Ophir 1987.
Methods |
Study design: 2 groups of participants were randomised in a double‐blind design Study duration: 1987 |
|
Participants |
Inclusion criteria
Participants with a naturally acquired common cold Exclusion criteria
|
|
Interventions |
Treatment group
Warm vapour inhalation via RhinoTherm device delivering heated vapour at 42 °C to 44 °C (study group) at 40 L/min. An identical‐looking and ‐sounding instrument delivered air at room temperature (22 °C to 24 °C) to the placebo group at the flow rate of 2 L/min. A full course consisted of 2 treatments lasting 20 minutes, with 60‐ to 90‐minute intervals Control group
|
|
Outcomes |
Symptom score index: Symptom score index was calculated for each day by dividing the sum of recorded on that day by 3. Symptomatic improvement was noticed in 26/32 steam‐treated participants and 7/30 placebo‐treated participants Nasal resistance: Objective measure of nasal potency the morning after treatment improved in 61% to 74% of participants in the steam‐treated group and only 6% to 8% of participants in the placebo‐treated group. There was a significant improvement in the nasal blockade index in the active group (P < 0.01) |
|
Notes | The results of this study demonstrate a clear‐cut improvement in the symptom index in the treatment group. Symptomatic improvement at the end of the follow‐up period was reported by 92.9% of participants in the active treatment group and 84.6% of participants in the placebo group. Nasal patency was increased significantly in the active treatment group Funding source: RhinoTherm device used in study manufactured by Netzer Serani, Israel |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation was not described |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not clearly described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | An attempt was made to keep the intervention blinded by using identical‐looking and ‐sounding equipment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessed using similar scale for placebo and intervention group |
Incomplete outcome data (attrition bias) All outcomes | High risk | The attrition rate of the placebo group was more than the event rate of the placebo group |
Selective reporting (reporting bias) | Low risk | No published protocol was available. All outcomes listed in the methods section of the published trial were reported in the results |
Other bias | Unclear risk | None known. |