title: Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial.
abstract: BACKGROUND
  Systematic reviews support nasal saline irrigation for chronic or recurrent sinus symptoms, but trials have been small and few in primary care settings. Steam inhalation has also been proposed, but supporting evidence is lacking. We investigated whether brief pragmatic interventions to encourage use of nasal irrigation or steam inhalation would be effective in relieving sinus symptoms.
  
  
  METHODS
  We conducted a pragmatic randomized controlled trial involving adults (age 18-65 yr) from 72 primary care practices in the United Kingdom who had a history of chronic or recurrent sinusitis and reported a "moderate to severe" impact of sinus symptoms on their quality of life. Participants were recruited between Feb. 11, 2009, and June 30, 2014, and randomly assigned to 1 of 4 advice strategies: usual care, daily nasal saline irrigation supported by a demonstration video, daily steam inhalation, or combined treatment with both interventions. The primary outcome measure was the Rhinosinusitis Disability Index (RSDI). Patients were followed up at 3 and 6 months. We imputed missing data using multiple imputation methods.
  
  
  RESULTS
  Of the 961 patients who consented, 871 returned baseline questionnaires (210 usual care, 219 nasal irrigation, 232 steam inhalation and 210 combined treatment). A total of 671 (77.0%) of the 871 participants reported RSDI scores at 3 months. Patients' RSDI scores improved more with nasal irrigation than without nasal irrigation by 3 months (crude change -7.42 v. -5.23; estimated adjusted mean difference between groups -2.51, 95% confidence interval -4.65 to -0.37). By 6 months, significantly more patients maintained a 10-point clinically important improvement in the RSDI score with nasal irrigation (44.1% v. 36.6%); fewer used over-the-counter medications (59.4% v. 68.0%) or intended to consult a doctor in future episodes. Steam inhalation reduced headache but had no significant effect on other outcomes. The proportion of participants who had adverse effects was the same in both intervention groups.
  
  
  CONCLUSIONS
  Advice to use steam inhalation for chronic or recurrent sinus symptoms in primary care was not effective. A similar strategy to use nasal irrigation was less effective than prior evidence suggested, but it provided some symptomatic benefit.
  
  
  BACKGROUND
  ISRCTN, no. 88204146.
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis. p.little@soton.ac.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: Little
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Beth
authors.initials: B
authors.lastname: Stuart
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Mark
authors.initials: M
authors.lastname: Mullee
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Tammy
authors.initials: T
authors.lastname: Thomas
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Sophie
authors.initials: S
authors.lastname: Johnson
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Gerry
authors.initials: G
authors.lastname: Leydon
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: David
authors.initials: D
authors.lastname: Rabago
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Samantha
authors.initials: S
authors.lastname: Richards-Hall
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Ian
authors.initials: I
authors.lastname: Williamson
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Guiqing
authors.initials: G
authors.lastname: Yao
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: James
authors.initials: J
authors.lastname: Raftery
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Shihua
authors.initials: S
authors.lastname: Zhu
authors.affiliation: Primary Care Group (Little, Stuart, Moore, Thomas, Johnson, Williamson), Health Economic Analyses Team (Yao, Raftery, Zhu) and Research Design Service South Central (Mullee), Primary Care and Population Sciences Unit (Leydon), University of Southampton, Southampton, UK; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK; Department of Family Medicine and Community Health (Rabago), University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Michael
authors.initials: M
authors.lastname: Moore
mesh_terms: D000328:Adult; D000368:Aged; D002908:Chronic Disease; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D001239:Inhalation; D008297:Male; D008875:Middle Aged; D055556:Nasal Lavage / Q000379:methods*; D011320:Primary Health Care; D011788:Quality of Life; D012008:Recurrence; D012852:Sinusitis / Q000503:physiopathology / Q000628:therapy*; D013227:Steam; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D013227:Steam