8
S. CUDMORE ET AL.
Figure 4. Effect size for QOL sub-categories. The effect size was based on the difference within each treatment group over the five subcategories (using the Wilcoxon test). Cohen ’ s d determined the classification of the effect size (strength of the result). A statistic- ally significant difference exists between the two groups if the p -value from the statistical test is less than .05. Effect size quantifies the statistical difference – i.e. when the effect size is deemed as large, that means that a large difference exists between the two groups.
Table 6. Pairwise comparisons on PAC SYM scores.
95% Confidence Interval for Difference
% Score Mean Difference (Lepicol - Placebo)
PAC-SYM category
p -Value Lower Bound Upper Bound Effect size
All symptoms
12.318 13.098 8.717 10.722
.039 .005 .044 .109
23.989 22.098 17.199 23.916
0.647 4.098 0.236 2.472
0.549 0.721 0.510
Abdominal symptoms
Rectal symptoms Stool symptoms
0.414 Results from the pre-treatment phase were used as the baseline covariate. Abdominal symptoms are discomfort, pain, bloating, cramps; rectal symptoms are painful bowel movements, burning sensations, bleeding/tearing; and stool symptoms are incomplete bowel movements, stool too hard, stool too small, straining and false alarm. “ All symptoms ” are all 12 symptoms. A negative % score difference indicates an improvement in symptoms.
symptoms improved by 10.7 % in the Lepicol group versus placebo, but this was statistically insignificant ( p ¼ .109). Figure 5 indicates that for the 12 subcategories of the PAC-SYM, there was a larger effect size in almost all the constipation symptoms in the Lepicol group versus placebo, with the exception of two subcatego- ries (stool too small and painful bowel movements), where the effect size difference was small. Laxative use Overall there were 148 reported uses of laxatives in this study (aloe vera cleanse, annusol, ducolax, duphu- lac, movicol, fuca, lactulose, motilium, pineapple juice, senokot, supos). Chi-squared tests showed that the
highest proportion of laxative use (60 % of total) within the groups was during the 2-week pre-screen- ing phase (Table 7). Within the Lepicol treatment group the proportional use of laxatives decreased from 70 reported uses by 10 subjects (64.2 % of the total reported uses of laxatives in the group) in pre-treat- ment, to 32 uses by 7 subjects in week 2 (29.4 % of total usage in group), to 7 reported uses by 2 subjects in week 4 (6.4 % ). This decrease was found to be stat- istically significant ( p < .001). The high use of laxative in the Lepicol group was primarily due to one subject, but if this subject ’ s data was excluded the result was still significant. This subject consumed 28 doses of laxative (Ducolax, Duphalax, Movicol) in the 2 week run in period, versus 3 doses in the 4 week interven- tion period, but as did not exceed the recommended
Powered by FlippingBook