Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care

Journal Club

21/09/2016

Facilitated by Dr Amanda McCullough

1. Background

This is the first large-scale study to test the effect of nasal saline irrigation or steam inhalation compared to control on sinus symptoms using a pragmatic randomised controlled trial in a primary care setting. Previous studies of nasal irrigation have been small in size, and conducted in other settings, and evidence for steam inhalation is minimal.

2.  Paper presented

Little et al. Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial. CMAJ 2016; DOI: 10.1503/cmaj.160362

Design: Factorial randomised controlled trial.

Participants, Intervention, Comparison, Outcome: 

P: adults with chronic sinusitis with moderate to severe symptoms affecting quality of life

I : nasal saline irrigation OR steam inhalation OR both

C: usual care

O: primary outcome = RSDI; secondary: SNOT-20, severity of respiratory symptoms, EQ-5D, adverse events, reported use of over the counter (OTC) medication.

3.  Critical appraisal

This article was appraised using the RAMBO method:

Randomisation: The authors used computer generated, patient-level randomisation. Allocation was concealed by opaque envelopes. Whilst not the “gold standard” allocation procedure, we were satisfied that this did not introduce bias because groups were balanced at baseline indicating randomisation was effective.

Attrition: We noted overall attrition of 23%. Missing data were managed by multiple imputation. Attrition was not symmetrical, with greater attrition in the intervention groups (24-28% at 3 months; 28-33% at 6 months) compared to control (13% at 3 months; 19% at 6 months), indicating that there may have been attrition bias present. We suspected that this could have been due to lack of adherence in intervention groups than control, meaning patients were less willing to complete data collection. We would have been interested to see a “best case scenario” where all missing patients were assumed to benefit, and a “worst case scenario” where missing patients were assumed to not benefit from the intervention to allow us to judge the importance of these missing data. It would also have been useful to see outcomes analysed by adherence status, as it could be that those with higher adherence to the intervention obtained more benefit.

Measurements (Blinded and objective): All outcome measures were subjective (apart from medical records data on antibiotic use and doctor visits) and unblinded. We believed there was a risk of detection bias due to the placebo effect. Although we also acknowledged that this was difficult to address given the nature of the intervention and outcomes.

4.  Summary of results

This large, pragmatic trial demonstrated a modest benefit of nasal irrigation compared to control in terms of overall sinus symptoms, headache and use of OTC medicines. Steam inhalation did not result in any benefit in outcomes, with the exception of headache. Given the favourable balance of potential benefits to harms, nasal irrigation treatment offers a simple, safe, low cost alternative for patients who are often managed with antibiotics or more invasive interventions, like surgery. For this intervention to be replicated in general practice, it would be helpful for clinicians to have access to the youtube video of nasal irrigation, and a description of the verbal information provided to patients.