Topical Propranolol Improves Epistaxis Control in Hereditary Hemorrhagic Telangiectasia (HHT): A Randomized Double-Blind Placebo-Controlled Trial
Abstract
1. Introduction
2. Experimental Section
Statistical Analysis
3. Results
3.1. Study Participants
3.2. Primary Outcome
3.3. Secondary Outcomes
3.4. Nasal Endoscopy
3.5. Side Effects
3.6. Results of the Open-Label Phase of the Study
4. Discussion
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Inclusion criteria: |
Exclusion criteria:
|
Placebo (n = 10) | Propranolol (n = 10) | p | |
---|---|---|---|
Age—years (mean ± SD) | 51 ± 9 | 57 ± 11 | 0.262 |
Gender (F,M) | 9:1 | 6:4 | 0.152 |
Gene mutation (number of participants) | ACVRL1-8 Endoglin-1 ND-1 | ACVRL1-5 Endoglin-3 ND-2 | 0.223 |
ESS | 5.68 ± 1.8 | 6.50 ± 1.84 | 0.323 |
QOL | 34.75 ± 10.9 | 35.1 ± 6.7 | 0.932 |
Hemoglobin (g/dL) | 10.7 ± 2.52 | 10.57 ± 2.6 | 0.918 |
IV iron */IV PC * | 16/3 | 9/7 | 0.739/0.481 |
Ferritin | 65.4 ± 86.19 | 89.65 ± 212.04 | 0.715 |
Rhinology grading (number of patients) | 0.601 | ||
Grade I | 4 | 3 | |
Grade II | 5 | 5 | |
Grade III | 1 | 2 | |
Systolic BP mmHg (mean ± SD) | 110.2 ± 9.6 | 119.3 ± 12.3 | 0.09 |
Diastolic BP mmHg (mean ± SD) | 63.3 ± 9.2 | 69.0 ± 9.2 | 0.20 |
HR per minute (mean ± SD) | 76.0 ± 12.9 | 73.9 ± 111.7 | 0.71 |
Outcome Measure | Placebo (n = 10) | Propranolol (n = 10) | ||||
---|---|---|---|---|---|---|
Baseline | End of DB Phase | p | Baseline | End of DB Phase | p | |
Primary outcome | ||||||
ESS | 5.68 ± 1.8 | 5.33 ± 2.1 | 0.133 | 6.50 ± 1.84 | 4.47 ± 1.75 | 0.004 |
Secondary outcomes | ||||||
Hb g/dL | 10.7 ± 2.5 | 10.7 ± 2.3 | 0.91 | 10.5 ± 2.6 | 11.4 ± 2.02 | <0.001 |
Total PC units required * | 3 | 5 | 0.346 | 7 | 3 | <0.001 |
Total IV iron ** | 16 | 14 | 0.233 | 9 | 4 | 0.15 |
doses required * | ||||||
QOL | 34.75 ± 10.9 | 40.6 ± 9.11 | 0.03 | 35.1 ± 6.7 | 41 ± 7.39 | 0.048 |
Outcome Measure | Placebo | Propranolol | p |
---|---|---|---|
Primary outcome | |||
Change in ESS | −0.35 ± 0.68 | −2.03 ± 1.7 | 0.009 |
Secondary outcomes | |||
Change in Hb level (g/dL) | 0.68 ± 0.01 | 1.96 ± 0.85 | 0.216 |
Change in number of PC required | −0.20 ± 0.63 | −0.40 ± 0.69 | 0.029 |
Change in number of IV iron doses required * | −0.20 ± 0.63 | −0.50 ± 0.97 | 0.304 |
QOL | 6.11 ± 5.85 | 6.06 ± 5.90 | 0.986 |
Placebo (10) | Propranolol (10) | p | |
---|---|---|---|
Any burning sensation | 2 | 9 | 0.005 |
Sustained burning sensation | 0 | 4 | 0.086 |
Rhinorrhea | 0 | 3 | 0.06 |
Nasal dryness | 1 | 0 | 1 |
Otitis media | 0 | 1 | 1 |
Outcome Measure (mean ± SD) n = 15 | Double Blind Period | Open-Label Period | p |
---|---|---|---|
Epistaxis frequency, bleeds/day | 1.71 ± 1.34 | 1.24 ± 1.24 | <0.001 |
Epistaxis severity | 1.42 ± 0.64 | 1.03 ± 0.55 | <0.001 |
Epistaxis duration, minutes/day | 10.68 ± 9.01 | 6.13 ± 4.67 | <0.001 |
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Mei-Zahav, M.; Gendler, Y.; Bruckheimer, E.; Prais, D.; Birk, E.; Watad, M.; Goldschmidt, N.; Soudry, E. Topical Propranolol Improves Epistaxis Control in Hereditary Hemorrhagic Telangiectasia (HHT): A Randomized Double-Blind Placebo-Controlled Trial. J. Clin. Med. 2020, 9, 3130. https://doi.org/10.3390/jcm9103130
Mei-Zahav M, Gendler Y, Bruckheimer E, Prais D, Birk E, Watad M, Goldschmidt N, Soudry E. Topical Propranolol Improves Epistaxis Control in Hereditary Hemorrhagic Telangiectasia (HHT): A Randomized Double-Blind Placebo-Controlled Trial. Journal of Clinical Medicine. 2020; 9(10):3130. https://doi.org/10.3390/jcm9103130
Chicago/Turabian StyleMei-Zahav, Meir, Yulia Gendler, Elchanan Bruckheimer, Dario Prais, Einat Birk, Muhamad Watad, Neta Goldschmidt, and Ethan Soudry. 2020. "Topical Propranolol Improves Epistaxis Control in Hereditary Hemorrhagic Telangiectasia (HHT): A Randomized Double-Blind Placebo-Controlled Trial" Journal of Clinical Medicine 9, no. 10: 3130. https://doi.org/10.3390/jcm9103130
APA StyleMei-Zahav, M., Gendler, Y., Bruckheimer, E., Prais, D., Birk, E., Watad, M., Goldschmidt, N., & Soudry, E. (2020). Topical Propranolol Improves Epistaxis Control in Hereditary Hemorrhagic Telangiectasia (HHT): A Randomized Double-Blind Placebo-Controlled Trial. Journal of Clinical Medicine, 9(10), 3130. https://doi.org/10.3390/jcm9103130