Journal of Neurogastroenterology and Motility : eISSN 2093-0887 / pISSN 2093-0879

Table. 2.

Study Outcomes

Treatment outcomes Analysis Lactulose
(n = 69)
Combination
(n = 68)
S. boulardii (n = 50) P-values
Lactulose
vs Combination
Lactulose vsS. boulardii Combination vsS. boulardii
Treatment success rates at each visit
Week 12 ITT 18/69 (26.1) 28/68 (41.2) 4/50 (8.0) 0.086 0.019 < 0.001
Week 6 ITT 40/69 (58.0) 36/68 (52.9) 12/50 (24.0) 0.576 < 0.001 < 0.001
Week 2 ITT 39/69 (56.5) 42/68 (61.8) 19/50 (38.0) 0.799 0.087 0.018
PP 39/60 (65.0) 42/61 (68.9) 19/37 (51.4) 0.702 0.206 0.091
Clinical outcomes at week 2 Lactulose(n = 60) Combination(n = 61) S. boulardii (n = 37) P-values
Stool frequency/week PP 4.05 ± 2.49 4.57 ± 2.91 3.69 ± 2.60 0.264
Incontinency/week PP 0.53 ± 1.69 0.56 ± 1.66 0.96 ± 3.63 0.627
Stool consistency PP 3.38 ± 1.23 3.54 ± 1.32 2.92 ± 1.04 0.051
Painful defecations/week PP 0.48 ± 0.5 0.64 ± 0.97 0.68 ± 0.75 0.359
Follow-up loss rate ITT 9/69 (13.0) 7/68 (10.3) 13/50 (26.0) 0.616 0.072 0.025
Drug change rate during study period ITT 3/69 (4.3) 7/68 (10.3) 23/50 (46.0) 0.511 < 0.001 < 0.001

S. boulardii, Saccharomyces boulardii; ITT, intention-to-treat analysis; PP, per-protocol analysis.

Values are shown as n (%) or mean ± SD.

J Neurogastroenterol Motil 2022;28:454~462 https://doi.org/10.5056/jnm21130
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