Medical treatments for the maintenance therapy of reflux oesophagitis and endoscopic negative reflux disease

Clare Donnellan; Cathy Preston; Paul Moayyedi; Nav Sharma

doi:10.1002/14651858.CD003245.pub2

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Analysis 1.1

Comparison 1 Healing dose PPI versus placebo, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 1.2

Comparison 1 Healing dose PPI versus placebo, Outcome 2 Relative risk of relapse (symptoms).

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Analysis 1.3

Comparison 1 Healing dose PPI versus placebo, Outcome 3 Adverse effects, overall.

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Analysis 1.4

Comparison 1 Healing dose PPI versus placebo, Outcome 4 Adverse effects, headache.

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Analysis 1.5

Comparison 1 Healing dose PPI versus placebo, Outcome 5 Adverse effects, diarrhoea.

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Analysis 1.6

Comparison 1 Healing dose PPI versus placebo, Outcome 6 Adverse effects, abdominal pain.

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Analysis 2.1

Comparison 2 Maintenance dose PPI versus placebo, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 2.2

Comparison 2 Maintenance dose PPI versus placebo, Outcome 2 Relative risk of relapse (symptoms).

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Analysis 2.3

Comparison 2 Maintenance dose PPI versus placebo, Outcome 3 Adverse effects, overall.

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Analysis 2.4

Comparison 2 Maintenance dose PPI versus placebo, Outcome 4 Adverse effects, headache.

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Analysis 2.5

Comparison 2 Maintenance dose PPI versus placebo, Outcome 5 Adverse effects, diarrhoea.

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Analysis 2.6

Comparison 2 Maintenance dose PPI versus placebo, Outcome 6 Adverse effects, abdominal pain.

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Analysis 3.1

Comparison 3 Healing dose PPI versus Maintenance dose PPI, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 3.2

Comparison 3 Healing dose PPI versus Maintenance dose PPI, Outcome 2 Relative risk of relapse (symptoms).

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Analysis 3.3

Comparison 3 Healing dose PPI versus Maintenance dose PPI, Outcome 3 Adverse effects, overall.

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Analysis 3.4

Comparison 3 Healing dose PPI versus Maintenance dose PPI, Outcome 4 Adverse effects, headache.

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Analysis 3.5

Comparison 3 Healing dose PPI versus Maintenance dose PPI, Outcome 5 Adverse effects, diarrhoea.

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Analysis 3.6

Comparison 3 Healing dose PPI versus Maintenance dose PPI, Outcome 6 Adverse effects, abdominal pain.

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Analysis 4.1

Comparison 4 Healing dose PPI versus H2 receptor antagonist, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 4.2

Comparison 4 Healing dose PPI versus H2 receptor antagonist, Outcome 2 Relative risk of relapse (symptoms).

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Analysis 4.3

Comparison 4 Healing dose PPI versus H2 receptor antagonist, Outcome 3 Adverse effects, overall.

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Analysis 4.4

Comparison 4 Healing dose PPI versus H2 receptor antagonist, Outcome 4 Adverse effects, headache.

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Analysis 4.6

Comparison 4 Healing dose PPI versus H2 receptor antagonist, Outcome 6 Adverse effects, abdominal pain.

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Analysis 5.1

Comparison 5 Maintenance dose PPI versus H2 receptor antagonist, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 5.2

Comparison 5 Maintenance dose PPI versus H2 receptor antagonist, Outcome 2 Relative risk of relapse (symptoms).

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Analysis 5.3

Comparison 5 Maintenance dose PPI versus H2 receptor antagonist, Outcome 3 Adverse effects, overall.

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Analysis 5.4

Comparison 5 Maintenance dose PPI versus H2 receptor antagonist, Outcome 4 Adverse effects, headache.

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Analysis 5.5

Comparison 5 Maintenance dose PPI versus H2 receptor antagonist, Outcome 5 Adverse effects, abdominal pain.

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Analysis 6.1

Comparison 6 H2 receptor antagonist versus placebo, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 6.2

Comparison 6 H2 receptor antagonist versus placebo, Outcome 2 Relative risk of relapse (symptoms).

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Analysis 6.3

Comparison 6 H2 receptor antagonist versus placebo, Outcome 3 Adverse effects, overall.

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Analysis 7.1

Comparison 7 Prokinetic therapy versus placebo/no treatment, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 7.2

Comparison 7 Prokinetic therapy versus placebo/no treatment, Outcome 2 Relative risk of relapse (symptoms).

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Analysis 7.3

Comparison 7 Prokinetic therapy versus placebo/no treatment, Outcome 3 Adverse effects, overall.

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Analysis 7.4

Comparison 7 Prokinetic therapy versus placebo/no treatment, Outcome 4 Adverse effects, diarrhoea.

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Analysis 8.1

Comparison 8 Sucralfate versus placebo, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 8.2

Comparison 8 Sucralfate versus placebo, Outcome 2 Adverse effects, overall.

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Analysis 9.1

Comparison 9 Healing dose PPI versus Maintenance dose PPI 3yr follow up, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 9.2

Comparison 9 Healing dose PPI versus Maintenance dose PPI 3yr follow up, Outcome 2 Relative risk of relapse (symptoms).

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Analysis 9.3

Comparison 9 Healing dose PPI versus Maintenance dose PPI 3yr follow up, Outcome 3 Adverse effects, overall.

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Analysis 9.4

Comparison 9 Healing dose PPI versus Maintenance dose PPI 3yr follow up, Outcome 4 Adverse effects, diarrhoea.

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Analysis 10.1

Comparison 10 Endoscopic negative reflux disease ‐ cisapride versus placebo, Outcome 1 Relative risk of relapse (symptoms).

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Analysis 11.1

Comparison 11 Endoscopic negative reflux disease ‐ omeprazole 10mg versus.placebo, Outcome 1 Relative risk of relapse (symptoms).

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Analysis 11.2

Comparison 11 Endoscopic negative reflux disease ‐ omeprazole 10mg versus.placebo, Outcome 2 Adverse effects, overall.

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Analysis 12.1

Comparison 12 One daily 15mg lansoprazole versus alternate days of 30mg, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 12.2

Comparison 12 One daily 15mg lansoprazole versus alternate days of 30mg, Outcome 2 Relative risk of relapse (symptoms).

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Analysis 12.3

Comparison 12 One daily 15mg lansoprazole versus alternate days of 30mg, Outcome 3 Adverse effects, overall.

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Analysis 13.1

Comparison 13 Double dose PPI versus healing dose PPI, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 13.2

Comparison 13 Double dose PPI versus healing dose PPI, Outcome 2 Relative risk of relapse (symptoms).

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Analysis 14.1

Comparison 14 Healing dose PPI type 1 versus healing dose of PPI type 2, Outcome 1 Relative risk of relapse (oesophagitis).

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Analysis 14.2

Comparison 14 Healing dose PPI type 1 versus healing dose of PPI type 2, Outcome 2 Relative risk of relapse (symptoms).

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Analysis 15.1

Comparison 15 Overall adverse effects, Outcome 1 Relative risk of adverse effect PPI versus placebo.

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Analysis 15.2

Comparison 15 Overall adverse effects, Outcome 2 Relative risk of adverse effect PPI versus H2RA.

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Analysis 15.3

Comparison 15 Overall adverse effects, Outcome 3 Relative risk of adverse effect H2RA versus placebo.

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Comparison 1. Healing dose PPI versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	9	1385	Risk Ratio (M‐H, Random, 95% CI)	0.26 [0.19, 0.36]

2 Relative risk of relapse (symptoms) Show forest plot	9	1321	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.25, 0.46]

3 Adverse effects, overall Show forest plot	5	806	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [1.15, 1.51]

4 Adverse effects, headache Show forest plot	2	348	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.35, 3.62]

5 Adverse effects, diarrhoea Show forest plot	2	305	Risk Ratio (M‐H, Random, 95% CI)	2.52 [0.20, 31.76]

6 Adverse effects, abdominal pain Show forest plot	1	190	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [0.24, 8.24]

Comparison 1. Healing dose PPI versus placebo

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Comparison 2. Maintenance dose PPI versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	10	1465	Risk Ratio (M‐H, Random, 95% CI)	0.46 [0.38, 0.57]

2 Relative risk of relapse (symptoms) Show forest plot	10	1426	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.42, 0.69]

3 Adverse effects, overall Show forest plot	6	1057	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [1.09, 1.43]

4 Adverse effects, headache Show forest plot	2	336	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [0.46, 4.34]

5 Adverse effects, diarrhoea Show forest plot	1	183	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.04, 3.18]

6 Adverse effects, abdominal pain Show forest plot	1	183	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.05, 5.48]

Comparison 2. Maintenance dose PPI versus placebo

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Comparison 3. Healing dose PPI versus Maintenance dose PPI

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	22	5964	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.55, 0.73]

2 Relative risk of relapse (symptoms) Show forest plot	18	5116	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.68, 0.88]

3 Adverse effects, overall Show forest plot	10	2812	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.93, 1.09]

4 Adverse effects, headache Show forest plot	4	1764	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.86, 1.94]

5 Adverse effects, diarrhoea Show forest plot	4	2441	Risk Ratio (M‐H, Random, 95% CI)	1.30 [0.67, 2.53]

6 Adverse effects, abdominal pain Show forest plot	4	2590	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [0.76, 1.64]

Comparison 3. Healing dose PPI versus Maintenance dose PPI

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Comparison 4. Healing dose PPI versus H2 receptor antagonist

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	10	1583	Risk Ratio (M‐H, Random, 95% CI)	0.36 [0.28, 0.46]

2 Relative risk of relapse (symptoms) Show forest plot	5	797	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.39, 0.60]

3 Adverse effects, overall Show forest plot	3	469	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [0.89, 1.80]

4 Adverse effects, headache Show forest plot	1	189	Risk Ratio (M‐H, Fixed, 95% CI)	2.27 [1.04, 4.97]

6 Adverse effects, abdominal pain Show forest plot	1	259	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.43, 1.90]

Comparison 4. Healing dose PPI versus H2 receptor antagonist

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Comparison 5. Maintenance dose PPI versus H2 receptor antagonist

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	6	1156	Risk Ratio (M‐H, Random, 95% CI)	0.57 [0.47, 0.69]

2 Relative risk of relapse (symptoms) Show forest plot	4	831	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.47, 0.65]

3 Adverse effects, overall Show forest plot	3	574	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.11, 1.72]

4 Adverse effects, headache Show forest plot	1	188	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.46, 2.85]

5 Adverse effects, abdominal pain Show forest plot	1	261	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.55, 2.24]

Comparison 5. Maintenance dose PPI versus H2 receptor antagonist

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Comparison 6. H2 receptor antagonist versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	4	655	Risk Ratio (M‐H, Random, 95% CI)	0.57 [0.32, 1.01]

2 Relative risk of relapse (symptoms) Show forest plot	2	451	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.41, 0.67]

3 Adverse effects, overall Show forest plot	3	524	Risk Ratio (M‐H, Fixed, 95% CI)	1.36 [0.78, 2.37]

Comparison 6. H2 receptor antagonist versus placebo

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Comparison 7. Prokinetic therapy versus placebo/no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	4	1011	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.50, 0.84]

2 Relative risk of relapse (symptoms) Show forest plot	4	1101	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.57, 1.04]

3 Adverse effects, overall Show forest plot	5	1394	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [1.21, 1.93]

4 Adverse effects, diarrhoea Show forest plot	1	443	Risk Ratio (M‐H, Fixed, 95% CI)	3.15 [1.25, 7.89]

Comparison 7. Prokinetic therapy versus placebo/no treatment

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Comparison 8. Sucralfate versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	2	201	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.39, 0.80]

2 Adverse effects, overall Show forest plot	1	181	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [0.69, 3.39]

Comparison 8. Sucralfate versus placebo

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Comparison 9. Healing dose PPI versus Maintenance dose PPI 3yr follow up

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	1	243	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [0.62, 2.89]

2 Relative risk of relapse (symptoms) Show forest plot	1	243	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.80, 1.36]

3 Adverse effects, overall Show forest plot	1	243	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.73, 1.81]

4 Adverse effects, diarrhoea Show forest plot	1	243	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [0.43, 5.49]

Comparison 9. Healing dose PPI versus Maintenance dose PPI 3yr follow up

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Comparison 10. Endoscopic negative reflux disease ‐ cisapride versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (symptoms) Show forest plot	1	118	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.65, 1.14]

Comparison 10. Endoscopic negative reflux disease ‐ cisapride versus placebo

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Comparison 11. Endoscopic negative reflux disease ‐ omeprazole 10mg versus.placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (symptoms) Show forest plot	1	495	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.29, 0.53]

2 Adverse effects, overall Show forest plot	1	495	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.96, 1.26]

Comparison 11. Endoscopic negative reflux disease ‐ omeprazole 10mg versus.placebo

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Comparison 12. One daily 15mg lansoprazole versus alternate days of 30mg

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	2	189	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.46, 1.30]

2 Relative risk of relapse (symptoms) Show forest plot	2	187	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.46, 1.19]

3 Adverse effects, overall Show forest plot	1	52	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.11, 3.39]

Comparison 12. One daily 15mg lansoprazole versus alternate days of 30mg

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Comparison 13. Double dose PPI versus healing dose PPI

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	2	354	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.36, 1.15]

2 Relative risk of relapse (symptoms) Show forest plot	2	334	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.87, 1.47]

Comparison 13. Double dose PPI versus healing dose PPI

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Comparison 14. Healing dose PPI type 1 versus healing dose of PPI type 2

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of relapse (oesophagitis) Show forest plot	3	1020	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.65, 1.32]

2 Relative risk of relapse (symptoms) Show forest plot	3	1001	Risk Difference (M‐H, Fixed, 95% CI)	0.06 [0.01, 0.11]

Comparison 14. Healing dose PPI type 1 versus healing dose of PPI type 2

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Comparison 15. Overall adverse effects

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relative risk of adverse effect PPI versus placebo Show forest plot	6	1643	Risk Ratio (M‐H, Random, 95% CI)	1.28 [1.12, 1.47]

2 Relative risk of adverse effect PPI versus H2RA Show forest plot	6	1354	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [1.06, 1.57]

3 Relative risk of adverse effect H2RA versus placebo Show forest plot	2	352	Risk Ratio (M‐H, Fixed, 95% CI)	1.60 [0.77, 3.29]

Comparison 15. Overall adverse effects

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