorously and all findings are internally valid. Researchers should carefully examine associations between (and consider adjusting for) variables when attempting to identify heterogeneous treatment effects