Brief Article
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©2012 Baishideng Publishing Group Co. , Limited. All rights reserved.
World J Gastroenterol. Sep 7, 2012; 18(33): 4563-4569
Published online Sep 7, 2012. doi: 10.3748/wjg.v18.i33.4563
Table 1 Baseline characteristics and symptom scores (mean ± SD)
Test group (n = 58) Control group (n = 59) P valueAge (yr) 37.43 ± 10.27 34.24 ± 8.67 0.720 Male:female n (%) 17 (29.3):41 (70.7) 18 (30.5):41 (69.5) 0.887 BMI (kg/m2 ) 21.96 ± 3.01 21.28 ± 2.50 0.184 Subtype of IBS n (%) 0.919 Constipation 19 (32.8) 22 (37.3) Diarrhea 19 (32.8) 16 (27.1) Mixed 5 (8.6) 5 (8.5) Unsubtyped 15 (25.9) 16 (27.1) Abdominal symptoms Abdominal pain or discomfort (VAS) 34.05 ± 18.55 33.05 ± 19.94 0.779 Frequency of abdominal pain or discomfort/d 1.73 ± 2.03 1.21 ± 1.17 0.089 Abdominal distension or bloating (VAS) 44.40 ± 21.99 39.83 ± 20.82 0.281 Flatulence/d 5.19 ± 4.01 4.98 ± 2.88 0.749 Bowel habit Defecation frequency/wk 6.38 ± 5.98 5.69 ± 3.87 0.458 Defecation duration (min) 8.68 ± 6.35 8.85 ± 5.59 0.881 Urgency n (%) 23 (39.7) 22 (37.3) 0.792 Straining n (%) 39 (67.2) 37 (62.7) 0.608 Feeling of incomplete defecation n (%) 39 (67.2) 44 (74.6) 0.382 Stool consistency (BSS) 3.95 ± 1.64 3.54 ± 1.59 0.159 Bowel habit satisfaction (VAS) 32.33 ± 17.53 31.95 ± 18.22 0.909 Discomfort related to daily life (VAS) 36.21 ± 22.54 30.93 ± 17.58 0.160
Table 2 Study parameters at week 8 and changes from baseline in all patients (mean ± SD)
Test group (n = 58) Control group (n = 59) P value1 Baseline wk 8 Δ wk 8 P valueBaseline wk 8 Δ wk 8 P valueAbdominal symptoms Abdominal pain or discomfort (VAS) 34.05 ± 18.55 12.93 ± 14.99 -21.12 0 33.05 ± 19.94 16.5 ± 17.7 -16.53 < 0.001 0.26 Frequency of abdominal pain or discomfort/d 1.73 ± 2.03 0.84 ± 0.83 -0.89 0.004 1.21 ± 1.17 0.7 ± 0.8 -0.48 0.001 0.214 Abdominal distension or bloating (VAS) 44.40 ± 21.99 25.86 ± 18.1 -18.53 0 39.83 ± 20.82 28.8 ± 21.2 -11.02 < 0.001 0.096 Flatulence/d 5.19 ± 4.01 5.69 ± 5.08 0.5 0.391 4.98 ± 2.88 5.5 ± 4.0 0.51 0.266 0.991 Bowel habits Defecation frequency/wk 6.38 ± 5.98 7.23 ± 4.28 0.85 0.289 5.69 ± 3.87 6.7 ± 4.2 1.04 0.052 0.843 Defecation duration (min) 8.68 ± 6.35 7.47 ± 4.95 -1.22 0.07 8.85 ± 5.59 6.7 ± 3.9 -2.12 < 0.001 0.301 Urgency 23 (39.7%) 16 (27.6%) -7 0.118 22 (37.3%) 22 (37.3%) 0 1 0.146 Straining 39 (67.2%) 22 (37.9%) -17 0 37 (62.7%) 20 (33.9%) -17 0.002 0.959 Feeling of incomplete evacuation 39 (67.2%) 19 (32.8%) -20 0 44 (74.6%) 23 (39.0%) -21 < 0.001 0.815 Stool consistency (BSS) 3.95 ± 1.64 3.72 ± 1.02 -0.22 0.274 3.53 ± 1.59 3.88 ± 1.15 0.36 0.047 0.118 Bowel habit satisfaction (VAS) 32.33 ± 17.53 59.48 ± 19.21 27.16 0 31.95 ± 18.22 47.5 ± 20.1 15.51 < 0.001 0.01 Discomfort related to daily life (VAS) 36.21 ± 22.54 21.98 ± 19.91 -14.22 0 30.93 ± 17.58 22.9 ± 17.5 -8.05 0.007 0.199 Improvement in overall IBS symptoms (VAS) 64.2 ± 17.0 50.4 ± 20.5 < 0.001
Table 3 Study parameters at week 8 and changes from baseline in constipation-predominant irritable bowel syndrome patients (mean ± SD)
Test group (n = 19) Control group (n = 22) P value1 Baseline wk 8 Δ wk 8 P valueBaseline wk 8 Δ wk 8 P valueAbdominal symptoms Abdominal pain or discomfort (VAS) 28.95 ± 20.90 9.21 ± 12.39 -19.74 0.001 37.50 ± 25.30 15.91 ± 18.17 -21.59 0.001 0.8 Frequency of abdominal pain of discomfort/d 1.50 ± 1.17 0.89 ± 0.88 -0.61 0.032 1.27 ± 1.56 0.68 ± 0.78 -0.6 0.029 0.979 Abdominal distension or bloating (VAS) 44.74 ± 21.38 25.00 ± 16.67 -19.74 0.007 38.64 ± 22.79 26.14 ± 16.33 -12.5 0.031 0.393 Flatulence/wk 6.05 ± 5.03 6.13 ± 4.35 0.08 0.952 5.52 ± 3.34 6.02 ± 4.95 0.5 0.577 0.785 Bowel habit Defecation frequency/wk 3.82 ± 2.08 5.61 ± 3.54 1.79 0.002 3.43 ± 1.55 5.39 ± 3.97 1.96 0.032 0.872 Defecation duration (min) 12.26 ± 7.33 9.66 ± 5.28 -2.61 0.106 10.84 ± 6.49 6.59 ± 4.07 -4.25 < 0.001 0.358 Urgency 4 (21.1%) 4 (21.1%) 0 1 3 (13.6%) 6 (27.3%) 3 0.375 0.336 Straining 18 (94.7%) 11 (57.9%) -7 0.016 18 (81.8%) 12 (54.5%) -6 0.146 0.321 Feeling of incomplete evacuation 15 (78.9%) 7 (36.8%) -8 0.021 16 (72.7%) 9 (40.9%) -7 0.016 0.776 Stool consistency (BSS) 2.26 ± 0.45 3.05 ± 0.85 0.789 0 2.18 ± 0.66 3.27 ± 1.08 1.09 0.001 0.386 Bowel habit satisfaction 30.26 ± 19.68 56.58 ± 20.14 26.32 0 27.27 ± 18.76 44.32 ± 21.73 17.05 0.004 0.21 Discomfort related to daily life (VAS) 34.21 ± 22.38 18.42 ± 16.33 -15.79 0.014 36.36 ± 21.45 27.73 ± 15.25 -13.64 0.015 0.782 Improvement in overall IBS symptoms (VAS) 72.4 ± 18.4 50.0 ± 21.8 < 0.001
Table 4 Study parameters at week 8 and changes from baseline in diarrhea-predominant irritable bowel syndrome patients (mean ± SD)
Test group (n = 19) Control group (n = 16) P value1 Baseline wk 8 Δ wk 8 P valueBaseline wk 8 Δ wk 8 P valueAbdominal symptoms Abdominal pain or discomfort (VAS) 32.89 ± 14.56 9.21 ± 14.93 -23.68 0 29.69 ± 10.08 20.3 ± 18.8 -9.38 0.083 0.05 Frequency of abdominal pain or discomfort/d 2.45 ± 3.18 0.63 ± 0.83 -1.82 0.036 1.25 ± 0.71 0.91 ± 0.94 -0.34 0.245 0.117 Abdominal distension or bloating (VAS) 43.42 ± 23.34 25.00 ± 20.41 -18.42 0.012 35.94 ± 15.73 29.69 ± 20.85 -6.25 0.164 0.146 Flatulence/wk 4.63 ± 2.36 4.08 ± 2.67 -0.55 0.503 4.66 ± 2.15 5.50 ± 3.38 0.84 0.255 0.212 Bowel habit Defecation frequency/wk 10.55 ± 8.18 8.79 ± 4.46 -1.76 0.381 9.09 ± 4.19 9.09 ± 4.12 0 1 0.451 Defecation duration (min) 6.66 ± 5.57 6.58 ± 4.98 -0.08 0.938 8.00 ± 4.75 7.03 ± 3.81 -0.97 0.3 0.52 Urgency 10 (52.6%) 8 (42.1%) -2 0.625 12 (75.0%) 11 (68.8%) -1 1 0.867 Straining 8 (42.1%) 3 (15.8%) -5 0.063 7 (43.8%) 2 (12.5%) -5 0.063 0.707 Feeling of incomplete evacuation 13 (68.4%) 6 (31.6%) -7 0.039 12 (75.0%) 5 (31.3%) -7 0.016 0.826 Stool consistency (BSS) 5.42 ± 1.17 4.16 ± 0.38 -1.26 0.001 5.50 ± 1.10 4.88 ± 1.09 -0.63 0.036 0.738 Bowel habit satisfaction 31.58 ± 18.34 64.47 ± 19.21 32.9 0 40.63 ± 15.48 48.44 ± 17.00 7.81 0.173 0.006 Discomfort related to daily life (VAS) 36.84 ± 24.11 23.68 ± 25.65 -13.16 0.163 29.69 ± 13.60 28.13 ± 17.97 -1.56 0.751 0.292 Improvement in overall IBS symptoms (VAS) 61.8 ± 17.4 51.6 ± 14.3 0.07