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Pediatr Allergy Immunol 2003: 14: 140–143 Hypersaline nasal irrigation in childrenwith symptomatic seasonal allergic rhinitis:A randomized study Garavello W, Romagnoli M, Sordo L, Gaini RM, Di Berardino C, Angrisano A. Hypersaline nasal irrigation in children with symptomatic seasonal allergic rhinitis: A randomized study.
PediatrAllergyImmunol2003:14:140–143.Ó2003BlackwellMunksgaard and Alfonso Angrisano21Department of Otorhinolaryngology, D.N.T.B., Recent evidence suggests that nasal irrigation with hypertonic saline University of Milano Bicocca, Milano, 2Pediatric may be useful as an adjunctive treatment modality in the management of many sinonasal diseases. However, no previous studies have inves-tigated the efficacy of this regimen in the prevention of seasonal allergicrhinitis-related symptoms in the pediatric patient. Twenty children withseasonal allergic rhinitis to Parietaria were enrolled in the study. Tenchildren were randomized to receive three-times daily nasal irrigationwith hypertonic saline for the entire pollen season, which had lasted6 weeks. Ten patients were allocated to receive no nasal irrigation andwere used as controls. A mean daily rhinitis score based on the presenceof nasal itching, rhinorrea, nasal obstruction and sneezing was calcu-lated for each week of the pollen season. Moreover, patients wereallowed to use oral antihistamines when required and the mean numberof drug assumption per week was also calculated. In patients allocated Key words: hypertonic saline; allergic rhinitis; to nasal irrigation, the mean daily rhinitis score was reduced during 5 weeks of the study period. This reduction was statistically significantlydifferent in the 3th, 4th and 5th week of therapy. Moreover, a decreased consumption of oral antihistamines was observed in these patients. This Otorinolaringoiatria, Ospedale nuovo San Gerardo di effect became evident after the second week of treatment and resulted in Monza, Via Donizetti 106, 20052 Monza, ItalyTel.: +39 039 2333623 statistically significant differences during the 3th, 4th and 6th week. This study supports the use of nasal irrigation with hypertonic saline in the pediatric patient with seasonal allergic rhinitis during the pollen season.
This treatment was tolerable, inexpensive and effective.
Allergic rhinitis is a disease characterized by this regard, it has also been reported that an the classic symptoms of rhinorrhea, obstruction increased efficacy could be effected using hyper- of the nasal passage, sneezing and itching, all tonic saline instead of normal saline (6–9).
occurring in a temporal relationship to allergen However, statistical evidence to justify a wide- exposure (1). Treatment options include antihis- spread clinical use of nasal irrigation is still poor tamines, decongestants, anticholinergics and cor- (4). More specifically, to the best of our know- ticosteroids (1–3). At present, H1-antagonistic ledge, no previous studies have investigated the drugs are the most frequently used medication.
efficacy of nasal irrigation using hypertonic saline However, adequate management of the disease is in the prevention of seasonal allergic rhinitis a major and still largely unsolved topic in this symptoms in the pediatric patient. This issue is field (1). Recent studies have documented inter- herein addressed in a randomized study in which esting results using nasal irrigation as an adjunc- patients treated with nasal irrigation during the tive treatment modality in many sinonasal pollen season were compared with patients who diseases including allergic rhinitis (1, 4–6). In with 5 ml (2.5 ml in each nostril) sterile, room-temperature 3.0% hypertonic saline. The solu- Twenty children (8 boys) 6–12 years of age with tion was prepared in the laboratory of our seasonal allergic rhinitis who attended the Rhi- nological Service of the Department of Otolar- Patients and their parents were instructed to yngology of the San Gerardo Hospital entered record their daily symptoms on diary card. Nasal the study. Specifically, patients with seasonal symptoms included: (1) nasal itching, (2) rhinor- allergic rhinitis to Parietaria were enrolled, as rea, (3) nasal obstruction and, (4) sneezing.
this plant is known to be the most important hay Intensity of these four symptoms was rated fever-provoking plant in Italy (10). The study according to a 5 grade scale: 0 ¼ no symptom, was performed during the pollen season when the 1 ¼ slight, 2 ¼ mild, 3 ¼ moderate, 4 ¼ severe.
Total scores ranged from 0 to 16 and represented The diagnosis of seasonal allergic rhinitis to the sum of scores of these four symptoms. These Parietaria was based on (1) typical anamnesis for data were used to calculate a mean daily rhinitis seasonal allergic rhinitis for at least 2 years; (2) score for each week of the pollen season.
positive prick tests to Parietaria pollen extracts in Furthermore, patients were allowed to use oral a hydroglyceric solution titrated at 20.00 biolo- antihistamines to control rhinitis symptoms gical units (BU)/ml (SARM allergeni, Guidonia- when required. The daily oral intake of these Rome, Italy); (3) positive RAST to Parietaria drugs was also recorded on the same diary card pollens of at least class 2 (Pharmacia Diagnos- and the mean number of drug assumption per tics, Uppsala, Sweden; CAP system – FEIA).
week for each week of the pollen season was Exclusion criteria were the presence of symptoms of asthma, urticaria or eczema, a clinically Statistical analysis was performed using the relevant sensitization to other allergens and the Student’s t-test for independent samples and v2 use of specific immunotherapy within the past analysis to compare basal characteristics of the 2 years. All patients were under the care of two two groups. Mean daily rhinitis score and mean number of antihistamine assumptions were com- approved by the Institutional Review Board of pared using a non-parametric test (Wilcoxon’s San Gerardo Hospital, and informed consent test) adjusting for multiple comparisons. p < 0.05 was obtained from all the parents of the children was considered significant in all comparisons.
Parietaria pollen count per m3 of air was continuously taken with a volumetric pollen trap (Burkard Manufacturing, Rickmansworth, UK)placed in our area at a height of approximately No significant differences were found between 20 m. Although the concentration of Parietaria the two groups (active treatment and controls) in tended to be below 50 grains/m3 during the first terms of age, gender, years of clinically relevant and the last week of treatment, a concentration rhinitis, sensitization to other allergens and of Parietaria persistently over 50 grains/m3 was results of allergic diagnostic tests (data not documented during the other 4 weeks. These data confirmed that the study period was largely No patients were lost to follow-up and no coincident with the pollen season, when recruited adverse effects were reported. Significant clinical patients were expected to be symptomatic.
benefits were observed in children with seasonal A prospective non-blinded randomized trial allergic rhinitis to Parietaria who received a was performed. Randomization was achieved in regimen of three-times daily nasal irrigation with March 2001 before the onset of the pollen hypertonic saline during the pollen season (Fig. 1). Indeed, the mean daily rhinitis score according to a computer-generated list unknown was reduced during 5 weeks of the study treat- to the physicians. Six out of 26 children who were ment period. More specifically, this difference eligible for randomization refused to enter the resulted in statistical significance in the 3th, 4th study. Ten children were randomized to receive and 5th week of therapy. Conversely, the mean three-times daily nasal irrigation with hypertonic daily rhinitis score during the first week of saline for 6 weeks. Treatment began on April 30, treatment resulted similar in the two groups 2001 and lasted for 6 weeks. Ten patients were (Fig. 1). In regard to the use of oral antihista- allocated to receive no nasal irrigation treatment mines, a reduced assumption of this drug in and were used as controls. Nasal irrigation was administered using a disposable syringe filled drugs reported by the patients treated with this local therapy compared with controls and by the The use of nasal irrigation is currently recom- mended as an adjunctive treatment modality in Rhinitis score
many sinonasal diseases such as rhinosinusitis, allergic rhinitis and other sinonasal diseases(1, 4–6). In particular, Tamooka et al. have previously reported that nasal wash is efficient Study period (6 wk)
in the treatment of seasonal allergic rhinitis inadults (4). These authors, employing a patient- Fig. 1. Mean ± SD of the rhinitis score during the 6-week reported nasal disease-specific questionnaire, do- period of the pollen season for both patients treated withnasal irrigation (dotted line) and controls (solid line). Scores cumented a significant improvement in symp- represent the sum of scores of four different symptoms: toms score after nasal irrigation with hypertonic nasal itching, rhinorrea, nasal obstruction and sneezing.
saline. The results of our trial are in line with this Intensity of these four symptoms was rated according to a previous report. More specifically, to the best of 5-grade scale: 0 ¼ no symptom, 1 ¼ slight, 2 ¼ mild,3 ¼ moderate, 4 ¼ severe and a mean daily rhinitis score our knowledge, our study represents the first for each week of the pollen season was calculated. The mean comparative report clearly documenting the daily rhinitis score for each week of the pollen season was benefits of this therapeutic regimen in the pedi- reduced during 5 weeks of the study treatment period in atric patient with seasonal allergic rhinitis.
patients who were prescribed nasal irrigation. This differ-ence resulted in statistical significance (*) in the 3th, 4th and A controversy in our study may be related to the study design because our trial was notblinded and we did not use placebo. However,it should be noted that none of the availablestudies have conducted a true double-blinded placebo-controlled trial; although such studydesign would have been preferable, the extreme specificity of the way of administration hampersits application. At present, we are unable to assess the importance of the placebo effect in lets of antihistamines
observed in our study. Nevertheless, consideringthe marked beneficial effect in lowering symp- toms intensity, it is unlikely that this bias may Study period (6 wk)
Number of tab
exclusively explain the results observed in thistrial. Moreover, no differences in both symptoms Fig. 2. Mean ± SD number of oral intake of antihista- mines per week for each week of the pollen season in bothpatients treated with nasal irrigation (dotted line) and con- patients treated with nasal irrigation and controls trols (solid line). The assumption of this drug was reduced could be observed during the first week of the among patients allocated to nasal irrigation. This reduction study period when the placebo effect is expected resulted in statistical significance (*) during the 3th, 4th and to be more relevant. Finally, in our study, compliance with the study protocol was com-plete, patients were under the care of only two reduction became evident after the second week experienced physicians and the two study groups of treatment and resulted in statistical signifi- were comparable in terms of age and allergic cance during the 3th, 4th and 6th week of the rhinitis-related symptoms. Therefore, we esti- mate that other important sources of bias in ourtrial can be excluded.
In this study, hypertonic saline was chosen as several in vitro and in vivo studies have demon- The results of this comparative study demon- strated that an increased efficacy could be effec- strate that nasal irrigation using hypertonic ted using hypertonic saline instead of normal saline is effective in controlling allergic rhinitis- saline (6, 8–10). However, further studies are related symptoms in the pediatric patient during required to assess the most effective preparation the pollen season. The efficacy and the interest of to prescribe. The possibility of using a twice or this local management is also supported by the even a once daily nasal irrigation has also to be significant decrease of the use of antihistamine investigated as such a simpler protocol might be as effective as the longer one whereas patient 3. Delafuente JC, Davis TA, Davis JA. Pharmacother- adherence could be further increased.
apy of allergic rhinitis. Clin Pharm 1989: 8: 474–85.
In conclusion, this study supports the use of a 4. Tomooka LT, Murphy C, Davidson TM. Clinical study and literature review of nasal irrigation. Laryng- three-times daily regimen of nasal irrigation with hypertonic saline in the pediatric patient with 5. Ferguson BJ. Allergic rhinitis: options for pharmaco- seasonal allergic rhinitis. The treatment is toler- therapy and immunotherapy. Postgrad Med 1997: 101: able, inexpensive and effective. Further trials are required to identify the most appropriate proto- 6. Taccariello M, Parikh A, Darby Y, Scadding G.
col of treatment and to evaluate whether similar Nasal douching as a valuable adjunct in the manage-ment of chronic rhinosinusitis. Rhinology 1999: 37: results could be obtained also in patients with 7. Parsons DS. Chronic rhinosinusitis: amedical or sur- gical disease? Pediatr Sinusitis 1996: 29: 1–9.
8. Talbot AR, Herr TM, Parsons DS. Mucociliary clearance and buffered hypertonic saline solution. Lar- 1. Parikh A, Scadding GK. Seasonal allergic rhinitis.
9. Shoseyov D, Bibi H, Shai P, Shoseyov N, Shazberg G, 2. Lorenzo GD, Gervasi F, Drago A, et al. Comparison Hurvitz H. Treatment with hypertonic saline versus of the effects of fluticasone propionate, aqueous nasal normal saline nasal wash of pediatric chronic sinusitis.
spray and levocabastine on inflammatory cells in nasal J Allergy Clin Immunol 1998: 101: 602–5.
lavage and clinical activity during the pollen season in 10. Amato G, Spieksma FT, Liccardi G. Pollen related seasonal rhinitics. Clin Exp Allergy 1999: 29: 1367–77.
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