Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study

van de Hei, Susanne; McKinstry, Steven; Bardsley, George; Weatherall, Mark; Beasley, Richard; Fingleton, James

Participants had symptoms for a mean of 31 hours at presentation, at which time the mean modified Jackson score was 11.7 (Table 1 ). There were 27 participants who completed the modified Jackson score after ten days. Table 2 shows the mean (SD), median (IQR) and the range of the modified Jackson score from baseline to day 10 for both groups. The mean change in modified Jackson score from baseline was greater in the rhinothermy group than in the control group after 24 hours, and remained significantly greater than the control group until day 6 ( Table 3 ). Figure 2 shows a plot of the change from baseline of the modified Jackson score. In total 27 participants reported feeling "a lot better" within 10 days of randomisation; 17/20 8 participants from the rhinothermy group and all 10 control group participants. Two participants did 9 not fill in the modified Jackson score on the day they felt "a lot better". Therefore, an estimate of 10 the MCID used the scores of 25 participants, 16 in the rhinothermy group and nine in the control 11 group. We recognised post-hoc that the threshold "a lot better" corresponded to an estimate of 12 substantial clinical benefit rather than the MCID [32,33] and so have estimated the change which 13 represents substantial clinical benefit. The change from baseline modified Jackson score which 14 had the best sensitivity and specificity for the participants stating that they felt a lot better was 15 between 5 and 6 units on the modified Jackson Score on days 4 and 5 ( The difference in modified Jackson score between the rhinothermy group and the control group 20 was greater than the substantial clinical benefit threshold on days three, four, and five, p<0.001 21 (Table 3) . 22