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LPR After three months of treatment, however, the
differences in symptom improvement between the two
study groups became more obvious, reflected by a signifi-
cantly stronger decrease in the total RSI after esomeprazole
therapy. As a consequence, even in patients with suspected
LPR reporting early symptom relief under PPI medication,
the treatment should continue for at least three months.
In contrast to Vaezi et al who had performed the largest
double-blind and placebo-controlled trial evaluating a PPI
effect on LPR symptoms and laryngeal signs, we could
demonstrate that twice-daily esomeprazole was superior to
placebo in improving both LPR symptoms and laryngeal
findings. In the mentioned study, Vaezi et al included 145
patients receiving either 40 mg of esomeprazole (n 95) or
placebo (n 50) twice daily for 16 weeks. From their
findings, Vaezi et al concluded that compared with placebo
the PPI therapy was of no therapeutic benefit on signs and
symptoms associated with LPR However, they excluded
patients with moderate to severe heartburn from their study.
Thus, patients with a symptom typical for gastroesophageal
reflux disease (GERD) but also relevant for LPR (6% to
43% of LPR patients suffer from heartbur were not
part of the large study population. This could have affected
the study results. Another reason for this study result dif-
fering from our findings might be the fact that Vaezi et al
did not use the RFS for control of laryngeal changes due to
its lack of external validation.
Four further studies in the past also revealed no statisti-
cally significant benefit of a PPI therapy on characteristic
LPR symptoms and signs compared to placebo. Havas et al
performed a double-blind, placebo-controlled, and random-
ized study with 15 LPR patients evaluating the therapeutic
efficacy of 30 mg lansoprazole twice daily for 12 weeks
From their findings the authors concluded that lansoprazole
was not more effective than placebo in the treatment of
cervical symptoms of LPR and posterior pharyngolaryngi-
tis. As the study population was small and no regular sta-
tistical analysis of the results was performed, the signifi-
cance of this conclusion remains unclear. In a randomized,
double-blind, crossover study by Eherer et al, pantoprazole
40 mg twice daily for three months did not significantly
affect symptom or laryngeal scores compared with placebo
in 14 LPR patients
Nevertheless, the authors hypothesized that pantoprazole
compared to placebo may have resulted in faster improve-
ment of LPR symptoms. Again, the limitation of this study
is a small sample size, which makes it difficult to draw
meaningful conclusions from this data. Another double-
blind, randomized trial by Steward et al, comparing two-
month rabeprazole (20 mg twice daily) to placebo-control
PPI treatment, also failed to demonstrate significantly
greater improvement in reflux symptoms, health status, or
laryngeal appearance However, for laryngeal symptoms
such as hoarseness, dry cough, and throat clearing a statis-
Table 3
Change from baseline within each group after three months
Visit I vs visit III
Esomeprazole Placebo Difference
RSI
Total 14.27 1.58‡ 7.79 1.74‡ 6.48 2.34*
Hoarseness 1.37 0.33‡ 1.18 0.36† 0.19 0.48
Throat clear 1.80 0.26‡ 1.18 0.31† 0.62 0.41
Throat mucus 1.43 0.33† 0.96 0.27† 0.47 0.43
Difficulty swallowing 1.40 0.31‡ 0.57 0.28 0.83 0.42
Coughing after meals 1.17 0.37† 0.21 0.33 0.95 0.50
Breathing difficulties 0.87 0.27† 0.57 0.26* 0.30 0.38
Annoying cough 1.60 0.37† 1.07 0.34† 0.53 0.51
Throat sensations 2.27 0.28‡ 1.43 0.33† 0.84 0.43
Heartburn 1.97 0.31‡ 0.64 0.42 1.32 0.52*
RFS
Total 4.60 0.63‡ 2.32 0.76† 2.28 0.98*
Subglottic edema 0.00 0.10 0.21 0.21 0.21 0.24
Ventricular 0.53 0.20* 0.36 0.21 0.18 0.28
Erythema 0.77 0.20† 0.07 0.19 0.70 0.27*
Vocal fold edema 0.67 0.13‡ 0.46 0.16† 0.20 0.20
Diffuse laryngeal edema 0.83 0.16‡ 0.36 0.13* 0.48 0.21*
Posterior commissure hypertrophy 0.97 0.15‡ 0.32 0.12* 0.65 0.19
Granuloma/granulation tissue 0.07 0.07 0.00 0.15 0.07 0.16
Thick endolaryngeal mucus 0.67 0.20† 0.58 0.25* 0.10 0.32
Data are given as mean differences standard error of the mean (SEM). The first two data columns show differences from
baseline and the third demonstrates the difference between study groups. P values are from Wilcoxon signed rank test and
Mann-Whitney U test as appropriate.
*P 0.05; † P 0.01; ‡P 0.001.
Otolaryngology–Head and Neck Surgery, Vol 139, No 3, September 2008
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