Early pilot work suggested that compliance and attrition might be important issues.
This would require a minimum of 125 patients per group, or 316 in total, to allow for 4 study groups, 80% power, an α value of 0.05 and 80% follow-up. To detect an interaction of 10 points in the RSDI between intervention groups, we estimated that we would need to power the study to detect a 5-point (about 0.36 standard deviation) main effect.
Review of medical records for antibiotic use and physician visits was done at 6 months. Information on respiratory and sinus symptoms, belief in the need to see the doctor, adverse effects and use of over-the-counter medications was obtained at 3 and 6 months. The RSDI, SNOT-20, single-item sinus severity assessment and EQ-5D were completed at baseline, 3 and 6 months. A cost-effectiveness analysis will be reported elsewhere. The secondary outcome measures were the 20-item Sino-Nasal Outcome Test (SNOT-20) 15 a single-item sinus severity assessment 9 severity of respiratory symptoms (as determined by the number of days feeling unwell with respiratory tract infections or sinusitis) 16 reported use of over-the-counter medications, and reported headaches and adverse effects (e.g., nosebleeds, nasal burning or stinging) the EuroQol 5-dimension (EQ-5D) health-related quality-of-life index antibiotic prescription and visits to primary care physician and belief in antibiotics and belief in the need to see the doctor in future episodes. 9 Three months was the primary follow-up period specified in the funding application 6 months was included to document longer term effects. 14 We chose this measure because it permitted comparisons with findings from a previous US primary care trial. The primary outcome measure was the validated RSDI.
Sinus steam inhaler trial#
We conducted a large pragmatic randomized controlled trial of the effectiveness of brief advice to use nasal irrigation or steam inhalation in routine primary care for chronic or recurrent sinus symptoms. 9 The other (published since the Cochrane review) compared a positive-pressure squeeze bottle with saline nasal spray among 121 volunteers from various sources and found an 8.5-point improvement in the control group, as compared with a 15-point improvement in the irrigation group. 9, 10 One of the studies compared a gravity-based nasal irrigation device with routine care among 76 participants mainly from primary care settings it found that symptoms improved very little in the control group (by 1 point on the Rhinosinusitis Disability Index converted to a 100-point scale), as compared with a 14-point improvement in the irrigation group. Two small randomized controlled trials included some participants from primary care settings. 8 However, most of the trials were small, mainly from secondary care settings, and the review documented symptom data from only 129 participants, with high heterogeneity. 7 The Cochrane review of nasal saline irrigation reported benefit. 5 Steam inhalation is widely advocated in rhinosinusitis, but a Cochrane review of steam for the “common cold” found equivocal evidence, 6 and a recent primary care trial found no benefit and some harm (mild thermal injury) for pragmatic advice to inhale steam twice daily for a range of respiratory tract infections. 2 Antibiotics are prescribed for nearly all patients with sinusitis, 3 but the evidence is modest 4 and an international priority is to contain antibiotic resistance. 1 Quality of life of patients with chronic or recurrent sinusitis has been reported to be similar to congestive heart disease and chronic pulmonary disease. Rhinosinusitis probably affects more than 25 million Americans and 2.5 million Canadians.
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