Long-term treatment with probiotics in primary care patients with irritable bowel syndrome – a randomised, double-blind, placebo controlled trial

Figures & data

Figure 1. Flow chart demonstrating the number of patients in the different phases of the trial.

Table I. Baseline characteristics of the randomised patients.

	Total n = 131	Probiotics n = 67	Placebo n = 64
Demographic
Gender, female n (%)	97 (74)	51 (76)	46 (72)
Age, mean (SD)	30.52 (9.42)	31.63 (10.05)	29.38 (8.64)
Race, Danish origin n (%)	125 (95)	63 (94)	62(97)
Health related
Bodymass index, mean (SD)	24.56 (4.15)	24.68 (4.60)	24.42(3.64)
Allergy, n (%)	43 (33)	20 (30)	23 (36)
Smoking, yes n (%)	31 (24)	18 (27)	13 (20)
Symptoms
Duration of symptoms, years, mean (SD)	6.82 (6.99)	7.13 (6.95)	6.50 (7.03)
Severity last 7 days, n (%)
No symptoms	2(2)	1 (1)	1 (2)
Mild	42(32)	22 (33)	20 (31)
Moderate	80(61)	39 (58)	41 (64)
Severe	7(5)	5 (7)	2 (3)
First episode associated with acute diarrhea, n (%)	18 (14)	10 (15)	8 (13)
GSRS-IBS, 1–7
Total score, mean (SD)	3.09 (0.93)	3.05 (0.96)	3.13 (0.89)
IBS-subtype, n (%)
IBS with constipation, IBS-C	25 (19)	14 (21)	11 (17)
IBS with diarrhea, IBS-D	53 (40)	25 (37)	28 (44)
IBS mixed, IBS-M	50 (38)	25 (37)	25 (39)
IBS undefined, IBS-D	3 (2)	3 (4)	-
Prior treatment
Previous use of medicine, n (%)	97(74)	52(78)	45 (70)
Previous use of:
Ispaghula, n (%)	61(47)	31(46)	30(47)
Antispasmodics, n (%)	11 (9)	4(7)	7(12)
Laxatives, n (%)	21(17)	8(13)	13(22)
Loperamide, n (%)	11 (9)	8 (13)	3 (5)
Use of Complementary medicine, n (%)	47 (37)	25 (38)	22 (35)
Health-related quality of life
SF-36
PCS, mean, (SD)	49.00 (7.51)	48.27(7.38)	49.63 (7.60)
MCS, mean (SD)	48.26 (10.44)	49.10(9.99)	47.43(10.90)
IBS-QOL, total score (SD)	73.33 (17.83)	73.23 (17.21)	73.43 (18.61)
Psychological co morbidity
HADS
Anxiety score	7.10 (3.75)	6.81 (3.43)	7.42 (4.07)
Depression score	3.92 (3.5)	3.64 (3.29)	4.21 (3.71)

Table II. Change in gastrointestinal symptoms from baseline, GSRS-IBS^a.

	Baseline		After 3 months treatment			After 6 months treatment			After 6 months followup
	Probiotic n = 67	Placebo n = 64	Probiotic n = 54	Placebo n = 48	p*	Probiotic n = 54	Placebo n = 44	p**	Probiotic n = 48	Placebo n = 38	p***
Total score, mean (SD)	3.0 (1.0)	3.1 (0.9)	3.0 (1.2)	2.6 (0.8)	0.008	2.9 (1.1)	2.8 (1.0)	0.460	2.9 (1.1)	2.8 (0.9)	0.021
Pain, mean (SD)	3.3 (1.2)	3.5(1.2)	3.2(1.3)	3.0(1.1)	0.163	3.1 (1.3)	3.1(1.3)	0.799	3.2 (1.2)	2.9 (1.0)	0.035
Constipation, mean (SD)	2.4 (1.3)	2.6 (1.4)	2.4 (1.4)	2.3 (1.2)	0.348	2.3 (1.6)	2.3 (1.3)	0.652	2.4 (1.5)	2.2 (1.3)	0.147
Diarrhea, mean (SD	2.9 (1.3)	3.0 (1.2)	2.9 (1.4)	2.5 (1.1)	0.040	2.8 (1.4)	2.8 (1.3)	0.862	2.7 (1.2)	2.7 (1.2)	0.214
Satiety, mean (SD)	2.6 (1.4)	2.4 (1.4)	2.8 (1.6)	1.9 (1.2)	0.007	2.6 (1.4)	2.2 (1.3)	0.171	2.6 (1.3)	2.0 (1.4)	0.017
Bloating, mean (SD)	3.8 (1.3)	4.0 (1.4))	3.7 (1.6)	3.3 (1.3)	0.048	3.7 (1.4)	3.5 (1.3)	0.340	3.7 (1.5)	3.5 (1.1)	0.159

^aGastrointestinal Symptom Rating Scale specific for IBS/GSRS-IBS. Range 1–7. Increasing values reflect increasing symptoms.

*Difference between the groups concerning change in gastrointestinal symptoms from baseline till after 3 months treatment.

**Difference between the groups concerning change in gastrointestinal symptoms from baseline till after 6 months treatment.

***Difference between the groups concerning change in gastrointestinal symptoms from baseline till after 6 months follow-up.

Table III. Change in health-related quality of life from baseline, IBS-QOL^a.

	Baseline		After 6 months treatment			After 6 months followup
	Probiotic n = 62	Placebo n = 59	Probiotic n = 59	Placebo n = 49	p-Value*	Probiotic n = 59	Placebo n = 51	p-Value**
Total score, mean (SD)	73.2 (17.2)	73.4 (18.6)	78.3 (15.6)	78.0 (16.4)	0.535	81.7 (11.3)	77.1(16.7)	0.497
Dysphoria, mean (SD)	78.6 (20.5)	76.5 (23.0)	84.3 (17.1)	82.3 (19.9)	0.630	88.5 (12.2)	82.4 (20.1)	0.790
Interference, mean (SD)	69.6 (18.8)	73.2 (20.8)	77.1 (17.6)	77.1 (20.9)	0.377	80.5 (13.8)	74.3 (20.5)	0.310
Body image, mean (SD)	64.5 (21.3)	66.1 (23.1)	71.0 (21.2)	73.1 (19.3)	0.207	73.4 (15.1)	70.3 (19.7)	0.173
Health worry, mean (SD)	79.0 (19.0)	78.0 (17.4)	79.9 (15.4)	80.3 (15.3)	0.212	83.3 (11.7)	80.8 (15.7)	0.214
Food avoidance, mean (SD)	56.9 (29.7)	64.8 (26.8)	61.6 (26.3)	68.1 (24.9)	0.762	67.0 (20.6)	66.0 (26.5)	0.561
Social reaction, mean (SD)	73.7 (20.8)	73.8 (21.9)	80.5 (19.4)	77.0 (19.5)	0.371	82.8 (18.4)	75.8 (21.5)	0.561
Sexual, mean (SD)	78.2 (26.1)	72.5 (32.1)	82.4 (22.7)	79.6 (25.7)	0.580	86.7 (16.8)	80.6 (20.5)	0.962
Relations, mean (SD)	81.6 (20.3)	80.4 (20.2)	84.2 (19.8)	83.5 (16.7)	0.911	88.6 (15.3)	83.6 (17.3)	0.698

^aDisease specific HRQOL-questionaire, IBS-QOL. Range 0–100. Increasing values reflect increased well-being.

*Difference between the groups concerning change from baseline till 6 months.

**Difference between the groups concerning change from baseline till 12 months.

Figure 2. Proportion of patients reporting adequate relief of symptoms during treatment and follow-up. ITT- analysis, probiotic group (n = 67), placebo.