Low rates of serious complications and further procedures following surgery for base of thumb osteoarthritis: analysis of a national cohort of 43 076 surgeries.

OBJECTIVES: To determine the incidence of further procedures and serious adverse events (SAEs) requiring admission to hospital following elective surgery for base of thumb osteoarthritis (BTOA), and the patient factors associated with these outcomes. DESIGN: Population based cohort study. SETTING: National Health Service using the national Hospital Episode Statistics data set linked to mortality records over a 19-year period (01 April 1998-31 March 2017). PARTICIPANTS: 43 076 primary surgeries were followed longitudinally in secondary care until death or migration on 37 329 patients over 18 years of age. MAIN OUTCOME MEASURES: Incidence of further thumb base procedures (including revision surgery or intra-articular steroid injection) at any time postoperatively, and local wound complications and systemic events (myocardial infarction, stroke, respiratory tract infection, venous thromboembolic events, urinary tract infection or renal failure) within 30 and 90 days. To identify patient factors associated with outcome, Fine and Gray model regression analysis was used to adjust for the competing risk of mortality in addition to age, overall comorbidity and socioeconomic status. RESULTS: Over the 19 years, there was an increasing trend in surgeries undertaken. The rate of further thumb base procedures after any surgery was 1.39%; the lowest rates after simple trapeziectomy (1.12%), the highest rates after arthroplasty (3.84%) and arthrodesis (3.5%). When matched for age, comorbidity and socioeconomic status, those undergoing arthroplasty and arthrodesis were 2.5 times more likely to undergo a further procedure (subHR 2.51 (95% CI 1.81 to 3.48) and 2.55 (1.91 to 3.40)) than those undergoing simple trapeziectomy. Overall complication rates following surgery were 0.22% for serious local complications and 0.58% for systemic events within 90 days of surgery. CONCLUSIONS: The number of patients proceeding to BTOA surgery has increased over the last 19 years, with a low rate of further thumb base procedures and SAEs after surgery overall registered. Arthrodesis and arthroplasty had a significantly higher revision rate. TRIAL REGISTRATION NUMBER: NCT03573765.

The safety, efficacy and pharmaceutical quality of male enhancement nutraceuticals bought online: Truth versus claim.

OBJECTIVE: Nutraceutical products are widely used for their claimed therapeutic benefits. However, falsified or adulterated nutraceuticals present a major health threat to consumers. This study investigates the pharmaceutical quality, safety and anti-inflammatory effects of six male enhancement nutraceuticals that claim to be 100% natural. METHODS: Three batches of six male enhancement products were tested to detect the presence and levels of adulterants via high-performance liquid chromatography (HPLC). The pharmaceutical quality of the selected nutraceuticals was tested with near infrared spectroscopy (NIR) and SeDeM. The cytotoxic effects of these products on HepG2 cells were determined through cell proliferation (XTT) and lactate dehydrogenase (LDH) cytotoxicity assays. Lastly, the in vitro inflammatory effects of these products were investigated using murine J774 macrophages through cytokine release analysis. RESULTS: HPLC analysis detected the presence of sildenafil citrate, a vasodilator, and the active ingredient in Viagra and Revatio, in all batches of the products we analyzed. Amount of sildenafil citrate ranged from 0.45 mg to 51.85 mg among different batches. NIR assessment showed inter- and intra-batch heterogeneity in product composition. Results of the XTT and LDH assays showed significant cytotoxic effects of the analyzed products. XTT analysis revealed that the viability of HepG2 treated with tested products varied from 27.57% to 41.43%. Interestingly, the male enhancement products also showed anti-inflammatory effects. CONCLUSION: Despite their labeling as 100% natural, all products tested in this study contained levels of sildenafil citrate, which was not reported on the packaging. There was a lack of pharmaceutical uniformity among products of the same batch and across different batches. Additionally, the products we tested had cytotoxic effects. These study findings highlight the adulteration, poor quality and hazard of these nutraceuticals. Therefore, strict regulation of these products and standardization of the definition of nutraceuticals are urgently needed. Further, these falsely advertised products should be withdrawn from the market due to potential adverse effects on the health of their consumers.