Ziverel for PPI-refractory reflux symptoms: efficacy and mechanisms of action in humans

Figures & data

Figure 1. Flow-chart of the study design and study interventions.

Table 1. Baseline characteristics of included patients (n = 15).

	n	%	Median (range)
Demographics
Sex
Male	3	20.0
Female	12	80.0
Age at inclusion (years)			48 (33–63)
BMI			23.5 (22.2–30.5)
Currently smoking	2	13.3
Alcohol use
No	7	46.6
Mild (0-5 units/week)	8	53.5
Reflux symptom duration (months)			60 (14–98)
Total RDQ score			2.67 (2.25–3.75)
Medication use prior to participation
Proton pump inhibitors (PPI)	15	100
H2 antagonist	0	0
Antacids	2	13.3
Endoscopic findings
Endoscopy performed prior to inclusion	13	86.7
Reflux esophagitis	1	6.7
Grade A	1	6.7
Hiatal hernia	8	53.3
24-hour pH impedance performed	10	66.7
Total acid exposure (% of time with pH < 4)			4.1 (1.4–20.3)

BMI: body mass index; n: number of patients; PPI: proton pump inhibitor.

Figure 2. Time intervals for initial perception, discomfort and pain after starting esophageal acid perfusion.

Table 2. RDQ score and subscores after 4 weeks of treatment.

	After Ziverel treatment	After placebo treatment
RDQ total	2.6 (1.9–3.3)	2.5 (1.6–3.5)	p = 0.456
RDQ Heartburn	3 (1.8–4.5)	2.9 (1.3–3.5)	p = 0.119
RDQ Regurgitation	2.5 (1–3)	2.7 (1.9–3.5)	p = 0.285
RDQ GERD	2.6 (1.8–3.1)	2.8 (1.5–3.4)	p = 0.506
RDQ Dyspepsia	2.5 (1.8–3.8)	2.6 (1.6–3.8)	p = 0.432