ANTECEDENTES Y DESCRIPCIÓN DE LA SITUACIÓN ACTUAL DE LA

combined in this analysis and recommendation.

Nasal saline irrigation is a common treatment adjunct in the management of CRS. The favorable safety profile, lack of systemic pharmaceutical absorption risk, and patient acceptance make it an appealing long-term topical therapy

strategy.690 _{Although irrigation solutions often include}

either isotonic (ie, normal) or hypertonic saline, there is substantial variability in the volume (low or high), pressure (passive or active), and frequency of saline irrigation pro- tocols. Adverse effects of saline irrigations are rare, but in- clude local irritation, ear pain, nose bleeds, headache, nasal

burning, nasal drainage, and bottle contamination.690, 691

This review identified 12 studies evaluating saline irriga- tion for the management of CRS (10 RCTs, 1 systematic

review, and 1 meta-analysis).206, 209,692–701_{(Table VII-13).}

Five RCTs evaluated saline irrigation in patients who had not undergone surgery. All 5 demonstrated improved symptoms and QoL outcomes in patients with CRS. The

randomized trials by Bachmann et al.692 _{and Hauptman}

and Ryan206 _{evaluated the effects of isotonic and hy-}

pertonic saline irrigations and demonstrated that both solutions improve sinonasal symptoms, although there were no significant differences between groups. The study

by Rabago et al.209 _{randomized patients into 2 groups}

(hypertonic saline irrigations and no treatment) and eval- uated CRS-specific QoL, general QoL, symptom scores, and medication usage. The results demonstrated that daily hypertonic nasal saline irrigations significantly improved CRS-specific QoL, symptom scores, and decreased med- ication usage. However, there was no difference in the general QoL outcomes using the SF-12 questionnaire.

The randomized trial by Heatley et al.697 _compared

isotonic saline irrigations, using both bulb syringe and pot irrigations, to reflexology as a control. The results demonstrated that all groups received CRS-specific QoL improvements, and surprisingly there were no difference between the reflexology and saline irrigation groups. The

highest quality randomized trial by Pynnonen et al.700_com-

pared high-volume (240 mL) low-pressure isotonic saline irrigation to low-volume saline spray and evaluated CRS- specific QoL (SNOT-20) and symptom scores at 2, 4, and 8 weeks posttreatment. The results demonstrated that both groups received improvement in QoL at 8 weeks; however, there was a significantly larger improvement in both outcome measures in patients using high-volume saline

irrigations.700

Two randomized trials by Friedman et al. in evaluated the effectiveness of Dead Sea salt (DSS) irrigations on QoL.694, 695 _{The salt and mineral content of DSS has been} reported to have beneficial anti-inflammatory effects. The

2006 study failed to report the CRS cohort surgical history and the 2012 study included CRS patients with and with- out prior ESS. The 2006 study evaluated DSS irrigations (did not state the volume or delivery device) compared to hypertonic saline irrigations and demonstrated that DSS irrigations were superior to hypertonic saline irrigations in symptom and QoL improvement. The 2012 study compared DSS irrigations (syringe 20 mL per naris BID) to hypertonic saline irrigations plus INCS. The outcomes demonstrated that the DSS irrigations alone were as effective as hypertonic irrigations plus once daily INCS.

The systematic review and meta-analysis by Harvey

et al.696 _{included 8 studies that evaluated the following}

designs: saline vs no treatment; saline vs placebo; saline as an adjunct to INCS therapy; saline vs INCS therapy; and isotonic vs hypertonic saline irrigations. A few studies included pediatric patients with CRS and AR. The results showed that saline irrigations improve symptom outcomes when used as the sole CRS treatment modality; however, saline was shown to be less effective compared to INCS therapy. There is evidence to support that saline can im- prove symptoms when used as an adjunct to INCS therapy. Isotonic and hypertonic saline solutions appear to have similar effects on patient symptoms and QoL; however, hy- pertonic solutions may improve objective outcomes, such

as radiographic imaging. van den Berg et al.701 _reported

in their systematic review that the 2007 RCT by Pynnonen

et al.700 _{was the only study of high enough quality to}

discuss, and therefore concluded that high-volume normal saline irrigations may provide better outcomes compared to low-volume saline sprays in the management of CRS.

There is substantial evidence to support the use of nasal saline irrigations in the management of CRS. Because of the excellent safety profile of saline irrigations and low cost

(approximately US$0.24 per day),702_{there is a preponder-}

ance of benefit over harm. Isotonic saline irrigations may produce minor adverse events in 5% to 10% of cases, in- cluding nasal burning, ear plugging, and nausea. Evidence suggests that hypertonic saline irrigations may result in a higher rate of minor adverse events (10-25% of cases). No major adverse events were recorded from a meta-analysis

of 22 trials.696_{However, in 2011, there were 2 deaths from}

amoebic meningoencephalitis suspected to be related to

irrigating with Naegleria fowleri–contaminated water.703

Until further research elucidates the safety of using tap water, it is recommended to use a clean water source (avoiding well water) for irrigation solution.

Bacterial contamination of saline irrigation bottles has been reported in up to 50% and 80% of bottles after 1 and

2 weeks, respectively.691 _{Although there is no association}

between irrigation bottle contamination and clinical infection for patients with CRS, it has been suggested to regularly disinfect and replace bottles. A recent review suggests that postirrigation microwave decontamination is

an effective disinfecting strategy.704

Given the preponderance of benefit in combination with an aggregate grade A of evidence, a “Strong

FIGURE VII-1. Evidence-based recommendations for diagnosis and treatment of chronic rhinosinusitis.

TABLE VII-13. Evidence for CRSsNP and CRSwNP management with saline irrigation

Study Year LOE Study design Study groups Clinical endpoint Conclusions

Harvey696 _{2007 1a Meta-analysis CRS patients 1. QoL; 2. Symptom; 3.}

Radiologic

Saline irrigations improve CRS symptoms as a sole modality and as an adjunct to INCS. Not as effective as INCS

Friedman694 _{2012 1b RCT, double-blind 1. Dead sea salt irrigation;}

2. Hypertonic saline+ INCS

1. QoL (SNOT-20); 2. Endoscopy

Dead sea salt irrigation alone was equally as effective as INCS+hypertonic saline Liang698 _{2008 1b RCT, no blinding CRS patients after ESS}

treated with: 1. NS plus debridement; 2. Debridement alone

1. Symptoms; 2. Endoscopy Mild CRS had better symptom and endoscopy scores with irrigations added. No difference in moderate-severe CRS Hauptman206 _{2007 1b RCT 1. NS; 2. Hypertonic saline 1. Symptoms; 2. Acoustic}

rhinometry; 3. Saccharine clearance

Both treatments improved nasal stuffiness and obstruction. NS improved nasal airway patency Pynnonen700 _{2007 1b RCT 1. High-volume,} low-pressure NS irrigation; 2. NS low-volume spray 1. QoL (SNOT-20); 2. Symptom

SNOT-20 improvement in both groups. High-volume low-pressure irrigation group received more Friedman695 _{2006 1b DBRCT 1. Dead Sea salt irrigation;}

2. Hypertonic saline irrigation

RQLQ Dead Sea salt irrigations received better symptom relief compared to hypertonic saline irrigations Pinto699 _{2006 1b DBRCT 1. NS; 2. Hypertonic}

saline; 3. No irrigations

Symptoms No difference in symptoms between NS and no irrigation. Worse pain and nasal drainage with hypertonic irrigation van den Berg701 _{2014 2a Systematic review Saline therapy for CRS Only included and discussed 1}

study with high enough quality

High-volume NS irrigation provides better QoL improvement then low-volume NS spray Freeman693 _{2008 2b RCT, no blinding 1. NS (low volume}

atomized spray); 2. No irrigations

Endoscopy NS provided early (3 weeks) endoscopic improvement. No difference in long-term (3 months) endoscopic findings

Rabago209 _{2002 2b RCT, no blinding 1. Hypertonic saline; 2. No}

treatment

1. QoL (RSDI; SF-12); 3. Symptom score)

Hypertonic saline irrigation improved RSDI and symptom scores. No improvement in SF-12 Heatley697 _{2001 2b RCT, no blinding 1. NS in bulb syringe; 2.}

NS in pot irrigation; 3. Reflexology as placebo

RSOM-31; SNOT-20; SF-36 All groups had improvement in RSOM-31 and SNOT-20 scores. No difference between NS irrigation groups and reflexology Bachmann692 _{2000 2b RCT, no blinding 1. NS; 2. Hypertonic saline 1. Symptoms; 2. Endoscopy;}

3. Mucociliary clearance; 4. Rhinomanometry; 5. Olfactometry

No difference between NS and hypertonic irrigation

Recommendation” for its use in the management of CRS is provided. Although nasal saline irrigations can improve symptom and CRS-specific QoL outcomes, it is important to recognize that it is often implemented as an adjunct to other topical therapy strategies. Isotonic and hypertonic saline irrigations appear to provide similar subjective outcomes and high-volume saline irrigation appears to be superior to low-volume nasal saline spray techniques.

r

_{Aggregate Grade of Evidence: A (Level 1a: 1 study; Level}

1b: 6 studies; Level 2a: 1 study; Level 2b: 4 studies).

r

_{Benefit: Improved QoL, symptoms, and endoscopic, and}

radiologic outcomes. Well tolerated. No risk of systemic adverse effects. Low cost.

r

Harm: Local irritation, nasal burning, headaches, and

ear pain/congestion. Low risk of infection from contam- ination.

r

Cost: Minimal (US$0.24/day). Patient time for applica-

tion.

r

Benefits-Harm Assessment: Preponderance of benefit

over harm.

r

Value Judgments: Important to use nasal saline irrigation

as an adjunct to other topical therapy strategies. Higher-

volume (>200 mL) irrigations appear to be superior to

low-volume nasal sprays, but further trials are required.

r

_{Policy Level: Strong recommendation.}

r

_{Intervention: High-volume (>200 mL) nasal saline irri-}

gations are strongly recommended as an adjunct to other medical therapies for CRS.

VII.E.2.a. CRSsNP Management: Topical Cor-

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