Additional data needed on saline for nasal use

Upper respiratory tract infections are very common in the pediatric population and many of the various pharmacotherapeutic treatment options for these infections have been previously discussed in the Pharmacology Consult column, including antibiotics, over-the-counter products and intranasal corticosteroid agents.

This month’s column will review the use of nasal saline-based products, including irrigations, sprays, drops or other dosage forms, that have also been studied and advocated to treat and prevent the symptoms associated with various maladies of the upper respiratory tract in children.

Clinical uses

Saline solution applied nasally has been evaluated in controlled trials for a variety of conditions, including acute and chronic rhinosinusitis, allergic conditions and acute upper respiratory infection (URI).

Although many of these studies have been conducted in adults, several controlled trials have been conducted in children. Evidence from adult trials indicates that nasal saline irrigation effectively reduces symptoms associated with chronic rhinosinusitis, and use of nasal saline solutions may also be helpful for allergic rhinitis and acute URI.

Several adult controlled trials evaluating saline irrigation have been published, with positive results. A recently published Cochrane review concluded that benefits from nasal saline irrigation outweigh minor, common adverse effects when used for chronic rhinosinusitis. Not all adult studies evaluating nasal saline solutions have demonstrated effectiveness, however.

In a controlled trial of adults with URI or acute rhinosinusitis, thrice-daily hypertonic saline spray was compared with normal saline spray or observation. No benefit was noted on symptom resolution for either saline spray product as compared with observation in this trial. In another controlled trial, isotonic saline large volume, low-pressure nasal irrigation was compared with saline nasal spray in adults with chronic nasal and sinus symptoms. Although trial participants randomly assigned to nasal saline spray demonstrated improved symptom scores with treatment, participants treated with saline irrigation improved significantly more.

Pediatric studies

Irrigation with normal saline was evaluated in children aged 3 to 12 years with acute sinusitis in a controlled, randomized study of three weeks duration. All 69 children received antibiotics, mucolytics and nasal decongestants. The treatment group additionally received nasal irrigation with normal saline. A volume of 15 to 20 mL of normal saline was administered into each nostril one to three times daily in a fast, upward sitting or standing position.

Treatment effect was assessed by nasal symptom and quality of life scoring, nasal peak expiratory flow and radiologic findings. Children receiving saline irrigation improved as compared to control children, as evidenced by improved quality of life scores and nasal peak expiratory flow. Statistically improved symptom scores were demonstrated for daytime rhinorrhea and nocturnal nasal congestion in the treatment group. No difference in radiologic findings between groups after treatment was found. Adverse effects were not assessed in detail in this study and described only as not significantly occurring.

In a randomized, double blind study, hypertonic (3.5%) saline wash was compared with normal saline (0.9%) for four weeks in 30 children with chronic sinusitis (Shoseyov, 1998). Treatment effect was evaluated by symptom (cough, nasal secretions/post nasal drip) and radiologic scoring. Ten drops (1 mL) of the blinded saline solution was instilled nasally three times daily in a fast, upward (sitting or standing) manner, and then quickly removed to minimize salty or burning adverse effects. The treatment group improved significantly in all outcome measures, and the normal saline group improved significantly only in the postnasal drip score. Children receiving hypertonic saline complained more of nasal burning and itching, but only during the first three to four days.

Slapak and colleagues evaluated isotonic nasal wash in 401 children (6-10 years) with uncomplicated URI in a randomized, non-blinded manner in the Czech Republic. Inclusion criteria state that children with the common cold or flu were eligible, although “flu” diagnosis was not described. Children were treated with antipyretics, nasal decongestants, mucolytics and antibiotics, as necessary. Saline wash was added to these therapies for the treatment group. The saline wash used was a French commercial product produced from processed Atlantic seawater (isotonic, but containing trace elements and minerals). Three delivery methods were used, including medium jet flow, fine spray and a dual fine spray formula for eye and nose wash. Treatment was given six times daily for acute illness and then three times daily for prevention. Children were treated for acute illness for three weeks and followed for 12 weeks total.

Primary outcome measures included nasal and symptom scoring (unknown scale validation), and secondary measures included additional medication use, reported illness days and missed school. Children receiving saline treatment reported faster symptom improvement, including nasal secretion, nasal obstruction and sore throat, and children assigned to saline washes reported less mucolytic and nasal decongestant use than control children not receiving saline washes.

For prevention, children receiving saline washes reported less dry cough, nasal secretion, nasal breathing, less additional medication use and fewer days of illness. Most children tolerated the saline washes well, with few complaints of burning. No differences in treatment efficacy were found between the three saline wash delivery methods, although children tended to prefer the fine spray method.

Additional pediatric studies have evaluated nasal saline solution for treatment of allergic rhinitis. In a small study of 20 Italian children with seasonal allergic rhinitis to Parietaria (a flowering plant), hypertonic (3%) saline irrigation given three times daily for six weeks in a randomized, non-blinded manner, was compared with control children treated similarly, without saline irrigation. Saline solution was instilled as 2.5 mL into each nostril with a syringe, although further description of the administration technique was not given. Nasal symptom scoring (unknown scale validation) and antihistamine use were assessed for treatment efficacy. Children receiving hypertonic saline reported improved nasal symptom scores and less antihistamine use than control children (P<0.05).

The same author also evaluated hypertonic (3%) nasal saline spray in 44 children with rhinoconjunctivitis due to grass pollen allergy. Forty-four children (5-14 years) with seasonal grass pollen rhinoconjunctivitis were randomly assigned to treatment with thrice-daily nasal rinsing with hypertonic (3%) saline solution using an atomizer (three sprays per nostril) for seven weeks. Children randomly assigned to control therapy did not receive nasal saline sprays, and both groups used antihistamines as needed. Scoring for nasal and ocular symptoms (unknown scale validation) and antihistamine use was used to evaluate treatment effect.

Although symptom scoring was improved for the saline treatment group, differences between the treatment and control groups were statistically significant only for the last two weeks of the study (weeks 6, 7). Antihistamine use was decreased in the treatment group for five to seven weeks. Adherence with therapy was not described, and treatment adverse effects were described only as not occurring in children receiving saline spray.

Conclusion

Several surveys of family physicians and pediatric otolaryngologists demonstrate that use of nasal saline is commonly recommended for chronic sinusitis and other illnesses causing nasal symptoms.

Several controlled studies have been published with adult trial participants, and they have demonstrated benefit. A recently-published Cochrane review concluded that benefits from nasal saline irrigation outweigh minor, common adverse effects when used for chronic rhinosinusitis.

Controlled trials with children have also been published, using saline solution delivered by various methods for acute and chronic sinusitis, allergic rhinitis and URI. These trials have also demonstrated benefit, including symptom improvement and less use of additional medications. The methodology of some of these trials can be criticized, however, for not using blinded assessment, lack of placebo control or use of symptom scoring scales that may not have been validated.

An AAP clinical practice guideline on sinusitis published in 2001 offers no recommendation for or against use of saline irrigation. A recent abstract published in 2009 found that most subjects who had used nasal saline irrigation regularly for one year for rhinosinusitis actually demonstrated a significant decrease in infection rate after stopping nasal saline irrigation. Study authors attributed this to a depletion of natural immune elements by frequent nasal saline irrigation.

Adverse effects from nasal saline use in published trials have generally been mild, although they are often not clearly defined. As various delivery methods have been evaluated, and varying concentrations of saline (isotonic to 3.5%) have been used, the most effective and well-tolerated delivery method and salt concentration are not known. Commercially-available products, including Neti pots, rinses and sprays are commonly available. Recipes for home mixing of saline solutions can also be commonly found.

It seems reasonable to consider using saline solution for several pediatric illness producing nasal symptoms. The most effective delivery method and tonicity are not known, however. Correct technique of use should be adequately demonstrated, and younger children may not tolerate some delivery methods or higher salt concentrations. Additional data from controlled trials would be beneficial to define the role and use of nasal saline solutions in children.

Edward Bell, PharmD, is Professor of Clinical Sciences at Drake University College of Pharmacy of Blank Children’s Hospital and Clinics Des Moines, Iowa.

For more information:

• Harvey R. Nasal saline irrigations for the symptoms of chronic rhinosinusitis. Cochrane Database of Systematic Reviews; 4, 2009.
• Garavello W. Hypersaline nasal irrigation in children with symptomatic seasonal allergic rhinitis: a randomized study. Pediatr All and Immunol. 2003;14:140-143.
• Garavello W. Nasal rinsing with hypertonic solution: an adjunctive treatment for pediatric seasonal allergic rhinoconjunctivitis. Internat Arch of All and Immunol. 2005;137:310-4.
• Nsouli TM. Long-term use of nasal saline irrigation: harmful or helpful? Amer Acad of Allergy, Asthma and Immunol. 2009; Abstract O32.
• Shoseyov D, et al. Treatment with hypertonic saline versus normal saline nasal wash of pediatric chronic sinusitis. JACI. 1998;101:602-5
• Schwartz RH. The nasal saline flush procedure. PIDJ. 1997;16:725
• Slapak I. Efficacy of isotonic nasal wash (seawater) in the treatment and prevention of rhinitis in children. Arch of Otolar Head and Neck Surg. 2008;134:67-74.
• Subcommittee on Management of Sinusitis and Committee on Quality Improvement. Clinical practice guideline: management of sinusitis. Pediatrics. 2001;108:798-808.
• Wang YH. Efficacy of nasal irrigation in the treatment of acute sinusitis in children. International J Pediatr Oto. 2009;73:1696-1701.