In:
PLOS ONE, Public Library of Science (PLoS), Vol. 18, No. 6 ( 2023-6-23), p. e0287714-
Abstract:
Despite the advances in the treatment of cardiovascular diseases, effective treatment remains to be established to improve the quality of life and prognosis of patients with chronic coronary syndromes. This study was aimed 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 through upregulation of endothelial nitric oxide synthase (eNOS). Methods and findings We conducted a randomized, double-blind, placebo-controlled (RCT) pilot trial of the LIPUS therapy for patients with refractory angina pectoris. The patients who received optimal medical therapy without indication of PCI or CABG due to the lack of graftability or complexity of coronary lesions were enrolled. They were randomly divided into the LIPUS treatment group (N = 31) and the placebo group (N = 25) in a 1:1 fashion. The LIPUS therapy was performed in a transthoracic manner for 20 min for 3 sections each (mitral, papillary muscle, and apex levels) under the conditions that we identified; frequency 1.875 MHz, intensity 0.25 MPa, and 32 cycles. The primary endpoint was weekly use of nitroglycerin. Secondary endpoints included stress myocardial perfusion imaging and others. The average weekly nitroglycerin use (times/week) was decreased from 5.50 to 2.44 in the LIPUS group and from 5.94 to 2.83 in the placebo group. The changes in the average weekly nitroglycerin use were comparable; -3.06 (95% CI: -4.481 to -1.648) in the LIPUS group (P 〈 0.01) and -3.10 (95% CI: -4.848 to -1.356) in the placebo group (P 〈 0.01). No adverse effects were noted. Conclusions 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. The present findings need to be confirmed in another trial with a large number of patients. (Registration ID: UMIN000012369).
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0287714
DOI:
10.1371/journal.pone.0287714.g001
DOI:
10.1371/journal.pone.0287714.g002
DOI:
10.1371/journal.pone.0287714.t001
DOI:
10.1371/journal.pone.0287714.t002
DOI:
10.1371/journal.pone.0287714.t003
DOI:
10.1371/journal.pone.0287714.s001
DOI:
10.1371/journal.pone.0287714.s002
DOI:
10.1371/journal.pone.0287714.s003
DOI:
10.1371/journal.pone.0287714.s004
DOI:
10.1371/journal.pone.0287714.s005
DOI:
10.1371/journal.pone.0287714.s006
DOI:
10.1371/journal.pone.0287714.s007
DOI:
10.1371/journal.pone.0287714.s008
DOI:
10.1371/journal.pone.0287714.s009
DOI:
10.1371/journal.pone.0287714.r001
DOI:
10.1371/journal.pone.0287714.r002
DOI:
10.1371/journal.pone.0287714.r003
DOI:
10.1371/journal.pone.0287714.r004
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2023
detail.hit.zdb_id:
2267670-3
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