A comprehensive clinical trial sponsored by University College London (UCL), the University of East Anglia, and Guy's and St Thomas' NHS Foundation Trust found that sinus surgery is more effective than antibiotics at treating chronic rhinosinusitis.
One in every ten
people in the United Kingdom suffers from chronic rhinosinusitis (CRS),
sometimes known as sinusitis. Symptoms include a blocked and runny nose, loss
of smell, facial pain, fatigue, and worsening of respiratory difficulties, such
as asthma. It generally resembles the symptoms of a bad cold, but it can
persist for months or even years.
The team conducted a randomised controlled
patient trial comparing sinus surgery with long-term antibiotic use and a
placebo.
More than 500
patients from around the UK participated, all of whom used nasal steroids and
saline rinses as part of their usual care - both of which have been shown to
help alleviate the condition.
The researchers found that surgery was effective
at relieving sinusitis symptoms, and trial participants who underwent surgery
were still feeling better six months later, according to the findings published
in The Lancet. Of those who underwent surgery, 87 per cent 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 East Anglia (UEA), Guy's and St Thomas' NHS Foundation Trust,
the University of Southampton, the University of Oxford, UCLH, and Imperial
College London. The programme is funded by the National Institute for Health
and Care Research.
Lead author Professor Carl Philpott, from UEA's
Norwich Medical School, one of the Chief Investigators of the MACRO trial,
said, "Chronic rhinosinusitis causes the spaces inside the nose and head,
called sinuses, to become inflamed and swollen. This common condition keeps
mucus from draining. It gives patients a very stuffy nose, breathing through
the nose can be really hard, and it is the major underlying cause of smell loss
in the general population. What we found is that surgery was effective at
reducing symptoms six months on, while taking the course of antibiotics seemed
to make little difference."
"We hope our findings will help reduce the
length of time for patients to get treatment. Streamlining clinical pathways
will help reduce unnecessary visits and consultations, and save on healthcare
resources."
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 Claire Hopkins (Guy's Hospital,
London), one of the Chief Investigators of the MACRO trial, said,
"Although sinus surgery is commonly performed within the NHS, uncertainty
regarding its effectiveness has led to restricted access for many patients in
the NHS. The results of the MACRO trial highlight the significant improvements
in quality of life that many patients experience after surgery, and should give
them and their referring primary care doctors more confidence in seeking
treatment for chronic rhinosinusitis. We hope that this work will enhance the
care for adult patients with chronic rhinosinusitis within the NHS, and
beyond."
Study co-author Professor Anne Schilder (UCL Ear
Institute), director of the NIHR UCLH Biomedical Research Centre Hearing Health
Theme, who is leading the project at UCL, commented, "Here we have
provided robust evidence that surgery is an effective means to treat chronic
rhinosinusitis when local treatments have failed, which should be welcome news
to the large numbers of people with the condition."
"The MACRO trial has shown the value of
research collaboration across specialities and organisations. It was the first
NIHR programme grant for our speciality, recognising the need for better
evidence for the management of common ENT conditions and the strength of our
collaborative team. The commitment of our investigators, research nurses and of
course our patient participants across 20 UK sites made it a success."
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. (ANI)
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