NIHR Signal Saline irrigation and corticosteroid spray are effective first choice treatments for chronic sinusitis

Published on 22 December 2015

The authors of this systematic review found that high-volume saline irrigation and corticosteroid nasal sprays were effective at reducing symptoms of sinusitis. They recommend a combination of these two therapies as the first line treatment of choice, in accordance with guidelines from the Royal College of Surgeons and ENT UK.

In addition they found that, in those with nasal polyps, corticosteroids sprays reduced the polyp size, and during acute exacerbations a two to three week course of oral corticosteroids, doxycycline or a leukotriene antagonist was the most effective strategy. For those without polyps a three month course of a macrolide antibiotic may be most effective. Chronic sinusitis is likely to be caused by a range of different factors and future research should try and subdivide cases where possible, based on the cause. The cost effectiveness of some options such as the leukotriene antagonists were not considered in their recommendation.

Saline irrigation and corticosteroid spray are effective first choice treatments for chronic sinusitis

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Why was this study needed?

The sinuses are small, air-filled cavities behind the cheekbones and forehead. Sinuses produce mucus, which drains through small channels into the nose. In sinusitis, the lining of the sinuses becomes inflamed and the channels blocked, causing symptoms such as headaches, facial tenderness and blocked or runny nose. Chronic sinusitis is when symptoms last longer than 12 weeks. It is estimated to affect about 10% of adults in the UK, though is more common in smokers.

The causes of chronic sinusitis remain unclear. The condition is usually defined by the presence or absence of nasal polyps, which are swellings of the mucous lining of the sinuses that protrude into the nose. There are a range of possible medical and surgical treatments for chronic sinusitis. This review sought to identify the most effective treatments for the medical management of adult chronic sinusitis.

What did this study do?

This was a systematic review of randomised controlled trials (RCTs) and other systematic reviews and meta-analyses that had investigated the effectiveness of medical treatments for chronic sinusitis in adults. Surgical techniques were not considered. Treatments were split into those primarily aimed at maintenance or symptom control and those aimed at providing intermittent or rescue treatment during acute exacerbations when symptoms are particularly bad.

Twenty-nine studies were included: 12 meta-analyses (including over 60 RCTs), 13 systematic reviews and four additional RCTs. The authors assessed each of these studies and assigned it a level of evidence. For each review question, results were taken from the study assigned the highest level of evidence.

Some of the included studies contained moderate to high risk of bias, such as biased allocation to treatment or control groups. Studies also varied in the diagnostic criteria used or included mixed groups of sinusitis patients, both with and without nasal polyps. However, the results for saline irrigation and nasal corticosteroids came from large meta-analyses including a large number of people and were reliable.

What did it find?

Maintenance treatment:

  • Saline irrigation resulted in a large improvement in symptoms compared with no treatment (standardised mean difference [SMD] 1.42, 95% confidence interval [CI] 1.01 to 1.84). This result came from a meta-analysis of eight studies that included almost 400 people with and without nasal polyps. High volume (greater than 100ml) irrigation was superior to lower volume techniques.
  • In people with polyps, corticosteroid nasal spray moderately reduced symptom score compared to placebo (SMD -0.46, 95% CI -0.65 to -0.27). It also reduced polyp size (SMD -0.73, 95% CI -1 to -0.46) and risk of polyp recurrence after surgery by about 40% (relative risk [RR] 0.59, 95% CI 0.45 to 0.79). These results came from the largest meta-analysis including 40 studies and 3,624 people with nasal polyps. Similar improvements in symptoms were seen in two other meta-analyses of people with polyps, and two smaller meta-analyses of people without nasal polyps.

Intermittent or rescue treatment:

  • For people with polyps, there was some evidence that three weeks treatment with oral corticosteroids or oral doxycycline (an antibiotic) reduced polyp size compared to placebo for three months after treatment. Leukotriene antagonists (normally used for asthma treatment) also improved symptoms compared to placebo. These results were from a systematic review without meta-analysis.
  • For people without polyps, macrolide antibiotics for three months improved quality of life compared to placebo (SMD -0.43, 95% CI -0.82 to -0.05). This was from a meta-analysis of two studies.

What does current guidance say on this issue?

There is no NICE guidance on the management of chronic sinusitis. A 2013 commissioning guide from the Royal College of Surgeons and ENT UK recommends offering all patients saline irrigation and nasal corticosteroids. It also suggests oral corticosteroid (prednisolone) followed by nasal drops for those with nasal polyps, and to re-assess symptoms after three months.

Clinical Knowledge Summaries, a decision support tool published by NICE, suggests a range of options to consider. They include nasal corticosteroids for up to three months, especially if there is suspicion of an allergic cause. They also suggest that nasal irrigation with saline solution may relieve congestion and nasal discharge, and if the person suffers from recurrent acute episodes then occasional use of a nasal decongestant may be warranted for a maximum of one week.

What are the implications?

The review suggests that the treatment of choice should be a combination of high-volume saline irrigation with nasal corticosteroid spray. During acute exacerbations, a two to three week course of oral corticosteroids, doxycycline or a leukotriene antagonist may be considered for people with nasal polyps, while a three month course of macrolide antibiotics may be suitable for those without polyps.

An evidence-based algorithm for the treatment of chronic sinusitis in adults, based on the results of the review, is provided in the article. It includes dosages, length of treatment and alternative therapies to consider.

The authors suggest that future research should consider further ways to classify chronic sinusitis, rather than just on whether or not nasal polyps are present. Treatment ideally needs to be personalised based on the causative factors at work.

Citation

Rudmik L, Soler ZM. Medical therapies for adult chronic sinusitis: a systematic review. JAMA. 2015;314(9):926-39.

Bibliography

Clinical Knowledge Summaries. Sinusitis. London: National Institute for Health and Care Excellence; 2013.

Commissioning guide: rhinosinusitis. London: Royal College of Surgeons and ENT UK; 2013.

Fokkens WJ, Lund VJ, Mullol J, et al. European position paper on rhinosinusitis and nasal polyps 2012. Rhinol Suppl 2012;(23):1–298.

Hastan D, Fokkens WJ, Bachert C, et al. Chronic rhinosinusitis in Europe – an underestimated disease. A GA²LEN study. Allergy 2011;66(9):1216–231.

Patient UK. Sinusitis: professional reference. Leeds: EMIS Group; 2014.

Why was this study needed?

The sinuses are small, air-filled cavities behind the cheekbones and forehead. Sinuses produce mucus, which drains through small channels into the nose. In sinusitis, the lining of the sinuses becomes inflamed and the channels blocked, causing symptoms such as headaches, facial tenderness and blocked or runny nose. Chronic sinusitis is when symptoms last longer than 12 weeks. It is estimated to affect about 10% of adults in the UK, though is more common in smokers.

The causes of chronic sinusitis remain unclear. The condition is usually defined by the presence or absence of nasal polyps, which are swellings of the mucous lining of the sinuses that protrude into the nose. There are a range of possible medical and surgical treatments for chronic sinusitis. This review sought to identify the most effective treatments for the medical management of adult chronic sinusitis.

What did this study do?

This was a systematic review of randomised controlled trials (RCTs) and other systematic reviews and meta-analyses that had investigated the effectiveness of medical treatments for chronic sinusitis in adults. Surgical techniques were not considered. Treatments were split into those primarily aimed at maintenance or symptom control and those aimed at providing intermittent or rescue treatment during acute exacerbations when symptoms are particularly bad.

Twenty-nine studies were included: 12 meta-analyses (including over 60 RCTs), 13 systematic reviews and four additional RCTs. The authors assessed each of these studies and assigned it a level of evidence. For each review question, results were taken from the study assigned the highest level of evidence.

Some of the included studies contained moderate to high risk of bias, such as biased allocation to treatment or control groups. Studies also varied in the diagnostic criteria used or included mixed groups of sinusitis patients, both with and without nasal polyps. However, the results for saline irrigation and nasal corticosteroids came from large meta-analyses including a large number of people and were reliable.

What did it find?

Maintenance treatment:

  • Saline irrigation resulted in a large improvement in symptoms compared with no treatment (standardised mean difference [SMD] 1.42, 95% confidence interval [CI] 1.01 to 1.84). This result came from a meta-analysis of eight studies that included almost 400 people with and without nasal polyps. High volume (greater than 100ml) irrigation was superior to lower volume techniques.
  • In people with polyps, corticosteroid nasal spray moderately reduced symptom score compared to placebo (SMD -0.46, 95% CI -0.65 to -0.27). It also reduced polyp size (SMD -0.73, 95% CI -1 to -0.46) and risk of polyp recurrence after surgery by about 40% (relative risk [RR] 0.59, 95% CI 0.45 to 0.79). These results came from the largest meta-analysis including 40 studies and 3,624 people with nasal polyps. Similar improvements in symptoms were seen in two other meta-analyses of people with polyps, and two smaller meta-analyses of people without nasal polyps.

Intermittent or rescue treatment:

  • For people with polyps, there was some evidence that three weeks treatment with oral corticosteroids or oral doxycycline (an antibiotic) reduced polyp size compared to placebo for three months after treatment. Leukotriene antagonists (normally used for asthma treatment) also improved symptoms compared to placebo. These results were from a systematic review without meta-analysis.
  • For people without polyps, macrolide antibiotics for three months improved quality of life compared to placebo (SMD -0.43, 95% CI -0.82 to -0.05). This was from a meta-analysis of two studies.

What does current guidance say on this issue?

There is no NICE guidance on the management of chronic sinusitis. A 2013 commissioning guide from the Royal College of Surgeons and ENT UK recommends offering all patients saline irrigation and nasal corticosteroids. It also suggests oral corticosteroid (prednisolone) followed by nasal drops for those with nasal polyps, and to re-assess symptoms after three months.

Clinical Knowledge Summaries, a decision support tool published by NICE, suggests a range of options to consider. They include nasal corticosteroids for up to three months, especially if there is suspicion of an allergic cause. They also suggest that nasal irrigation with saline solution may relieve congestion and nasal discharge, and if the person suffers from recurrent acute episodes then occasional use of a nasal decongestant may be warranted for a maximum of one week.

What are the implications?

The review suggests that the treatment of choice should be a combination of high-volume saline irrigation with nasal corticosteroid spray. During acute exacerbations, a two to three week course of oral corticosteroids, doxycycline or a leukotriene antagonist may be considered for people with nasal polyps, while a three month course of macrolide antibiotics may be suitable for those without polyps.

An evidence-based algorithm for the treatment of chronic sinusitis in adults, based on the results of the review, is provided in the article. It includes dosages, length of treatment and alternative therapies to consider.

The authors suggest that future research should consider further ways to classify chronic sinusitis, rather than just on whether or not nasal polyps are present. Treatment ideally needs to be personalised based on the causative factors at work.

Citation

Rudmik L, Soler ZM. Medical therapies for adult chronic sinusitis: a systematic review. JAMA. 2015;314(9):926-39.

Bibliography

Clinical Knowledge Summaries. Sinusitis. London: National Institute for Health and Care Excellence; 2013.

Commissioning guide: rhinosinusitis. London: Royal College of Surgeons and ENT UK; 2013.

Fokkens WJ, Lund VJ, Mullol J, et al. European position paper on rhinosinusitis and nasal polyps 2012. Rhinol Suppl 2012;(23):1–298.

Hastan D, Fokkens WJ, Bachert C, et al. Chronic rhinosinusitis in Europe – an underestimated disease. A GA²LEN study. Allergy 2011;66(9):1216–231.

Patient UK. Sinusitis: professional reference. Leeds: EMIS Group; 2014.

Medical Therapies for Adult Chronic Sinusitis: A Systematic Review

Published on 2 September 2015

Rudmik, L.,Soler, Z. M.

Jama Volume 314 , 2015

IMPORTANCE: Chronic sinusitis is a common inflammatory condition defined by persistent symptomatic inflammation of the sinonasal cavities lasting longer than 3 months. It accounts for 1% to 2% of total physician encounters and is associated with large health care expenditures. Appropriate use of medical therapies for chronic sinusitis is necessary to optimize patient quality of life (QOL) and daily functioning and minimize the risk of acute inflammatory exacerbations. OBJECTIVE: To summarize the highest-quality evidence on medical therapies for adult chronic sinusitis and provide an evidence-based approach to assist in optimizing patient care. EVIDENCE REVIEW: A systematic review searched Ovid MEDLINE (1947-January 30, 2015), EMBASE, and Cochrane Databases. The search was limited to randomized clinical trials (RCTs), systematic reviews, and meta-analyses. Evidence was categorized into maintenance and intermittent or rescue therapies and reported based on the presence or absence of nasal polyps. FINDINGS: Twenty-nine studies met inclusion criteria: 12 meta-analyses (>60 RCTs), 13 systematic reviews, and 4 RCTs that were not included in any of the meta-analyses. Saline irrigation improved symptom scores compared with no treatment (standardized mean difference [SMD], 1.42 [95% CI, 1.01 to 1.84]; a positive SMD indicates improvement). Topical corticosteroid therapy improved overall symptom scores (SMD, -0.46 [95% CI, -0.65 to -0.27]; a negative SMD indicates improvement), improved polyp scores (SMD, -0.73 [95% CI, -1.0 to -0.46]; a negative SMD indicates improvement), and reduced polyp recurrence after surgery (relative risk, 0.59 [95% CI, 0.45 to 0.79]). Systemic corticosteroids and oral doxycycline (both for 3 weeks) reduced polyp size compared with placebo for 3 months after treatment (P < .001). Leukotriene antagonists improved nasal symptoms compared with placebo in patients with nasal polyps (P < .01). Macrolide antibiotic for 3 months was associated with improved QOL at a single time point (24 weeks after therapy) compared with placebo for patients without polyps (SMD, -0.43 [95% CI, -0.82 to -0.05]). CONCLUSIONS AND RELEVANCE: Evidence supports daily high-volume saline irrigation with topical corticosteroid therapy as a first-line therapy for chronic sinusitis. A short course of systemic corticosteroids (1-3 weeks), short course of doxycycline (3 weeks), or a leukotriene antagonist may be considered in patients with nasal polyps. A prolonged course (3 months) of macrolide antibiotic may be considered for patients without polyps.

Polyps are fleshy bulges in the lining of the sinuses and nose which may eventually become larger grape-like lumps and can block the nasal passages. The interventions discussed in this article work by various methods. Corticosteroids reduce inflammation, decrease vascular permeability and reduce the release of mucus. Saline irrigation helps remove mucus and may remove the environmental triggers that cause the symptoms. It also assists in restoring normal mucus clearance from the respiratory tract. Doxycycline and other antibiotics (macrolide and non-macrolide) eradicate infection through a range of mechanisms, such as inhibiting bacterial cell wall formation or fragmenting bacterial DNA. Leukotriene antagonists block the action of leukotrienes which are inflammatory chemicals released by the body after coming in contact with an allergy trigger.

Expert commentary

The conclusions reached are the same as those of the European position paper on sinusitis in 2012. Adults receiving treatment for chronic sinusitis from their GP tend to receive multiple medications, with 91% receiving an antibiotic prescription even though commissioning guidance does not recommend antibiotic use in primary care. GPs often prescribe repeated courses, which may cause resistance. There is growing interest in immune-modulating effects of macrolide antibiotics in chronic airway inflammatory disease, with low-dose long term macrolide being prescribed for its immune response and not primarily as an anti-bacterial agent. Recently, some Clinical Commissioning Groups have insisted on a three month trial of macrolide antibiotics prior to secondary care referral, despite a lack of high-level evidence.

Symptom duration before surgery varies from under one to over 10 years. If surgery is less effective than continued medical therapy, patients may be exposed to unnecessary risks and morbidity. If better, current delays reflect suboptimal patient care.

Carl Philpott, ENT Lead for Eastern Clinical Research Network and Patient and Public Involvement Champion for NIHR ENT Specialty Group, Honorary Consultant ENT Surgeon and Rhinologist, James Paget University Hospital