GI Symptom Severity over Time
Baseline and steady dose segments
A total of 9,591 daily symptom evaluation records from those who completed the study were analyzed. Participants experienced a median of 3 (range = 0–8) GI symptoms in all the study segments. The severity of each GI symptom was between minor and small in the baseline as well as the steady dose 1 and 2 segments for each supplement group. The median severity was 0 for the symptoms of nausea (range = 0 – 3), belching, feeling of fullness, bloating, and abdominal cramping (range for the latter 4 symptoms = 0 – 4). The severity of flatus was a median of 1 (range = 0 – 4) for the placebo, CMC and psyllium groups and 1.5 (0 – 4) for the gum arabic group in the baseline segment. Flatus severity was 1 (0 – 4) for the placebo and gum arabic groups and 2 (0 – 4) for CMC and psyllium groups in the steady dose 1 and 2 segments. The median number of times of flatus in the four supplement groups was 3 to 4.5 (range = 0 to 75) in the baseline segment and 5 – 6 (range = 0 – 93) in steady dose 1 and 2. There was no statistical difference in the severity of any symptom among the groups or between the baseline and steady dose segments. There was also no statistical difference in the median number of flatus episodes that occurred among groups or study segments.
Symptom Type and Severity over Time
Mixed modeling analyses, which used the daily ratings of symptom severity and adjusted for study day, segment, and group, showed that there were differences in the severity of specific symptoms over time (Table 5). The odds of having greater severity of flatus, belching, fullness, and bloating in the steady dose 1 segment were 1.5 – 1.9 times higher than in the baseline segment; the odds in the steady dose 2 segment were 1.4 – 1.7 times higher than baseline. The likelihood of greater belching was higher in the steady dose 1 segment compared to the steady dose 2 segment while the likelihood of a greater feeling of fullness was higher in the steady dose 2 segment. Even though there was a greater likelihood of having an increased feeling of fullness in the latter study segments, during a segment, the odds of feeling full decreased .01 per day as each day of a segment passed. The odds of greater abdominal cramping were 20% higher in the steady dose 1 segment than the steady dose 2 segment.