The fourth item in the Rome III criteria, which asks about painful defecation or stool consistency, was judged as positive if a subject always or sometimes had painful defecation or always had hard stool of Bristol Stool Scale
type 1 or 2.
TABLE 5 Seven-day stool diary Date Time of bowel movement Straining (yes/no) Feeling of incomplete evacuation (yes/no) Stool consistency (1-7, from Bristol Stool Scale
) Urge (yes/no) Digital maneuvers (yes/no) Drug therapies (including over-the-counter drugs) Comments (include other symptoms) Key points and recommendations
Tolerability was evaluated using the gastrointestinal tolerability questionnaire, which assesses symptoms like flatulence and abdominal cramping, and the Bristol Stool Scale
, which assesses stool consistency.
Favorable trends were also observed on other evaluated endpoints, including the Bristol stool scale
, number of daily evacuations and stool weight, which were consistent with the CFA results.
Stool consistency was evaluated according to the Bristol stool scale
(a 7-point scale, ranging from 1= separate hard lumps like nuts to 7 = watery) ; in this study, the scores were allotted as follows: Bristol type 4-7 = score 0, Bristol type 3 = score 1, Bristol type 2 = score 2, and Bristol type 1 = score 3.
Favorable trends were also observed on other evaluated endpoints, including Bristol stool scale
, number of daily evacuations and weight of stool, and these were consistent with the CFA results.