INTERNATIONAL JOURNAL OF FOOD SCIENCES AND NUTRITION 7
Figure 3. Average and confidence interval of stool consistency using a weighted average distance (weighted according to the fre- quency of each stool type) for stool type away from type 01 on the Bristol Stool Scale.
Table 5. Pairwise comparison of Lepicol versus Placebo on QOL score with results from the pre- treatment used as the baseline covariate. 95% Confidence Interval for Difference
% ScoreMean Difference (Lepicol - Placebo)
QOL category All categories
p -Value Lower Bound Upper Bound Effect size
12.033 15.176 10.509 8.595 13.060 28.488
.051 .030 .055 .155 .067 .003
24.096 28.855 21.229 20.516 27.036 47.224
0.031
0.514 0.545 0.492 0.364 0.464
Intensity of symptoms
1.498 0.212
Effect on daily life
Feelings
3.326 0.916
Life with constipation
Satisfaction 0.749 The analysis was carried out by standardising the total scores of the subcategories. A negative % score indicates an improvement in QOL. 9.752
(painful bowel movements, burning sensation, bleed- ing/tearing) and stool symptoms (incomplete bowel movement, stool too hard, stool too small, straining and false alarm). While the overall constipation scores improved for both groups throughout the study ( p ¼ .001), constipation symptoms were lower by 12.32 % in the Lepicol group versus placebo group ( p ¼ .039) as shown in Table 6. When broken into the three categories it was found that on aver- age subjects ’ abdominal symptoms were improved by 13.1 % ( p ¼ .005) and rectal symptoms by 8.7 % ( p ¼ .044) in the Lepicol group over placebo. Stool
with a medium effect size of .749). These data are shown in Figure 4, which indicates that the effect size for each of the QOL sub-categories is greater in the Lepicol group than in the placebo. Constipation symptoms The constipation symptoms were assessed using the PAC-SYM questionnaire at the start (visit 2) and end (visit 3) of the 4 week intervention period. This questionnaire is divided into three categories with a total of 12 questions; abdominal symptoms (discom- fort, pain, bloating, cramps), rectal symptoms
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