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World J Gastroenterol. Feb 14, 2014; 20(6): 1594-1601
Published online Feb 14, 2014. doi: 10.3748/wjg.v20.i6.1594
Published online Feb 14, 2014. doi: 10.3748/wjg.v20.i6.1594
Recombinant streptokinase vs phenylephrine-based suppositories in acute hemorrhoids, randomized, controlled trial (THERESA-3)
Francisco Hernández-Bernal, Carmen M Valenzuela-Silva, Ana Aguilera-Barreto, Pedro A López-Saura, Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba
Georgina Castellanos-Sierra, Karem M Catasús-Álvarez, “Juan B. Zayas” Hospital, Santiago de Cuba 90100, Cuba
Roselin Valle-Cabrera, National Center for the Coordination of Clinical Trials, Havana 10600, Cuba
Author contributions: Hernandez-Bernal F, Castellanos-Sierra G, Valenzuela-Silva CM, Aguilera-Barreto A and López-Saura PA concept and designed this study; Castellanos-Sierra G was the clinical investigator with more patients recruited and treated; Hernandez-Bernal F, Catasús-Alvarez KM and Valle-Cabrera R took part in trial coordination and monitoring; Hernandez-Bernal F, Castellanos-Sierra G, Valenzuela-Silva CM, Catasús-Alvarez KM and Valle-Cabrera R collected the data and their management; Valenzuela-Silva CM and López-Saura PA contributed to the statistical analyses; Hernandez-Bernal F, Castellanos-Sierra G, Valenzuela-Silva CM, Aguilera-Barreto A and López-Saura PA analyzed and interpreted the data; Hernandez-Bernal F, Valenzuela-Silva CM and López-Saura PA drafted the manuscript and made the final approval of the version to be published.
Supported by Heber Biotec, Havana (products, reagents) and the Ministry of Public Health of Cuba (hospital facilities and general medical care of the patients)
Correspondence to: Dr. Francisco Hernández-Bernal, Center for Genetic Engineering and Biotechnology, PO Box 6162, Havana 10600, Cuba. hernandez.bernal@cigb.edu.cu
Telephone: +53-7-2087421 Fax: +53-7-2736008
Received: May 29, 2013
Revised: August 22, 2013
Accepted: September 4, 2013
Published online: February 14, 2014
Processing time: 264 Days and 7.5 Hours
Revised: August 22, 2013
Accepted: September 4, 2013
Published online: February 14, 2014
Processing time: 264 Days and 7.5 Hours
Core Tip
Core tip: Medical treatments for acute hemorrhoidal disease come very seldom from randomized, controlled clinical trials. The paper describes that a candidate to a new therapeutic alternative, based on thrombolysis, shows significant efficacy advantage with respect to a widely used, over-the-counter, hemorrhoidal product.