Are PPIs Effective for Treating Persistent Throat Symptoms?

Proton pump inhibitors are not effective for treating persistent throat symptoms, according to the results of a new study.

The researchers conducted a pragmatic, double-blind, placebo-controlled, randomized trial that compared the proton pump inhibitor (PPI) lansoprazole to placebo. The primary outcome of this trial was symptomatic response at 16 weeks of use, with the secondary outcomes being symptom response at 12 months, quality of life, and throat appearances. Outcomes were measured through the total reflux symptom index (RSI) score.

Included in the study were 346 patients with mild or severe persistent throat symptoms. All participants were aged 18 years or older, and presented to 1 of 8 ear, nose, and throat outpatient clinics within the United Kingdom. Of the total participants, 57% were female and the mean age was 52.2 years.

The participants were randomly assigned to either 30 mg of lansoprazole (n= 172) or placebo (n= 174) twice daily for the 16-week study period. Severe symptoms were present in 47% of all participants (n= 162), and the patients were randomized by baseline symptom severity.

Of the 346 participants included in the study, 220 individuals were included in the primary analysis as they completed the primary outcome measure within the 14-20-week window.

Not only were the mean RSI scores similar for lansoprazole and placebo at baseline (22.0 and 21.7, respectively), but the results indicated a similar reduction in RSI scores at 16 weeks for both lansoprazole (17.4, 15.5 to 19.4) and placebo (15.6, 13.8 to 17.3). These improved RSI scores were adjusted for site and baseline symptom severity. The researchers did not observe a statistically significant difference between the groups.

In addition, lansoprazole was not more beneficial than placebo for any subsequent measures, including the RSI score at 12 months (16.0 and 13.6, respectively).

“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,” the researchers concluded.

—Leigh Precopio

Reference:

O’Hara J, Stocken DD, Watson GC, et al. Use of proton pump inhibitors to treat persistent throat symptoms: multicenter, double blind, randomized, placebo-controlled trial. BMJ. 2021; 372: m4903. doi: 10.1136/bmj.m4903