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Drugs called proton pump inhibitors (PPIs) are increasingly used to treat throat symptoms such as the feeling of a lump in the throat or throat clearing. However, new research found PPIs offer no benefit over dummy pills. The researchers say these drugs should not be prescribed to treat throat symptoms.

Persistent throat symptoms, which also include a hoarse voice or coughing, are common reasons for people to attend hospital throat or voice clinics. GPs and hospital doctors often prescribe PPIs to treat these symptoms.

PPI drugs reduce the amount of acid the stomach makes. They are believed to ease throat symptoms by reducing the amount of acid escaping from the stomach into the throat (known as silent or laryngopharyngeal reflux).

This study, the largest of its kind, showed that a typical PPI drug, lansoprazole, does not improve symptoms. The researchers say the routine practice of giving this medication for unexplained throat symptoms should stop. Other potentially helpful approaches should be explored instead.

What’s the issue?

Persistent throat symptoms are a common reason for people to go to their GP, and for GPs to refer people to hospital throat or voice clinics. In one year alone, the researchers estimate that more than 57,000 people were referred for this reason.

Symptoms include a feeling of a lump in the throat, a cough, throat clearing, or a hoarse voice. The sensation of a lump in the throat affects up to half of the general population at some stage.

To treat the symptoms, GPs and hospital doctors regularly prescribe PPIs. This is in the belief that the throat symptoms are caused by stomach acid entering the throat (known as silent or laryngopharyngeal reflux). Despite their widespread use, there is little evidence to show these medications are effective.

PPI drugs such as omeprazole, lansoprazole, pantoprazole are not expensive. But they are prescribed in vast numbers and this costs the NHS more than £300 million a year. They can interact with people’s other medications and may cause side effects. When taken for a short time, any side effects are usually mild and include headaches and feeling sick. When taken for a long time, side effects from PPIs can be serious, including an increased risk of bone fractures.

The current study set out to determine whether PPIs offer any benefit for persistent throat symptoms.

What’s new?

The study included 346 adults with persistent, unexplained throat symptoms (lasting for more than 6 weeks). They were being treated at eight NHS hospitals in the UK.

Each participant took two pills daily for 16 weeks. Half of the participants were given PPIs (lansoprazole); the other half were given identical-looking dummy pills (placebo). People did not know which pill they were taking.

Participants completed questionnaires before they began taking the pills, 16 weeks later, and at 12 months. The questionnaires measured symptoms and quality of life.

People in both the PPI and placebo groups reported similar improvements in throat symptoms. There was no benefit in taking the PPI.

The study found that:

    • throat symptoms and quality of life improved in both groups at 16 weeks and 12 months
    • improvements were no better for people who had taken PPIs compared to those on placebo; this was true whether their symptoms were mild or severe at the beginning of the study
    • the findings were the same regardless of participants’ age, sex, whether or not they smoked, their alcohol consumption or their weight
    • reported side effects were similar in both groups and included headaches, diarrhoea, and feeling sick
    • there was a single severe side effect (a rash) in the PPI group.

Why is this important?

PPIs are commonly prescribed for persistent throat symptoms. This research found they are no more effective at improving symptoms than dummy pills.

This was the largest trial of its kind. It specifically tested the PPI lansoprazole, but the researchers suggest the findings apply equally to other PPIs (omeprazole, pantoprazole). The findings are particularly relevant to non-specialists, including GPs and patients. The new evidence should inform decisions about treatment for persistent throat symptoms.

PPIs may have side effects, especially after long-term use, and they cost the NHS money. Vast numbers of PPI prescriptions are given each year to people with unexplained throat symptoms. The current study suggests this practice should stop.

Both groups in the study reported an improvement in throat symptoms over time. But participants were still left with more symptoms than others in the general population. There is a clear need to find effective treatments.

What’s next?

Since PPIs are no more effective than placebo, healthcare professionals should not prescribe them to patients for unexplained throat symptoms.

Future research should focus on new approaches for persistent throat symptoms. These could include therapies to address anxieties or alter behaviours. Other medicines might also help. The researchers are planning a trial to test the effectiveness of over-the-counter seaweed preparations (such as Gaviscon). It forms a protective layer that floats on top of the contents of the stomach. This stops stomach acid escaping. Many people with persistent throat symptoms try this medication, but it is not known if it is more effective than placebo.

The researchers say that their findings, which suggest a common treatment should be stopped, need to be included in guidelines. Currently, however, there are no national guidelines for persistent throat symptoms.

You may be interested to read

This NIHR Alert is based on: Wilson JA, and others. Lansoprazole for persistent throat symptoms in secondary care: the TOPPITS RCT. Health Technology Assessment 2021;25:3

Another summary of this research: O’Hara, J, and others. Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo-controlled trial. BMJ 2021;372:m4903

 

Funding: This research was funded by the NIHR Health Technology Assessment programme.

Conflicts of Interest: The study authors declare no conflicts of interest.

Disclaimer: NIHR Alerts are not a substitute for professional medical advice. They provide information about research which is funded or supported by the NIHR. Please note that views expressed in NIHR Alerts are those of the author(s) and reviewer(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.


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Comments

Study author

A lot of people suffer with persistent throat symptoms. Traditionally, these have proven difficult to treat. There’s a popular myth that the symptoms are related to stomach acid. Without a robust UK trial, we saw nothing to question the increasing prescription of acid-suppressing medication.Our study clearly shows no benefit over placebo in treating persistent throat symptoms. The findings are definitive and should change practice.We know these stomach acid-reducing drugs are widely prescribed in primary and secondary care. Our findings show they should not be used just to give the patient something to try. People actually need their symptoms addressing, and this evidence should encourage research into more effective treatments.James O’Hara, Clinical Senior Lecturer, Newcastle University. Honorary Consultant Ear Nose & Throat (ENT) surgeon, Newcastle upon Tyne Hospitals NHS Foundation Trust 

Professional organisations  

Chronic throat symptoms are highly prevalent in the UK adult population and the NHS presently has no comprehensive guidelines for their management. These symptoms are commonly treated with PPIs and attributed to ‘laryngopharyngeal reflux’, which does not have a universally agreed definition.ENT UK and the British Laryngological Association (BLA) welcome the report’s findings. Empirical and indiscriminate use of PPIs accounts for significant direct and indirect costs, both to patients and to the healthcare system. Blind use of PPIs in the absence of gastroesophageal reflux symptoms should be discouraged. Often PPIs are prescribed without necessary dietary and lifestyle enquiry. Many factors should be considered in making a diagnosis, including allergic predisposition, eating habits, diet and psycho-social factors.This study illustrates the positive placebo benefit of intervention, rather than the impact of PPIs. It invites multidisciplinary follow-on research into alternative therapies for mental health and well-being, lifestyle and eating habits.Samit Majumdar on behalf of the British Laryngological Association and Taran Tatla on behalf of ENT UK 

ENT Consultant 

This is an excellent study. The impact could be very great indeed. Non-specific throat symptoms are common, and anecdotally may have become even more common during the COVID-19 pandemic. They account for a lot of primary care attendances and reattendances each year, as well as secondary care referrals.Better education for professionals managing these patients is needed to reduce the use of PPIs. Better public education is also needed on the potential links between their symptoms and diet, exercise, work-life balance, and mental health.Many patients, especially the growing elderly population, take PPIs for years through repeat prescriptions in primary care. Longer-term risks to their bone and gut health are significant.Stopping PPIs for non-specific throat symptoms could help reduce the very large drug budget for PPIs. It could also lead to indirect cost savings through the investigation of alternative treatment options. These include dietary, lifestyle, and mental health therapies, as well as other pharmaceutical agents (alginates, anti-cough, allergy agents) and herbal remedies (honey).Taran Tatla, Consultant ENT Surgeon, London North West Healthcare NHS Trust 

Member of the public 

The findings are relevant to the general public, especially people in middle age upwards, as throat problems are widespread.The study raises interesting questions about the placebo effect, or the effect of being listened to, on some health outcomes. Further study into lifestyle, mental health and wellbeing could help find a non-pharmaceutical treatment for a number of sufferers.Sara Kirkham, Public Contributor, Manchester 
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