Simple saline solution to alleviate chronic nosebleeds

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nosebleedwebSquirting a simple saline solution into the nose twice a day could alleviate chronic nosebleeds just as effectively as spraying with any one of three different medications, reports a University of Utah study.

“This research highlights that there could be a benefit even in the simplest of interventions,” says corresponding author Dr Kevin Whitehead, associate professor of internal medicine at the University of Utah School of Medicine and director of the Utah HHT Clinical Centre. “No drug proved to be any better than the saline placebo, but the majority of patients improved over the course of treatment – even those using saline.”

Whitehead’s collaborators included investigators from five other study sites across the US including senior author Dr James Gossage, director of the pulmonary vascular disease programme at Augusta University.

While nosebleeds are an occasional nuisance for most of us, they are an unpleasant fact of life for those with haemorrhagic telangiectasia (HHT). One bloody nose per week is not uncommon, and some with the condition have more than two a day. Doctors have tried prescribing drugs off-label to treat what can be a debilitating problem, but with mixed results. The NOSE (North American Study of Epistaxis in HHT) phase 2 clinical trial was designed to determine how three of these medications – bevacizumab, estriol, and tranexamic acid – stacked up against one another.

121 study participants were randomly assigned one of the drugs, or a saline placebo, to spray into their nose twice a day during a 12-week treatment period. Each day they logged how many bloody noses they had, how long they lasted, and checked the boxes next to descriptions that matched their symptoms, such as whether their nosebleeds were “typically gushing or pouring”. Both at the beginning and end of the treatment period, participants received a composite score between 0-10 based on their answers (10 being the most severe), a routine method for assessing severity.

The majority of participants’ severity scores dropped, and by nearly identical amounts, from between 5-6 to between 3-4. A significant improvement, says Whitehead. Participants reported a positive change regardless of which drug they used, or whether they misted their nose with placebo.

“The results suggest that medicines that people all over the world have used appear to have no benefit over plain saline,” says Gossage.

The idea that simple hydration from any nasal spray, even saline, could prevent nosebleeds certainly makes sense, says Whitehead. People are at higher risk for nosebleeds when their nose dries out, for instance when they’re in an arid climate for extended periods of time. Further, the most dreaded but proven remedy – surgically sealing shut the nose – effectively keeps the nasal cavity permanently moist.

Yet the investigators cannot completely rule out the possibility that symptoms may have improved because of a placebo effect: that participants reported better outcomes because they expected to see an improvement. What’s more, it could be that some of the drugs would work better if taken at a higher dose, or if applied as a gel or polymer that adheres better to the inside of the nasal cavity.

Nevertheless, the results from this clinical trial were enough to convince Whitehead, Gossage, and their colleagues, to routinely recommend saline nasal spray to their patients with HHT. “We stress the importance of hydration,” says Whitehead. “We tell them that something as simple as a morning and night saline spray could offer them some benefit.”

Nosebleeds caused by HHT are not fundamentally different from common nosebleeds, but scientists have yet to test whether saline could work just as well for anyone. “There are no data for extrapolating these results to patients with nosebleeds who don’t have HHT,” says Gossage. “But certainly it’s an easy thing to try.”

Abstract
Importance: Epistaxis is a major factor negatively affecting quality of life in patients with hereditary hemorrhagic telangiectasia (HHT; also known as Osler-Weber-Rendu disease). Optimal treatment for HHT-related epistaxis is uncertain.
Objective: To determine whether topical therapy with any of 3 drugs with differing mechanisms of action is effective in reducing HHT-related epistaxis.
Design, Setting, and Participants: The North American Study of Epistaxis in HHT was a double-blind, placebo-controlled randomized clinical trial performed at 6 HHT centers of excellence. From August 2011 through March 2014, there were 121 adult patients who met the clinical criteria for HHT and had experienced HHT-related epistaxis with an Epistaxis Severity Score of at least 3.0. Follow-up was completed in September 2014.
Interventions: Patients received twice-daily nose sprays for 12 weeks with either bevacizumab 1% (4 mg/d), estriol 0.1% (0.4 mg/d), tranexamic acid 10% (40 mg/d), or placebo (0.9% saline).
Main Outcomes and Measures: The primary outcome was median weekly epistaxis frequency during weeks 5 through 12. Secondary outcomes included median duration of epistaxis during weeks 5 through 12, Epistaxis Severity Score, level of hemoglobin, level of ferritin, need for transfusion, emergency department visits, and treatment failure.
Results: Among the 121 patients who were randomized (mean age, 52.8 years [SD, 12.9 years]; 44% women with a median of 7.0 weekly episodes of epistaxis [interquartile range {IQR}, 3.0-14.0]), 106 patients completed the study duration for the primary outcome measure (43 were women [41%]). Drug therapy did not significantly reduce epistaxis frequency (P = .97). After 12 weeks of treatment, the median weekly number of bleeding episodes was 7.0 (IQR, 4.5-10.5) for patients in the bevacizumab group, 8.0 (IQR, 4.0-12.0) for the estriol group, 7.5 (IQR, 3.0-11.0) for the tranexamic acid group, and 8.0 (IQR, 3.0-14.0) for the placebo group. No drug treatment was significantly different from placebo for epistaxis duration. All groups had a significant improvement in Epistaxis Severity Score at weeks 12 and 24. There were no significant differences between groups for hemoglobin level, ferritin level, treatment failure, need for transfusion, or emergency department visits.
Conclusions and Relevance: Among patients with HHT, there were no significant between-group differences in the use of topical intranasal treatment with bevacizumab vs estriol vs tranexamic acid vs placebo and epistaxis frequency.

Authors
Kevin J Whitehead; Nathan B Sautter; Justin P McWilliams; Murali M Chakinala; Christian A Merlo; Maribeth H Johnson; Melissa James; Eric M Everett; Marianne S Clancy; Marie E Faughnan; S Paul Oh; Scott E Olitsky; Reed E Pyeritz; James R Gossage

University of Utah School of Medicine material
JAMA abstract


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