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Recombinant streptokinase vs phenylephrine-based suppositories in acute hemorrhoids, randomized, controlled trial
Francisco Hernández-Bernal1, Georgina Castellanos-Sierra1, Carmen M Valenzuela-Silva1
1Francisco Hernández-Bernal, Carmen M Valenzuela-Silva, Ana Aguilera-Barreto, Pedro A López-Saura, Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba.
World Journal of Gastroenterology
|March 4, 2014
Summary
Recombinant streptokinase (rSK) suppositories demonstrated superior efficacy in treating acute hemorrhoidal disease compared to phenylephrine, showing faster symptom resolution and a lower need for thrombectomy with no adverse events.
Area of Science:
- Gastroenterology
- Pharmacology
Background:
- Acute hemorrhoidal disease presents a significant clinical challenge.
- Limited treatment options exist for effective and safe hemorrhoid management.
Purpose of the Study:
- To compare the efficacy and safety of recombinant streptokinase (rSK) suppositories against phenylephrine suppositories for acute hemorrhoidal disease.
Main Methods:
- A multicenter, randomized, open-label, active-controlled trial.
- 1:1 randomization to rSK (200,000 IU) or 0.25% phenylephrine suppositories.
- Evaluations at 3, 5, and 10 days, assessing complete clinical response, time to response, and need for thrombectomy.
Main Results:
- Significantly higher complete response rates at day 5 for rSK (75.5%) versus phenylephrine (32.7%) (P < 0.001).
- rSK showed a shorter median time to complete response (4.9 days vs. 9.8 days) (P = 0.031).
- Lower incidence of thrombectomy needed in the rSK group (1/59 vs. 8/57) (P = 0.016), with no reported adverse events.
Conclusions:
- rSK suppositories offer a significant therapeutic advantage over phenylephrine for acute hemorrhoidal illness.
- rSK demonstrates a favorable safety profile, making it a promising treatment option.
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