The delta changes of stool frequency between the run-in and the intervention phase did not show significant differences between groups.
Stool frequency (number of days with bowel movement) was evaluated over 2-week intervals and treatment effects were investigated for the delta changes of stool frequency between run-in phase and last 2 weeks of intervention phase.
IBS is defined as recurrent abdominal pain or discomfort at least 3 days a month in the past 3 months prior to the survey and associated with at least two of the three criteria related to defecation (onset associated with a change in frequency of stool, onset associated with a change in consistency of stool, or improvement of symptoms with defecation) [ 16].
The definition applied required recurrent abdominal pain or discomfort frequency of at least 2 days a week with at least two of the following (1): improvement with defecation (2); onset associated with a change in frequency of stool; and (3) onset associated with a change in the form of stool.
For the diagnosis of IBS, patients must have recurrent abdominal pain or discomfort for at least 3 months in the previous 6 months, with 2 or more of the following symptoms: (1) relief with defecation, (2) onset associated with a change in frequency of stool, and (3) onset associated with a change in form (appearance) of stool.
IBS was defined according to the Rome II criteria as abdominal discomfort or pain that has at least two of the following three features: (1) relieved with defecation; (2) onset associated with a change in frequency of stool; and/or (3) onset associated with a change in form (appearance) of stool [ 68].
IBS was ascribed based on the Rome III diagnostic criteria for IBS [ 10] which requires abdominal pain or discomfort in at least 3 of the previous 6 months, with 2 or more of the following criteria: [1] pain or discomfort improved after defecation; [2] pain or discomfort associated with a change in frequency of stool, or [3] pain or discomfort associated with a change in the form of stool.
Other symptoms such as generalized itching, fever, and changes in color of stool or urine may also occur.
Current guidance in the United Kingdom from the National Institute for Health and Clinical Excellence (NICE) recommends the decision for urgent referral to a specialist based on a series factors such as age, menopausal status, change of bowel habit, stool frequency, rectal bleeding, abdominal mass and anaemia (National Institute for Health and Clinical Excellence, 2005).
Other secondary outcomes are change in frequency of stooling per day and change in hours of sleep per day during the same time frames.
