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

Table 2 Medical history at baseline

System organ class	G-PUR®, n = 14	Placebo, n = 16	Total, n = 30
MedDRA term
Immune system disorders	10 (71%)	6 (38%)	16 (53%)
Seasonal allergy	7 (50%)	3 (19%)	10 (33%)
Drug hypersensitivity	2 (14%)	2 (13%)	4 (13%)
Allergy to animal	1 (7%)	1 (6%)	2 (7%)
Allergy to plants	2 (14%)	0 (0%)	2 (7%)
Food allergy	1 (7%)	1 (6%)	2 (7%)
Mite allergy	1 (7%)	1 (6%)	2 (7%)
Perfume sensitivity	1 (7%)	0 (0%)	1 (3%)
Metabolism and nutrition disorders	3 (21%)	7 (44%)	10 (33%)
Vitamin D deficiency	1 (7%)	5 (31%)	6 (20%)
Lactose intolerance	2 (14%)	1 (6%)	3 (10%)
Fructose intolerance	1 (7%)	1 (6%)	2 (7%)
Folate deficiency	0 (0%)	1 (6%)	1 (3%)
Food intolerance	0 (0%)	1 (6%)	1 (3%)
Hypercholesterolemia	0 (0%)	1 (6%)	1 (3%)
Psychiatric disorders	3 (21%)	5 (31%)	8 (27%)
Depression	2 (14%)	2 (13%)	4 (13%)
Anxiety disorder	0 (0%)	3 (19%)	3 (10%)
Burnout syndrome	1 (7%)	0 (0%)	1 (3%)
Sleep disorder	1 (7%)	0 (0%)	1 (3%)
Gastrointestinal disorders	1 (7%)	5 (31%)	6 (20%)
Gastritis	0 (0%)	3 (19%)	3 (10%)
Gastroesophageal reflux disease	1 (7%)	1 (6%)	2 (7%)
Hiatus hernia	0 (0%)	1 (6%)	1 (3%)
Nausea	0 (0%)	1 (6%)	1 (3%)

Data are presented for patients randomized to receive G-PUR^® or placebo, given as absolute numbers and percent of group. Headings represent the standard nomenclature and structure from the Medical Dictionary for Regulatory Activities. MedDRA: Medical Dictionary for Regulatory Activities.