Risk of basal cell carcinoma in a randomized clinical trial of aspirin and folic acid for the prevention of colorectal adenomas

Patients with the genetic disorder basal cell naevus syndrome are at risk of developing multiple basal cell carcinomas, a form of skin cancer. Treatment with the non‐steroidal anti‐inflammatory drug called celecoxib appears to reduce the risk. There is some evidence that other non‐steroidal anti‐inflammatory drugs, including aspirin, may slightly reduce the risk of non‐melanoma skin cancers in general. High amounts of folic acid in the diet may be linked to a slightly increased risk of basal cell carcinoma. Adenomas are polyps of the large bowel (colon and rectum) which are often multiple; they can develop into bowel cancer. They can be detected and removed by colonoscopy, which is repeated at regular intervals. Aspirin and folic acid may prevent the recurrence of these adenomas. The authors of this study, based in the United States and Canada, studied over a thousand patients with colorectal adenomas (aged 21‐80) who were participating in a trial of aspirin and folic acid in prevention of further polyps, over a 3‐6 year period. The authors looked at pathology reports to see if there was a different incidence of basal cell carcinoma in patients on aspirin/folic acid or placebo (no treatment). 104 of 958 patients eligible for the study developed basal cell carcinoma. Overall, aspirin and/or folic acid therapy had no significant effect on the development of basal cell carcinoma, although aspirin appeared to reduce the risk of further skin cancers in the small group who had been previously diagnosed with skin cancer. They conclude that the protective effect of aspirin against skin cancer is limited to individuals with a high risk of developing skin cancer.     

Biophysical integrated approach for the management of early stages of CKD in elderly patients: a 12-month controlled study

Background

Chronic Kidney Disease (CKD) and its clinical evolution are an emerging issue, due to an increasingly aging population. Consequently, the evaluation of integrative strategies to manage the decline in renal function is warranted. The previous evidence indicates that a biophysical integrated approach can significantly improve renal function. Nevertheless, controlled trials assessing the clinical efficacy of this strategy are still needed.

Methods

A 12-month controlled study was designed to assess the clinical outcome of a group of elderly patients affected by stage II/IIIa CKD randomly assigned to either control or biophysical treatment. In addition to the standard treatment with renin–angiotensin–aldosterone system inhibitors, the biophysical group underwent electromagnetic information transfer through aqueous system procedure every 3 months. Estimated glomerular filtration rate (eGFR), according to CKD–epidemiology collaboration formula, was calculated at baseline and every 3 months.

Results

A total of 238 patients were included in the study, 118 (73.9?±?3.8 years) in the biophysical therapy group and 120 (74.6?±?4.2 years) in the control group. At baseline, mean eGFR was 69?±?11.8 ml/min in the biophysical group and 70.7?±?11.5 ml/min in the control group. After 1 year, eGFR was 74.1?±?12.3 ml/min in the biophysical group, compared to 66.3?±?11.9 ml/min in the control group, with a statistically significant difference between groups (p?<?0.0001). The observed improvement in eGFR in the biophysical group was independent of age, gender, and antihypertensive treatment.

Conclusion

This study shows a potential contribution of a biophysical integrated strategy to support renal function against its natural decline in the elderly, warranting further clinical evaluation.

     

Changes in total sperm count after gastric bypass and sleeve gastrectomy: the BARIASPERM prospective study

BackgroundThe massive weight loss induced by bariatric surgery is associated with major benefits, but the effect on semen variables is still uncertain.ObjectivesTo explore semen modifications with gastric bypass and sleeve gastrectomy.SettingFive French University Hospitals.MethodsMale candidates for bariatric surgery with no history of infertility were recruited in this controlled prospective study. Sperm characteristics were collected before surgery and then 6 months and up to 12 months after surgery.ResultsForty-six adult men who underwent gastric bypass (n = 20) or sleeve gastrectomy (n = 26) were included. Total sperm count tended to be lower at 6 months and showed a significant decrease at 12 months in both surgery groups, at ?69.5 million (?96.8 to ?42.2 million; P = 0.0021). Total sperm count at 12 months relative to baseline was ?41.4 million (P = .0391) after gastric bypass and ?91.1 million (P = .0080) after sleeve gastrectomy. This was counterbalanced by an associated resolution of hypogonadism and decrease of DNA fragmentation in most patients with time after surgery.ConclusionImprovement in some semen variables after bariatric surgery observed in 3 previous studies is in contrast to the lower mean total sperm count found in this study at 1 year. The possible reversibility of this effect in the long term and the impact of surgery on fertility both remain unknown.     

Strategic, value-based delivery in global health care: innovations at Harvard University and Brigham and Women's Hospital

Investments in global health have more than doubled over the past decade, generating a cadre of new institutions. To date, most of the funded research in global health has focused on discovery, and, more recently, on the development of new tools, which has tightened the implementation bottleneck. This article introduces the concept of global health delivery and the need to catalog and analyze current implementation efforts to bridge gaps in delivery. Global health delivery is complex and context-dependent and requires an interdisciplinary effort, including the application of strategic principles. Furthermore, delivery is necessary to ensure that the investments in research, discovery, and development generate value for patients and populations. This article discusses the application of value-based delivery to global health. It provides some examples of approaches to aggregating implicit knowledge to inform practice. With global health delivery, the aim is to transform global health scale-up from a series of well-intentioned but often disconnected efforts to a value-based movement based upon 21st-century technology, standards, and efficiency.     

The trazodone metabolite meta-chlorophenylpiperazine can cause false-positive urine amphetamine immunoassay results

Amphetamines and methamphetamines are part of an important class of drugs included in most urine drugs of abuse screening panels, and a common assay to detect these drugs is the Amphetamines II immunoassay (Roche Diagnostics). To demonstrate that meta-chlorophenylpiperazine (m-CPP), a trazodone metabolite, cross-reacts in the Amphetamines II assay, we tested reference standards of m-CPP at various concentrations (200 to 20,000 g/L). We also tested real patient urine samples containing m-CPP (detected and quantified by HPLC) with no detectable amphetamine, methamphetamine, or MDMA (demonstrated by GC MS). In both the m-CPP standards and the patient urine samples, we found a strong association between m-CPP concentration and Amphetamines II immunoreactivity (r = 0.990 for the urine samples). Further, we found that patients taking trazodone can produce urine with sufficient m-CPP to result in false-positive Amphetamines II results. At our institution, false-positive amphetamine results occur not infrequently in patients taking trazodone with at least 8 trazodone-associated false-positive results during a single 26-day period. Laboratories should remain cognizant of this interference when interpreting results of this assay.