Background
Methods
Literature search
Inclusion and exclusion criteria
Outcome measures
Study characteristics
Control mortality rate (CMR)
Quality assessment for selected trials and data extraction
Statistical analysis
Results
Trial selection and features (Figure 1 and Additional file 1: Table S1)
Author | Year | Allocation | Concealment | Blinding | Outcome data addressed | Selective outcome reporting | Other bias | ITT analysis |
---|---|---|---|---|---|---|---|---|
Skyring A [27] | 1965 | no | yes | yes | no | no | no | no |
Ryall RJ [28] | 1966 | no | no | no | no | no | no | no |
Trapnell JE [29] | 1967 | no | yes | yes | no | no | no | no |
Bachrach WH [31] | 1968 | no | yes | yes | no | no | no | no |
Möller C [32] | 1969 | no | no | no | no | no | no | no |
Baden H [33] | 1969 | no | yes | yes | no | no | no | no |
Trapnell JE [34] | 1974 | no | yes | yes | no | no | no | no |
MRC Multicenter Trial [35] | 1977 | no | yes | yes | no | no | no | no |
Gauthier A [36] | 1978 | no | yes | yes | no | yes | no | no |
Imrie CW [37] | 1978 | no | yes | yes | no | no | no | no |
MRC Multicenter Trial [41] | 1980 | no | yes | yes | no | yes | no | no |
Freise J [42] | 1986 | no | yes | yes | no | no | no | no |
Yang CY [43] | 1987 | no | no | no | no | no | no | no |
Goebell H [44] | 1988 | no | yes | yes | yes | no | no | no |
Valderrama R [46] | 1992 | yes | yes | yes | yes | no | no | no |
Büchler M [47] | 1993 | yes | yes | yes | yes | yes | no | yes |
Chen HM [49] | 2000 | no | no | no | no | yes | no | no |
Quality assessment (Additional file 1: Table S1 and Table 2)
Outcomes | No. of studies | Pooled risk difference | NNT | Heterogeneity | Statistical method by effect model | Quality of a body of evidence | ||||
---|---|---|---|---|---|---|---|---|---|---|
Value | 95%CI | Value | 95%CI | I2value(%) | ||||||
Lower | Upper | NNTB | NNTH | |||||||
Death | 17 | -0.02 | -0.05 | 0.01 | 74.8 | NNTH 62.4 to ∞ to NNTB 23.4 | 0 | M-H | low | |
High quality studies | 6 | -0.02 | -0.06 | 0.02 | 624.6 | NNTH 24.6 to ∞ to NNTB 26.7 | 34.1 | M-H | ||
Aprotinin | 11 | -0.01 | -0.05 | 0.02 | 89.3 | NNTH 38.8 to ∞ to NNTB 20.8 | 0 | M-H | ||
Gabexate mesilate | 6 | -0.02 | -0.07 | 0.03 | 54.3 | NNTH 33.3 to ∞ to NNTB 14.9 | 31.1 | M-H | ||
Daily dosage >900 mg of GM | 5 | -0.02 | -0.09 | 0.04 | 55.2 | NNTH 8.3 to ∞ to NNTB 14.C | 47.0 | M-H | ||
Daily dosage >1500 mg of GM | 2 | -0.09 | -0.33 | 0.15 | 33.6 | NNTH 17.8 to ∞ to NNTB 8.6 | 79.0 | D-L | ||
Mild pancreatitis | 7 | 0.00 | -0.03 | 0.04 | 177.5 | NNTH 24.5 to ∞ to NNTB 33.9 | 0 | M-H | ||
Moderate to severe pancreatitis | 10 | -0.03 | -0.07 | 0.01 | 1604 | NNTH 23.0 to ∞ to NNTB 23.7 | 19.7 | M-H | ||
Severe pancreatitis | 2 | -0.19 | -031 | -0.08 | 5.2 | 3.2 to 12.7 | 0 | M-H | ||
With sponsor | 9 | -0.02 | -0.06 | 0.02 | 67.0 | NNTH 43.0 to ∞ to NNTB 18.8 | 15.0 | M-H | ||
Without sponsor | 8 | -0.02 | -0.06 | 0.03 | 68.4 | NNTH 31.9 to ∞ to NNTB 16.5 | 0 | M-H | ||
Abdominal pain | 2 | -0.26 | -0.40 | -0.13 | 3.9 | 2.5 to 9.6 | 85.0 | D-L | very low | |
High quality study | 1 | -0.14 | -0.32 | 0.03 | 6.9 | NNTH 30.1 to ∞ to NNTB 3.1 | Uncalculatable | M-H | ||
Pseudocyst formation | 5 | -0.00 | -0.05 | 0.03 | 298.6 | NNTH 27.3 to ∞ to NNTB 23.1 | 0 | M-H | low | |
Intra-abdominal abscess formation | 4 | -0.01 | -0.04 | 0.02 | 113.2 | NNTH 65.3 to ∞ to NNTB 30.3 | 0 | M-H | low | |
Surgical intervention | 3 | -0.08 | -0.17 | -0.00 | 11.8 | 6.0 to 443.8 | 60.5 | D0L | very low | |
High quality study | 1 | 0.00 | -0.10 | 0.11 | 225.8 | NNTH 8.9 to ∞ to NNTB 9.7 | Uncalculatable | M-H | ||
Bowel obstruction | 3 | -0.06 | -0.12 | -0.00 | 6.3 | 4.0 to 14.5 | 58.8 | D-L | very low | |
High quality study | 1 | -0.03 | -0.08 | 0.02 | 33.9 | NNTH 44.2 to ∞ to NNTB 12.3 | Uncalculatable | M-H | ||
Any major complications | 5 | -0.01 | -0.08 | 0.06 | 76.4 | NNTH 15.7 to ∞ to NNTB 11.1 | 0 | M-H | low |
Primary outcome: preventing death (Tables 1 and 3)
No | Subgroup | Trial (n) | Citations | Effectiveness | Heterogeneity |
---|---|---|---|---|---|
1 | High-quality | 6 | No significant | Moderate | |
2 | Aprotinin | 11 | No significant | Low | |
3 | Gabexate mesilate | 6 | No significant | Low to moderate | |
4 | Gabexate mesilate daily administrated dosage>900mg | 5 | No significant | Low to moderate | |
5 | Gabexate mesilate daily administrated dosage>1500mg | 2 | No significant | Low to moderate | |
6 | Trials with CMR≦0.10 | 7 | No significant | Low to moderate | |
7 | Trials with CMR>0.10 | 10 | No significant | Low to moderate | |
8 | Trials with CMR>0.20 | 2 | No significant | Low to moderate | |
9 | Trials with industrial support | 9 | No significant | Low to moderate | |
10 | Trials with industrial support | 8 | No significant | Low to moderate |
Secondary outcomes
Preventing abdominal pain
Preventing pseudocyst formation
Preventing intra-abdominal abscess formation
Preventing surgical intervention
Preventing bowel obstruction
Preventing major complications
Publication bias (Figure 4)
Sensitivity analysis for trial quality (Tables 4 and 5)
No. of studies | Pooled RD | 95% CI | |
---|---|---|---|
Overall | 17 | -0.02 | -0.05 to 0.01 |
Jadad score ≧1 | 14 | -0.02 | -0.05 to 0.01 |
Jadad score ≧2 | 12 | -0.01 | -0.04 to 0.02 |
Jadad score ≧3 | 6 | -0.02 | -0.06 to 0.02 |
No. of studies | Pooled RD | 95% CI | |
---|---|---|---|
Overall | 17 | -0.02 | -0.05 to 0.01 |
CMR ≧0.10 | 10 | -0.03 | -0.07 to 0.01 |
CMR ≧0.20 | 2 | -0.19 | -0.31 to -0.08 |