A randomized prospective study comparing the efficacy of on-demand therapy versus continuous therapy for 6 months for long-term maintenance with omeprazole 20 mg in patients with gastroesophageal reflux disease in Japan

Figures & data

Table I. Characteristics of study patients at baseline.

	Continuous group (n = 59)	On-demand group (n = 58)	p-Value
Mean age ± SD	57.9 ± 11.0	60.2 ± 11.9	0.25
Gender M:F	41:18	34:24	0.22
Body mass index ± SD	24.2 ± 4.1	23.4 ± 2.9	0.41
Smoking %	39.3	23.2	0.07
Drinking %	58.6	42.1	0.08
Hiatal hernia %	62.1	63.8	0.85
Modified LA classification before initial therapy
M	18	17	0.03
A	15	26
B	23	11
C	1	4
D	2	0
Global Overall Symptom score at baseline mean ± SE
Stomach pain	1.75 ± 0.16	1.57 ± 0.14	0.55
Heartburn	1.98 ± 0.17	1.72 ± 0.15	0.28
Regurgitation	1.81 ± 0.16	1.83 ± 0.13	0.40
Postprandial fullness	1.93 ± 0.15	1.81 ± 0.13	0.68
Vomiting	1.56 ± 0.15	1.34 ± 0.08	0.95
Belching	1.80 ± 0.17	1.86 ± 0.14	0.48
Early satiety	1.56 ± 0.13	1.57 ± 0.11	0.51
Bloating	1.75 ± 0.18	1.83 ± 0.12	0.10

Table II. Alterations in Quality of Life in Reflux and Dyspepsia, Japanese version scores during maintenance therapy.

	Baseline	8 weeks	16 weeks	24 weeks
Continuous group
Overall average	6.34 ± 0.12	6.35 ± 0.13	6.52 ± 0.10	6.66 ± 0.07
Emotional distress	6.21 ± 0.14	6.22 ± 0.16	6.51 ± 0.11	6.55 ± 0.09
Sleep disturbance	6.20 ± 0.17	6.13 ± 0.19	6.45 ± 0.13	6.69 ± 0.07
Food/Drink problems	6.25 ± 0.12	6.33 ± 0.13	6.40 ± 0.13	6.56 ± 0.09
Physical/Social functioning	6.62 ± 0.13	6.77 ± 0.07	6.81 ± 0.05	6.85 ± 0.04
Vitality	6.41 ± 0.13	6.28 ± 0.15	6.44 ± 0.13	6.67 ± 0.07
On-demand group
Overall average	6.30 ± 0.14	6.42 ± 0.08	6.39 ± 0.11	6.37 ± 0.14
Emotional distress	6.13 ± 0.17	6.33 ± 0.11	6.31 ± 0.13	6.26 ± 0.15
Sleep disturbance	6.33 ± 0.13	6.38 ± 0.09	6.25 ± 0.14	6.36 ± 0.14
Food/Drink problems	6.18 ± 0.15	6.31 ± 0.11	6.47 ± 0.08	6.38 ± 0.13
Physical/Social functioning	6.57 ± 0.13	6.75 ± 0.07	6.79 ± 0.06	6.59 ± 0.14
Vitality	6.28 ± 0.15	6.34 ± 0.11	6.11 ± 0.19	6.26 ± 0.17

Data are shown as mean + SE.

Figure 1. Percentages of patients who achieved symptom relief in the continuous and on-demand groups according to GOS scores at baseline and at the 4-, 8-, 16-, and 24-week visits. There were no significant between-group differences in the percentage of patients who achieved symptom relief at any visit.

Figure 2. Mean number of consumed tablets per week recorded on a daily chart. Data are shown with standard deviation.

Figure 3. Percentage of patients who were symptom free for 6 or more days a week as recorded on a daily chart. **p < 0.01, *p < 0.05 versus on-demand group.

Table III. Patients' characteristics at baseline according to classification of Grade M and Grade ≥ A.

	Grade M (n = 35)	Grade ≥ A (n = 82)	p-Value
Mean age	56.2 ± 12.8	60.3 ± 10.8	0.16
Gender M:F	21:14	54:28	0.55
Body mass index	22.9 ± 4.3	24.2 ± 3.1	0.06
Hiatal hernia %	37.1	74.0	<0.01
Smoking %	18.2	36.7	0.05
Drinking %	54.3	48.8	0.58

Figure 4. Percentages of patients classified as (a) Grade M or (b) Grade ≥ A who achieved symptom relief in the continuous and on-demand groups according to the GOS. *p < 0.05 versus on-demand group.

Figure 5. Percentages of patients classified as (a) Grade M or (b) Grade ≥ A who were symptom free for ≥6 days a week in the continuous and on-demand groups according to daily chart entries. **p < 0.01, *p < 0.05 versus on-demand group.