Phase II evaluation of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes

Purpose

Hot flashes are a significant source of symptom burden that negatively impacts quality of life (QOL). For women who have contraindications to, or are unwilling to consider, estrogens or antidepressants for bothersome hot flashes, there are limited effective pharmacologic or complementary and alternative medicines.

Methods

This single-arm phase II trial studied the efficacy of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes. Eligible women were required to have reported ≥14 hot flashes per week for ≥1 month. The patients were treated with SAMe at a dose of 400 mg twice daily to evaluate whether a reduction in hot flash score appeared to be better than the historical placebo response of approximately 25 %. The women kept a daily hot flash diary during a baseline week and then daily during weeks 2–7. The primary endpoint was the change from baseline to week 7 in hot flash score and hot flash frequency. Secondary endpoints included toxicity analyses and the effect of SAMe on QOL.

Results

From October 28, 2010 to January 30, 2012, 43 women were treated with SAMe. The decrease in mean percent of baseline hot flash score and frequency was 35.4 and 32.6 %, respectively. When compared to the historical placebo response of 25 %, the effect of SAMe on hot flash score was not statistically significant (p?=?0.09). Treatment was well tolerated with expected grade 1/2 gastrointestinal toxicity and no negative effect on QOL.

Conclusions

The use of SAMe does not appear to significantly reduce hot flashes more than would be expected with a placebo.

     

Precipitating factors leading to decompensation of heart failure. Traits among urban blacks

Potential precipitating factors that led to cardiac decompensation and subsequent hospital admission for heart failure were examined in 101 patients in a large public hospital serving a predominantly working-class minority population. Ninety-seven percent of patients were black; their age was 59 +/- 14 years (mean +/- SD); on average, they were hospitalized three times in the preceding year for problems related to their heart failure. Potential precipitating factors for decompensated heart failure were identified in 93% of patients. Lack of adherence to the prescribed medical regimen was the most commonly identified causative factor and was noted in 64% of the cases; noncompliance with diet amounted to 22%, with drugs to 6%, and with the combination of drugs and diet to 37%. Other factors also related to hospitalization were cardiac arrhythmias (29%), emotional/environmental issues (26%), inadequately conceived drug therapy (17%), pulmonary infections (12%), and thyrotoxicosis (1%). Thus, the key preventive measure necessary in at least two thirds of patients centered around better adherence to drug and/or diet regimen, highlighting the precept that better patient education is mandatory if we are to minimize the number of hospital admissions for decompensated heart failure.     

Standardization of pelvic lymphadenectomy performed at radical cystectomy: can we establish a minimum number of lymph nodes that should be removed?

BACKGROUND: The number of lymph nodes (LNs) removed during radical cystectomy (RC) for transitional cell carcinoma (TCC) of the bladder affects overall and disease-specific survival, but no consensus exists regarding the minimum number of LNs that should be removed. The goal of the current study was to determine if a threshold number of nodes exists, above which taking additional LNs has no clinical benefit. METHODS: A total of 1121 patients were identified who underwent RC for clinically localized TCC of the bladder between January 1990 and April 2004. To determine the relation of LNs removal and overall survival, a Cox proportional hazards model was used with pathologic stage, age, and comorbidity as covariates. A dose-response curve, adjusted for covariates, was modeled to assess the impact of an increasing number of LNs removed on overall survival. RESULTS: A median of 9 LNs were removed (range, 0-53 LNs). In multivariable analysis, all covariates (number of LNs removed, age, stage of disease, and comorbidity) were found to be predictive of survival. The dose-response curve for number of LNs versus survival revealed that, when adjusted for covariates, the probability of survival did not plateau but instead continued to rise as the number of LNs removed increased. CONCLUSIONS: No evidence was found that a minimum number of LNs is sufficient for optimizing bladder cancer outcomes when a limited or extended pelvic LN dissection is performed during RC. Instead, the probability of survival continues to rise as the number of LNs removed increases. This study supports a more extended LN dissection at the time of RC, and highlights the challenges of interpreting retrospective LN dissection data.     

Efficacy and costs of a one-day hands-on EASIE endoscopy simulator train-the-trainer workshop

BACKGROUND: The efficacy of an intensive hands-on training in endoscopic hemostasis on the compactEASIE simulator has been previously demonstrated in a randomized prospective trial. In the current study, we evaluated how quickly and effectively new tutors, without simulator training experience, are able to acquire teaching skills in endoscopic hemostasis. METHODS: Five tutors with prior Erlangen Active Simulator for Interventional Endoscopy (EASIE) teaching experience instructed 7 endoscopists without prior EASIE experience on how to teach when using the model. These new tutors then independently conducted a workshop for 8 fellows in 4 hemostasis techniques. Results were compared with a historical control trained similarly by experienced tutors. Two one-day workshops in endoscopic hemostasis on the compactEASIE ex vivo endoscopy simulator were conducted in a category A hospital in New York City, New York. Skill scores at the end of training were compared with baseline skills assessments, and qualitative ratings of the new tutors were obtained from both the trainees and the experienced tutors. RESULTS: Significant improvement was achieved by the fellows in all 4 skills areas. Both the expert tutors and the trainees consistently rated the teaching skill of the new tutors highly. Fellows' skill acquisition using new tutors was of similar magnitude to that achieved in the prior EASIE trial using experienced trainers teaching the fellows. CONCLUSIONS: It is feasible to conduct an effective EASIE train-the-trainer course in one day. Tutors trained in this manner are able to provide a similar educational experience with objective improvement in trainee skill to experts who have conducted many hands-on workshops.     

Preoperative radiation and complication rates after double free flap reconstruction of head and neck cancer

Introduction

In this study, we explore whether preoperative external beam radiation affects complication rates in patients that have undergone double simultaneous free tissue transfer for head and neck defects.

Intraoperative electromagnetic navigational bronchoscopic localization of small,deep, or subsolid pulmonary nodules

Background

Localizing small or deep pulmonary nodules or subsolid ground-glass opacities often is difficult during video-assisted thoracoscopic surgery (VATS) or robotic-assisted thoracoscopic surgery (RATS). This can result in larger resections or conversion to thoracotomy. The goal of this study is to evaluate the role of electromagnetic navigational bronchoscopic localization (ENBL) as a safe and accurate intraoperative method to localize small, deep, or subsolid nodules.

Total ankle arthroplasty and ankle arthrodesis in rheumatic disease patients: An analysis of outcomes and complications using the National Inpatient Sample (NIS) database

IntroductionRheumatoid arthritis (RA), can manifest as an inflammatory arthropathy in the ankle. As a result, this study sought to examine the role of RA with respect to complications in patients undergoing either total ankle arthroplasty or ankle arthrodesis by utilizing the National Inpatient Sample to assess for correlations.MethodsAdmissions for TAA and AA were extracted from the National Inpatient Sample using primary ICD-9-CM diagnosis codes. Patients aged 18–65 years with a duration of hospital stay of >3 days and isolated complications were included. Multivariable regression was then performed within matched groups to determine differences.ResultsThere was decreased risk of myocardial infarction, pulmonary embolism, surgical site infection, and urinary tract infection in patients with RA. Postoperative development of pneumonia was seen at a higher rate in patients with RA.ConclusionRA is not associated with a markedly increased complication burden in the appropriately chosen surgical candidate for ankle arthrodesis and ankle arthroplasty.     

Determinants and prognostic implications of malignant ascites in metastatic papillary renal cancer

Objective

To describe the incidence of ascites in metastatic papillary renal cell cancer (pRCC), identify the factors associated with its development and evaluate its prognostic effect on the survival of these patients.