Nasal saline irrigations for the symptoms of chronic rhinosinusitis
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To evaluate the effectiveness and safety of topical saline in the management of chronic rhinosinusitis.
Background
Chronic rhinosinusitis (CRS) is common disorder with a significant impact on the quality of life and health burden within the adult population (Gliklich 1995). Chronic rhinosinusitis is thought to affect between 5% and 15% of the population (Melen 1994). The diagnosis of rhinosinusitis is based on sino‐nasal symptoms and is considered chronic when these have been present for 12 weeks or more (EPOS 2005). The recognition that rhinitis and sinusitis coexist and are concurrent in most individuals has allowed both these groups to evolve into the common terminology of rhinosinusitis (EPOS 2005). It is a diagnosis that is made by a wide variety of practitioners, including primary care physicians, otolaryngologists, immunologists, allergists and respiratory physicians. It is the principal diagnosis in nearly 2% of all patient visits to primary care (Schappert 1992). Medical therapy has been the basis for treating chronic rhinosinusitis. Short and long‐term antibiotic therapy, topical and systemic steroids, topical and oral decongestants, oral antihistamines, mast cell stabilisers, anti‐leukotriene agents, mucolytics, topical antibiotics, topical and systemic antimycotics, proton pump inhibitors, bacterial lysates, immunotherapy, phytotherapy and avoidance of environmental factors have all played a role in the management of chronic rhinosinusitis (EPOS 2005). Surgery has an important, albeit evolving, role in the management of chronic rhinosinusitis (Smith 2005). Common to both modern and traditional therapy regimes is nasal irrigation. Delivered by bottle, spray, pump or nebuliser, the topical use of saline has been included as a supplement to most treatment protocols.
Saline irrigations and sprays are commonly upheld as a homeopathic adjunct in the treatment of sino‐nasal disease. The nature of its benefit is difficult to define physiologically. The mechanical clearance of mucous alone is commonly proposed for the basis of its benefit. However, there is an increasing perception that saline has a contributory role in the resolution of inflammation and not just symptom relief. Many theories exist on the potential beneficial physiological effects of topical saline. Improvement in mucous clearance, enhanced ciliary beat activity, removal of antigen, biofilm or inflammatory mediators and a protective role on sino‐nasal mucosa have all been proposed. At its most homeopathic foundations, saline irrigation may have an impact on managing the symptoms solely attributable to chronic rhinosinusitis.
Currently the medical literature includes recommendations for saline in a variety of sino‐nasal complaints:
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Allergic rhinitis (IRMWS 1994)
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Pregnancy rhinitis (Ellegard 2006)
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Pediatric chronic sinusitis (Muntz 2004)
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Primary care recommendations (Seaton 1998)
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Sinonasal sarcoid (Long 2001)
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Wegner's granulomatosis (Tami 2005)
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Chronic rhinosinusitis (EPOS 2005)
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Post‐operative care (Seppey 1996)
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Decontamination of radioactive material (Berger 2003)
So ubiquitous is its use, the recommendation that saline should be used as a routine adjuvant to every treatment of acute or chronic rhinopathy has also been made (Passali 2005).
The direct clinical effectiveness of saline in treatment protocols in not clear. We will assess the evidence for the clinical effectiveness of topical saline therapy in the management of chronic rhinosinusitis.
Objectives
To evaluate the effectiveness and safety of topical saline in the management of chronic rhinosinusitis.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials which fulfil the criteria outlined below. Controlled clinical trials will also be identified by the search.
Types of participants
Adults and children with the symptoms of chronic rhinosinusitis. This will include patients suffering from persistent allergic rhinitis and chronic rhinosinusitis (EPOS 2005). Endoscopic and CT evidence of sinusitis will not be essential as recruitment from the primary care setting is anticipated.
Types of interventions
The use of saline delivered to the nose by any means (douche, irrigation, pulsed, spray or nebuliser) where treatment comparison groups include:
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Saline versus no saline
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Saline versus 'placebo'
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Standard therapy with saline versus standard therapy alone
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Saline alone versus active agent
The 'placebo' for nasal saline irrigation will encompass any intervention which has no known biological activity but provides a similar level of interaction within the setting of chronic disease. The aim of 'placebo' in this setting is to reduce the maintenance and performance bias of patients within trials.
Standard therapy with saline versus standard therapy alone for chronic rhinosinusitis will include any commonly used agents as outlined in EPOS 2005, where the addition of saline has been used to directly assess the benefit of its addition. Trials that use saline as a placebo for other therapies, and not for therapeutic intent, will be excluded.
Types of outcome measures
Primary outcomes
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Validated quality of life measures, both generic and disease specific
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Symptom scores (visual analogue scores or Likert scores)
Secondary outcomes
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Adverse events
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Radiological scores (Lund and Mackay CT scores)
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Endoscopic scores (Lund or EPOS)
Search methods for identification of studies
We will search the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, current issue), MEDLINE (1950 onwards), EMBASE (1974 onwards), CINAHL (Cumulative Index to Nursing and Allied Health Literature), mRCT (metaRegister of Controlled Trials, including www.ClinicalTrials.gov), NRR (National Research Register), LILACS, KoreaMed, IndMED, PakMediNet, Scolio, Zetoc and ISI Proceedings.
CENTRAL will be searched using the following strategy:
#1 NOSE single term (MeSH)
#2 NASAL CAVITY single term (MeSH)
#3 NASAL MUCOSA single term (MeSH)
#4 PARANASAL SINUSES single term (MeSH)
#5 PARANASAL SINUS DISEASES single term (MeSH)
#6 exp SINUSITIS single term (MeSH)
#7 exp RHINITIS single term (MeSH)
#8 NASAL POLYPS single term (MeSH)
#9 NASAL OBSTRUCTION single term (MeSH)
#10 nose OR nasal* OR sinus* OR rhinosinus* OR paranasal* OR rhinitis* OR nasosinus* OR pansinus*
#11 #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10
#12 HYPERTONIC SOLUTIONS single term (MeSH)
#13 SOLUTIONS single term (MeSH)
#14 SALINE SOLUTION HYPERTONIC single term (MeSH)
#15 SODIUM CHLORIDE single term (MeSH)
#16 saline OR sodium chloride OR salt water OR hypertonic* OR isotonic*
#17 #12 OR #13 OR #14 OR #15 OR #16
#18 douch* OR spray* OR wash* OR rinse* OR rinsing OR irrigat*
#19 #17 AND #18
#20 IRRIGATION single term (MeSH)
#21 irrigation
#22 #19 OR #20 OR #21
#23 #11 AND #22
Search strategies for MEDLINE and EMBASE can be found in Table 1.
| MEDLINE (OVID) | EMBASE (OVID) |
| 1. NOSE/ | 1. NOSE/ |
Reference lists from identified publications will be scanned to identify further trials, and authors will be contacted as necessary. A forward search will be undertaken on the authors of the identified trials.
We will consider non‐English language publications if the translated abstract indicates that the study is a randomised controlled trial with the focus on saline use in the management of chronic rhinosinusitis.
Data collection and analysis
Study selection
The initial search results will be scanned by one author to identify trials which loosely meet the inclusion criteria. The full text articles of all the retrieved trials of possible relevance will be reviewed by the two authors (RH and SAH) and the inclusion criteria applied independently. Any differences in opinion about which studies to include in the review will be resolved by discussion.
Data extraction
Data from the studies will be extracted by one author and rechecked by the other. Data extraction will be performed using standardised forms so as to allow an intention‐to‐treat analysis. Where data are missing, one author will write to the authors of the studies requesting further information.
Quality assessment
The quality of all included trials will be assessed independently by the two authors (RH and SAH) and any differences in opinion will be resolved by discussion. A modification of the method used by Chalmers 1990 will be used. The selected studies will be assessed for the following characteristics:
1. The adequacy of the randomisation process;
2. The potential for selection bias after allocation to study group, i.e. losses to follow up and whether analysis was by intention‐to‐treat;
3. Quality of outcome assessment;
4. Blinding of the outcome assessment with the understanding that by the nature of the intervention, when the patients were the outcome assessors they could not be blinded to the therapy given.
Studies will be graded A, B or C for their overall methodological quality:
A: Minimisation of bias in all three categories above, i.e. adequate randomisation; few losses to follow up and intention‐to‐treat analysis, high quality outcome assessment;
B: Each of the criteria in A partially met;
C: One or more of the criteria in A not met.
Study quality may be used for sensitivity analysis.
Adverse events will be recorded in table form. This information will be taken into consideration when writing the discussion. Further information on adverse events will be taken into consideration in the review discussion.
Data analysis
We plan to analyse data by intention‐to‐treat. If data are comparable and of sufficient quality, they will be combined to give a summary measure of effect otherwise data will not be combined.
| MEDLINE (OVID) | EMBASE (OVID) |
| 1. NOSE/ | 1. NOSE/ |
