Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial
2021
Abstract Objective To assess the use of proton pump inhibitors
(PPIs) to treat persistent throat symptoms. Design Pragmatic, double blind, placebo controlled,
randomised trial. Setting Eight ear, nose, and throat outpatient clinics,
United Kingdom. Participants 346 patients aged 18 years or older with
persistent throat symptoms who were randomised
according to recruiting centre and baseline
severity of symptoms (mild or severe): 172 to
lansoprazole and 174 to placebo. Intervention Random blinded allocation (1:1) to either 30 mg
lansoprazole twice daily or matched placebo twice
daily for 16 weeks. Main outcome measures Primary outcome was symptomatic response at 16
weeks measured using the total reflux symptom
index (RSI) score. Secondary outcomes included
symptom response at 12 months, quality of life,
and throat appearances. Results Of 1427 patients initially screened for
eligibility, 346 were recruited. The mean age of
the study sample was 52.2 (SD 13.7) years, 196
(57%) were women, and 162 (47%) had severe
symptoms at presentation; these characteristics
were balanced across treatment arms. The primary
analysis was performed on 220 patients who
completed the primary outcome measure within a
window of 14-20 weeks. Mean RSI scores were
similar between treatment arms at baseline:
lansoprazole 22.0 (95% confidence interval 20.4 to
23.6) and placebo 21.7 (20.5 to 23.0).
Improvements (reduction in RSI score) were
observed in both groups—score at 16 weeks:
lansoprazole 17.4 (15.5 to19.4) and placebo 15.6
(13.8 to 17.3). No statistically significant
difference was found between the treatment arms:
estimated difference 1.9 points (95% confidence
interval −0.3 to 4.2 points; P=0.096) adjusted for
site and baseline symptom severity. Lansoprazole
showed no benefits over placebo for any secondary
outcome measure, including RSI scores at 12
months: lansoprazole 16.0 (13.6 to 18.4) and
placebo 13.6 (11.7 to 15.5): estimated difference
2.4 points (−0.6 to 5.4 points). Conclusions No evidence was found of benefit from PPI
treatment in patients with persistent throat
symptoms. RSI scores were similar between the
lansoprazole and placebo groups after 16 weeks of
treatment and at the 12 month follow-up. Trial registration ISRCTN Registry ISRCTN38578686 and EudraCT
2013-004249-17.
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