Efficacy of buffered hypertonic saline nasal irrigation in children with symptomatic allergic rhinitis: A randomized double-blind study

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Abstract

Background

Nasal irrigation has been used as an adjunctive therapy of allergic rhinitis (AR). Available evidence suggested that buffered hypertonic saline (BHS) is superior to buffer normal saline (BNS) for relief nasal symptoms.

Objective

To evaluate the effectiveness of BHS nasal irrigation in the management of children with symptomatic AR.

Design

This was a randomized, prospective, double-blind placebo-controlled study.

Methods

The present study was a randomized prospective double-blind placebo-controlled study. Eighty-one children with symptomatic AR who had a total nasal symptom score (TNSS)  4 were included in this study. Each participant was randomly treated with either normal saline (NSS) or BHS by a blinded investigator. Nasal saccharine clearance time (SCT) and TNSS were measured before and 10 min after nasal irrigation. Quality of life (QoL) was assessed using the questionnaire for Thai allergic rhinoconjunctivitis patients (Rcq-36). The 7-point Likert scale for satisfaction was also performed. All participants were assigned to perform nasal irrigation twice daily for the period of 4 weeks. During this period, they recorded TNSS, side effects and antihistamine use on daily diary card. A physical examination and subjective evaluation were performed at 2nd and 4th week visits, and daily diary cards were collected.

Results

Patients with BHS were significantly improved in SCT (39.2% versus 15.5%, P = 0.009) and TNSS (82.7% versus 69.3%, P = 0.006) compared to the NSS group. However, at 2nd and 4th week both groups had improvement in TNSS and QoL compared to baseline visit. There was a significant improvement in mean QoL score in BHS group at 2nd week visit compared to NSS group (P = 0.04) but not at the 4th week. Nasal congestion but not TNSS was significantly improved in the BHS group (P = 0.04). Moreover, a decreased use of oral antihistamine was observed in BHS group (P = 0.04). There were few complaints reported, and side effects were seen equally in both groups.

Conclusion

Nasal irrigation with BHS causes an improvement in SCT, TNSS and QoL compare to NS in children with symptomatic AR.

Introduction

Allergic rhinitis (AR) is the one of most common chronic diseases in Thailand. It affects both adolescents and younger children, with prevalence estimates ranging from approximately 10–45% [1], [2], [3], [4], [5], [6]. The incidence of AR is ever higher because of an increase of environmental pollution due to industrialization and urbanization. Although AR is not life-threatening, AR symptoms, including sneezing, rhinorrhea, nasal itching and congestion, have an impact on the physical, social and emotional function and a deleterious impact on quality of life (QoL) [7]. Avoidance of the allergen is the best treatment, but pharmacotherapy has an important role in treatment. Furthermore, nasal irrigation with saline may be useful as an adjunctive treatment [8], [9], [10]. Nasal irrigation can facilitate the evacuation of potential allergens and irritant-containing mucus, improve mucociliary transport function of the nasal mucosa and improve nasal patency.

It has been suggested that buffered hypertonic saline (BHS) is superior to buffered normal saline (BNS) [11], [12], [13] and hypertonic saline (HS) is better to normal saline (NSS) [14], [15]. The possible explanation is that hypertonicity can cause reduction of mucosal edema due to osmotic pressure-induced water transport through the mucosal epithelial membrane thereby reducing nasal congestion and improving mucociliary clearance [16]. Alkaline pH is also better for ciliary function [16]. However, there are contradictory reports with regard to the use of HS especially in AR patient. The major controversies center around whether HS is more irritating and whether HS is superior to NS in terms of improving mucociliary clearance. Concern about irritation comes from the observation that hyperosmolar saline stimulates the secretion of histamine and Substances P and activates nociceptive nerves [17], [18]. For instance, Baraniuk et al. [17] reported that the nasal hypertonic saline leads to substance P release and glandular secretion by means of stimulating nociceptive nerves and induces sensation of pain, nasal blockage, and rhinorrhea. The significant changes of pain sensation and nasal blockage were present at a concentration of 2.7%, whereas rhinorrhea was detectable only above a concentration of 5.4%. The more concentrated the saline solution, the greater the intensity of symptoms. However, there were no changes in plasma extravasation, vascular tone or mucosal thickening at these concentrations. On the other hand, Garavello et al. [19] found that with 3% hypertonic saline applied to AR child patient cause no sign of that unsatisfied side effect.

With regard to mucociliary clearance, 3% hypertonic saline was shown to improve mucociliary clearance time. Hauptman et al. [11] compared the efficacy between BNS and BHS and found that BNS and BHS both improved the mucociliary clearance time but BHS was more irritating. In particular, Brown et al. [10] and Harvey et al. [20] reported that nasal irrigation caused a significant improved in saccharine clearance time (SCT) and total nasal symptom score (TNSS) especially in HS. Ural et al. [21] reported that Nasal irrigation with isotonic or hypertonic saline can improve mucociliary clearance time in various nasal pathologies. He meets that, isotonic saline improved mucociliary clearance times significantly in allergic rhinitis when compare to 3% hypertonic saline, By the reason mentioned above, this study try to decrease the concentration of hypertonic solution in the attempt to lower side effect and increase efficacy by adding baking soda which will raise pH value [12], [13]. It therefore remains unclear whether HS would be superior to NS and well-tolerated in children with AR. However, exact optimal salinity and pH of nasal irrigation fluid are still not known. The concentration of 0.9%, 2%, 2.3% and 3% saline solution had been reported [15], [22], but salinity between 0.9% and 2% saline solution have not been studied.

Until now, there were no previous controlled trials studies comparing the effectiveness on SCT and allergic symptom of the NSS and HS use in children with symptomatic AR. The purpose of this study was to compare the effect of BHS and NSS on SCT and TNSS and to compare patient satisfaction with respect to nasal irrigation, QoL, and side effects in a pediatric population of AR patients.

To evaluate the effectiveness of BHS nasal irrigation in the management of children with symptomatic AR.

Section snippets

Participants

A randomized prospective double blind placebo controlled study was designed. Eighty-one children with AR, aged 6–15 years, were recruited from a pediatric allergy clinic, Thammasat Hospital, between June and November 2010. Approval for the study was granted by the Institutional Ethics Committee of the Thammasat Hospital, and informed consent was obtained from all parents before study entry. The inclusion criteria for this study were as follows: (1) age 6–15 years, (2) diagnosed AR obtained by

Results

Eighty-one AR children participated in the study including 49 boys and 32 girls, with an average of 10.53 ± 2.37 years (range 6.1–15.5 years). Patients were randomized into two groups. One group received 1.25% BHS (24 boys and 16 girls, with an average age of 10.3 ± 2.2 years). The other group received NSS (25 boys and 16 girls, with an average age of 9.9 ± 2.5 years). At baseline there were no significant differences in demographic data, TNSS, SCT, 7-point Likert scale for satisfaction to use nasal

Discussion

The use of nasal irrigation is currently recommended as an adjunctive treatment modality in many sinonasal disease such as rhinosinusitis, AR and other sinonasal diseases [5], [7], [8]. Various studies have used different tonicities of NaCl solution. In this study we demonstrate that both BHS and NSS significantly decreased SCT in children with symptomatic AR, but the decrease in SCT was larger with BHS than NSS. The results are in line with previous studies. Cingi et al. [26] found that

Acknowledgements

The study was performed at Thammasat Hospital. The cost was partially supported by Thammasat Research Grant. Buffered hypertonic saline and normal saline was prepared in powder as pre-mix sachets with quality control by SEA PHARM Co., Ltd.

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  • Cited by (0)

    The clinical trial registration number: NCT01441778.

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