Randomized Controlled Trial
Copyright ©The Author(s) 2021.
World J Clin Cases. Sep 6, 2021; 9(25): 7417-7432
Published online Sep 6, 2021. doi: 10.12998/wjcc.v9.i25.7417
Table 1 Content of low fermentable oligo, di- and monosaccharides and polyols diet recommended for patients
Energy1600-2000 kcal/d
Protein75 -90 g/d
Fat75-85 g/d
Carbohydrate186-240 g/d
Starch120-25 g/d
Sugars50 -75 g/d
Non-starch polysaccharide13–16 g/d
Total FODMAPs19.0-9.6 g/d
Fructans2.5-3.5 g/d
GOS0.8-1.4 g/d
Lactose4.3-4.5 g/d
Total fructose12.7-5.9 g/d
Excess fructose1.9-2.0 g/d
Sorbitol0.3-0.5 g/d
Mannitol0.1 -0.2 g/d
Table 2 Patients’ demographic characteristics, comorbidities and treatments they received

Total, n = 85
Group 1, n = 43
Group 2, n = 42
P value
Age (mean ± SD)43.6 ± 13.043.6 ± 12.243.6 ± 14.00.888
Gender, n (%)
Female62 (72.9)33 (76.7)29 (69.0)0.425
Male23 (27.1)10 (23.3)13 (31.0)
Employment status, n (%)
No49 (57.6)25 (58.1)24 (57.1)0.926
Yes36 (42.4)18 (41.9)18 (42.9)
Comorbid diseases
Hashimoto’s thyroiditis, n (%)
No67 (78.8)36 (83.7)31 (73.8)0.263
Yes18 (21.2)7 (16.3)11 (26.2)
Allergic asthma, n (%)
No77 (90.6)36 (83.7)41 (97.6)0.058
Yes8 (9.4)7 (16.3)1 (2.4)
Hypertension, n (%)
No72 (84.7)38 (88.4)34 (81.0)0.342
Yes13 (15.3)5 (11.6)8 (19.0)
Gastritis, n (%)
No77 (90.6)37 (86.0)40 (95.2)0.265
Yes8 (9.4)6 (14.0)2 (4.8)
Hyperlipidemia, n (%)
No78 (91.8)40 (93.0)38 (90.5)0.713
Yes7 (8.2)3 (7.0)4 (9.5)
Depression, n (%)
No80 (94.1)41 (95.3)39 (92.9)0.676
Yes5 (5.9)2 (4.7)3 (7.1)
Comorbidity, n (%)
No26 (30.6)12 (27.9)14 (33.3)0.587
Yes59 (69.4)31 (72.1)28 (66.7)
Abdominal surgery, n (%)
No50 (58.8)24 (55.8)26 (61.9)0.568
Yes35 (41.2)19 (44.2)16 (38.1)
Drug use
Systematic drug use, n (%)
No28 (32.9)14 (32.6)14 (33.3)0.939
Yes57 (67.1)29 (67.4)28 (66.7)
PPI use, n (%)
No67 (78.8)32 (74.4)35 (83.3)0.315
Yes18 (21.2)11 (25.6)7 (16.7)
Psychiatric drug use, n (%)
No71 (83.5)34 (79.1)37 (88.1)0.262
Yes14 (16.5)9 (20.9)5 (11.9)
CCB use, n (%)
No69 (81.2)36 (83.7)33 (78.6)0.544
Yes16 (18.8)7 (16.3)9 (21.4)
Beta-blocker use, n (%)
No75 (88.2)38 (88.4)37 (88.1)> 0.999
Yes10 (11.8)5 (11.6)5 (11.9)
Table 3 Irritable bowel syndrome sub-type breakdown by groups

Total, n = 85
Group 1, n = 43
Group 2, n = 42
P value
IBS subtype, n (%)
Constipation43 (50.6)23 (53.5)20 (47.6)0.415
Diarrhea23 (27.1)9 (20.9)14 (33.3)
Mixed19 (22.4)11 (25.6)8 (19.0)
Table 4 Comparison of visual analogue scale and irritable bowel syndrome symptom severity scale scores before and after treatment

Group 1


Group 2


Before treatment
After treatment
P valueBefore treatment
After treatment
P valueP’ value
mean ± SD
mean ± SD
mean ± SD
mean ± SD

VAS4.6 ± 2.72.0 ± 1.9< 0.0014.7 ± 2.71.8 ± 2.0< 0.0010.754
IBS-SSS310.0 ± 78.4172.0 ± 93.0< 0.001317.0 ± 87.5175.0 ± 97.7< 0.0010.610
Pain severity49.4 ± 24.124.4 ± 20.8< 0.00146.4 ± 23.122.6 ± 19.8< 0.0010.616
Abdominal pain severity 52.9 ± 23.926.7 ± 21.4< 0.00153.6 ± 25.028.6 ± 23.1< 0.0010.843
Abdominal distention severity65.1 ± 25.134.3 ± 25.0< 0.00168.5 ± 23.533.9 ± 24.0< 0.0010.660
Satisfaction with intestinal habits 70.9 ± 24.941.6 ± 33.3< 0.00173.5 ± 27.243.4 ± 31.6< 0.0010.559
IBS quality of life74.8 ± 22.144.6 ± 26.1< 0.00175.0 ± 22.446.5 ± 23.3< 0.0010.957
Table 5 Comparison of the change in visual analogue scale and irritable bowel syndrome symptom severity scale scores in both groups before and after treatment
Parameters
Total, n = 85
Group 1, n = 43
Group 2, n = 42
P value
VAS [Median (min-max)]-50.0 [(-100.0)-40.0]-50.0 [(-100.0)-0.0]-58.3 [(-100.0)-40.0]0.778
IBS-SSS[Median (min-max)]-47.3 [(-100.0)-30.3)]-43.5 [(-93.0)-0.0)]-50.0 [(-100.0)-30.3)0.871
Pain severity-50.0 [(-100.0)-50.0]-50.0 [(-100.0)-0.0]-50.0 [(-100.0)-50.0]0.799
Abdominal pain severity -50.0 [(-100.0)-50.0]-50.0 [(-100.0)-0.0]-50.0 [(-100.0)-50.0]0.857
Abdominal distention severity-50.0 [(-100.0)-0.0]-50.0 [(-100.0)-0.0]-50.0 [(-100.0)-0.0]0.561
Satisfaction with intestinal habits -50.0 [(-100.0)-203.0]-50.0 [(-100.0)-100.0]-50.0 [(-100.0)-203.0]0.953
IBS quality of life-50.0 [(-100.0)-51.5]-50.0 [(-100.0)-0.0]-50.0 [(-100.0)-51.5]0.960
Table 6 Irritable bowel syndrome symptom severity scale scores before and after treatment
After treatmentBefore treatment, n (%)
KappaP value
Mild
Moderate
Severe
All patientsAsymptomatic3 (50.0)2 (6.5)4 (8.3)0.0210.648
Mild3 (50.0)22 (71.0)17 (35.4)
Moderate0 (0)6 (19.4)17 (35.4)
Severe0 (0)1 (3.2)10 (20.8)
Group 1Asymptomatic2 (66.7)1 (6.7)2 (8.0)0.0130.840
Mild1 (33.3)11 (73.3)9 (36.0)
Moderate0 (0)3 (20.0)9 (36.0)
Severe0 (0)0 (0)5 (20.0)
Group 2 Asymptomatic1 (33.3)1 (6.2)2 (8.7)0.0310.649
Mild2 (66.7)11 (68.8)8 (34.8)
Moderate0 (0)3 (18.8)8 (34.8)
Severe0 (0)1 (6.2)5 (21.7)
Table 7 Comparison of stool changes in groups before and after treatment according to the Bristol stool scale
After treatment
Before treatment
Kappa
P value
Type 1, 2
Type 3, 4
Type 5-7
All patientsType 1, 212 (35.3)2 (9.1)2 (6.9)0.1750.006
Type 3, 418 (52.9)16 (72.7)19 (65.5)
Type 5-74 (11.8)4 (18.2)8 (27.6)
Group 1Type 1, 24 (23.5)2 (14.3)1 (8.3)0.0610.448
Type 3, 412 (70.6)10 (71.4)9 (75.0)
Type 5-71 (5.9)2 (14.3)2 (16.7)
Group 2Type 1, 28 (47.1)0 (0)1 (5.9)0.260.005
Type 3, 46 (35.3)6 (75.0)10 (58.8)
Type 5-73 (17.6)2 (25.0)6 (35.3)
Table 8 The relationship between adherence to diet and changes in visual analogue scale and irritable bowel syndrome symptom severity scale scores
ScoresGroup 1; adherence to diet
Group 2; adherence to diet
r
P value
r
P value
VAS0.2260.1450.4250.005
IBS-SSS0.2260.1440.4340.004
Pain severity0.2330.1330.2530.106
Abdominal pain severity 0.2980.0520.2870.065
Abdominal distention severity0.0010.9950.2980.055
Satisfaction with intestinal habits 0.0920.5570.3280.034
IBS quality of life0.2640.0880.3900.011