Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding

Aravamuthan Sreedharan; Janet Martin; Grigorios I Leontiadis; Stephanie Dorward; Colin W Howden; David Forman; Paul Moayyedi

doi:10.1002/14651858.CD005415.pub2

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Figure 1

Funnel plot of comparison: 1 Main analysis, outcome: 1.1 Mortality ‐ 30 days or at point closest to 30 days.

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Figure 2

Funnel plot of comparison: 1 Main analysis, outcome: 1.2 Rebleeding within 30 days.

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Figure 3

Funnel plot of comparison: 1 Main analysis, outcome: 1.3 Surgery for continued or recurrent bleeding within 30 days of randomisation.

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Figure 4

Funnel plot of comparison: 1 Main analysis, outcome: 1.5 Proportion of patients with stigmata of recent haemorrhage.

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Figure 5

Funnel plot of comparison: 1 Main analysis, outcome: 1.8 Endoscopic haemostatic therapy at index endoscopy.

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Analysis 1.1

Comparison 1 Main analysis, Outcome 1 Mortality ‐ 30 days or at point closest to 30 days.

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Analysis 1.2

Comparison 1 Main analysis, Outcome 2 Rebleeding within 30 days.

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Analysis 1.3

Comparison 1 Main analysis, Outcome 3 Surgery for continued or recurrent bleeding within 30 days of randomisation.

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Analysis 1.4

Comparison 1 Main analysis, Outcome 4 Patients requiring blood transfusion (post hoc analysis).

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Analysis 1.5

Comparison 1 Main analysis, Outcome 5 Proportion of patients with stigmata of recent haemorrhage.

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Analysis 1.6

Comparison 1 Main analysis, Outcome 6 Proportion of patients with blood in stomach (post hoc analysis).

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Analysis 1.7

Comparison 1 Main analysis, Outcome 7 Proportion of patients with active bleeding.

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Analysis 1.8

Comparison 1 Main analysis, Outcome 8 Endoscopic haemostatic therapy at index endoscopy.

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Analysis 2.1

Comparison 2 Analysis according to degree of allocation concealment, Outcome 1 Mortality.

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Analysis 2.2

Comparison 2 Analysis according to degree of allocation concealment, Outcome 2 Rebleeding within 30 days.

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Analysis 2.3

Comparison 2 Analysis according to degree of allocation concealment, Outcome 3 Surgery for continued or recurrent bleeding within 30 days of randomisation.

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Analysis 3.1

Comparison 3 Analysis according to control treatment, Outcome 1 Mortality.

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Analysis 3.2

Comparison 3 Analysis according to control treatment, Outcome 2 Rebleeding within 30 days.

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Analysis 3.3

Comparison 3 Analysis according to control treatment, Outcome 3 Surgery for continued or recurrent bleeding within 30 days of randomisation.

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Analysis 4.1

Comparison 4 Analysis according to route of PPI administration, Outcome 1 Mortality.

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Analysis 4.2

Comparison 4 Analysis according to route of PPI administration, Outcome 2 Rebleeding within 30 days.

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Analysis 4.3

Comparison 4 Analysis according to route of PPI administration, Outcome 3 Surgery for continued or recurrent bleeding within 30 days of randomisation.

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Analysis 5.1

Comparison 5 Analysis according to the PPI used, Outcome 1 Mortality.

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Analysis 5.2

Comparison 5 Analysis according to the PPI used, Outcome 2 Rebleeding within 30 days.

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Analysis 5.3

Comparison 5 Analysis according to the PPI used, Outcome 3 Surgery for continued or recurrent bleeding within 30 days of randomisation.

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Analysis 6.1

Comparison 6 Analysis according to report of endoscopic haemostatic treatment, Outcome 1 Mortality.

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Analysis 6.2

Comparison 6 Analysis according to report of endoscopic haemostatic treatment, Outcome 2 Rebleeding.

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Analysis 6.3

Comparison 6 Analysis according to report of endoscopic haemostatic treatment, Outcome 3 Surgery.

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Analysis 7.1

Comparison 7 Analysis restricted to peptic ulcer patients, Outcome 1 Mortality.

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Analysis 7.2

Comparison 7 Analysis restricted to peptic ulcer patients, Outcome 2 Rebleeding.

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Analysis 7.3

Comparison 7 Analysis restricted to peptic ulcer patients, Outcome 3 Surgery.

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Comparison 1. Main analysis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality ‐ 30 days or at point closest to 30 days Show forest plot	6	2223	Odds Ratio (M‐H, Fixed, 95% CI)	1.12 [0.75, 1.68]

2 Rebleeding within 30 days Show forest plot	5	2121	Odds Ratio (M‐H, Fixed, 95% CI)	0.81 [0.62, 1.06]

3 Surgery for continued or recurrent bleeding within 30 days of randomisation Show forest plot	5	2165	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.65, 1.25]

4 Patients requiring blood transfusion (post hoc analysis) Show forest plot	4	1512	Odds Ratio (M‐H, Fixed, 95% CI)	0.95 [0.78, 1.16]

5 Proportion of patients with stigmata of recent haemorrhage Show forest plot	4	1332	Odds Ratio (M‐H, Fixed, 95% CI)	0.67 [0.54, 0.84]

6 Proportion of patients with blood in stomach (post hoc analysis) Show forest plot	3	1230	Odds Ratio (M‐H, Random, 95% CI)	0.64 [0.32, 1.30]

7 Proportion of patients with active bleeding Show forest plot	4	1332	Odds Ratio (M‐H, Fixed, 95% CI)	0.74 [0.54, 1.02]

8 Endoscopic haemostatic therapy at index endoscopy Show forest plot	3	1983	Odds Ratio (M‐H, Fixed, 95% CI)	0.68 [0.50, 0.93]

Comparison 1. Main analysis

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Comparison 2. Analysis according to degree of allocation concealment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality Show forest plot	6	2223	Odds Ratio (M‐H, Fixed, 95% CI)	1.12 [0.75, 1.68]

1.1 Degree of allocation concealment: A	1	631	Odds Ratio (M‐H, Fixed, 95% CI)	1.16 [0.41, 3.23]
1.2 Degree of allocation concealment: non‐A	5	1592	Odds Ratio (M‐H, Fixed, 95% CI)	1.12 [0.72, 1.73]
2 Rebleeding within 30 days Show forest plot	5	2121	Odds Ratio (M‐H, Fixed, 95% CI)	0.81 [0.62, 1.06]

2.1 Degree of concealment: A	1	631	Odds Ratio (M‐H, Fixed, 95% CI)	1.40 [0.56, 3.53]
2.2 Degree of concealment : non‐A	4	1490	Odds Ratio (M‐H, Fixed, 95% CI)	0.77 [0.58, 1.02]
3 Surgery for continued or recurrent bleeding within 30 days of randomisation Show forest plot	5	2165	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.65, 1.25]

3.1 Degree of concealment: A	1	631	Odds Ratio (M‐H, Fixed, 95% CI)	0.67 [0.19, 2.39]
3.2 Degree of concealment: non‐A	4	1534	Odds Ratio (M‐H, Fixed, 95% CI)	0.92 [0.66, 1.29]

Comparison 2. Analysis according to degree of allocation concealment

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Comparison 3. Analysis according to control treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality Show forest plot	6	2223	Odds Ratio (M‐H, Fixed, 95% CI)	1.12 [0.75, 1.68]

1.1 PPI versus placebo	3	1983	Odds Ratio (M‐H, Fixed, 95% CI)	1.19 [0.78, 1.81]
1.2 PPI versus H2RA	2	160	Odds Ratio (M‐H, Fixed, 95% CI)	0.66 [0.18, 2.44]
1.3 PPI versus No Treatment	1	80	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Rebleeding within 30 days Show forest plot	5	2121	Odds Ratio (M‐H, Fixed, 95% CI)	0.81 [0.62, 1.06]

2.1 PPI versus placebo	3	1983	Odds Ratio (M‐H, Fixed, 95% CI)	0.87 [0.66, 1.16]
2.2 PPI versus H2RA	1	58	Odds Ratio (M‐H, Fixed, 95% CI)	0.56 [0.14, 2.26]
2.3 PPI versus No Treatment	1	80	Odds Ratio (M‐H, Fixed, 95% CI)	0.39 [0.14, 1.12]
3 Surgery for continued or recurrent bleeding within 30 days of randomisation Show forest plot	5	2165	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.65, 1.25]

3.1 PPI versus placebo	3	1983	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.64, 1.27]
3.2 PPI versus H2RA	1	102	Odds Ratio (M‐H, Fixed, 95% CI)	1.53 [0.45, 5.18]
3.3 PPI versus No Treatment	1	80	Odds Ratio (M‐H, Fixed, 95% CI)	0.37 [0.07, 2.02]

Comparison 3. Analysis according to control treatment

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Comparison 4. Analysis according to route of PPI administration

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality Show forest plot	6		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Oral PPI	1	205	Odds Ratio (M‐H, Fixed, 95% CI)	0.39 [0.07, 2.07]
1.2 Intravenous PPI	5	2018	Odds Ratio (M‐H, Fixed, 95% CI)	1.21 [0.80, 1.84]
2 Rebleeding within 30 days Show forest plot	5	2121	Odds Ratio (M‐H, Fixed, 95% CI)	0.81 [0.62, 1.06]

2.1 Oral PPI	1	205	Odds Ratio (M‐H, Fixed, 95% CI)	1.01 [0.40, 2.54]
2.2 Intravenous PPI	4	1916	Odds Ratio (M‐H, Fixed, 95% CI)	0.79 [0.60, 1.05]
3 Surgery for continued or recurrent bleeding within 30 days of randomisation Show forest plot	5	2165	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.65, 1.25]

3.1 Oral PPI	1	205	Odds Ratio (M‐H, Fixed, 95% CI)	0.49 [0.12, 2.01]
3.2 Intravenous PPI	4	1960	Odds Ratio (M‐H, Fixed, 95% CI)	0.93 [0.67, 1.30]

Comparison 4. Analysis according to route of PPI administration

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Comparison 5. Analysis according to the PPI used

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality Show forest plot	6	2223	Odds Ratio (M‐H, Fixed, 95% CI)	1.12 [0.75, 1.68]

1.1 IV Omeprazole	4	1938	Odds Ratio (M‐H, Fixed, 95% CI)	1.21 [0.80, 1.84]
1.2 IV Pantoprazole	1	80	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.3 Oral Lansoprazole	1	205	Odds Ratio (M‐H, Fixed, 95% CI)	0.39 [0.07, 2.07]
2 Rebleeding within 30 days Show forest plot	5	2121	Odds Ratio (M‐H, Fixed, 95% CI)	0.81 [0.62, 1.06]

2.1 IV Omeprazole	3	1836	Odds Ratio (M‐H, Fixed, 95% CI)	0.84 [0.63, 1.13]
2.2 IV Pantoprazole	1	80	Odds Ratio (M‐H, Fixed, 95% CI)	0.39 [0.14, 1.12]
2.3 Oral Lansoprazole	1	205	Odds Ratio (M‐H, Fixed, 95% CI)	1.01 [0.40, 2.54]
3 Surgery for continued or recurrent bleeding within 30 days of randomisation Show forest plot	5	2165	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.65, 1.25]

3.1 IV Omeprazole	3	1880	Odds Ratio (M‐H, Fixed, 95% CI)	0.97 [0.69, 1.37]
3.2 IV Pantoprazole	1	80	Odds Ratio (M‐H, Fixed, 95% CI)	0.37 [0.07, 2.02]
3.3 Oral Lansoprazole	1	205	Odds Ratio (M‐H, Fixed, 95% CI)	0.49 [0.12, 2.01]

Comparison 5. Analysis according to the PPI used

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Comparison 6. Analysis according to report of endoscopic haemostatic treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality Show forest plot	6	2223	Odds Ratio (M‐H, Fixed, 95% CI)	1.12 [0.75, 1.68]

1.1 Report of using Endoscopic Haemostatic treatment	3	1983	Odds Ratio (M‐H, Fixed, 95% CI)	1.19 [0.78, 1.81]
1.2 No report of using endoscopic haemostatic treatment	3	240	Odds Ratio (M‐H, Fixed, 95% CI)	0.66 [0.18, 2.44]
2 Rebleeding Show forest plot	5	2121	Odds Ratio (M‐H, Fixed, 95% CI)	0.81 [0.62, 1.06]

2.1 Report of using Endoscopic haemostatic treatment	3	1983	Odds Ratio (M‐H, Fixed, 95% CI)	0.87 [0.66, 1.16]
2.2 No report of using endoscopic haemostatic treatment	2	138	Odds Ratio (M‐H, Fixed, 95% CI)	0.45 [0.20, 1.03]
3 Surgery Show forest plot	5	2165	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.65, 1.25]

3.1 Report of using endoscopic haemostatic treatment	3	1983	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.64, 1.27]
3.2 No report of using endoscopic haemostatic treatment	2	182	Odds Ratio (M‐H, Fixed, 95% CI)	0.91 [0.35, 2.36]

Comparison 6. Analysis according to report of endoscopic haemostatic treatment

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Comparison 7. Analysis restricted to peptic ulcer patients

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality Show forest plot	2	580	Odds Ratio (M‐H, Fixed, 95% CI)	1.59 [0.85, 2.97]

2 Rebleeding Show forest plot	2	880	Odds Ratio (M‐H, Fixed, 95% CI)	0.86 [0.59, 1.26]

3 Surgery Show forest plot	2	880	Odds Ratio (M‐H, Fixed, 95% CI)	0.91 [0.59, 1.40]

Comparison 7. Analysis restricted to peptic ulcer patients

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