A blind, randomized comparison of racecadotril and loperamide for stopping acute diarrhea in adults

Table 1 Baseline patient characteristics (mean±SD).

Characteristics	Racecadotril (n = 31)	Loperamide (n = 31)	P
Male/Female	15 (48.4)/16 (51.6%)	17 (54.8%)/14 (45.2)	0.7997
Oriental	31 (100%)	31 (100%)	1
Age (yr)	38.4±15.1	34.7±12.3	0.2961
Weight (kg)	57.4±12.7	59.6±9.0	0.4339
Height (cm)	162.6±9.6	164.8±9.6	0.357
BMI	21.5±3.3	22.0±2.9	0.6074

Table 2 Mean duration of symptom (h).

Symptom	Population	Racecadotril	Loperamide	P
Abdominal pain	ITT	16	14	0.9509
	PP	16	15	0.7177
Abdominal distension	ITT	12	14	0.5602
	PP	12	12	0.525

Table 3 Rates of improvement in anal burn and nausea.

Symptom	Population	Racecadotril (%)	Loperamide (%)	P
Anal burn	ITT	22/31 (71.0)	23/31 (74.2)	0.7353
	PP	18/23 (78.3)	19/25 (76.0)	0.7428
Nausea	ITT	23/31 (74.2)	24/31 (77.4)	0.659
	PP	18/23 (78.3)	20/25 (80.0)	0.6475

Table 4 Clinical response by treatment group.

Population	Racecadotril (%)	Loperamide (%)	P
ITT
Clinical success	22/31 (87.1)	27/31 (87.1)	0.7212
PP
Clinical success	22/23 (95.6)	23/25 (92.0)	0.6248

Table 5 Treatment-related adverse events with an incidence of more than 1 %.

Population event	Racecadotril (n = 31) (%)	Loperamide (n = 21) (%)
Constipation	4 (12.9)	9 (29.0)
Bloody stool	1 (14.2)	1 (9.1)
Skin itching	2 (28.6)	0 (0.0)
Abdominal pain on palpation	1 (14.3)	0 (0.0)