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Chronic rhinosinusitis (CRS), or sinusitis, is a long-term condition affecting one in 10 UK adults. Symptoms include a blocked and runny nose, loss of smell, facial pain, tiredness and worsening of breathing problems, such as asthma. It’s often similar to the symptoms of a bad cold, but it can last for months or even years.
The team carried out a randomised controlled patient trial comparing sinus surgery with long-term use of antibiotics, and a placebo drug.
More than 500 patients took part from around the UK, and all of them used nasal steroids and saline rinses as part of their usual care – both of which have been shown to help the condition.
The researchers found that surgery was most effective at relieving sinusitis symptoms, and trial participants were still feeling better six months later, according to the findings published in The Lancet. Of those who underwent surgery, 87% said their quality of life had improved six months on.
A three-month course of low dose antibiotics was not found to be helpful as there was no significant difference in outcomes between those on antibiotics and those in the placebo arm of the trial.
The study is part of the MACRO programme, involving a collaborative group of researchers from UCL (the trial’s sponsor), the University of Oxford, the University of East Anglia (UEA), Guy’s and St Thomas’ NHS Foundation Trust, the University of Southampton, UCLH, and Imperial College London. The programme is funded by the National Institute for Health and Care Research.
Professor Jonathan Cook, Interim Co-Director of OCTRU and chief methodologist for the study said: ‘Chronic rhinosinusitis can have a major effect on quality of life but there has been some uncertainty about the benefit of surgery to patients despite widespread use. Additionally, the potential benefit of clarithromycin, an antibiotic used to treat various infections, was unclear. This has contributed to varying access to different treatment options for patients across the UK in recent years. It’s has been great to be involved from the beginning to shape the design of MACRO study to ensure it addresses these two important areas of uncertainty. OCTRU was set-up to deliver important studies like this, which are designed and conducted in a reliable way, and in order to help patients and doctors make informed decisions.’
For the trial, all participants received nasal steroids and saline rinses as standard care, alongside their randomly allocated treatment option of either sinus surgery, antibiotics or placebo tablets. They were followed up after three and six months, where researchers examined their nose and sinuses, took airflow readings and conducted smell tests to gauge the success of each treatment in terms of improvement of symptoms, quality of life and possible side effects.
Professor David Beard, Director of SITU and one of the co-applicants said: ‘The findings of our study could be a game-changer for patients worldwide. The efficient trial design for MACRO (answering two questions at once) is exactly the sort of evaluation we should be doing to discover the efficacy of common surgery and pharmaceutical interventions. It has been a longish journey but the commitment of all our investigators, clinicians, research nurses, and of course our patient participants across 20 UK sites, has delivered a wonderful landmark study.’
Jim Boardman, MACRO patient representative, said: 'I’ve lived under a cloud for years with CRS, as have many others I’ve met with the same condition. There’s a persistent headache and blocked nose along with the loss of sense of smell, which removes a whole dimension of everyday experience and enjoyment. A clear path to successful treatment will be welcomed by all CRS sufferers.'
The researchers are now continuing their research to assess the cost-effectiveness of sinus surgery, while also continuing to follow up trial participants over longer periods of time to see how long the benefits last.