Category: Professional Posters
Purpose: Complementary alternative medicine (CAM) therapy is seen as a natural alternative to active pharmaceutical ingredients. However, the market for CAM products is sparsely regulated, allowing manufacturers to produce and sell adulterated supplements, while promoting them as natural and pure. A prevalent use of CAM products is for erectile dysfunction, often used in substitute for phosphodiesterase-5 inhibitors (PDE5-I). Sexual enhancement products account for 14.1% of emergency department visits due to CAM therapy, possibly due to adulteration of these products¹. This study investigates some male enhancement CAM products sold online label claim authenticity, possible adulteration with PDE5-I, quality and safety.
Methods: Six male enhancement CAM products were surveyed and purchased through an retail store in three different batches. High- performance liquid chromatography was used to detect possible adulteration with PDE5-I. Reversed phase C18 column was used (column length of 25 cm) along with acetonitrile:10 mM aqueous ammonium formate in ratio 50:50 as the mobile phase. The flow rate in the run was 1 ml/min (DAD detection at λmax of 230 nm). Near Infrared Spectroscopy (NIR) and SeDeM analyses were used to measure the inter and intra variability amongst these products and their pharmaceutical quality and reproducibility. Furthermore, content uniformity, weight variation, and friability tests were used to investigate the physical properties and quality.
Results: All of the 6 products tested contained Sildenafil at varying levels between 0.64 mg- 49.6 mg. Amounts varied widely within brands, with one product ranging in levels between 10mg and 40mg between each capsule tested. NIR spectroscopy and weight variation revealed that the products showed low levels of uniformity across and within brands. SeDeM analysis revealed the products were close to equivalence to each other.
Conclusion: Patients using adulterated CAMs could cause more harm to their health due to dangerous drug interactions. If patients are unaware of the true components in CAM products, then a patient may be taking a duplication therapy, unbeknownst to them and their healthcare providers. Using a PDE-5 inhibitor with another vasodilator or antihypertensive API could result in orthostatic hypotension, dizziness, weakness, and other severe symptoms. If symptoms continue, this could lead to hospitalization, permanent damage, strokes, or death. Health systems should be wary of CAM products for male enhancement and advocate for the use of safe prescription alternatives under medical supervision.