Safety and efficacy of purified clinoptilolite-tuff treatment in patients with irritable bowel syndrome with diarrhea: Randomized controlled trial

Table 3 Study outcome variables at week 12 of treatment with G-PUR^® or placebo

Outcome variable		G-PUR®, n = 14	Placebo, n = 16	RD/MD (95%CI)	Odds ratio (95%CI)	P value
SGA of Relief responders, end of study1		3 (21%)	4 (25%)	0.04 (-0.28-0.38)	0.82 (0.18-3.73)	1.0000
Abdominal pain responders2		13 (93%)	13 (81%)	0.12 (-0.20-0.40)	3 (0.39-41.55)	0.6015
Daily abdominal pain reduction3		94 (IQR: 81-100)	83 (IQR: 65-92)	-14.9 (-31.87-2.07)	N/A	0.0353
Proportion of BSFS 50% responders		7 (50%)	5 (31%)	0.19 (-0.19-0.51)	2.2 (0.55-11.05)	0.4572
Proportion of BSFS 30% responders		10 (71%)	7 (44%)	0.28 (-0.11-0.58)	3.21 (0.76-12.03)	0.1590
Combined abdominal pain and BSFS 50% response		6 (43%)	4 (25%)	0.18 (-0.19-0.50)	2.25 (0.49-8.68)	0.4421
Decrease in d with diarrhea per week		2.4	0.3	N/A	N/A	0.4176
IBS-SSS		-90 (IQR: -170 to -40)	-55 (IQR: -100 to -10)	31.6 (-42.25-105.5)	N/A	0.3950
SF-12		53 (IQR: 50-55)	49 (IQR: 42-51)	-5.40 (-9.15 to -1.65)	N/A	0.0127
PSQ absolute change	Total	-7 (IQR: -28-0)	5 (IQR: -5-12)	11.0 (-2.65-24.65)	N/A	0.0843
	Tension	-20 (IQR: -40-0)	-3 (IQR: -13-13)	16.2 (0.7-31.7)	N/A	0.0399
	Joy	13 (IQR: -7-20)	-10 (IQR: -20-0)	-10.4 (-25.3-4.5)	N/A	0.1176
	Demands	-7 (IQR: -33-13)	10 (IQR: -7-20)	14.3 (-5.35-33.95)	N/A	0.1795
	Worries	0 (IQR: -13-0)	0 (IQR: -7-13)	3.2 (-11.56-17.96)	N/A	0.5587

¹Subject’s Global Assessment (SGA) of Relief response assessment was based on the last four post-randomization SGAs, or if fewer than four post-randomization SGAs were available, then all post-randomization SGAs were used. Patients were considered responders if they answered ‘considerably relieved’ or ‘completely relieved’ at least 50% of the time or at least ‘somewhat relieved’ 100% of the time.

²Abdominal pain response was defined as an at least 30% improvement in abdominal pain on at least 50% of days with available electronic patient-reported outcome diary entries as compared to the patient’s worst abdominal pain reported in the screening/run-in phase (‘baseline abdominal pain’).

³The median proportion of days with an at least 30% improvement in abdominal pain compared to the patient’s worst abdominal pain documented in the screening/run-in phase.

Data are presented as absolute numbers and percent of group or median with interquartile range. Risk difference for proportional variables and mean differences for normally distributed variables, with 95% confidence intervals are given. Odds ratio is provided for proportional variables. BSFS: Bristol Stool Form Scale; N/A: Not available; PSQ: Perceived Stress Questionnaire; SF-12: 12-item Short Form survey; IBS-SSS: Irritable Bowel Syndrome-Symptoms Severity Scale; IQR: Interquartile range; RD: Risk difference; MD: Mean differences; CI: Confidence intervals.