title: Recombinant streptokinase vs phenylephrine-based suppositories in acute hemorrhoids, randomized, controlled trial (THERESA-3).
abstract: OBJECTIVE
  To compare the efficacy and safety of recombinant streptokinase (rSK) and phenylephrine-based suppositories in acute hemorrhoidal disease.
  
  
  METHODS
  A multicenter (14 sites), randomized (1:1), open, parallel groups, active controlled trial was done. After inclusion, subjects with acute symptoms of hemorrhoids, who gave their written, informed consent to participate, were centrally randomized to receive, as outpatients, rSK (200000 IU) or 0.25% phenylephrine suppositories, which had different organoleptic characteristics. Treatment was administered by the rectal route, one unit every 6 h during 48 h for rSK, and up to a maximum of 5 d (20 suppositories) for phenylephrine. Evaluations were performed at 3, 5 and 10 d post-inclusion. The main end-point was the 5(th)-day complete clinical response (disappearance of pain and edema, and ≥ 70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were evaluated too.
  
  
  RESULTS
  5(th) day complete response rates were 83/110 (75.5%) and 36/110 (32.7%) with rSK and phenylephrine suppositories, respectively. This 42.7% difference (95%CI: 30.5-54.2) was highly significant (P < 0.001). The advantage was detected since the early 3(rd) day evaluation (37.3% vs 6.4% for the rSK and active control groups, respectively; P < 0.001) and was kept even at the late 10(th) day assessment (83.6% vs 58.2% for rSK and phenylephrine, respectively; P < 0.001). Time for complete response was significantly shorter (P = 0.031; log-rank test) in the rSK group (median: 4.9 d; 95%CI: 4.8-5.0) with respect to the active control (median: 9.8 d; 95%CI: 9.8-10.0). Thrombectomy was necessary in 1/59 and 8/57 patients with baseline thrombosis in the rSK and phenylephrine groups, respectively (P = 0.016). There were no adverse events attributable to the experimental treatment.
  
  
  CONCLUSIONS
  rSK suppositories showed a significant advantage over a widely used over-the-counter phenylephrine preparation for the treatment of acute hemorrhoidal illness, with an adequate safety profile.
authors.affiliation: Francisco Hernández-Bernal, Carmen M Valenzuela-Silva, Ana Aguilera-Barreto, Pedro A López-Saura, Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba.
authors.forename: Francisco
authors.initials: F
authors.lastname: Hernández-Bernal
authors.affiliation: Francisco Hernández-Bernal, Carmen M Valenzuela-Silva, Ana Aguilera-Barreto, Pedro A López-Saura, Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba.
authors.forename: Georgina
authors.initials: G
authors.lastname: Castellanos-Sierra
authors.affiliation: Francisco Hernández-Bernal, Carmen M Valenzuela-Silva, Ana Aguilera-Barreto, Pedro A López-Saura, Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba.
authors.forename: Carmen M
authors.initials: CM
authors.lastname: Valenzuela-Silva
authors.affiliation: Francisco Hernández-Bernal, Carmen M Valenzuela-Silva, Ana Aguilera-Barreto, Pedro A López-Saura, Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba.
authors.forename: Karem M
authors.initials: KM
authors.lastname: Catasús-Álvarez
authors.affiliation: Francisco Hernández-Bernal, Carmen M Valenzuela-Silva, Ana Aguilera-Barreto, Pedro A López-Saura, Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba.
authors.forename: Roselin
authors.initials: R
authors.lastname: Valle-Cabrera
authors.affiliation: Francisco Hernández-Bernal, Carmen M Valenzuela-Silva, Ana Aguilera-Barreto, Pedro A López-Saura, Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba.
authors.forename: Ana
authors.initials: A
authors.lastname: Aguilera-Barreto
authors.affiliation: Francisco Hernández-Bernal, Carmen M Valenzuela-Silva, Ana Aguilera-Barreto, Pedro A López-Saura, Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba.
authors.forename: Pedro A
authors.initials: PA
authors.lastname: López-Saura
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006484:Hemorrhoids / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010656:Phenylephrine / Q000627:therapeutic use*; D013300:Streptokinase / Q000627:therapeutic use*; D013488:Suppositories; D015912:Thrombolytic Therapy; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D013488:Suppositories; D010656:Phenylephrine; D013300:Streptokinase
keywords: Hemorrhoids; Phenylephrine; Randomized clinical trial; Streptokinase; Suppository; Thrombolysis