Proton pump inhibitor treatment of patients with gastroesophageal reflux-related chronic cough: A comparison between two different daily doses of lansoprazole

Table 1 Demographics, clinical details and outcome of investigations performed in the 45 patients with chronic cough

	All patients	GERD symptoms
		Present	Absent
Subjects	45	25	20
Age (mean±SD)	54.5 ± 11.1	54.6 ± 12.8	54.4 ± 8.6
Gender, male (%)	7 (15.5)	3 (12.0)	4 (20.0)
Upper endoscopy positive (%)	7 (15.5)	3 (12.0)	4 (20.0)
pH-metry positive (%)	26 (57.8)	13 (52.0)	13 (65.0)
PPI test positive (%)	23 (51.1)	13 (52.0)	10 (50.0)

No statistical differences between the groups in any of the parameters.

Table 2 Analysis of concordance between 24 h pH-metry and PPI test

	24 h pH-metry		Total
	Positive	Negative
PPI test positive	12	11	23
PPI test negative	14	8	22
Total	26	19

Youden’s index = -0.1174 K (measure of reliability) = -0.115 (no reliability).

Table 3 Characteristics of the patients entering the randomized double-blind phase of the study

	Lansoprazole (30 mg/d)(n = 17)	Lansoprazole (60 mg/d)(n = 18)
Age (mean±SD)	57.5 ± 11.9	52.4±10.0
Gender, male (% )	3 (17.6)	2 (11.1)
Upper endoscopy positive (%)	4 (23.5)	3 (16.7)
pH-metry positive (%)	13 (76.5)	10 (55.5)
PPI test positive (%)	11 (64.7)	11 (61.1)

No statistical differences between the groups in any of the parameters.

Table 4 Patient symptoms evaluated at baseline (visit 1), after the PPI test (visit 2) and at the end of the 12-week lansoprazole treatment period (visit 3)

	Visit 1		Visit 2		Visit 3
	VAS	Score	VAS	Score	VAS	Score
Lansoprazole	8 (7.5-9.5)	9 (8-9)	2 (1.5-5.5)b	4 (3-7)a	1 (0-4.5)b	3 (0-6.5)b
(30 mg/d)
(n = 17)
Lansoprazole	9 (8-9)	8 (7-9)	2 (1-6.5)b	3.5 (3-7)a	1 (0-5)b	3 (0-6.25)b
(60 mg/d)
(n = 18)

Data expressed as median (25%-75% quartiles).

^bP < 0.001 vs visit 1;

^aP < 0.005 vs visit 1.

Table 5 Comparison between patients with symptomatic response and non-responders

	Responders [n = 21 (%)]	Non-responders [n = 14 (%)]
GER symptoms	14 (66.7)	5(35.7)
Treatment with	11 (52.4)	7(50.0)
60 mg/d lansoprazole
Erosive esophagitis	5 (23.8)	2(14.3)
pH-metry positive	10 (47.6)	13(92.8)
PPI test positive	18 (85.7)	4(28.6)b

Responders = patients with VAS and score values of 0; non-responders = patients with VAS and score values ≥1;

^bP < 0.01 vs responders.