A Randomized, Double-blind, Placebo-controlled Pilot Trial of Low-intensity Pulsed Ultrasound Therapy for Refractory Angina Pectoris

Despite the advances in the treatment of cardiovascular diseases, effective treatment remains to be established to improve the quality of life of patients with chronic coronary syndrome. The aim of this study was to evaluate the effectiveness and safety of the low-intensity pulsed ultrasound (LIPUS) therapy, which we have developed as a novel non-invasive angiogenic therapy. We conducted a randomized, double-blind, placebo-controlled (RCT) pilot trial of the LIPUS therapy for patients with refractory angina pectoris without indication for PCI or CABG despite optimal medical therapy. The primary endpoint, the changes in weekly use of nitroglycerin were comparable; -3.06 (95% CI: -4.481 to -1.648) in the LIPUS group and − 3.10 (95% CI: -4.848 to -1.356) in the placebo group (both P < 0.01). In the present study, the LIPUS therapy did not further ameliorate chest pain as compared with optimal medications alone in patients with refractory angina pectoris (Registration ID: UMIN000012369).