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Efficacy of Isotonic Nasal Wash (Seawater) in the
Treatment and Prevention of Rhinitis in Children

Ivo Šlapak, MD; Jana Skoupá, MD; Petr Strnad, MD; Pavel Horník, MD Objective: To evaluate the potential of nasal isotonic
Results: At visit 2, patients in the saline group achieved
saline application to prevent reappearance of cold and primary end points (measured on a 4-point numeric scale on which 1 indicated no symptoms and 4, severe symp-toms) in the parameters nasal secretion and obstruction Design: Prospective, multicenter, parallel-group, open,
(mean scores vs nonsaline group, 1.79 vs 2.10 and 1.25 vs 1.58, respectively) (P Ͻ.05 for both). During the pre-vention phase (at visit 3, 8 weeks after study entry) pa- Setting: Eight pediatric outpatient clinics.
tients in the saline group showed significantly lower scoresin sore throat, cough, nasal obstruction, and secretion Patients: A total of 401 children (aged 6-10 years) with
(P Ͻ.05 for all). By visit 3, significantly fewer children in the saline group were using antipyretics (9% vs 33%),nasal decongestants (5% vs 47%), mucolytics (10% vs Interventions: We randomly assigned patients to 2 treat-
ment groups, one with just standard medication, the other
37%), and systemic antiinfectives (6% vs 21%) (P Ͻ.05 with nasal wash with a modified seawater solution (Physi- for all). During the same period children in the saline omer) plus standard medication, and observed them for group also reported significantly fewer illness days (31% vs 75%), school absences (17% vs 35%), and complica-tions (8% vs 32%) (P Ͻ.05 for all). Similar results were Main Outcome Measures: The primary efficacy end
points were nasal symptoms resolution during acute ill-ness (visits 1 and 2). We also looked for reappearance Conclusion: Children in the saline group showed faster
of cold or flu, consumption of medication, complica- resolution of some nasal symptoms during acute illness tions, days off school, and reported days of illness dur- and less frequent reappearance of rhinitis subsequently.
ing the following weeks when preventive potential wasevaluated (visits 3 and 4).
Arch Otolaryngol Head Neck Surg. 2008;134(1):67-74 UPPERRESPIRATORYTRACT provessymptomsandoftendecreasesthe
Less literature is available for URTI as- prevalence of sinusitis is as high as 32% cacy of hypertonic and normal saline spray in this age group.2 Nasal irrigation with iso- tonic saline solutions seems effective in servation-only control group. Another re- in a variety of indications as an adjunc- tive treatment.3 Although saline nasal wash assess whether daily application of nasal Author Affiliations: Pediatric
lines, scientific evidence of its efficacy is that assessed the use of adjunct nasal wash to 200 patients with allergic rhinitis or evaluated its preventive potential. We were nicity6 or delivery devices7 or assessed the potential of nasal wash to prevent or re- higher risk of URTI and sinusitis than other Pediatric Clinic, Motol TeachingHospital, Prague (Dr Strnad), groups.12 We therefore carried out a pro- sults are controversial, nasal irrigation im- (REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 134 (NO. 1), JAN 2008 2008 American Medical Association. All rights reserved.
medication use were assessed at 4 visits over the course of the Table 1. Chemical Composition of Isotonic Saline Solutiona
trial. Acute illness was evaluated during the first 2 visits (up to3 weeks), prevention during the following 2 visits (up to 12 Concentration
weeks). The third visit, scheduled for week 8 after study en-try, could be conducted over the telephone.
Elements, mg/L
On study entry, children in the saline group and their par- ents were instructed about usage; the number of bottles pro- vided was recorded in the protocol; and the patients were asked to return empty bottles, which were weighed to assess com- pliance. No restrictions were placed on the use of concomi- tant medication during acute illness, with the exception of sys- temic antihistamines, which are sometimes used to reducemucosal swelling. Long-term use of systemic antihistamines for Trace Elements, µg/L
other indications (eg, allergy) initiated before trial entry was Saline nasal wash was administered 6 times per day during acute illness and 3 times per day during the prevention phase.
For the medium jet flow (saline group 1) 9 mL of saline was (Physiomer; Goemar Laboratoire de la Mer, Saint Malo, France).
administered per application and per nostril; for both othersprays (saline groups 2 and 3), the volume was 3 mL per ap- to pediatric outpatient clinics for treatment of acute cold or flu. The study was performed in 2 phases: initially we Randomization of patients was done by the physician. Pa- focused on symptom relief during acute illness, and we tients were allocated to 1 of 4 groups (no wash or 1 of 3 types then assessed preventive potential in the same patient of nasal wash) based on the sequence of their appearance in The primary objectives of this trial were to (1) prove the efficacy and safety of nasal saline wash as adjunctive PARAMETERS EVALUATED
treatment during uncomplicated acute rhinitis for the reso-lution of nasal symptoms and (2) evaluate its potential At the first visit, we evaluated baseline parameters (sex, age, to prevent the recurrence of cold and flu and complica- duration of illness, and concomitant diseases and medication) tions. Secondary objectives included the evaluation of 2 and overall health status (using a qualitative range from excel- different cleansing strengths (a medium jet and a fine lent to unsatisfactory). On entry and at all subsequent visits,nasal and several other parameters representing the status of spray) and 2 isotonic formulations with different ionic the upper respiratory tract were assessed by the physician using compositions (a nasal wash formula and a dual formula a qualitative predefined range (1, no symptoms, through 4, se- vere symptoms). Some parameters had different scales, which
are specified in Tables 2, 3, 4, and 5. Concomitant medica-
tion use was also recorded at each visit, not by brand or mol-ecule, but by group (eg, mucolytics). At all visits, parents wereasked about days of sickness and absence from school. From The study was approved by the ethics committee of the Motol the second visit, patients in the saline group were evaluated for Teaching Hospital in Prague and the ethics committee of the Teach- their attitude concerning tolerability and sensations reported ing Hospital in Brno. All parents signed an informed consent form during and after application, using a qualitative range. Ad- and obtained relevant information about the trial, which was de- verse events were recorded separately as was discontinuation.
signed as a multicenter, parallel group, open, and randomized com- No laboratory testing was scheduled. Empty bottles returned parison. Eight pediatric outpatient clinics participated in the study; were weighed to assess compliance. Patients with a compli- every child was assessed by the same physician at each visit. Eli- ance rate estimated at less than 75% were excluded from evalu- gible patients were aged 6 to 10 years and were seeing the phy- ation. For evaluation purposes, all the qualitative parameters sician for a common cold or flu. Specific exclusion criteria were anatomic sinonasal disorders, known severe immune defi- Most of the parameters (clinical status) were evaluated by ciency, and concomitant corticosteroid medication.
physicians during scheduled visits. Patients and/or parents as- A total of 401 children met the inclusion criteria and were sessed health status and parameters related to saline safety and randomized to receive either standard treatment including an- tipyretics, nasal decongestants, mucolytics (those could be givenbased on patient status and parent discretion), and/or sys-temic antibiotics (n = 101) without saline wash, or these same STATISTICAL ANALYSIS
standard treatments with saline wash. The saline solution usedwas a commercially available product processed from Atlantic Statistical analysis was carried out using StatSoft Statistica soft- Ocean seawater (Physiomer; Goemar Laboratoire de la Mer, Saint ware, version 7.1 (StatSoft Inc, Tulsa, Oklahoma). The level of Malo, France). As electrodialysis is used to establish isotonic- statistical significance was set at .05 for each comparison.
ity, the trace elements and minerals remain in concentrations simi- Descriptive statistics are provided for quantitative para- lar to those found in seawater (Table 1). Patients randomized
meters such as mean, standard deviation, and median. Qualita- to the saline group were evaluated in 3 delivery strength sub- tive data are presented as absolute frequencies and percentages.
groups: (1) medium jet flow (n=100); (2) fine spray (n=100); Individual parameters were separately evaluated at each visit.
and (3) a dual formula for eye and nose wash with a fine spray For data measured on a Likert scale, the hypothesis of no dif- (n=100). All researchers were blinded to saline solutions used.
ference in medians among 4 compared groups was evaluated Patients were observed for a total of 12 weeks, from Janu- using the Kruskal-Wallis 1-way analysis of variance based on ary to April 2006, during which health status, symptoms, and ranks (corrected for ties). If this test showed significant differ- (REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 134 (NO. 1), JAN 2008 2008 American Medical Association. All rights reserved.
Table 2. Selected Characteristics of 390 Patientsa
Isotonic Saline Wash
Medium Jet
Fine Spray
Dual Formula
(n = 289)c
Abbreviations: AH, antihistamines; V, visits during the trial.
a All data are reported as mean [SD] value or number (percentage) of patients.
b Multiple comparisons of treatments vs control if Kruskal-Wallis or logistic regression results were significant.
d Rhinologic symptom scores: 1, no symptoms; 2, mild; 3, moderate; and 4, severe.
e Secretion types: 1, absent; 2, serosal; 3, seropurulent; and 4, purulent.
f Breathing scores: 1, without any difficulty; 2, minor difficulties; 3, difficult; and 4, impossible.
ence among the groups, we performed multiple comparisons ACUTE ILLNESS PHASE (VISIT 2)
between treatments (based on joint ranking).
For dichotomous data, we performed a logistic regression analysis, followed in case of significance by comparisons of Rhinologic score was used for efficacy assessment. Indi- “treated” groups vs control. Bonferroni correction for mul- vidual symptoms recorded in the protocol as predefined tiple comparisons was used for these contrasts.
qualitative measures were converted to a numerical scale In addition, we added a comparison of patients using nasal for evaluation purposes (score range, 1-4; 1, absence of wash (treated) vs control (untreated), without differentiation symptoms, through 4, severe symptoms). The parameters of individually treated subgroups. Mann-Whitney and ␹2 tests assessed included nasal secretion and its type, nasal ob- struction, sore throat, cough and expectoration including Spontaneous complaints and local adverse events reported the nature of the expectorate, sneezing, itching, and loss by the patients were listed by groups using nasal wash.
of senses of smell and taste. Although the severity of symp-toms was comparable at baseline, we saw faster clearing of some nasal symptoms in the saline groups. Symptom scoresthat differed significantly between groups were nasal se- Of 401 patients, 390 were finally assessed; 1 patient was cretion, type of nasal secretion, nasal obstruction, and sore not available for visit 3 and was excluded from evaluation throat (Table 3). Similar results were obtained if indi- after the second visit. The remaining 10 patients either did vidual nasal wash subgroups and control were compared.
not come to the second visit (n=4), did not comply with When comparing the consumption of pharmaceuti- the entry criteria (n=2), or the parents decided not to con- cals, we noted significantly lower consumption of nasal tinue (n=2); 1 patient was admitted to the hospital, and 1 decongestants and mucolytics in the treatment groups was excluded because of low compliance. The average du- than in controls. Other medication evaluated did not dif- ration of the trial was 86 days. Baseline characteristics among groups were comparable as well as the average number of At visit 2, physicians were asked to assess the change days between individual visits (Table 2).
in health status compared with the entry visit. A qualitative (REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 134 (NO. 1), JAN 2008 2008 American Medical Association. All rights reserved.
Table 3. Efficacy Parameters at Visit 2 (Acute Phase)a
Isotonic Saline Wash
Medium Jet
Fine Spray
Dual Formula
(n = 289)c
a All data are reported as mean [SD] score or number (percentage) of patients.
b Multiple comparisons of treatments vs control if Kruskal-Wallis or logistic regression results were significant.
d Rhinologic symptom scores: 1, no symptoms; 2, mild; 3, moderate; and 4, severe.
f Secretion types: 1, absent; 2, serosal; 3, seropurulent; and 4, purulent.
g Breathing scores: 1, without any difficulty; 2, minor difficulties; 3, difficult; and 4, impossible.
h Health status scores: 1, cured; 2, significant improvement; 3, partial improvement; and 4, no change.
Table 4. Efficacy Parameters at Visit 3 (Preventive Phase)a
Isotonic Saline Wash
Medium Jet
Fine Spray
Dual Formula
(n = 288)c
a All data are reported as mean [SD] score or number (percentage) of patients.
b Multiple comparisons of treatments vs control if Kruskal-Wallis or logistic regression results were significant.
d Rhinologic symptom scores: 1, no symptoms; 2, mild; 3, moderate; and 4, severe.
f Secretion types: 1, absent; 2, serosal; 3, seropurulent; and 4, purulent.
g Breathing scores: 1, without any difficulty; 2, minor difficulties; 3, difficult; and 4, impossible.
(REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 134 (NO. 1), JAN 2008 2008 American Medical Association. All rights reserved.
Table 5. Efficacy Parameters at Visit 4 (Preventive Phase)a
Isotonic Saline Wash
Medium Jet
Fine Spray
Dual Formula
(n = 288)c
a All data are reported as mean [SD] score or number (percentage) of patients.
b Multiple comparisons of treatments vs control if Kruskal-Wallis or logistic regression results were significant.
d Rhinologic symptom scores: 1, no symptoms; 2, mild; 3, moderate; and 4, severe.
f Secretion types: 1, absent; 2, serosal; 3, seropurulent; and 4, purulent.
g Breathing scores: 1, without any difficulty; 2, minor difficulties; 3, difficult; and 4, impossible.
range was used that was converted to a numerical scale with absence from school), absence from school, and com- for the purposes of evaluation (1, cured; 2, significant plications (Table 5). Most recorded events were otitis me- improvement; 3, partial improvement; and 4, no change).
dia, tonsillopharyngitis, bronchitis, and sinusitis.
Health status improved significantly more in the groupsusing saline (Table 3).
At trial entry and at the final visit, parents were asked torate the child’s health status on a 4-point qualitative scale, For efficacy evaluation during the preventive period, simi- which was converted to a numeric scale for evaluation lar measures were chosen to assess whether regular (3 (1, excellent; 2, good; 3, satisfactory; and 4, unsatisfac- times per day) nasal wash with isotonic saline can pre- tory). At baseline, the mean score was identical for the vent the recurrence of URTIs. Besides rhinologic para- control and saline groups (mean score, 2.45), which rep- meters and medication intake, days of reported illness, resented an average status of good to satisfactory. At visit days of absence from school, and reported complica- 4, after 12 weeks in the study, the parents of children using saline rated the health status of their children as signifi- Rhinologic symptoms were scored the same as for acute cantly better than did parents of children in the control illness and evaluated about 8 weeks after study entry. In group (1.51 vs 2.16) (Table 6). Similar results were ob-
several parameters, including dry cough, nasal secre- tained if individual nasal wash subgroups and control were tion, and nasal breathing, saline groups had signifi- cantly lower occurrence or severity of symptoms (Table 4and Table 5). Table 5 summarizes the results at the final SAFETY AND TOLERABILITY
visit (during week 12 after the study entry).
In terms of medication used, at visit 3, a significantly To assess safety and tolerability, we evaluated only the higher percentage of control patients than patients in the saline subgroups. Starting from visit 2, children were saline groups was using antipyretics, mucolytics, nasal asked about their sensations and feelings during and decongestants, and systemic antibiotics (Table 4). The approximately 5 minutes after application of the nasal same results (with the exception of systemic antibiot- wash. Their qualitative assessment was converted to a ics) were obtained at the final visit (Table 5).
5-point numeric scale for further evaluation (1, very Significantly fewer patients who used long-term saline pleasant; 2, pleasant; 3, no complaints; 4, unpleasant; wash reported days of illness (whether or not associated and 5, very unpleasant). Children using the fine spray (REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 134 (NO. 1), JAN 2008 2008 American Medical Association. All rights reserved.
Table 6. Change in Health Status Reported by Parents
by Study Enda

Isotonic Saline Wash
2.45 [0.59] 2.48 [0.58] 2.42 [0.56] 2.43 [0.58] 2.45 [0.57] 2.16 [0.64] 1.43 [0.52]d 1.54 [0.67]d 1.55 [0.58]d 1.51 [0.59]d a All data are reported as mean [SD] scores. Health status scores: 1, cured; 2, significant improvement; 3, partial improvement; and 4, no change.
b Multiple comparisons of treatments vs control if Kruskal-Wallis or logistic regression results were significant.
Figure 2. Sensations after application. Patients rated their sensations
5 minutes after isotonic saline wash application using a qualitative scale
transformed into a quantitative range for evaluation (1, very pleasant;
2, pleasant; 3, no complaints; 4, unpleasant; and 5, very unpleasant).
The study results show that saline nasal wash signifi- cantly improved nasal symptoms in the common cold inchildren and shows potential to prevent the recurrence of URTI. Results were robust, consistent, and statisti-cally significant in contrast to the few published articles that do not clearly show the benefits of nasal wash to treatthe common cold.3 Some literature describes the preven- Based on in vitro findings, saline has an anti- inflammatory activity because it reduces the production Figure 1. Sensations during application. Patients rated their sensations
and release of interleukin 8 by the respiratory epithe- during isotonic saline wash application using a qualitative scale transformed lium.13 Among other mechanisms of action, a favorable into a quantitative range for evaluation (1, very pleasant; 2, pleasant;3, no complaints; 4, unpleasant; and 5, very unpleasant).
environment for ciliary movement is assumed, espe-cially in alkaline solutions.14 However, another publica-tion reported decreased ciliary activity in isotonic 0.9% (groups 2 and 3) reported higher comfort during and saline solution.15 These numerous conflicting results sug- after application than the medium jet users (group 1) gest that the exact mechanism of action is still un- (Figure 1 and Figure 2). By visit 4, the scores had
known. It is not clear whether the effect is predomi- improved, but they remained worse in group 1 (me- nantly mechanical, based on clearing mucus, or whether dium jet) than in the other groups. However, this differ- salts and trace elements in seawater solutions play a sig- ence was not statistically significant.
nificant role. Moreover a number of commercially avail- All the patients’ complaints were recorded in the able products differ in tonicity, dilution, application de- protocol during the course of the study. Overall, saline vice, and other aspects. In our study, we used an undiluted nasal wash was well tolerated; most complaints product for which isotonicity was achieved by using elec- appeared in the medium jet group and were associated trodialysis. This manufacturing process preserves the con- with the stronger flow of the wash. The number of centrations of ions and trace elements to levels compa- complaints was too low for statistical analysis. At the second visit, only 25 patients recorded nasal wash com- Since we assessed the potential of seawater as an ad- plaints (8.7%), and at the final visit, this number had junctive treatment and evaluated it in prevention, we used dropped to 7 (2.4%). The other reported complaints nonblinded trials and observation to compare nasal wash were burning and bitter taste. Three patients of 288 with standard treatment. Physicians were aware which patients used nasal wash and their assignment to par- (REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 134 (NO. 1), JAN 2008 2008 American Medical Association. All rights reserved.
ticular groups. However, physicians were not informed cussion, the authors admit that the rather small sample about the composition and device used in these groups; size might have affected the results. Our study was con- the nasal wash bottles were not labeled.
ducted during a shorter period of time (from January to This largely nonblinded aspect is a weakness of the April 2006), with a limited recruitment period of 8 weeks present study. However, the large number of partici- to secure a comparable epidemiologic situation. The study pants, multicenter design, and consistence of results be- by Adam et al10 used a solution prepared from pickling tween individual parameters (assessed by physician, pa- salt and baking soda compared with the isotonic undi- tient, and parent) lower the risk of bias. A blinded luted seawater solution used during our study. This raises comparison of several presentations (eg, physiologic sa- again the question about the effect of seawater trace ele- line solution and diluted solution) could be a topic for Another drawback of the present study is the miss- PREVENTION OF UPPER RESPIRATORY
ing link between statistical and clinical significance in INFECTIONS
the symptom score. We used a self-designed outcome scalewithout performing any additional analysis to establish At the third and fourth visits, children using saline na- a minimal clinically significant difference. This repre- sal wash on a regular basis (3 times daily) showed fewer sents a limitation especially in the acute illness phase rhinologic symptoms. The recorded symptoms were con- analysis, where differences are rather small. However, dur- sistent with the medication consumed; a higher percent- ing the prevention phases, a reduced incidence of other age of children in the control group used antipyretics, relevant measures (eg, reported illness, school absence, mucolytics, nasal decongestants, and systemic antibiot- occurrence of complications, and medication use) sup- ics. Antibiotics are frequently used in children, and the ports the validity of the clinical benefits of nasal wash.
resulting resistant strains of bacteria represent a threat Even the difference of 0.98 in nasal secretion score and all over Europe.18 Saline nasal wash seems to be an ap- 0.97 in nasal breathing score seems to be clinically rel- propriate means to achieve lower antibiotic consump- evant (by judgment of physicians involved in the trial).
tion while reducing upper URTI infections and their com- Children were asked to use nasal wash on a frequent plications. Moreover, other evaluated parameters also basis especially during acute illness. We did not hear sub- support preventive findings: a reduction in reported ill- stantial complaints about compliance, and good compli- ness at visit 3 (untreated, 75% vs treated, 31%) and at ance seemed to be confirmed by the weight of returned visit 4 (untreated, 52% vs treated, 22%) compared with empty bottles. We excluded only 1 patient for poor controls; a 51% improvement in school absences at the third visit (17% vs 35%) and a 64% reduction at the fi-nal visit (9% vs 25%), although both groups had similar ACUTE ILLNESS
absences from school during the period of acute illness(52% vs 50%). The same trends were noted for compli- During acute illness, children using isotonic saline showed cation rates. All of these results are supported by higher faster resolution of nasal secretion and obstruction as well parent satisfaction with the treatment.
as a reduction in the quantity of used medication; the dif- An article by Tano and Tano11 reported the preven- ference in medication use was significant for nasal de- tive potential of saline nasal wash in young adults. Pa- congestants (PϽ.001) and mucolytics (P=.002). The re- tients were randomly divided into 2 parallel groups. Each duced use of topical decongestants is important since they group recording symptoms used either physiologic sa- are appropriate only on a short-term basis. Long-term use line spray or no nasal irrigation. After the first 10 weeks, of topical decongestants, which commonly occurs, es- both groups switched regimens and continued for an- pecially in children, might lead to complications, includ- other 10 weeks. The study found a significant reduction ing paranasal sinusitis and histologic changes in the mu- in the number of days when nasal symptoms occurred cosa. These complications were reported in experimental (secretion and/or blocked nose) and a reduction of URTI animals after long-term application of phenylephrine and episodes during the nasal wash period. Although Tano oxymetazoline.16 Furthermore, benzalkonium chloride, and Tano11 studied adults and evaluated parameters not which is often used as a preserving agent in nasal decon- identical to ours, both studies showed efficacy to pre- gestants or nasal corticosteroids, showed long-term ad- verse events on the nasal mucosa when used in combi-nation with a vasoactive substance.17 NASAL WASH SUBGROUPS
In addition to faster symptom resolution, the saline nasal wash group in the present study showed a signifi- We did not find robust significant differences either dur- cantly higher improvement in health status, as assessed ing acute illness or in the prevention phase among indi- by physicians, than did the control group (P = .02).
vidual nasal wash subgroups, although the groups dif- Our outcomes were different from findings pub- fered in cleansing strengths (medium jet and fine spray) lished by Adam et al10 in 1998, who did not find differ- and saline ionic composition. In this age group, we did ences between adults treated for common cold and rhino- not find results supporting the hypothesis that stronger sinusitis with either isotonic or hypertonic nasal wash flow would be more effective than a fine spray. Further- compared with an observation group. Different results more, a reduction in concentration of sodium ions and could be explained by the different study population (chil- higher potassium content was not less effective. These dren vs adults) and sample size (390 vs 119). In the dis- findings do not fully support the assumptions concern- (REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 134 (NO. 1), JAN 2008 2008 American Medical Association. All rights reserved.
ing the importance of sodium chloride with respect to Role of the Sponsor: The sponsor participated in the study
design and contributed by supplying the product for na- In conclusion, the present trial has shown the effi- sal wash. The sponsor did not conduct, manage, or ana- cacy of isotonic saline nasal wash processed from Atlan- lyze the data and was not involved in result interpreta- tic Ocean seawater in faster symptom resolution, reduc- tion or in the preparation of the manuscript.
tion of medical treatment, and improved health status in Previous Presentation: This article was presented at The
common cold and flu. During the weeks after acute ill- American Society of Pediatric Otolaryngology 2007 An- ness when preventive potential was assessed, regular iso- nual Meeting; April 28, 2007; San Diego, California.
tonic saline nasal wash proved to reduce episodes of URTIs Additional Contributions: Philippe Contencin, MD, pro-
compared with the control (observation only) group. Re- vided critical revision of a previous draft of this article.
sults showing reduction in URTIs were robust and con-sistent in a number of parameters, including rhinologic symptoms, medication consumption, reported illness,school absence, and complication rate. Children showed 1. Wald ER, Guerra N, Byers C. Upper respiratory tract infections in young chil- a higher acceptance for the milder cleansing strength (fine dren: duration of and frequency of complications. Pediatrics. 1991;87(2): 2. Van Cauwenberge P, Watelet JB. Epidemiology of chronic rhinosinusitis. Thorax.
Submitted for Publication: February 4, 2007; final re-
3. Papsin B, McTavish A. Saline nasal irrigation: its role as an adjunct treatment.
vision received September 6, 2007; accepted September Can Fam Physician. 2003;49:168-173.
4. Fokkens W, Lund V, Bachert C, et al. EAACI position paper on rhinosinusitis and Correspondence: Jana Skoupa´, MD, Pod Sˇmuky´rˇkou 2,
nasal polyps. Allergy. 2005;60(5):583-601.
150 00 Prague 5, Czech Republic (
5. van Cauwenberge P, Bachert C, Passalacqua G, et al. Consensus statement on the treatment of allergic rhinitis. Allergy. 2000;55(2):116-134.
Author Contributions: Drs Sˇlapak and Skoupa´ had full
6. Shoseyov D, Bibi H, Shai P, Shoseyov N, Shazberg G, Hurvitz H. Treatment with access to all the data in the study and take responsibility hypertonic saline versus normal saline nasal wash of pediatric chronic sinusitis.
for the integrity of the data and the accuracy of the data J Allergy Clin Immunol. 1998;101(5):602-605.
analysis. Study concept and design: Sˇlapak, Skoupa´, Strnad, 7. Heatley DG, McConnell KE, Kille TL, Leverson GE. Nasal irrigation for the alleviation and Hornı´k. Acquisition of data: Sˇlapak, Strnad, and of sinonasal symptoms. Otolaryngol Head Neck Surg. 2001;125(1):44-48.
8. Garavello W, Romagnoli M, Sordo L, Gaini RM, Di Berardino C, Angrisano A.
Hornı´k. Analysis and interpretation of data: Sˇlapak, Skoupa´, Hypersaline nasal irrigation in children with symptomatic seasonal allergic rhi- Strnad, and Hornı´k. Drafting of the manuscript: Sˇlapak, nitis: a randomized study. Pediatr Allergy Immunol. 2003;14(2):140-143.
Skoupa´, and Hornı´k. Critical revision of the manuscript 9. Brown CL, Graham SM. Nasal irrigations: good or bad? Curr Opin Otolaryngol for important intellectual content: Sˇlapak, Skoupa´, Strnad, Head Neck Surg. 2004;12(1):9-13.
and Hornı´k. Statistical analysis: Skoupa´ and Strnad. Ob- 10. Adam P, Stiffman M, Blake RL. A clinical trial of hypertonic saline nasal spray in subjects with the common cold or rhinosinusitis. Arch Fam Med. 1998;7(1): tained funding: Sˇlapak, Skoupa´, Strnad, and Hornı´k. Ad- ministrative technical and material support: Sˇlapak, Skoupa´, 11. Tano L, Tano K. A daily nasal spray with saline prevents symptoms of rhinitis.
Strnad, and Hornı´k. Study supervision: Sˇlapak, Strnad, and Acta Otolaryngol. 2004;124(9):1059-1062.
12. Nash DR, Harman J, Wald ER, Kelleher KJ. Antibiotic prescribing by primary care Financial Disclosure: Dr Sˇlapak has received speakers’
physicians for children with upper respiratory tract infections. Arch Pediatr Ado- honoraria from GlaxoSmithKline and Servier. Dr Skoupa´ lesc Med. 2002;156(11):1114-1119.
13. Tabary O, Muselet C, Yvin JC, Halley-Vanhove B, Puchelle E, Jacquot J. Physi- has received speakers’ honoraria from Roche, Zentiva, omer reduces the chemokine interleukin-8 production by activated human res- Pfizer, and GlaxoSmithKline; she is currently working piratory epithelial cells. Eur Respir J. 2001;18(4):661-666.
on several projects funded by Pfizer, GlaxoSmithKline, 14. Talbot AR, Herr TM, Parsons DS. Mucociliary clearance and buffered hypertonic Zentiva, Schering AG, Sanofi-Aventis, and Gedeon- saline solution. Laryngoscope. 1997;107(4):500-503.
Richter and will work on projects for Eli Lilly and Astellas 15. Boek WM, Keles N, Graamans K, Huizing EH. Physiologic and hypertonic saline solution impair ciliary activity in vitro. Laryngoscope. 1999;109(3): 396-399.
in the near future. Dr Strnad has received speakers’ hono- 16. Min YG, Kim HS, Suh SH, Jeon SY, Son YI, Yoon S. Paranasal sinusitis after raria from Merck & Co Inc. Dr Hornı´k has received speak- long-term use of topical nasal decongestants. Acta Otolaryngol. 1996;116(3): ers’ honoraria from Schering-Plough and has been or is currently an investigator in clinical studies sponsored by 17. Halle´n H, Graf P. Benzalkonium chloride in nasal decongestive sprays has a long- lasting adverse effect on the nasal mucosa of healthy volunteers. Clin Exp Allergy.
Funding/Support: This study was funded by Goemar
18. Agence Franc¸aise de Se´curite´ Sanitaire des Produits de Sante´. Systemic antibi- Laboratoires La Madeleine, Avenue du Ge´ne´ral Patron, otic treatment in upper and lower respiratory tract infections: official French guidelines. Clin Microbiol Infect. 2003;9(12):1162-1178.
(REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 134 (NO. 1), JAN 2008 2008 American Medical Association. All rights reserved.


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Draft eln fact sheet v

FACT SHEET PROCTER & GAMBLE USES SAFE DIGITAL SIGNATURE STANDARD FOR ELECTRONIC LABORATORY NOTEBOOK PROJECT To be deployed to up to 4500 P&G scientists and technicians WHAT : Procter & Gamble (P&G) is using the SAFE digital signature standard in its Electronic Laboratory Notebook (ELN) project, reaching potentially 4500 people inside the company. This project is

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