Comparison of preference and safety of powder and liquid lactulose in adult patients with chronic constipation

Figures & data

Figure 1 Study randomization and design.

Note: *Or within 7 days of day 14 of the study.

Table 2 Patient preference data in terms of overall preference and preference of taste, consistency, and portability

Which product would you rather take?	Randomization sequence
	Powder/liquid (n = 23)	Liquid/powder (n = 27)	Overall (n = 50)
Powder	12 (52%)	11 (41%)	23 (46%)
Liquid	7 (30%)	6 (22%)	13 (26%)
No preference	4 (17%)	8 (30%)	12 (24%)
Missing	0	2 (7%)	2 (4%)
P valuea			0.181
P valueb			0.153
Which product did you prefer in terms of taste?
Powder	12 (52%)	11 (41%)	23 (46%)
Liquid	7 (30%)	9 (33%)	16 (32%)
No preference	4 (17%)	5 (19%)	9 (18%)
Missing	0	2 (7%)	2 (4%)
P valuea			0.341
P valueb			0.560
Which product did you prefer in terms of consistency?
Powder	11 (48%)	11 (41%)	22 (44%)
Liquid	7 (30%)	7 (26%)	14 (28%)
No preference	5 (22%)	7 (26%)	12 (24%)
Missing	0	2 (7%)	2 (4%)
P valuea			0.318
P valueb			0.435
Which product did you prefer in terms of portability?
Powder	17 (74%)	16 (59%)	33 (66%)
Liquid	1 (4%)	4 (15%)	5 (10%)
No preference	5 (22%)	5 (19%)	10 (20%)
Missing	0	2 (7%)	2 (4%)
P valuea			<0.001
P valueb			<0.001

Notes:

a P value is based on a Mainland–Gart test, including only patients who recorded a preference (preferred Kristalose^®, preferred lactulose);

b P value is based on a Prescott test, including only patients who recorded a response (preferred Kristalose, preferred lactulose, no preference).

Table 3 Adverse events experienced by patients while taking liquid or powder lactulose

System organ class (preferred term)	Liquid (n = 50)	Powder (n = 50)
Any treatment-emergent event	10 (20%)	13 (26%)
P value		0.635
Gastrointestinal disorders	9 (18%)	12 (24%)
P value		0.624
Flatulence	6 (12%)	7 (14%)
P value		>0.999
Abdominal distension	2 (4%)	3 (6%)
P value		>0.999
Diarrhea	1 (2%)	2 (4%)
P value		> 0.999
Abdominal pain upper	1 (2%)	1 (2%)
P value		>0.999
Nausea	1 (2%)	1 (2%)
P value		>0.999
Abdominal pain lower	0	1 (2%)
P value		>0.999
Constipation	1 (2%)	0
P value		>0.999
Vomiting	0	1 (2%)
P value		>0.999
Musculoskeletal and connective tissue disorders	0	2 (4%)
P value		0.495
Muscle spasms	0	2 (4%)
P value		0.495
Nervous system disorders	2 (4%)	0
P value		0.495
Dizziness	1 (2%)	0
P value		>0.999
Headache	1 (2%)	0
P value		>0.999
Respiratory, thoracic, and mediastinal disorders	2 (4%)	0
P value		0.495
Pharyngolaryngeal pain	2 (4%)	0
P value		0.495
Cough	1 (2%)	0
P value		>0.999
Metabolism and nutrition disorders	1 (2%)	0
P value		>0.999
Hyperglycemia	1 (2%)	0
P value		>0.999
Uncoded	0	1 (2%)
P value		>0.999
Menstrual cramps	0	1 (2%)
P value		>0.999

Table 1 Patient demographics

Age (years)
n	50
Mean (SD)	48.61 (14.95)
Median	48.5
Minimum, maximum	20.75, 81.17
Gender
Male	13 (26%)
Female	37 (74%)
Race
Caucasian	13 (26%)
African-American	26 (52%)
Hispanic	9 (18%)
Asian	1 (2%)
Other	1 (2%)
Height (cm)
Mean (SD)	167.18 (10.41)
Median	165.95
Minimum, maximum	142.2, 191.4
Weight (kg)
Mean (SD)	87.42 (20.98)
Median	81.55
Minimum, maximum	54.4, 142.8

Abbreviation: SD, standard deviation.

Figure 2 Preference data in terms of overall preference and preference of taste, consistency, and portability in all patients (includes those who expressed ‘no preference’).

Figure 3 Preference data in terms of overall preference and preference of taste, consistency, and portability in only the patients who expressed a preference for powder or liquid lactulose.