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Chapter 2 38 Table 2.1 Demographical and clinical characteristics of the total study population and Rome IV-positive and –negative subjects, separated for definition 1 and 2 of surrogate Rome IV criteria, i.e. assessed using end-of-day symptom diaries. Definition 1: Abdominal pain score ≥2 Definition 2: Abdominal pain score ≥3 Total N =404 Rome IV-positive N =353 (87.4%) Rome IV-negative N =51 Rome IV-positive N =249 (61.6%) Rome IV-negative N =155 Female sex , N (%) 293 (72.5) 263 (74.5) 30 (58.8) # 195 (78.3) 98 (63.2)* Age , median [IQR] 45 [28 - 59] 45 [27 - 58] 53 [32 - 65] # 42 [26 - 57] 51 [36 - 63]* BMI , median [IQR] 24.03 [21.41 – 27.63] 23.94 [21.38 – 27.69] 24.62 [21.58 – 27.52] 24.08 [21.40 – 27.47] 23.96 [21.45 – 27.98] Subtype Rome III , N (%) IBS-D IBS-C IBS-M IBS-U 140 (34.7) 81 (20.0) 159 (39.4) 24 (5.9) 118 (33.4) 73 (20.7) 142 (40.2) 20 (5.7) 22 (43.1) 8 (15.7) 17 (33.3) 4 (7.8) 85 (34.1) 51 (20.5) 101 (40.6) 12 (4.8) 55 (35.5) 30 (19.4) 58 (37.4) 12 (7.7) Secondary/tertiary care , N (%) 291 (72.0) 262 (74.4) 29 (56.9) # 194 (78.2) 97 (62.6)* Hypersensitive , N (%) 87 (44.4) a 85 (47.5) b 2 (11.8) c * 72 (57.1) d 15 (21.4) e * 14-day mean score , median [IQR] Abdominal pain Abdominal discomfort Abdominal bloating Flatulence Constipation Diarrhea 2.21 [1.57 – 2.92] 2.43 [1.93 – 2.93] 2.07 [1.50 – 2.79] 2.21 [1.71 – 2.86] 1.29 [1.00 – 1.86] 1.21 [1.00 – 1.64] 2.36 [1.79 – 3.00] 2.50 [2.14 – 3.00] 2.21 [1.64 – 2.86] 2.29 [1.79 – 2.93] 1.36 [1.00 – 1.93] 1.29 [1.07 – 1.71] 1.07 [1.00 – 1.21]* 1.50 [1.07 – 1.86]* 1.43 [1.07 – 2.00]* 1.71 [1.29 – 2.33]* 1.00 [1.00 – 1.29]* 1.07 [1.00 – 1.29]* 2.71 [2.29 – 3.29] 2.72 [2.36 – 3.21] 2.43 [1.93 – 3.18] 2.43 [1.93 – 3.07] 1.50 [1.07 – 2.07] 1.31 [1.07 – 1.98] 1.43 [1.17 – 1.77]* 1.79 [1.43 – 2.21]* 1.71 [1.14 – 2.07]* 1.93 [1.36 – 2.36]* 1.08 [1.00 – 1.43]* 1.08 [1.00 – 1.43]* GSRS , median [IQR] Abdominal Pain Diarrhea Syndrome Constipation Syndrome Indigestion Syndrome Regurgitation Syndrome 3.33 [2.33 – 4.00] 3.33 [2.00 – 4.33] 3.00 [2.33 – 4.00] 4.00 [3.25 – 5.00] 1.50 [1.00 – 3.00] 3.33 [2.33 – 4.25] 3.33 [2.33 – 4.67] 3.00 [2.33 – 4.33] 4.00 [3.25 – 5.00] 1.50 [1.00 – 3.00] 2.67 [1.67 – 3.33]* 2.67 [1.67 – 4.00] # 2.00 [1.33 – 3.33]* 3.75 [2.75 – 4.50] 1.00 [1.00 – 2.00]# 3.67 [2.67 – 4.33] 3.67 [2.33 – 4.67] 3.33 [2.33 – 4.33] 4.25 [3.25 – 5.25] 1.75 [1.00 – 3.50] 2.67 [2.00 – 3.67]* 3.00 [2.00 – 4.00]* 2.67 [1.67 – 3.67]* 3.75 [2.75 – 4.50]* 1.00 [1.00 – 2.50]* HADS , N (%) Depression ≥8 Anxiety ≥8 76 (19.0) 142 (35.6) 73 (21.0) 131 (37.6) 3 (5.9)* 11 (21.6)# 59 (24.1) 105 (42.9) 17 (11.0)* 37 (24.0)* SF-36 , median [IQR] Physical Composite Score (PCS) Mental Composite Score (MCS) 42.83 [33.98 – 50.28] 49.75 [41.23 – 55.82] 41.67 [32.98 – 49.11] 49.41 [41.15 – 55.37] 49.92 [41.42 – 53.89]* 51.03 [41.98 – 57.73] 39.23 [29.84 – 46.95] 48.31 [40.76 – 54.58] 48.99 [39.41 – 52.62]* 51.34 [42.16 – 57.19]# Differences tested using Mann-Whitney U test for continuous data and Ȥ 2 - or Fisher’s exact test for categorical data. Significances are shown for both definitions of surrogate Rome IV criteria separately. # Significant difference between Rome IV-positive and Rome IV-negative subjects ( P <0.05); * Significant difference between Rome IV-positive and Rome IV- negative subjects ( P <0.001); a – e Number of subjects that underwent rectal barostat: a 196; b 179; c 17; d 126; e 70.