Lansoprazole for persistent throat symptoms in secondary care: the TOPPITS RCT.
Abstract
BACKGROUND
Persistent throat symptoms are commonly attributed to 'laryngopharyngeal reflux'. Despite a limited evidence base, these symptoms are increasingly being treated in primary care with proton pump inhibitors.
OBJECTIVE
To assess the value of proton pump inhibitor therapy in patients with persistent throat symptoms.
DESIGN
This was a double-blind, placebo-controlled, randomised Phase III trial.
SETTING
This was a multicentre UK trial in eight UK ear, nose and throat departments.
PARTICIPANTS
A total of 346 participants aged ≥ 18 years with persistent throat symptoms and a Reflux Symptom Index score of ≥ 10, exclusive of the dyspepsia item, were recruited.
INTERVENTION
Random allocation (1 : 1 ratio) to either 30 mg of lansoprazole twice daily or matched placebo for 16 weeks.
MAIN OUTCOME MEASURE
Symptomatic response (i.e. total Reflux Symptom Index score after 16 weeks of therapy).
RESULTS
A total of 1427 patients were screened and 346 were randomised. The mean age was 52 years (standard deviation 13.7 years, range 20-84 years); 150 (43%) participants were male and 196 (57%) were female; 184 (53%) participants had a mild Reflux Symptom Index minus the heartburn/dyspepsia item and 162 (47%) had a severe Reflux Symptom Index minus the heartburn/dyspepsia item. A total of 172 patients were randomised to lansoprazole and 174 were randomised to placebo.
MAIN OUTCOMES
A total of 267 participants completed the primary end-point visit (lansoprazole, n = 127; placebo, n =…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,427 participants or records.
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