2016 Section 5 Green Book

Squeeze bottle versus saline spray after endoscopic sinus

surgery for chronic rhinosinusitis: A pilot multicentre trial

K. I. Macdonald, M.D., F.R.C.S.C.,

E. D. Wright, M.D.C.M.,

M.Ed.

L. J. Sowerby, M.D., F.R.C.S.C.,

B. W. Rotenberg, M.D., F.R.C.S.C.,

C. J. Chin, M.D.,

L. Rudmik, M.D.,

M.Sc

., F.R.C.S.C.,

D. D. Sommer, M.D., F.R.C.S.C.,

S. Nayan, M.D.,

M. DesRosiers, M.D., F.R.C.S.C.,

M. A. Tewfik, M.D.C.M.,

M.Sc

., F.R.C.S.C.,

C. J. Valdes, M.D.,

E. Massoud, M.B.,

M.Sc

., F.R.C.S.C.,

D. Thomas, M.D.,

M.Sc

S. J. Kilty, M.D., F.R.C.S.C.,

A. Vescan, M.D., F.R.C.S.C.,

B. Mechor, M.D.,

M.Sc

., F.R.C.S.C.,

F. Lavigne, M.D., F.R.C.S.C.,

M. Fandino, M.D.,

M.Sc

A. R. Javer, M.D., F.R.C.S.C.,

and I. J. Witterick, M.D.,

M.Sc

., F.R.C.S.C.

ABSTRACT

Background:

There is a need for controlled trials to guide the perioperative management of patients undergoing endoscopic sinus surgery (ESS). The

authors performed a pilot multicenter trial to compare two types of saline delivery devices in this population.

Methods:

Patients were randomized to high volume saline irrigation with a squeeze bottle and low volume saline spray after ESS in patients with chronic

rhinosinusitis (CRS). Surgeons were blinded to treatment, and one-month postoperative scores for sinonasal outcomes [Sinonasal Outcome Test-22

(SNOT-22)] scale, nasal and sinus symptom score (NSS), and perioperative sinus endoscopy (POSE) scale were compared with preoperative scores.

Results:

Nine centers provided data for 86 patients. All three outcomes measures improved significantly for both groups. Saline spray: SNOT-22 48.8

versus. 23.7, treatment effect 25.1 (95% confidence interval [CI], 17.9–32.2), POSE 21.1 versus. 8.4, treatment effect 12.7 (95% CI, 9.2–16.1), and NSS 8.2

versus 5.0, treatment effect 3.1 (95% CI, 1.4–4.9) pre- and postoperatively, respectively (all p 0.0001). Squeeze bottle: SNOT-22 49.5 versus 23.6, treatment

effect 25.9 (95% CI, 20.3–31.6), POSE 18.6 versus 9.2, treatment effect 9.3, (95% CI 6.7–12.0), and NSS 9.0 versus 5.7, treatment effect 3.3 (95% CI, 2.3–4.3)

pre- and postoperatively, respectively (all p 0.0001). Analysis of variance did not identify a difference between the two treatment groups. Subgroup analysis

based on preoperative disease severity did not change the nonassociation of saline bottle with outcome measures. Post hoc sample size calculation determined

that 176 patients is required to detect an 8.9-point difference in SNOT-22 scores.

Conclusion:

In this pilot multicenter trial examining patients with chronic rhinosinusitis undergoing ESS, both squeeze bottle and saline spray showed

significant improvement in SNOT-22, POSE, and NSS scores at one-month postoperatively. Because the study was nonpowered, we cannot rule out a potential

difference between the two treatment groups.

(Am J Rhinol Allergy 29, e13–e17, 2015; doi: 10.2500/ajra.2015.29.4125)

hronic rhinosinusitis (CRS) is a common inflammatory condition

of the upper respiratory tract lasting more than 12 weeks. CRS

has an estimated prevalence of 5% in the Canadian population,

and

up to 16% in some adult populations in the United States.

Sinusitis is

associated with a major societal health care burden, costing billions of

dollars a year in North America.

3,4

The medical treatment of CRS includes topical saline and cortico-

steroid sprays, systemic steroids, and antimicrobials. Specifically, sa-

line nasal irrigation (SNI) is a safe, nonpharmacologic treatment and

is an important and effective treatment option in CRS management.

5,6

SNI can vary by concentration (

e.g.

, hypertonic, isotonic, and hypo-

tonic) and device (

e.g.

, bulb syringe, nasal mist, and squeeze bottle).

Despite a lack of controlled trials, there is an overall consensus

agreement for the use for SNI in the CRS population.

Three studies,

all more than 15 years old, examined saline formulations that are

currently unavailable in North America.

8–10

Harvey

et al.

explored

how irrigation is delivered and retained in the sinuses, using more

common devices.

11,12

In a cadaveric model, they compared squeeze

bottle with saline spray devices and found a greater sinus cavity

delivery (

0.02) in the former. More recently, an Australian

prospective trial randomized 74 postsurgical CRS patients to var-

ious saline formulations. They found that irrigation with Ringer’s

solution resulted in improved quality of life measures and endo-

scopic mucosal appearances, compared with normal and hyper-

tonic saline.

Examples of popular high-volume low-pressure and low-volume

formulations include squeeze bottle (NeilMed Pharmaceuticals, Inc.,

Santa Rosa, CA) and saline spray (Salinex, Sandoz, QC, Canada),

respectively. These are positive pressure treatments

that are used

globally, despite insufficient evidence demonstrating safety or effi-

cacy. This is likely in part because topical saline sprays are considered

safe, they do not require a prescription, and they are heavily mar-

keted. To date, there are no studies comparing high-volume, low-

pressure devices with low-volume devices in the postoperative CRS

patient.

The authors hypothesized that there is an advantage of squeeze

bottle over saline spray. The mechanical effect of high volume (240

mL) irrigation debrides and cleans a larger surface area of sinonasal

mucosa. A saline spray bottle contains 30 mL, a small portion of

which is expelled with each actuation and therefore may not have the

same cleansing effect.

There is growing interest to establish a collaborative Canadian

Rhinology group to perform multicenter clinical trials. In addition to

Department of Otolaryngology, Head and Neck Surgery, University of Ottawa,

Ottawa ON,

Division of Otolaryngology, Head and Neck Surgery, FRCSC, Univer-

sity of Alberta, Edmonton AB,

Department of Otolaryngology, Head and Neck

Surgery, Western University, London, ON,

Division of Otolaryngology, Head and

Neck Surgery, University of Calgary, Calgary AB,

Division of Otolaryngology, Head

and Neck Surgery, McMaster University, Hamilton ON,

Department of Otolaryn-

gology, Head and Neck Surgery, McGill University, Montreal QC,

Division of

Otolaryngology, Head and Neck Surgery, Dalhousie University, Halifax NS,

Depart-

ment of Otolaryngology, Head and Neck Surgery, University of Toronto, Toronto ON,

Department of Otolaryngology, Head and Neck Surgery, Universite de Montreal,

Montreal QC, and

Division of Otolaryngology, Head and Neck Surgery, University

of British Columbia, Vancouver BC

Presented at the 67th Annual Canadian Society Otolaryngology, Head and Neck

Surgery meeting in Banff, Alberta, Canada, June 2, 2013

The authors have no conflicts of interest to declare pertaining to this article

Address correspondence to Kristian Macdonald, M.D., F.R.C.S.C., 1081 Carling Av-

enue, G-3, Ottawa ON, Canada K1Y 4G2

E-mail address:

kristian.macdonald@gmail.com

Copyright

2015, OceanSide Publications, Inc., U.S.A.

Reprinted by permission of Am J Rhinol Allergy. 2015; 29(1):e13-e17.

127