Table 2.
+8 week follow-up | +12 week follow-up | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Probiotic | Placebo | ST | Probiotic | Placebo | ST | |||||||
p-value | p-value | |||||||||||
Outcome parameter | x̅ | Med | x̅ | Med | tT | UT | x̅ | Med | x̅ | Med | tT | UT |
GSRS | −0.04 ± 0.6 | 0 (−0.3–0.3) | −0.08 ± 0.6 | −0.1 (−0.30.1) | 0.63 | 0.18 | −0.07 ± 0.6 | 0 (−0.4–0.2) | −0.08 ± 0.6 | −0.1 (−0.4–0.2) | 0.91 | 0.42 |
Diarrhea | −0.09 ± 0.7 | 0 (−0.7–0.3) | −0.05 ± 1.0 | 0 (−0.3–0.3) | 0.63 | 0.89 | −0.12 ± 0.9 | 0 (−0.3–0.3) | −0.05 ± 0.9 | 0 (−0.3–0) | 0.61 | 0.52 |
Indigestion | −0.14 ± 0.9 | −0.3 (−0.6–0.3) | −0.15 ± 0.8 | 0 (−0.5–0) | 0.95 | 0.82 | −0.14 ± 0.9 | −0.1 (−0.5–0.3) | −0.13 ± 0.7 | 0 (−0.5–0.3) | 0.94 | 0.89 |
Constipation | 0.02 ± 1.1 | 0 (−0.7–0.7) | −0.03 ± 1.0 | 0 (−0.3–0.3) | 0.76 | 0.46 | −0.06 ± 1.1 | 0 (−0.7–0.3) | −0.10 ± 1.1 | 0 (−0.3−0.3) | 0.82 | 0.99 |
Abdom. pain | −0.07 ± 0.6 | 0 (−0.3–0.2) | −0.07 ± 0.7 | 0 (−0.3–0.3) | 0.94 | 0.92 | −0.08 ± 0.7 | 0 (−0.3–0.3) | −0.09 ± 0.7 | 0 (−0.3–0.3) | 0.95 | 0.86 |
Reflux | 0.12 ± 0.7 | 0 (0–0) | −0.13 ± 0.6 | 0 (0–0) | 0.02a | 0.02a | −0.02 ± 0.7 | 0 (0–0) | −0.09 ± 0.5 | 0 (0–0) | 0.45 | 0.33 |
EQ-5D | ||||||||||||
Index | 0 ± 0.1 | 0 (0–0) | −0.01 ± 0.1 | 0 (−0.1–0) | 0.35 | 0.23 | 0 ± 0.1 | 0 (0–0) | 0 ± 0.1 | 0 (0–0) | 0.87 | 0.79 |
VAS | 1.89 ± 10.7 | 0 (−5–5) | 0.60 ± 11.5 | 0 (−5–5) | 0.44 | 0.76 | 2.88 ± 9.8 | 0 (−30–0) | 3.47 ± 7.7 | 5 (0–10) | 0.66 | 0.29 |
HADS | −0.32 ± 3.5 | 0 (−2–1) | −0.41 ± 2.9 | 0 (−2–1.3) | 0.86 | 0.45 | −0.18 ± 4.4 | −0.5 (−2–1) | 0.05 ± 5.2 | 0 (−2–2) | 0.77 | 0.74 |
Depression | −0.01 ± 2.1 | 0 (−1–1) | −0.18 ± 1.9 | 0 (−1–0) | 0.60 | 0.79 | 0.04 ± 2.2 | 0 (−1–1) | −0.01 ± 2.8 | 0 (−1–1) | 0.89 | 0.91 |
Anxiety | −0.31 ± 2.1 | 0 (−1.3–1) | −0.23 ± 1.9 | 0 (−1–1) | 0.79 | 0.54 | −0.22 ± 2.7 | 0 (−2–0.13) | 0.06 ± 3.0 | 0 (−1–1) | 0.55 | 0.42 |
PSS | −0.41 ± 4.9 | −1 (−3–2) | −0.24 ± 5.4 | 0 (−3.8–3) | 0.82 | 0.59 | −1.55 ± 4.8 | −1 (−5–2) | −1.12 ± 4.4 | −1 (−4–1.8) | 0.57 | 0.58 |
x̅ = Mean ± SD
ST Significance testing between the two treatment groups
tT t-test
UT Mann-Whitney U-test
Med Median (IQR)
asignificant at the 95 confidence level