title: A prospective randomised single-blinded clinical trial comparing the efficacy and tolerability of the nasal douching products Sterimar™ and Sinus Rinse™ following functional endoscopic sinus surgery.
abstract: OBJECTIVE
  To compare the efficacy and tolerability of two commonly used nasal douching products, low-volume high-pressure Sterimar™ and high-volume low-pressure Sinus Rinse™ following functional endoscopic sinus surgery.
  
  
  METHODS
  Prospective randomised single-blinded study.
  
  
  METHODS
  Tertiary referral centre.
  
  
  METHODS
  Thirty-one patients, undergoing functional endoscopic sinus surgery for chronic rhinosinusitis with and without polyps, were recruited for the study. The patients acted as their own comparators self-administering each douche three times daily into one randomly allocated nostril for a period of 12 weeks following the surgery.
  
  
  METHODS
  The primary outcome measure was a blinded objective endoscopic assessment of each operated side using a modified Lund-Kennedy endoscopic assessment tool undertaken at 2, 4 and 12 weeks postoperatively. As secondary outcome measures, the patients were asked to express a preference between the two products based on perceived effectiveness and ease of use.
  
  
  RESULTS
  Compared with the preoperative scores, there was a statistically significant improvement in the SNOT-22 score at all three postoperative time points (P < 0.001). Compared with week 2, there was a statistically significant reduction in the modified Lund-Kennedy endoscopic scores (P < 0.05) for both Sterimar™ and Sinus Rinse™ at weeks 4 and 12. When comparing Sterimar™ with SinuRinse™, there was a statistically significant lower modified Lund-Kennedy score at 2 and 4 weeks postoperatively for the side treated with Sinus Rinse™ (P ≤ 0.05), indicating a more favourable outcome. However, this difference was not apparent at 12 weeks postoperatively (P = 0.66). At all time points, patients perceived Sinus Rinse™ to be more effective than Sterimar™ (P < 0.0001), but there was no significant difference in the patients' preference for either product (P > 0.05).
  
  
  CONCLUSIONS
  High-volume low-pressure saline irrigation is recommended as an efficacious, easy to use and well-tolerated adjunct to endoscopic sinonasal toilet in the early postoperative period following functional endoscopic sinus surgery.
authors.affiliation: Academic unit of Clinical and Experimental Sciences, Department of Otorhinolaryngology - Head and Neck Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK. R.J.Salib@southampton.ac.uk
authors.forename: R J
authors.initials: RJ
authors.lastname: Salib
authors.forename: S
authors.initials: S
authors.lastname: Talpallikar
authors.forename: S
authors.initials: S
authors.lastname: Uppal
authors.forename: S B
authors.initials: SB
authors.lastname: Nair
mesh_terms: D000281:Administration, Intranasal / Q000295:instrumentation; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007552:Isotonic Solutions / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D015508:Nasal Obstruction / Q000209:etiology / Q000517:prevention & control*; D009298:Nasal Polyps / Q000150:complications / Q000601:surgery; D057605:Natural Orifice Endoscopic Surgery / Q000009:adverse effects*; D057240:Patient Preference; D011446:Prospective Studies; D012220:Rhinitis / Q000150:complications / Q000601:surgery*; D016037:Single-Blind Method; D012852:Sinusitis / Q000150:complications / Q000601:surgery*; D012965:Sodium Chloride / Q000008:administration & dosage*; D007507:Therapeutic Irrigation / Q000295:instrumentation; D000267:Tissue Adhesions / Q000209:etiology / Q000517:prevention & control; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007552:Isotonic Solutions; D012965:Sodium Chloride