Assessment of treatment response in chronic constipation clinical trials

Figures & data

Table 1 CC symptoms reported in at least ten of the 67 studies reviewed

CC symptom	N of studies (N=67)
BM frequencya	67 (100%)
Stool consistency/hard, lumpy stoolsa	56 (83.6%)
Straininga	54 (80.6%)
Incomplete evacuationa	39 (58.2%)
Bloating	36 (53.7%)
Abdominal pain	28 (41.8%)
Abdominal discomfort	24 (35.8%)
Gas	13 (19.4%)
Unsuccessful attempts to have a BM	13 (19.4%)

Note:

a Symptoms included in the Rome Criteria for CC.

Abbreviations: CC, chronic constipation; N, number; BM, bowel movement.

Table 2 Demographic characteristics of interview participants

Demographic information	N=28
Sex
Female	24 (85.7%)
Male	4 (14.3%)
Age, years, average (range)	44.9 (19–74)
Race
White	19 (67.9%)
African American/black	9 (32.1%)
Educationa
High school	5 (17.9%)
Some college or 2-year degree	11 (39.3%)
College graduate	12 (42.9%)

Note:

a Does not equal 100% due to rounding.

Abbreviation: N, number.

Table 3 Symptoms reported by two or more participants (N=28)

Symptom	Reported spontaneously	Reported when probed	Total number of reports
Bowel symptoms
Infrequent BMs	28	0	28 (100.0%)
Incomplete BMs	13	15	28 (100.0%)
Straining	20	8	28 (100.0%)
Hard (or lumpy) stool	22	5	27 (96.4%)
Unsuccessful attempts to have a BM	18	3	21 (75.0%)
Stools too small (or too large)	18	2	20 (71.4%)
Long duration of bathroom visits	8	–	8 (28.6%)
Digital manipulation	4	–	4 (14.3%)
Abdominal symptoms
Abdominal pain	22	6	28 (100.0%)
Abdominal discomfort	15	13	28 (100.0%)
Bloating	22	5	27 (96.4%)
Gas	11	10	21 (75.0%)
Trapped gas	11	5	16 (57.1%)
Flatulence	7	5	12 (42.9%)
Gas pain	6	6	12 (42.9%)
Strong odor of gas	2	–	2 (7.1%)
Burping/belching	2	–	2 (7.1%)
Feeling of fullness	13	7	20 (71.4%)
Abdominal cramping	13	5	18 (64.3%)
Stomach pain/stomachache	14	4	18 (64.3%)
Feeling backed up	12	–	12 (42.9%)
Pain in sides or on one side	3	–	3 (10.7%)
Stomach upset	2	–	2 (7.1%)

Abbreviations: N, number; BM, bowel movement.

Table 4 Consequences of chronic constipation symptoms reported by two or more participants (N=28)

Concept	Total number of reports
Rectal consequences
Rectal pain	15 (53.6%)
Hemorrhoids	12 (42.9%)
Rectal bleeding	11 (39.3%)
Rectal tearing	7 (25.0%)
Rectal burning	3 (10.7%)
Other consequences or impacts
Moodiness, irritability	9 (32.1%)
Loss of appetite/early satiety	7 (25.0%)
Back pain, backache	7 (25.0%)
Headaches	6 (21.4%)
Nausea	5 (17.9%)
Heartburn, indigestion	5 (17.9%)
Fatigue, tiredness, low energy, lethargy	5 (17.9%)
Chest pain (due to gas pressure or feeling of fullness in chest)	4 (14.3%)
Feel “blah”, feel “miserable”, does not feel good	4 (14.3%)
Skin issues (for example, acne, skin not as supple)	3 (10.7%)
Weight gain, feel heavier	2 (7.1%)

Abbreviation: N, number.

Table 5 Summary of importance ratingsa for core symptoms

Symptom	Mean	Median	Range
BM completeness	3.0	3.0	2.5–3.0
Abdominal discomfort	2.9	3.0	2.0–3.0
BM frequency	2.8	3.0	2.0–3.0
Straining	2.7	3.0	1.0–3.0
Bloating	2.7	3.0	2.0–3.0
Stool consistency	2.7	3.0	1.0–3.0
Abdominal pain	2.4	3.0	0.0–3.0

Notes:

a Importance ratings: 0= totally irrelevant; 1= relevant but not important; 2= moderately important; 3= very important.

Abbreviation: BM, bowel movement.

Figure 1 Round 2 participant reports of the five most important CC symptoms to treat.

Note: Frequency equals the frequency with which each symptom was included by round 2 interview participants (N=13) in their list of the five most important CC symptoms to treat.
Abbreviations: BM, bowel movement; CC, chronic constipation; N, number.