INTERNATIONAL JOURNAL OF FOOD SCIENCES AND NUTRITION 9
Figure 5. PAC-SYM subcategory effect sizes. The effect size was based on the difference within each treatment group over the 12 subcategories (using the Wilcoxon test). Cohen ’ s d determined the classification of the effect size.
Table 7. Laxative use.
No. of reports of Laxative use (% within each group) Lepicol Placebo Total
Pre-treatment (weeks – 2 to 0)
70 (64.2%) 32 (29.4%)
19 (48.7%) 9 (23.1%) 11 (28.2%) 39 (100.0%)
89 (60.1%) 41 (27.7%) 18 (12.2%) 148 (100%)
Weeks 1 – 2 Weeks 3 – 4
7 (6.4%)
Total
109 (100.0%)
p -Value < .001 Number of reported uses of laxatives (and also expressed as the % use within each group) for each phase of the study. < .001 .116
Discussion The results of this double blind, placebo controlled, parallel clinical study, while they did not meet the pri- mary endpoint, did demonstrate that subjects who consumed 10 g (2 sachets) of a commercially available synbiotic, Lepicol, for 4 weeks experienced an improvement in the symptoms of chronic constipation versus placebo. The product contained fibre (psyllium husks), prebiotic (inulin) and 5 probiotic strains ( Lactobacillus rhamnosus PXN 54, Bifidobacterium bifidum PXN 23, Lactobacillus acidophilus PXN 35, Lactobacillus plantarum PXN 47 and Lactobacillus bul- garicus PXN 39). The fibre, prebiotic and probiotic strains separately have been previously associated with an improvement in constipation (McRorie et al. 1998; Marteau et al. 2011; Suares & Ford 2011; Petschow 2013). The results of a previous study with the same five probiotic strains in men with chronic constipation suggested that the product is effective in improving stool frequency and consistency in the male sample,
daily dose or study eligibility criteria the subject was not excluded from the study. In the placebo group there was a statistically insignificant drop ( p ¼ .116) in the proportional use of laxatives, from 48.7 % by 7 subjects (of the total reported uses of laxatives) in pre- treatment to 23.1 % by 3 subjects (weeks 1 – 2) to 28.2 % by 3 subjects (weeks 3 – 4). Safety data There were 51 reports of adverse events (AE) in total (23 Lepicol, 28 placebo) and no serious adverse events (SAE), with no statistical difference between groups ( p ¼ .575). Of the AEs, which varied from nettle stings to back pain, 98 % were categorised as mild by the clinical team ( p < .001), which also categorised 80.4 % of the AEs (82.6 % Lepicol, 78.6 % placebo) as unrelated or unlikely to be related to the treatment (Table 8). Overall, there was no significant difference between the groups ( p > .999).
Powered by FlippingBook