Holly Boyer1, Patricia Fernandes1, Chap Le2, Bevan Yueh1. 1. Department of Otolaryngology - Head and Neck Surgery, University of Minnesota Medical School, University of Minnesota, Minneapolis, MN. 2. Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.
Abstract
BACKGROUND: Our previous studies have demonstrated the tolerability and low side-effect profile of office-based sclerotherapy with sodium tetradecyl sulfate (STS) for treating recurrent epistaxis due to hereditary hemorrhagic telangiectasia (HHT). The objective of this study was to use a prospective randomized trial to determine the effectiveness of sclerotherapy with STS vs standard treatment. METHODS: This prospective randomized trial (conducted from November 1, 2011, through January 31, 2014) involved 17 patients with recurrent epistaxis due to HHT. We defined standard treatment as continuation of any treatment that the patient had previously undergone, such as moisturization, packing, and cautery. We used a crossover design, so study participants were randomized to either sclerotherapy or standard treatment during the first time period, and then to the other during the second period. The primary outcome measure was frequency and severity of epistaxis, as measured by the epistaxis severity score (ESS). The ESS is a 10-point scale, with higher scores corresponding to more bleeding. RESULTS: After controlling for treatment order, bleeding was substantially better controlled after sclerotherapy; the ESS after sclerotherapy was nearly one point lower than after standard treatment (-0.95, 1-sided p = 0.027). Treatment order, baseline ESS, the number of lesions, moisturization practices, and a history of previous blood transfusions did not significantly affect the results. CONCLUSION: This trial demonstrated that sclerotherapy with STS (vs standard treatment) significantly reduced epistaxis due to HHT.
RCT Entities:
BACKGROUND: Our previous studies have demonstrated the tolerability and low side-effect profile of office-based sclerotherapy with sodium tetradecyl sulfate (STS) for treating recurrent epistaxis due to hereditary hemorrhagic telangiectasia (HHT). The objective of this study was to use a prospective randomized trial to determine the effectiveness of sclerotherapy with STS vs standard treatment. METHODS: This prospective randomized trial (conducted from November 1, 2011, through January 31, 2014) involved 17 patients with recurrent epistaxis due to HHT. We defined standard treatment as continuation of any treatment that the patient had previously undergone, such as moisturization, packing, and cautery. We used a crossover design, so study participants were randomized to either sclerotherapy or standard treatment during the first time period, and then to the other during the second period. The primary outcome measure was frequency and severity of epistaxis, as measured by the epistaxis severity score (ESS). The ESS is a 10-point scale, with higher scores corresponding to more bleeding. RESULTS: After controlling for treatment order, bleeding was substantially better controlled after sclerotherapy; the ESS after sclerotherapy was nearly one point lower than after standard treatment (-0.95, 1-sided p = 0.027). Treatment order, baseline ESS, the number of lesions, moisturization practices, and a history of previous blood transfusions did not significantly affect the results. CONCLUSION: This trial demonstrated that sclerotherapy with STS (vs standard treatment) significantly reduced epistaxis due to HHT.
Authors: Holly Boyer; Patricia Fernandes; Olga Duran; David Hunter; George Goding Journal: Int Forum Allergy Rhinol Date: 2011-04-28 Impact factor: 3.858
Authors: William E Shiels; D Richard Kang; James W Murakami; Mark J Hogan; Gregory J Wiet Journal: Otolaryngol Head Neck Surg Date: 2009-08 Impact factor: 3.497
Authors: Cilgia Dür; L Anschuetz; S Negoias; O C Bulut; A Angelillo-Scherrer; M Caversaccio Journal: Eur Arch Otorhinolaryngol Date: 2021-03-04 Impact factor: 2.503