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Inhaled hypertonic saline
effective for cystic fibrosis
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Clinical Question:
Does inhaled hypertonic saline improve clinical outcomes in patients with
cystic fibrosis?
Bottom Line:
Hypertonic saline preceded by a bronchodilator is an inexpensive, safe, and
effective additional therapy for patients with cystic fibrosis.
Reference:
Elkins MR, Robinson M, Rose BR, et al, for the National Hypertonic Saline in
Cystic Fibrosis (NHSCF) Study Group. A controlled trial of long-term inhaled
hypertonic saline in patients with cystic fibrosis. N Engl J Med
2006;354:229-40. |
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Study Design:
Randomized controlled trial (double-blinded)
Synopsis:
Inhaled hypertonic saline acutely increases mucociliary clearance and, in
short-term trials, improves lung function in people with cystic fibrosis. We
tested the safety and efficacy of inhaled hypertonic saline in a long-term
trial. In this double-blind, parallel-group trial, 164 patients with stable
cystic fibrosis who were at least six years old were randomly assigned to
inhale 4 ml of either 7 percent hypertonic saline or 0.9 percent (control)
saline twice daily for 48 weeks, with quinine sulfate (0.25 mg per
milliliter) added to each solution to mask the taste. A bronchodilator was
given before each dose, and other standard therapies were continued during
the trial. The primary outcome measure, the rate of change (slope) in lung
function (reflected by the forced vital capacity [FVC], forced expiratory
volume in one second [FEV1], and forced expiratory flow at 25 to 75 percent
of FVC [FEF25-75]) during the 48 weeks of treatment, did not differ
significantly between groups (P=0.79). However, the absolute difference in
lung function between groups was significant (P=0.03) when averaged across
all post-randomization visits in the 48-week treatment period. As compared
with the control group, the hypertonic-saline group had significantly higher
FVC (by 82 ml; 95 percent confidence interval, 12 to 153) and FEV1 (by 68
ml; 95 percent confidence interval, 3 to 132) values, but similar FEF25-75
values. The hypertonic-saline group also had significantly fewer pulmonary
exacerbations (relative reduction, 56 percent; P=0.02) and a significantly
higher percentage of patients without exacerbations (76 percent, as compared
with 62 percent in the control group; P=0.03). Hypertonic saline was not
associated with worsening bacterial infection or inflammation. |
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