This study was conducted on a total of 60 patients of age group varying from 14 years to 60 years. Maximum number of patients fell into the age group of 20-30 years. Out of 60 patients, males were 36 (60%) and females were 24 (40%). The flowchart of the follow up is depicted in Figure 3. The mean RCAT scores for each group are listed in Table 2(a), 2(b), 2(c) and 2(d) for intragroup comparison and in Table 3 for intergroup comparison. The changes in scores with each visit are depicted graphical in Figure 4.
While the mean RCAT values between visit 1 and visit 2 increased in both the groups, indication improvement, the increase was found to be significant in the dietary modification (DM) group (24.75%, p=0.007) and not significant in the control group (10.86%, p=0.092).
Between the second and the third visit, there was a further increase (15.89%) in the mean RCAT value of the DM group. However, the mean RCAT value of the control group decreased (-4.69%) during the same time. While the intragroup changes in the mean RCAT value for neither of the two groups was not significant, the difference between the improvement of the DM group and the deterioration of the control group was significant (p=0.046).
There was an increase in the mean RCAT values for both the groups between visit 3 to visit 4. The increase in the score of the DM group (10.29%) was relatively more than the increase (8.93%) in the score of the control group, but neither of the two increases was significant.
The overall increase in the mean RCAT value between visit 1 to 4 was significant in the DM group (69.66%, p=0.009) and the control group (28.79%, p=0.031), both. While this increase was relatively more in the dietary modification group, the difference between the improvements was not significant (p=0.115).
Table 2(a) - Intragroup Comparison Between Visit 1 And Visit 2
|
Dietary Modification Group
|
Control Group
|
Number of Subjects
|
Mean
|
SD
|
Number of Subjects
|
Mean
|
SD
|
RCAT- 1
|
14
|
14.43
|
3.63
|
19
|
16.47
|
3.95
|
RCAT- 2
|
14
|
18.00
|
3.44
|
19
|
18.26
|
5.00
|
Intragroup
Visit 1 - 2
|
t-value
|
3.20
|
t-value
|
1.78
|
p-value
|
0.007
|
p-value
|
0.092
|
Table 2(b) - Intragroup Comparison Between Visit 2 And Visit 3
|
Dietary Modification Group
|
Control Group
|
Number of Subjects
|
Mean
|
SD
|
Number of Subjects
|
Mean
|
SD
|
RCAT- 2
|
9
|
16.78
|
2.44
|
14
|
18.29
|
4.63
|
RCAT- 3
|
9
|
19.44
|
3.88
|
14
|
17.43
|
3.76
|
Intragroup Visit 2 - 3
|
t-value
|
2.18
|
t-value
|
0.80
|
p-value
|
0.061
|
p-value
|
0.439
|
Table 2(c) - Intragroup Comparison Between Visit 3 And Visit 4
|
Dietary Modification Group
|
Control Group
|
Number of Subjects
|
Mean
|
SD
|
Number of Subjects
|
Mean
|
SD
|
RCAT- 2
|
7
|
19.57
|
3.41
|
9
|
17.33
|
3.54
|
RCAT- 3
|
7
|
21.57
|
5.06
|
9
|
18.89
|
4.37
|
Intragroup Visit 3 - 4
|
t-value
|
1.73
|
t-value
|
1.58
|
p-value
|
0.134
|
p-value
|
0.154
|
Table 2(d) - Intragroup Comparison Between Visit 1 And Visit 4
|
Dietary Modification Group
|
Control Group
|
Number of Subjects
|
Mean
|
SD
|
Number of Subjects
|
Mean
|
SD
|
RCAT- 2
|
7
|
12.71
|
2.06
|
9
|
14.67
|
4.36
|
RCAT- 3
|
7
|
21.57
|
5.06
|
9
|
18.89
|
4.37
|
Intragroup Visit 1 - 4
|
t-value
|
3.78
|
t-value
|
2.62
|
p-value
|
0.009
|
p-value
|
0.031
|
The changes in SIGN score are listed in Table 4. The change in SIGN score between visit 1 and visit 2 was relatively more, indicating no improvement, in the control group (0.21±0.71) than that in the DM group (0.07±0.73). The difference was not found to be statistically significant (p=0.733).
The changes in SIGN score from visit 2 to visit 3 and from visit 3 to visit 4 were relatively more in the DM group (0.11±0.78, 0.29±0.76) than in the control group (0.00±0.68, 0.11±0.60). However, the differences between the changes of the two groups were not found to be statistically significant (p=0.829, p=0.606).
The overall change in SIGN score from visit 1 to visit 4 was relatively more in the DM group (0.43±1.27) than in the control group (0.33±0.71), but the difference between these was not statistically significant (p=1.000).
Table - 3 Intergroup comparison of RCAT
Table 4 – Intergroup Comparison of Sign Scores
Time Intervals
|
DIETARY
MODIFICATION GROUP
|
CONTROL GROUP
|
z-value
|
p-value
|
Δ Mean
Sign Score
|
SD
|
Δ Mean Sign
Score
|
SD
|
Day 1 - Day 3
|
0.07
|
0.73
|
0.21
|
0.71
|
0.682
|
0.733
|
Day 3 - Day 10
|
0.11
|
0.78
|
0.00
|
0.68
|
0.765
|
0.829
|
Day 10 - Day 15
|
0.29
|
0.76
|
0.11
|
0.60
|
0.552
|
0.606
|
Day 1 - Day 15
|
0.43
|
1.27
|
0.33
|
0.71
|
0.956
|
1.000
|
Over the course of the 4 visits, 23 and 21 patients were lost to in-person follow up for the DM group and the control group, respectively. While the patients were omitted from the statistical analysis, telephonic follow-up was done for all the patients that were lost to in-person follow-up. Fifteen patients (65.21%) patients in the DM Group and nine patients (42.86%) in the control group telephonically reported satisfactory improvement in their symptoms.
In the parallel study of 252 allergic rhinitis patients that were provided dietary counselling, 202 patients followed the diet. Out of the patients that followed the diet, 185 (91.58%) patients reported satisfactory improvement in symptoms, while 17 (8.42%) reported no improvement in their symptoms. All the 50 patients that did not follow the dietary suggestions did not report any relief in symptoms [Fig. 6].
Interestingly, the patients who were relieved of symptoms of allergic rhinitis on dietary intervention, remained symptoms free for almost 9 months. However, symptoms of rhinitis recurred in 85 patients. They reported in OPD again and were counselled to follow dietary advice and all of them showed marked improvement in their symptoms in next 6 months.